Patient interface textile seal with silicone layer

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 Art

[0002] 2 Background of the Technology 2.1 Field of the Technology The present technology relates to one or more of the diagnosis, treatment, prevention, and amelioration of respiratory-related diseases. The present technology also relates to medical devices or apparatuses and their use.

[0003] 2.2 Description of Related Technologies 2.2.1 The Human Respiratory System and Its Diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0004] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. When the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] A range of respiratory diseases exist. Certain diseases can be characterized by specific symptoms (e.g., apnea, hypopnea, and hyperventilation).

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

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by the onset of upper airway closure or obstruction during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue area, as well as the normal loss of the soft palate and posterior oropharyngeal wall during sleep. Due to such conditions, the breathing stops of affected patients typically last for 30 to 120 seconds, and sometimes the breathing stops 200 to 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular disease and brain damage. This syndrome is a common disease, especially common in middle-aged overweight men, but patients have no awareness of symptoms. See U.S. Patent 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, in which alternating cycles of increasing and decreasing ventilation, known as the CSR cycle, continue periodically. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CCR is accompanied by repeated sleep awakenings, which can cause severe insomnia, increased sympathetic nerve activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory insufficiency is a general term for respiratory disorders, referring to the inability of the lungs to perform sufficient oxygen inhalation or sufficient CO2 exhalation to meet the patient's needs. Respiratory insufficiency may include some or all of the following diseases.

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

[0011] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other clear causes of hypoventilation. Symptoms include dyspnea, headache upon waking, 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 an increase in resistance to air movement, prolongation of the expiratory phase of breathing, and a decrease in normal elasticity in the lungs. Examples of COPD are emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing a number of disorders and diseases that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Some NMD patients are characterized by progressive muscle impairment, which can result in inability to walk, confinement to a wheelchair, dysphagia, reduced respiratory muscle strength, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified into the following rapid - and slow - progressive types: (i) Rapid - progressive disorders: Characterized by muscle impairment that worsens over several 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 slow - progressive disorders: Characterized by muscle impairment that worsens over several years and only results in a slightly reduced life expectancy (e.g., limb - girdle, facioscapulohumeral, and myotonic muscular dystrophy). Respiratory failure symptoms in NMD include increased general weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, headache upon waking, and difficulty with concentration and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that cause ineffectiveness of the connection between the respiratory muscles and the thorax. These disorders are mainly characterized by restrictive disorders and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may develop severe respiratory failure. The symptoms of respiratory failure are listed below: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, headache on waking, fatigue, poor sleep quality, and loss of appetite.

[0015] To treat or improve such conditions, a range of treatments are used. Additionally, in other respects, healthy individuals can also advantageously utilize preventive treatment for respiratory diseases. However, there are multiple deficiencies in these.

[0016] 2.2.2 Treatment methods A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are used for the treatment of one or more of the above respiratory diseases.

[0017] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, continuous positive pressure ventilation therapy functions as an air splint, thereby preventing upper airway closure. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following regarding the device used for treatment provision, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, lack of aesthetic appeal.

[0018] Non-invasive ventilation (NIV) provides ventilatory assistance to a patient through the upper airway and performs part or all of the respiratory function to assist the patient's breathing and / or maintain an appropriate oxygen level in the body. The ventilatory assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0019] Invasive ventilation (IV) provides ventilatory assistance to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] 2.2.3 Treatment system These treatments can be provided by a treatment system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring without treating the disease.

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

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

[0023] 2.2.3.1 Patient interface A patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an airflow to an airway inlet. The airflow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby facilitating gas delivery at a sufficient distributed pressure together with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the atmospheric pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of gas supply to the airway at a positive pressure of about 10 cmH2O.

[0024] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of a mask for purely decorative purposes, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the surroundings.

[0025] Certain masks may be clinically unfavorable in the present technology (e.g., when the mask blocks airflow through the nose and only allows airflow through the mouth).

[0026] In certain masks, it may be uncomfortable or impractical in the present technology if the patient has to insert a part of the mask structure into the mouth and create and maintain a sealed state via the lips.

[0027] Certain masks may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on a pillow).

[0028] In the design of patient interfaces, there are multiple challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from individual to individual. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout a respiratory treatment.

[0029] Due to these challenges, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the following reasons: overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic mask, while tolerable for their original use, can be unacceptably uncomfortable for long-term (e.g., several hours) wear in such cases. Due to such discomfort, the patient's compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0030] CPAP treatment is extremely effective in the treatment of certain respiratory diseases when the patient is committed to the treatment. If the mask is uncomfortable or difficult to use, the patient may not commit to the treatment. Since patients are often recommended to clean the mask 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 can affect the patient's compliance.

[0031] Masks designed for the treatment of sleep apnea may be suitable for other uses in some cases, as masks for other uses (e.g., pilots) may be inappropriate for the treatment of sleep apnea.

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

[0033] 2.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Since the patient interface makes direct contact with the patient's face, the shape and configuration of the seal-forming structure can have a direct impact on the effectiveness and comfort of the patient interface.

[0034] The patient interface can be characterized in part according to the design intent of where the seal-forming structure engages the face during use. In one form of the patient interface, the seal-forming structure can include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed to rest, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming structure can include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces can be known by various names such as nasal masks, full face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0035] A seal-forming structure that may be effective in one region of the patient's face may be inappropriate in another region, for example, due to different shapes, structures, variabilities, and sensitive regions of the patient's face. For example, the sealing portion of a swimming goggle placed on the patient's forehead may be inappropriate for use on the patient's nose.

[0036] A particular seal-forming structure can be designed for mass production so that one design fits a wide range of different face shapes and sizes and is comfortable and effective. To form a seal, it is necessary to conform one or both of the patient's face shape and the seal-forming structure of the mass-produced patient interface to the extent of the mismatch between them. As a result, it can lead to patient discomfort.

[0037] A seal-forming structure may not fit another individual even if it fits one individual. Further, a design that fits a patient at one pressure or one position may be inappropriate at other pressures or other positions. In some designs, leakage can occur when the patient moves (e.g., while sleeping).

[0038] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when a force is applied to the patient interface with the seal-forming structure engaged against the patient's face. This seal-forming structure may include an air or fluid-filled cushion or may include a molded or formed surface of an elastomeric sealing element such as rubber. With this type of seal-forming structure, when the fit is inappropriate, a gap can occur between the seal-forming structure and the face, and additional force is 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 disposed around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the seal-forming portion of the type described above, when the alignment between the face and the mask is not good, additional force may be required to achieve a seal or leakage may occur from the mask. Further, when the shape of the seal-forming structure does not match the shape of the patient, creases or buckling may occur in the seal-forming portion during use, causing leakage.

[0040] Furthermore, in some manufacturing processes, even during use, undesirable creases, wrinkles or buckling occur in the seal-forming structure.

[0041] Another type of seal-forming structure may include a friction fit element that is inserted into the nostril, for example, but there are also patients who find these seal-forming parts uncomfortable.

[0042] Another form of seal-forming structure may use an adhesive part to achieve sealing. Among patients, there are also those who always feel it inconvenient to attach or remove the adhesive part to their face.

[0043] There is a disclosure regarding a technology for a range of patient interface seal-forming structures in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.

[0044] One form of nasal pillow can be found in the Adam circuit 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 Puritan-Bennett Corporation.

[0045] ResMed Limited manufactures the following products using nasal pillows: the SWIFT® Nasal Pillow Mask, the SWIFT® II Nasal Pillow Mask, the SWIFT® LT Nasal Pillow Mask, the SWIFT® FX Nasal Pillow Mask, and the MIRAGELIBERTY® Full Face Mask. The following patent applications assigned to ResMed Limited describe embodiments of nasal pillow masks: International Patent Application WO2004 / 073,778 (in particular, describes the appearance of ResMed Limited's SWIFT® nasal pillow), U.S. Patent Application No. 2009 / 0044808 (in particular, describes the appearance of ResMed Limited's SWIFT® LT nasal pillow); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (in particular, describe the appearance of ResMed Limited's MIRAGE LIBERTY® Full Face Mask); International Patent Application WO2009 / 052,560 (in particular, describes the appearance of ResMed Limited's SWIFT® FX nasal pillow).

[0046] 2.2.3.1.2 Positioning and Stabilization The seal-forming structure of a patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that interfere with the seal. Therefore, various techniques are used to position the seal-forming structure and maintain the seal against the appropriate part of the face.

[0047] In one technique, an adhesive part is used. See, for example, U.S. Patent Application Publication US2010 / 0000534. However, when using an adhesive part, there may be discomfort.

[0048] In another technique, one or more straps and / or stabilization harnesses are used. In the case of many such harnesses, one or more of the following points apply: poor fit, bulky, uncomfortable, and difficult to handle.

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

[0050] Air pressure generators are known in a wide range of applications (e.g., industrial scale ventilation systems). However, air pressure generators for medical use have specific requirements that are not satisfied by more general air pressure generators (e.g., reliability requirements, size requirements, and weight requirements for medical devices). In addition, even devices designed for medical treatment may be defective in relation to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

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

[0052] Table of noise output levels of conventional RPT devices (measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744 for only 1 sample). [Table 1]

[0053] One known RPT device used for the treatment of sleep apnea is the S9 Sleep Therapy System (manufacturer: ResMed Limited). Another example of an RPT device is a ventilator. In the case of a ventilator (e.g., the ResMed Stellar® series of adult and pediatric ventilators), it can provide assistance for invasive and non-invasive independent breathing for patients for a certain range for the treatment of multiple conditions (non-limiting examples include NMD, OHS, and COPD).

[0054] The ResMed AirSense ™ 150 ventilator and the ResMed V60 ™ ventilator can provide invasive and non-invasive assisted dependent breathing suitable for adult or pediatric patients for the treatment of multiple conditions. With these ventilators, volume ventilation mode and pressure ventilation mode using single or double limb circuits can be obtained. The RPT device typically includes a pressure generator (e.g., an electric blower or a compressed gas reservoir) and is configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway with positive pressure. The outlet of the RPT device is connected to the patient interface as described above via an air circuit.

[0055] Numerous options can be presented to the device designer. Since design criteria often conflict with each other, certain design options may be far from convention or unavoidable. Additionally, the comfort and effectiveness of a particular aspect can also be significantly affected by minor changes in one or more parameters.

[0056] 2.2.3.3 Humidifier If the delivery of the air flow is carried out without humidification, it can lead to drying of the airway. When a humidifier is used together with the RPT device and the patient interface, humidified gas is generated, so the drying of the nasal mucosa is minimized and the comfort of the patient airway is increased. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort compared to cold air.

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

[0058] Medical humidifiers are typically used to increase the humidity and / or temperature of an air flow relative to the ambient air when a patient is asleep or at rest (e.g., in a hospital), if necessary. A medical humidifier placed near a patient's head may be small. A medical humidifier may be configured to only humidify and / or heat the air flow delivered to the patient and not humidify and / or heat the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can humidify the air that is inhaled into the patient's body through breathing, but in the case of these systems, since they also humidify and / or heat the entire room, it can be uncomfortable for the occupants. Further, in the case of medical humidifiers, there may be more stringent safety restrictions than for industrial humidifiers.

[0059] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more defects. That is, in the case of such medical humidifiers, some may have inappropriate humidification, while others may be difficult or inconvenient for patients to use.

[0060] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is following one or more "compliance rules" with their RPT device). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient needs to use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's 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 the usage rate over a given period, and compare this to the compliance rule. When a healthcare provider determines that a patient has used their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0061] In the treatment of patients, there may be other ways to benefit from the communication of treatment data to third parties or external systems.

[0062] In the case of existing processes for communicating and managing such data, one or more of high cost, time consumption, and high error occurrence may occur.

[0063] 2.2.3.5 Ventilation technology Some forms of treatment systems may include a ventilation part for pushing out the exhaled carbon dioxide. This ventilation part may enable the gas flow from the internal space of the patient interface (for example, the plenum chamber) to the outside of the patient interface (for example, the surroundings).

[0064] This ventilation part may include an orifice, and when using a mask, the gas can flow through the orifice. In the case of a large number of such ventilation parts, the sound is noisy. In other cases, it may be blocked during use, resulting in insufficient extrusion. In the case of some ventilation parts, for example, due to sound or airflow concentration, it may interfere with the sleep of patient 1000 and co-sleeper 1100.

[0065] ResMed Limited has developed a plurality of improved mask ventilation technologies. See the following: International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; US Patent No. 6,581,594; US Patent Application Publication No. US2009 / 0050156; US Patent Application Publication No. 2009 / 0044808.

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

Table 2

[0067] (*Measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample)

[0068] List the sound pressure values of various objects as follows

Table 3

[0069] 2.2.4 Screening, diagnosis, and monitoring systems A polysomnogram (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary diseases and typically requires specialized clinical staff for system application in many cases. In PSG, typically 15 to 20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyography (EMG)). For PSG of sleep disordered breathing, patients had to be observed in a specialized hospital for two nights. That is, the first night was for pure diagnosis, and the second night was necessary for titration of treatment parameters by a clinician. Therefore, PSG is costly and has low convenience. Screening / diagnosis / monitoring of sleep disordered breathing is particularly unsuitable at home.

[0070] Clinical experts can appropriately diagnose or monitor patients based on visual observation of PSG signals. However, there are situations where there is no clinical expert or payment to a clinical expert is not possible. Opinions of clinical experts may differ regarding the patient's condition. Furthermore, some clinical experts may apply different criteria depending on the time.

Summary of the Invention

Means for Solving the Problems

[0071] 3 Brief Description of the Technology The present technology relates to the provision of medical devices used in the diagnosis, improvement, treatment, or prevention of respiratory diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0072] The first aspect of the present technology relates to an apparatus used for the diagnosis, improvement, treatment, or prevention of respiratory diseases.

[0073] Another aspect of the present technology relates to a method used in the diagnosis, improvement, treatment, or prevention of respiratory disorders.

[0074] One aspect of a particular form of the present technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0075] Another aspect of the present technology relates to a seal-forming structure of 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 of a patient interface using a flat woven composite for the production of a curved-shaped 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, and the seal-forming structure being free (or having few) of buckling or wrinkles.

[0079] Another aspect of the present technology relates to a patient interface including a woven membrane containing a knitted fabric material.

[0080] One form of the knitted fabric material is warp knitting.

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

[0082] In one form, the woven membrane is stretchable (e.g., evenly stretchable) in both the vertical and horizontal directions.

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

[0084] Another aspect of the technology relates to a patient interface with a wide range of wear.

[0085] Another aspect of the technology relates to a seal-forming structure of a patient interface, the seal-forming structure including a sealing portion (e.g., including a textile material) that is held taut prior to use.

[0086] Another aspect of the technology relates to a seal-forming structure of a patient interface, the seal-forming structure including a textile membrane to which no tension is applied and that has no wrinkles, creases, dimples, or buckles on its outer surface.

[0087] Another aspect of the technology relates to a seal-forming structure of a patient interface. The seal-forming structure includes a textile membrane having a bridge portion that relaxes and / or buckles with excess material.

[0088] Another aspect of the technology relates to a cushion assembly that interfaces with a patient's airway, including at least the patient's nostrils. The cushion assembly is configured to maintain a therapeutic pressure higher than the ambient air pressure during the patient's entire breathing cycle during sleep so as to improve sleep disordered breathing. The cushion assembly can include: 1) a plenum chamber that at least partially forms a cavity that can be pressurized up to a therapeutic pressure of at least 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an airflow at the therapeutic pressure for the patient's breathing; and 2) a seal-forming structure having a textile membrane constructed and arranged to form a pressure assist seal against a region of the patient's face that surrounds an inlet to the patient's airway below the nasal bridge region of the patient's face, the textile membrane having holes formed therein such that the airflow at the therapeutic pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity during the patient's entire breathing cycle during use.

[0089] In an example: (a) the fabric film includes a fabric material adapted to contact the patient's face and an air-impermeable silicone layer added thereto, and the fabric material includes 1) nylon and / or polyester and 2) elastane; (b) the count of nylon and / or polyester is in the range of 20 to 80 denier; (c) the fabric film is stretchable in both the fabric direction and the path direction.

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

[0091] In a further example: (a) the fabric material is an elastic weft knitting; (b) the fabric material includes nylon, polyester or a nylon / polyester composite; (c) the fabric material includes 1) 75% to 85% of nylon, polyester, or a nylon / polyester composite, and 2) 15% to 25% of elastane; (d) the thickness of the fabric material is in the range of 0.18 mm to 0.32 mm; (e) the machine gauge of the fabric material is in the range of 30 GG to 60 GG; (f) the fabric weight of the fabric material is in the range of 105 gsm to 160 gsm; (g) the fabric film has the same or similar surface friction in both the fabric direction and the path direction of the fabric material; (h) the fabric 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 fabric material has a mélange aesthetic; (k) the fabric material has a solid color aesthetic.

[0092] Another aspect of the technology relates to a patient interface for delivering an air flow in a sealed manner to an inlet to a patient's airway that includes at least the patient's nostril inlets at a positive pressure relative to the ambient air pressure continuously. The patient interface may include: 1) a cushion assembly as described in any of the above aspects; and 2) a positioning and stabilization structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a strap, the strap being constructed and arranged such that at least a portion thereof is placed in a region of the patient's head above the upper ear base points of the patient's head during use.

[0093] In an example: (a) the patient interface further includes a ventilation structure that allows the gas exhaled by the patient to flow continuously from the inside of the cavity to the surroundings, the ventilation structure being sized and shaped to maintain the therapeutic pressure within the cavity during use; (b) a plenum chamber and a seal-forming structure form an oronasal cushion assembly or a nasal cushion.

[0094] Another aspect of the technology relates to a method of forming a cushion assembly for a patient interface. The cushion assembly is configured to interface with a patient's airway that includes at least the patient's nostrils. The cushion assembly is configured to maintain a therapeutic pressure higher than the ambient air pressure during the entire patient breathing cycle during the patient's sleep and during use, such that sleep disordered breathing is improved. The method includes: 1) providing a textile material having a first side and a second side, the first side of the textile material being configured to promote delivery of an air flow at the therapeutic pressure to the patient's airway by contacting the patient's face during use; and 2) forming a textile membrane configured to form a pressure assist seal against a region of the patient's face surrounding an inlet to the patient's airway below the nasal bridge region of the patient's face by adding an air-impermeable silicone layer to the textile material, the textile membrane having holes formed therein, whereby the air flow at the therapeutic pressure is delivered to at least the inlet to the patient's nostrils.

[0095] In an example: (a) the textile material includes 1) nylon and / or polyester and 2) elastane; (b) the count of nylon and / or polyester is in the range of 20 to 80 denier; (c) the textile film has stretchability in both the weaving direction and the path direction.

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

[0097] Another aspect of the present technology relates to a patient interface for delivering an air flow in a sealed manner to an inlet to a patient's airway including at least the patient's nostril inlet at a positive pressure continuously with respect to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's breathing cycle during the patient's sleep so that sleep disordered breathing is improved, and the patient interface includes: 1) a plenum chamber at least partially forming a cavity pressurizable to at least a therapeutic pressure of 6 cmH2O above the ambient air pressure, the plenum chamber being adapted to receive the air flow at the therapeutic pressure for the patient's breathing, the plenum chamber; and 2) a seal forming structure having a textile film constructed and arranged to form a pressure assist seal against a region of the patient's face surrounding the inlet to the patient's airway, the textile film having holes formed therein such that the air flow at the therapeutic pressure is delivered to at least the inlet to the patient's nostrils, the seal forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's breathing cycle during use.

[0098] In an embodiment, (a) the seal-forming structure includes a support structure for supporting the fabric membrane, and the support structure is configured to connect to a plenum chamber; (b) the fabric membrane is attached to the support structure along the outer periphery of the fabric membrane in such a manner that the fabric membrane is taut before use.

[0099] Another aspect of the present technology relates to a patient interface for delivering an air flow in a sealed manner to an inlet to a patient's airway, including at least the patient's nostril inlets, at a continuously positive pressure relative to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's respiratory cycle during the patient's sleep, so as to improve sleep disordered breathing. The patient interface includes: 1) a plenum chamber that at least partially forms a cavity that can be pressurized up to a therapeutic pressure of at least 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive the air flow at the therapeutic pressure for the patient's breathing, the plenum chamber; and 2) a seal-forming structure having a fabric membrane constructed and arranged to form a pressure assist seal against a region of the patient's face surrounding the inlet to the patient's airway, the fabric membrane having holes formed therein such that the air flow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use. The seal-forming structure may include a flexible support structure for supporting the fabric membrane, the support structure being connected to the plenum chamber and being more rigid than the fabric membrane. During use, the fabric membrane may be configured to be pressed against the patient's face so that the patient's nose is not received within the cavity. The fabric membrane may extend radially inwardly beyond the support structure by being attached to the support structure along the outer periphery of the fabric membrane.

[0100] In an embodiment, (a) the plenum chamber and the support structure include silicone and form a one-piece structure having a first lateral support portion of a first thickness and a nasal base section of a second thickness less than the first thickness disposed at a second center, and the nasal base section is configured to be bent or form a pivot point when the fabric membrane engages the patient's face, whereby the right and left lateral portions of the support structure deform inwardly to cradle the patient's nose; (b) the support structure includes a base cushion; (c) the support structure includes a foam; (d) the support structure includes silicone and the fabric membrane is formed to the inner edge of the support structure; (e) the fabric membrane has a dome shape in the corner regions of the fabric membrane; (f) the fabric membrane has a saddle shape in the lower central region of the fabric membrane configured to seal under the patient's nose during use.

[0101] In a further embodiment, (a) the fabric membrane includes a fabric material to which a membrane layer is added to make the fabric material substantially air-impermeable; (b) the thickness of the fabric 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 fabric material is weft-knitted; (e) the weight of the fabric material is in the range of 105 gsm to 120 gsm; (f) the machine gauge of the fabric material is in the range of 44 GG to 60 GG; (g) the fabric material has a mélange appearance; (h) the fabric material has a solid color appearance; (i) the membrane layer includes silicone; (j) the fabric material includes nylon, spandex, or polyester; (k) during use, the treatment pressure in the cavity biases the fabric membrane towards the patient's face; (l) the plenum chamber includes silicone and is formed integrally with the support structure.

[0102] In a further embodiment, (a) the patient interface is a positioning and stabilization structure that provides a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a strap, the strap being constructed and arranged such that at least a portion thereof is placed in a region of the patient's head above the suprameatal point of the patient's head when in use, and further including the positioning and stabilization structure; (b) the patient interface is a ventilation structure that allows the gas exhaled by the patient to continuously flow from inside the cavity to the surroundings, the ventilation structure being sized and shaped to maintain the therapeutic pressure within the cavity when in use, and further including the ventilation structure; (c) the plenum chamber and the seal-forming structure form a nose and mouth cushion assembly; (d) the plenum chamber and the seal-forming structure form a nose cushion.

[0103] Another aspect of the present technology relates to a patient interface for delivering an air flow in a sealed manner to an inlet to a patient's airway, including at least the patient's nostril inlets, at a positive pressure continuously with respect to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's breathing cycle during the patient's sleep, so as to improve sleep disordered breathing. The patient interface includes: 1) a plenum chamber at least partially forming a cavity pressurizable up to a therapeutic pressure of at least 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive the air flow at the therapeutic pressure for the patient's breathing, the plenum chamber; and 2) a seal-forming structure having a fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face surrounding the inlet to the patient's airway, the fabric membrane having at least one hole formed therein, whereby the air flow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's breathing cycle during use. The seal-forming structure may include a flexible support structure for supporting the fabric membrane, the support structure being more rigid than the fabric membrane, and the support structure being connected to the plenum chamber. At the transition site, the fabric membrane may extend radially inwardly beyond the support structure by being attached to the support structure along the outer edge of the fabric membrane and the inner edge of the support structure. At the transition site, both the support structure and the fabric membrane may extend in a direction from the front side of the seal-forming structure along a curved portion to the front patient-facing side of the seal-forming structure.

[0104] In an embodiment, (a) at the transition site, the support structure and the fabric membrane generally have the same radius of curvature; (b) the fabric membrane extends continuously along a curve from the transition site to the inner edge of the fabric membrane; (c) in use, the fabric membrane is configured to be pressed against the patient's face so that the patient's nose is not received into the cavity; (d) at least one hole of the fabric membrane includes two holes, and a bridge portion is disposed between the two holes of the fabric membrane; (e) the support structure includes silicone, and the fabric membrane is shaped to the inner edge of the support structure; (f) the seal-forming structure has a seamless transition along its outer surface from the support structure to the fabric membrane.

[0105] In a further embodiment, (a) the fabric membrane includes a fabric material, and a membrane layer is added thereto to make the fabric material substantially air-impermeable; (b) the thickness of the fabric membrane is in the range of 0.3 mm to 0.5 mm; (c) the fabric material is weft-knitted; (d) the membrane layer includes silicone; (e) the fabric material includes polyamide (e.g., nylon), spandex, or polyester; (f) in use, the treatment pressure in the cavity causes the fabric membrane to be directed towards the patient's face; (g) the plenum chamber and the seal-forming structure form an oronasal cushion assembly; (h) the plenum chamber and the seal-forming structure form a nasal cushion.

[0106] Another aspect of the present technology relates to a patient interface for delivering an air flow in a sealed manner to an inlet of a patient's airway including at least the patient's nostril inlet at a positive pressure continuously with respect to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's breathing cycle during the patient's sleep, so that sleep disordered breathing is improved. The patient interface includes: 1) a plenum chamber at least partially forming a cavity pressurizable up to a therapeutic pressure of at least 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the therapeutic pressure for the patient's breathing, a plenum chamber; and 2) a seal forming structure having a fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face surrounding the inlet to the patient's airway, the fabric membrane having at least one hole formed therein, whereby an air flow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, and the seal forming structure is constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's breathing cycle during use. The fabric membrane may include a fabric material, to which a membrane layer is added to make the fabric material substantially air impermeable, and the fabric material may be a weft knitted fabric. The seal forming structure may include a flexible support structure for supporting the fabric membrane, the support structure may be connected to the plenum chamber, and the support structure may be more rigid than the fabric membrane. The fabric membrane may extend radially inwardly beyond the support structure by being attached to the support structure along the outer periphery of the fabric membrane. During use, the fabric membrane may be configured to be pressed against the patient's face so that the patient's nose is not received within the cavity. The fabric membrane may have a dome shape in a corner region of the fabric membrane configured to seal the lowest point region of the patient's nasal wing, and may have a saddle shape in a lower central region of the fabric membrane configured to seal under the patient's nose.

[0107] In an embodiment, (a) during use, the treatment pressure within the cavity urges the fabric membrane towards the patient's face, assisting the fabric membrane in forming a seal with the patient's face; (b) at least one aperture in the fabric membrane includes two apertures, with a bridge portion disposed between the two apertures in the fabric membrane. When the bridge portion buckles with excess material, the fabric membrane expands to accommodate noses of different sizes; (c) the support structure includes silicone, and the fabric membrane is shaped to the inner edge of the support structure; (d) the plenum chamber includes silicone and is formed integrally with the support structure; (e) the fabric membrane is attached to the support structure in such a manner that the fabric membrane is taut prior to use; (f) a first region of the fabric membrane is taut prior to use, and a second region of the fabric membrane has no tension applied prior to use.

[0108] In a further embodiment, (a) the fabric membrane has four-way elasticity; (b) the fabric membrane has a first elasticity in the left / right lateral direction and a second different elasticity in the up / down direction, and the elasticity in the first direction is higher than the elasticity in the second direction; (c) the membrane layer includes silicone; (d) the fabric material includes nylon, spandex, or polyester; (e) the plenum chamber and the seal-forming structure form an oral-nasal cushion assembly; (f) the plenum chamber and the 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. The cushion assembly is configured to deliver an airflow in a sealed manner to an inlet of a patient's airway, including at least the patient's nostril inlets, at a continuous positive pressure relative to the ambient air pressure, and the cushion assembly is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's breathing cycle during the patient's sleep, so as to improve sleep disordered breathing. The method includes the following: 1) forming an airtight fabric composite having a flat shape by adding an air-impermeable material to a fabric material; 2) cutting the fabric composite to a desired dimension according to the specific type of cushion assembly to be used; and 3) overmolding a flexible support structure onto the cut fabric composite to form a seal-forming structure having a fabric membrane, whereby the fabric membrane is attached to the support structure along the outer edge of the fabric membrane and the inner edge of the support structure. In the overmolding step, the fabric composite can be held in place by a vacuum, so that it has a non-flat shape during overmolding, whereby a curved non-flat shape is imparted to the fabric membrane. No small wrinkles, creases, folds and / or buckling are formed in the fabric membrane.

[0110] In an embodiment, (a) the seal-forming structure has a seamless transition along its outer surface from the support structure to the fabric membrane; (b) at the transition site, the fabric membrane is attached to the support structure along the outer edge of the fabric membrane and the inner edge of the support structure, so as to extend radially inwardly beyond the support structure, and at the transition site, both the support structure and the fabric membrane extend in a direction from the front side of the seal-forming structure to the front patient-facing side of the seal-forming structure along a curved portion; (c) two holes are formed in the fabric membrane, a bridge site is disposed between the two holes in the fabric membrane, and when the bridge site buckles with excessive material, the fabric membrane expands to accommodate noses of different sizes; (d) the support structure includes silicone.

[0111] Another aspect of the present technology relates to a seal-forming structure of a patient interface, the seal-forming structure including a support structure and a sealing portion, the support structure supporting the sealing portion, the sealing portion being attached to the support structure along the outer periphery of the sealing portion so as to extend radially inwardly beyond the support structure, and in use, the sealing portion being configured to be pressed against the patient's face so that the patient's nose is not received in the cavity, and the sealing portion being put in a taut state due to the reaction stress of the support structure and / or the elastic extensibility characteristics of the fabric, whereby the sealing portion applies a force to the patient's face.

[0112] According to a further aspect of the present technology, the sealing portion includes a fabric. In a further embodiment, the patient interface includes a plenum chamber, the support structure being configured to connect to the plenum chamber, the plenum chamber at least partially forming a cavity that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's breathing. 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 inlet to the patient's airway, the sealing portion having holes formed therein, whereby an air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the cavity throughout the patient's breathing cycle in use. In a further embodiment, the support structure includes silicone and / or a thermoplastic elastomer.

[0113] According to a further aspect of the present technology, the 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 of a patient interface, the seal-forming structure including a support structure and a sealing portion, the support structure supporting the sealing portion and being attached to the support structure along the outer periphery of the sealing portion in such a way that the sealing portion is taut prior to use.

[0115] According to a further aspect of the present technology, the sealing portion includes a textile material. In a further embodiment, the patient interface includes a plenum chamber, the support structure being configured to connect to the plenum chamber, the plenum chamber at least partially forming a cavity that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's breathing. 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 inlet to the patient's airway, the sealing portion having holes formed therein such that an air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the cavity throughout the patient's breathing cycle during use. In a further embodiment, the support structure includes silicone and / or a thermoplastic elastomer.

[0116] Another aspect of the present technology relates to a seal-forming structure of a patient interface. The seal-forming structure includes a support structure and a sealing portion, the sealing portion being supported by the support structure, the sealing portion including a textile material, the sealing portion being attached to the support structure along the outer periphery thereof, the support structure being more rigid than the sealing portion, and the support structure having a first member having a first thickness and a second member having a second thickness different from the first thickness.

[0117] According to a further aspect of the present technology, the support structure includes silicone and / or a thermoplastic elastomer, the patient interface includes a plenum chamber, the support structure is configured to connect to the plenum chamber, the plenum chamber at least partially forms a cavity that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, and the plenum chamber includes a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration. In a further embodiment, the sealing portion is constructed and arranged to form a seal against an area of the patient's face surrounding the entrance to the patient's airway, the sealing portion has a hole formed therein, whereby an air flow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the cavity throughout the patient's breathing cycle during use.

[0118] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed with a peripheral shape that is complementary to the shape of the intended wearer.

[0119] One aspect of one form of the present technology is a method of manufacturing the device.

[0120] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person with limited experience using this type of medical device.

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

[0122] Another aspect of the present technology relates to a treatment system for treating sleep disordered breathing. The system includes: 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 apparatuses can be implemented to improve functions in a processor (e.g., the functions of a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the described methods, systems, devices, and apparatuses enable improvements in the technical field of the automatic management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0124] Of course, some of the above aspects can form sub-aspects of the present technology. Also, various combinations of sub-aspects and / or any one of the aspects can be made, which can also constitute further aspects or sub-aspects of the present technology.

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

Brief Description of the Drawings

[0126] 4 Brief Description of the Drawings The present technology is illustrated as a non-limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements: 4.1 Treatment System

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Mode for Carrying Out the Invention

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

[0129] The following description is provided in relation to 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 can be combined with one or more features of another embodiment or other embodiments. Additionally, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0130] 5.1 Treatment Method In one form, the present technology includes a method for treating a respiratory disease. The method includes the step of applying a positive pressure to the entrance of the airway of patient 1000.

[0131] In a specific embodiment of the present technology, an air supply at positive pressure is provided to the nasal passage of the patient via one or both of the nostrils.

[0132] In a specific embodiment of the present technology, mouth breathing is restricted, limited, or prevented.

[0133] 5.2 Treatment System In one form, the technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device can include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000 (see, e.g., FIGS. 1A-1C).

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

[0135] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0136] A patient interface 3000 according to one form of the technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the ambient.

[0137] A patient interface 3000 according to one form of the technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the ambient.

[0138] A patient interface 3000 according to one form of the technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the ambient.

[0139] 5.3.1 Plenum Chamber The plenum chamber has an edge with a shape that is complementary to the surface contour of an average person's face in the area where a seal is formed during use. During use, the peripheral edge of the plenum chamber is positioned close to the adjacent surface of the face. The actual contact with the face is provided by a seal-forming structure. The seal-forming structure can extend around the entire perimeter of the plenum chamber during use. In some forms, the plenum chamber and the seal-forming structure are formed from a single homogeneous piece of material. In an example, the plenum chamber can be constructed from a flexible material (e.g., silicone) and formed as a one-piece structure with a support structure (e.g., any of the materials described herein as suitable for the support structure and / or the plenum chamber). In an example, the seal-forming structure can be an extension of the plenum chamber or formed as part of the plenum chamber such that the seal-forming structure is included in the plenum chamber. In such an example, the support structure and the fabric membrane can be considered part of the plenum chamber.

[0140] 5.3.2 Seal-Forming Structure In one form of the present technology, the seal-forming structure 3100 can provide a target seal-forming area and further provide a cushioning function. The target seal-forming area is the area where a seal can occur in the seal-forming structure 3100. The area where the seal actually occurs (i.e., the actual sealing surface) can vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement location of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

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

[0142] In a particular form of the present technology, the seal-forming structure 3100 is composed of a biocompatible material (e.g., liquid silicone rubber (LSR) (or "silicone")).

[0143] The seal-forming structure 3100 according to the present technology can be composed of a soft, flexible and resilient material (e.g., silicone).

[0144] In some forms, such as those shown in FIGS. 5 to 77, the seal-forming structure has a sealing portion that includes a textile material. The textile material can cover all or part of the seal-forming structure. In some forms, the textile can include a material formed by a fiber web and adapted to be impermeable to air. For example, the textile can have an air-impermeable film on at least one of its surfaces, thereby forming a textile film or a textile sealing portion.

[0145] In some forms, the textile film can be constructed to elastically stretch in at least one dimension. For example, if the textile film is constructed from a fiber web, the textile film can be capable of stretching in the longitudinal warp direction and / or the transverse weft direction across the textile film. In some forms, the textile film is constructed to elastically stretch beyond the range achievable by conventional silicone seal-forming structures.

[0146] In some forms, the textile film is constructed to be substantially inelastic in at least one dimension. For example, if the textile film is constructed from a textile material, the textile film can be capable of substantially withstanding elongation in one or both of the longitudinal warp direction or the transverse weft direction across the textile film.

[0147] The textile film can include a single layer or multiple layers. In forms where multiple layers are used, the individual layers can be formed using the same material or a variety of different materials each having unique material properties.

[0148] In some forms, the fabric membrane can include at least one layer that exhibits substantially air-impermeable properties while maintaining the material properties necessary to provide comfort to the patient and minimal pressure points. For example, as shown in FIG. 78, in some forms, the fabric membrane can include an air-impermeable material 10131 formed on the inner surface of the fabric material 10133. The air-impermeable material can be laminated onto the fabric material in some forms. In some forms, the air-impermeable material and the fabric material can be selected such that the resulting fabric membrane can exhibit a predetermined overall elasticity or elastic resistance as needed. For example, the addition of the air-impermeable material (or membrane layer) can provide elasticity (or stretchability) to the fabric material, thereby increasing the stretchability of the resulting fabric membrane.

[0149] In some forms, the membrane can exhibit a low spring constant (i.e., high adaptability) in both the warp and weft directions. In such forms, in contrast to conventional designs where distortion of the patient's face 1300 can occur due to the fixed cushion (for the formation of an effective seal), the fabric material and / or the resulting fabric membrane can have a material spring constant and spring length such that the fabric membrane is more compliant than the patient's skin that engages the fabric membrane. This can improve mask comfort and reduce the formation of "hot spots" of local pressure, which is advantageous.

[0150] In some forms, the surface of the fabric material that contacts the patient's face 1300 can have low friction properties. This can improve the surface texture comfort of the fabric membrane, reduce friction against the patient's face 1300, which is advantageous. The surface of the fabric material (e.g., herringbone) can have a first coefficient of friction in a first direction. The first coefficient of friction is different (e.g., higher or lower) from the coefficient of friction in a second direction. In contrast, for a fabric with higher friction, it can cause snagging or friction of the fabric membrane in the contact area of the patient's face during use. Such friction or snagging can cause distortion or deformation of the fabric membrane, which in turn can lead to a decrease in seal effectiveness and the possibility of undesirable air leakage from the device.

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

[0152] In certain forms of the technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate different size and / or shape ranges. For example, the system can include one form of seal-forming structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head.

[0153] Although specific illustrated examples or features of specific illustrated examples (e.g., seal-forming structure 3100) may be referred to herein (e.g., using reference numerals), it should be noted that 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 uses a pressure-assisted sealing mechanism. In use, the sealing flange can act on its underside in easy response to the system positive pressure within the plenum chamber 3200 to form a tight sealing engagement with the surface. The pressure-assisted mechanism can act in conjunction with the 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). This member extends around the edge length of the plenum chamber 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0156] In one form, a fabric membrane (e.g., one containing nylon, polyester, a mixture of nylon and polyester, microfiber, or polyurethane) is used as the face contact portion of the seal-forming structure 3100 for a CPAP mask. The fabric membrane can have properties such that it can be stretched in at least one dimension. The fabric membrane can be held under tension across the support structure before and / or during use. Before use, the fabric membrane may be permanently attached (e.g., formed) or, alternatively, attached to the support structure as a removable module (pre-tensioned and slightly stretched).

[0157] Alternatively, since the fabric can be formed into a complex three-dimensional predefined shape, no tension is applied (e.g., it is loose, relaxed and / or has no small wrinkles) before and / or during use, but there is substantially no leakage causing small wrinkles. Due to manufacturing, the fabric polymer can shrink, resulting in the loss of the inherent pre-tension in the fabric membrane, but the fabric membrane can remain substantially free of small wrinkles.

[0158] FIG. 79 shows an example in which a light tension is applied to the fabric film in both the X and Y directions through the fabric surface. Before the patient's face 1300 (e.g., nose) approaches and presses against the fabric film 3130, the fabric film is adapted to form a flat surface without obstructions (e.g., wrinkles, folds or creases) in the fabric 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 fabric film so that there is substantially no leakage that would cause creases in the fabric film. Doing so can be advantageous because the fabric film will reliably form a smooth and continuous seal around the patient's face 1300. As a result, improvement in respiratory pressure therapy may be possible by reducing the occurrence of folds or creases in the members of the seal-forming structure 3100 that could be sources of leakage of therapeutic air. Doing so can also be advantageous in that the fabric film is forced to face the patient's face 1300 (FIG. 80), ensuring that the fabric film is in a state below the minimum threshold tension.

[0159] In some forms, regions of the fabric membrane can be pre-tensioned and slightly stretched, while other regions of the fabric membrane can remain relaxed. For example, in some forms, the sub-nasal region can be pre-tensioned, while the regions outside the nose and / or surrounding the patient's mouth in a cup shape can be kept in a non-tensioned state (e.g., by excess material), so that a saddle-shaped region or valley shape is formed prior to use. This can be advantageous as it can improve seal efficiency while reducing pressure (i.e., "hot spots") on regions where the anthropometric elements of the face protrude into or over a longer distance into the cavity. In another example, the sides of the nasal region and / or the nasal bridge region can remain non-tensioned and / or relaxed prior to use when providing additional material to conform to the facial contour of these sensitive facial regions. In another example, a bridge site (e.g., bridge site 3104) extending between two nostril openings can be in a non-tensioned state, can relax and / or can buckle (e.g., by excess material as shown in, for example, FIG. 33-1 prior to use). The bridge site (e.g., 3104) with excess material can allow the fabric membrane to expand (e.g., in the up / down (height) direction) and be able to accommodate different sized noses.

[0160] In some forms, instead of providing pre-tensioned regions, the fabric membrane can be formed such that there is substantially no leakage that would cause wrinkles. Such a formation can be advantageous because it can be difficult to form a complex three-dimensional shape with substantially no leakage from a relaxed fabric membrane or from a fabric membrane containing material that has not had excessive tension applied. Using a fabric membrane with no applied tension can also result in less pressure on the patient's face, and thus increased comfort in some arrangements.

[0161] In some forms, the fabric membrane can be in a substantially tension-free state and can be formed on a support structure or directly on a plenum chamber (such that no tension is added and / or remains in a relaxed state). In an example, even in this case, such a fabric membrane can maintain a wrinkle-free state so as to avoid leakage in the seal with the patient's face. In some forms, a tension-free and / or wrinkle-free fabric membrane can utilize cushion support (e.g., a base cushion, a seal support region (e.g., a support structure) and / or the air pressure within a cavity) so as to be able to form an effective seal against the patient's face.

[0162] In some forms, a tensioned and / or wrinkle-free state of the fabric membrane (see FIGS. 80 and 81) can be maintained to maintain sealing contact with the patient's face 1300 by one or a combination of those described below: a) The pre-applied tensile stress of the fabric membrane and additional applied tensile stress upon engagement of the fabric membrane with the patient's face 1300; b) A pre-formed state of the fabric membrane that has no added tension and is formed as a substantially flat surface without leakage that would cause obstructions (e.g., wrinkles, creases, buckles or wrinkles) in the fabric membrane; c) The rigidity of the support structure and / or plenum chamber and the ability of the support structure and / or plenum chamber to respond and react to applied tensile stress (upon engagement of the patient's face 1300 with the fabric membrane); and d) The air pressure further applied from within the cavity to the inner surface of the fabric membrane. By the internal air pressure adding further tensile stress to the inner surface of the fabric membrane, the fabric membrane can be further stretched against the patient's face 1300 and the fabric membrane can be stressed against the patient's face 1300 (e.g., a pressure-assisted seal is created).

[0163] By continuously holding the fabric membrane under tensile stress and / or in a state without small wrinkles before and during use, the small wrinkles and / or ruptures of the seal formation structure can be minimized while the fabric membrane can be adapted to the profile of the patient's face. Thereby, in some forms, it may also be possible to improve the seal performance by maximizing the contact area of the fabric membrane on the patient's face 1300. Thereby, in some forms, it may also be possible to improve the performance (when receiving an impact by an external lateral force or a longitudinal force (e.g., tube drag force) of the CPAP device).

[0164] In some forms, when the plenum chamber is pulled away from the patient's face 1300 by a short distance, the addition of air pressure from within the plenum chamber can assist in maintaining an effective seal in the fabric membrane. The addition of air pressure may be sufficient to elastically stretch the fabric membrane in at least one dimension to form a "hovercraft"-like balloon effect on the anthropometric outer shape of the patient's face 1300, whereby an effective seal is maintained on the anthropometric outer shape of the patient's face 1300.

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

[0166] In some forms, the magnitude of the tensile stress can be varied across the seal formation structure fabric membrane as needed. For example, stress concentration regions can be present in the vicinity of one or more holes in the fabric membrane that serve as a passage for treatment application in a more stretched material.

[0167] In some forms, the seal-forming structure can use a plurality of different cushion configurations (e.g., a single air-assisted fabric membrane, a double air-assisted fabric membrane, a fabric membrane including a compression support portion, or a fabric membrane including a TPU / TPE / Si support portion). In some forms, the cushion configuration of the seal-forming structure can be formed so as to advantageously provide a "one-size-fits-most" solution.

[0168] In an example, the seal-forming structure and the plenum chamber can be applied to nasal cushions, nasal cradles, oro-nasal cushions, ultra-mini full-face masks, full-face masks, and other suitable cushion arrangement configurations.

[0169] In some forms, the fabric membrane can be configured to generate an effective seal over the tip of the patient's nose, as shown by way of example in FIG. 58. In some forms, since the fabric membrane can be configured to generate an effective seal against the subnasal site of the patient's nose, the fabric membrane does not engage the tip of the nose, as shown, for example, in FIG. 40.

[0170] In some forms, when the wrinkle-free state of the fabric membrane (to conform to the patient's face 1300) is stretched and / or maintained during use, stress can be applied to the wall portions of the support structure. Due to this stress, the wall portions of the support structure can be pulled inwardly towards each other during use. In some forms, the support structure can be adapted to withstand additional stress loads so as to avoid inward deformation. Thus, due to the rigidity of the support structure, additional stress can be applied to the fabric membrane, and as a result, the fabric membrane can elastically stretch during use.

[0171] In some forms, 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 dynamically support the fabric membrane using internal air pressure. Doing so may advantageously provide additional support to the fabric membrane under dynamic loads (e.g., tube drag). In other forms, the pleats, folds or gussets may use internal air pressure to decouple a dynamic load (e.g., tube drag) from the seal forming structure. In some forms, when a load is applied to the inner surface of the fabric membrane by the air pressure within the cavity, causing additional tensile stress to occur, the fabric membrane substantially fills the pressed outer shape of the patient's face 1300 (e.g., around both sides of the nose). In some forms, the elasticity of the fabric membrane is combined with the load of the internal air pressure to elastically stretch the fabric membrane, forming a larger seal contact area on the patient's face. Doing so may be advantageous in providing a continuous seal in some forms, even if the mask is partially displaced from an optimal interface with the patient's face. This is because the fabric membrane may partially expand due to the reaction force from the internal air pressure (i.e., the "hovercraft effect").

[0172] In some forms, such as those shown in FIGS. 35-37 and FIGS. 54-56, one or more grip pads 29150, 31150 can be placed on the fabric membrane. In one example, the grip pads 29150, 31150 can be configured such that either is substantially flat along the side of the fabric membrane facing the patient. In other examples, by embossing the grip pads 29150, 31150, beads or rims can be formed in the grip pads that protrude slightly above the surface of the fabric membrane. In some forms, the grip pads 29150, 31150 can have a high coefficient of friction. In some forms, the grip pads can have a predetermined shape (e.g., oval (see FIGS. 35, 37, 54, and 56), circular, square, etc.). In some forms, the grip pads can be elongate (see FIGS. 35 and 54). In some forms, the grip pads 29150, 31150 can be linear. In some forms, the grip pads can be arranged within a pattern across the surface of the seal-forming structure 3100. In some forms, the grip pads can be arranged to be scattered across the surface of the seal-forming structure 3100 (see FIGS. 37 and 56). In some forms, the grip pads can be arranged to form a perimeter adjacent to the periphery of the fabric membrane (see FIGS. 34, 35, 54, and 55). In some forms, the grip pads 29150, 31150 forming the perimeter can be in the form of a dotted line (see FIGS. 35 and 54). In some forms, the grip pads forming the perimeter can be in the form of a solid line (see FIGS. 36 and 55). In some forms, the grip pads forming the perimeter can be in the form of multiple lines (dotted or solid) or combinations thereof. In some forms, the grip pads can assist the fabric membrane in gripping the patient's face. In one example, the grip pads can be formed as a relatively thin silicone layer added to the surface of the fabric membrane.

[0173] In some forms, the fabric membrane can be integrated with the support structure by attaching (e.g., molding) the outer edge (e.g., the outer perimeter) of the fabric membrane around the lip (e.g., the inner edge) of the curved edge of the support structure. In one embodiment, the fabric membrane can be angled slightly inwardly towards the inside of the mask. In one example, the fabric membrane is attached to provide the 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-contact side of the seal-forming structure (see FIG. 11). In this way, it becomes possible to eliminate the portion that curves from the rear side to the front side from the fabric membrane. With this arrangement, the fabric membrane can be provided only along the front surface of the seal-forming structure as shown in FIGS. 11 to 17, for example. Such an arrangement can be advantageous because there is no need to fold or cut the fabric membrane to conform to the corners of the support structure. This is useful for reducing the occurrence of protruding folds or wrinkles (which can cause leakage) in the fabric membrane, thereby improving the seal performance.

[0174] In some forms, the fabric membrane can be attached to the outer edge of the fabric membrane such that the fabric membrane forms a portion of the seal-forming structure that curves from the front side of the seal-forming structure to the rear face-contact side (see, for example, FIGS. 33-1 to 33-4, 73, and 74). Thereby, more portions of the surface of the fabric membrane (opposite to the support structure) are provided for engagement with the patient's face, which can improve comfort. In one example, the attachment of the fabric membrane to the support structure is performed by a specific process (as will be described later) that can form a site that is curved without the occurrence of folds, wrinkles, creases, or buckling on the fabric membrane surface. As will be understood, in some examples, at the transition site 36, both the support structure and the fabric membrane can have a radius of curvature (e.g., the same or a similar radius of curvature) in the direction from the front side of the seal-forming structure to the rear side of the seal-forming structure along the curved portion 35 (see FIGS. 33-1 to 33-4). Since a pre-defined curvature can be imparted to the fabric membrane, a portion of the fabric membrane that is not directly supported by the support structure extends along the curved portion 35 (FIGS. 33-2 to 33-4). Thereby, the generation in a specific region (e.g., the lateral side portion 3250 and / or the corner region 3252) of the dome-shaped (e.g., convex dome) fabric membrane can be assisted, whereby, for example, as shown in FIG. 33-1, the seal of the fabric membrane against the outer shape of the patient's face (e.g., the lowest point region of the patient's nasal alae (i.e., the corner of the nasal region (i.e., the region where the wing terminates on the upper lip near the nasolabial groove))) can be assisted. The dome shape can assist in avoiding the formation of wrinkles, creases, folds, and buckling in the fabric membrane, so the occurrence of leakage paths can be assisted. Also, the dome shape can assist the fabric in reaching areas where it is difficult to seal the patient's face (e.g., the corners of the nasal region). Since the fabric membrane 29130 can have a saddle shape in the intermediate subnasal point region 3260 configured to seal the patient's subnasal point, it conforms to the saddle shape formed by the patient's nasolabial angle and upper lip as shown in FIG. 33-1. Similarly, the nasal tip point region 3270 can also have a saddle shape configured to seal the conforming profile shown at or below the patient's nasal tip point.The curvature (e.g., the magnitude of the curvature and / or the radius of curvature) in the direction of the curved portion 35 of the fabric membrane can vary in different regions of the cushion assembly along the outer periphery of the fabric membrane. For example, as shown in FIG. 33-2, the fabric membrane 29130 in the intermediate nose tip region 3270 can have a curvature in the direction of the curved portion 35 that is different from that of the fabric membrane in the intermediate subnasal region 3260. In the example of FIG. 33-2, the fabric membrane within the nose tip region 3270 can have a curvature (e.g., a negative curvature in the downward / upward direction along the curve 35) that is relatively larger (e.g., a smaller radius) than the curvature (e.g., a negative curvature in the downward / upward direction along the curve 35) in the intermediate subnasal region 3260. In one example, the curvature (e.g., the magnitude of the curvature and / or the radius of curvature) at the lateral side portion 3250 of the fabric membrane can be different from the curvature in the intermediate nose tip region 3270 and / or the intermediate subnasal region 3260. The nose portions of the cushion assemblies 14105, 30105, 31105 can have similar dome-shaped and saddle-shaped features, as shown, for example, in FIGS. 43, 52, and 61.

[0175] In the example of FIG. 73, the curvature of the fabric membrane 16230 from the connection with the support structure 16220 (e.g., at the transition site) can be continuous to the inner edge of the fabric membrane. For example, the fabric membrane can have a dome shape or a saddle shape at the inner edge of the fabric membrane in a particular region of the cushion.

[0176] In some forms, the fabric membrane can be angled slightly inward or curved (e.g., with a positive curvature in the left - right direction) as it approaches the interior of the mask, as shown for example in FIGS. 11 - 17, FIGS. 23 - 26, and FIGS. 33 - 37. In some forms, the fabric membrane can form a dome shape on the support structure, as shown for example in FIGS. 19 - 22 and FIGS. 43 - 50. Any of the cushion assemblies disclosed herein can have a fabric membrane attached to the outer edge of the fabric membrane, so that the fabric membrane forms part of the seal - forming structure and extends from the front side to the rear face - contact side of the seal - forming structure along the curved portion 35 as described above for FIG. 33 - 1. Note that, for example, the fabric membrane 6130 of the cushion assembly 6105 can have a greater portion of the dome shape due to a further convexity from one lateral side to the other lateral side.

[0177] In some forms where the fabric membrane is not under continuous tension (before and / or during use) or is inelastic, the fabric membrane can form an improved air - assisted seal on the patient's face. This improved air - assisted seal dynamically conforms to changes / movements (i.e., the "hovercraft" effect), for example, because the fabric membrane is thinner and has lower structural rigidity than a silicone membrane.

[0178] In some forms, the fabric membrane can be supported by a secondary or tertiary support structure that can function as a cushion support. The cushion support can provide additional flexibility and can be suitable for use with most patient faces (one - size fits most). The second or third support layer can be formed using a fabric membrane, a fabric containing a PU / Si membrane, a laminated open - cell foam, a laminated PU foam, a PU molding, a TPU / TPE, or silicone. In some forms, the additional support layer itself can be supported by a structural / hard plastic (e.g., PP / PC / PA / PET or other suitable material).

[0179] In some forms, 3D printing the fabric membrane and / or the cushion support section as a "skeleton" can reduce the thickness, which can result in a reduction in mask weight.

[0180] In some forms, multiple different layers of the mask layer can be printed with different rigidities, hardnesses or thicknesses. For example, the "skeleton" member can be formed using Si, PU foam, PU solid material or any suitable plastic material.

[0181] In some forms, pleats or creases can be formed along the cushion assembly (e.g., in the fabric membrane and / or the support structure), so that a dynamic force / support or decoupling region can be obtained.

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

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

[0184] In one form, the seal-forming structure includes a region having an adhesive surface or an adhesive face.

[0185] In certain forms of the present technology, the seal-forming structure can include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a site having an adhesive surface or an adhesive face.

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

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

[0188] 5.3.2.3 Upper Lip Region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the upper lip region (i.e., the upper lip) of the patient's face during use.

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

[0190] 5.3.2.4 Jaw Region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the jaw region of the patient's face during use.

[0191] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over the jaw region of the patient's face during use.

[0192] 5.3.2.5 Forehead Region In one form, the seal-forming structure forms a seal over the forehead region of the patient's face during seal use. In such a form, the plenum chamber may cover the eyes during use.

[0193] 5.3.2.6 Nasal Pillows In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is configured and arranged to form a seal with each 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 part of the frustum of the cone forms a seal on the lower side of the patient's nose, the stem portion, and a flexible region on the lower side of the frustum of the cone, connecting the frustum of the cone to the stem portion. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem portion. The flexible region may function to facilitate a freely jointed structure. The freely jointed structure corresponds to the mutual movement between both the displacement and the angle of the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stem portion is connected.

[0195] 5.3.3 Nasal Cushion Referring to FIGS. 5-14, patient interfaces 3000, 6000 having a cushion assembly 3105 including a seal forming structure 3100 and a plenum chamber 3200 are 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. Referring to FIGS. 28-32, a cushion assembly 8105 including a seal forming structure 8100 and a plenum chamber 3200 is shown in accordance with a fifth embodiment of the present technology. FIG. 3 shows a patient interface 9000 having a cushion assembly 9105 including seal forming structures 9100 and 9200 according to a sixth embodiment of the present technology.

[0196] It should be understood that FIGS. 11-14 include dashed lines that define the boundaries of regions of different thicknesses, all of which are nominal boundaries 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 regarded as nasal cradle cushions and are intended to provide a pressurized gas flow to the patient's nostrils by sealing at least the lower side of the patient's nose. The exemplary 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 tip of the nose depending on the size and shape of the patient's nose. The exemplary seal-forming structures may also engage the patient's face at least above the upper lip. Therefore, the exemplary seal-forming structures may seal the patient's upper lip during use. Further, since the patient's mouth remains exposed by the seal-forming structures of the illustrated examples, the patient may be able to breathe freely (i.e., directly into the atmosphere) without interference from the seal-forming structures. The nasal cradle below the nose may be configured not to have an aperture sized to receive the patient's nose within the cavity. Further, the height of the cushion from the lower edge of the fabric membrane in the middle subnasal point region to the upper edge of the fabric membrane in the middle nasal tip point region may be less than the width of the cushion in the left-right direction from one lateral edge of the fabric membrane to the other lateral edge of the fabric membrane (see FIGS. 33 and 33-1).

[0198] Examples of nasal cradle cushions (e.g., the exemplary seal-forming structures disclosed herein) may include a superior saddle-shaped or concave region having a positive curvature across the cushion. Also, while the nasal cradle cushion may be understood to have a single target seal-forming region or surface, the 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 lower side of the patient's nose. These two surfaces on the patient's face form a nasolabial angle therebetween (see FIG. 2E). The cradle cushion may be shaped to have a nasolabial angle in the range of 90 degrees to 120 degrees.

[0199] Furthermore, the exemplary seal-forming structures may be shaped and sized such that no part of the seal-forming structure enters the patient's nostrils during use.

[0200] Prenum chamber Referring to FIGS. 5 to 17, the prenum chamber 3200 has an edge shaped to be complementary to the surface contour of an average person's face in the region where a seal is formed during use. In use, the peripheral edge of the prenum chamber 3200 is positioned close to the adjacent surface of the face. The actual contact with the face is provided by the seal formation structure 3100. The seal formation structure 3100 can extend around the entire edge of the prenum chamber 3200 during use.

[0201] In a particular form of the present technology, the prenum chamber 3200 is constructed from a material of relatively high rigidity (e.g., polycarbonate) compared to the seal formation structure. Alternatively, the prenum chamber 3200 can 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 the prenum chamber). In one embodiment, the seal formation structure may be an extension of the prenum chamber or may be formed as part of the prenum chamber such that the seal formation structure is included in the prenum chamber. In such an example, the support structure and the fabric membrane can be regarded as part of the prenum chamber. In another embodiment, the prenum chamber 3200 can be constructed from a transparent material (e.g., transparent polycarbonate). The use of a transparent material can reduce the pressing force of the patient interface and assist in improving compliance with the treatment. The use of a transparent material can assist the clinician in checking the placement and function of the patient interface.

[0202] In a particular form of the present technology, the prenum chamber 3200 is composed of a translucent material. By using a translucent material, the pressing force of the patient interface can be reduced, and compliance with the treatment can be assisted in improving.

[0203] Figures 5 and 10 to 17 show examples of a seal forming structure 3100 provided with a plenum chamber 3200. The seal forming structure 3100 may include a plenum chamber connection opening through which the seal forming structure 3100 is hermetically joined to the plenum chamber 3200. The seal forming structure 3100 and the plenum chamber 3200 may at least partially form a cavity 3101 pressurized by an air flow. In the illustrated embodiment, the seal forming structure 3100 and the plenum chamber 3200 together form the cavity 3101.

[0204] The connection at the plenum chamber connection opening 3106 between the seal forming structure 3100 and the plenum chamber 3200 may be a permanent connection. The connection at the plenum chamber connection opening 3106 between the seal forming structure 3100 and the plenum chamber 3200 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, a plenum chamber inlet port may be provided as a hollow path forming a plenum chamber lateral end 3202 sized and structured to receive an air flow. A plenum chamber connector 3204 may also be provided at each lateral side of the plenum chamber 3200 outside the lateral side of the plenum chamber lateral end 3202. The plenum chamber connector 3204 may be connected 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 may be provided on the other side. In a further example, 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 end 3202 can receive the pressurized gas flow from the positioning and stabilization structure 3300. Next, the pressurized gas flow can pass through the plenum chamber 3200 and then through the seal formation structure 3100 and enter the patient's airway for exhalation.

[0207] The manner in which the end 3314 of the positioning and stabilization structure 3300 can be connected to the plenum chamber lateral end 3202 is shown. In these embodiments, each plenum chamber connector 3204 can include a slot 3209, a chamfered edge 3208, and a notch 3206 that can be removably connected by snap fitting to a clip of the positioning and stabilization structure.

[0208] The plenum chamber 3200 shown in FIGS. 18-32 substantially according to the third, fourth, and fifth aspects of the present technology can be similar or identical to the plenum chambers of FIGS. 10-17. It should also be noted that one or more aspects of the present technology can be combined with one or more of the following aspects: US Provisional Application No. 62 / 764,992 (filing date: August 20, 2018, title: "Patent Interface") or PCT / AU2019 / 050873 (filing date: August 20, 2019). Each of these references is hereby incorporated by reference in its entirety for all purposes. For example, the plenum chamber of the present technology can be identical to the plenum chamber in any of the embodiments of the '992 application or the '837 application. Further, instead of the seal formation structure disclosed herein, any of the seal formation structures in any of the patient interfaces disclosed in the '992 application or the '873 application can be used, and the seal formation structure of the present technology can include any of the features of the seal formation structures in any of the embodiments of the '992 application or the '873 application.

[0209] In the examples of FIGS. 28 to 32, like the plenum chamber 3200 described above, the plenum chamber 13200 has a plenum chamber lateral end 3202, a plenum chamber connector 3204, a notch 3206, a chamfered edge 3208, and a slot 3209. However, the ventilation portion 3400 can be provided by a ventilation insert 13400. The ventilation insert 13400 is removably or permanently attached to the plenum chamber 13200 (e.g., by insertion into an opening in the plenum chamber). Note that in any of the other examples, a ventilation insert can be provided (e.g., the ventilation portion 3400 in the plenum chamber 3200 of FIGS. 10 to 27 can be provided by a ventilation insert 13400 as shown, for example, in FIGS. 28 to 32).

[0210] In the example of FIG. 38, the frame 9200 can include a centrally located connection portion for the air circuit 4170. The frame can also include a headgear attachment site 9210 at its lateral side. The seal forming structure 9100 can be connected to the frame 9200 by connectors 9122 spaced apart. These connectors 9122 can include clips on the seal forming structure and receiving connectors on the frame.

[0211] The seal forming structure of the present technology The seal forming structures 3100, 5100, 6100, 7100, 8100, 9100, 29100 can include support structures 3120, 6120, 7120, 8120, 9120, 29120 that provide support to sealing portions 3130, 5130, 6130, 7130, 8130, 9130, 29130 (e.g., fabric membranes). The sealing portions are configured to engage the patient's face in a sealed manner. Also, depending on the size and outer shape of the patient's nose, in the examples of FIGS. 5 to 27, the support structure can also engage the patient's face in a sealed manner.

[0212] The exemplary seal-forming structures 3100, 5100, 6100, 7100, 8100, 9100, 29100 differ in various ways as further described below, and each may include a support structure having at least two regions (e.g., two, three, or four regions) of different thicknesses (e.g., the seal-forming structure 3100 includes a support structure 3120 having 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 connected to the plenum chamber, and portion (d2) may be adjacent to or connected to the sealing portion, so that structural stability in the connection to the plenum chamber and flexibility in the interface with the patient are obtained. Alternatively, the thicker lateral support region 3122 may be disposed, for example, at the corner of the nasal region of the seal-forming structure (e.g., may be directly connected to the fabric membrane), so as to ensure proper sealing in the area of the lowest point of the alae nasi of the patient's face.

[0213] Furthermore, in the described embodiments, each sealing portion has two separate nostril openings 3102, each corresponding to one of the patient's nostrils, to provide air flow to both of the patient's nostrils. A bridge portion 3104 may be provided between the nostril openings 3102. The bridge portion 3104 may assist in providing a taut fabric membrane before and / or during use. In another example, a single hole may be used to provide a pressurized flow to both of the patient's nostrils.

[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 hermetically joined to the plenum chamber 3200. In the embodiments of FIGS. 5-38, the support structures 3120, 5120, 6120, 7120, 8120, 9120, 29120 are directly connected to the plenum chamber or frame. Thus, the support structure may include an opening through which the support structure is hermetically joined to the plenum chamber 3200.

[0215] The support structure can be less rigid than the plenum chamber 3200 and can be constructed from silicone, foam (e.g., polyurethane foam) (see FIGS. 28 - 32), solid polyurethane material, thermoplastic elastomer (e.g., thermoplastic polyurethane), a suitable plastic, or other suitable materials as described later. Further, the sealing portion can be less rigid than the support structure and can be constructed from a fabric material (e.g., nylon, polyester, nylon and polyester mixtures, microfiber, or polyurethane as described in more detail later, for example). The sealing portion described in any of the examples of the present disclosure can be referred to as a fabric sealing portion or a fabric film and can include a fabric material having an air - impermeable material applied by lamination, coating, or other means.

[0216] Since the support structure can have apertures formed therein, an inner edge of the support structure is obtained. Along this inner edge, a sealing portion (e.g., the outer periphery of the sealing portion) is attached to the support structure, as shown, for example, in FIGS. 11 - 27 and FIGS. 33 - 38, to extend the sealing portion inward in the radial direction of the seal - forming structure (beyond or to a further extent than the support structure). For example, the sealing portion may be formed around the inner edge of the support structure or may be connected to the support structure by other suitable methods as described later. However, in the alternative example of FIGS. 28 - 32, the sealing portion 8130 may be laminated (e.g., foam) on the support structure 8120.

[0217] Referring to FIGS. 11 to 14, the wall structure of the seal forming portion 3100 may include a lateral support region 3122. The lateral support region 3122 is thicker compared to other parts of the wall structure of the support structure 3120. The lateral support region 3122 may be provided at the outermost side of each seal forming structure 3100. The seal forming structure 3100 may include two lateral support regions 3122. These two lateral support regions 3122 are respectively spaced distally from the plane that bisects the seal forming structure 3100 and is parallel to the sagittal plane of the patient during use. Since these lateral support regions 3122 may be the thickest parts of the seal forming structure 3100, resistance to lateral displacement (for example, when a patient sleeping on their side presses the pillow against the seal forming structure laterally) is obtained, and a strong engagement with the patient's wings is obtained. The thickness of the lateral support region 3122 may be approximately 0.9 mm to approximately 1.5 mm or approximately 1.3 mm to approximately 1.4 mm or approximately 1.3 mm or approximately 1 mm to approximately 1.5 mm. Since the lateral support region 3122 is the thickest region in the seal forming structure 3100 in the described figures, the lateral support region 3122 may also provide the highest resistance to deformation.

[0218] Furthermore, sufficient rigidity can be obtained from the lateral support region 3122 to ensure proper sealing (for example, by the lateral support region 3122) in the region of the lowest point of the patient's facial alar (i.e., the region where the wing terminates at the upper lip near the nasolabial groove), which is a region with particularly complex geometry. In the case of the region of the lowest point of the patient's facial alar, the geometry is particularly complex because at least three facial surfaces (the wing, the upper lip, and the cheek) converge in this region. Therefore, due to the sufficient rigidity in the lateral support region 3122, the seal forming structure 3100 can be biased (without buckling) into the region of the lowest point of the alar by the tensile force from the positioning and stabilizing structure 3300. The lateral support region 3122 may be disposed in the region of the patient's face below the alar of the patient and below and laterally outward of the patient's nose (for example, between the nasolabial groove and the region of the upper lip disposed below the alar).

[0219] The seal formation structure 5100 in the embodiments of FIGS. 15 to 17 may have a sealing portion 5130 that is extended compared to the sealing portion 3130 of FIGS. 11 to 14. That is, within the seal formation structure 5100, the support structure 5120 contracts and the sealing portion 5130 expands, whereby the sealing portion 5130 may be configured to engage the lowest point region of the alae nasi of the patient's face during use. As a result, the seal formation structure 5100 may be more flexible and compliant so as to be able to conform more easily to the patient's facial contour.

[0220] Referring to FIGS. 18 to 22, since the seal formation structure in this example is arranged so as to obtain a larger cavity 3101, the sealing portion 6130 protrudes further from the plenum chamber in the direction of the patient's face during use due to an increase in tension in the sealing portion, whereby the sealing portion expands balloon-like outward. During use, since the patient's nose can be pressed against the sealing portion 6130 in the direction of the cavity 3101 and the plenum chamber 3200, as shown in FIG. 18, the sealing portion 6130 stretches and reverses, and the patient's nose is received by the space generated by the cavity 3101, and the sealing portion 6130 seals above the tip point of the patient's nose. In contrast, the sealing portions 3130 and 5130 seal below the tip point of the patient's nose as shown in FIG. 10.

[0221] The sealing portion 7130 in the example of FIGS. 23 to 27 is also configured to seal above the tip point of the patient's nose due to the height of the cushion. Compared with the sealing portion 6130, the sealing portion 7130 is configured to seal further in the direction of the cerion along the nasal bridge.

[0222] In the exemplary cushion assembly of FIGS. 28-32, the support structure 8120 can be provided by a foam material laminated on the plenum chamber 3200. The sealing portion 8130 may be laminated directly on the support structure. The support structure 8120 can extend across the plenum chamber connection opening, except for a pair of holes formed therein corresponding to the nostril openings 3102 in the sealing portion 8130. With such an arrangement, a compression seal is obtained against the patient's face, and when 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 profile through compression of the support structure 8120.

[0223] The cushion assembly 8105 is configured to seal under the patient's nose. The seal forming structure 8100 includes an end portion 8122. The end portion 8122 extends curvilinearly around the rear portion of the plenum chamber 3200 and is configured to engage the patient's upper lip during use.

[0224] Referring to FIGS. 33-37, the cushion assembly 29105 is similar to the cushion assembly 3105 but can extend further in the left-right lateral direction. The cushion assembly 29105 includes a seal forming structure 29100, a support structure 29120, and a sealing portion 29130. Referring to FIG. 33-1, the cushion assembly 29105-1 is similar to the cushion assembly 29105, but as described above, it can have a formed fabric film 29105 such that the fabric film forms a part of the seal forming structure that extends curvilinearly from the front side to the rear face contact side of the seal forming structure.

[0225] As described above, FIGS. 35-37 show the grip pads 29150 on the surface of the fabric film.

[0226] In the example of FIG. 38, the sealing portion 9130 is arranged to seal above the tip of the patient's nose.

[0227] 5.3.3.1 Positioning and Stabilization Structure The cushion assemblies 3105, 5105, 6105, 7105, 8105, 29105 of the patient interfaces 3000, 6000 of the present technology can be held in a sealed position by a positioning and stabilizing structure 3300 during use. The cushion assembly 9105 of the patient interface 9000 of the present technology can be held in a sealed position by a positioning and stabilizing structure 9300 during use.

[0228] In one form, the positioning and stabilizing structures 3300, 9300 provide a holding force sufficient to overcome the effect of the positive pressure in the cavity 3101 to lift off the face.

[0229] In one form, the positioning and stabilizing structure provides a holding force sufficient to overcome the gravitational force on the patient interface.

[0230] In one form, the positioning and stabilizing structure provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface (e.g., due to tubing drag or accidental interference with the patient interface).

[0231] In one form of the present technology, positioning and stabilizing structures 3300, 9300 are provided that are configured for the patient to be worn during sleep. 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 not to be overly large or bulky so as to interfere with the patient lying in a supine sleep position with the back of the patient's head resting on a pillow.

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

[0234] In one form of the present technology, the positioning and stabilization structures 3300, 9300 include a release site disposed between a front portion of the positioning and stabilization structure and a rear portion of the positioning and stabilization structure. This release site is not resistant to compression and can be, for example, a flexible or flimsy strap. The release site is constructed and arranged so as to avoid a situation where, when the patient lies with the head on the pillow, the presence of the release site causes force to be transmitted along the positioning and stabilization structure to the rear portion and disrupts the seal.

[0235] In one form of the present technology, the positioning and stabilization structure includes a strap composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous such that moisture (e.g., sweat) can pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0236] In a particular form of the present technology, the positioning and stabilization structure includes a strap that is stretchable (e.g., stretchable with resiliency). For example, the strap can be configured to be taut during use and direct a force that causes a seal-forming structure to adhere to a portion of the patient's face. In one embodiment, the strap can be configured as a tie.

[0237] In one form of the present technology, the positioning and stabilization structure includes a first tie that is constructed and arranged such that, during use, at least a portion of its lower edge moves upward and passes over to the upper ear base point of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0238] In one form of the present technology suitable for a nose-only mask or a full-face mask, the positioning and stabilization structure includes a second tie. The second tie is constructed and arranged such that at least a portion of its upper edge passes below the lower ear base point on the lower side of the patient's head and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head when in use.

[0239] In one form of the present technology suitable for a nose-only mask or a full-face mask, the positioning and stabilization structure includes a third tie constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move in different separation directions.

[0240] In a particular form of the present technology, the positioning and stabilization structure includes a strap that is bendable and for example non-rigid. An advantage of this aspect is that the strap is more comfortable when the patient lies on their side during sleep.

[0241] In a particular form of the present technology, the positioning and stabilization structure includes a strap configured to be breathable such that water vapor can pass through the interior.

[0242] In a particular form of the present technology, a system is provided that includes more than one positioning and stabilization structure 3300, 9300. Each positioning and stabilization structure is configured to provide a holding force for accommodating different sizes and / or ranges of shapes. For example, the system may include a form of positioning and stabilization structure suitable for a large-sized head rather than a small-sized head and another form suitable for a small-sized head rather than a large-sized head.

[0243] 5.3.3.1.1 Positioning and Stabilization Structure of the Present Technology FIG. 5 shows an example of the present technique including a positioning and stabilization structure 3300. In this example, the positioning and stabilization structure 3300 includes a side portion 3302 and an upper portion 3304 in the form of conduits that direct the flow of pressurized gas from the hub 3306 to the end 3314. The positioning and stabilization structure 3300 can be arranged such that the hub 3306 and the decoupling structure 3500 are disposed above the patient's head during use. As described below, the decoupling structure 3500 can be rotatable within the hub 3306, and when the patient is wearing the patient interface 3000, for example during treatment, the hub 3306 and the decoupling structure 3500 are disposed above the patient's head, so that the patient can move more freely (without getting entangled with the air circuit 4170).

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

[0245] The upper portion 3304 of the positioning and stabilization structure 3300 has peaks and valleys (or bellows), so that the upper portion 3304 can be made to correspond to the shape of the corresponding portion of the patient's head during use. The peaks and valleys of the upper portion 3304 allow the upper portion 3304 to be extended or contracted along the longitudinal axis so as to correspond to larger or smaller heads. The peaks and valleys of the upper portion 3304 allow the upper portion 3304 to be bent to different radii of curvature so as to correspond to patient heads of different shapes and sizes.

[0246] The side portion 3302 of the positioning and stabilization structure 3300 does not have to be formed with the peaks and valleys of the upper portion 3304. Therefore, it may be advantageous if the extensibility and flexibility of the side portion 3302 can be made lower than that of the upper portion 3304, because the shape and size variability of the side portions of the patient's head is reduced.

[0247] The end 3314 can be connected to each plenum chamber lateral end 3202. As described above, the plenum chamber lateral end 3202 receives the pressurized gas flow from the positioning and stabilization structure 3300. This pressurized gas flow reaches the patient's airway through the plenum chamber 3200 and the seal formation structure 3100. As described above, the end 3314 can be connected to the plenum chamber connector 3204 of each plenum chamber lateral end 3202.

[0248] The positioning and stabilization structure 3300 can be structured and arranged to direct the force / tension provided from the lateral portions 3302 into a partially upward and partially rearward force vector applied to the plenum chamber 3200. Specifically, due to this partially upward and partially rearward force vector, the fabric film of the seal formation structure 3100 is brought into sealing contact under the patient's nose (e.g., at or below the tip of the nose and at least above the upper lip vermilion).

[0249] Also, each of the lateral portions 3302 can include a tab 3308 that receives the rear strap end 3311 of the rear strap 3310. The rear strap 3310 can be length adjustable, for example, by a hook and loop material arrangement configuration, such that hook material is provided externally at one of the rear strap ends 3311 and the remaining portion of the rear strap 3310, and loop material is provided externally at the other. Thus, since the rear strap 3310 is length adjustable, the tension on the lateral portion 3302 can be increased to pull the seal formation structure 3100 into sealing engagement with the patient's face at a desired amount of pressure (i.e., tightly enough to avoid leakage and tightly enough not to cause discomfort).

[0250] By providing a sleeve 3312 on the lateral portion 3302, the patient's face can also be protected like a cushion from the lateral portion 3302. The sleeve 3312 can be constructed of a soft - feeling breathable fabric material.

[0251] In another example shown in FIG. 6, the patient interface 6000 includes a positioning and stabilization structure 6300. The positioning and stabilization structure 6300 has at least one tube 6350. The at least one tube 6350 is formed by a fabric material (e.g., a sheet or layer of one or more fabric materials) and receives pressurized air from the air delivery tube 6348 via the connection port 6600. The tube 6350 includes a left arm 6305 and a right arm 6307.

[0252] In some forms, the fabric tube 6350 can be formed with a first side configured to contact the patient. This can be referred to as the inner layer 6352. The fabric conduit can also include a second side. This second side is attached to the inner layer but faces in the opposite direction from the patient and can be referred to as the outer layer 6354. The inner layer and the outer layer can be fixed to each other along the edges of the inner layer and the outer layer, respectively, such that a flow path or passageway is formed between the seams of the inner layer and the outer layer. That is, the space between the seams remains unattached and forms the air passage 6372. The inner layer and the outer layer can be joined using various techniques that impart specific attributes to the seams or joints. For example, in some forms, ultrasonic welding, high-frequency welding, as well as cutting and welding techniques are used to form the seams. Adding heat to a specific area activates the thermosetting or thermoplastic material used in the tube 6350. This heat can be used not only for joining the layers to each other but also for thermoforming a layer such as the outer layer 6354. Additionally, in some forms, bonding such as stitching or an adhesive can be used to join the layers to each other. In some forms, stitching is not used. In further forms, materials beyond those disposed within the layers are not used in joining the inner and outer layers of the tube. For example, in some forms, the inner layer and the outer layer can be formed such that additional materials such as an adhesive or stitching are not required in joining the inner layer and the outer layer.

[0253] The inner layer and the outer layer 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 in the opposite direction from the inner layer, and the outer surface of the inner layer faces in the opposite direction from the outer layer. Further, in a form including a single sheet, the inner surface is the surface of the sheet and is disposed inwardly or disposed toward itself.

[0254] In some forms, the sheet or the sheet of the tube may include an air-impermeable layer or membrane. In some forms, the inner surfaces of both layers include a membrane configured to limit or inhibit the passage of air 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 woven sheet of the inner layer or the outer layer. In other forms, the impermeable layer may exceed the thickness of the woven sheet of either layer. The impermeable layer or membrane or film may be made completely impermeable to air movement, or may be formed to allow a predetermined rate or air movement and a specific pressure.

[0255] Since the membrane can be formed of a thermoplastic or thermosetting material, when exposed to a specific temperature, after the membrane material is molded or formed into a specific form, it can be cured or solidified or solidified by cooling. In some forms, the membrane can be formed of silicone or polyurethane. In some forms, by pre-forming the outer layer 6354, in an unpressurized or supported state, the outer layer 6354 is pre-arranged and pre-formed to extend in a separated direction from the inner layer 6352 between the opposing joints 6312. That is, since the outer layer 6354 can support its own weight, even if it is not supported by pressurized air or other support mechanisms, the outer layer 6354 remains spaced from the inner layer 6352 between the joints 6312.

[0256] In contrast, the inner layer 6352 can be a flexible component. When the inner layer 6352 is attached and fixed to the edge of the outer layer 6354, the inner layer 6352 becomes a substantially planar layer.

[0257] As shown in FIG. 7 and particularly as shown in FIG. 8, the inner layer 6352 includes a fabric sheet 6360 together with a membrane 6362. The fabric sheet 6360 can be formed of felt, foam material, woven fabric, knitting, or non-woven material or other fiber web.

[0258] The outer layer 6354 includes a tube sheet 6364 and an outer covering 6366. In some forms, both sides of the tube sheet 6364 can be covered by 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 surface 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 in forming an airtight tube. The membrane 6370 can assist in joining the tube sheet 6364 to the outer covering 6366.

[0259] One or more aspects of the present technology can be combined with one or more of the following aspects: U.S. Provisional Application No. 62 / 821,878 (filing date: March 21, 2019, title: "Textile Headgear Tubing for a Patient Interface") or PCT / AU2019 / 050655 (filing date: June 25, 2019). It should also be understood that each of these documents is incorporated herein by reference in its entirety. For example, the positioning and stabilization structures of the present technology can be the same as the positioning and stabilization structures in any of the embodiments of the '968 application or the '655 application. Further, instead of the cushion assembly or seal-forming structure disclosed herein, any of the cushion assemblies or seal-forming structures in any of the patient interfaces disclosed in the '968 application or the '655 application can be used.

[0260] In another example shown in FIG. 38, the patient interface 9000 includes a positioning and stabilization structure 9300. The positioning and stabilization structure 9300 has a pair of sides that extend between the patient's eyes and ears on each side of the patient's head. These sides may include holes or other connectors for connection to the headgear attachment site 9210 of the frame 9200. The positioning and stabilization 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 crown of the patient's head.

[0261] 5.3.3.2 Ventilation part In one form, the patient interfaces 3000, 6000, 9000 include a ventilation part 3400 configured and arranged to allow the extrusion of exhaled gas (e.g., carbon dioxide), as shown in FIG. 5 for example.

[0262] In a particular form, the ventilation part 3400 is configured to allow a continuous ventilation flow from the inside of the cavity 3101 to the atmosphere when the pressure in the plenum chamber is positive with respect to the atmosphere. The ventilation part 3400 is configured such that, while maintaining the treatment pressure in the plenum chamber during use, the magnitude of the ventilation flow rate is large enough to reduce the rebreathing of exhaled CO2 by the patient.

[0263] One form of the ventilation part 3400 according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0264] The ventilation part 3400 can be arranged within the plenum chamber 3200. The ventilation part 3400 may include a plurality of holes as described above. The holes of the ventilation part 3400 can be divided into two groups spaced laterally. Since the axes of the flow paths passing through each of the holes of the ventilation part 3400 can be parallel, cross-flow is avoided and further noise generation is avoided. The ventilation holes can be circular.

[0265] The radius of the hole portion of the ventilation part 3400 may be configured to decrease from the inside to the outside of the plenum chamber 3200. A draft gradient is provided for each ventilation hole. The diameter of each hole portion is smaller at the front end than at the rear end. The draft gradient means that the cross-section of the hole portion does not become smaller over the entire thickness of the chassis, thereby assisting in providing a flushing of carbon dioxide at a high humidity level. Further, when the draft gradient is large, the manufacture of the plenum chamber 3200 can be made easier (especially when the plenum chamber 3200 is formed from an injection-molded plastic material). The draft gradient enables the use of relatively thick ventilation pins in the mold and easier injection.

[0266] The hole portions of the ventilation part 3400 may be provided in two sets toward the middle portion of the plenum chamber 3200, and these sets may be symmetric across the center line of the plenum chamber 3200. Providing a pattern of a plurality of ventilation holes may enable noise reduction and dispersion of flow concentration.

[0267] The hole portions of the ventilation part 3400 may be arranged at an optimal distance in the direction away from the center line of the plenum chamber 3200. Arranging the hole portions of the ventilation part 3400 toward the center line may reduce the possibility of the ventilation holes being blocked when the patient is sleeping in a reclined position, which may be advantageous. However, if the ventilation holes are arranged too close to the middle portion of the plenum chamber 3200, especially since the cross-section of the plenum chamber 3200 in the illustrated example is minimized at the center (due to the overall shape of the plenum chamber 3200), the plenum chamber 3200 may become overly weak at the center. Depending on the location of the hole portions of the ventilation part 3400, blockage of the hole portions during reclined sleeping can be avoided while keeping the middle member of the chassis sufficiently strong.

[0268] Regarding the optimization of the size and number of each vent hole, even in extreme humidification, the optimization can be performed to achieve the necessary carbon dioxide flushing while achieving a balance with noise reduction. In the described example, the overall ventilation volume of the system cannot be obtained from the vent holes of the ventilation part 3400. The decoupling structure 3500 may include a decoupling structure ventilation part 3402. The decoupling structure ventilation part 3402 may include one or a plurality of holes through the decoupling structure 3500. The decoupling structure ventilation part 3402 can perform the function of bleeding off the excessive pressure generated by the RPT device 4000 (before reaching the patient), while the ventilation part 3400 can perform the function of flushing the carbon dioxide exhaled by the patient during treatment.

[0269] Figures 31 and 32 show another example of the ventilation part 3400. In this example, holes are provided in the ventilation insert 13400. The ventilation insert is removably or permanently attached to the plenum chamber 3200 at the ventilation insert opening. The ventilation insert 13400 can be constructed from a material that is more flexible than the material of the plenum chamber 3200.

[0270] 5.3.3.3 Decoupling Structure(s) In one form, the patient interfaces 3000, 6000, 9000 include at least one decoupling structure (e.g., a swivel or ball and socket).

[0271] The above-described hub 3306 is connected to the decoupling structure 3500. The decoupling structure 3500 is a rotatable elbow in these examples. The decoupling structure 3500 can be rotatable 360° within the hub 3306 during use. To remove the decoupling structure 3500 from the hub 3306, the button 3504 can be manually pressed to release a fastener (not shown) from within the hub 3306.

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

[0273] The disengagement structure 3500 is rotatable, the disengagement structure 3500 is in the form of an elbow, and the swivel 3502 is rotatable on the disengagement structure 3500, which can lead to an increase in degrees of freedom, and as a result, a decrease in tube resistance and torque on the patient interface 3000 due to the connection to the air circuit 4170.

[0274] 5.3.3.4 Connection Port The connection port 3600 enables connection to the air circuit 4170.

[0275] 5.3.3.5 Frontal Support In one form, the patient interface includes a frontal support 3700.

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

[0277] 5.3.3.7 Port In one form of the present technology, the patient interfaces 3000, 6000, 9000 include one or more ports that enable access to the volume within the cavity 3101. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the characteristics of the gas (e.g., pressure) within the cavity 3101.

[0278] 5.3.4 Full - Face Mask Cushion 5.3.4.1 First Illustrated Example Referring to FIGS. 39 - 50, the patient interface 14000 includes a cushion assembly 14105 with a seal - forming structure 14100. The seal - forming structure 14100 is configured to individually seal around the patient's nostrils and mouth (i.e., an oro - nasal cushion assembly or an ultra - compact 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] Referring to FIGS. 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 a patient's nostrils and mouth (i.e., an oronasal cushion assembly or a sub - miniature full - face mask). The cushion assembly 31105 is at least partially formed by a seal - forming structure 31100 and a plenum chamber 31200 attached to a plenum chamber according to an example of the present technology.

[0280] The cushion assembly 31105 includes a nose portion 31101, a nose - portion aperture 31103, a mouth portion 31102, a mouth - portion aperture 31104, a cavity 31001, a support structure 31120, a sealing portion 31130, and a ventilation portion 31400, which are similar to the features shown in FIGS. 39 - 50 and are not individually discussed. A pair of plenum - chamber apertures are configured to receive an air flow.

[0281] As described above, FIGS. 54 - 56 show grip pads 31150 on the surface of the fabric membrane.

[0282] Plenum chamber The plenum chamber 14200 has an edge shaped to be complementary to the surface contour of an average person's face in the region where a seal is formed during use. During use, the peripheral edge of the plenum chamber 14200 is positioned close to the adjacent surface of the face. The actual contact with the face is provided by the seal - forming structure 14100. The seal - forming structure 14100 can extend around the entire edge of the plenum chamber 14200 during use.

[0283] In certain forms of the present technology, the plenum chamber 14200 is constructed from a material of relatively high rigidity (e.g., polycarbonate) compared to the seal-forming structure. In another embodiment, the plenum chamber 14200 may be constructed from a transparent material (e.g., transparent polycarbonate). The use of a transparent material may reduce the harshness of the patient interface pressing and may assist in improving compliance with treatment. The use of a transparent material may assist the clinician in viewing the placement and function of the patient interface.

[0284] In certain forms of the present technology, the plenum chamber 14200 is composed of a translucent material. By using a translucent material, the harshness of the patient interface pressing can be reduced, and compliance with treatment can be assisted.

[0285] The plenum chamber 14200 according to an embodiment of the present technology may include plenum chamber holes on each side surface. The plenum chamber holes may provide pneumatic communication between the conduit connector 14800 (described in more detail below) and the cavity 14001. The connection rim portion around each plenum chamber hole may facilitate mechanical connection (e.g., snap fit or friction fit) with each conduit connector. Since the plenum chamber 14200 may be composed of a material of sufficient rigidity, when the conduit connector 14800 is connected to or removed from the plenum chamber 14200, auditory and / or tactile feedback can be delivered to the patient.

[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 mechanical interlock. In a mechanical connection, no chemical bond is formed between the plenum chamber 14200 and the seal-forming structure 14100.

[0287] Seal-forming structure Referring to FIGS. 39-50, the seal-forming structure 14100 may include a nose portion 14101 having a pair of nose site holes 14103 for sealing the patient's nostrils. In the described embodiment, two separate holes 14103 are provided, each corresponding to one of the patient's nostrils, to provide an air flow to both of the patient's nostrils. A bridge portion 14106 may be provided between the nostril openings 14103. In another example, a single hole may be used to provide a pressurized flow to both of the patient's nostrils.

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

[0289] The seal-forming structure 14100 may at least partially form a cavity 14001 that is pressurized by an 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 may include a support structure 14120 that provides support to a sealing portion 14130 (e.g., a fabric membrane). The sealing portion is configured to engage the patient's face in a sealed manner. Also, depending on the size and contour of the patient's nose, the support structure may engage the patient's face in a sealed manner as well.

[0291] The wall structure that may be included in the support structure 14120 may have at least two regions of different thicknesses (for example, it may include the parts of the support structure adjacent to or connected to the plenum chamber 14200. These parts may be thicker than the parts of the support structure adjacent to or connected to the sealing part 14130 of the support structure, so that structural stability in the connection with the plenum chamber 14200 and flexibility in the interface with the patient can be obtained). FIG. 84 illustrates an example in which the part (d1) of the support structure may be thicker than the part (d2) of the support structure. For example, the part (d1) may be adjacent to or connected to the plenum chamber, and the part (d2) may be adjacent to or connected to the sealing part, so that structural stability in the connection with the plenum chamber and flexibility in the interface with the patient can be obtained. Alternatively, the thicker lateral support region 3122 may be arranged, for example, at the corners of the nasal region and / or the regions of the oral site of the seal-forming structure (for example, it may be directly connected to the fabric film), so that proper sealing in the region of the lowest point of the alae nasi and / or the oral region of the patient's face is ensured.

[0292] As described above, the seal-forming structure 14100 may be hermetically 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 (for example, polyurethane foam), polyurethane solid material, thermoplastic elastomer (for example, thermoplastic polyurethane), suitable plastic or other suitable materials as described later. Further, the sealing part 14130 may be less rigid than the support structure 14120 and may be constructed from a fabric material (for example, nylon, polyester, nylon and polyester mixture, microfiber or polyurethane as described in more detail later).

[0293] Since the support structure 14120 can have an aperture formed therein, an inner edge of the support structure is obtained. Along this inner edge, a sealing portion 14130 (e.g., the outer periphery of the sealing portion) is attached to the support structure as shown in FIGS. 43 to 46, for example, and the sealing portion is extended inward in the radial direction of the seal-forming structure (beyond the support structure or to a further range than the support structure). For example, the sealing portion may be formed around the inner edge of the support structure, or may be connected to the support structure by other suitable methods as described later.

[0294] In the example of FIG. 49, the support structure 14120 can extend into a cavity 14001 that forms a base cushion 14121 that provides support to the sealing portion 14130. The base cushion 14121 and the sealing portion 14130 can form a double-wall structure around the sealing portion. In another example, a second or third base cushion layer can be provided to form a triple- or quadruple-wall structure. In the example of FIG. 49, the base cushion is constructed of a foamed material (e.g., polyurethane foam). In another example, the base cushion 14122 can be constructed of silicone as shown in FIG. 50. However, it is recognized that the base cushion can 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 of the following: U.S. Provisional Application No. 62 / 609,909 (filed December 22, 2017) or WO2019 / 119058 (filed December 21, 2018), both titled "Conduit Headgear Connector for Patient Interface". Note also that the entire contents of each of these documents are incorporated by reference herein. For example, the conduits and positioning and stabilization structures of the present technology may be identical to the conduits and positioning and stabilization structures in any of the embodiments of the '909 application or the '058 application. Further, instead of the cushion assemblies and seal-forming structures disclosed herein, the cushion assemblies (seal-forming structures and plenum chambers) and seal-forming structures in any of the patient interfaces disclosed in the '909 application or the '058 application may be used.

[0296] 5.3.4.1.1 Positioning and Stabilization Structure

[0297] The seal-forming structure 14100 of the patient interface 14000 of the present technology can be held in a sealed position by the positioning and stabilization structure 14300 during use.

[0298] In one form, the positioning and stabilization structure 14300 provides a holding force sufficient to overcome the effect of the positive pressure in the cavity 14001 for lifting off the face.

[0299] In one form, the positioning and stabilization structure 14300 provides a holding force sufficient to overcome the gravitational force on the patient interface 14000.

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

[0301] In one form of the technology, a positioning and stabilization structure 14300 is provided that is configured to be worn by a patient during sleep. In one embodiment, the positioning and stabilization structure 14300 has a non - obtrusive outer shape or cross - sectional thickness so as to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilization structure 14300 includes at least one strap having a rectangular cross - section. In one embodiment, the positioning and stabilization structure 14300 includes at least one flat strap.

[0302] In one form of the technology, a positioning and stabilization structure 14300 is provided that is configured such that when a patient lies in a supine sleep position with the patient's head resting on the rear region of the patient's head, it does not have an overly large or bulky size that would be obstructive.

[0303] In one form of the technology, a positioning and stabilization structure 14300 is provided that is configured such that when a patient lies in a lateral sleep position with the patient's head resting on the lateral region of the patient's head, it does not have an overly large or bulky size that would be obstructive.

[0304] In one form of the technology, the positioning and stabilization structure 14300 includes a decoupling site disposed between a front portion of the positioning and stabilization structure 14300 and a rear portion of the positioning and stabilization structure 14300. This decoupling site is not resistant to compression and can be, for example, a flexible or flimsy strap. The decoupling site is constructed and arranged such that when a patient lies with the head on a pillow, the presence of the decoupling site can avoid a situation where the force to the rear portion is transmitted along the positioning and stabilization structure 3300 and the seal is obstructed.

[0305] In one form of the present technology, the positioning and stabilization structure 14300 includes a strap composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous such that moisture (e.g., sweat) can 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 stabilization structure 14300 includes a strap that is stretchable (e.g., stretchable with resilience). For example, the strap can be configured to be taut when in use and direct a force to hold the seal-forming structure in close contact with a portion of the patient's face. In one embodiment, the strap can be configured as a tie.

[0307] In one form of the present technology, the positioning and stabilization structure can include a first tie (e.g., the upper strap 14302 (FIG. 41)). The first tie is constructed and arranged such that at least a portion of its lower edge moves upward and passes over to the supra-aural point of the patient's head during use.

[0308] In one form of the present technology suitable for a full-face mask, the positioning and stabilization structure includes a second tie (e.g., the lower strap 14303 (FIG. 41)). The second tie is constructed and arranged such that at least a portion of its upper edge passes below the infra-aural point on the lower side of the patient's head and covers or is placed below the occipital bone of the patient's head during use.

[0309] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a third tie (e.g., the strap connector 14304 (FIG. 39)) constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move away from each other in a divergent direction.

[0310] In certain forms of the technology, the positioning and stabilization structure 14300 includes straps that are bendable and for example non-rigid. An advantage of this aspect is that the straps are more comfortable when the patient lies on their side during sleep.

[0311] In certain forms of the technology, the positioning and stabilization structure 14300 includes straps configured to be breathable such that water vapor can pass therethrough.

[0312] In certain forms of the technology, a system is provided that includes more than one positioning and stabilization structure 14300. Each positioning and stabilization structure is configured to provide a holding force for accommodating different size and / or shape ranges. For example, the system may include one form of the positioning and stabilization structure 14300 suitable for a large-sized head rather than a small-sized head and another form suitable for a small-sized head rather than a large-sized head.

[0313] The positioning and stabilization structure 14300 may include a clip 14301 for securing each tie to the conduit connector 14800, as shown for example in FIG. 39. A magnet having an opposite polarity is disposed on each of the clip 14301 and the conduit connector 14800 to facilitate connection therebetween.

[0314] 5.3.4.1.2 Ventilation section In one form, the patient interface 14000 includes a ventilation section 14400 configured and arranged to allow for the expulsion of exhaled gas (e.g., carbon dioxide), as shown in FIG. 39.

[0315] In a particular form, the vent 14400 is configured to allow a continuous airflow from the inside of the plenum chamber 14200 to the atmosphere when the pressure in the plenum chamber is positive with respect to the atmosphere. The vent 14400 is configured such that, during use, while maintaining the therapeutic pressure in the plenum chamber, the magnitude of the airflow is large enough to reduce the rebreathing of exhaled CO2 by the patient.

[0316] One form of the vent 14400 according to this technology includes a plurality of holes (e.g., from about 20 to about 80 holes or from about 40 to about 60 holes or from about 45 to about 55 holes).

[0317] As shown in FIG. 47, the vent 3400 can be disposed within the plenum chamber 14200. Alternatively, the vent 14400 is disposed within a disconnect structure (e.g., a swivel).

[0318] FIG. 39 shows an example of the vent 14400 provided on the connection port 14600 (e.g., a swivel elbow). In variations of these examples, the vent 14400 may be excluded from the connection port 14600.

[0319] The conduit connector 14800, which will be described in more detail below, may also include a ventilation feature.

[0320] 5.3.4.1.3 Disconnect Structure(s) In one form, the patient interface 14000 includes at least one disconnect structure (e.g., a swivel or ball and socket).

[0321] 5.3.4.1.4 Connection Port The connection port 14600 enables connection to the air circuit 4170. The connection port 14600 according to one embodiment of this technology can be connected to the connection port housing 14903. The connection port 14600 can be rotatable with respect to the connection port housing 14903, and the connection to the air circuit 4170 can also be rotatable.

[0322] The connection port 14600 and the connection port housing 14903 can be arranged above the patient's head during use.

[0323] 5.3.4.1.5 Frontal support The embodiments of the patient interface of the present technology shown in FIGS. 39 to 50 do not include a frontal support. A modified example of the patient interface of the present technology may include a frontal support.

[0324] 5.3.4.1.6 Conduit The patient interface 14000 according to an embodiment of the present technology may include a conduit 14900 for supplying a pressurized air flow from the connection port 14600 to the cavity 14001 in the plenum chamber 14200. The conduit 14900 can be joined above the patient's head in the connection port housing 14903 and can pass between the corresponding ones of the patient's eyes and ears along the lateral side of the patient's head. The conduit 14900 can be connected to the cushion assembly 14105 (for example, the plenum chamber 14200) via the conduit connector 14800 so as to provide a pressurized air flow to the cavity 14001, as described below.

[0325] The conduit 14900 can also enable the stabilization and positioning of the seal formation structure 14100 on the patient's face. Therefore, the conduit 14900 can function in the same manner as the tie of the positioning and stabilization structure 14300. Therefore, the mechanical connection from the conduit 14900 to the conduit connector 14800 can be sufficient to conduct the tensile force in the conduit 3900 through the conduit connector 14800 to the seal formation structure 14100.

[0326] The conduit 14900 can include features of similar conduits disclosed in International Application Publication WO2017 / 124155Al. The entire content of this document is incorporated herein by reference for reference purposes. For example, the conduit 14900 of the present technology can include the features of the headgear tube 3350 described in FIGS. 3A to 3L of this document and the related description.

[0327] By providing the conduit 14900 with a sleeve 14901, the patient's face can also be protected like a cushion from the conduit 14900. The sleeve 14901 may be removable. The sleeve 14901 may be composed of a breathable material.

[0328] The conduit 14900 may also include a tie connector 14902 for facilitating the connection of the positioning and stabilization structure 14300 to the tie.

[0329] 5.3.4.1.7 Conduit Connector According to an embodiment of the present technology, the patient interface 14000 may include a conduit connector 14800 that connects the conduit 14900 to the cushion assembly 14105 to provide a flow of pressurized air to the cavity 14001. Each of the conduit connectors 14800 may be formed with a conduit connector housing 14801. The conduit connector 14800 may provide other functions as described below (e.g., ventilation of the plenum chamber 14200, connection to the positioning and stabilization structure 14300, and prevention of asphyxiation by inclusion of the anti-asphyxiation valve 14850).

[0330] Figures 43 to 50 show some views of the conduit connector 14800 of the patient interface 14000 according to an embodiment of the present technology.

[0331] In FIGS. 39 to 50, the state in which the conduit connector 14800 is attached to the plenum chamber 14200 at the plenum chamber hole is shown. As can be understood, one conduit connector 14800 is provided at each lateral side portion of the cushion assembly 14105, and each conduit connector 14800 is connected to the plenum chamber hole at each corresponding lateral side portion of the cushion assembly 14105. Each of the conduit connectors 14800 may include a conduit connector attachment structure for connecting each of the conduit connectors 14800 to each plenum chamber hole at a connection 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 can each be relatively rigid so as to enable auditory feedback and / or tactile feedback in relation to 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 aspect, 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 can be ultrasonically welded to the plenum chamber 14200. The connection between the conduit connector 14800 and the plenum chamber 14200 is either removable or permanent and is also designed to be robust enough to transmit the tension from the conduit 14900 to the plenum chamber 14200 (without interfering with the connection). This is because, as described above, the conduit connector 14800 can facilitate the positioning and stabilization of the seal forming structure 14100 on the patient's head.

[0332] To improve the aesthetics of the patient interface 14000, the conduit connector 14800 may be attached to the lateral side of the plenum chamber 14200. As described above, by constructing the plenum chamber 14200 of a transparent or translucent material, visual recognition of the patient-facing features may be enabled. For example, by providing the conduit connector 14800 laterally to the plenum chamber as shown in the illustrated embodiment, a larger view of the patient's face can be obtained, and this arrangement configuration enables improvement in the aesthetics of the patient interface 14000. This is in contrast to alternative designs where the elbow and air circuit can be joined to the center of the plenum chamber 14200 and the patient's face is obstructed.

[0333] Each of the conduit connectors 14800 may also include a conduit connection end portion 14802 that connects to the respective conduit 14900. The connection between the conduit 14900 and the conduit connector 14800 at the conduit connection end portion 14802 may be removable or may be permanent. The conduit connector inlet hole 14803 may be formed in the conduit connector housing 14801 at the conduit connection end portion 14802 to receive the pressurized air flow. The conduit connector 14800 may include a structure (e.g., an undercut) to facilitate a removable snap-fit connection with the corresponding conduit 14900. Each conduit 14900 may include, at its end, a relatively high-rigidity structure that connects to the conduit connector 14800 to facilitate such a connection. The conduit connector 14800 may be joined to the conduit 14900 by friction fit. Here too, as described above, since the conduit 14900 provides a positioning and stabilization function for installing a sealing structure at a therapeutically effective sealing position on the patient's face, the connection between the conduit 14900 and the conduit connector 14800 at the conduit connection end portion 14802 can be made sufficiently secure to transmit the tensile force 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 portion 14802).

[0334] The ventilation function of the patient interface 14000 can also be obtained by the conduit connector 14800. The conduit connector housing 14801 may include a ventilation inlet that is in pneumatic communication with the cavity 14001 during the assembly of the patient interface 14000. The conduit connector housing 14801 may also include at least one conduit connector vent hole 14831. As can be seen from the illustrated embodiment, each conduit connector housing 14801 includes a plurality of conduit connector vent holes 14831. As a result, it becomes possible to appropriately mix the newly introduced air and the existing air in the plenum chamber 14200, thereby improving the extrusion of carbon dioxide and increasing the amount of fresh air provided to the patient for breathing.

[0335] As shown in FIGS. 39 to 41, the connection of the positioning and stabilization structure 3300 to the tie can also be obtained by the conduit connector 3800. The lower tie can be joined to the conduit connector 3800 by the clip 14301. The clip 14301 and the conduit connector 14800 may include magnets having opposite polarities for facilitating connection. The connection between the tie of the positioning and stabilization structure 14300 and the conduit connector 14800 may be releasable. Due to the tension from the lower tie of the positioning and stabilization structure 14300, the lower part of the seal forming structure 14100 can be biased to make a sealed 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 valve In one form, the patient interface 14000 includes an anti-asphyxiation valve. As best shown in FIGS. 47 and 48, the conduit connectors 14800 may each include an anti-asphyxiation valve assembly 14850. Thus, the patient interface 14000 may include two anti-asphyxiation valve assemblies 14850. The anti-asphyxiation valve assemblies 14850 may each operate independently of each other (i.e., in response to a cessation of the pressurized air flow). For example, if the pressurized air flow stops and one of the anti-asphyxiation valve assemblies 14850 is blocked (e.g., by a pillow) when the patient is lying on their side, the other anti-asphyxiation valve assembly 14850 can function to avoid asphyxiation of the patient.

[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 enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the properties (e.g., pressure) of the gas within the plenum chamber 14200.

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

[0339] The cushion assembly 30105 includes a nose portion 30101, a nose portion aperture 30103, a mouth portion 30102, a mouth portion aperture 30104, a cavity 30001, a support structure 30120, and a sealing portion 30130, which are similar to the features shown in FIGS. 39-56 and are not discussed individually. The inlet port 30240 is formed within the plenum chamber and configured to receive an air flow for the air circuit.

[0340] 5.3.4.2.1 Positioning and Stabilization Structure FIGS. 57-66 show a patient interface 30000 according to an example of the present technology. The patient interface 30000 has a positioning and stabilization structure 30300 and a plenum chamber 30200 having a seal-forming structure 30100. In this example, the positioning and stabilization structure 30300 includes a frame 30350 and a plurality 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 be connected 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 others, or may be permanently connected to the frame.

[0342] The positioning and stabilization structure 30300 may include a plurality of straps or strap portions. These straps or strap portions are connected to the frame 30350 and pass around the patient's head to support the plenum chamber in a sealed position relative to the patient's face. It is understood that a single "strap" may be formed by a plurality of lengths of material (singular or plural) that are separately cut or formed to produce a longer length and joined at the ends, or a single "strap" may be a single length of material (singular or plural).

[0343] In the example shown in FIGS. 57-66, the positioning and stabilization structure 30300 includes a pair of upper straps 30310. Each upper strap is configured to pass between each eye and ear of the patient. Further, the positioning and stabilization structure includes a pair of lower straps 30320 configured to be disposed under the zygomatic bones of the patient on both cheeks of the patient. In this example, the plenum chamber is held in place via a four-point connection to the headgear strap via the frame 30350.

[0344] The isolation of the frame is shown in FIGS. 63-64. The frame includes a frame inlet connection port 30354. The frame inlet connection port 30354 may be configured to connect to a source of pressurized breathable gas (e.g., air). In one example, the frame inlet connection port 30354 may be configured to enable connection to a swivel elbow assembly 30610 that provides a connection port 30600 for connection to the air circuit 4170. In this example, the frame inlet connection port includes a connection rim 30355. The connection rim 30355 may include a flange extending radially outward. The swivel elbow assembly 30610 may 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 provide a fluid connection to the plenum chamber. Thus, the frame 30350 enables a fluid connection between the swivel elbow assembly 30610 and the interior of the plenum chamber 30200.

[0345] Frame 30350 also includes a pair of opposing upper strap connection points 30315 that are connection destinations of the upper straps 30310. In this example, each upper strap connection point includes an aperture formed in the frame. Each upper strap 30310 can be connected to each upper strap connection point 30315 by passing through the aperture, looping back on itself, and then fixing itself. Each upper strap can be fixed to itself via hook and loop material configured to releasably couple when contacted. In another example, each upper strap 30310 can pass through each aperture, loop back on itself, and then be fixed to itself by a band, clip, or the like. In yet another example, the upper strap can be connected to the frame via a side release buckle connection.

[0346] Frame 30350 also includes a pair of opposing lower strap connection points 30325 that are connection destinations of the lower straps 30320. 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. This magnet or material is attached to the magnet at the lower strap connection point 30325. In this example, each lower strap clip 30326 includes an aperture. Through this aperture, after passing the end of each lower strap, it can be looped back and fixed to itself (e.g., by hook and loop material, a band, a clip, or the like). In another example, the lower strap can be connected to the frame via a side release buckle connection and connected to a hook or any other suitable connection.

[0347] In one example, the frame 30350 and the upper strap connection points 30315 are structured and arranged to direct the force / tension provided from the upper strap 30310 to a partially upward and partially rearward force vector applied to the plenum chamber 30200. Specifically, due to this partially upward and partially rearward force vector, the nose portion 30101 of the seal forming structure 3100 is brought into sealing contact with the peripheral area under the patient's nose and the patient's upper lip.

[0348] The upper straps 30310 can each be selectively adjustable. For example, to change the effective length of each upper strap, the amount of the upper strap that loops back on itself after passing through the aperture at each upper strap connection point 30315 can be changed. Increasing the amount of the upper strap passing through the aperture effectively reduces the length of the upper strap, thereby enabling a change in the force vector and adjustment of the fit of the patient interface.

[0349] In one example, the frame 30350 and the lower strap connection points 30325 are structured and arranged to direct the force / tension provided from the lower strap 30320 to a force vector that is partially rearward and partially downward to the portion applied to the plenum chamber. Specifically, due to the partially rearward and partially downward force vector, the oral site 30102 is sealingly contacted with the patient's face around the periphery of the patient's mouth. The partially downward force added from the lower strap to the frame can balance the partially upward force added from the upper strap and any downward-directed force that can be applied from the patient's nose to the seal-forming structure.

[0350] The lower strap 30320 can be selectively adjustable. For example, the change in the effective length of each lower strap can be achieved by changing the amount of each lower strap that loops back on itself after passing each lower strap through the aperture in each lower strap clip 30326. Increasing the amount of each lower strap passing through the aperture effectively reduces the length of the lower strap, thereby enabling a change in the force vector and adjustment of the fit of the patient interface.

[0351] The positioning and stabilization structure 30300 may also include one or more of a crown strap 30330, a pair of lateral crown straps 30332, and a neck strap 30334. In the examples shown in FIGS. 57-66, the upper strap 30310 and the lower strap 30320 are connected to the ends of the crown strap 30330. The crown strap is configured to pass around the patient's head and be disposed against the upper and rear-facing surfaces. The crown strap 30330 may be configured to be disposed on the vertex of the patient's skull. Each end of the crown strap is also connected to each of the upper strap 30310 and each of the pair of lateral crown straps 30332. Each of the lateral crown straps is connected between the upper strap and the lower strap at 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 through the sagittal plane and be disposed against the lower and / or rear-facing surface of the patient's head or be disposed behind the patient's neck. The neck strap may be disposed above or below the occipital bone of the patient's skull.

[0352] The length of the crown strap 30330 can be selectively adjusted. The crown strap 30330 is formed by two strap portions connected by a link having a pair of apertures. These two strap portions forming the crown strap each loop back after passing through each aperture and can be secured to themselves via, for example, hook and loop material, additional clips, bands, and / or others. The amount of each upper strap portion sent through the link can be varied for adjustment of the length of the crown strap 30330 and thus the fit of the positioning and stabilization structure.

[0353] After adjustment of all headgear straps and achieving the desired fit of the patient interface 30000, the lower strap 30320 can be quickly disengaged from the lower strap connection point 30325 on the frame 30350 by the magnetic clip connection provided by the lower strap clip 30326, thereby enabling removal of the patient interface 30000 from the patient without strap adjustment. Similarly, when the patient re - wears the patient interface, the lower strap clip can be quickly disengaged at the lower strap connection point to fit the patient interface without the need for strap adjustment. Further advantages and features of the positioning and stabilization structure including the magnetic clip are described in WO2014 / 110622, which is hereby incorporated by reference in its entirety.

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

[0355] Also, one or more aspects of the technology may be combined with one or more of the following aspects: PCT / AU2019 / 050278 (filing date: March 28, 2019, title: "Patient Interface"). Note this reference is hereby incorporated by reference in its entirety.

[0356] 5.3.4.2.2 Ventilation part In one form, the patient interface 30000 includes a ventilation part 30400 configured and arranged to allow the extrusion of exhaled gas (e.g., carbon dioxide).

[0357] In certain embodiments, the vent 30400 is configured to allow a continuous flow of air from the inside of the plenum chamber 30200 to the atmosphere when the pressure in the plenum chamber is positive relative to the atmosphere. The vent is configured such that, during use, while maintaining the therapeutic pressure within the plenum chamber, the vent flow rate is large enough to reduce rebreathing of exhaled CO2 by the patient.

[0358] One form of the vent according to the present technique includes a plurality of holes (e.g., from about 20 to about 80 holes or from about 40 to about 60 holes or from about 45 to about 55 holes).

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

[0360] In the example shown in FIGS. 57 - 66, the patient interface 30000 includes a vent 30400. In this example, the vent includes passages within a frame and a swivel elbow assembly. Through these passages, air flow from the inside of the plenum chamber to the surroundings is enabled. As shown in FIG. 59, after air has flowed into the swivel elbow assembly 30610, it can flow to the surroundings through external holes of the swivel elbow assembly that form part of the vent 30400. The swivel elbow assembly 30610 can be substantially similar to that described in International Publication No. WO2017 / 049357A1, which is incorporated herein by reference in its entirety.

[0361] 5.3.4.2.3 Disconnect Structure(s) In one embodiment, the patient interface 30000 includes at least one disconnect structure (e.g., a swivel or ball and socket).

[0362] 5.3.4.2.4 Connection Port The connection port 30600 enables 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 FIG. 3A. In other examples, the patient interface may exclude the forehead support site. Additionally, the patient interface 30000 may be configured to not contact the patient's forehead at all.

[0364] 5.3.4.2.6 Anti-asphyxia valve In one form, the patient interface 30000 includes an anti-asphyxia 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 enable access to the amount within the plenum chamber. In one form, this allows a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the characteristics of the gas (e.g., pressure) within the plenum chamber 302000.

[0366] 5.3.4.3 Third illustrated example Figures 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 that includes a seal-forming structure 16200, an air delivery connector (e.g., elbow assembly 16600), and a positioning and stabilization structure (e.g., a headgear 16800 that includes an upper side strap 16802, a lower side strap 16804, and a head crown strap 16806). In use, one form of the seal-forming structure 16200 is arranged to surround the inlet of the airway of the patient 1000 so as to facilitate the supply of air at positive pressure to the airway. In the example shown in Figures 46 - 56, the patient interface is a full-face / oronasal interface type that includes a seal-forming structure 16200 configured to form a seal around the patient's nose and mouth. However, aspects 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 can also be commonly referred to as a cushion. FIGS. 67 and 68 are exemplary views of the patient interface 16000 with the arm cover 16750 for the upper arm 16134 of the frame assembly 16100 attached thereto. FIG. 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 is connected to the frame assembly 16100 (via a first retaining feature on the frame assembly) independently from the elbow assembly 16600, and the elbow assembly 16600 is connected to the frame assembly 16100 (via a second retaining feature on the frame assembly) independently from the cushion assembly 16175. That is, the retaining connections from the cushion assembly 16175 and the elbow assembly 16600 to the frame assembly 16100 are separate and distinct from each other, 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 provided within the air flow path. That is, the elbow assembly 16600 is structured to establish a rigid connection and a dynamic seal with the frame assembly 16100, and the cushion assembly 16175 is structured to establish a separate hard-to-hard connection and a static seal with the frame assembly 16100.

[0370] Also, in the example of the patient interface 16000, the frame assembly 16100 includes a lockout function along the opening 16105 that is structured and arranged to avoid direct connection or insertion of the air circuit 4170 (e.g., the air delivery tube). In this arrangement configuration, since the use of the elbow assembly 16600 is required for the interconnection of the frame assembly 16100 and the air circuit 4170, the elbow assembly 16600 (and its vent and anti-asphyxiation valve (AAV)) is surely present in the system.

[0371] Frame assembly Referring again to FIGS. 67 - 77, the frame assembly 16100 includes a shroud or wall member 16110 of a pair (i.e., right and left) of upper headgear connector arms 16134 that extend from each side of the upper portion of the shroud 16110 (each including two flexible portions 16140 and 16145), and a pair (i.e., right and left) of lower headgear connector arms 16154 that extend from each side of the lower portion of the shroud 16110. Each lower headgear connector arm 16154 includes a magnetic connector 16155 (including a magnet in a container). The magnetic connector 16155 is structured to position and connect a headgear clip 16160 (including a magnet in a container) provided to each lower headgear strap 16804 of the headgear.

[0372] In the illustrated example, the opening 16105 of the shroud 16110 (e.g., constructed of 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 Referring to FIGS. 67-77, the body, chassis, plenum chamber or shell 16180 included in the cushion assembly 16175 is connected to or otherwise provided in the seal forming structure or cushion 16200 (see FIGS. 70 and 71). The shell 16180 may be permanently connected to the cushion 16200 (e.g., by integral molding, overmolding), or removably connected to the cushion 16200 (e.g., by mechanical connection). In the example, the cushion 16200 is constructed of a relatively flexible or compliant material, and the shell 16180 is constructed of a relatively rigid material (e.g., polycarbonate). The shell 16180 and the cushion 16200 cooperate to form a cavity 16500 (e.g., FIGS. 70, 71 and 73). The shell 16180 includes an opening 16305 for delivering 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 a plurality of functions. For example, it at least partially forms a cavity for delivering pressurized gas to the patient's airway inlet. The shell 6180 is a rigid structure that directs forces for sealing against the patient's face onto the seal forming structure. This force is obtained by the tension from tightening the headgear strap. These forces are transferred from a pair of upper and lower headgear straps to corresponding upper and lower arms. In the example, since the upper and lower arms comprise the frame assembly, headgear tension is applied to the shell 16180.

[0375] The shell 16180 of the cushion assembly 16175 is repeatedly engageable with and releasably disengagable from the shroud 16110 of the frame assembly 16100 via a mechanical connection (e.g., snap-fit connection). The inner annular flange of the shroud 16110 extends through the shell 16180 opening 16305, and the tabs or catches of the flange engage or interlock onto the rear side of the annular flange 16310 of the shell 16180 to releasably connect the frame assembly 16100 to the cushion assembly 16175. Such a connection provides an easy-to-use, sealed hard-to-hard connection, minimizing rattling and rocking movement between components and reducing the impact on stability. Also, such a connection applies an appropriate force vector for sealing onto the cushion assembly 16175 while stably holding the cushion assembly 16175 in place.

[0376] In the example shown in FIG. 67, the elbow assembly 16600 includes a first end 16610 and a second end 16620. The first end 16610 is releasably engaged with (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 indirect connection and seal with the frame assembly 16100.

[0377] In this example, the first end 16610 includes an inner radial wall portion and an outer radial wall portion. The inner and outer radial wall portions define radial channels leading to a plurality of ventilation holes 16700 to allow exhaled gas from the patient interface to escape.

[0378] Moreover, one or more aspects of the present technology may be combinable with one or more of the following aspects: US Patent Application Publication No. 2018 / 0250486 (filing date: March 12, 2018, title: "Patient Interface"). It should be understood that the entire document is incorporated herein by reference. For example, instead of the cushion assembly 16175 disclosed herein, a cushion assembly in any of the patient interface embodiments disclosed in the '486 publication may be used. Further, instead of the seal-forming structure 16200 disclosed herein, a seal-forming structure in any of the patient interfaces disclosed in the '486 publication may be used.

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

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

[0381] The support structure 16220 may include a wall structure having at least two regions of different thicknesses (e.g., the portion of the support structure adjacent to or connected to the shell 16180 may be thicker than the portion of the support structure adjacent to or connected to the sealing portion 16230, so that structural stability in the connection with the shell 16180 and flexibility in the interface with the patient are obtained). FIG. 84 illustrates an example in which 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 to or connected to the plenum chamber, and the portion (d2) may be adjacent to or connected to the sealing portion, so that structural stability in the connection with the frame and flexibility in the interface with the patient are obtained. Alternatively, the thicker lateral support region 3122 may be disposed, for example, in the sub-cheek region of the seal-forming structure (e.g., may be directly connected to the fabric film), so that proper sealing in the sub-cheek region of the patient's face is ensured.

[0382] The support structure 16220 may be less rigid than the shell 16180 and may be constructed from silicone, foam (e.g., polyurethane foam), solid polyurethane material, thermoplastic elastomer (e.g., thermoplastic polyurethane), a suitable plastic, or other suitable materials as described later. Further, the sealing portion 16230 may be less rigid than the support structure 16220 and may be constructed from a fabric material (e.g., nylon, polyester, nylon and polyester mixture, microfiber, or polyurethane as described in more detail later, for example).

[0383] Since the support structure 16220 can have an aperture formed therein, an inner edge of the support structure is obtained. Along this inner edge, a sealing portion 16230 (e.g., the outer periphery of the sealing portion) is attached to the support structure, as shown in FIGS. 71 and 73 to 77, for example, to extend the sealing portion inward in the radial direction of the seal-forming structure (beyond the support structure or to an even further range than the support structure). For example, the sealing portion may be formed around the inner edge of the support structure, or may be connected to the support structure by other suitable methods as described later.

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

[0385] 5.3.4.3.1 Positioning and Stabilization Structure The seal-forming structure of the patient interface of the present technology can be held in a sealed position by a positioning and stabilization structure during use.

[0386] In one form of the present technology, a positioning and stabilization structure configured to be worn by a patient during sleep is provided. In one embodiment, the positioning and stabilization structure has a low profile or cross-sectional thickness so as to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilization structure includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilization structure includes at least one flat strap.

[0387] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous such that moisture (e.g., sweat) can 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 stabilization structure includes a strap that is stretchable (e.g., stretchable with resilience). For example, the strap can be configured to be taut when in use and direct the force that holds the cushion in close contact with a portion of the patient's face. In one embodiment, the strap can be configured as a tie.

[0389] In certain forms of the present technology, the positioning and stabilization structure includes a strap that is bendable and, for example, non-rigid. An advantage of this aspect is that the strap is more comfortable when the patient lies on their side during sleep.

[0390] In certain forms of the present technology, the positioning and stabilization structure provides a holding force configured to correspond to a particular size of head and / or face shape. For example, one form of the positioning and stabilization structure provides a holding force suitable for a large-sized head rather than a small-sized head. In another example, one form of the positioning and stabilization structure provides a holding force suitable for a small-sized head rather than a large-sized head.

[0391] 5.3.4.3.2 Ventilation Port In one form, the patient interface includes a ventilation port configured and arranged to allow the extrusion of exhaled gas (e.g., carbon dioxide).

[0392] One form of the ventilation port according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0393] The ventilation part can be arranged in the plenum chamber or the shell. Alternatively, the ventilation part is arranged within a disengagement structure (e.g., a swivel).

[0394] 5.3.4.3.3 Disengagement structure(s) In one form, the patient interface includes at least one disengagement structure (e.g., a swivel or ball-and-socket joint).

[0395] 5.3.4.3.4 Connection port The connection port enables connection to the 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 form, 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 valve In one form, the patient interface includes an anti-asphyxiation valve.

[0399] 5.3.4.3.7 Port In one form of the present technology, the patient interface includes one or more ports that enable access to the quantity within the cavity. In one form, this enables a clinician to supply supplementary oxygen. In one form, this enables direct measurement of the characteristics of the gas (e.g., pressure) within the cavity.

[0400] 5.3.5 Arrangement configuration of the support structure and the sealing part The support structure and the sealing part in the above example may have a plurality of different configurations and arrangement configurations.

[0401] In use, the sealing contact between the sealing portion (e.g., a fabric membrane) and the patient's face can be maintained as follows: 1) the tension in the fabric membrane (e.g., a weak tension) and / or the elastic elongation characteristics (e.g., elasticity) of the material of the sealing portion (e.g., a fabric material, an air-impermeable layer material, and / or a composite material of the fabric membrane); 2) the reaction stress of the support structure; 3) the pre-formed state of the fabric membrane with no tension applied and formed as a substantially flat surface without leaks that would cause obstructions (e.g., wrinkles, folds, buckles, or creases) in the fabric membrane; and / or 4) the air pressure within the cavity relative to the inner surface of the sealing portion. Each of these factors can contribute to maintaining a certain tension in the sealing portion such that the sealing portion conforms to the anthropometric profile of the patient's face, thereby achieving minimization of wrinkles or ruptures and maximization of the contact area of the sealing portion.

[0402] In some examples, the sealing portion can include a relatively thin, compliant, and stretchable elastic material (e.g., a fabric membrane including a suitable fabric material (e.g., nylon, polyester, a nylon and polyester mixture, microfiber, or polyurethane)). Before and during use, the sealing portion can be held taut and under tension by the support structure. Since the sealing portion can be shaped or otherwise attached (e.g., by adhesion, use of an adhesive) to the support structure, the sealing portion is pre-tensioned (slightly stretched) such that there are no wrinkles in the material of the sealing portion. Doing so can be advantageous because it ensures the formation of a smooth, continuous seal on the patient's face by the sealing portion (without using any bent sections that could cause air leakage). Further, the sealing portion can be shaped or have curvature imparted thereto, for example, by thermoforming, such that the sealing portion maintains its shape. The curvature can also be imparted to the sealing portion from the support structure.

[0403] For example, as shown in FIGS. 11-17 and FIGS. 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) and can cradle the patient's nose.

[0404] In some forms, for example as shown in FIGS. 10-66, the patient's nose is not intended to be received within a cavity formed by a plenum chamber and a seal-forming structure. Instead, in contrast to conventional masks, the patient's nose is intended to be pressed against the fabric membrane, such that the fabric membrane comfortably forms a reliable seal against the patient's airway corresponding to the outer contour of the patient's face. In this way, the fabric membrane can stretch to conform to the patient's face. The bridge sites 3104 and 1406 extending between the nostril openings can assist in maintaining the fabric membrane in a taut state before and / or during use. The bridge site can also have the function of assisting in providing a sealing portion that presses against the patient's nose instead of receiving the patient's nose within a cavity by eliminating a central opening within the fabric membrane. Thereby, a different sealing experience as compared to conventional masks can also be obtained. Such a sealing experience can improve comfort due to contact with the compliant fabric membrane as compared to conventional masks of stiffer materials or conventional sealing arrangements (where the contact area between the sealing portion and the nose and / or around the mouth is small).

[0405] The sealing portion can be constructed from a single or multiple layers of material (e.g., fabric material). The fabric membrane (and / or the fabric material of the fabric membrane) can exhibit a low spring constant (i.e., be extremely compliant in both warp and weft). In the case of conventional masks (e.g., silicone sealing membranes), discomfort can occur on the patient's skin during the formation of an effective seal due to the fixed cushion. In contrast to this conventional mask, since the present fabric membrane can have a material spring constant and spring length (i.e., the amount of material available for stretching), the present fabric membrane is more compliant than the patient's skin and thus more easily conforms to the features of the patient's face. Thereby, mask comfort can be improved and the formation of "hot spots" of local pressure can be reduced.

[0406] Compared with conventional silicone membranes and compression foam seals, the sealing portion of the present technology has a higher flexible structural rigidity, and thus has dynamic spring-back characteristics, which enables the sealing portion to recover more quickly (when obstructed by an external force). Furthermore, due to the lower structural rigidity, the required sealing force is also reduced, making the sealing portion more comfortable and reducing the occurrence of facial scars during use.

[0407] The fabric membrane can exhibit variable tension across the material (e.g., lower tension can be exhibited in the vicinity of holes or more highly stretched material). In some forms, the material surface of the sealing portion in contact with the patient's face can have low friction characteristics (e.g., low friction finish), which is advantageous because it can improve patient comfort and lead to improved material adaptability to the patient's face.

[0408] The fabric membrane can also include at least one layer that exhibits substantially air-impermeable characteristics while maintaining the resilient elongation characteristics necessary for comfort and minimal pressure points. That is, when a membrane layer or laminate film layer (e.g., a polymer (e.g., silicone, polyurethane, thermoplastic polyurethane (TPU), polyester, nylon)) is added to the fabric material, a substantially airtight material is obtained. In another example, by weaving the fabric fibers tightly, a substantially air-impermeable material is obtained.

[0409] In some forms, the thickness of the fabric material of the sealing portion can be in the range of 0.275 (for example, 0.275 to 0.075 mm, 0.275 to 0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225 to 0.09 mm, 0.225 to 0.095 mm, 0.225 mm, or 0.25 mm) or less. The thickness of the film layer can be in the range of 0.03 to 0.01 mm (for example, 0.015, 0.02 mm, or 0.025 mm). The overall composite material thickness of the fabric material of the sealing portion can be in the range of 0.305 mm or less (for example, 0.305 to 0.085 mm, 0.305 to 0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255 to 0.10 mm, 0.255 to 0.105 mm, 0.25 mm, or 0.275 mm). In an example, a fabric composite including a microfiber fabric and a polyurethane film layer can have these dimensions.

[0410] In another example, the thickness of the fabric material of the sealing portion can be in the range of 0.15 mm to 0.5 mm (for example, 0.2 mm to 0.4 mm, or 0.3 mm to 0.4 mm, or 0.25 mm, or 0.3 mm, or 0.4 mm). The thickness of the film layer can be in the range of 0.03 mm to 0.125 mm (for example, 0.05 mm to 0.1 mm, or 0.075 mm to 0.1 mm, or 0.05 mm to 0.075 mm, or 0.05 mm, or 0.075 mm, or 0.1 mm). The overall composite material thickness of the fabric material of the sealing portion having a film layer can be in the range of 0.18 mm to 0.625 mm (for example, 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 a mixed fabric of nylon and polyester and a silicone film layer can have these dimensions.

[0411] Due to the stiffness and resilience of the support structure, the tensile force may be transferred to the sealing part. The support structure can be formed from a variety of materials (e.g., silicone, foam (e.g., polyurethane foam), solid polyurethane material, thermoplastic elastomer (TPE) (e.g., thermoplastic polyurethane (TPU)), and suitable plastic materials). The support structure can be configured to generate several different cushion shapes, including sealing parts having a single air-assisted sealing part (e.g., fabric film) and a base cushion support layer(s), such as a double air-assisted sealing part (e.g., double fabric film), a sealing part including a compression support part (e.g., open-cell foam, polyurethane foam, gel), a sealing part with TPU, TPE or silicone support, or a double air-assisted sealing part with additional support (e.g., a double fabric film with a foam laminate layer (e.g., open-cell, polyurethane) provided on the inner membrane or a TPU, TPE, polyurethane or silicone molding layer placed thereon).

[0412] The base cushion layer(s) can assist in optimizing the contact surface area between the sealing part and the patient's face. Further, in an example where the sealing part is constructed from a breathable material (e.g., breathable fabric), the base cushion layer(s) can provide a sufficient contact area at the rear side of the sealing part, so that the sealing part with the patient's face is properly sealed and leakage is avoided.

[0413] During use, the engagement between the patient's face 1000 and the sealing part 10130 generates temporary distortion forces that attempt to pull the wall parts of the support structure 10120 towards each other, as shown in FIG. 81. The support structure 10120 responds to this distortion force with an outward pulling reaction force. Due to the reaction force, by preferentially stretching the more compliant sealing part, more tension is transferred to the sealing part 10130 by applying the spring force generated within the sealing part to the patient's face.

[0414] In some examples, the support structure may include a biasing portion that uses internal air pressure to dynamically support the support structure and the sealing portion. By doing so, additional support for the sealing portion may be advantageously obtained under dynamic loads (e.g., tube drag).

[0415] Also, the air pressure within the cavity and the action on the inner surface of the sealing portion may enable the surface of the fabric film to be held without micro-wrinkles, wrinkles, buckling, or creases when presented to the patient's face (e.g., by tension generation in the sealing portion), whereby the sealing portion may substantially fill and press against the contour of the patient's face (e.g., around the sides of the nose). As a result, the compliant sealing portion may be able to form a larger seal contact area on the patient's face. The tension in the sealing portion generated by the air pressure within the cavity may also be advantageous in providing a continuous seal even when the mask is partially displaced from an optimal positioning on the patient's face. This is because the sealing portion may be able to partially expand (due to the opposing force from the internal air pressure) (i.e., the "hovercraft effect").

[0416] Even in an example where the fabric film is not under a constant tension (e.g., is also non-elastic), since the sealing portion is thinner and has a lower structural stiffness than the support structure, the sealing portion may be maintained in a sealing contact state with the patient's face by the air pressure within the cavity and may form an improved air-assisted seal on the patient's face that dynamically conforms to changes / movements (i.e., the "hovercraft effect").

[0417] By forming the sealing portion on the inner edge of the support structure or, in other cases, attaching the sealing portion to the inner edge of the support structure, the sealing portion can be integrated with the support structure. Thus, for example, when attaching the outer periphery of the sealing portion to the inner edge of the support structure, the sealing portion can be extended inward in the radial direction of the seal formation structure so as to extend beyond the support structure or over a wider range than the support structure. Since the inner edge of the support structure can be curved, the sealing portion can be slightly angled inward toward the inside of the mask. By attaching the sealing portion along the inner edge of the support structure, it becomes unnecessary to crease or cut the sealing portion to conform it to the corners of the support structure. Thereby, the occurrence of protruding creases or wrinkles (which may cause leakage) in the sealing portion can be advantageously reduced, and thereby the seal performance can be improved.

[0418] As described above, the seal formation structure may be removably connected or fixedly attached to the plenum chamber. In some forms, the sealing portion may have a removable structure or a modular structure. For example, the sealing portion can be attached along the perimeter to a support frame structure. The support frame can be removably attached to the support structure as a module. The sealing portion can be attached to the support frame so as to reduce the situation where creases or wrinkles protrude on the fabric surface. Using a modular arrangement configuration makes it possible to perform complex joints in a state without simple stress, which can substantially lead to simplification of the manufacture of the sealing portion (for example, a fabric sealing portion). It may be possible to process the sealing portion to have substantially self-cleaning properties, but using a modular sealing portion can also provide a cheaper and more hygienic alternative.

[0419] The support frame can be pre-formed to have a flat shape or a three-dimensional shape (e.g., an arcuate shape) so as 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 positioning pins / holes, dovetails).

[0420] The sealing portion can have an underlying cushion support layer(s) (e.g., a second cushion layer, a third cushion layer or subsequent cushion layers) therein. The underlying cushion layer(s) can provide additional flexibility and make the cushion suitable for use on most patients' faces (e.g., can fit most in one size). For example, the sealing portion can be constructed as: a dual air assist type sealing portion (e.g., a dual fabric film), a sealing portion including a compression support layer(s) (e.g., open cell foam, polyurethane foam, gel), a sealing portion with a TPU, TPE or silicone support layer(s), or a dual air assist type sealing portion with additional support layer(s) (e.g., a dual fabric film with a foam laminate layer (e.g., open cell, polyurethane) provided on the inner membrane or a TPU, TPE, polyurethane or silicone molding layer placed thereon).

[0421] In some examples, the support layer can be supported by a rigid structure (e.g., plastic (e.g., polypropylene (PP), polycarbonate (PC), polyamide (PA) or polyethylene terephthalate (PET))).

[0422] In some examples, 3D printing the seal portion, support layer, and / or support structure as a "skeleton" can lead to a reduction in the structural thickness, which can also result in a reduction in the importance of the mask. Also, different layers of the mask can be printed with different rigidities, hardnesses, or thicknesses. For example, the "skeleton" member can be formed using silicone, foam (e.g., polyurethane foam), polyurethane (e.g., solid polyurethane 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 Woven Fabric Membrane According to an example of the technology of the present disclosure, the sealing formation structure can include a woven fabric membrane including a woven fabric material. An airtight membrane / film or layer can be coated on or otherwise added to the woven fabric material to obtain an air-retaining woven composite. After cutting (e.g., die cutting, ultrasonic, laser, or RF) the woven composite into a desired shape, it can be attached to the support structure. The resulting woven seal portion (or woven fabric membrane) can be attached to the support structure (e.g., silicone, TPE) by, for example, overmolding or injection molding. In another example, the woven seal portion can be heat welded onto the support structure material (e.g., silicone, TPE) at its own edge (outer perimeter).

[0424] A woven fabric is a material that includes at least one natural or artificial fiber (e.g., spun yarn or sewing thread). The fiber can be a filament (mono or poly), strand, sewing thread, or twisted yarn. The fiber(s) can 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). The woven fabric can be formed by various techniques (e.g., weaving, knitting, crocheting, knotting, tufting, bonding, felting, taffeta, or braiding), including, for example, woven fabric materials and non-woven materials (e.g., by knitting together or interlacing one or more of the above fibers).

[0425] In one example, the fabric material is a knitted material. A reason why the knitted material may be suitable is that when using the knitted material, elasticity (e.g., stretchability) can be obtained in the fabric (especially as compared to the fabric material). By doing so, it can be advantageous because comfort for the patient can be obtained as described below. The elasticity can be obtained in all directions (e.g., four-way stretch / elasticity (e.g., substantially equal elasticity in all directions)), and can be obtained at least in the left-right lateral direction of the fabric film. The fabric material may have, for example, a weft-knit structure or a warp-knit structure. A reason why the weft-knit structure is more desirable is that the elasticity of the weft-knit fabric is higher than that of the warp-knit fabric.

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

[0427] 5.3.5.1.1 Manufacturing In an example, an overmolding process may be used for the construction of a seal-forming structure having, for example, a flexible support structure (e.g., silicone) attached to the fabric film.

[0428] As shown in Figure 117, in step 10, an airtight fabric composite can be formed by combining the fabric material with an impermeable material. When attaching the impermeable layer to the fabric material as shown in Figure 78, for example, a thermal process may be used. The fabric composite may have a flat shape (e.g., sheet shape).

[0429] In step 12, the fabric composite can be cut into a desired shape according to a specific cushion assembly intended for use.

[0430] In step 14, when a support structure (e.g., silicone) is overmolded onto the fabric composite, a seal-forming structure can be formed together with the fabric membrane. When the fabric composite is held in place by a vacuum, the fabric composite has a non-flat pre-defined shape during the overmolding process. That is, when a flat fabric composite is overmolded with a support structure, a curvature is imparted to the fabric composite, forming a fabric membrane that can have a curvature (without generating small wrinkles, folds, creases, and / or buckling into the fabric membrane). As can be seen from FIG. 33-1, the fabric membrane can 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 fabric membrane can have a radius of curvature (e.g., the same or a similar radius of curvature) along the curved portion 35. Since a pre-defined curvature can be imparted to the fabric membrane, a portion of the fabric membrane that is not directly supported by the support structure extends along the curved portion 35 (FIGS. 33-2 to 33-4). As described above, the fabric membrane can also have dome-shaped and saddle-shaped curvatures, for example, in other regions of the fabric membrane. The fabric membrane has a concave curved profile (e.g., a positive curvature in the left-right direction) from one lateral side (right) to the opposite lateral side (left), which is imparted during the overmolding process and maintained by connection to the support structure (see, for example, FIGS. 11 to 17, FIGS. 23 to 27, and FIGS. 33 to 37). In another example, the fabric membrane can have a negative curvature (which can be imparted during the overmolding process) in the down / up direction and can be maintained by connection to the support structure (see, for example, FIGS. 18 to 22).

[0431] The support structure can be shaped onto the fabric composite such that the outer surface of the seal-forming structure is smooth and seamless in the transition from the support structure to the fabric membrane (see FIG. 33-4). The support structure can be joined to the impermeable material of the fabric membrane. The outer surface of the seal-forming structure can be smooth and seamless, but a step can be provided on the inner surface of the seal-forming structure if the thickness of the support structure is different from the thickness of the impermeable layer (e.g., greater).

[0432] The seal forming structure is formed by an overmolding process to impart curvature to the fabric film without causing any small wrinkles, folds, creases and / or buckling in the fabric film.

[0433] 5.3.5.1.2 Examples of fabric films The exemplary properties and structural arrangements of the fabric composites used as materials for the fabric film are described below.

[0434] 5.3.5.1.2.1 Fabric composite structure A variety of combinations of fabric 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 disposed between two fabric layers (e.g., a mixture of nylon, nylon and polyester, a mixture of nylon and spandex, a mixture of polyester and spandex, or a mixture of nylon / polyester / spandex). A further fabric layer is required to protect the TPU film from damage (e.g., during cleaning).

[0435] In another example, a two-layer configuration is used that includes a fabric (e.g., a mixture of nylon, nylon and polyester, a mixture of nylon and spandex, a mixture of polyester and spandex, or a mixture of nylon / polyester / spandex) having a silicone layer (e.g., as placed as a coating). In the case of this composite material, only one layer of fabric is required and it can be less expensive than the three-layer configuration described above.

[0436] In another example, a fabric material (e.g., a microfiber or a polyurethane material) can be coated with a polyurethane film to form a two-layer configuration.

[0437] 5.3.5.1.2.2 Fabric materials As described above, a plurality of textile materials can be used to form the sealing part (e.g., nylon, polyester, spandex, a mixture of nylon and polyester, a mixture of nylon and spandex, a mixture of polyester and spandex, a nylon / polyester / spandex mixture, microfiber or polyurethane).

[0438] In one example, a nylon material is used. Since nylon is softer than polyester, the benefit of comfort can be provided to the patient. Since nylon is also stronger than polyester, an improvement in lifespan and durability is obtained. Furthermore, since nylon has a higher melting temperature compared to polyester, it can withstand higher temperature manufacturing conditions.

[0439] In another example, a mixture material of nylon and polyester is used. This material is more desirable because the addition of polyester results in lower moisture absorption and thus less irritation to the patient. The mixture of nylon and polyester is also less expensive than nylon.

[0440] 5.3.5.1.2.3 Textile Material Thickness In one embodiment, the thickness of the textile material of the sealing part can be in the range of 0.15 mm to 0.5 mm (e.g., 0.2 mm to 0.4 mm, or 0.3 mm to 0.4 mm, or 0.25 mm, or 0.3 mm, or 0.4 mm). Such a thickness can be suitable for a nylon material or a mixed material of nylon and polyester.

[0441] In another embodiment, the thickness of the textile material of the sealing part can 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 a thickness can be suitable for a microfiber textile material or a polyurethane textile material.

[0442] 5.3.5.1.2.4 Air-impermeable layer thickness In an example where silicone is used as the film / film layer, the thickness of the silicone can be in the range of 0.03 mm to 0.125 mm (for example, 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 (for example, 0.05 mm) may lead to weight reduction of the product, and higher stretchability can be obtained compared to a thicker silicone layer (for example, 0.1 mm), so it may be more desirable. However, a thicker silicone layer (for example, 0.1 mm) has higher durability than a thinner layer (for example, 0.05 mm).

[0443] In another example, a polyurethane film is used as the film layer, and the thickness of the polyurethane film can be 0.03 to 0.01 mm (for example, 0.015, 0.02 mm or 0.025 mm).

[0444] 5.3.5.1.2.5 Overall thickness of the fabric composite In an example where the fabric material is coated with a silicone film / film layer, the thickness of the overall composite material can be in the range of 0.18 mm to 0.625 mm (for example, 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] A thicker fabric film thickness (for example, 0.5 mm) can be more robust and the traces can be thinner. These fabric films are less likely to flutter, so handling during manufacturing can be easier.

[0446] Using an intermediate level of thickness (for example, 0.35 mm to 0.45 mm) can result in a flexible lightweight structure, the handling during manufacturing becomes relatively easy, and higher comfort can be provided to the patient compared to the case of a thicker fabric film.

[0447] In the case of a thinner fabric membrane, a very lightweight structure can be obtained, and a soft and comfortable feel can be provided to the patient, but the durability can be lower than that in the case of a thicker fabric membrane.

[0448] In an example where the fabric 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 Knitted structure The fabric material of the fabric membrane can have, for example, a weft-knit structure or a warp-knit structure. In the case of a weft-knit fabric, a material with higher elasticity than a warp-knit fabric is obtained, so a weft-knit fabric is more desirable. In the case of this knitted fabric, when the patient's face stretches when engaging with the fabric membrane, the force added from the fabric membrane to the patient's face can be reduced, so higher comfort can be provided to the patient.

[0450] In one example, since the weft direction can have higher elasticity or stretch, the weft direction (the direction of path 80) can extend in the nasal width direction of the fabric membrane. Alternatively, the weft direction can extend in the nasal length direction (vertical direction).

[0451] Furthermore, weft knitting is more suitable for the production of relatively thin materials as disclosed herein, for example. Also, weft knitting is generally less expensive than warp knitting.

[0452] However, in some examples, warp knitting is more desirable because it has less shrinkage than weft-knit materials.

[0453] 5.3.5.1.2.7 Knitting machine The weft knitted fabric material can have a single jersey knit structure that provides a technical front and a technical back with different appearances. The single jersey knit can be formed by a set of needles and can provide knitting stitches on the technical front (front) and purl stitches on the technical back. In one example, the technical front can form the outer surface of the fabric film, and the air-impermeable film can be attached to the technical back. Alternatively, the technical front can be directed towards the inner surface of the fabric film to which this film is attached. In another example, the fabric can be an interlock knit.

[0454] In an example where the fabric film includes an air-impermeable film sandwiched between two fabric layers, the exposed surface of the fabric film can be formed by the technical front of each fabric material.

[0455] 5.3.5.1.2.8 Fabric weight The weight of the fabric material is in the range of 95 grams per square meter (gsm) to 130 gsm (for example, 105 gsm to 120 gsm, or 110 gsm to 115 gsm, or 105 gsm, or 110 gsm, or 120 gsm). In the case of a higher weight fabric (for example, 120 gsm), due to the high weight / thickness, it can provide a desirable comfortable fabric feel even after being coated by a laminate layer. In the case of a lower weight fabric (for example, 105 gsm), it is more desirable because it enables weight reduction of the product.

[0456] 5.3.5.1.2.9 Machine gauge The machine gauge of the fabric material (i.e., the number of stitches per inch) can vary. For example, the machine gauge can be in the range of 35GG to 70GG (for example, 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" (for example, E35 to E70).

[0457] Using a relatively larger gauge material (e.g., 44GG) is desirable because it provides more options for the mélange material. However, using a finer gauge material (e.g., 60GG) is also desirable because it increases material flexibility and can lead to improved patient comfort.

[0458] 5.3.5.1.2.10 Aesthetics The fabric material can have a solid color aesthetic or a mélange aesthetic. The mélange material can be considered as a material made with more than one color of fabric / yarn, made with or later individually dyed different fabrics / yarns of different colors. In the case of the mélange material, it is desirable because the ability to conceal dust or dirt is higher, making it easier to improve the cleanliness of the product. In the case of the mélange material, it can also be useful during manufacturing because it is easier to visually and accurately align the fabric weave structure during cutting and / or overmolding.

[0459] However, in the case of the solid color material, it is desirable because there is an increased option for a finer gauge material (e.g., 55GG+) that is softer and more comfortable for the patient.

[0460] 5.3.5.1.3 Fabric Membrane with an Air-Iimpermeable Silicone Layer In another example, an air-impermeable silicone layer 32130-2 that can be included in the sealing part 32130 (or fabric membrane) is provided (e.g., coated) on the fabric material 32130-1 as shown in FIGS. 118 to 120.

[0461] The silicone layer 32130 can enable the sealing part 32130 to have flexibility and stretchability (while also providing the outer surface of a silicone layer with a smooth feel and excellent durability and abrasion resistance).

[0462] Since the sealing portion 32130 can have the same or similar stretchability / elasticity and tensile strength characteristics in both the fabric direction and the path direction, it can adapt to various facial features and achieve an effective and robust seal against the patient's face.

[0463] The overall thickness of the sealing portion 32130 can be in the range of 0.2 mm to 0.46 mm (for example, 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] Note that the values of any material property (singular or plural) described anywhere in this disclosure can be applicable to this example of the fabric film (for example, in addition to any property or value described in this section).

[0465] 5.3.5.1.3.1 Fabric Material The fabric material 32130-1 to which the silicone layer 32130-2 is applied can be an elastic knitted (for example, weft knitted) fabric material.

[0466] The fabric material can have a single jersey knit structure with a machine gauge in the range of 30 to 60 GG (for example, 35 GG to 55 GG or 44 GG to 60 GG or 40 GG to 50 GG or 55 GG to 60 GG or 44 GG or 50 GG or 55 GG or 60 GG). This single jersey knit structure provides different appearances for the technical side and the technical back side. As described above, a single jersey knit can be formed by a set of needles, providing knit stitching on the technical side (front) and welt stitching on the technical back side. In the example, the technical side can form the outer surface of the fabric film that contacts the patient's skin, and the silicone layer 32130-2 can be attached to the technical back side. Alternatively, the technical side can be directed towards the inner surface of the fabric film, and the silicone layer can be added to the technical side. In another example, the fabric material can have an interlock knit structure.

[0467] The textile material can be produced by dopant dyeing, piece dyeing or yarn dyeing so as to obtain a solid color or mélange fabric.

[0468] The textile material 32130-1 can include nylon (e.g., nylon 6), polyester, spandex, Lycra and / or LYCRA. For example, the textile material can include nylon (or polyester or a nylon / polyester mixture) and elastane (e.g., spandex (or Lycra or LYCRA)). In an example, the textile material can include 75 to 95% (e.g., 80%, 85%, 90% or 95%) of nylon (or polyester or a nylon / polyester mixture) and 5 to 25% (e.g., 5%, 10%, 15% or 20%) of elastane (e.g., spandex (or Lycra or LYCRA)). In other examples, spandex (or Lycra or LYCRA) can exceed 25% and nylon (or polyester or a nylon / polyester mixture) can be less than 75%.

[0469] The count of nylon 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 count of the nylon / polyester mixture can be FDY (or DTY) (20 - 80D / 17 - 144F). In other examples, the denier of nylon, polyester, and / or the nylon / polyester mixture can be, for example, 30 - 70D, 40 - 60D, 20 - 30D, 20 - 50D, 50 - 70D, 20D, 40D, 60D, or 80D. Further, in other examples, the number of filaments of nylon, polyester, and / or the nylon / polyester mixture can be, for example, 20 - 130F, 40 - 110F, 60 - 90F, or 70 - 80F. These yarns can be multifilament yarns as indicated by the number of filaments described above. Spandex (or Lycra or like) 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 partially determine the thickness, density, elasticity, and / or handfeel of the fabric.

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

[0471] As described above, the fabric material can have elasticity in all directions (e.g., four-way stretch / elasticity (e.g., can have substantially equal elasticity in all directions (i.e., can have substantially equal stretchability / elasticity in the weaving direction and the course direction as well as in the left-right direction of at least the lateral direction of the fabric film)). The fabric material can be stretched without curvature at the weaving edge. The stretchability / elasticity of the fabric material promotes the stretchability / elasticity of the fabric film in all directions, whereby it adapts (e.g., stretches and adapts) to the outer shape of the patient's face without the occurrence of folds or wrinkles and without the occurrence of discomfort to the patient.

[0472] The fabric material is made for silicone coating, molding or lamination, and no silicone softening agent is added to the fabric surface. This is because the use of such agents can cause peeling and affect the bonding strength of the fabric.

[0473] It should be noted that the bonding strength between the fabric material 32130-1 and the silicone layer 32130-2 can be affected due to the surface texture or roughness of the yarn. Since a relatively higher surface roughness makes the bonding easier, the bonding strength is also higher. Furthermore, since multifilament yarns have a larger surface area compared to monofilament yarns, the bonding strength between the fabric material and the silicone layer is higher.

[0474] It should be noted that the use of a crosslinking agent can provide chemical bonds. However, in the example, no crosslinking agent is present, so only physical bonding is provided.

[0475] The fabric material 32130-1 forming the patient contact side of the sealing part 32130 may have the same or similar surface friction and roughness in both the fabric direction and the path direction, so that the bonding force of the silicone layer 32130-2 to the fabric material becomes substantially uniform in all directions (i.e., over the entire surface of the fabric material). Thereby, it is possible to avoid the peeling of the silicone layer 32130-2 from the fabric material. The same or similar surface friction and roughness in the fabric direction and the path direction also provide a soft and smooth surface on the patient contact side, making it comfortable for the patient. In an example, the average value of the coefficient of friction (MIU) in the fabric direction and the path direction can be 0.7 to 5.0 (for example, 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). Further, the average deviation of the surface roughness (SMD) in the fabric direction and the path direction can be 0.7 to 5.0 (for example, 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 average value of the coefficient of friction (MIU) in the fabric direction and the path direction based on the surface test method KES-FB4 on a sample with dimensions of 200mm x 200mm can be 0.3 to 2.0 (for example, 0.5 to 1.8, 0.8 to 1.5 or 1.0 to 1.5, 0.5, 1.0, 1.5 or 2.0). Further, the average deviation of the surface roughness (SMD) in the fabric direction and the path direction can be 0.3 to 2.0 (for example, 0.5 to 1.8, 0.8 to 1.5, 1.0 to 1.5, 0.5, 1.0, 1.5 or 2.0).

[0477] The fabric material may have high pilling resistance and excellent anti-snagging properties (for example, both are grade 5 (i.e., almost no pilling formation and almost no snagging)).

[0478] The sealing part 32130 can be made stronger in the fabric direction and more extensible in the path direction, so that the dimensional stability during the stretching of the sealing part is improved.

[0479] The thickness of the fabric material 32130-1 can be from 0.18 mm to 0.32 mm (for example, from 0.2 mm to 0.3 mm, from 0.2 m to 0.28 mm or from 0.225 mm to 0.275 mm).

[0480] 5.3.5.1.3.2 Air-impermeable silicone layer The silicone layer 32130-2 can have a see-through or transparent appearance.

[0481] The thickness of the silicone layer 32130-2 can be in the range of 0.04 mm to 0.125 mm (for example, 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). Thereby, a highly durable and tough air-impermeable layer is obtained. However, it should be noted that since the silicone layer penetrates into the fabric material during curing, the thickness of the silicone layer 32130-2 may not be uniform across the sealing portion 32130.

[0482] 5.3.5.2 Diagrammatic examples of the arrangement configurations of the support structure and the sealing portion Figures 81 to 112 show a plurality of different cushion assembly configurations including various support structures and sealing portion arrangement configurations and / or processes. It should be noted that these examples can be applied to any of the patient interfaces and / or cushion assemblies described in the present disclosure. Furthermore, any feature of any example can be applied to different examples and / or used in combination with different features. The plenum chamber, support structure and sealing portion shown in these figures can be constructed from any of the appropriate materials described above. It should also be noted that components such as the support structure can include more than one material. For example, the base cushion of the support structure can include a material different from the support structure.

[0483] Referring to FIG. 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 the cavity 10001. In some examples, the clip 10126 can be formed from polyurethane, polypropylene (PP), or polyethylene terephthalate (PET). The plenum chamber 10200 can be constructed from a material that is more rigid than the clip (e.g., polycarbonate or polyurethane with a higher Shore A hardness than the clip). The support structure 10120 and the sealing portion 10130 are configured within a cushion arrangement having a single air-assisted sealing portion 10130 (e.g., a fabric film).

[0484] The connection between the outer periphery (or outer edge) of the fabric film and the inner edge of the support structure can be formed in a plurality of different manners. As shown in FIGS. 83 and 85, this connection can form an overlap joint where the edge of the fabric film overlaps the edge of the support structure. In an example, a recess for receiving the sealing portion 10130 is formed by the attachment site 10122 of the support structure, and a smooth outer surface is formed by the support structure and the sealing portion as shown in FIG. 83. This overlap can be minimal and provided only for manufacturing purposes (i.e., necessary for attaching the sealing portion and the support structure (e.g., by overmolding and / or injection molding)). In the case of a conventional arrangement, the overlap region can be arranged to provide additional support (e.g., stiffness) to the sealing portion due to the presence of the support structure (in such an arrangement, this overlap can vary around the seal-forming structure to vary the level of support or stiffness (e.g., reduction in overlap, reduction in support, higher flexibility, reduction in tension in the high-sensitivity nasal bridge region), which is in contrast to the above).

[0485] In contrast to the above-described overlapping joint, a connection between the fabric membrane and the support structure can form a joint from end to end (e.g., a butting joint) as shown in FIG. 84. Due to manufacturing techniques (e.g., overmolding, injection molding), the joint from end to end can have a certain overlap, but such an overlap is small and constant enough to be negligible around the sealing portion in the connection with the support structure. In other words, as described above, all the overlaps of the support structure and the fabric membrane are not designed to adjust the stiffness, tension, flexibility, or support in different regions of the face (e.g., reducing overlap, reducing support, increasing flexibility, reducing tension in the sensitive nasal bridge region).

[0486] Instead, whether an overlapping joint is provided or a joint from end to end is provided, using this arrangement configuration, the flexible fabric membrane can appropriately correspond to the characteristics of the patient's face. That is, this seal-forming structure is designed such that the characteristics of the patient's face (e.g., the nose) sink into the fabric membrane that gently accepts the patient's face.

[0487] The sealing portion may be adhered to or molded (e.g., overmolded or injection molded) onto the support structure, or may be attached to the support structure by other means. In another example, as shown in FIG. 84, the recess can be removed, and the sealing portion 10130 and the support structure 10120 can be attached from end to end using the attachment site 10122. Further, FIG. 84 shows that the portion (d1) of the support structure 10120 adjacent to or connected to the plenum chamber 10200 can be thicker than the portion (d2) of the support structure 10120 adjacent to or connected to the sealing portion 10130, so that structural stability in the connection with the plenum chamber and flexibility in the interface with the patient can be obtained.

[0488] In FIG. 85, the support structure 10120 includes a base 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 mounting portion 10122 of the support structure may be configured to sandwich the ends of the sealing portion between the opposing portions of the mounting portion 10122.

[0489] In another example, as shown in FIG. 86, the plenum chamber 11200 may have a base cushion 11121 mounted therein. Thus, while the base cushion 11121 may be permanently attached to the plenum chamber 11200, the support structure 10120 and the sealing portion 10130 may be removably connected to the plenum chamber via clips 10126 and connectors 10210.

[0490] Referring to FIGS. 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 the sealing portion 10130. Since the support structure 10120 may include inwardly curved ends 10142, an air-assisted support region 10144 is formed. The air-assisted support region 10144 acts on the support structure and the sealing portion by optimizing the force due to the air pressure in the cavity, biasing the sealing portion into sealing contact with the patient's face.

[0491] Referring to FIG. 89, the support structure 12120 includes a base cushion 12121. The support structure and / or the base cushion may be formed, for example, of 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 a base cushion 15121. In this example, the support structure is formed by a foam (e.g., polyurethane foam molding), but it may be formed of TPE, TPU, or any other suitable material. As shown in FIG. 90A-1, the sealing portion 10130 may have a film layer or film laminate layer 10131 that provides a substantially airtight material. Alternatively, the support structure 15120 may be adhered, joined, or attached to the plenum chamber 10200 by other means.

[0493] FIG. 90B shows an example similar to the example of FIG. 90A, but the sealing portion 10130 in FIG. 90B is directly connected to the plenum chamber 10200, and a seamless cover may be formed on the base cushion 15121. The sealing portion 10130 and the base cushion 15121 may be adhered or joined to the plenum chamber 10200 in other ways. Alternatively, the sealing portion 10130 and / or the base cushion 15121 may be removably connected to the plenum chamber.

[0494] Referring to FIG. 91, the support structure 17120 includes a first portion 17123 and a base cushion 17121. The first portion 17123 may be connected to the plenum chamber and may be constructed of a material having a higher rigidity than the material of the base cushion 17121. For example, both the first portion 17123 and the base cushion may be constructed of polyurethane, but the polyurethane material of the first portion may have a higher hardness than the material of the base cushion. The reinforcing member 17125 may extend along the outer periphery of the cushion spanning the intersection between the first portion 17123 and the base cushion 17121 to provide structural support.

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

[0496] As shown in FIG. 93, the support structure 24120 may include a rigid clip 24126 that supports a base cushion 24121. The base cushion 24121 may include an outer fabric layer 10132 and an inner layer (e.g., constructed of foam) encapsulated by a fabric layer and a clip. The support structure 24120 may be removably connectable to a cushion (e.g., a frame, a 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 as a unit to the cushion (e.g., a frame, a plenum chamber, or other part of the support structure). The sealing portion 10130 may be connected to the base cushion 24121, for example, by thermoforming. The base cushion may also be formed by thermoforming.

[0497] Referring to FIG. 94, the support structure 18120 may include a rigid clip 18126 that supports a base cushion 18121 (e.g., constructed of foam). The support structure 18120 may be removably connectable to a cushion (e.g., a frame, a 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 a cushion (e.g., a frame, a plenum chamber, or other portion of the support structure) as a unit. The sealing portion 10130 may be attached to the base cushion 18121, for example, by thermoforming. The base cushion may also be formed by thermoforming.

[0498] Referring to FIG. 95, the support structure 19120 includes a first portion 19123 and a base cushion 19121. The first portion 19123 may be connected to a plenum chamber and may be constructed of a material having a higher rigidity than the material of the base cushion 19121. For example, the first portion may be constructed of polyurethane, and the base cushion may be constructed of foam.

[0499] Referring to FIG. 96, the support structure 20120 includes a first portion 20123 and a base cushion 20121. The first portion 20123 may be connected to a plenum chamber and may be constructed of a material having a different rigidity or Shore A hardness than the material of the base cushion. For example, both the first portion 20123 and the base cushion 20121 may be constructed of polyurethane, while the first portion 20123 may have a lower rigidity or higher rigidity or higher Shore A hardness or lower Shore A hardness than the base cushion 20121. In another example, the first portion 20123 and the base cushion 20121 may be constructed of the same material and may have the same rigidity or Shore A hardness.

[0500] The support structure 21120 in FIG. 97 includes a first part 21123 and a base cushion 21121, and is similar to the support structure 20120 described above, except that a second sealing layer (e.g., the fabric layer 10132) forming a double woven fabric film is included in the cushion. The base cushion 21121 may be molded or attached in other ways under the fabric layer 10132.

[0501] Referring to FIG. 98, the support structure 22120 includes a first part 22123 and a base cushion 22121, and is similar to the support structure 21120 described above, except that the base cushion 22121 is a laminated foam layer or is attached in other ways under the fabric layer 10132.

[0502] Referring to FIG. 99, the illustrated cushion assembly includes a double sealing structure without base cushion support. The cushion assembly includes a first fabric layer 10130 and a second fabric layer 10132 connected to the 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 section. The support section 10135 can be constructed, for example, by TPU or foam (e.g., polyurethane foam molding). With the support section 10135, resilience can be imparted to the sealing section, and the fabric layer can bounce back more quickly from an external force. The support section 10135 can be removably connected to the support structure 10120 as a modular unit with a fabric layer. In another example, the support section 10135 is removably connected to a plenum chamber.

[0504] Referring to FIGS. 101 and 102, the sealing portion modular assembly 26400 can be permanently or removably connected to the support structure 26120 (or to the plenum chamber 10200, for example, by mechanical clips). The sealing portion modular assembly can include a skeleton support frame 26450 to which the sealing portion 10130 is attached. The sealing portion 10130 may be thermoformed or insert molded, for example, to attach the sealing portion to the support frame 26450. The sealing portion can be formed and held in a curved or three-dimensional shape by the thermoforming process or the molding process and / or by the support frame itself. The support structure 26120 can be constructed, for example, of insert molded polyurethane.

[0505] In the example of FIG. 103, the fabric film 10130 and / or the support structure can be removable or configured as modular. As shown in FIG. 103, the fabric film 10130 can be attached to the modular support structure 26480 at the periphery. Next, the modular support structure 26480 can be removably engaged to the plenum chamber as a module. By using a modular formation, the protrusion of creases or wrinkles on the fabric film surface can be advantageously reduced.

[0506] In some forms, the fabric film can be a sleeve or sock and can be adapted to cover and hold above the plenum chamber or support structure.

[0507] With the modular fabric film seal, all complex joints can be made in a state without simple stress, which can also substantially lead to simplification of manufacturing. Some fabrics can be processed to have substantially self-cleaning properties, but with the modular fabric film, a cheaper and more hygienic alternative can also be advantageously obtained. In some forms, the fabric film or the support structure can be a removable and / or replaceable sub-assembly and can be attached to the plenum chamber, the support structure or the frame assembly.

[0508] In the form in which the fabric film is attached to the support frame of the modular support structure 26480, the support frame may be pre-formed flat (as shown in FIG. 103) or pre-formed as a 3D structure such as an arc.

[0509] In some forms, the modular support structure 26480 may engage the plenum chamber through corresponding male / female positioning pins / holes. In some forms, the modular support structure may form an effective airtight seal with the plenum chamber using a rabbet arrangement around the peripheral side of the structure. The modular support structure 26480 may be formed of, for example, a plastic material, polyurethane or similar material.

[0510] Referring to FIGS. 104-106, a process of insert molding a sealing portion (e.g., a fabric material) as in-mold decoration (IMD) is illustrated. As shown in FIGS. 104 and 105, when the first mold 26500 is brought into contact with the second mold 26550, the sealing portion 10130 can be attached to the support frame 26450 while imparting a curvature to the sealing portion. Due to this molding process, the sealing portion 10130 can also be stretched, so that when the sealing portion is attached to the support frame 26450, the sealing portion is maintained in a taut state before use.

[0511] Referring to FIGS. 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. By spacing the upper support frame portion 27202 from the lower support frame portion 27204, an elastic region 27108 is formed. In the elastic region 27108, the sealing portion stretches and the upper support frame portion 27202 and the lower support frame portion 27204 are spaced apart, enabling it to accommodate patients with a range of face sizes.

[0512] As shown in FIGS. 109 and 110, it may be possible to scan a patient's face to generate a custom mask. To obtain a three-dimensional profile, a face scan can 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., a foam) between the support element and the sealing portion. As shown in FIG. 84, the cushion assembly may be arranged to stretch so as to accommodate patients of 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 specific folds or pivot points. For example, a thinner region of the support structure may be designed to create a fold or pivot point. In an example, the lower central portion of the support structure 3120 (e.g., the nasal base region 3112) may be made relatively thinner, 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, whereby the left and right lateral portions of the support structure deform inwardly to cradle the patient's face (e.g., the nose), making it possible to accommodate the patient's engagement. The upper front region 3109 may also be made thinner compared to the lateral support region 3122, so that a fold or pivot point is created.

[0514] Thus, in the examples of FIGS. 111 and 112, the support structure 3120 can have three regions with different stiffnesses (e.g., by having different thicknesses). The thickness of the upper front region 3109 can be the same as or greater than the thickness of the nasal base region 3112. The thickness of the lateral support region 3122 can be made greater than the thicknesses of the upper front region 3109 and the nasal base region 3112. Thus, the lateral support region can be more rigid than the upper front region 3109, and the upper front region 3109 can be more rigid than the nasal base region 3112. Note that both the plenum chamber and the support structure can be formed of a flexible material (e.g., silicone) and can be molded into a one-piece structure (e.g., integrally molded). Thereby, the bending / folding / pivoting of the cushion assembly to accommodate the features of the patient's face can be assisted. In one embodiment, the seal-forming structure can be an extension of the plenum chamber such that the seal-forming structure is included in the plenum chamber, or alternatively, can be formed as part of the plenum chamber. In such an example, the support structure and the fabric membrane can be considered part of the plenum chamber.

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

[0516] In one form, the RPT device 4000 is constructed and arranged to deliver an air flow 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 external housing 4010. The external housing 4010 is formed by two parts, an upper part 4012 and a lower part 4014. Further, the external housing 4010 may include one or more panels 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 pneumatic path of the pneumatic RPT device 4000 may include one or more pneumatic circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0519] One or more of the pneumatic path items may be arranged within a removable integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be arranged within the external housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 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 treatment 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 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0521] 5.5 Glossary For the purposes of the disclosure of the present technology, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may also apply.

[0522] 5.5.1 General Air: In certain forms of the technology, air may mean the atmosphere, and in other forms of the technology, air may mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0523] Atmosphere: In certain forms of the technology, the term “atmosphere” should be taken to mean (i) outside of the treatment system or the patient, and (ii) that which directly surrounds the treatment system or the patient.

[0524] For example, the ambient humidity for a humidifier may be the humidity of the air directly surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0525] In another example, the ambient pressure may be the pressure directly surrounding or outside of the body.

[0526] In certain forms, the ambient (e.g., acoustic) noise can be considered to be the background noise level in the room where the patient is located, for example, other than noise generated from an RPT device or from a mask or patient interface. The ambient noise can originate from sources outside the room.

[0527] Auto Positive Airway Pressure (APAP) Therapy: A form of CPAP therapy that can automatically adjust the treatment pressure between a minimum and a maximum, for example, in response to the presence or absence of signs of SDB events during breathing.

[0528] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the treatment pressure is substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet may increase slightly during exhalation and decrease slightly during inhalation. In some forms, the pressure varies between different respiratory cycles of the patient (e.g., increased in response to detection of signs 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. The flow rate can refer to the instantaneous amount. In some cases, when referring to the flow rate, it can refer to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to the flow rate, it can refer to a vector quantity (i.e., a quantity having both magnitude and direction). The flow rate may be given the symbol Q. The "flow rate" may be abbreviated as "flow" or "airflow" in some cases.

[0530] In an example of a patient's breathing, the flow rate can be nominally positive pressure with respect to the inhalation portion of the patient's breathing cycle and thus negative with respect to the exhalation portion of the patient's breathing cycle. The total flow rate Qt is the flow rate of air exiting the RPT device. The ventilation flow rate Qv is the flow rate of air exiting the ventilation holes to allow the outflow of the exhaled gas. The leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. The breathing flow rate Qr is the flow rate of air received in the patient's respiratory system.

[0531] Humidifier: The term "humidifier" is interpreted to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air stream to improve the patient's medical breathing condition.

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

[0533] Noise conduction (acoustic): In this document, conductive noise refers to noise conveyed to the patient by an air pressure type path (e.g., an air circuit and the patient interface and the air inside thereof). In one form, conductive noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0534] Noise emission (acoustic): In this document, emitted noise refers to noise conveyed to the patient by the surrounding air. In one form, the emitted noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO3744.

[0535] Noise ventilation (acoustic): In this document, ventilation noise refers to noise generated by an air flow through any ventilation (e.g., ventilation holes in a patient interface).

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

[0537] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH2O, g-f / cm 2 , and hectopascal). 1 cmH2O is equal to 1 g-f / cm 2 and is approximately 0.98 hectopascal. In this specification, unless otherwise specified, pressure is given in the unit of cmH2O.

[0538] The pressure in the patient interface is denoted by the symbol Pm, and the treatment pressure representing the target value to be achieved by the mask pressure Pm at the current time is denoted by the symbol Pt.

[0539] Respiratory pressure therapy (RPT): Addition of an air supply to the airway inlet at a treatment pressure that is typically positive pressure with respect to the atmosphere.

[0540] Ventilator: A mechanical device that provides pressure assistance when a patient performs part or all of the breathing motion.

[0541] 5.5.1.1 Materials Silicone or silicone elastomer: A synthetic rubber. As used herein, when referring to silicone, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this trademark). Another LSR manufacturer is Wacker. Unless otherwise stated, the Shore A (or Type A) indentation hardness of the exemplary form of LSR, when measured by ASTM D2240, is about 35 to about 45.

[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 release energy during unloading.

[0544] Resilient: Substantially all energy is released during unloading. For example, it includes certain silicones and thermoplastic elastomers.

[0545] Hardness: The ability of a material to resist deformation of itself (e.g., as described by the Young's modulus or an indentation hardness scale measured on a standardized sample size). · "Soft" materials may include silicone or thermoplastic elastomer (TPE), and can be easily deformed, for example, under finger pressure. · "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and cannot be easily deformed, for example, under finger pressure.

[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, tension, bending or torsion). A structure or component can provide different resistances in different directions.

[0547] Flabby structure or component: A structure or component that changes (e.g., bends) its shape within a relatively short period (e.g., 1 second) when supported under its own weight.

[0548] Rigid structure or component: A structure or component that undergoes substantially no shape change when subjected to the loads typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a sealed manner against the patient airway inlet under a pressure load of, for example, approximately 20 - 30 cmH2O.

[0549] As an example, an I-beam may include different bending rigidities (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be flabby in a first direction and rigid in a second direction.

[0550] 5.5.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a continuous period, for example, 10 seconds. Obstructive apnea is said to occur when, despite the patient's effort, air flow is not allowed due to some airway obstruction. Central apnea refers to a state where apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to a state where a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0551] Respiratory rate: The patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0552] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0553] Effort (respiratory): Respiratory effort is said to refer to the movement performed by the spontaneous breathing of a person attempting 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 interpreted as a situation in a patient's respiration where an increase in the patient's effort does not cause a corresponding increase in flow. When flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0556] Types of waveforms of inspiratory flow limitation: (ii) Flattening: After an ascent, a relatively flat portion follows, and then a descent occurs. (ii) M-shaped: Having one local peak at the rise and one local peak at the fall, with a relatively flat portion between these two peaks. (ii) Chair-shaped: Having a single local peak that occurs at the rising portion, followed by a relatively flat portion. (ii) Inverse chair-shaped: A single local peak follows a relatively flat portion, and this peak occurs at the falling portion.

[0557] Hypopnea: According to some definitions, hypopnea means a decrease in flow rather than an interruption of flow. In one form, when a flow decrease below a threshold velocity continues over a duration, it is said that hypopnea has occurred. When hypopnea is detected due to a decrease in respiratory effort, it is said that central hypopnea has occurred. In one form in adults, any of the following may occur and be regarded as hypopnea: (ii) A 30% decrease in patient respiration for at least 10 seconds + associated 4% desaturation, or, (ii) A decrease in patient respiration (less than 50%) that continues for at least 10 seconds, with associated desaturation of at least 3% or arousal occurring.

[0558] Hyperpnea: The flow increases to a level higher than the normal flow rate.

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

[0560] Patency (airway): The degree to which the airway is open or the range over which the airway is open. Airway patency means being open. Quantification of airway patency can be performed, for example, with a value (1) indicating patency and a value (0) indicating closure (obstruction).

[0561] Positive end-expiratory pressure (PEEP): A pressure that exceeds the atmospheric pressure in the lungs and exists at the end of exhalation.

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

[0563] Respiratory gas flow ...

Claims

**Claim 1** A cushion assembly that interfaces with the airway of a patient, including at least the patient's nostrils, the cushion assembly being configured to maintain a therapeutic pressure higher than the ambient air pressure during use throughout the patient's respiratory cycle during the patient's sleep for the improvement of sleep disordered breathing, the cushion assembly comprising: At least 6 cmH above the ambient air pressure ２ A plenum chamber that at least partially forms a cavity capable of being pressurized to a therapeutic pressure of at least 6 cmH O, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the therapeutic pressure for a patient's respiration, the plenum chamber; and A seal-forming structure having a fabric membrane constructed and arranged to form a pressure assist seal against the area of the patient's face surrounding the entrance to the patient's airway below the nasal bridge region of the patient's face, the fabric membrane having holes formed therein, whereby an airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use; comprising; The fabric membrane includes a fabric material adapted to contact the patient's face and an air-impermeable silicone layer applied thereto, the fabric material comprising 1) nylon and / or polyester, and 2) elastane; The denier of the nylon and / or polyester is in the range of 20 to 80 denier; The fabric membrane is stretchable in both the fabric direction and the path direction; A cushion assembly. **Claim 2** The cushion assembly of claim 1, wherein the denier of the nylon and / or polyester is in the range of 20 to 50 denier. **Claim 3** The cushion assembly of claim 1 or 2, wherein the denier of the elastane is in the range of 20 to 120 D. **Claim 4** The cushion assembly according to any one of claims 1 to 3, wherein the coefficient of friction of the fabric material is in the range of 0.7 to 5.

0. **Claim 5** The cushion assembly according to any one of claims 1 to 4, wherein the average deviation of the surface roughness is in the range of 0.7 to 5.

0. **Claim 6** The cushion assembly according to any one of claims 1 to 5, wherein the fabric membrane has the same or similar stretchability in both the fabric direction and the path direction of the fabric material. **Claim 7** The cushion assembly according to any one of claims 1 to 6, wherein the fabric membrane has the same or similar tensile strength in both the fabric direction and the path direction of the fabric material. **Claim 8** The thickness of the fabric film is within the range of 0.2 mm to 0.46 mm, the cushion assembly according to any one of claims 1 to 7.

9. The fabric material is an elastic weft knitted fabric, the cushion assembly according to any one of claims 1 to 8.

10. The fabric material includes nylon, polyester, or a composite of nylon / polyester, the cushion assembly according to any one of claims 1 to 9.

11. The fabric material includes 1) 75% to 85% of nylon, polyester, or a composite of nylon / polyester, and 2) 15% to 25% of elastane, the cushion assembly according to any one of claims 1 to 10.

12. The thickness of the fabric material is within the range of 0.18 mm to 0.32 mm, the cushion assembly according to any one of claims 1 to 11.

13. The machine gauge of the fabric material is within the range of 30 GG to 60 GG, the cushion assembly according to any one of claims 1 to 12.

14. The fabric weight of the fabric material is within the range of 105 gsm to 160 gsm, the cushion assembly according to any one of claims 1 to 13.

15. The fabric film has the same or similar surface friction in both the weaving direction and the path direction of the fabric material, the cushion assembly according to any one of claims 1 to 14.

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

17. The thickness of the air-impermeable silicone layer is within the range of 0.04 mm to 0.125 mm, the cushion assembly according to any one of claims 1 to 16.

18. The fabric material has a mélange aesthetic, the cushion assembly according to any one of claims 1 to 17.

19. The fabric material has a solid color aesthetic, the cushion assembly according to any one of claims 1 to 17.

20. A patient interface for delivering an air flow in a sealed manner to an inlet to the patient's airway including at least the patient's nostril inlet at a continuous positive pressure with respect to ambient air pressure, the patient interface comprising: The cushion assembly according to any one of claims 1 to 19; and A positioning and stabilization structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a tie, the tie being constructed and arranged such that at least a portion thereof is placed in use in a region of the patient's head above the upper ear base point of the patient's head. A patient interface including the above.

21. The patient interface according to claim 20, further comprising a ventilation structure that enables the gas exhaled by the patient to continuously flow from the inside of the cavity to the surroundings, the ventilation structure being sized and shaped to maintain the therapeutic pressure within the cavity in use.

22. The patient interface according to claim 20 or 21, wherein the plenum chamber and the seal-forming structure form a nose and mouth cushion assembly.

23. The patient interface according to any one of claims 20 or 21, wherein the plenum chamber and the seal-forming structure form a nose cushion.

24. A treatment system for use in the treatment of sleep disordered breathing, comprising: The patient interface according to any one of claims 20 to 23; A respiratory pressure therapy (RPT) device for supplying breathable gas at a positive pressure; and An air delivery tube for passing the breathable gas from the RPT device to the patient interface. A treatment system including the above.

25. A method of forming a cushion assembly for a patient interface, the cushion assembly being configured to interface with the patient's airway including at least the patient's nostrils, the cushion assembly being configured to maintain a therapeutic pressure higher than the ambient air pressure during the entire patient's breathing cycle during the patient's sleep for the improvement of sleep disordered breathing, the method comprising: Providing a textile material having a first side and a second side, the first side of the textile material being configured to contact the patient's face in use for facilitating the delivery of air flow at the therapeutic pressure to the patient's airway. Forming a fabric membrane configured to form a pressure assist seal against an area of the patient's face surrounding an inlet to the patient's airway below the nasal bridge area of the patient's face by adding an air-impermeable silicone layer to the fabric material, the fabric membrane having holes formed therein such that an air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils. Including The fabric material includes 1) nylon and / or polyester and 2) elastane. The denier of the nylon and / or polyester is in the range of 20 to 80 denier. The fabric membrane has stretchability in both the weaving direction and the path direction. Method. **Claim 26** The method of claim 25, wherein the denier of the nylon and / or polyester is in the range of 20 to 50 denier. **Claim 27** The method of claim 25 or 26, wherein the denier of the elastane is in the range of 20 to 120 D. **Claim 28** The method of any one of claims 25 to 27, wherein the coefficient of friction of the fabric material is in the range of 0.7 to 5.

0. **Claim 29** The method of any one of claims 25 to 28, wherein the fabric material includes 1) 75% to 85% of nylon, polyester, or a nylon / polyester composite and 2) 15% to 25% of air-astane. **Claim 30** The method of any one of claims 25 to 29, wherein the fabric material is an elastic weft knit fabric.

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