Fabric seal with air-assisted biasing unit

Abstract

This invention relates to one or more of the diagnosis, treatment, prevention, and improvement of respiratory diseases. The invention also relates to medical devices or apparatus and their use. [Solution] The patient interface includes a plenum chamber and a seal-forming structure. The seal-forming structure includes a support structure 10120 positioned to support a sealing portion 10130 adapted to engage tightly with the patient's face during use. The seal-forming structure may also be configured to expand under pressure within the cavity of the cushion assembly during use, extending the coverage area of ​​the sealing portion and releasing the sealing portion from external forces.

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims the benefit of International Application No. PCT / IB2019 / 058832, filed on March 16, 2019, Australian Provisional Application No. AU2019900644, filed on February 28, 2019, and US Provisional Application No. 62 / 805,147, filed on February 13, 2019. The entire contents of each of these documents are incorporated herein by reference in their entirety.

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

Background Art

[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 airways.

[0004] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The main 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 terminal bronchioles. The bronchi form the airways for conduction and are not involved in gas exchange. As 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 onsets (e.g., apnea, respiratory depression, and hyperventilation).

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

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by the onset of closure or obstruction of the upper airway during sleep. This results from a combination of an abnormally small upper airway, normal loss of muscle tone in the tongue region, and normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result of this condition, respiratory cessation in affected patients typically lasts 30 to 120 seconds, sometimes as many as 200 to 300 times a night. Consequently, excessive daytime sleepiness occurs, which can lead to cardiovascular disease and brain injury. This condition is common, particularly prevalent in overweight middle-aged men, although patients often have no subjective symptoms. See Patent Document 1 (U.S. Patent No. 4,944,310: Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, characterized by alternating, cyclical increases and decreases in ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to recurrent hypoxia, CSR can be harmful. In some patients, CSR is accompanied by recurrent sleep-wake cycles, which result in severe insomnia, increased sympathetic activity, and increased afterload. See Patent Document 2 (U.S. Patent No. 6,532,959: Berthon-Jones).

[0009] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to produce enough oxygen inhalation or CO2 exhalation to meet the patient's needs. Respiratory failure may encompass some or all of the following conditions:

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

[0011] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

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

[0013] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage, which can lead to inability to walk, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified into rapidly progressive and slowly progressive types: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over several months and leads to death within several years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: characterized by muscle damage that worsens over several years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increased general weakness, dysphagia, dyspnea at exertion and rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0014] Chest wall disorders are a group of thoracic deformities that cause dysfunction in the connection between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term excess carbon dioxide respiratory failure. Scoliosis and / or kyphosis can develop into severe respiratory failure. Symptoms of respiratory failure include: exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of treatments are used to treat or improve such conditions. Furthermore, otherwise healthy individuals can also take advantage of preventive treatments for respiratory diseases. However, these have several drawbacks.

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

[0017] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves, for example, pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, allowing CPAP to function as an air splint, thereby preventing upper airway obstruction. Since CPAP treatment for OSA can be voluntary, patients may choose not to adhere to treatment if they notice one or more of the following regarding the device used to deliver the treatment: discomfort, difficulty of use, high cost, or lack of aesthetic appeal.

[0018] Non-invasive ventilation (NIV) provides ventilatory support to the patient through the upper airway, assisting with some or all of the respiratory function and / or maintaining adequate oxygen levels throughout the body. Ventilation support is provided through a non-invasive patient interface. NIV is used to treat forms of respiratory failure and pulmonary stenosis, such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

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

[0020] 2.2.3 Treatment System These treatments may be provided by treatment systems or devices. Such systems and devices may also be used for screening, diagnosing, or monitoring diseases without treating them.

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

[0022] Another form of treatment system is the 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 the 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 along 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 the 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 a higher external pressure and not maintain internal air at a pressure higher than the surroundings.

[0025] Certain masks may be clinically unfavorable in the art (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 art when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal 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 among individuals. 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 the 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 reasons such as overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of incorrect 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 administration mask can withstand their original uses, but in such cases of masks, they can be unacceptably uncomfortable for wearing over a long period (e.g., several hours). Due to such discomfort, the patient's compliance with treatment may decrease. This is particularly 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 may affect the patient's compliance.

[0031] In the case of masks for other uses (e.g., pilots), they may not be suitable for use in the treatment of sleep apnea, so masks designed for use in the treatment of sleep apnea may be suitable for other uses.

[0032] For these reasons, the patient interface for CPAP delivery during sleep forms 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 comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0034] Patient interfaces can be partially characterized according to the design intent of where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure may 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 patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and the nasal bridge region of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth region by forming a seal, for example, on the lower lip region of the face during use. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces may be known by various names by their manufacturers, such as nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nasal masks.

[0035] A sealing structure that may be effective in one area of ​​a patient's face may be unsuitable in another area due to, for example, different facial shapes, structures, variability, and sensitive areas of the patient's face. For instance, the sealing portion of swimming goggles that rests on a patient's forehead may be unsuitable for use over the patient's nose.

[0036] Specific seal-forming structures can be designed for mass production so that a single design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. To form a sealing area, one or both the patient's facial shape and the mass-produced patient interface seal-forming structure must be adapted to a certain extent, potentially leading to patient discomfort.

[0037] A seal-forming structure that fits one individual may not fit another. Furthermore, a design that fits a patient at one pressure or position may be unsuitable at other pressures or positions. In some designs, leakage may occur when the patient moves (for example, while sleeping).

[0038] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal the patient's face when force is applied to the patient interface while the seal-forming structure is engaged with the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or it may include a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0039] Another type of seal-forming structure uses a thin flap seal positioned around the perimeter of the mask to provide a self-airtight seal against the patient's face when positive pressure is applied inside the mask. Similar to the previously mentioned types of seal-forming structures, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the seal-forming structure does not conform to the patient's shape, creases or buckling may occur in the seal-forming portion during use, leading to leakage.

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

[0041] Other types of seal-forming structures may include, for example, friction-fitting elements inserted into the nostrils, but some patients may find these seal-forming parts uncomfortable.

[0042] Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive to their face.

[0043] The technology for forming a patient interface seal within a certain range is disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0044] One form of nasal pillow is found in the Adam 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.), which was transferred to Puritan-Bennett Corporation.

[0045] ResMed Limited manufactures the following products using nasal pillows: SWIFT® nasal pillow mask, SWIFT® II nasal pillow mask, SWIFT® LT nasal pillow mask, SWIFT® FX nasal pillow mask, and MIRAGELIBERTY® full-face mask. The following patent applications, assigned to ResMed Limited, describe examples of nose pillow masks: International Patent Application WO2004 / 073, 778 (in particular, describing the features of ResMed Limited's SWIFT® nose pillow); U.S. Patent Application 2009 / 0044808 (in particular, describing the features of ResMed Limited's SWIFT® LT nose pillow); International Patent Applications WO2005 / 063, 328 and WO2006 / 130, 903 (in particular, describing the features of ResMed Limited's MIRAGE LIBERTY® full-face mask); International Patent Application WO2009 / 052, 560 (in particular, describing the features of ResMed Limited's SWIFT® FX nose pillow).

[0046] 2.2.3.1.2 Positioning and Stabilization The seal-forming structures of patient interfaces used in positive pressure air therapy are subjected to corresponding forces from the air pressure that can disrupt the seal. Therefore, various techniques are employed to position the seal-forming structures and maintain a seal over the appropriate portion of the face.

[0047] In one technology, adhesive joints are used. For example, see U.S. Patent Application Publication US2010 / 0000534. However, the use of adhesive joints can sometimes cause discomfort.

[0048] In other technologies, one or more straps and / or stabilization harnesses are used. In many such harnesses, one or more of the following apply: poor fit, bulkiness, discomfort, and difficulty of handling.

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

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

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

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

[0053] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another embodiment of an RPT device is the ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide assistance for invasive and non-invasive independent breathing for a range of patients for the treatment of multiple conditions (e.g., NMD, OHS, and COPD).

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

[0055] Device designers may be presented with countless options. Because design criteria often conflict, certain design choices may be far removed from convention, or even unavoidable. Furthermore, the comfort and effectiveness of a particular design can be significantly affected by even minor changes in one or more parameters.

[0056] 2.2.3.3 Humidifier Delivering airflow without humidification can lead to airway dryness. Using a humidifier with the RPT device and patient interface generates humidifying gas, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, adding warm air to the facial area around the patient interface generally provides greater comfort than cool air.

[0057] While a certain range of artificial humidification devices and systems are publicly known, they do not meet the specific requirements of medical humidifiers.

[0058] Medical humidifiers are typically used to increase the humidity and / or temperature of an airflow relative to the ambient air as needed, when a patient is sleeping or at rest (e.g., in a hospital). Medical humidifiers placed by the bedside may be small in size. They may be configured to humidify and / or heat only the airflow delivered to the patient, and not the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can humidify the air inhaled into the patient's body through breathing, but these systems also humidify and / or heat the entire room, which can be uncomfortable for the occupant. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0059] Although numerous medical humidifiers are publicly known, these humidifiers may suffer from one or more defects. Specifically, some medical humidifiers may not humidify properly, or they 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 prescribed respiratory therapy is "compliant" (for example, whether the patient is using their RPT device in accordance with one or more "compliance rules"). For example, a compliance rule for CPAP therapy might require a patient to use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period in order to be considered compliant. To determine patient compliance, an RPT device provider (e.g., a healthcare provider) may manually collect data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once a healthcare provider determines that a patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify third parties that the patient is compliant.

[0061] In patient treatment, there may be other ways in which communication of treatment data to third parties or external systems may be beneficial.

[0062] Existing processes for communicating and managing such data can be costly, time-consuming, and prone to errors.

[0063] 2.2.3.5 Ventilation Technology Some forms of treatment systems may include vents to expel exhaled carbon dioxide. These vents may allow gas to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0064] These vents may include orifices, through which gas can flow when the mask is in use. In the case of numerous such vents, noise is generated. In other cases, they may become blocked during use, resulting in insufficient airflow. In some cases, the sleep of the patient 1000 and the person sharing the bed 1100 may be disturbed, for example, due to noise or concentrated airflow.

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

[0066] Table of noise levels for conventional masks (ISO 17510-2:2007, 10 cmH2O pressure at 1 m) [Table 2]

[0067] (*Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744.)

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

[0069] 2.2.4 Screening, diagnostic, and monitoring systems Polysomnography (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary disorders, and typically requires specialized clinical staff for system application. PSG typically involves placing 15-20 tactile sensors on the body to record various bodily signals (e.g., electroencephalography (EEG), electrocardiogram (ECG), electrooculography (EOG), and electromyography (EMG)). For PSG of sleep-disordered breathing, patients needed to be observed over two nights in a specialized hospital; the first night was purely for diagnosis, and the second night was necessary for clinicians to titrate treatment parameters. Therefore, PSG is costly and inconvenient. Screening / diagnosis / monitoring of sleep-disordered breathing is particularly unsuitable for home use.

[0070] Clinical professionals can appropriately diagnose or monitor patients based on visual observation of PSG signals. However, there are situations where clinical professionals are unavailable or cannot be paid. Clinical professionals may have differing opinions regarding a patient's condition. Furthermore, a particular clinical professional may apply different criteria depending on the time period. [Prior art documents] [Patent Documents]

[0071] [Patent Document 1] U.S. Patent No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 [Overview of the project] [Means for solving the problem]

[0072] 3. A brief explanation of the technology This technology relates to the provision of medical devices used in the diagnosis, improvement, treatment, or prevention of respiratory diseases, which have one or more of the following advantages: improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0073] A first aspect of this technology relates to a device used for the diagnosis, improvement, treatment, or prevention of respiratory diseases.

[0074] Another aspect of this technology relates to a method used in the diagnosis, improvement, treatment, or prevention of respiratory disorders.

[0075] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0076] Another aspect of this technology relates to a seal-forming structure for a patient interface, the seal-forming structure comprising a woven fabric membrane.

[0077] In one form, the fabric membrane is air-impermeable.

[0078] Another aspect of this technology relates to a manufacturing process for a patient interface using a flat fabric composite for generating a curved fabric membrane.

[0079] Another aspect of this technology relates to a seal-forming structure for a patient interface, the seal-forming structure comprising a woven film, the seal-forming structure being free from (or with minimal) buckling or wrinkling.

[0080] Another aspect of this technology relates to a patient interface including a woven membrane containing a knitted fabric material.

[0081] One form of knitted or woven material is warp knitting.

[0082] One form of knitted or woven material is weft knitting.

[0083] In one embodiment, the woven film is extensible in both the vertical and horizontal directions (e.g., uniformly extensible).

[0084] In one form, the woven film is more extensible in the horizontal direction than in the vertical direction.

[0085] Another aspect of this technology relates to a patient interface with a wide range of wearability.

[0086] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure comprising a sealing portion (including, for example, a woven material) that is held taut before use.

[0087] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure comprising a woven fabric film that is not subjected to tension and does not have wrinkles, folds, small wrinkles or buckling on the outer surface of the woven fabric film.

[0088] Another aspect of this technology relates to a seal-forming structure for a patient interface. The seal-forming structure includes a woven membrane having a bridging portion that slackens and / or buckles with excess material.

[0089] Another aspect of this technology relates to a patient interface for delivering airflow in a sealed manner to an entrance to a patient's airway, including at least the patient's nostril inlet, at a continuously positive pressure relative to the ambient air pressure. The patient interface is configured to improve sleep-disordered breathing by maintaining a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, which is higher than ambient air pressure, throughout the patient's respiratory cycle during sleep, and the patient interface includes a cushion assembly, the cushion assembly includes: 1) a plenum chamber that at least partially forms a cavity pressurized to a therapeutic pressure of at least 6 cmH2O, which is higher than ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's breathing; and 2) a seal-forming structure having a woven membrane constructed and positioned to form a pressure-assist seal to 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, the woven membrane having holes formed therein so that airflow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0090] In the example: (a) The seal-forming structure includes a flexible support structure for holding the fabric membrane in a predetermined curved shape, and the fabric membrane is configured to seal the underside of the patient's nose, including the subnasal point and the nasal tip; (b) The seal-forming structure includes a seal biasing portion extending along the periphery of the cushion assembly, at least in the lateral region of the cushion assembly, and the seal biasing portion is less rigid than the adjacent portion of the support structure, and is configured to expand when the cavity is pressurized during use, so that the seal biasing portion covers the entire area of ​​the fabric membrane. (c) The sealing biasing section is configured such that the coverage area of ​​the fabric membrane extends over a distance longer than at least a portion of the central region of the cushion assembly within the lateral region of the cushion assembly. Therefore, when the sealing biasing section is activated during use, a bending or flexible region is formed by the central region, allowing the fabric membrane in the lateral region to cradle or pinch the patient's nasal ala.

[0091] In further examples: (a) the fabric membrane in the lateral region extends in the posterior-upward and lateral directions to facilitate cradling or pinching of the patient's nasal wings when the sealing bias is activated during use; (b) the fabric membrane is configured to press against the patient's face during use so that the patient's nose is not receptive to the cavity; (c) the sealing bias is omitted in at least a portion of the central part of the cushion assembly; (d) the sealing bias extends around the entire periphery of the cushion assembly; (e) the size of the sealing bias varies around the periphery of the cushion assembly; (f) the sealing bias is larger in the lateral region and smaller in the central region of the cushion assembly; (g) the size of the sealing bias is tapered, being larger in the lateral region and becoming smaller towards the central region of the cushion assembly.

[0092] In further examples: (a) the sealing biasing portion includes a concave channel or recess; (b) the sealing biasing portion includes an external projection; (c) the sealing biasing portion includes at least one fold, pleat or ridge; (d) the at least one fold, pleat or ridge allows the fabric membrane to move in a telescopic manner towards the patient's face when the sealing biasing portion is activated; (e) the sealing biasing portion includes multiple folds, pleats or ridges; (f) the multiple folds, pleats or ridges form a sinusoidal shape in cross-section; (g) the sealing biasing portion includes steps and wings, the steps and wings being at angles to each other.

[0093] In further examples: (a) the sealing biasing portion is positioned between the support structure and the fabric membrane; (b) the sealing biasing portion is positioned between the plenum chamber and the support structure; (c) the cushion assembly includes a stem projecting from the plenum chamber to the support seal-forming structure; (d) the sealing biasing portion extends through the lateral region of the cushion assembly at an angle α with respect to a plane extending along the front side of the cushion assembly; (e) the angle α is 30° to 60°; (f) the seal-forming structure is positioned such that the fabric membrane has a saddle shape configured to accommodate the underside of the patient's nose when in use.

[0094] In further examples: (a) the support structure and sealing biasing portion include silicone; (b) the woven film extends radially inward beyond the support structure by being attached to the support structure along the outer circumference of the woven film; (c) the support structure includes silicone and the woven film is formed to the inner edge of the support structure; (d) at least one hole in the woven film includes two holes, with a bridge portion positioned between the two holes of the woven film; (e) the woven film includes a woven film, the woven film includes a woven material, therefor to which a film layer is added to make the woven material substantially air-impermeable; (f) the plenum chamber includes silicone and is formed in one piece with the support structure;

[0095] In further embodiments, (a) the patient interface is a positioning and stabilizing structure that provides force to hold a seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure further includes a tie, the tie being constructed and positioned so that at least a portion of it rests on a region of the patient's head above the superior base of the ear when in use; (b) the patient interface is a ventilation structure that allows gas exhaled by the patient to flow continuously from inside the cavity to the surroundings, the ventilation structure being sized and shaped to maintain therapeutic pressure within the cavity when in use; (c) the plenum chamber and seal-forming structure form a nasal cushion.

[0096] Another aspect of this technology relates to a patient interface for delivering airflow in a sealed manner to an entrance to a patient's airway, including at least the patient's nostril inlet, at a continuously positive pressure relative to the ambient air pressure. The patient interface is configured to improve sleep-disordered breathing by maintaining a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, which is higher than ambient air pressure, throughout the patient's respiratory cycle during sleep, and the patient interface includes a cushion assembly, the cushion assembly includes: 1) a plenum chamber that at least partially forms a cavity pressurized to a therapeutic pressure of at least 6 cmH2O, which is higher than ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's breathing; and 2) a seal-forming structure having a sealing portion constructed and positioned to form a pressure-assist seal to 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, the sealing portion having holes formed therein so that airflow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0097] In the example: (a) The seal-forming structure includes a flexible support structure that supports the sealing portion, the sealing portion being configured to seal the underside of the patient's nose, including the subnasal point and the nasal tip; (b) The seal-forming structure includes a seal biasing portion positioned together with the sealing portion along the patient-facing rear surface of the cushion assembly, the seal biasing portion including at least one fold, pleat or ridge extending between the sealing portion and the support structure; (c) The seal biasing portion is configured to expand upon pressure in the cavity during use, thereby extending the sealing portion beyond other parts of the patient-facing rear surface of the cushion assembly to at least part of the patient's face or to act in a nesting manner.

[0098] In further examples: (a) The sealing biasing portion includes a plurality of folds, pleats, or ridges that form a sinusoidal shape in cross-section; (b) The sealing biasing portion is located at least within the lateral region of the cushion assembly; (c) The sealing portion is configured to extend over a longer distance in the lateral region of the cushion assembly than in the central region of the cushion assembly, or to operate in a nested manner, so that when the sealing biasing portion is activated in use, the central region forms a bent or flexible region, thereby the lateral region (d) The sealing portion within the region holds the patient's nasal ala in a cradle or pinch position; (e) The size of the sealing portion varies around the periphery of the cushion assembly; (g) The sealing portion is larger in the lateral region and smaller in the central region of the cushion assembly; (f) The sealing portion extends around the entire periphery of the cushion assembly; (h) The sealing portion is omitted in at least a portion of the central part of the cushion assembly; (i) The support structure and the sealing portion include silicone; (i) The sealing portion includes a woven membrane.

[0099] Another aspect of this technology relates to a patient interface for delivering airflow in a sealed manner to an entrance to a patient's airway, including at least the patient's nostril inlet, at a continuously positive pressure relative to the ambient air pressure. The patient interface is configured to improve sleep-disordered breathing by maintaining a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, which is higher than ambient air pressure, throughout the patient's respiratory cycle during sleep, and the patient interface includes a cushion assembly, the cushion assembly includes: 1) a plenum chamber that at least partially forms a cavity pressurized to a therapeutic pressure of at least 6 cmH2O, which is higher than ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's breathing; and 2) a seal-forming structure having a sealing portion constructed and positioned to form a pressure-assist seal to 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, the sealing portion having holes formed therein so that airflow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0100] In the example: (a) the seal-forming structure includes a flexible support structure that supports the sealing portion; (b) the plenum chamber inlet port is formed on the front side of the plenum chamber and is provided on the front side of the plenum chamber with a connector structure adapted to connect to an air supply pipe; (c) the front side of the plenum chamber includes one or more connector gussets, pleats or ridges including a fold, the connector gussets or pleats including a fold extending adjacent to or around the inlet port and configured to disengage the seal-forming structure from external forces acting on the air supply pipe.

[0101] In further examples: (a) the patient interface further includes an air supply tube connected to the front of the plenum chamber and in fluid communication with an inlet port; (b) the sealing portion includes a fabric membrane configured to seal the underside of the patient's nose, including the subnasal point and the nasal tip; (c) the patient interface further includes a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie being constructed and positioned so that at least a portion of it rests on a region of the patient's head above the superior base of the patient's head when in use.

[0102] Another aspect of this technology relates to a patient interface for delivering airflow in a sealed manner to an entrance to a patient's airway, including at least the patient's nostril inlet, at a continuously positive pressure relative to the ambient air pressure. The patient interface is configured to improve sleep-disordered breathing by maintaining a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, which is higher than ambient air pressure, throughout the patient's respiratory cycle during sleep, and the patient interface includes: 1) a plenum chamber that at least partially forms a cavity pressurized to a therapeutic pressure of at least 6 cmH2O, which is higher than ambient air pressure, and the plenum chamber is adapted to receive airflow at the therapeutic pressure for the patient's breathing; and 2) a seal-forming structure having a woven membrane constructed and positioned to form a seal against the area of ​​the patient's face surrounding the entrance to the patient's airway, the woven membrane having holes formed therein so that airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0103] In the embodiment, (a) the seal-forming structure includes a support structure for supporting the woven film, the support structure is configured to connect to a plenum chamber; and (b) the woven film is attached to the support structure along the outer circumference of the woven film in such a manner that the woven film is taut before use.

[0104] Another aspect of this technology relates to a patient interface for delivering airflow in a sealed manner to an entrance to a patient's airway, including at least the patient's nostril inlet, at a continuously positive pressure relative to the ambient air pressure. The patient interface is configured to improve sleep-disordered breathing by maintaining a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, which is higher than ambient air pressure, throughout the patient's respiratory cycle during sleep, and the patient interface includes: 1) a plenum chamber that at least partially forms a cavity pressurized to a therapeutic pressure of at least 6 cmH2O, which is higher than ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's breathing; and 2) a seal-forming structure having a woven membrane constructed and positioned to form a seal against the area of ​​the patient's face surrounding the entrance to the patient's airway, the woven membrane having holes formed therein so as to allow airflow at the therapeutic pressure to be delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned 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 woven membrane, the support structure being connected to the plenum chamber and being more rigid than the woven membrane. During use, the woven membrane may be configured to press against the patient's face so that the patient's nose is not receptive to the cavity. The woven membrane may extend radially inward beyond the support structure by being attached to the support structure along the outer circumference of the woven membrane.

[0105] In the embodiment, (a) the plenum chamber and support structure comprises silicone and forms a one-piece structure having a first lateral support portion of a first thickness and a second centrally located nasal base section of a second thickness less than the first thickness, the nasal base section configured to fold or form a pivot point when the fabric membrane engages with the patient's face, thereby causing the right and left lateral portions of the support structure to deform inward to surround the patient's nose (cradle); (b) the support structure comprises a base cushion; (c) the support structure comprises foam; (d) the support structure comprises silicone and the fabric membrane is molded to the inner edge of the support structure; (e) the fabric membrane has a dome shape in the corner region of the fabric membrane; (f) the fabric membrane has a saddle shape in the lower central region of the fabric membrane, configured to seal the area under the patient's nose when in use.

[0106] In further embodiments, (a) the woven membrane comprises a woven material to which a membrane layer is added to make the woven material substantially air-impermeable; (b) the thickness of the woven membrane is in the range of 0.3 mm to 0.5 mm; (c) the thickness of the membrane layer is in the range of 0.05 mm to 0.1 mm; (d) the woven material is weft-knitted; (e) the weight of the woven material is in the range of 105 gsm to 120 gsm; (f) the mechanical gauge of the woven material is in the range of 44 GG to 60 GG; (g) the woven material has a melange appearance; (h) the woven material has a solid color appearance; (i) the membrane layer contains silicone; (j) the woven material contains nylon, spandex, or polyester; (k) during use, the treatment pressure in the cavity directs the woven membrane toward the patient's face; (l) the plenum chamber contains silicone and is formed as one piece with the support structure.

[0107] In further embodiments, (a) the patient interface is a positioning and stabilizing structure that provides force to hold a seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure further includes a tie, the tie being constructed and positioned so that at least a portion of it rests on a region of the patient's head above the upper earlobe point of the patient's head when in use; (b) the patient interface is a ventilation structure that allows gas exhaled by the patient to flow continuously from inside the cavity to the surroundings, the ventilation structure being sized and shaped to maintain therapeutic pressure within the cavity when in use, the ventilation structure further includes; (c) the plenum chamber and seal-forming structure form an oro-nasal cushion assembly; (d) the plenum chamber and seal-forming structure form a nasal cushion.

[0108] Another aspect of this technology relates to a patient interface for delivering airflow in a sealed manner to an entrance to a patient's airway, including at least the patient's nostril inlet, at a continuously positive pressure relative to the ambient air pressure. The patient interface is configured to improve sleep-disordered breathing by maintaining a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, which is higher than ambient air pressure, throughout the patient's respiratory cycle during sleep, and the patient interface includes: 1) a plenum chamber that at least partially forms a cavity pressurized to a therapeutic pressure of at least 6 cmH2O, which is higher than ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's breathing; and 2) a seal-forming structure having a woven membrane constructed and positioned to form a seal over a region of the patient's face surrounding the entrance to the patient's airway, the woven membrane having at least one hole formed therein so as to allow airflow at the therapeutic pressure to be delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned 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 woven membrane, the support structure being more rigid than the woven membrane, and the support structure being connected to the plenum chamber. At the transition area, the woven membrane may extend radially inward beyond the support structure by being attached to the support structure along the outer edge of the woven membrane and the inner edge of the support structure. At the transition area, both the support structure and the woven membrane may extend along the curved portion in the direction from the anterior side of the seal-forming structure to the anterior patient-facing side of the seal-forming structure.

[0109] In the embodiment, (a) at the transition area, the support structure and the woven film have generally the same radius of curvature; (b) the woven film extends continuously along a curve from the transition area to the inner edge of the woven film; (c) during use, the woven film is configured to press against the patient's face so that the patient's nose is not receptive to the cavity; (d) at least one hole in the woven film comprises two holes, with a bridge portion positioned between the two holes of the woven film; (e) the support structure comprises silicone, and the woven film is molded 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 woven film.

[0110] In further embodiments, (a) the woven membrane comprises a woven material to which a membrane layer is added to make the woven material substantially air-impermeable; (b) the thickness of the woven membrane is in the range of 0.3 mm to 0.5 mm; (c) the woven material is weft-knitted; (d) the membrane layer contains silicone; (e) the woven material includes nylon, spandex, or polyester; (f) during use, the therapeutic pressure within the cavity directs the woven membrane toward the patient's face; (g) the plenum chamber and seal-forming structure form an oro-nasal cushion assembly; and (h) the plenum chamber and seal-forming structure form a nasal cushion.

[0111] Another aspect of this technology relates to a patient interface for delivering airflow in a sealed manner to an entrance to a patient's airway, including at least the patient's nostril inlet, at a continuously positive pressure relative to the ambient air pressure. The patient interface is configured to improve sleep-disordered breathing by maintaining a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, which is higher than ambient air pressure, throughout the patient's respiratory cycle during sleep, and the patient interface includes: 1) a plenum chamber that at least partially forms a cavity pressurized to a therapeutic pressure of at least 6 cmH2O, which is higher than ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's breathing; and 2) a seal-forming structure having a woven membrane constructed and positioned to form a seal over a region of the patient's face surrounding the entrance to the patient's airway, the woven membrane having at least one hole formed therein so as to allow airflow at the therapeutic pressure to be delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use. The woven membrane may include a woven material to which a membrane layer is added to make the woven material substantially air-impermeable, and the woven material may be a weft-knit fabric. The seal-forming structure may include a flexible support structure for supporting the woven membrane, the support structure may be connected to a plenum chamber, and the support structure may be more rigid than the woven membrane. The woven membrane may extend radially inward beyond the support structure by being attached to the support structure along the outer circumference of the woven membrane. When in use, the woven membrane may be configured to press against the patient's face so that the patient's nose is not receptive to the cavity. The woven membrane may have a dome shape in the corner region of the woven membrane configured to seal the area of ​​the lowest point of the patient's nasal wings, and a saddle shape in the lower central region of the woven membrane configured to seal the area below the patient's nose.

[0112] In the embodiment, (a) during use, the therapeutic pressure within the cavity directs the woven membrane toward the patient's face, helping the woven membrane form a seal with the patient's face; (b) at least one hole in the woven membrane comprises two holes, with a bridge portion positioned between the two holes in the woven membrane, and when the bridge portion buckles with excess material, the woven membrane expands to accommodate noses of different sizes; (c) the support structure comprises silicone, and the woven membrane is molded to the inner edge of the support structure; (d) the plenum chamber comprises silicone and is formed as a one-piece with the support structure; (e) the woven membrane is attached to the support structure in such a manner that the woven membrane is taut before use; (f) a first region of the woven membrane is taut before use, and a second region of the woven membrane is untensioned before use.

[0113] In further embodiments, (a) the woven film has elasticity in four directions; (b) the woven film has a first elasticity in the left-right transverse direction and a second different elasticity in the up / down direction, with the elasticity in the first direction being higher than the elasticity in the second direction; (c) the film layer contains silicone; (d) the woven material contains nylon, spandex, or polyester; (e) the plenum chamber and seal-forming structure form an orb-nasal cushion assembly; (f) the plenum chamber and seal-forming structure form a nasal cushion.

[0114] Another aspect of the present technology relates to a method for forming a cushion assembly for a patient interface. The cushion assembly is configured to deliver airflow in a sealed manner to an entrance to the patient's airway, including at least the patient's nostril inlet, at a continuously positive pressure relative to the ambient air pressure, and the cushion assembly is configured to improve sleep-disordered breathing by maintaining a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O, which is higher than the ambient air pressure when used, throughout the patient's respiratory cycle during sleep. The method includes: 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 desired dimensions 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, so that 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. During the overmolding step, the fabric composite can be held in place by vacuum, resulting in a non-flat shape during overmolding, thereby imparting a curved, non-flat shape to the fabric film. The fabric film is free from wrinkles, creases, folds, and / or buckling.

[0115] In the embodiment, (a) the seal-forming structure has a seamless transition along its outer surface from the support structure to the woven film; (b) at the transition, the woven film extends radially inward beyond the support structure by being attached to the support structure along the outer edge of the woven film and the inner edge of the support structure, and at the transition, both the support structure and the woven film extend along the curved portion in the direction from the front side of the seal-forming structure to the anterior patient-facing side of the seal-forming structure; (c) two holes are formed in the woven film, and a bridge portion is positioned between the two holes in the woven film, and when the bridge portion buckles with excess material, the woven film expands to accommodate noses of different sizes; (d) the support structure contains silicone.

[0116] Another aspect of the present technology relates to a seal-forming structure for a patient interface. The seal-forming structure includes 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 circumference of the sealing portion, so that the sealing portion extends radially inward beyond the support structure, and the sealing portion is configured to press against the patient's face when in use, so that the patient's nose is not received within the cavity, and tension is applied to the sealing portion due to the response stress of the support structure and / or the elastic stretch properties of the fabric, so that a force is applied from the sealing portion to the patient's face.

[0117] In a further embodiment of the present technology, the sealing portion includes a fabric. In a further embodiment, the patient interface includes a plenum chamber, and the support structure is configured to connect to the plenum chamber, the plenum chamber at least partially forming a cavity pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, and the plenum chamber includes a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's breathing. In a further embodiment, the sealing portion is constructed and positioned to form a seal over an area of ​​the patient's face surrounding the entrance to the patient's airway, the sealing portion having a hole formed therein, thereby delivering airflow at the therapeutic pressure at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the cavity for the entire patient's respiratory cycle during use. In a further embodiment, the support structure includes a silicone and / or thermoplastic elastomer.

[0118] According to a further aspect of this technology, the wall structure of the support structure between the sealing portion and the plenum chamber comprises a first member having a first thickness and a second member having a second thickness different from the first thickness.

[0119] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure comprising a support structure and a sealing portion, the support structure supporting the sealing portion and being attached to the support structure along the outer circumference of the sealing portion in such a manner that the sealing portion is taut before use.

[0120] In a further embodiment of the present technology, the sealing portion comprises a woven material. In a further embodiment, the patient interface comprises a plenum chamber, the support structure is configured to connect to the plenum chamber, the plenum chamber at least partially forms a cavity pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, and the plenum chamber comprises a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's respiration. In a further embodiment, the sealing portion is constructed and positioned to form a seal over an area of ​​the patient's face surrounding the entrance to the patient's airway, the sealing portion having a hole formed therein, thereby delivering airflow at the therapeutic pressure at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the cavity for the entire patient's respiratory cycle during use. In a further embodiment, the support structure comprises silicone and / or thermoplastic elastomer.

[0121] Another aspect of the present technology relates to a seal-forming structure for 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 comprising a woven material and attached to the support structure along the outer circumference of the sealing portion, 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.

[0122] According to a further embodiment of the present technology, the support structure comprises a silicone and / or thermoplastic elastomer, the patient interface comprises a plenum chamber, the support structure is configured to connect to the plenum chamber, the plenum chamber at least partially forms a cavity pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, and the plenum chamber includes a plenum chamber inlet port sized and constructed to receive airflow at therapeutic pressure for the patient's respiration. In a further embodiment, a sealing portion is constructed and positioned to form a seal over an area of ​​the patient's face surrounding the entrance to the patient's airway, the sealing portion having a hole formed therein so that airflow at therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain therapeutic pressure within the cavity for the entire patient's respiratory cycle during use.

[0123] Another aspect of one form of this technology is a patient interface molded or otherwise constructed together with a peripheral shape that is complementary to the shape of the intended wearer.

[0124] One embodiment of this technology is a method for manufacturing an apparatus.

[0125] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has limited experience using this type of medical device.

[0126] One embodiment of this technology is a patient interface that can be cleaned at the patient's home, for example, with soapy water, and does not require any special cleaning equipment.

[0127] Another aspect of this technology relates to a therapeutic system for use in the treatment of 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 a breathable gas under positive pressure; and 3) an air delivery tube for passing the breathable gas from the RPT device to the patient interface.

[0128] The methods, systems, devices, and apparatus described may be embodied in a way that enables improvements in the functionality of processors (e.g., processors of computers for specific purposes, respiratory monitors, and / or respiratory therapy devices). Furthermore, the methods, systems, devices, and apparatus described may enable improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep-disordered breathing).

[0129] Of course, some of the above embodiments may form sub-embodiments of the present technology. Furthermore, various combinations of sub-embodiments and / or various other embodiments may constitute further embodiments or sub-embodiments of the present technology.

[0130] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0131] 4. Brief Description of the Drawings This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals include the following similar elements: [Brief explanation of the drawing]

[0132] [Figure 1A] 4.1 Treatment System: The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal pillow and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. A bedmate 1100 is also illustrated. The patient is sleeping in a supine sleeping position. [Figure 1B] The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal mask and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 removes a full face mask and receives positive pressure air from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. 4.2 Respiratory system and facial anatomy [Figure 2A] This diagram outlines the human respiratory system, including the nasal and oral cavities, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] This is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of the face including several features of surface anatomical structures, including the upper lip, upper lip robe, lower lip robe, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and corners of the mouth. The superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, therion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, ala apex, superior and inferior base of the ear. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankforth horizontal and nasolabial angles are indicated. The coronal plane is also shown. [Figure 2F] This is a pedicle view of the nose, including several features such as the nasolabial folds, lower lip, upper lip red, nostrils, subnasal point, columella, nasal tip, main axis of the nostrils, and median sagittal plane. [Figure 2G] This is a lateral view of the surface features of the nose. [Figure 2H] This shows the subcutaneous structure of the nose, including the lateral nasal cartilage, nasal septal cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibrous adipose tissue. [Figure 2I] This shows a mid-nasal incision located a few millimeters from the midline sagittal plane, particularly the medial crura of the nasal septum cartilage and the greater alar cartilage. [Figure 2J] This is a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K] This is a lateral view of the skull showing the external shape of the head surface and several muscles. The following bones are illustrated: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is illustrated. The following muscles are illustrated: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2L] This shows the anterolateral aspect of the nose. 4.3 Patient Interface [Figure 3A] This shows a patient interface in the form of a nasal mask, which is one embodiment of this technology. [Figure 3B] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively large compared to the magnitude of curvature shown in 3C. [Figure 3C] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 3B. [Figure 3D] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature value at this point is zero. [Figure 3E] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 3F. [Figure 3F] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively large compared to the curvature shown in Figure 3E. [Figure 3G] A mask cushion containing two pillows is shown. The outer surface of the cushion is illustrated. The edges of the surface are illustrated. The dome region and saddle region are illustrated. [Figure 3H] A mask cushion is shown. The outer surface of the cushion is illustrated. The edges of the surface are illustrated. The path on the surface between point A and point B is illustrated. The straight-line distance between A and B is illustrated. Two saddle-shaped regions and a dome-shaped region are illustrated. [Figure 3I] The surface of the structure is shown, and one-dimensional holes are present within this surface. The planar curves in the illustration form the boundaries of the one-dimensional holes. [Figure 3J] This is a cross-sectional view through the structure in Figure 3I. The illustrated surface defines the two-dimensional hole in the structure in Figure 3I. [Figure 3K] Figure 3I is a perspective view of the structure including two-dimensional and one-dimensional holes. The surfaces that define the two-dimensional holes in the structure of Figure 3I are also shown. [Figure 3L] This shows a mask with an inflatable bladder that acts as a cushion. [Figure 3M] Figure 3L is a cross-sectional view of the mask, showing the inner surface of the bladder. The inner surface defines the two-dimensional holes within the mask. [Figure 3N] Figure 3L shows a further cross-section through the mask. The inner surface is also illustrated. [Figure 3O] This demonstrates the left-hand rule. [Figure 3P] I will demonstrate the right-hand rule. [Figure 3Q] Shows the left ear, including the left ear spiral. [Figure 3R] Shows the right ear, including the right ear spiral. [Figure 3S] The right hand demonstrates a spiral. [Figure 3T]This is a diagram of a mask that includes a sign of the twist of the spatial curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] This is a diagram of the plenum chamber 3200, showing the median sagittal plane and the central contact surface. [Figure 3V] Figure 3U is a rear view of the plenum chamber. The directions in the figure are perpendicular to the central contact surface. In Figure 3V, the plenum chamber is divided into left-hand and right-hand sides by the median sagittal plane. [Figure 3W] Figure 3V is a cross-sectional view through the plenum chamber, taken in the median sagittal plane shown in Figure 3V. The "central contact" surface is illustrated. The central contact surface is perpendicular to the median sagittal plane. The orientation of the central contact surface corresponds to the orientation of tendon 3210. Tendon 3210 rests on the median sagittal plane and contacts the cushion of the plenum chamber only at two points on the median sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the geometry of the cushion in this region, the central contact surface may contact both the upper and lower points. [Figure 3X] Figure 3U shows the plenum chamber 3200 in the position for use on the face. The median sagittal plane of the plenum chamber 3200 generally coincides with the median sagittal plane of the face when the plenum chamber is in the position for use. The central contact surface generally corresponds to the "face plane" when the plenum chamber is in the position for use. In Figure 3X, the plenum chamber 3200 is part of a nasal mask, with the upper point 3220 resting approximately on the serion and the lower point 3230 resting on the upper lip. 4.4 RPT Device [Figure 4A] This shows an RPT device based on one form of this technology. 4.5 Patient Interface Using This Technology [Figure 5] This is a perspective view of a patient interface according to one embodiment of this technology, as it is being worn by a patient. [Figure 6] This is a perspective view of a patient interface, according to another embodiment of this technology, being worn by a patient. [Figure 7] This is a cross-sectional view of the positioning and stabilization structure along line 7-7 in Figure 6. [Figure 8]Figure 7 is an enlarged view of a part of the positioning and stabilization structure. [Figure 9] Figure 7 is an enlarged view of a part of the positioning and stabilization structure. [Figure 10] Figure 5 is a front view of the cushion assembly positioned on the patient's face. [Figure 11] Figure 5 is a front view of the cushion assembly. [Figure 12] Figure 5 is a top perspective view of the cushion assembly. [Figure 13] Figure 5 is a top view of the cushion assembly. [Figure 14] Figure 5 is a side view of the cushion assembly. [Figure 15] Figure 5 is a front view of the cushion assembly. [Figure 16] Figure 5 is a side view of the cushion assembly. [Figure 17] Figure 5 is a top view of the cushion assembly. [Figure 18] This is a front view of a cushion assembly according to another embodiment of the technology, positioned on the patient's face. [Figure 19] Figure 18 is a top view of the cushion assembly. [Figure 20] Figure 18 is a front view of the cushion assembly. [Figure 21] Figure 18 is a bottom view of the cushion assembly. [Figure 22] Figure 18 is a side perspective view of the cushion assembly. [Figure 23] This is a front view of a cushion assembly according to another embodiment of this technology. [Figure 24] Figure 23 is a bottom perspective view of the cushion assembly. [Figure 25] Figure 23 is a side perspective view of the cushion assembly. [Figure 26] Figure 23 is a top perspective view of the cushion assembly. [Figure 27] Figure 23 is a rear perspective view of the cushion assembly. [Figure 28] This is a top perspective view of a cushion assembly according to another embodiment of this technology. [Figure 29] Figure 28 is a front view of the cushion assembly. [Figure 30] Figure 28 is a side perspective view of the cushion assembly. [Figure 31] Figure 28 is a rear perspective view of the cushion assembly. [Figure 32] Figure 28 is a bottom view of the cushion assembly. [Figure 33] This is a front perspective view of a cushion assembly according to another embodiment of this technology. [Figure 33-1] This is a front perspective view of a cushion assembly according to another embodiment of this technology. [Figure 33-2] This is a cross-sectional view along line 33-2-33-2 in Figure 33-1. [Figure 33-3] This is a cross-sectional view along line 33-3-33-3 in Figure 33-1. [Figure 33-4] This is an enlarged detail taken from Figure 33-2. [Figure 34] Figure 33 is a cross-sectional view of the cushion assembly. It is a front perspective view of the cushion assembly, in which the grip pad is arranged on a woven film according to the example of this technology. [Figure 35] This is a front perspective view of a cushion assembly, in which the grip pad is positioned on a woven film as an example of this technology. [Figure 36] This is a front perspective view of a cushion assembly, in which the grip pad is positioned on a woven film as an example of this technology. [Figure 37] This is a front perspective view of a cushion assembly, in which the grip pad is positioned on a woven film as an example of this technology. [Figure 38] This is a perspective view of a patient interface, according to another embodiment of this technology, being worn by a patient. [Figure 39] This is a perspective view of a patient interface according to another embodiment of this technology. [Figure 40]Figure 39 is a perspective view of the patient interface as it is worn by a patient. [Figure 41] Figure 40 is a side view of the patient interface. [Figure 42] Figure 40 is a front perspective view of the patient interface. [Figure 43] Figure 39 is a front view of the patient interface cushion assembly. [Figure 44] Figure 39 is a top view of the cushion assembly. [Figure 45] Figure 39 is a bottom view of the cushion assembly. [Figure 46] Figure 39 is a front perspective view of the cushion assembly. [Figure 47] Figure 39 is a rear perspective view of the cushion assembly. [Figure 48] Figure 39 is a side perspective view of the cushion assembly. [Figure 49] Figure 39 is a front perspective view of the cushion assembly, showing the inner portion of the cushion assembly. [Figure 50] Figure 39 is a front view of the cushion assembly, showing the inner portion of the cushion assembly. [Figure 51] This is a rear view of a cushion assembly according to one embodiment of this technology. [Figure 52] Figure 51 is a front view of the cushion assembly. [Figure 53] Figure 51 is a cross-sectional view of the cushion assembly. [Figure 54] This is a front perspective view of a cushion assembly, in which the grip pad is positioned on a woven film as an example of this technology. [Figure 55] This is a front perspective view of a cushion assembly, in which the grip pad is positioned on a woven film as an example of this technology. [Figure 56] This is a front perspective view of a cushion assembly, in which the grip pad is positioned on a woven film as an example of this technology. [Figure 57]This is a perspective view of the patient interface 30000 according to one embodiment of this technology. [Figure 58] Figure 57 is a perspective view of the patient interface 30000 as it is worn by a patient. [Figure 59] Figure 57 is a cross-sectional view of the patient interface 30000. [Figure 60] Figure 57 is a side view of the patient interface 30000 as it is worn by a patient. [Figure 61] Figure 57 is a front perspective view of the cushion assembly 30105. [Figure 62] Figure 57 is a rear perspective view of the cushion assembly 30105. [Figure 63] Figure 57 is a front view of frame 30350. [Figure 64] Figure 57 is a rear view of frame 30350. [Figure 65] Figure 57 is a rear view of the patient interface 30000 as it is worn by a patient. [Figure 66] Figure 57 shows the straps of the positioning and stabilization structure 30300 of the patient interface 30000. [Figure 67] This is a perspective view of a patient interface, according to another embodiment of this technology, being worn by a patient. [Figure 68] Figure 67 is a side view of the patient interface. [Figure 69] Figure 67 is an exploded view of the patient interface, showing the cushion assembly, frame assembly, arm cover, and elbow assembly. [Figure 70] This is a front exploded view of a cushion assembly according to one embodiment of this technology. [Figure 71] Figure 70 is a rear exploded view of the cushion assembly. [Figure 72] Figure 67 is a front view of the patient interface cushion assembly. [Figure 73] Figure 72 is a front perspective view of the cushion assembly. [Figure 74] Figure 72 is a rear perspective view of the cushion assembly. [Figure 75] Figure 72 is a top perspective view of the cushion assembly. [Figure 76] Figure 72 is a bottom perspective view of the cushion assembly. [Figure 77] Figure 72 is a side perspective view of the cushion assembly. [Figure 78] This is a schematic diagram of a process for providing an air-impermeable layer to a woven fabric material according to one embodiment of this technology. [Figure 79] This is a schematic diagram showing a patient's face positioned on a woven membrane with low tension before use. [Figure 80] This is a schematic diagram illustrating the force applied from the woven fabric to the patient's face due to tensile stress within the fabric. [Figure 81] This is a schematic diagram of the tension applied to the sealing portion of a cushion assembly according to one embodiment of this technology. [Figure 82] This is a schematic diagram illustrating the force applied from the fabric membrane to the patient's face due to the air pressure within the cavity formed by the cushion assembly. [Figure 83] This is a cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 84] This is a cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 85] This is a cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 86] This is a cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 87] This is a partial perspective view of the support structure and sealing portion of a cushion assembly having an external sealing biasing portion according to one embodiment of this technology. [Figure 88] This is a partial perspective view of the support structure and sealing portion of a cushion assembly having an internal sealing biasing portion according to one embodiment of this technology. [Figure 89] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 90A] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 90A-1] This is an enlarged view of a section of the sealing part of the cushion assembly shown in Figure 90A. [Figure 90B] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 91] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 92] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 93] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 94] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 95] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 96] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 97] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 98] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 99] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 100] This is a partial cross-sectional view of a cushion assembly according to one embodiment of this technology. [Figure 101] This is a cross-sectional view of a modular sealing assembly according to one embodiment of this technology. [Figure 102] This is a partial cross-sectional view of a cushion assembly incorporating the modular sealing assembly shown in Figure 101, according to one embodiment of this technology. [Figure 103] This is a perspective view of a modular support structure according to one embodiment of this technology. [Figure 104]This shows the process of forming a sealing portion onto a support structure according to one embodiment of this technology. [Figure 105] This shows the process of forming a sealing portion onto a support structure according to one embodiment of this technology. [Figure 106] These are side views of the modular sealing assembly formed by the process shown in Figures 104 and 105. [Figure 107] This example of the technology demonstrates a cushion assembly that "fits everything in one size." [Figure 108] This example of the technology demonstrates a cushion assembly that "fits everything in one size." [Figure 109] This example of the technology shows a custom-made cushion assembly fabricated using the three-dimensional outline obtained by scanning a patient's face. [Figure 110] This example of the technology shows a custom-made cushion assembly fabricated using the three-dimensional outline obtained by scanning a patient's face. [Figure 111] This is a front perspective view of a cushion assembly according to another embodiment of this technology. [Figure 112] Figure 111 is a rear perspective view of the seal-forming structure of the cushion assembly. [Figure 113] This shows the knitting process. [Figure 114] This shows the knitting process. [Figure 115] This shows a warp-knitted fabric according to one embodiment of this technology. [Figure 116] This shows a weft-knitted fabric according to one embodiment of this technology. [Figure 117] This is a block diagram illustrating a process using this technology in which a support structure is overmolded onto a woven composite to form a seal-forming structure together with the woven film. [Figure 118A] This is a schematic diagram showing the cushion assembly during use. [Figure 118B] This is a schematic diagram showing the cushion assembly during use. [Figure 118C]This is a schematic diagram showing the cushion assembly during use. [Figure 119A] This is a perspective view of a cushion assembly according to one embodiment of this technology. [Figure 119A-1] This is a detailed enlarged view of the seal biasing mechanism in Figure 119A. [Figure 119B] Figure 119A is a perspective view of the cushion assembly, showing how the sealing portion expands due to the pressure on the cavity of the cushion assembly during use. [Figure 120] This is a bottom perspective view of a cushion assembly according to another embodiment of this technology. [Figure 121] This is a bottom perspective view of a cushion assembly according to another embodiment of this technology. [Figure 122A] This is a top perspective view of a cushion assembly according to another embodiment of this technology. [Figure 122B] Figure 122A is a bottom perspective view of the cushion assembly. [Figure 123A] This is a top perspective view of a cushion assembly according to another embodiment of this technology. [Figure 123B] Figure 123A is a bottom perspective view of the cushion assembly. [Figure 124] This is a partial perspective view of a cushion assembly according to another embodiment of this technology. [Figure 125] This is a front perspective view of a cushion assembly according to another embodiment of this technology. [Figure 126] This is a front perspective view of a cushion assembly according to another embodiment of this technology. [Figure 127] This is a front perspective view of a cushion assembly according to another embodiment of this technology. [Figure 128] This is a rear perspective view of a cushion assembly according to another embodiment of this technology. [Modes for carrying out the invention]

[0133] 5. Detailed Description of Examples of the Technology Before describing the technology in further detail, it should be understood that the technology is not limited to the specific embodiments which may differ as described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0134] The following description is provided in relation to a variety of embodiments that may share one or more common properties and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or any other embodiment. In addition, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0135] 5.1 Treatment In one embodiment, the technology includes a method for treating respiratory diseases. The method includes the step of applying positive pressure to the airway entrance of 1000 patients.

[0136] In certain embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0137] In certain embodiments of this technology, mouth breathing is restricted, limited, or prevented.

[0138] 5.2 Treatment System In one embodiment, the technology includes an apparatus or device for the treatment of respiratory distress. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000 (see, for example, Figures 1A-1C).

[0139] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of this technology includes the following functional modes: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3700. In some embodiments, the functional modes may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes. When in use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airway to facilitate positive pressure air supply to the airway.

[0140] If a patient interface cannot comfortably deliver the minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0141] A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 6 cmH2O relative to the surroundings.

[0142] A patient interface 3000 in one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 10 cmH2O relative to the surroundings.

[0143] A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 20 cmH2O relative to the surroundings.

[0144] 5.3.1 Plenum Chamber The plenum chamber has edges shaped to be complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber is positioned close to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure. The seal-forming structure may extend around the entire periphery of the plenum chamber during use. In some embodiments, the plenum chamber and seal-forming structure are formed from a single homogeneous material piece. In one embodiment, the plenum chamber may be constructed from a flexible material (e.g., silicone) and may be formed as a one-piece structure with a support structure (e.g., from any of the materials described herein as suitable for the support structure and / or the plenum chamber). In one embodiment, the seal-forming structure may be an extension of the plenum chamber or may be formed as part of the plenum chamber, so that the seal-forming structure is included within the plenum chamber. In such examples, the support structure and the woven film may be considered as part of the plenum chamber.

[0145] 5.3.2 Seal-forming structure In one embodiment of this technology, the seal-forming structure 3100 may provide a target seal-forming region and further provide a cushioning function. The target seal-forming region is the region in the seal-forming structure 3100 where sealing can occur. The region where sealing actually occurs (i.e., the actual sealed surface) may vary from patient to patient in a given treatment session, depending on a range of factors (e.g., the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0146] In one embodiment, the target seal formation region is located on the outer surface of the seal formation structure 3100.

[0147] In a particular form of this technology, the seal-forming structure 3100 is made of a biocompatible material (for example, liquid silicone rubber (LSR) (or "silicone")).

[0148] The seal-forming structure 3100 produced by this technology may be made of a soft, flexible, and elastic material (for example, silicone).

[0149] In some forms, seal-forming structures can be constructed or molded from a single, homogeneous piece of material (e.g., liquid silicone rubber, fabric).

[0150] For example, in some embodiments as shown in Figures 5 to 77, the seal-forming structure has a sealing portion comprising a woven material. The woven material may cover all or part of the seal-forming structure. In some embodiments, the woven material may be formed by a fiber network and may include a material adapted to be impermeable to air. For example, the woven material may have an air-impermeable film on at least one of its surfaces, thereby forming a woven film or woven sealing portion.

[0151] In some forms, the woven membrane may be constructed to be elastically stretchable in at least one dimension. For example, if the woven membrane is constructed from a fiber network, the membrane may be able to stretch in the longitudinal warp and / or transverse weft directions across the membrane. In some forms, the woven membrane is constructed to be elastically stretchable to a extent beyond what is achievable by conventional silicone seal-forming structures.

[0152] In some forms, the woven membrane is constructed to be substantially inelastic in at least one dimension. For example, if the woven membrane is constructed from a woven material, the membrane may be able to withstand stretching in one or both of the longitudinal warp or transverse weft directions across the membrane.

[0153] A woven film may consist of a single layer or multiple layers. In configurations using multiple layers, each layer may be formed from the same material or from a variety of different materials, each possessing unique material properties.

[0154] In some embodiments, the woven membrane may include at least one layer that exhibits substantially air-impermeable properties (while maintaining the material properties necessary to provide comfort and minimal pressure points to the patient). For example, as shown in Figure 78, in some embodiments, the woven membrane may include an air-impermeable material 10131 formed on the inner surface of the woven material 10133. In some embodiments, the air-impermeable material may be laminated on the woven material. In some embodiments, the air-impermeable material and the woven material may be selected so that the resulting woven membrane may exhibit a predetermined overall elasticity or elastic resistance as needed. For example, the addition of an air-impermeable material (or membrane layer) may provide elasticity (or extensibility) in the woven material, thereby increasing the extensibility of the resulting woven membrane.

[0155] In some forms, the membrane may 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 may occur due to the fixed cushion (for the formation of an effective seal), the woven material and / or the resulting woven membrane may have a material spring constant and spring length such that the woven membrane is more pliable than the patient's skin engaging with it. This can improve mask comfort and reduce the formation of localized pressure "hot spots," which is advantageous.

[0156] In some forms, the surface of the textile material that comes into contact with the patient's face 1300 may have low friction properties. This is advantageous because it can improve the surface texture comfort of the textile film and reduce friction against the patient's face 1300. The surface of the textile material (e.g., herringbone) may have a first coefficient of friction in a first direction. The first coefficient of friction is different from the coefficient of friction in a second direction (e.g., higher or lower). In contrast, textiles with higher friction may cause snagging or friction of the textile film in the area of ​​contact with the patient's face during use. Such friction or snagging may cause distortion or deformation of the textile film, which in turn leads to reduced sealing effectiveness and the possibility of undesirable air leakage from the device.

[0157] In some forms, the overall thickness of the woven material of the woven film is 0.275 mm or less.

[0158] In certain embodiments of this technology, a system is provided comprising 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 may include one form of seal-forming structure 3100 suitable for large heads rather than small heads, and another suitable for small heads rather than large heads.

[0159] In this specification, specific examples or features of specific examples (e.g., seal-forming structure 3100) may be referred to (e.g., by reference numerals), but it should be noted that such discussions may also apply to other examples and / or features (e.g., seal-forming structure 5100).

[0160] 5.3.2.1 Sealing mechanism In one embodiment, the seal-forming structure includes a sealing flange using a pressure-assisted sealing mechanism. During use, the sealing flange can readily respond to the positive system pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure.

[0161] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than approximately 1 mm (e.g., approximately 0.25 mm to approximately 0.45 mm). This member extends around the perimeter length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is positioned between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the perimeter length. The support flange is or includes a spring-like element and functions to support the sealing flange so as not to buckle during use.

[0162] In one form, a fabric membrane (e.g., one containing nylon, polyester, a mixture of nylon and polyester, microfibers, 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 is capable of stretching in at least one dimension. The fabric membrane can be held under tension across a 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).

[0163] Alternatively, since the fabric can be formed into a complex three-dimensional predefined shape, no tension is applied before and / or during use (e.g., it is loose, relaxed, and / or has no small wrinkles), and 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 be kept substantially free of small wrinkles.

[0164] Figure 79 shows an example in which light tension is applied to the fabric membrane 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 membrane 3130, the fabric membrane is adapted to form a consistent surface without any obstructions (e.g., wrinkles, folds, or creases) in the fabric material before contact between the patient's face 1300 and the seal-forming structure 3100. In some embodiments, this can be achieved by applying light pre-tension or by shaping the fabric membrane so that there is substantially no leakage that would cause creases in the fabric membrane. This may be advantageous because it ensures that the fabric membrane forms a smooth and continuous seal on and around the patient's face 1300. As a result, respiratory pressure therapy may be improved by reducing the occurrence of folds or creases in the members of the seal-forming structure 3100, which could be sources of therapeutic air leakage. This method is advantageous because it forces the fabric membrane to face the patient's face 1300 (Figure 80), thus ensuring that the fabric membrane is under the lowest threshold tension.

[0165] 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 held in a tension-free state (e.g., by excess material) to form a saddle-shaped region or valley shape prior to use. This can enable an improvement in seal efficiency, which can be advantageous, while reducing pressure (i.e., "hot spots") on regions where anthropometric elements of the face project into or over a longer distance into the cavity. In another example, the sides of the nasal region and / or nasal bridge region can remain unstressed and / or relaxed prior to use when providing additional material to conform to the facial profile of these sensitive facial regions. In another example, a bridge site (e.g., bridge site 3104) extending between two nostril openings can be unstressed, relaxed, and / or buckled (e.g., by excess material as shown in FIG. 33-1 prior to use). The bridge site (e.g., 3104) with excess material enables the fabric membrane to expand (e.g., in the up / down (height) direction) to accommodate different sized noses.

[0166] In some forms, instead of providing pre-tensioned regions, the fabric membrane may be formed such that there is substantially no leakage that causes wrinkles. Such 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 been subjected to excessive tension. Using a fabric membrane with no added tension can also result in less pressure on the patient's face, and thus increased comfort in some arrangements.

[0167] In some forms, the woven membrane may be substantially tension-free and may be formed on a support structure or directly on the plenum chamber (remaining tension-free and / or relaxed). In this example, even in this case, such a woven membrane may remain wrinkle-free to avoid leakage in the seal with the patient's face. In some forms, a tension-free and / or wrinkle-free woven membrane may utilize cushioning support (e.g., base cushion, seal support area (e.g., support structure) and / or air pressure within the cavity) to form an effective seal with the patient's face.

[0168] In some forms, the tensile and / or wrinkle-free state of the fabric membrane (see Figures 80 and 81) can be maintained to maintain sealing contact with the patient's face 1300 by one or a combination of the following: a) Pre-applied tensile stress and further applied tensile stress of the fabric membrane upon engagement between the patient's face 1300 and the fabric membrane; b) The pre-formed state of a woven film that is free from leakage causing interference in the woven film (e.g., wrinkles, creases, buckling, or small wrinkles), is not subjected to tension, and is formed as a substantially constant surface; c) The rigidity of the support structure and / or plenum chamber, and the ability of the support structure and / or plenum chamber to withstand and respond to additional tensile stress (when the patient's face 1300 is engaged with the woven membrane); and d) Further air pressure applied from within the cavity to the inner surface of the fabric membrane. The internal air pressure applies further tensile stress to the inner surface of the fabric membrane, which can further stretch the fabric membrane against the patient's face 1300, and the fabric membrane can be stressed against the patient's face 1300 (for example, a pressure-assisted seal is generated).

[0169] By continuously maintaining the woven membrane under tensile stress and / or free of wrinkles before and during use, the woven membrane can be adapted to the patient's facial profile while minimizing wrinkles and / or ruptures in the seal-forming structure. This may also improve sealing performance by maximizing the contact area of ​​the woven membrane on the patient's face 1300 in some configurations. This may also improve the performance of the CPAP device (when subjected to external lateral or longitudinal forces (e.g., tube drag)) in some configurations.

[0170] In some configurations, when the plenum chamber is pulled a short distance away from the patient's face 1300, the addition of air pressure from within the plenum chamber can help maintain an effective seal in the woven membrane. The addition of air pressure may be sufficient to elastically stretch the woven membrane by at least one dimension, creating a "hovercraft"-like balloon effect on the anthropometric outline of the patient's face 1300, thereby maintaining an effective seal on the anthropometric outline of the patient's face 1300.

[0171] In some configurations, the woven membrane may be held under tension by a relatively rigid support structure. In various configurations, the support structure may be formed from, for example, silicone, PU foam, PU solid material, or another suitable material. In some configurations, the support structure may be relatively less rigid than the shell or frame of the plenum chamber.

[0172] In some configurations, the magnitude of tensile stress can be varied across the seal-forming structure of the woven film as needed. For example, stress concentration regions may be located near one or more holes in the woven film that serve as pathways for treatment application in more stretched materials.

[0173] In some embodiments, the seal-forming structure may utilize multiple different cushioning configurations (e.g., a single air-assisted woven film, a double air-assisted woven film, a woven film including compression support, or a woven film including TPU / TPE / Si support). In some embodiments, the cushioning configuration of the seal-forming structure may be formed to advantageously provide a "one-size-fits-all" solution.

[0174] In the example, the seal-forming structure and plenum chamber can be applied to nasal cushions, nasal cradles, oral-nasal cushions, ultra-miniature full-face masks, full-face masks, and other suitable cushioning configurations.

[0175] In some embodiments, the fabric membrane may be configured to create an effective seal across the patient's nasal tip, as shown as an example in Figure 58. In some embodiments, the fabric membrane may be configured to create an effective seal over the subnasal point of the patient's nose, so that the fabric membrane does not engage with the nasal tip, as shown, for example, in Figure 40.

[0176] In some configurations, stretching and / or maintaining the wrinkle-free state of the woven membrane during use (to fit the patient's face 1300) can impart stress to the walls of the support structure. This stress can cause the walls of the support structure to be pulled inward relative to each other during use. In some configurations, the support structure can be adapted to withstand the additional stress load to avoid inward deformation. As a result, the rigidity of the support structure can impart further stress to the woven membrane, causing it to elastically stretch during use.

[0177] For example, in some embodiments as shown in Figures 87 and 88, the support structure may include pleats or folds (e.g., seal biasing portions 10140, 10140') that dynamically support the woven membrane using internal air pressure. This may favorably provide further support to the woven membrane under dynamic loads (e.g., tube drag). In other embodiments, the pleats or folds may use internal air pressure to release the dynamic load (e.g., tube drag) from the seal-forming structure. In some embodiments, the air pressure within the cavity applies a load to the inner surface of the woven membrane, generating further tensile stress, causing the woven membrane to substantially fill the pressed outline of the patient's face 1300 (e.g., around both sides of the nose). In some embodiments, the elasticity of the woven membrane, combined with the load of internal air pressure, causes the woven membrane to elastically stretch, forming a larger seal contact area on the patient's face. This approach can be advantageous in providing a continuous seal, even if the mask is partially displaced from its optimal interface with the patient's face in some configurations, because the fabric membrane can partially expand due to the reaction force from internal air pressure (i.e., the "hovercraft effect").

[0178] For example, in several embodiments as shown in Figures 35-37 and 54-56, one or more grip pads 29150, 31150 may be placed on the fabric membrane. In one example, the grip pads 29150, 31150 may be configured such that one of them is substantially flat along the patient-facing surface of the fabric membrane. In other embodiments, the grip pads 29150, 31150 may be embossed to form a bead or rim that protrudes slightly above the surface of the fabric membrane. In some embodiments, the grip pads 29150, 31150 may have a high coefficient of friction. In some embodiments, the grip pads may have a predetermined shape (e.g., elliptical (see Figures 35, 37, 54, and 56), circular, square, etc.). In some embodiments, the grip pads may be elongated (see Figures 35 and 54). In some embodiments, the grip pads 29150, 31150 may be linear in shape. In some embodiments, the grip pads may be arranged within a pattern spanning the surface of the seal-forming structure 3100. In some embodiments, the grip pads may be arranged scattered across the surface of the seal-forming structure 3100 (see Figures 37 and 56). In some embodiments, the grip pads may be arranged to form a perimeter near the edge of the fabric membrane (see Figures 34, 35, 54 and 55). In some embodiments, the perimeter-forming grip pads 29150, 31150 may take the form of dotted lines (see Figures 35 and 54). In some embodiments, the perimeter-forming grip pads may take the form of solid lines (see Figures 36 and 55). In some embodiments, the perimeter-forming grip pads may take the form of multiple lines (dotted or solid) or a combination thereof. In some embodiments, the grip pads may help the fabric membrane grip the patient's face. In one example, the grip pad may be formed as a relatively thin silicone layer added to the surface of a woven film.

[0179] In some configurations, the woven film can be integrated with the support structure by attaching (e.g., shaping) the outer edge (e.g., outer circumference) of the woven film around the curved lip (e.g., inner edge) of the support structure. In one embodiment, the woven film may be angled slightly inward toward the inside of the mask. In one example, the woven film 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 of the seal-forming structure toward the rear face-contact side (see Figure 11). This makes it possible to eliminate the portion of the woven film that curves from the rear side toward the front side. This configuration allows the woven film to be provided only along the front surface of the seal-forming structure, for example, as shown in Figures 11 to 17. Such a configuration may be advantageous because it does not require folding or cutting the woven film to conform to the corners of the support structure. This is useful in reducing the occurrence of protruding folds or wrinkles (which can cause leakage) in the woven film, and thus can improve sealing performance.

[0180] In some forms, the woven membrane may be attached to the outer edge of the woven membrane such that it forms a portion of the seal-forming structure that curves from the front to the rear face-contact side of the seal-forming structure (see, for example, Figures 33-1 to 33-4, Figure 73, and Figure 74). This may improve comfort by providing more of the surface of the woven membrane (facing the support structure) for engagement with the patient's face. In one example, the attachment of the woven membrane to the support structure may be carried out by a specific process (as described later) that can form a portion that is curved without the occurrence of folds, wrinkles, creases, or buckling on the surface of the woven membrane. As understood, in some examples, at the transition portion 36, both the support structure and the woven membrane may have a radius of curvature (e.g., the same or similar radius of curvature) along the curved portion 35 from the front to the rear of the seal-forming structure (see Figures 33-1 to 33-4). The woven membrane can be given a predetermined curvature so that a portion of the woven membrane not directly supported by the support structure extends along the curved portion 35 (Figures 33-2 to 33-4). This can facilitate the formation of a dome shape (e.g., a convex dome) in specific regions of the woven membrane (e.g., the lateral portion 3250 and / or corner region 3252), thereby facilitating the sealing of the woven membrane against the contours of the patient's face (e.g., the lowest point region of the nasal alae of the patient's face (i.e., the corner of the nasal region (i.e., the region where the alae terminate at the upper lip near the nasolabial fold))), as shown, for example, in Figure 33-1. The dome shape can help avoid the formation of wrinkles, creases, folds and buckling in the woven membrane, thus facilitating the creation of leakage pathways. The dome shape can also help the woven fabric reach areas of the patient's face that are difficult to seal (e.g., the corner of the nasal region). The fabric membrane 29130 may have a saddle shape in the intermediate subnasal region 3260 configured to seal the patient's subnasal point, so as shown in Figure 33-1, it conforms to the saddle shape formed by the patient's nasolabial angle and upper lip. Similarly, the nasal tip region 3270 may also have a saddle shape configured to seal the conforming profile shown at or below the patient's nasal tip.The curvature (e.g., the magnitude of the curvature and / or radius of curvature) of the woven membrane in the direction of the curved portion 35 may differ in different regions of the cushion assembly along the outer circumference of the woven membrane. For example, as shown in Figure 33-2, the curvature of the woven membrane 29130 in the intermediate nasal tip region 3270 may differ from that of the woven membrane in the intermediate subnasal point region 3260 in the direction of the curved portion 35. In the example in Figure 33-2, the woven membrane within the nasal tip region 3270 may have a relatively larger (e.g., smaller radius) curvature (e.g., negative curvature in the downward / upward direction along the curve 35) than the curvature in the intermediate subnasal region 3260 (e.g., negative curvature in the downward / upward direction along the curve 35). In one example, the curvature (e.g., the magnitude of the curvature and / or radius of curvature) of the lateral portion 3250 of the woven membrane may differ from the curvature in the intermediate nasal tip region 3270 and / or the intermediate subnasal point region 3260. The nose portions of cushion assemblies 14105, 30105, and 31105 may have similar dome-shaped and saddle-shaped features, as shown, for example, in Figures 43, 52, and 61.

[0181] In the example shown in Figure 73, the curvature of the woven membrane 16230 from the connection with the support structure 16220 (for example, at the transition area) may be continuous with the inner edge of the woven membrane. For example, the woven membrane may have a dome shape or a saddle shape at the inner edge of the woven membrane in a particular region of the cushion.

[0182] In some embodiments, the woven membrane may be angled slightly inward or curved as it approaches the inside of the mask (e.g., positive curvature in the left-right direction), as shown, for example, in Figures 11-17, 23-26, and 3-37. In some embodiments, the woven membrane may form a dome shape on the support structure, as shown, for example, in Figures 19-22 and 43-50. Note that since any of the cushion assemblies disclosed herein may have a woven membrane attached to the outer edge of the woven membrane, the woven membrane forms part of the seal-forming structure and extends along the curved portion 35 from the front to the rear face-contact side of the seal-forming structure as described above for Figure 33-1, the woven membrane 6130 of cushion assembly 6105, for example, may have a larger dome shape due to a further convex shape from one lateral side to the other.

[0183] In some forms where the woven membrane is not under continuous tension (before and / or during use) or is inelastic, the woven membrane may form an improved air-assisted seal on the patient's face. This improved air-assisted seal dynamically adapts to changes / movements (i.e., a "hovercraft" effect), for example, due to the woven membrane being thinner and having lower structural rigidity than a silicone membrane.

[0184] In some forms, the woven membrane may be supported by a secondary or tertiary support structure that can function as a cushion support, or it may function as a biasing mechanism that is pressure-assisted and helps seal the patient's face. The cushion support may provide further flexibility and may be suitable for use on most patients' faces (one size fits most). The second or third support layer may be formed using a woven membrane, a woven fabric containing a PU / Si membrane, a laminated open-cell foam, a laminated PU foam, PU molding, TPU / TPE, or silicone. In some forms, the further support layer itself may be supported by a structural / rigid plastic (e.g., PP / PC / PA / PET or other suitable material).

[0185] In some forms, 3D printing the fabric membrane and / or the cushion support member as a "skeleton" can reduce the thickness, which can result in a reduction in mask weight.

[0186] 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, solid PU material, or any suitable plastic material.

[0187] 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 dynamic force / support or decoupling regions can be obtained.

[0188] 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.

[0189] In one form, the seal-forming structure can include a biasing mechanism that assists in sealing between the fabric contact portion (sealing portion) of the seal-forming structure and the patient's face.

[0190] 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.

[0191] In one form, the seal-forming structure includes a region having an adhesive surface or an adherent surface.

[0192] 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 adherent surface.

[0193] 5.3.2.2 Nasal bridge or nasal ridge region In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the nasal bridge region or nasal ridge region of the patient's face when in use.

[0194] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the nasal bridge region or nasal ridge region of the patient's face when in use.

[0195] 5.3.2.3 Upper lip area

[0196] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when in use on the upper lip region (i.e., the upper lip) of the patient's face.

[0197] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the upper lip region of the patient's face when in use.

[0198] 5.3.2.4 Jaw region In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the jaw region of the patient's face when in use.

[0199] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the jaw region of the patient's face when in use.

[0200] 5.3.2.5 Frontal Area In one embodiment, the seal-forming structure forms a seal on the forehead area of ​​the patient's face when the seal is in use. In this embodiment, the plenum chamber can cover the eye when in use.

[0201] 5.3.2.6 Nasal pillow In one embodiment, 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 positioned to form a seal with each nostril of the patient's nose.

[0202] A nasal pillow according to one aspect of this technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the underside of the patient's nose, on the stalk, and on a flexible region on the underside of the frustum of the cone, connecting the frustum of the cone to the stalk. In addition, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the stalk. The flexible region may function to facilitate a flexible connection structure. The flexible connection structure accommodates both the displacement and angle of the frustum of the cone and the mutual movement between the nasal pillow and the structure to which it is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stalk is connected.

[0203] 5.3.3 Nose cushion Referring to Figures 5 to 14, patient interfaces 3000 and 6000 having a cushion assembly 3105 including a seal-forming structure 3100 and a plenum chamber 3200 are shown according to a first embodiment of the Art. Figures 15 to 17 show a cushion assembly 5105 including a seal-forming structure 5100 and a plenum chamber 3200 according to a second embodiment of the Art. Figures 18 to 22 show a cushion assembly 6105 including a seal-forming structure 6100 and a plenum chamber 3200 according to a third embodiment of the Art. Figures 23 to 27 show a cushion assembly 7105 including a seal-forming structure 7100 and a plenum chamber 3200 according to a fourth embodiment of the Art. Referring to Figures 28 to 32, a cushion assembly 8105 including a seal-forming structure 8100 and a plenum chamber 3200 is shown according to a fifth embodiment of the Art. Figure 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.

[0204] Figures 11-14 include dashed lines defining the boundaries of regions of different thicknesses; it should be understood that these are merely nominal boundaries and not actual structures.

[0205] Examples of the seal-forming structures 3100, 5100, 6100, 7100, 8100, and 9100 described in the above paragraphs may be considered as nasal cradle cushions and are intended to provide a pressurized gas flow to the patient's nostrils by sealing at least the underside of the patient's nose. The exemplary seal-forming structures engage with the patient's face below the bridge of the nose and, in some examples, may engage with the patient's nose below the nasal tip, depending on the size and shape of the patient's nose. The exemplary seal-forming structures may also engage with the patient's face at least above the upper vermilion. Thus, the exemplary seal-forming structures may seal the patient's upper lip when in use. Furthermore, 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 on the underside of the nose may be configured not to have an aperture of a size that would accommodate the patient's nose within the cavity. Furthermore, the height of the cushion from the lower edge of the woven membrane in the intermediate subnasal region to the upper edge of the woven membrane in the intermediate nasal tip region may be less than the width of the cushion in the left-right direction from one lateral edge of the woven membrane to the other lateral edge of the woven membrane (see Figures 33 and 33-1).

[0206] An example of a nasal cradle cushion (e.g., the exemplary seal-forming structure disclosed herein) may include an upper saddle-shaped or concave region having positive curvature across the cushion. A nasal cradle cushion may also be understood as having a single target seal-forming region or surface, while a pillow cushion may have two target seal-forming regions (one for each nostril). A cradle cushion may also have a posterior wall that contacts the patient's upper lip and an upper central surface that contacts the underside of the patient's nose. These two surfaces on the patient's face create a nasolabial angle between them (see Figure 2E). A cradle cushion may be shaped to have a nasolabial angle ranging from 90 to 120 degrees.

[0207] Furthermore, the exemplary seal-forming structure may be shaped and sized such that no part of the seal-forming structure enters the patient's nostril during use.

[0208] Plenum Chamber Referring to Figures 5 to 17, the plenum chamber 3200 has edges that are shaped to complement the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber 3200 is positioned close to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100, which may extend around the entire edge of the plenum chamber 3200 during use.

[0209] In certain embodiments of this technology, the plenum chamber 3200 is constructed from a material that is relatively more rigid than the seal-forming structure (e.g., polycarbonate). Alternatively, the plenum chamber 3200 may be constructed from a flexible material (e.g., silicone) and may be formed as a one-piece structure with a support structure (e.g., from any of the materials described herein as suitable for the support structure and / or the plenum chamber). In one embodiment, the seal-forming structure may be an extension of the plenum chamber, or may be formed as part of the plenum chamber, so that the seal-forming structure is included in the plenum chamber. In such an example, the support structure and the woven membrane may be considered as part of the plenum chamber. In another embodiment, the plenum chamber 3200 may be constructed from a transparent material (e.g., transparent polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help clinicians confirm the placement and function of the patient interface.

[0210] In a specific form of this technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the intrusiveness of the patient interface, thereby helping to improve compliance with treatment.

[0211] Figures 5 and 10-17 show an example of a seal-forming structure 3100 with a plenum chamber 3200. The seal-forming structure 3100 may include a plenum chamber connection opening to which the seal-forming structure 3100 is sealed to the plenum chamber 3200. The seal-forming structure 3100 and the plenum chamber 3200 may at least partially form a cavity 3101 that is pressurized by airflow. In the illustrated embodiment, the seal-forming structure 3100 and the plenum chamber 3200 together form the cavity 3101.

[0212] The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 may be a permanent connection. The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 may be a chemical bond. The joining of the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening may be done 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 a mechanically removable connection.

[0213] At each side of the plenum chamber 3200, the plenum chamber lateral end 3202 may be provided as a hollow path forming a plenum chamber inlet port sized and constructed to receive airflow. Plenum chamber connectors 3204 may also be provided at each lateral end of the plenum chamber 3200 that is laterally outward from the plenum chamber lateral end 3202. The plenum chamber connectors 3204 may be connected to each end 3314 of the positioning and stabilization structure 3300. The connection between the plenum chamber connectors 3204 and each end 3314 of the positioning and stabilization structure 3300 may be detachable on both sides. In other examples, a permanent connection may be provided on one side and a detachable connection on the other. In further examples, both connections between the plenum chamber connectors 3204 and each end 3314 of the positioning and stabilization structure 3300 may be permanent.

[0214] The plenum chamber side end 3202 can receive the pressurized gas flow from the positioning and stabilizing structure 3300. The pressurized gas flow then passes through the plenum chamber 3200 and then through the seal-forming structure 3100 to enter the patient's airway for exhalation.

[0215] The diagram shows how the end 3314 of the positioning and stabilizing structure 3300 can be connected to the lateral end 3202 of the plenum chamber. In these embodiments, each plenum chamber connector 3204 may include a slot 3209, a chamfered edge 3208, and a notch 3206 which can be snap-fitted and removable to a clip of the positioning and stabilizing structure.

[0216] The plenum chambers 3200 substantially described in the third, fourth, and fifth embodiments of this technology, and thus shown in Figures 18 to 32, may be similar to or identical to the plenum chambers in Figures 10 to 17. It should also be noted that one or more embodiments of this technology may be combined with one or more of the following: U.S. Provisional Application No. 62 / 764,992 (filed August 20, 2018, title: "Patent Interface") or PCT / AU2019 / 050873 (filed August 20, 2019). These documents are incorporated herein by reference in their entirety. For example, the plenum chamber of this technology may be identical to the plenum chamber in either the '992 application or the '837 application. Furthermore, instead of the seal-forming structures disclosed herein, any of the seal-forming structures in either the '992 or '873 application disclosed in the patient interface may be used, and the seal-forming structures of this technology may include any of the features of the seal-forming structures in either the '992 or '873 application embodiments.

[0217] In the examples shown in Figures 28 to 32, the plenum chamber 13200, like the plenum chamber 3200 described above, 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 section 3400 may be provided by a ventilation insert 13400. The ventilation insert 13400 is removable or permanently attached to the plenum chamber 13200 (for example, by insertion into an opening in the plenum chamber). Note that in any of the other examples, a ventilation insert may be provided (for example, the ventilation section 3400 in the plenum chamber 3200 in Figures 10 to 27 may be provided by a ventilation insert 13400 as shown in Figures 28 to 32).

[0218] In the example shown in Figure 38, the frame 9200 may include a centrally located connector for the air circuit 4170. The frame may also include a headgear mounting section on its lateral side. The seal-forming structure 9100 may be connected to the frame 9200 by spaced-out connectors 9122. These connectors 9122 may include a clip on the seal-forming structure and a receiving connector on the frame.

[0219] Seal formation structure of this technology The seal-forming structures 3100, 5100, 6100, 7100, 8100, 9100, and 29100 may include support structures 3120, 6120, 7120, 8120, 9120, and 29120 that provide support to the sealing portions 3130, 5130, 6130, 7130, 8130, 9130, and 29130 (e.g., a woven film). The sealing portions are configured to engage airtightly with the patient's face. Depending on the size and shape of the patient's nose, the support structures may also engage airtightly with the patient's face, as in the examples in Figures 5 to 27.

[0220] Exemplary seal-forming structures 3100, 5100, 6100, 7100, 8100, 9100, and 29100 differ in various embodiments described below, but each may include a support structure having at least two regions of different thicknesses (e.g., two, three, or four regions) (for example, seal-forming structure 3100 includes a support structure 3120 (having a wall structure with a lateral support region 3122 having a greater thickness than other parts of the wall structure)). For example, as shown in Figure 59, part (d1) of the support structure may be thicker than part (d2) of the support structure. For example, part (d1) may be adjacent to or connected to the plenum chamber, and part (d2) may be adjacent to or connected to the sealing portion, thereby providing structural stability in connection with the plenum chamber and flexibility in the interface with the patient. Alternatively, the thicker lateral support region 3122 may be positioned, for example, at the corner of the nasal region of the seal-forming structure (for example, directly connected to the fabric membrane), thereby ensuring proper sealing at the lowest point of the nasal ala of the patient's face.

[0221] Furthermore, in the described embodiment, each sealing portion has two separate nasal openings 3102 corresponding to either of the patient's nostrils in order to provide airflow to both nostrils. A bridge portion 3104 may be provided between the nasal openings 3102. The bridge portion 3104 may help provide a taut fabric membrane before and / or during use. In another example, a single opening may be used to provide pressurized flow to both nostrils of the patient.

[0222] In some embodiments, as described above, the seal-forming structure 3100 may include a plenum chamber connection opening into which the seal-forming structure 3100 is sealed to the plenum chamber 3200. In the embodiments shown in Figures 5 to 38, the support structures 3120, 5120, 6120, 7120, 8120, 9120, and 29120 are directly connected to the plenum chamber or frame. Therefore, the support structures may include an opening into which the support structures are sealed to the plenum chamber 3200.

[0223] The support structure may be less rigid than the plenum chamber 3200 and may be constructed from silicone, foam (e.g., polyurethane foam) (see Figures 28-32), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable material as described later. Furthermore, the sealing portion may be less rigid than the support structure and may be constructed from woven material (e.g., nylon, polyester, nylon and polyester mixtures, microfiber, or polyurethane as described in more detail later). The sealing portion described in any example of this disclosure may be referred to as a woven sealing portion or woven film and may include a woven material having an air-impermeable material that has been laminated, coated, or otherwise added.

[0224] The support structure may have an aperture formed internally, thus providing an inner edge of the support structure. Along this inner edge, a sealing portion (e.g., the outer circumference of the sealing portion) is attached to the support structure, for example, as shown in Figures 11-27 and 33-38, extending the sealing portion radially inward of the seal-forming structure (beyond or beyond the support structure). For example, the sealing portion may be formed around the inner edge of the support structure, or it may be connected to the support structure by other suitable methods as described later. However, in the alternative examples in Figures 28-32, the sealing portion 8130 may be laminated on the support structure 8120 (e.g., foam).

[0225] Referring to Figures 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 than other parts of the wall structure of the support structure 3120. A lateral support region 3122 may be provided on 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 spaced apart distal to the plane that bisects the seal-forming structure 3100, which is parallel to the sagittal section of the patient during use. Since these lateral support regions 3122 may be the thickest parts of the seal-forming structure 3100, they are resistant to lateral displacement (for example, when a patient sleeping with their head on their side presses a pillow laterally against the seal-forming structure) and provide a robust engagement with the patient's wing. 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 shown in the figure, the lateral support region 3122 may also provide the highest resistance to deformation.

[0226] Furthermore, the lateral support region 3122 can provide sufficient rigidity to ensure proper sealing (e.g., by the lateral support region 3122) in the lowermost alae region of the patient's face (i.e., the region where the alae terminate in the upper lip near the nasolabial fold), which is a region where the geometry is particularly complex. In the lowermost alae region of the patient's face, the geometry is particularly complex because at least three facial surfaces (alae, upper lip, and cheek) converge in this region. Therefore, sufficient rigidity in the lateral support region 3122 allows the seal-forming structure 3100 to be biased (without buckling) into the lowermost alae region by tensile forces from the positioning and stabilizing structure 3300. The lateral support region 3122 can be positioned in the lower and laterally outward region of the patient's face and nose within the lower alae region of the patient's face and nose (e.g., between the nasolabial fold and the region of the upper lip located below the alae).

[0227] The seal-forming structure 5100 in the embodiments shown in Figures 15 to 17 may have an expanded sealing portion 5130 compared to the sealing portion 3130 in Figures 11 to 14. That is, the support structure 5120 may contract within the seal-forming structure 5100, and the sealing portion 5130 may expand, thereby configuring the sealing portion 5130 to engage with the lowest point region of the nasal ala of the patient's face when in use. As a result, the seal-forming structure 5100 may be more flexible and pliable, allowing it to more easily conform to the facial contours of the patient.

[0228] Referring to Figures 18 to 22, the seal-forming structure in this example is arranged to obtain a larger cavity 3101, so that the sealing portion 6130 protrudes further from the plenum chamber toward the patient's face during use due to the increased tension in the sealing portion, thereby causing the sealing portion to expand outward in a balloon shape. During use, the patient's nose can be pressed against the sealing portion 6130 toward the cavity 3101 and the plenum chamber 3200, so as shown in Figure 18, the sealing portion 6130 extends and inverts, and the patient's nose is received by the space created by the cavity 3101, and the sealing portion 6130 seals above the tip of the patient's nose. In contrast, the sealing portions 3130 and 5130 seal below the tip of the patient's nose, as shown in Figure 10.

[0229] In the examples shown in Figures 23 to 27, the sealing portion 7130 is also configured to seal above the tip of the patient's nose due to the height of the cushion. Compared to the sealing portion 6130, the sealing portion 7130 is configured to seal further in the direction of the selion along the bridge of the nose. It will be accomplished.

[0230] In the exemplary cushion assemblies of Figures 28 to 32, the support structure 8120 may be provided by a foam material laminated onto the plenum chamber 3200. The sealing portion 8130 may be laminated directly onto the support structure. The support structure 8120 may extend across the plenum chamber connection opening, except for a pair of holes formed internally in the sealing portion 8130 corresponding to the nasal opening 3102. This arrangement provides a compression seal to the patient's face, and when the cushion assembly 8105 is pulled toward the patient's face by the headgear, the seal-forming structure 8100 conforms to the contours of the patient's face through the compression of the support structure 8120.

[0231] The cushion assembly 8105 is configured to seal the underside of the patient's nose. The seal-forming structure 8100 includes an end portion 8122. The end portion 8122 extends in a curved manner around the posterior portion of the plenum chamber 3200 and is configured to engage with the patient's upper lip during use.

[0232] Referring to Figures 33 to 37, cushion assembly 29105 is similar to cushion assembly 3105, but may extend further in the left-right lateral direction. Cushion assembly 29105 includes a seal-forming structure 29100, a support structure 29120, and a sealing portion 29130. Referring to Figure 33-1, cushion assembly 29105-1 is similar to cushion assembly 29105, but as described above, it may have a fabric film 29105 formed such that the fabric film forms a portion of the seal-forming structure that extends curvedly from the front side of the seal-forming structure to the rear face-contact side.

[0233] As described above, Figures 35 to 37 show the grip pads 29150 on the surface of the woven film.

[0234] In the example shown in Figure 38, the sealing portion 9130 is positioned to seal above the tip of the patient's nose.

[0235] 5.3.3.1 Positioning and stabilization structure The cushion assemblies 3105, 5105, 6105, 7105, 8105, and 29105 of the patient interfaces 3000 and 6000 of this technology can be held in a sealed position by the positioning and stabilization structure 3300 during use. The cushion assembly 9105 of the patient interface 9000 of this technology can be held in a sealed position by the positioning and stabilization structure 9300 during use.

[0236] In one embodiment, the positioning and stabilizing structures 3300 and 9300 provide at least sufficient holding force to overcome the effect of positive pressure in the cavity 3101 that causes the face to lift away from the face.

[0237] In one configuration, the positioning and stabilizing structure provides sufficient holding force to overcome the gravitational forces on the patient interface.

[0238] In one embodiment, the positioning and stabilizing structure provides a holding force as a safety margin to eliminate the possibility of destructive effects on the patient interface (e.g., due to tube dragging or accidental interference with the patient interface).

[0239] In one embodiment of this technology, positioning and stabilizing structures 3300, 9300 are provided, configured to be worn by a patient while sleeping. In one embodiment, the positioning and stabilizing structure has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilizing structure includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilizing structure includes at least one flat strap.

[0240] In one embodiment of this technology, a positioning and stabilizing structure is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a supine position with the posterior region of the patient's head resting on a pillow.

[0241] In one embodiment of this technology, a positioning and stabilizing structure is provided that is not excessively large or bulky in size so as not to interfere with a patient sleeping in a lateral sleeping position with the side of the patient's head resting on a pillow.

[0242] In one embodiment of this technology, the positioning and stabilizing structures 3300, 9300 include a release portion positioned between the front portion and the rear portion of the positioning and stabilizing structure. This release portion is not compressible and may be, for example, a flexible or flimsy strap. The release portion is constructed and positioned so as to prevent a situation in which, when a patient lies down with their head on a pillow, the presence of the release portion transmits force along the positioning and stabilizing structure to the rear portion, thereby interfering with the seal.

[0243] In one embodiment of this technology, the positioning and stabilizing structure includes a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam material is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0244] In certain embodiments of this technology, the positioning and stabilizing structure includes a stretchable (e.g., stretchable with elasticity) strap. For example, the strap may be configured to be taut when in use, directing the force that causes the seal-forming structure to adhere to a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0245] In one embodiment of this technology, the positioning and stabilizing structure includes a first tie, which is constructed and positioned such that, during use, at least a portion of its lower edge passes over the patient's head to the superior base of the ear and covers a portion of the parietal bone without covering the occipital bone.

[0246] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a second tie. The second tie is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the inferior foot of the patient's head and covers or rests on the occipital bone of the patient's head.

[0247] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a third tie constructed and positioned to interconnect the first tie and the second tie to reduce the tendency of the first tie and the second tie to move apart in different directions.

[0248] In certain embodiments of this technology, the positioning and stabilizing structure includes a flexible and, for example, non-rigid strap. An advantage of this embodiment is that the strap is more comfortable when the patient lies down while sleeping.

[0249] In certain embodiments of this technology, the positioning and stabilizing structure includes a strap configured to be breathable, allowing water vapor to pass through its interior.

[0250] In certain embodiments of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300, 9300. Each positioning and stabilizing structure is configured to provide holding force to accommodate different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure suitable for a large head rather than a small head, and another form suitable for a small head rather than a large head.

[0251] 5.3.3.1.1 Positioning and stabilization structure of this technology Figure 5 shows an example of the present technology including a positioning and stabilization structure 3300. In this example, the positioning and stabilization structure 3300 includes a lateral 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 portion 3314. The positioning and stabilization structure 3300 may be positioned such that the hub 3306 and the disconnection structure 3500 are positioned above the patient's head when in use. As described below, the disconnection structure 3500 may 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 disconnection structure 3500 are positioned above the patient's head, allowing the patient to move more freely (without entanglement with the air circuit 4170).

[0252] The positioning and stabilizing structure 3300 can be constructed from silicone. For example, the lateral section 3302, the upper section 3304, the hub 3306, and the lateral end 3314 can be constructed or molded from a single piece of silicone.

[0253] The upper part 3304 of the positioning and stabilizing structure 3300 has peaks and valleys (or bellows sections), allowing it to conform to the shape of corresponding parts of the patient's head during use. The peaks and valleys of the upper part 3304 allow it to extend or contract along its longitudinal axis to accommodate larger or smaller heads. The peaks and valleys of the upper part 3304 allow it to flex to different radii of curvature to accommodate patient heads of different shapes and sizes.

[0254] The lateral portion 3302 of the positioning and stabilizing structure 3300 does not necessarily have to be formed together with the peaks and valleys of the upper portion 3304. Therefore, it may be advantageous if the extensibility and flexibility of the lateral portion 3302 can be lower than that of the upper portion 3304, as this reduces the variability in the shape and size of the side of the patient's head.

[0255] End 3314 may 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 stabilizing structure 3300. This pressurized gas flow reaches the patient's airway through the plenum chamber 3200 and the seal-forming structure 3100. As described above, end 3314 may be connected to the plenum chamber connector 3204 of each plenum chamber lateral end 3202.

[0256] The positioning and stabilizing structure 3300 may be constructed and arranged such that it directs the force / tension provided from the lateral portion 3302 into partially upward and partially backward force vectors applied to the plenum chamber 3200. In particular, these partially upward and partially backward force vectors cause the fabric membrane of the seal-forming structure 3100 to make airtight contact with the patient's nose below (e.g., at or below the nasal tip, and at least above the upper lip robe).

[0257] Furthermore, each of the lateral portions 3302 may include a tab 3308 that receives the rear strap end 3311 of the rear strap 3310. The rear strap 3310 may be length-adjustable, for example, by a hook-and-loop material arrangement configuration, so that the hook material is externally provided at one of the rear strap ends 3311 and the rest of the rear strap 3310, and the loop material is externally provided at the other. In this way, the length-adjustable rear strap 3310 allows the tension on the lateral portions 3302 to be increased, pulling the seal-forming structure 3100 to seal and engage with the patient's face at a desired amount of pressure (i.e., tight enough to avoid leakage but not to cause discomfort).

[0258] By providing a sleeve 3312 to the lateral portion 3302, the patient's face can be protected from the lateral portion 3302 like a cushion. The sleeve 3312 may be constructed from a soft, breathable woven material.

[0259] In another example shown in Figure 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 of a textile material (e.g., one or more sheets or layers of textile material) and receives pressurized air from an air delivery tube 6348 via a connection port 6600. The tube 6350 includes a left arm 6305 and a right arm 6307.

[0260] In some embodiments, the fabric conduit 6350 may be formed with a first side configured to contact the patient. This may be called the inner layer 6352. The fabric conduit may also include a second side. This second side is attached to the inner layer but faces away from the patient and may be called the outer layer 6354. The inner and outer layers may be fixed to each other along their edges, thereby forming a flow path or passage between the seams of the inner and outer layers. That is, the space between the seams is left unattached, forming an air passage 6372. The inner and outer layers may be joined using various techniques that impart specific attributes to the seams or joints. For example, in some embodiments, seams are formed using ultrasonic welding, high-frequency welding, and cutting and welding techniques. Applying heat to specific areas activates the thermosetting or thermoplastic material used in the conduit 6350. This heat may be used not only for joining the layers together but also for thermoforming layers such as the outer layer 6354. Furthermore, in some forms, layers can be joined together using adhesives such as sutures or glues. In some forms, sutures are not used. In further forms, no material beyond the material placed within the layer is used in joining the inner and outer layers of the tube. For example, in some forms, the inner and outer layers may be formed such that no additional material such as adhesives or sutures is required in joining the inner and outer layers.

[0261] 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. Furthermore, in a form including a single sheet, the inner surface is the surface of the sheet and is positioned inward or toward itself.

[0262] In some embodiments, a sheet or tube sheet may include an air-impermeable layer or membrane. In some embodiments, the inner surfaces of both layers include a membrane configured to restrict or inhibit air from passing through the layer from the inner surface to the outer surface. The impermeable layer may be a thin layer less than the thickness of the inner or outer fabric sheet. In other embodiments, the impermeable layer may exceed the thickness of either fabric sheet of the layer. The impermeable layer or membrane or film may be completely impermeable to air movement, or it may be formed to allow a predetermined speed or air movement and a specific pressure.

[0263] The film can be formed from a thermoplastic or thermosetting material so that, when exposed to a specific temperature, the film material can be molded or formed into a specific shape, and then cured or solidified, or solidified by cooling. In some embodiments, the film can be formed from silicone or polyurethane. In some embodiments, by pre-forming the outer layer 6354, in an unpressurized or supported state, the outer layer 6354 is pre-positioned and pre-formed so that, in an unpressurized or supported state, the outer layer 6354 extends away from the inner layer 6352 between the opposing joints 6312. That is, the outer layer 6354 can support its own weight, and therefore remains spaced apart from the inner layer 6352 between the joints 6312 even without support by pressurized air or other support mechanisms.

[0264] 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.

[0265] As shown in Figure 7, and particularly as shown in Figure 8, the inner layer 6352 includes a woven sheet 6360 together with the membrane 6362. The woven sheet 6360 may be formed from felt, foam material, woven fabric, knitted fabric, or nonwoven material or other fiber mesh.

[0266] The outer layer 6354 includes a tube sheet 6364 and an outer covering 6366. In some embodiments, both sides of the tube sheet 6364 can be covered with a membrane. As shown in Figure 9, the tube sheet 6364 includes a membrane 6368 exposed to the chamber of the tube 6350 and a membrane 6370 along the opposite side of the tube sheet 6364. The membrane 6368 can help provide a seal between the inner layer 6352 and the outer layer 6354 and help form an airtight tube. The membrane 6370 can help bond the tube sheet 6364 to the outer covering 6366.

[0267] One or more aspects of this technology may be combined with one or more aspects of the following: U.S. Provisional Application No. 62 / 821,878 (filed March 21, 2019, title: "Textile Headgear Tubing for a Patient Interface") or PCT / AU2019 / 050655 (filed June 25, 2019). These documents are incorporated herein by reference in their entirety. For example, the positioning and stabilization structures of this technology may be identical to those in any embodiment of the '968 or '655 application. Furthermore, instead of the cushion assembly or seal-forming structure disclosed herein, one of the cushion assembly or seal-forming structures in any of the patient interfaces disclosed in the '968 or '655 application may be used.

[0268] In another example shown in Figure 38, the patient interface 9000 includes a positioning and stabilization structure 9300. The positioning and stabilization structure 9300 has a pair of lateral sections extending between the patient's eyes and ears on each side of the patient's head. These lateral sections may include holes or other connectors for connection to the headgear mounting portion 9210 of the frame 9200. The positioning and stabilization structure 9300 also includes a rear strap 9310 extending around the rear of the patient's head and a crown strap 9312 extending across the top of the patient's head.

[0269] 5.3.3.2 Ventilation In one embodiment, the patient interfaces 3000, 6000, and 9000 include a vent 3400 configured and positioned to allow the expulsion of a gas (e.g., carbon dioxide), as shown in Figure 5, for example.

[0270] In a particular configuration, the vent 3400 is configured to allow a continuous airflow from the inside of the cavity 3101 to the atmosphere when the pressure inside the plenum chamber is positive relative to the atmosphere. The vent 3400 is configured to maintain the therapeutic pressure inside the plenum chamber during use, while ensuring that the airflow is large enough to reduce patient rebreathing of exhaled CO2.

[0271] One form of the ventilation section 3400 according to this technology includes a plurality of holes (for example, about 20 to 80 holes, or about 40 to 60 holes, or about 45 to 55 holes).

[0272] The vent section 3400 may be located within the plenum chamber 3200. The vent section 3400 may include multiple holes as described above. The holes of the vent section 3400 may be divided into two groups spaced laterally apart. Since the axes of the flow paths passing through each hole of the vent section 3400 may be parallel, cross-flow is avoided, and further noise generation is prevented. The vent holes may be circular.

[0273] The radius of the holes in the vent section 3400 may decrease from the inside to the outside of the plenum chamber 3200. Each vent is provided with a draft angle. The diameter of each hole is smaller at the front end than at the rear end. The draft angle helps to provide effective carbon dioxide flushing at high humidity levels because the cross-section of the hole does not decrease across the entire chassis thickness. Furthermore, a larger draft angle may make the manufacturing of the plenum chamber 3200 easier (especially when the plenum chamber 3200 is formed from injection-molded plastic material). The draft angle allows for the use of relatively thick vent pins in the mold and easier injection.

[0274] The holes in the ventilation section 3400 may be provided in two sets toward the middle portion of the plenum chamber 3200, and these sets may be symmetrical across the centerline of the plenum chamber 3200. Providing a pattern of multiple ventilation holes may enable noise reduction and dispersion of flow concentration.

[0275] The holes in the ventilation section 3400 can be positioned at an optimal distance from the centerline of the plenum chamber 3200. Positioning the holes in the ventilation section 3400 toward the centerline may reduce the likelihood of the ventilation holes becoming blocked when the patient is lying down, which may be advantageous. However, if the ventilation holes are positioned too close to the middle portion of the plenum chamber 3200, the plenum chamber 3200 may become excessively weak in the center, especially in the illustrated example, because the cross-section of the plenum chamber 3200 is minimized at the center (due to the overall shape of the plenum chamber 3200). Depending on the location of the holes in the ventilation section 3400, it may be possible to avoid blockage of the holes when the patient is lying down, while keeping the intermediate members of the chassis sufficiently strong.

[0276] The size and number of each vent can be optimized to achieve a balance between noise reduction and the necessary carbon dioxide flushing, even under extreme humidification. In the example described, the total airflow of the system cannot be obtained from the vents of the vent section 3400. The disconnection structure 3500 may include a disconnection structure vent section 3402. The disconnection structure vent section 3402 may include one or more holes through the disconnection structure 3500. The disconnection structure vent section 3402 may function to bleed off excess pressure generated by the RPT device 4000 (before it reaches the patient), while the vent section 3400 may function to flush away carbon dioxide exhaled by the patient during treatment.

[0277] Figures 31 and 32 show another example of the ventilation section 3400. In this example, the holes are provided in the ventilation insert 13400. The ventilation insert is removable or permanently attached to the plenum chamber 3200 at the ventilation insert opening. The ventilation insert 13400 may be constructed from a material that is more flexible than the material of the plenum chamber 3200.

[0278] 5.3.3.3 Decoupled Structures (Multiple or Single) In one embodiment, the patient interfaces 3000, 6000, and 9000 include at least one decoupling structure (e.g., a swivel or bulbolar fovea).

[0279] The hub 3306 described above is connected to a release structure 3500. The release structure 3500 is a rotatable elbow in these examples. The release structure 3500 may be 360° rotatable within the hub 3306 during use. The release structure 3500 may be detachable from the hub 3306 by manually pressing a button 3504 that releases a catch (not shown) from within the hub 3306.

[0280] The release structure 3500 may also include a swivel 3502 that allows for a rotatable connection to the air circuit 4170.

[0281] The fact that the release structure 3500 is rotatable, that the release structure 3500 takes the form of an elbow, and that the swivel 3502 is rotatable on the release structure 3500 all contribute to an increase in degrees of freedom, which in turn leads to a reduction in tube drag and torque on the patient interface 3000 due to the connection to the air circuit 4170.

[0282] 5.3.3.4 Connection Ports Connection port 3600 allows connection to the air circuit 4170.

[0283] 5.3.3.5 Forehead support In one embodiment, the patient interface includes a forehead support portion 3700.

[0284] 5.3.3.6 Suffocation prevention valve In one embodiment, the patient interface includes an anti-choking valve.

[0285] 5.3.3.7 Ports In one embodiment of this technology, patient interfaces 3000, 6000, and 9000 include one or more ports that allow access to the volume within the cavity 3101. In one embodiment, this enables a clinician to supply supplemental oxygen. In one embodiment, this enables direct measurement of the properties of the gas (e.g., pressure) within the cavity 3101.

[0286] 5.3.4 Full Face Mask Cushion 5.3.4.1 First illustrative example Referring to Figures 39 to 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., a mouth-nose cushion assembly or a miniature full-face mask). The cushion assembly 14105 is at least partially formed by the seal-forming structure 14100 and the plenum chamber 14200, which are attached to a plenum chamber according to an example of the present art.

[0287] A cushion assembly 31105 is illustrated with reference to Figures 51 to 56. 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 seal separately around the patient's nostrils and mouth (i.e., a mouth-nose cushion assembly or a miniature full-face mask). The cushion assembly 31105 is at least partially formed by the seal-forming structure 31100 and the plenum chamber 31200 attached to a plenum chamber according to an example of the present art.

[0288] The cushion assembly 31105 includes a nose portion 31101, a nose portion opening 31103, a mouth portion 31102, a mouth portion opening 31104, a cavity 31001, a support structure 31120, a sealing portion 31130, and a ventilation portion 31400, which are similar in features to those shown in Figures 39 to 50 and are not discussed individually. A pair of plenum chamber openings are configured to receive airflow.

[0289] As described above, Figures 54 to 56 show the grip pads 31150 on the surface of the woven film. Plenum Chamber

[0290] The plenum chamber 14200 has edges that are shaped to be complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber 14200 is positioned close to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 14100, which may extend around the entire edge of the plenum chamber 14200 during use.

[0291] In certain embodiments of this technology, the plenum chamber 14200 is constructed from a material (e.g., polycarbonate) that is relatively more rigid than 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 intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help clinicians confirm the placement and function of the patient interface.

[0292] In a specific form of this technology, the plenum chamber 14200 is constructed from a translucent material. The use of a translucent material can reduce the intrusiveness of the patient interface, thereby aiding in improved compliance with treatment.

[0293] The plenum chamber 14200 according to embodiments of this technology may include plenum chamber holes on each side. The plenum chamber holes allow for pneumatic communication between the conduit connector 14800 (described in more detail below) and the cavity 14001. A connecting rim around each plenum chamber hole facilitates mechanical connection (e.g., snap-fit ​​or friction-fit) with each conduit connector. The plenum chamber 14200 may be constructed of a sufficiently rigid material so that auditory and / or tactile feedback can be provided to the patient when the conduit connector 14800 is connected to or removed from the plenum chamber 14200.

[0294] The seal-forming structure 14100 may be sealed and connected to the plenum chamber 14200. The connection may be permanent, or the seal-forming structure 14100 may be removable from the plenum chamber 14200. The seal-forming structure 14100 may be overmolded onto the plenum chamber 14200. The seal-forming structure 14100 and the plenum chamber 14200 may be joined by a mechanical interlock. In the mechanical connection, no chemical bond is formed between the plenum chamber 14200 and the seal-forming structure 14100.

[0295] seal-forming structure Referring to Figures 39 to 50, the seal-forming structure 14100 may include a nasal portion 14101 having a pair of nasal portion openings 14103 for sealing the patient's nostrils. In the described embodiment, two separate openings 14103 are provided, each corresponding to one of the patient's nostrils, providing airflow to both of the patient's nostrils. A bridge portion 14106 may be provided between the nasal openings 14103. In another example, a single opening may be used to provide pressurized airflow to both of the patient's nostrils.

[0296] The seal-forming structure 14100 may include a mouth portion 14102 having a mouth portion opening 14104 for sealing the patient's mouth.

[0297] The seal-forming structure 14100 can at least partially form a cavity 14001 that is pressurized by airflow. The plenum chamber 14200 may be joined with the seal-forming structure 14100 to further form the cavity 14001.

[0298] The seal-forming structure 14100 may include a support structure 14120 that provides support to the sealing portion 14130 (e.g., a woven film). The sealing portion is configured to engage airtightly with the patient's face. Depending on the size and shape of the patient's nose, the support structure may also engage airtightly with the patient's face.

[0299] The wall structure that may be included in the support structure 14120 may include at least two regions of different thicknesses (for example, a portion of the support structure adjacent to or connected to the plenum chamber 14200. These portions may be thicker than the portion of the support structure adjacent to or connected to the sealing portion 14130, thereby providing structural stability in connection with the plenum chamber 14200 and flexibility in the interface with the patient). Figure 84 illustrates an example where portion (d1) of the support structure may be thicker than portion (d2) of the support structure. For example, portion (d1) may be adjacent to or connected to the plenum chamber, and portion (d2) may be adjacent to or connected to the sealing portion, thereby providing structural stability in connection with the plenum chamber and flexibility in the interface with the patient. Alternatively, thicker lateral support regions 3122 may be positioned, for example, at the corners of the nasal region and / or the oral region of the seal-forming structure (e.g., directly connected to the fabric membrane), thereby ensuring proper sealing at the lowest point of the nasal ala and / or the oral region of the patient's face.

[0300] As described above, the seal-forming structure 14100 may be sealed to the plenum chamber 14200. The support structure 14120 may be less rigid than the plenum chamber 14200 and may be constructed from silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable material as described later. Furthermore, the sealing portion 14130 may be less rigid than the support structure 14120 and may be constructed from woven material (e.g., nylon, polyester, nylon and polyester mixture, microfiber, or polyurethane as described in more detail later).

[0301] The support structure 14120 may have an aperture formed internally, thus providing an inner edge of the support structure. Along this inner edge, a sealing portion 14130 (e.g., the outer circumference of the sealing portion) is attached to the support structure, for example, as shown in Figures 43 to 46, extending the sealing portion radially inward of the seal-forming structure (beyond or beyond the support structure). For example, the sealing portion may be formed around the inner edge of the support structure, or it may be connected to the support structure by other suitable methods as described later.

[0302] In the example shown in Figure 49, the support structure 14120 may extend into a cavity 14001 that forms a base cushion 14121 providing support to the sealing portion 14130. The base cushion 14121 and the sealing portion 14130 may form a double-wall structure around the sealing portion. In another example, a second or third base cushion layer may be provided to form a triple or quadruple-wall structure. In the example shown in Figure 49, the base cushion is constructed from a foamed material (e.g., polyurethane foam). In another example, the base cushion 14122 may be constructed from silicone as shown in Figure 50. However, it is recognized that the base cushion may be constructed from other suitable materials (e.g., textiles).

[0303] One or more embodiments of this technology may be combined with one or more embodiments 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 that both are referred to in their entirety as such). These documents are incorporated herein by reference. For example, the conduit and positioning and stabilization structures of this technology may be identical to those in any embodiment of the '909 or '058 application. Furthermore, instead of the cushion assembly and seal-forming structure disclosed herein, a cushion assembly (seal-forming structure and plenum chamber) and seal-forming structure from any patient interface disclosed in the '909 or '058 application may be used.

[0304] 5.3.4.1.1 Positioning and stabilization structure The seal-forming structure 14100 of the patient interface 14000 of this technology can be held in a sealed position by the positioning and stabilizing structure 14300 during use.

[0305] In one embodiment, the positioning and stabilizing structure 14300 provides at least sufficient holding force to overcome the effect of positive pressure in the cavity 14001 that causes it to lift away from the face.

[0306] In one embodiment, the positioning and stabilizing structure 14300 provides sufficient holding force to overcome the attractive force on the patient interface 14000.

[0307] In one embodiment, the positioning and stabilizing structure 14300 provides a holding force as a safety margin to eliminate the possibility of destructive effects on the patient interface 14000 (for example, those resulting from tube dragging or accidental interference with the patient interface).

[0308] In one embodiment of this technology, a positioning and stabilization structure 14300 is provided, configured to be worn by a patient while sleeping. In one embodiment, the positioning and stabilization structure 14300 has an inconspicuous shape or cross-sectional thickness 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.

[0309] In one embodiment of this technology, a positioning and stabilizing structure 14300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a supine position with the posterior region of the patient's head resting on a pillow.

[0310] In one embodiment of this technology, a positioning and stabilizing structure 14300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a lateral position with the side of the patient's head resting on a pillow.

[0311] In one embodiment of this technology, the positioning and stabilizing structure 14300 includes a release portion positioned between the front portion and the rear portion of the positioning and stabilizing structure 14300. This release portion is not compressible and may be, for example, a flexible or flimsy strap. The release portion is constructed and positioned so as to prevent a situation in which, when a patient lies down with their head on a pillow, the presence of the release portion transmits force to the rear portion along the positioning and stabilizing structure 3300, thereby interfering with the seal.

[0312] In one embodiment of this technology, the positioning and stabilizing structure 14300 includes a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam material is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0313] In certain embodiments of this technology, the positioning and stabilizing structure 14300 includes an extendable (e.g., extendable with elasticity) strap. For example, the strap may be configured to be taut when in use, directing the force that brings the seal-forming structure into contact with a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0314] In one embodiment of this technology, the positioning and stabilizing structure may include a first tie (e.g., an upper strap 14302 (Figure 41)). The first tie is constructed and positioned such that, in use, at least a portion of its lower edge moves over to the upper base of the patient's head.

[0315] In one embodiment of the present technology suitable for a full-face mask, the positioning and stabilizing structure includes a second tie (e.g., a lower strap 14303 (Figure 41)). The second tie is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the inferior base of the patient's head and covers or rests on the occipital bone of the patient's head.

[0316] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a third tie (e.g., a strap connector 14304 (Figure 39)) constructed and positioned 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 apart in different directions.

[0317] In certain embodiments of this technology, the positioning and stabilizing structure 14300 includes a flexible and, for example, non-rigid strap. An advantage of this embodiment is that the strap is more comfortable when the patient lies down while sleeping.

[0318] In a particular embodiment of this technology, the positioning and stabilizing structure 14300 includes a strap configured to be breathable, allowing water vapor to pass through its interior.

[0319] In certain embodiments of this technology, a system is provided comprising more than one positioning and stabilizing structure 14300. Each positioning and stabilizing structure is configured to provide holding force to accommodate different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 14300 that is suitable for a large head rather than a small head, and for another small head rather than a large head.

[0320] The positioning and stabilizing structure 14300 may include clips 14301 for securing each tie to the conduit connector 14800, as shown in Figure 39, for example. The clips 14301 and the conduit connector 14800 are each equipped with magnets having opposite polarities to facilitate connection between them.

[0321] 5.3.4.1.2 Ventilation In one embodiment, the patient interface 14000 includes a vent 14400 configured and positioned to allow the expulsion of gases (e.g., carbon dioxide), as shown in Figure 39.

[0322] In a particular configuration, the vent 14400 is configured to allow a continuous airflow from the inside of the plenum chamber 14200 to the atmosphere when the pressure inside the plenum chamber is positive relative to the atmosphere. The vent 14400 is configured to maintain the therapeutic pressure inside the plenum chamber during use, while ensuring that the airflow is large enough to reduce patient rebreathing of exhaled CO2.

[0323] One embodiment of the ventilation section 14400 according to this technology includes a plurality of holes (for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0324] The ventilation section 3400 may be located within the plenum chamber 14200, as shown in Figure 47. Alternatively, the ventilation section 14400 may be located within a release structure (e.g., a swivel).

[0325] Figure 39 shows an example of a ventilation section 14400 provided on a connection port 14600 (e.g., a swivel elbow). In variations of these examples, the ventilation section 14400 may be removed from the connection port 14600.

[0326] The conduit connector 14800, described in more detail below, may also include a ventilation feature.

[0327] 5.3.4.1.3 Decoupled Structures (Multiple or Single) In one embodiment, the patient interface 14000 includes at least one decoupling structure (e.g., a swivel or bulbolar fovea).

[0328] 5.3.4.1.4 Connection Port The connection port 14600 enables connection to the air circuit 4170. In one embodiment of this technology, the connection port 14600 may be connected to a connection port housing 14903. The connection port 14600 may be swivelable relative to the connection port housing 14903, and the connection portion to the air circuit 4170 may also be swivelable.

[0329] The connection port 14600 and the connection port housing 14903 can be positioned above the patient's head during use.

[0330] 5.3.4.1.5 Forehead support The embodiments of the patient interface of this technology shown in Figures 39 to 50 do not include a forehead support. Modified versions of the patient interface of this technology may include a forehead support.

[0331] 5.3.4.1.6 Conduit The patient interface 14000 according to an embodiment of this technology may include a conduit 14900 for supplying pressurized airflow from a connection port 14600 to a cavity 14001 within a plenum chamber 14200. The conduit 14900 may be joined in the connection port housing 14903 above the patient's head and may pass along the side of the patient's head between the corresponding eyes and ears of the patient. The conduit 14900 may be connected to a cushion assembly 14105 (e.g., a plenum chamber 14200) via a conduit connector 14800 to provide pressurized airflow to the cavity 14001, as described below.

[0332] The conduit 14900 may also enable stabilization and positioning of the seal-forming structure 14100 on the patient's face. Thus, the conduit 14900 may function similarly to a tie for the positioning and stabilization structure 14300. Therefore, the mechanical connection from the conduit 14900 to the conduit connector 14800 may be sufficient to transmit the tensile force in the conduit 3900 to the seal-forming structure 14100 through the conduit connector 14800.

[0333] Conduit 14900 may include features of a similar conduit disclosed in International Patent Publication WO2017 / 124155Al, which is incorporated herein by reference in its entirety. For example, conduit 14900 of this art may include features of headgear conduit 3350 as described in Figures 3A–3L and related descriptions of this document.

[0334] By providing a sleeve 14901 to the conduit 14900, the patient's face can be protected from the conduit 14900 like a cushion. The sleeve 14901 may be removable. The sleeve 14901 may be made of a breathable material.

[0335] The conduit 14900 may also include a tie connector 14902 for facilitating connection to the tie of the positioning and stabilizing structure 14300.

[0336] 5.3.4.1.7 Conduit Connectors The patient interface 14000, according to embodiments of the present technology, may include conduit connectors 14800 that connect conduits 14900 to a cushion assembly 14105 to provide a flow of pressurized air to the cavity 14001. Each conduit connector 14800 may be formed together with a conduit connector housing 14801. The conduit connectors 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 asphyxiation prevention by incorporating the asphyxiation prevention valve 14850).

[0337] Figures 43 to 50 show several diagrams of the conduit connector 14800 of the patient interface 14000 according to an embodiment of this technology.

[0338] Figures 39 to 50 illustrate how the conduit connectors 14800 are attached to the plenum chamber 14200 in the plenum chamber holes. As can be understood, one conduit connector 14800 is provided on each lateral side of the cushion assembly 14105, and each conduit connector 14800 connects to the plenum chamber hole on each corresponding lateral side of the cushion assembly 14105. Each conduit connector 14800 may include a conduit connector mounting structure for connecting each conduit connector 14800 to each plenum chamber hole at a connecting rim (not shown). This connection may be mechanical (e.g., snap-fit ​​or friction-fit). This connection may also be removable. The materials of the conduit connectors 14800 and the plenum chamber 14200 may be selected to facilitate the desired connection feature, respectively. For example, the materials of the conduit connector 14800 and the plenum chamber 14200 may be relatively rigid, respectively, to allow auditory and / or tactile feedback in relation to the snap-fit. The materials of the conduit connector 14800 and the plenum chamber 14200 may be different in at least one embodiment, or the materials may be the same. The conduit connector 14800 may be permanently connected to the plenum chamber at the plenum chamber hole. For example, the conduit connector 14800 may be ultrasonically welded to the plenum chamber 14200. The connection between the conduit connector 14800 and the plenum chamber 14200 may be removable or permanent and may be designed to be robust enough to allow tension from the conduit 14900 to be transmitted 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.

[0339] To improve the aesthetics of the patient interface 14000, the conduit connector 14800 may be mounted on the side of the plenum chamber 14200. As described above, by constructing the plenum chamber 14200 from a transparent or translucent material, the patient's facial features may be made visible. For example, by providing the conduit connector 14800 on the side of the plenum chamber as shown in the illustrated embodiment, the patient's face can be viewed more clearly, and this arrangement improves the aesthetics of the patient interface 14000. This is in contrast to alternative designs where the patient's face is obstructed because the elbow and air circuit can be joined to the center of the plenum chamber 14200.

[0340] Each conduit connector 14800 may also include a conduit connection end 14802 that connects to each conduit 14900. The connection between the conduit 14900 and the conduit connector 14800 at the conduit connection end 14802 may be removable or permanent. A conduit connector inlet hole 14803 may be formed in the conduit connector housing 14801 at the conduit connection end 14802 to receive pressurized airflow. 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 a relatively rigid structure at its end 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, as described above, the conduit 14900 provides positioning and stabilization functions for installing the seal-forming structure in a therapeutically effective sealed position on the patient's face. Therefore, the connection between the conduit 14900 and the conduit connector 14800 at the conduit connection end 14802 can be made sufficiently and reliably possible, and the transmission of tensile force from the conduit 14900 to the conduit connector 14800 can be made (without interfering with the connection between the conduit 14900 and the conduit connector 14800 at the conduit connection end 14802).

[0341] The conduit connector 14800 may also provide ventilation for the patient interface 14000. The conduit connector housing 14801 may include a vent that is in pneumatic communication with the cavity 14001 during 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 multiple conduit connector vent holes 14831. As a result, it is possible to properly mix the newly introduced air with the existing air in the plenum chamber 14200, thereby improving carbon dioxide expulsion and increasing the amount of fresh air provided to the patient for breathing.

[0342] As shown in Figures 39 to 41, the conduit connector 3800 may also provide a connection to the tie of the positioning and stabilizing structure 3300. The lower tie may be joined to the conduit connector 3800 by a clip 14301. The clip 14301 and the conduit connector 14800 may include magnets with opposite polarity to facilitate connection. The connection between the tie of the positioning and stabilizing structure 14300 and the conduit connector 14800 may be detachable. The tension from the lower tie of the positioning and stabilizing structure 14300 biases the lower part of the seal-forming structure 14100, allowing it to engage tightly 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.

[0343] 5.3.4.1.8 Suffocation prevention valve In one embodiment, the patient interface 14000 includes an asphyxiation prevention valve. As best shown in Figures 47 and 48, each conduit connector 14800 may include an asphyxiation prevention valve assembly 14850. Thus, the patient interface 14000 may include two asphyxiation prevention valve assemblies 14850. Each asphyxiation prevention valve assembly 14850 may operate independently of each other (i.e., in response to the cessation of pressurized airflow). For example, if the pressurized airflow stops when the patient is lying on their side and one asphyxiation prevention valve assembly 14850 is blocked (e.g., by a pillow), the other asphyxiation prevention valve assembly 14850 may function to prevent the patient from asphyxiating.

[0344] 5.3.4.1.9 Port In one embodiment of this technology, the patient interface 14000 includes one or more ports that allow access to the volume within the plenum chamber 4200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the gas (e.g., pressure) within the plenum chamber 14200.

[0345] 5.3.4.2 Second illustrative example Figures 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 mouth-nose cushion assembly or a miniature full-face mask). The cushion assembly 30105 is at least partially formed by the seal-forming structure 30100 and the plenum chamber (or shell) 30200 attached to the plenum chamber according to an example of the present technology.

[0346] The cushion assembly 30105 includes a nose portion 30101, a nose portion opening 30103, a mouth portion 30102, a mouth portion opening 30104, a cavity 30001, a support structure 30120, and a sealing portion 30130, which are similar in features to those shown in Figures 39 to 56 and are not discussed individually. The inlet port 30240 is formed within the plenum chamber and is configured to receive airflow for the air circuit.

[0347] 5.3.4.2.1 Positioning and stabilization structure Figures 57 to 66 show a patient interface 30000 according to an example of the present technology. The patient interface 30000 includes 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.

[0348] 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 different types of removable connections to the frame, snap-fits, removable press-fits or other, or it may be permanently connected to the frame.

[0349] The positioning and stabilizing structure 30300 may include multiple straps or strap portions. These straps or strap portions connect 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. A single “strap” may be formed from multiple lengths of material (one or more) that are separately cut or formed and then joined at the ends to produce a longer length, or a single “strap” may be made from a single length of material (one or more).

[0350] In the example shown in Figures 57 to 66, the positioning and stabilizing structure 30300 includes a pair of upper straps 30310. Each upper strap is configured to pass between each of the patient's eyes and ears. Furthermore, the positioning and stabilizing structure includes a pair of lower straps 30320 configured to be positioned above both of the patient's cheeks, below the patient's cheekbones. In this example, the plenum chamber is held in place via four-point connections to the headgear straps via a frame 30350.

[0351] Figures 63 and 64 show the frame in isolation. 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 allow connection to a swivel elbow assembly 30610, which provides a connection port 30600 for connection to an air circuit 4170. In this example, the frame inlet connection port includes a connection rim 30355. The connection rim 30355 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 a plenum chamber. Therefore, the frame 30350 enables fluid connection between the swivel elbow assembly 30610 and the inside of the plenum chamber 30200.

[0352] The frame 30350 also includes a pair of opposing upper strap connection points 30315 to which the upper straps 30310 are connected. 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 to itself, and then securing itself. Each upper strap can be secured to itself via hook-and-loop material configured to be released when in contact. In another example, each upper strap 30310 can be secured to itself by a band, clip, etc., after passing through each aperture and looping back to itself. In yet another example, the upper straps can be connected to the frame via a side-release buckle connection.

[0353] The frame 30350 also includes a pair of opposing lower strap connection points 30325 to which the lower strap 30320 is connected. In this example, each lower strap connection point includes a magnet. Each lower strap includes a lower strap clip 30326 which 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, the end of each lower strap can be passed, looped back, and secured to itself (e.g., by hook and loop material, strap, clip, etc.). In another example, the lower strap may be connected to the frame via a side-release buckle connection and to a hook or any other suitable connection.

[0354] In one example, the frame 30350 and the upper strap connection point 30315 are constructed and positioned such that the force / tension provided by the upper strap 30310 is directed to a partially upward and partially backward force vector applied to the plenum chamber 30200. Specifically, this partially upward and partially backward force vector causes the nasal portion 30101 of the seal-forming structure 3100 to make sealing contact with the lower periphery of the patient's nose and the patient's upper lip.

[0355] Each upper strap 30310 may be selectively adjustable. For example, to change the effective length of each upper strap, the amount of upper strap that loops back to itself after passing through the aperture at each upper strap connection point 30315 can be changed. Increasing the amount of upper strap passing through the aperture effectively reduces the length of the upper strap, thereby allowing for changes in the force vector and adjustment of the fit of the patient interface.

[0356] In one example, the frame 30350 and the lower strap connection point 30325 are constructed and positioned such that the force / tension provided by the lower strap 30320 is directed to partially backward and partially possible force vectors applied to the plenum chamber. Specifically, the partially backward and partially downward force vectors cause the mouth portion 30102 to make sealing contact with the patient's face around the periphery of the patient's mouth. The partially downward force applied from the lower strap to the frame can balance the partially upward force applied from the upper strap and any downward-directed force that may be applied from the patient's nose to the seal-forming structure.

[0357] The lower straps 30320 may be selectively adjustable. For example, the effective length of each lower strap can be changed by changing the amount of each lower strap that loops back to itself after passing 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 allowing for changes in the force vector and adjustment of the fit of the patient interface.

[0358] The positioning and stabilization structure 30300 may also include one or more of the apical coronal strap 30330, a pair of lateral coronal straps 30332, and a cervical strap 30334. In the example shown in Figures 57 to 66, the upper strap 30310 and lower strap 30320 are connected to the ends of the apical coronal strap 30330. The apical coronal strap is configured to pass around the patient's head and be positioned against surfaces facing upward and backward. The apical coronal strap 30330 may be configured to be positioned on the parietal bone of the patient's skull. Each end of the apical coronal strap is also connected to each of the upper straps 30310 and each of the pair of lateral coronal straps 30332. Each lateral coronal strap is connected between the upper and lower straps at each side of the patient's head. The lower ends of the lateral coronal straps 30332 are interconnected by the cervical strap 30334. The cervical strap may be configured to pass through the sagittal plane and be positioned against the downward and / or backward-facing surface of the patient's head or on the back of the patient's neck. The cervical strap may be positioned above or below the occipital bone of the patient's skull.

[0359] The length of the apex crown strap 30330 is selectably adjustable. The apex crown strap 30330 is formed by two strap sections connected by a link having a pair of apertures. Each of these two strap sections forming the apex crown strap loops back after passing through each aperture and can be secured to itself via, for example, hook-and-loop material, additional clips, bands and / or other means. The amount of each upper strap section passed through the link can be changed to adjust the length of the apex crown strap 30330 and thus the fit of the positioning and stabilizing structure.

[0360] After all headgear straps have been adjusted and the desired fit of the patient interface 30000 has been achieved, the magnetic clip connection provided by the lower strap clip 30326 allows the lower strap 30320 to be quickly disengaged from the lower strap connection point 30325 on the frame 30350, thereby enabling the removal of the patient interface 30000 from the patient without strap adjustment. Similarly, when the patient puts on the patient interface again, 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 incorporated herein by reference.

[0361] In certain embodiments of this technology, a system is provided that includes more than one positioning and stabilizing structure. Each positioning and stabilizing structure is configured to provide holding force to accommodate different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure that is suitable for a large head rather than a small head, and for another small head rather than a large head.

[0362] Furthermore, note that one or more aspects of this technology may be combined with one or more aspects of the following: PCT / AU2019 / 050278 (filing date: March 28, 2019, title: "Patient Interface"). This document is incorporated herein by reference in its entirety.

[0363] 5.3.4.2.2 Ventilation In one embodiment, the patient interface 30000 includes a vent 30400 configured and positioned to allow the expulsion of exhaled gases (e.g., carbon dioxide).

[0364] In a particular configuration, the vent 30400 is configured to allow a continuous airflow from the inside of the plenum chamber 30200 to the atmosphere when the pressure inside the plenum chamber is positive relative to the atmosphere. The vent is configured such that, during use, the airflow rate is large enough to reduce patient rebreathing of exhaled CO2 while maintaining the therapeutic pressure inside the plenum chamber.

[0365] One form of ventilation using this technology includes a plurality of holes (for example, about 20 to 80 holes, or about 40 to 60 holes, or about 45 to 55 holes).

[0366] The ventilation section 30400 may be located within the plenum chamber. Alternatively, the ventilation section may be located within a release structure (e.g., a swivel).

[0367] In the example shown in Figures 57 to 66, the patient interface 30000 includes a vent 30400. In this example, the vent includes passages within the frame and swivel elbow assembly. These passages allow air to flow from the inside of the plenum chamber to the surroundings. As shown in Figure 59, after air has flowed into the swivel elbow assembly 30610, it can flow to the surroundings through an external hole in the swivel elbow assembly that forms part of the vent 30400. The swivel elbow assembly 30610 may be substantially similar to that described in International Publication WO2017 / 049357A1, which is incorporated herein by reference.

[0368] 5.3.4.2.3 Decoupled Structures (Multiple or Single) In one embodiment, the patient interface 30000 includes at least one decoupling structure (e.g., a swivel or bulbolar fovea).

[0369] 5.3.4.2.4 Connection Port Connection port 30600 allows connection to the air circuit 4170.

[0370] 5.3.4.2.5 Forehead support In one embodiment, the patient interface 30000 includes a forehead support portion 3700 as shown in Figure 3A. In other examples, the patient interface may omit the forehead support portion. Furthermore, the patient interface 30000 may be configured so as not to come into contact with the patient's forehead at all.

[0371] 5.3.4.2.6 Choking prevention valve In one embodiment, the patient interface 30000 includes an asphyxiation prevention valve.

[0372] 5.3.4.2.7 Port In one embodiment of this technology, the patient interface 30000 includes one or more ports that allow access to the volume within the plenum chamber. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the gas (e.g., pressure) within the plenum chamber 302000.

[0373] 5.3.4.3 Third Illustration 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 including a seal-forming structure 16200, an air delivery connector (e.g., an elbow assembly 16600), and a positioning and stabilizing structure (e.g., a headgear 16800 including an upper side strap 16802, a lower side strap 16804, and a crown strap 16806). In use, one form of the seal-forming structure 16200 is positioned to surround the airway entrance of the patient 1000 to facilitate positive pressure air delivery to the airway. In the example shown in Figures 46–56, the patient interface is a full-face / mouth-nose interface type including a seal-forming structure 16200 constructed to form a seal around the mouth of the patient's nose. However, embodiments of the present technology may be adapted for use with other suitable types of interfaces (e.g., nasal interfaces, nasal prongs, pillows).

[0374] The seal-forming structure 16200 may also be commonly referred to as a cushion. Figures 67 and 68 are illustrative diagrams of the patient interface 16000 with an arm cover 16750 attached for the upper arm 16134 of the frame assembly 16100. Figure 69 is an illustrative diagram of the patient interface 16000 with the headgear 16800 and arm cover 16750 removed.

[0375] In this example, the cushion assembly 16175 is connected to the frame assembly 16100 independently of the elbow assembly 16600 (via a first retaining feature on the frame assembly), and the elbow assembly 16600 is connected to the frame assembly 16100 independently of the cushion assembly 16175 (via a second retaining feature on the frame assembly). That is, the retaining connections from the cushion assembly 16175 and the elbow assembly 16600 to the frame assembly 16100 are separate and independent from each other, allowing for independent engagement and disengagement.

[0376] In the example of patient interface 16000, a first seal for the air passage 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 passage. That is, the elbow assembly 16600 is constructed to establish a rigid-to-hard connection and dynamic seal together with the frame assembly 16100, and the cushion assembly 16175 is constructed to establish a separate hard-to-hard connection and static seal together with the frame assembly 16100.

[0377] Furthermore, in the example of patient interface 16000, the frame assembly 16100 includes a lockout function along the opening 16105, which is structured and positioned to avoid direct connection or insertion of the air circuit 4170 (e.g., an air delivery tube). In this configuration, the use of the elbow assembly 16600 is required for the interconnection of the frame assembly 16100 and the air circuit 4170, so that the elbow assembly 16600 (and its vents and anti-asphyxiation valve (AAV)) is ensured to be present in the system.

[0378] Frame assembly Referring again to Figures 67-77, the frame assembly 16100 includes a pair of upper headgear connector arms 16134 (i.e., right and left) extending from each upper side of the shroud 16110 (including two flexible sections 16140 and 16145, respectively) of the shroud or wall member 16110, and a pair of lower headgear connector arms 16154 (i.e., right and left) extending from each lower side 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 constructed to position and connect headgear clips 16160 (including a magnet in a container) provided to each lower headgear strap 16804 of the headgear.

[0379] In the illustrated example, the opening 16105 of the shroud 16110 (constructed from a relatively rigid plastic material such as polycarbonate, for example) is bounded by an outer annular flange and an inner annular flange. Cushion Assembly & Elbow Assembly

[0380] Referring to Figures 67 to 77, the body, chassis, plenum chamber, or shell 16180 included in the cushion assembly 16175 is connected to or otherwise provided with a seal-forming structure or cushion 16200 (see Figures 70 and 71). The shell 16180 may be permanently connected to the cushion 16200 (e.g., by integral molding, overmolding) or removablely connected to the cushion 16200 (e.g., by mechanical connection). In the example, the cushion 16200 is constructed of a relatively flexible or pliable material, and the shell 16180 is constructed of a relatively rigid material (e.g., polycarbonate). The shell 16180 and cushion 16200 cooperate to form a cavity 16500 (e.g., Figures 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.

[0381] The shell 6180 has multiple functions. For example, it forms at least partially a cavity for the delivery of 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. These forces are obtained by the tension from the tightening of the headgear straps. These forces are transferred from a pair of upper and lower headgear straps to the corresponding upper and lower arms. In this example, the upper and lower arms are equipped with a frame assembly so that headgear tension is applied to the shell 6180.

[0382] The shell 16180 of the cushion assembly 16175 is repeatedly engageable with the shroud 16110 of the frame assembly 16100 via a mechanical connection (e.g., a snap-fit ​​connection) and removably disengaged from the shroud 16110 of the frame assembly 16100. The inner annular flange of the shroud 16110 extends through the opening 16305 of the shell 16180, and a tab or catch on the flange engages with the rear side of the annular flange 16310 of the shell 16180 or interlocks on the rear side of the annular flange 16310 of the shell 16180, thereby removably connecting the frame assembly 16100 to the cushion assembly 16175. Such a connection provides a sealed, hard-to-hard connection while maintaining ease of use, minimizing rattling and oscillating motion between components and reducing the impact on stability. Furthermore, this connection applies an appropriate force vector for sealing to the cushion assembly 16175 while stably holding the cushion assembly 16175 in place.

[0383] In the example shown in Figure 67, the elbow assembly 16600 includes a first end 16610 and a second end 16620. The first end 16610 is releasably engaged with the frame assembly 16100 by a pinch arm 16650 (and together form a swivel connection). The second end 16620 is adapted to connect to the air circuit 4170 (for example, via a swivel connector 16625). The elbow assembly 16600 is constructed such that a rigid joint and seal is established together with the frame assembly 16100.

[0384] In this example, the first end portion 16610 includes an inner radial wall and an outer radial wall. The inner and outer radial walls define radial channels leading to a plurality of vents 16700, allowing exhaled gases to exit from the patient interface.

[0385] Furthermore, it should be understood that one or more aspects of this technology may be combined with one or more aspects of the following: U.S. Patent Application Publication No. 2018 / 0250486 (filing date: March 12, 2018, title: "Patient Interface"). The entire document is incorporated herein by reference. For example, instead of the cushion assembly 16175 disclosed herein, a cushion assembly from any embodiment of the patient interface disclosed in the '486 publication may be used. Furthermore, instead of the seal-forming structure 16200 disclosed herein, a seal-forming structure from any patient interface disclosed in the '486 publication may be used.

[0386] seal-forming structure As described above, the shell 16180 is provided in a manner that it is sealed to a seal-forming structure or cushion 16200, and the shell 16180 and cushion 16200 cooperate to form a cavity 16500.

[0387] The cushion 16200 may include a support structure 16220 that provides support to the sealing portion 16230 (e.g., a woven membrane). The sealing portion is configured to engage tightly with the patient's face.

[0388] The support structure 16220 may include a wall structure having at least two regions of different thicknesses (for example, a portion of the support structure adjacent to or connected to the shell 16180 may be thicker than a portion of the support structure adjacent to or connected to the sealing portion 16230, thereby providing structural stability in connection with the shell 16180 and flexibility in the interface with the patient). Figure 84 illustrates an example where a portion (d1) of the support structure may be thicker than a portion (d2) of the support structure. For example, portion (d!) may be adjacent to or connected to the plenum chamber, and portion (d2) may be adjacent to or connected to the sealing portion, thereby providing structural stability in connection with the frame and flexibility in the interface with the patient. Alternatively, a thicker lateral support region 3122 may be located, for example, in the lower cheek region of the seal-forming structure (for example, directly connected to the fabric membrane), thereby ensuring proper sealing in the lower cheek region of the patient's face.

[0389] The support structure 16220 may be less rigid than the shell 16180 and may be constructed from silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable material as described later. Furthermore, the sealing portion 16230 may be less rigid than the support structure 16220 and may be constructed from woven material (e.g., nylon, polyester, nylon and polyester mixture, microfiber, or polyurethane as described in more detail later).

[0390] The support structure 16220 may have an aperture formed internally, thus providing an inner edge of the support structure. Along this inner edge, a sealing portion 16230 (e.g., the outer circumference of the sealing portion) is attached to the support structure, for example, as shown in Figures 71 and 73-77, extending the sealing portion radially inward of the seal-forming structure (beyond or beyond the support structure). For example, the sealing portion may be formed around the inner edge of the support structure, or it may be connected to the support structure by other suitable methods as described later.

[0391] The support structure 16220 may extend into the cavity 16500 that forms a base cushion 16221 providing support to the sealing portion 16230, as shown in Figures 73 and 77. The base cushion 16221 and the sealing portion 16230 may form a double-wall structure around the sealing portion. In another example, a second or third base cushion layer may be provided to form a triple or quadruple-wall structure. The base cushion may be constructed of the same material as the support structure, or of other suitable material (e.g., textile).

[0392] 5.3.4.3.1 Positioning and stabilization structure The seal-forming structure of the patient interface in this technology can be held in a sealed position by a positioning and stabilizing structure during use.

[0393] In one embodiment of this technology, a positioning and stabilizing structure is provided that is configured to be worn by a patient while sleeping. In one embodiment, the positioning and stabilizing structure has a low profile or cross-sectional thickness to reduce the perceived bulk 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.

[0394] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam material is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0395] In certain embodiments of this technology, the positioning and stabilizing structure includes a stretchable (e.g., stretchable with elasticity) strap. For example, the strap may be configured to be taut when in use, directing the force that brings the cushion into close contact with a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0396] In certain embodiments of this technology, the positioning and stabilizing structure includes a flexible and, for example, non-rigid strap. An advantage of this embodiment is that the strap is more comfortable when the patient lies down while sleeping.

[0397] In certain embodiments of this technology, the positioning and stabilizing structure provides a holding force configured to accommodate a head of a specific size and / or face of a particular shape. For example, one embodiment of the positioning and stabilizing structure provides a holding force suitable for a large head rather than a small head. In another example, one embodiment of the positioning and stabilizing structure provides a holding force suitable for a small head rather than a large head.

[0398] 5.3.4.3.2 Ventilation In one embodiment, the patient interface includes a vent configured and positioned to allow the expulsion of exhaled gases (e.g., carbon dioxide).

[0399] One form of ventilation using this technology includes a plurality of holes (for example, about 20 to 80 holes, or about 40 to 60 holes, or about 45 to 55 holes).

[0400] The ventilation section may be located within the plenum chamber or shell. Alternatively, the ventilation section may be located within a release structure (e.g., a swivel).

[0401] 5.3.4.3.3 Decoupled Structures (Multiple or Single) In one embodiment, the patient interface includes at least one decoupling structure (e.g., a swivel or bulbolar fovea).

[0402] 5.3.4.3.4 Connection Port The connection port allows connection to an air circuit.

[0403] 5.3.4.3.5 Forehead support In the illustrated example, the frame assembly 6100 is provided without a front support.

[0404] In another form, the patient interface may include a forehead support. For example, a frame assembly may include a forehead support.

[0405] 5.3.4.3.6 Choking prevention valve In one embodiment, the patient interface includes an anti-choking valve.

[0406] 5.3.4.3.7 Port In one embodiment of this technology, the patient interface includes one or more ports that allow access to the volume within the cavity. In one embodiment, this enables a clinician to supply supplemental oxygen. In another embodiment, this enables direct measurement of the properties of the gas (e.g., pressure) within the cavity.

[0407] 5.3.5 Arrangement of support structure and sealing section The support structure and sealing portion in the above example may have multiple different configurations and arrangements.

[0408] During use, sealing contact between the sealing portion (e.g., fabric membrane) and the patient's face can be maintained by: 1) tension in the fabric membrane (e.g., weak tension) and / or the elastic stretch properties (e.g., elasticity) of the sealing portion material (e.g., fabric material, air-impermeable layer material and / or composite material of the fabric membrane); 2) the reaction stress of the support structure; 3) the pre-formed state of the fabric membrane, which is not tensioned and formed as a substantially constant surface without leakage causing interference in the fabric membrane (e.g., wrinkles, creases, buckling or folds); and / or 4) the air pressure in the cavity relative to the inner surface of the sealing portion. Each of these factors can contribute to maintaining a constant tension in the sealing portion so that it conforms to the anthropometric shape of the patient's face, thereby minimizing folds or ruptures and maximizing the contact area of ​​the sealing portion.

[0409] In some cases, the sealing portion may comprise a relatively thin, flexible, and stretchable elastic material (e.g., a woven film containing a suitable woven material (e.g., nylon, polyester, a nylon-polyester mixture, microfiber, or polyurethane)). Before and during use, the sealing portion may be held taut and tensioned by the support structure. Since the sealing portion may be molded to the support structure or otherwise attached to the support structure (e.g., by bonding or using adhesive), the sealing portion is pre-tensioned (slightly stretched) and any small wrinkles in the sealing portion material are eliminated. This 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 folded sections that could cause air leakage). Furthermore, the sealing portion may be shaped or curvatured by, for example, heat molding, so that the sealing portion maintains its shape. Curvature may also be imparted to the sealing portion from the support structure.

[0410] For example, as shown in Figures 11-17 and 23-37, the sealing portion may have a concave curved profile (e.g., positive curvature in the left-right direction) from one lateral side (right) to the opposite lateral side (left), so as to surround (cradle) the patient's nose.

[0411] In some configurations, as shown in Figures 10 to 66, for example, the patient's nose is not intended to be received within a cavity formed by the plenum chamber and seal-forming structure. Instead, in contrast to conventional masks, the patient's nose is intended to be pressed against the fabric membrane, so that the fabric membrane comfortably forms a reliable seal against the patient's airway, conforming to the contours of the patient's face. In this way, the fabric membrane can stretch to conform to the patient's face. Bridge portions 3104 and 1406 extending between the nostril openings can help maintain the fabric membrane taut before and / or during use. The bridge portions may also serve to help provide a sealing portion that presses against the patient's nose instead of receiving it within a cavity, by eliminating a central opening in the fabric membrane. This also results in a different sealing experience in contrast to conventional masks. Such sealing experience suggests that comfort may be improved by contact with a flexible woven membrane compared to conventional masks or conventional sealing configurations made of more rigid materials (where the contact area of ​​the sealing portion with the nose and / or mouth area is smaller).

[0412] The sealing portion may be constructed from a single or multiple layers of material (e.g., woven material). The woven membrane (and / or the woven material of the woven membrane) may exhibit a low spring constant (i.e., extremely flexible in both the warp and weft). With conventional masks (e.g., silicone sealing membranes), discomfort to the patient's skin may occur during effective seal formation due to the fixing cushion. In contrast to this conventional mask, the woven membrane may have a material spring constant and spring length (i.e., the amount of material available for stretching), and because it is more flexible than the patient's skin, it conforms more easily to the patient's facial features. This can improve mask comfort and reduce the formation of localized pressure "hot spots".

[0413] Compared to conventional silicone membrane and compressed foam seals, the sealing portion of this technology has higher structural rigidity and flexibility, resulting in dynamic springback characteristics. This allows the sealing portion to recover more quickly (when obstructed by external forces). 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 scarring during use.

[0414] Woven membranes can exhibit variable tension across the material (for example, lower tension near pores or more stretched areas of the material). In some forms, the material surface of the sealing portion that comes into contact with the patient's face may have low friction properties (e.g., a low-friction finish), which is advantageous because it can improve patient comfort and lead to improved material adaptability with the patient's face.

[0415] The woven membrane may also include at least one layer that exhibits substantially air-impermeable properties while maintaining the elastic stretch properties necessary for comfort and minimum pressure points. That is, by adding a membrane layer or laminate film layer (e.g., a polymer (e.g., silicone, polyurethane, thermoplastic polyurethane (TPU), polyester, nylon)) to the woven material, a substantially airtight material is obtained. In another example, a substantially air-impermeable material is obtained by weaving woven fibers very tightly.

[0416] In some forms, the thickness of the woven material in the sealing portion may be in the range of 0.275 mm or less (e.g., 0.275 to 0.075 mm, 0.275 to 0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225 to 0.09 mm, 0.225 to 0.095 mm, 0.225 mm, or 0.25 mm). The thickness of the film layer may be in the range of 0.03 to 0.01 mm (e.g., 0.015, 0.02 mm, or 0.025 mm). The overall composite material thickness of the woven fabric material in the sealing area may be within the range of 0.305 mm or less (e.g., 0.305-0.085 mm, 0.305-0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255-0.10 mm, 0.255-0.105 mm, 0.25 mm, or 0.275 mm). In the example, a woven composite including a microfiber fabric and a polyurethane film layer may have these dimensions.

[0417] In another embodiment, the thickness of the woven material in the sealing portion may 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). The thickness of the film layer may be in the range of 0.03 mm to 0.125 mm (e.g., 0.05 mm to 0.1 mm, or 0.075 mm to 0.1 mm, or 0.05 mm to 0.075 mm, or 0.05 mm, or 0.075 mm, or 0.1 mm). The overall composite material thickness of the woven material in the sealing portion having a film layer may 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). For example, a woven composite including nylon or a nylon and polyester blend woven fabric and a silicone film layer may have these dimensions.

[0418] The rigidity and elasticity of the support structure may transfer tensile forces to the sealing portion. The support structure can be formed from a variety of materials (e.g., silicone, foam (e.g., polyurethane foam), polyurethane solid materials, thermoplastic elastomers (TPE) (e.g., thermoplastic polyurethane (TPU)), and suitable plastic materials). The support structure may be configured to produce several different cushion shape configurations, including sealing portions having a single air-assisted sealing portion (e.g., a woven film) and one or more base cushion support layers, for example, a double air-assisted sealing portion (e.g., a double woven film), a sealing portion including a compression support (e.g., open-cell foam, polyurethane foam, gel), a sealing portion with TPU, TPE, or silicone support, or a double air-assisted sealing portion with further support (e.g., a double woven film with a foam laminate layer (e.g., open-cell, polyurethane) in the inner film or a TPU, TPE, polyurethane, or silicone molded layer).

[0419] A base cushioning layer(s) can help optimize the contact surface area of ​​the sealing portion with the patient's face. Furthermore, in cases where the sealing portion is constructed from a breathable material (e.g., a breathable fabric), the base cushioning layer(s) can provide sufficient contact area on the rear side of the sealing portion, thus ensuring a proper seal between the sealing portion and the patient's face and preventing leakage.

[0420] During use, the engagement between the patient's face 1000 and the sealing portion 10130 generates a temporary strain force, which attempts to pull the walls of the support structure 10120 toward each other, as shown in Figure 81. The support structure 10120 responds to this strain force with an outward pulling reaction force. Due to this reaction force, the more flexible sealing portion is preferentially extended, and the spring force generated within the sealing portion is applied to the patient's face, thereby transferring more tension to the sealing portion 10130.

[0421] In some examples, the support structure may include a seal biasing section that uses internal air pressure to dynamically support the support structure and the sealing section. This may provide advantageous additional support for the sealing section under dynamic loads (e.g., pipe drag).

[0422] The air pressure within the cavity and its action on the inner surface of the sealing area can also help maintain the surface of the fabric membrane without wrinkles, creases, buckling, or folds when presented to the patient's face (e.g., by tension generation in the sealing area), allowing the sealing area to substantially fill and press against the contours of the patient's face (e.g., around the sides of the nose). As a result, a flexible sealing area may be able to form a larger sealing contact area on the patient's face. The tension in the sealing area generated by the air pressure within the cavity may also be advantageous in providing a continuous seal, even if the mask is partially displaced from its optimal positioning on the patient's face, because the sealing area may partially expand (due to counteracting forces from the internal air pressure) (i.e., the "hovercraft effect").

[0423] Even in cases where the woven membrane is not under constant tension (e.g., is inelastic), the sealing portion is thinner and has lower structural rigidity than the supporting structure, so the sealing portion can be maintained in sealing contact with the patient's face by the air pressure within the cavity, forming an improved air-assisted seal that dynamically adapts to changes / movements (i.e., the "hovercraft effect").

[0424] The sealing portion can be integrated with the support structure by forming it on the inner edge of the support structure or, in other cases, attaching it to the inner edge of the support structure. Therefore, for example, when attaching the outer circumference 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-forming structure, extending beyond or over a wider area than the support structure. Since the inner edge of the support structure can be curved, the sealing portion can be angled slightly inward toward the inside of the mask. Attaching the sealing portion along the inner edge of the support structure eliminates the need to fold or cut the sealing portion to conform it to the corners of the support structure. This can advantageously reduce the occurrence of protruding folds or wrinkles (which could cause leakage) in the sealing portion, thereby improving sealing performance.

[0425] As previously described, the seal-forming structure may be removably connected to or fixedly attached to the plenum chamber. In some embodiments, the sealing section may have a removable or modular structure. For example, the sealing section may be attached peripherally to a support frame structure. The support frame may be removably attached to the support structure as a module. The sealing section may be attached to the support frame in a manner that reduces the occurrence of creases or wrinkles protruding on the fabric surface. Using a modular arrangement configuration can substantially simplify the manufacturing of the sealing section (e.g., fabric sealing section) because complex joining can be performed in a simple, stress-free manner. While it may be possible to process the sealing section to be substantially self-cleaning, using a modular sealing section may provide a less expensive and more hygienic alternative.

[0426] The support frame may be pre-formed to have a flat shape or a three-dimensional shape (e.g., a curved shape) (to impart a curved shape to the sealing portion). The support frame may form an airtight seal together with the support structure. In some examples, the support frame may engage with the support structure by connectors (e.g., male / female positioning pins / holes, joints).

[0427] The sealing section may have one or more base cushion support layers (e.g., a second cushion layer, a third cushion layer, or subsequent cushion layers) internally. The base cushion layer(s) may provide additional flexibility and make the cushion suitable for use on most patients' faces (e.g., one size fits most). For example, the sealing section may be constructed as: a double air-assisted sealing section (e.g., a double woven fabric membrane), a sealing section including a compression support layer(s) (e.g., open-cell foam, polyurethane foam, gel), a sealing section with one or more TPU, TPE, or silicone support layers, or a double air-assisted sealing section with one or more additional support layers (e.g., a double woven fabric membrane with a foam laminate layer(e.g., open-cell, polyurethane) in the inner membrane or with a TPU, TPE, polyurethane, or silicone molded layer).

[0428] In some cases, the support layer may be supported by a rigid structure (e.g., plastic (e.g., polypropylene (PP), polycarbonate (PC), polyamide (PA), or polyethylene terephthalate (PET))).

[0429] In some cases, 3D printing the sealing portion, support layer, and / or support structure as a “skeleton” can lead to a reduction in structural thickness, and therefore a reduction in mask weight. Furthermore, different layers of the mask can be printed with different stiffness, hardness, or thickness. For example, the “skeleton” component can be formed using silicone, foam (e.g., polyurethane foam), polyurethane (e.g., polyurethane solid material), or any suitable plastic material. In some cases, a sealing biasing portion can be formed that allows for dynamic support during use.

[0430] 5.3.5.1 Seal biasing section Figures 118A to 128 show a range of different cushion assemblies illustrating various sealing biasing portions 32160 and / or connector gussets 32172, as an example of the art of the present disclosure. The cushion assemblies are nasal cradle cushions intended to seal at least the underside of a patient's nose, as described above for the examples in Figures 5 to 37, and may include any of the features of any nasal cushion described in other examples in the present disclosure. For example, the cushion assemblies disclosed in this section may include a base cushion as described in other examples of nasal cradle retention. As those skilled in the art will understand, the sealing biasing portion 32160 may also be used in other types of cushions (e.g., other types of cushions described in the present disclosure (e.g., nasal, oral-nasal, full-face)). In the area where the sealing portion 32130 is directly attached to the sealing biasing portion 32160, the inner edge of the sealing portion may be attached (e.g., molded) to the sealing biasing portion (in a similar manner as described elsewhere in the present disclosure regarding the connection from the sealing portion to the support structure).

[0431] As described above, the plenum chamber 3200 may be constructed from a material that is relatively more rigid than the seal-forming structure 32100. Alternatively, the plenum chamber 3200 may be constructed from a flexible material (e.g., silicone) and may be formed as a one-piece structure with the support structure 32120 (for example, the seal-forming structure may be an extension of the plenum chamber, or it may be formed as part of the plenum chamber (so that the seal-forming structure is enclosed by the plenum chamber as described above)). As an example of such a configuration, the plenum chamber 3200 may extend seamlessly into the seal-forming structure 32120, as shown in Figure 128.

[0432] In some examples, the support structure 32120 and the sealing portion 32130 may include a fabric. In other examples, the sealing portion 32120 may not include a fabric (for example, it may include silicone). The plenum chamber connector 3204 described in this section may be identical or similar to the plenum chamber connector 3204 described elsewhere in this disclosure.

[0433] As described herein, a specific manufacturing process may be required to generate circular or curved (e.g., dome-shaped) portions of the woven sealing portion having curvature in two or more directions. Such curved portions may allow the patient's face to sink into the woven membrane, thereby improving the fit to the contour of the face and tending to result in a more dynamic seal that can withstand at least a certain amount of external force. A dynamic seal can be considered a seal that maintains sealing contact with, for example, the patient's face when the cushion body (e.g., plenum chamber, support structure) and the patient's face are moving relative to each other. Therefore, improving the dynamic sealing capability of the woven sealing portion with the sealing biasing portion 32160 and extending the coverage area of ​​the sealing portion without requiring such a specific manufacturing process may be particularly advantageous in conjunction with the woven membrane. Even when such circular portions are provided in the woven sealing portion, the sealing biasing portion 32160 may further improve the sealing capability of the woven membrane.

[0434] The coverage area of ​​the sealing portion 32130 can be considered, for example, as the maximum possible distance between the front side of the plenum chamber 3200 and / or cushion assembly and the sealing portion 32130. That is, the coverage area of ​​the sealing portion can be considered as the maximum possible distance by which the cushion assembly (e.g., the side wall including the seal biasing portion 32160) causes the sealing portion 32130 to protrude from the front side of the plenum chamber and / or cushion assembly. When the cavity is not pressurized, the sealing portion 32130 has a specific maximum possible distance from the front side of the plenum chamber and / or cushion. When the cavity is pressurized, the seal biasing portion 32160 expands, and the maximum possible distance changes (possibly depending on the pressurization level in the cavity). Therefore, when the cavity in the cushion assembly is pressurized during use and the seal biasing portion 32160 expands, the maximum possible distance between the front side of the plenum chamber 3200 and / or cushion assembly and the sealing portion increases, and the coverage area of ​​the sealing portion increases.

[0435] Note that at a first pressurization level sufficient to at least partially inflate the seal biasing portion 32160, the maximum possible distance is greater than when the cavity is unpressurized, but smaller than the maximum possible distance at higher pressurization levels. This is because this first level may not be sufficient to fully stretch the seal biasing portion 32160 (e.g., thick material). Furthermore, even if the pressurization level is sufficient to fully stretch the seal biasing portion 32160, some slack may remain in the seal biasing portion due to the fit of the headgear, nose size, etc.

[0436] When the sealing biasing portion 32160 is expanded during use, the sealing portion 32130 may move or advance toward at least a portion of the patient's face. This can facilitate sealing by the sealing portion toward areas of complex geometry (e.g., the nasal wings and the lowest point of the nasal wings). If the sealing portion 32130 does not move over its maximum distance, a certain amount of slack may remain in the sealing biasing portion 32160, allowing the sealing biasing portion to absorb the dynamic forces applied to the cushion assembly while maintaining sealing contact with the patient's face by the sealing portion.

[0437] Structures that may be included in the seal-forming structure 32100 (e.g., seal biasing portion 32160) provide a pressure-assisted biasing mechanism that improves the sealing ability of the sealing portion (e.g., a fabric membrane). In some embodiments, the arrangement of the seal biasing portion 32160 may be configured such that when activated under internal pressure, the active region 32140 of the sealing portion can engage in the positive direction with the corresponding region of the patient's face. As shown in Figures 118A to 127, the sealing biasing portion 32160 may be configured to expand to extend the coverage area of ​​the sealing portion 32130, thereby enabling: 1) the expansion of the sealing biasing portion allows the sealing portion to advance and cover and seal thinner noses, thus allowing the sealing portion to better accommodate a certain range of nose sizes (e.g., wider noses and thinner noses); and 2) the sealing portion to effectively and positively engage with the area of ​​the patient's face (which may normally be difficult to seal without causing discomfort (e.g., overtightening of the headgear can lead to airway obstruction before the introduction of pressurized air)).

[0438] For example, the sealing biasing portion 32160 (e.g., Figure 119A) may extend the coverage of the active region 32140 of the sealing portion (e.g., within the lateral region 32136 of the cushion assembly positioned to facilitate sealing around the alae and / or the lowest point of the alae). Furthermore, as described below, the inactive region 32142 of the sealing portion (e.g., in the central (i.e., intermediate) region 32138) may represent a region of the sealing portion. In this region, the sealing biasing portion 32160 is absent and does not affect the coverage of the sealing portion, and / or is present and affects the coverage of the sealing portion to a lower degree than in the active region 32140 of the sealing portion. The central region may be configured to seal the patient's subnasal point and columella (up to the nasal tip or a point above it and below the bridge of the nose) (however, in some examples, the sealing portion may seal below the nasal tip). In one example (for instance, Figure 119B), the inactive region 32142 works in cooperation with the active region 32140 to generate a cradle-holding or pinching action for better sealing of the nasal ala and the lowest point of the nasal ala. Thus, the seal biasing portion 32160 can improve the dynamic stability of the seal-forming structure and further improve sealing in hard-to-cover areas, thereby advantageously generating a more efficient and robust seal on the patient's face.

[0439] During treatment, when the cavity within the cushion assembly is pressurized, the seal-forming structure 32100 expands, and as a result, the seal biasing portion 32160 is forcibly elastically stretched like an air spring, so that the sealing portion 32130 can move in the rearward direction (or in the rearward and upward directions (e.g., rearward and upward)) (i.e., towards the patient's face). As treatment continues due to the presence of pressurized air in the cavity, the seal biasing portion 32160 may remain expanded (i.e., may remain biased), so that an air-assisted spring is effectively formed within the cushion assembly (e.g., within the seal-forming structure).

[0440] However, if the cushion assembly is configured to perform the cradle-holding or pinch-holding action described above (e.g., Figure 119B), the lateral region 32136 expands or inward radially (e.g., left-right) toward the center of the cushion assembly due to the seal biasing portion 32160, pressing the sealing portion toward the nasal side (e.g., nasal ala). To facilitate such a cradle-holding or pinch-holding action, at least a portion of the central region 32138 may function as a hinge, pivot axis and / or bending / flexible region. The cradle-holding or pinch-holding action of the seal biasing portion 32160 during expansion may cause the sealing portion 32130 to move in the direction in which the component is located in the rearward and upward directions (e.g., rearward-upward) and in the left-right directions (in other words, rearward-upward and left-right).

[0441] Furthermore, it should be noted that the arrangement of the seal-forming structure 32100 is such that (for example, as shown in Figures 119A to 127) the sealing portion 32130 may have a saddle shape (for example, a concave curvature in the left-right direction and a convex curvature in the up-down direction), allowing it to accommodate the underside of the patient's nose. This saddle shape also tends to allow the sealing portion to cradle-hold the patient's nose (simply by expanding towards the patient's face under pressure in the cavity).

[0442] The increased pressure within the cavity allows the seal biasing portion 32160 to expand to a greater extent (up to the maximum extension length), thereby increasing the force that engages the active area 32140 of the sealing portion with the patient's face. In this way, the seal biasing portion 32160 can effectively extend the patient contact portion of the seal-forming structure 3100. As a result, this can lead to an increase in the range of the profile that can be accommodated by a single-size patient interface. As described above, the seal biasing portion 32160 can also improve the efficiency of the seal formed between the sealing portion 32130 and the patient's face by extending the coverage area of ​​the sealing portion and releasing the external force. Furthermore, the provision of the seal biasing portion 32160 can reduce the occurrence of blockages before pressurized air is introduced during treatment (such blockages may occur, for example, when the headgear is overtightened, when it is difficult to create a seal over the coverage area of ​​the patient's face), thus leading to improved patient comfort.

[0443] Referring to Figure 118A, when a patient with wider physical features (e.g., a wider nose) engages with the sealing portion 32130, the active areas of the sealing portion can expand outward relative to each other (i.e., they can spread outward in the isolation direction), thus enabling a correspondence and seal to such patient features. Due to the pressurization within the cavity, the sealing biasing portion 32160 can be pressurized, so a slight spring force can be applied to the wider nose, potentially improving the seal without discomfort. In contrast, as shown in Figure 118B, when a patient with narrower physical features (e.g., a narrower / thinner nose) wears the patient interface, the active areas can be biased inward relative to each other due to the pressurization of the cavity within the cushion assembly during use (e.g., cradle hold, clamp or pinch hold), thereby providing a correspondence and seal to the unique facial features of a particular patient. In other words, the sealing portion 32130 extends due to the expansion of the sealing biasing portion 32160 caused by the pressurization in the cavity, resulting in better contact with and sealing of the thinner surface of the nose.

[0444] In some configurations, when activated during use, the seal biasing portion 32160 may mechanically support the active area 32140 of the sealing portion. This can lead to increased dynamic stability of the seal formed on the patient's face. The seal biasing portion 32160 may be configured to expand easily under pressure (for example, it may be formed of a relatively thin material (e.g., silicone)). In such examples, the seal biasing portion may have a thickness smaller than the support structure and / or adjacent portions of the plenum chamber.

[0445] In the example, the geometry (e.g., shape and thickness) and material properties (e.g., stretch properties of the woven film) of the seal-forming structure 32100 may be adapted to complement the ability of the seal biasing portion 32160 to elastically stretch under pressure. The combined effect of the air spring properties and mechanical support properties of the seal biasing portion 32160 may improve the dynamic stability and support of the sealing portion 32130 in maintaining sealing contact with the patient's face. That is, the seal biasing portion 32160 may be configured to maintain contact between the sealing portion 32130 and the patient's face (when the cushion assembly moves dynamically in the direction away from the patient's face by a relatively small distance (e.g., 2-7 mm, 3-5 mm) or moves laterally across the patient's face).

[0446] For example, when a patient is sleeping on their side, the cushion assembly may experience forces from the pillow. Due to these dynamic forces, the cushion assembly may move away from or across the patient's face. The seal biasing portion 32160 works in cooperation with the geometry and material properties of the seal-forming structure 32100 to absorb such dynamic forces, helping to maintain continuous contact (and thus continuous sealing) with the patient's face, thereby achieving a "disconnection effect" that allows the dynamic forces to be disconnected from the sealing portion. In other words, the seal biasing portion 32160 enables the disconnection of movement between the sealing portion 32130 and the rest of the cushion assembly (e.g., plenum chamber, support structure). For example, as shown in Figure 118C, when a force is applied to the cushion assembly and the cushion assembly is pulled away from the patient's face, or when the cushion assembly moves laterally across the patient's face, the seal biasing region 32160 can be adjusted to maintain pressurized contact of the sealing portion 32130 with the patient's face (for example, by allowing lateral movement of the seal-forming structure).

[0447] In some configurations, the dynamic support area that may be provided by the seal biasing portion 32160 is activated when the cavity is pressurized and is primarily designed to help support the sealing portion to maintain a tight seal with the patient's face (without applying significant biasing force to the sealing portion). In an example, when the seal biasing portion 32160 is activated, the dynamic force applied to the cushion assembly is adjusted so that the sealing portion 32130 can engage tightly with the patient's face (while maintaining a certain slack in the seal biasing portion). In this way, the seal biasing portion 32160 is primarily designed to absorb external loads applied to the patient interface, thus enabling the sealing portion to disengage from such external forces.

[0448] Referring to Figures 118A to 127, the seal biasing portion 32160 may be formed from a flexible material (e.g., silicone). The seal biasing portion 32160 may be formed from the same material as the support structure 32120 (e.g., including all materials described in this disclosure as suitable for the support structure). Alternatively, the seal biasing portion 32160 may include a woven fabric (e.g., one contained in or the same woven fabric as a composite material used as a woven film). As described above, the seal biasing portion is made flexible so that it expands when the cavity in the cushion assembly is pressurized during use. To facilitate the expansion of the seal biasing portion 32160, the wall structure of the seal biasing portion may be thinner than (or otherwise less rigid than) adjacent portions of the support structure 32120 and / or the plenum chamber 3200, and therefore more easily expandable.

[0449] The sensitivity and efficiency of activating the seal biasing section 32160 can be adjusted by adjusting the wall thickness of the seal biasing section. That is, a relatively thinner wall structure is activated more easily under pressure, while a relatively thicker wall structure is not activated as easily. In one example, the wall thickness of the seal biasing section 32160 (e.g., silicone) may be 0.2 mm to 0.6 mm (e.g., 0.3 mm to 0.5 mm); however, in other examples, the wall thickness may be thicker (e.g., 0.6 mm to 0.8 mm) or thinner (e.g., 0.1 mm to 0.2 mm).

[0450] In some examples, the thickness of the sealing biasing portion 32160 may vary around the periphery of the cushion assembly (for example, the wall thickness in a first region (e.g., the lateral region 32136 of the cushion assembly) may differ from the wall thickness in a second region (e.g., the central region 32138 of the cushion assembly). In an example, the wall thickness of the sealing biasing portion 32160 in the lateral region 32136 may be thinner than the wall thickness of the sealing biasing portion in the central region 32138, thereby facilitating the cradle retention or clamping of the patient's nose by the sealing portion 32130 in the lowest point region of the nasal ala when the sealing biasing portion 32160 is activated, improving the creation of sealing contact with the nasal ala and the hard-to-reach lowest point region of the nasal ala on the patient's face.

[0451] In some examples, the seal biasing portion 32160 may be formed as a concave (or concave) channel 32165 (e.g., Figure 121) or an external projection 32167 (e.g., Figure 126) (or a combination of both in the form of an accordion). When expanded, the seal biasing portion 32160 moves to a linear position, thereby extending the coverage area of ​​the sealing portion 32130. The seal biasing portion 32160 may extend along the periphery 32122 (e.g., Figures 120 and 121) of the support structure 32120, in which case the seal biasing portion 32160 may be directly connected to the sealing portion 32130. In another example, the seal biasing portion 32160 may extend along the periphery 32125 of the plenum chamber 3200 (for example, Figures 122A to 123B), so that the support structure 32120 can be directly connected to the sealing portion 32130 (for example, to better support the sealing portion). Alternatively, the seal biasing portion 32160 may be located in the middle of the support structure.

[0452] In the example, wrinkles may be formed by the channel 32165 or the projection 32167. In some embodiments, the channel 32165 may have a saddle shape (e.g., Figure 121), and the projection 32167 may have a dome shape (e.g., Figure 126) (or multiple saddle and dome shapes may exist (when the channel and projection are used in combination)).

[0453] For example, in the examples shown in Figures 121, 123A, 123B, and 125-127, the sealing biasing portion 32160 may extend around the entire periphery of the cushion assembly.

[0454] The coverage area of ​​the sealing portion 32130 can be adjusted by adjusting the size of the sealing biasing portion (e.g., the depth of the channel 32165 or the range of the protrusion 32167). That is, a deeper channel or larger protrusion will result in a larger coverage area, while a shallower channel or smaller protrusion will result in a smaller coverage area. Furthermore, the depth of the channel 32165 and / or the range of the protrusion 32167 can vary around the periphery of the cushion assembly. For example, a relatively deeper channel 32165 or larger protrusion 32167 may be provided in the lateral region 32136 of the cushion assembly, and a relatively shallower channel or smaller protrusion may be formed within the central region 32138 of the cushion assembly (e.g., Figure 121). This may allow the sealing portion 32130 to engage tightly with the patient's nose through a pinch-holding or cradle-holding action, and to provide a more effective seal at the alae of the patient's face and the hard-to-reach lowest point of the alae. In such examples, at least a portion of the central region 32138 may function as a hinge, pivot axis, and / or a bending / flexible region.

[0455] Furthermore, as shown in Figures 121 to 123B, as the seal biasing portion extends around the periphery of the cushion assembly, the seal biasing portion 32160 can be tapered from a larger (e.g., deeper channel) seal biasing portion 32160 to a smaller (e.g., shallower channel) seal biasing portion (or vice versa). That is, for example, as shown in Figures 122A to 123B, the seal biasing portion 32160 can be tapered from a deeper channel in the lateral region 32136 to a shallower channel in or near the central region 32138. Those skilled in the art will also understand that the depth of the channel 32165 or projection 32167 can be uniform around the entire or a portion of the periphery of the cushion assembly.

[0456] Furthermore, it should be noted that the seal biasing portion 32160 may be omitted in certain areas of the cushion assembly in order to modify the coverage area of ​​the sealing portion 32130 around the periphery of the cushion assembly as desired. For example, as shown in Figures 119A-120, 122A, and 122B, the seal biasing portion 32160 may be omitted in at least a portion of the central region 32138. Thus, two seal biasing portions 32160, each partially extending around the periphery of the cushion assembly, are formed in the lateral region 32136. This can also enhance the pinch-holding or cradle-holding action of the cushion assembly, enabling a tighter engagement with the patient's nose and more effective sealing at the nasal wings and the hard-to-reach lowest point of the nasal wings on the patient's face. In other examples, the seal biasing portion 32160 may be omitted in other areas of the cushion assembly (e.g., the lateral region 32136).

[0457] 5.3.5.1.1 Example of an upper seal biasing section Referring to Figures 119A-119B, the sealing biasing portion 32160 may be positioned along the rear patient-facing surface of the cushion assembly. The rear patient-facing surface may be the surface or side of the cushion assembly that directly faces the patient's face during use and may include at least a portion of the sealing portion 32130, the sealing biasing portion 32160, and / or the support structure 32120. In the illustrated example, the sealing biasing portion 32160 includes at least one fold, pleat, or ridge (e.g., multiple folds, pleats, or ridges 32162 that form a substantially sinusoidal shape in cross-section, as shown in Figure 119A-1). As shown in Figure 119A, the sealing biasing portion 32160 may extend between the sealing portion 32130 and the support structure 32120, so that a first end of the sealing biasing portion is connected to the sealing portion and a second end of the sealing biasing portion is connected to the support structure. In the region where the sealing portion 32130 is attached to the seal biasing portion 32160, the inner edge of the sealing portion may be attached to the seal biasing portion (for example, it may be molded).

[0458] Prior to the pressurization of the cavity within the cushion assembly, the sealing portion 32130 may be positioned substantially coplanar (i.e., substantially in the same straight line or at the same height) with the rearmost portion of the sealing biasing portion 32160 (e.g., the rearward-facing fold, pleat, or ridge 32162 shown in Figure 119A-1). When the cavity is pressurized, the fold, pleat, or ridge 32162 may be straightened (or moved to a straight position), resulting in the sealing portion 32130 extending or acting in a nested manner toward at least a portion of the patient's face beyond the sealing biasing portion 32160 and other portions of the rearward patient-facing surface (e.g., in a direction having both rear-upward and lateral components for cradle-holding or covering the nasal wings under the force imparted by the pressure within the cavity of the cushion assembly).

[0459] In the illustrated example, the sealing biasing portion 32160 extends around or is located within the lateral region 32136 of the cushion assembly and is omitted in at least a portion of the central region 32138. As a result, the active region 32140 of the sealing portion 32130 is located within the lateral region 32136, and the inactive region of the sealing portion is located in at least a portion of the central region 32138 of the cushion assembly.

[0460] As described above, during startup under pressurized conditions, the sealing biasing portion 32160 can extend the coverage area of ​​the active region 32140, as shown in Figure 119B. This can enhance the pinch-holding or cradle-holding action of the cushion assembly (for example, the sealing portion can cover or pinch-hold / cradle-hold the sides and / or the lowest point of the nasal alae of the patient's face). In another example, if such a centrally located sealing biasing portion is smaller than the sealing biasing portion 32160 in the lateral region 32136, the pinch-holding or cradle-holding action may also be provided within a cushion assembly having the sealing biasing portion 32160 in the central region 32138 (for example, a sealing biasing portion extending around the entire periphery (or a sealing biasing portion surrounding the sealing portion on the patient-facing surface at the rear of the cushion assembly)). That is, the size of the sealing biasing portion 32160 may vary in different regions around the cushion assembly. Furthermore, as described above, the sealing biasing portion may also be uniform around the entire periphery of the cushion assembly.

[0461] 5.3.5.1.2 Example of a side seal biasing section Referring to Figures 120 to 128, the sealing biasing portion 32160 may be located on the side surface of the cushion assembly, or it may be part of the side surface of the cushion assembly. The side surface can be considered as a side wall or a wall structure extending around the outer periphery of the cushion assembly.

[0462] In the example shown in Figure 120, the seal biasing portion 32160 is positioned on the peripheral portion 32122 of the support structure 32120, so that the seal biasing portion is directly connected to the sealing portion 32130. In some examples, the portion of the seal biasing portion 32160 that connects to the sealing portion may be thicker than other portions of the seal biasing portion, so that a desired level of support can be provided to the sealing portion. The support structure 32120 may be positioned between the plenum chamber 3200 and the seal biasing portion 32160.

[0463] In the example shown in Figure 120, the sealing biasing portion 32160 may be formed by being less rigid (e.g., thinner) than the adjacent portion of the support structure 32120. Alternatively, the sealing biasing portion 32160 may be formed by a concave channel (or recess), an external projection, a fold, a pleat, or a ridge.

[0464] As shown in Figure 120, the sealing biasing portion 32160 may extend around the periphery of the cushion assembly in the lateral region 32136 and may be omitted in at least a portion of the central region 32138 of the cushion assembly. As described above, such an arrangement can extend the coverage area of ​​the active region 32140 when activated under pressure, thereby promoting the pinch-holding or cradle-holding action of the cushion assembly.

[0465] It should be further noted that the sealing biasing portion 32160 may extend at an angle α (e.g., 30° to 60°, 45°) with respect to the horizontal (or a plane extending along the front side of the cushion assembly) through the lateral region 32136. This can position the sealing portion 32130 and facilitate its inward and lateral extension when the sealing biasing portion 32160 is activated during use, thereby allowing the patient's nose to be held securely in the cradle at the nasal ala.

[0466] Referring to Figure 121, the seal biasing portion 32160 may extend around the entire periphery of the cushion assembly. The seal biasing portion 32160 may be positioned on the peripheral portion 32122 of the support structure 32120 so that the seal biasing portion is directly connected to the sealing portion 32130 (the support structure 32120 connects the seal biasing portion 32160 to the plenum chamber 3200). As described with reference to Figure 120, in some examples, a thicker portion of the seal biasing portion 32160 may be used for connection to the sealing portion 32130.

[0467] The sealing biasing portion 32160 may be formed as a concave channel 32165, and the size of the sealing biasing portion (e.g., the depth of the channel) may be tapered as it extends along the periphery of the cushion assembly. For example, the sealing biasing portion 32160 may be tapered from a larger sealing biasing portion 32136 in the lateral region to a relatively smaller sealing biasing portion 32160 in the central region 32138, as shown in Figure 121. This arrangement configuration allows the coverage of the sealing portion 32130 in the lateral region 32136 to extend over a longer distance than the coverage of the sealing portion in or to the central region 32138, thereby promoting the pinch-holding or cradle-holding action of the cushion assembly.

[0468] Returning to Figures 122A and 122B, since the seal biasing portion 32160 may be positioned on the periphery portion 32125 of the plenum chamber 3200, the support structure 32120 is positioned between the seal biasing portion 32160 and the sealing portion 32130.

[0469] In this configuration, by directly connecting the support structure 32120 to the sealing section 32130, it may be possible to improve the support of the sealing section compared to the configuration shown in the example in Figure 120.

[0470] Similar to the example in Figure 120, as shown in Figures 122A and 122B, the seal biasing portion 32160 may extend around the periphery of the cushion assembly within the lateral region 32136 and may be omitted in at least a portion of the central region 32138 of the cushion assembly. The concave channel 32165 of the seal biasing portion 32160 may taper along the periphery of the cushion assembly from a larger seal biasing portion within the lateral region 32136 to a relatively smaller seal biasing portion 32160 and then to the central region 32138. Furthermore, as described above, this seal biasing configuration may extend the coverage area of ​​the active region 32140 during activation under pressure, thereby promoting the pinch-holding or cradle-holding action of the cushion assembly.

[0471] Referring to Figures 123A and 123B, since the seal biasing portion 32160 may be positioned on the peripheral portion 32125 of the plenum chamber 3200, the support structure 32120 is positioned between the seal biasing portion 32160 and the sealing portion 32130.

[0472] Similar to the example in Figure 121, the seal biasing portion 32160 may extend around the entire periphery of the cushion assembly. The concave channel 32165 of the seal biasing portion 32160 may be tapered from a larger seal biasing portion in the lateral region 32136 to a relatively smaller seal biasing portion 32160 in the central region 32138, as shown in Figures 123A and 123B.

[0473] As described above, this arrangement configuration makes it possible to extend the coverage area of ​​the sealing portion 32130 within the lateral region 32136 to a distance longer than the distance over which the sealing portion covers the central region 32138 or extends to the central region 32138, thereby promoting the pinch-holding or cradle-holding action of the cushion assembly.

[0474] Referring to Figure 124, the seal biasing portion 32160 is provided around the lateral region 32136 of the cushion assembly and is omitted in at least a portion of the central region 32138, so that an active region 32140 and an inactive region 32142 are formed. The seal biasing portion 32160 may include a step 32164 and a wing 32166. The step 32164 and the wing 32166 extend from the support structure 32120 in a vertical or rearward direction (or rearward and upward (e.g., rearward upward) or rearward upward and lateral directions).

[0475] Step 32164 is directly connected to the support structure 32120. Step 32164 may extend from the support structure toward the patient's face (e.g., posteriorly upward and laterally) during use and may be positioned at an angle to the support structure. Wing 32166 is directly connected to step 32164. Wing 32166 may be positioned at an angle to step 32164 but may extend further toward the patient's face (e.g., posteriorly upward and laterally). Such an angled arrangement configuration of step 32164 and wing 32166 may generate one or more folds, wrinkles, pleats or bends in the material of the sealing biasing portion 32160, and these folds, wrinkles, pleats or bends may be straightened (or moved to a straightened position) when expanded, thereby extending the coverage area of ​​the sealing portion 32160 and also forming a release arrangement configuration for releasing external forces from the sealing portion.

[0476] Step 32164 and / or wing 32166 may contain a material that is relatively thinner (or otherwise less rigid) than the support structure 32120, so that the seal biasing portion 32160 can be activated by pressurization of the cavity in the cushion assembly.

[0477] As described above, by arranging the sealing biasing portion 32160 within the lateral region 32136 (while omitting at least a portion of the central region 32138), the coverage area of ​​the lateral region during startup under pressurization can be extended, thereby promoting the pinch-holding or cradle-holding action of the cushion assembly. In other examples, the sealing biasing portion 32160 may extend around the entire periphery of the cushion assembly, and the size of the sealing biasing portion may vary around the periphery (for example, smaller portions (i.e., relatively smaller steps and / or wings) may be provided in the central region, and larger portions (i.e., relatively larger steps and / or wings) may be provided in the lateral region).

[0478] 5.3.5.1.2.1 Example of a stem-supported seal biasing mechanism Referring to Figures 125 to 127, the cushion assembly has a sealing portion 32130 connected to the plenum chamber via a support structure 32120. The support structure 32120 includes a stem 32135 (not shown) protruding from the plenum chamber. A seal biasing portion 32160 may extend around the periphery of the cushion assembly. Because the seal biasing portion is less rigid (e.g., thinner) than adjacent portions of the support structure, the seal biasing portion 32160 may extend the coverage area of ​​the sealing portion 32130, potentially allowing the sealing portion to be disengaged from external forces applied to the plenum chamber when the cavity within the cushion assembly is pressurized.

[0479] The seal biasing unit 32160 can support the sealing unit 32130 in a gimbal-like or ball joint-like manner, thereby enabling movement and flexibility in multiple directions. In this way, the seal biasing unit 32160 is configured to isolate the sealing unit 32130 and to avoid situations (similar to those generally found in force-absorbing suspension systems) where dynamic influences occurring in the plenum chamber affect the efficiency of the sealing unit.

[0480] In the example, as shown in Figure 126, the seal biasing portion 32160 may be formed as an external projection 32167. In the example in Figure 127, the seal biasing portion 32165 is formed as a concave channel 32165 (e.g., concave or recessed). In other examples, the seal biasing portion 32160 may include a plurality of projections and / or channels.

[0481] The size of the sealing biasing portion 32160 (e.g., larger or smaller channels or protrusions) may vary around the periphery of the cushion assembly and may be omitted in certain areas in other examples as described above. The sealing biasing portion 32160 may also be tapered around the periphery of the cushion assembly as described above.

[0482] As described above, by arranging the sealing biasing portion 32160 in the lateral region 32136 while omitting (or making smaller) at least a portion of the central region 32138, the coverage area of ​​the lateral region can be extended during startup under pressure, thereby promoting the pinch-holding or cradle-holding action of the cushion assembly. Furthermore, it should be noted that the arrangement of the seal-forming structure 32100 is such that the sealing portion 32130 is saddle-shaped to accommodate the area below the patient's nose. As described above, this saddle shape allows the sealing portion to expand towards the patient's face under pressure in the cavity, and the patient's nose may also tend to be held in a cradle position.

[0483] Furthermore, the size of the seal biasing portion 32160 can be selected according to the length of the stem 32135. For example, if the seal biasing portion is larger, the stem 32135 can be made shorter, as the seal biasing portion enables the sealing portion 32130 to adequately cover the patient's sealing area during startup.

[0484] 5.3.5.1.3 Connector gusset As shown in Figure 128, the air pipe connection portion of the cushion assembly includes an inlet port 32170. The inlet port 32170 is configured to receive airflow from an air supply pipe (e.g., an elbow assembly connected to the air supply pipe, as understood by those skilled in the art). For example, the inlet port 32170 may be formed on the front side of the plenum chamber, as shown in Figure 128. The plenum chamber may include a connector structure that connects to the air supply pipe (e.g., via an elbow assembly).

[0485] The air pipe connection may include a connector gusset 32172 configured to absorb dynamic forces (e.g., external forces applied to the air supply pipe, i.e., pipe drag). The connector gusset 32172 may include one or more folds, pleats, and / or ridges formed along the front wall of the plenum chamber adjacent to the inlet port. As shown in Figure 128, since the connector gusset surrounds the inlet port, the folds, pleats, or ridges form a circular arrangement configuration that extends around the entire perimeter of the plenum chamber adjacent to the inlet port, and is therefore substantially coaxial with the inlet port. In other examples, the connector gusset 32172 may be interrupted rather than extending entirely around the cushion assembly (e.g., in the connector gusset, diametrically opposed portions may extend around the inlet port and be interrupted by the folds, pleats, or ridges). In examples, the connector gusset 32172 may have an accordion configuration.

[0486] The connector gusset 32172 is designed to absorb the dynamic force applied to the supply pipe and to release the force from the seal-forming structure (e.g., the sealing portion), thereby improving the dynamic stability of the sealing portion 32130 during use.

[0487] 5.3.5.2 Textile membrane According to an example of the technology of this disclosure, the sealing structure may include a woven film containing a woven material. The woven material may be coated or otherwise fitted with an airtight film or layer to obtain an air-retaining woven composite. The woven composite can be cut (e.g., die-cut, ultrasonic, laser or RF) to a desired shape and then attached to a support structure. The resulting woven sealing portion (or woven film) may be attached to a support structure (e.g., silicone, TPE) by, for example, overmolding or injection molding. In another example, the woven sealing portion may be heat-welded at its edges (outer circumference) onto the support structure material (e.g., silicone, TPE).

[0488] Textiles are materials that contain at least one natural or artificial fiber (e.g., spun yarn or sewing yarn). Fibers can be filaments (mono or poly), strands, sewing yarns, or twisted yarns. Fibers (one or more) 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). Textiles can be formed by a variety of techniques (e.g., weaving, knitting, crocheting, knotting, touching, bonding, felting, tufting, or braiding), including woven and nonwoven materials (e.g., by knitting or interlacing one or more of the above fibers).

[0489] In one example, the woven material is a knitted material. One reason why a knitted material may be preferable is that it can provide elasticity (e.g., stretchability) in the woven material (especially compared to a woven material). This can be advantageous because it provides comfort for the patient, as described below. The elasticity can be obtained in all directions (e.g., stretch / elasticity in four directions (e.g., substantially equal elasticity in all directions)), and at least in the transverse left-right direction of the woven membrane. The woven material may have, for example, a weft-knitted structure or a warp-knitted structure. One reason why a weft-knitted structure is more preferable is that the elasticity of a weft-knitted fabric is higher than that of a warp-knitted fabric.

[0490] Figure 113 shows the weave 70 of the weft-knitted fabric, or the direction in which a loop of one thread connects to a loop of another thread. Figure 114 shows the path 80 or direction of the loop from a single sewing thread. In the warp knitting 90 of the basic closed loop shown in Figure 115, the weave and path run parallel to each other. In the weft knitting 100 shown in Figure 116, the weave 70 progresses perpendicular to the path 80.

[0491] 5.3.5.2.1 Manufacturing In the example, an overmolding process may be used to construct a seal-forming structure having, for example, a flexible support structure (e.g., silicone) attached to a woven film.

[0492] As shown in Figure 117, in step 10, an airtight woven composite can be formed by combining the woven material with an impermeable material. For example, as shown in Figure 78, a thermal process may be used when attaching the impermeable layer to the woven material. The woven composite may have a flat shape (e.g., a sheet shape).

[0493] In step 12, the fabric composite can be cut into the desired shape according to the specific cushion assembly to be used.

[0494] In step 14, when the support structure (e.g., silicone) is overmolded onto the fabric composite, the seal-forming structure may be formed together with the fabric film. When the fabric composite is held in place by vacuum, the fabric composite has a non-flat, predefined shape during the overmolding process. That is, when a flat fabric composite is overmolded with the support structure, curvature is imparted to the fabric composite, forming a fabric film that can have curvature (without causing small wrinkles, folds, creases, and / or buckling in the fabric film). As can be seen in Figure 33-1, the fabric film may extend along the curved portion 35 from the front to the rear of the seal-forming structure. In one embodiment, as shown in Figure 33-1, both the support structure and the fabric film may have a radius of curvature (e.g., the same or similar radius of curvature) along the curved portion 35. The woven film may be given a predetermined curvature so that a portion of the woven film not directly supported by the support structure extends along the curved portion 35 (Figures 33-2 to 33-4). As described above, the woven film may also have dome-shaped and saddle-shaped curvature in other regions of the film, for example. The woven film has a concave curved profile from one lateral side (right) to the opposite lateral side (left) (e.g., positive curvature in the left-right direction), which is given during the overmolding process and maintained by connections to the support structure (see, for example, Figures 11 to 17, 23 to 27, and 33 to 37). In another example, the woven film may have negative curvature in the downward / upward direction (which may be given during the overmolding process) and can be maintained by connections to the support structure (see, for example, Figures 18 to 22).

[0495] The support structure can be molded onto the woven composite such that the outer surface of the seal-forming structure is smooth and seamless during the transition from the support structure to the woven film (see Figure 33-4). The support structure can be bonded to the impermeable material of the woven film. The outer surface of the seal-forming structure may be smooth and seamless, but a step may 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)).

[0496] The overmolding process creates a seal-forming structure that imparts curvature to the fabric film without causing any small wrinkles, folds, creases, or / or buckling in the fabric film.

[0497] 5.3.5.2.2 Examples of Textile Membranes The following describes exemplary properties and structural configurations of textile composites used as materials for textile films.

[0498] 5.3.5.2.2.1 Textile composite structure A variety of combinations of woven materials and membrane / film layers can be used. In one example, a three-layer configuration is used in which a thermoplastic polyurethane (TPU) film is placed between two woven layers (e.g., nylon, a mixture of nylon and polyester, a mixture of nylon and spandex, a mixture of polyester and spandex, or a nylon / polyester / spandex mixture). An additional woven layer is required to protect the TPU film from damage (e.g., during cleaning).

[0499] In another example, a two-layer configuration is used, which includes a fabric (e.g., nylon, a mixture of nylon and polyester, a mixture of nylon and spandex, a mixture of polyester and spandex, or a nylon / polyester / spandex mixture) having a silicone layer (e.g., placed as a coating). In the case of this composite material, only one layer of fabric is required, and therefore it may be less expensive than the three-layer configuration described above.

[0500] In another example, a woven material (e.g., microfiber or polyurethane material) may be coated with a polyurethane film to form a two-layer configuration.

[0501] 5.3.5.2.2.2 Textile materials As described above, multiple textile materials can be used to form the sealing portion (e.g., nylon, polyester, spandex, nylon and polyester mixtures, nylon and spandex mixtures, polyester and spandex mixtures, nylon / polyester / spandex mixtures, microfiber, or polyurethane).

[0502] In one example, nylon material is used. Because nylon is softer than polyester, it can provide patients with the benefit of greater comfort. Nylon is also stronger than polyester, resulting in improved lifespan and durability. Furthermore, because nylon has a higher melting point than polyester, it can withstand higher temperature manufacturing conditions.

[0503] In another example, a mixture of nylon and polyester is used. This material is preferable because, due to the addition of polyester, it has lower moisture absorption and therefore causes less irritation to the patient. The nylon and polyester mixture is also less expensive than nylon alone.

[0504] 5.3.5.2.2.3 Fabric Thickness In one embodiment, the thickness of the woven material in the sealing portion may 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). Such thicknesses may be suitable for nylon material or a blend of nylon and polyester.

[0505] In another embodiment, the thickness of the woven material in the sealing portion may be within the range of 0.275 (e.g., 0.275 to 0.075 mm, 0.275 to 0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225 to 0.09 mm, 0.225 to 0.095 mm, 0.225 mm, or 0.25 mm) or less. Such thicknesses may be suitable for microfiber woven materials or polyurethane woven materials.

[0506] 5.3.5.2.2.4 Thickness of the air-impermeable layer In applications where silicone is used as a membrane / film layer, the thickness of the silicone can range from 0.03 mm to 0.125 mm (e.g., 0.05 mm, 0.05 mm to 0.1 mm, or 0.05 mm to 0.075 mm, or 0.075 mm to 0.1 mm, or 0.1 mm). Thinner silicone layers (e.g., 0.05 mm) may be preferable because they can lead to a lighter product and provide higher extensibility than thicker silicone layers (e.g., 0.1 mm). However, thicker silicone layers (e.g., 0.1 mm) are more durable than thinner layers (e.g., 0.05 mm).

[0507] In another example, a polyurethane film is used as a membrane layer, and the thickness of the polyurethane film may be 0.03 to 0.01 mm (e.g., 0.015, 0.02 mm, or 0.025 mm).

[0508] 5.3.5.2.2.5 Overall thickness of the woven composite In examples where a textile material is coated with a silicone film / membrane layer, the overall composite thickness may be in the range of 0.18 mm to 0.625 mm (e.g., 0.25 mm to 0.6 mm, or 0.25 mm to 0.5 mm, or 0.3 mm to 0.5 mm, or 0.35 mm to 0.45 mm, or 0.3 mm, or 0.35 mm, or 0.4 mm, or 0.45 mm, or 0.5 mm).

[0509] Thicker fabric film thicknesses (e.g., 0.5 mm) can be more robust and leave less trace. These fabric films may be easier to handle during manufacturing because they are less likely to flap around.

[0510] Using an intermediate thickness (e.g., 0.35 mm to 0.45 mm) can result in a flexible, lightweight structure, making it relatively easy to handle during manufacturing and potentially providing greater comfort to the patient than thicker fabric membranes.

[0511] While thinner fabric membranes can result in extremely lightweight structures and provide a soft, comfortable feel to the patient, they may be less durable than thicker fabric membranes.

[0512] In examples where a woven material is coated with a polyurethane film, the overall thickness of the composite material may be within the range of 0.305 mm or less (e.g., 0.305 to 0.085 mm, 0.305 to 0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255 to 0.10 mm, 0.255 to 0.105 mm, 0.25 mm, or 0.275 mm).

[0513] 5.3.5.2.2.6 Knitting structure The woven material of the woven membrane may have, for example, a weft-knitted structure or a warp-knitted structure. In the case of a weft-knitted fabric, a material with higher elasticity can be obtained than a warp-knitted fabric, making the weft-knitted fabric more desirable. In the case of this knitted fabric, the force applied from the woven membrane to the patient's face can be reduced by stretching when the patient's face engages with the woven membrane, thus potentially providing the patient with greater comfort.

[0514] In one example, the weft direction may have greater elasticity or stretchability, so the weft direction (direction of the path 80) may extend in the nose width direction of the fabric membrane. Alternatively, the weft direction may extend in the nose length direction (vertical direction).

[0515] Furthermore, weft knitting is more suitable for producing relatively thin materials, such as those disclosed herein. Also, weft knitting is generally less expensive than warp knitting.

[0516] However, in some cases, warp knitting is preferable because it shrinks less than weft knitting.

[0517] 5.3.5.2.2.7 Knitting Machines A weft-knitted fabric material may have a single jersey knit structure that provides a technical front and a technical back with different appearances. A single jersey knit may be formed by a single set of needles and may provide knit stitches on the technical front and purl stitches on the technical back. In one example, the technical front may form the outer surface of the fabric membrane, and an air-impermeable membrane may be attached to the technical back. Alternatively, the technical front may be oriented toward the inner surface of the fabric membrane, to which this membrane is attached.

[0518] In one example, which includes an air-impermeable membrane sandwiched between two fabric layers, the exposed surface of the fabric membrane may be formed depending on the technical aspects of each fabric material.

[0519] 5.3.5.2.2.8 Fabric weight The weight of the woven material ranges from 95 grams / square meter (gsm) to 130 gsm (e.g., 105 gsm to 120 gsm, or 110 gsm to 115 gsm, or 105 gsm, or 110 gsm, or 120 gsm). Heavier woven fabrics (e.g., 120 gsm) can provide a desirable comfortable woven feel even after coating with a laminate layer due to their higher weight / thickness. Lighter woven fabrics (e.g., 105 gsm) are more desirable because they allow for lighter products. 5.3.5.2.2.9 Mechanical Gauges

[0520] The machine gauge (i.e., stitches per inch) of the woven material can vary. For example, the mac...

Claims

1. A patient interface for delivering airflow in a sealed manner to the entrance of the patient's airway, including at least the nostril entrance, at a continuous positive pressure relative to the ambient air pressure, wherein the patient interface is used during the patient's sleep and throughout the patient's respiratory cycle at a pressure higher than the ambient air pressure of approximately 4 cmH ２ O ~ approx. 30cmH ２ The patient interface is configured to maintain a therapeutic pressure in the range of O to improve sleep-disordered breathing, and the patient interface includes a cushion assembly. The aforementioned cushion assembly is: At least 6 cmH above ambient air pressure ２ A plenum chamber that forms at least partially a cavity pressurized to a therapeutic pressure of O, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at therapeutic pressure for the patient's respiration, A seal-forming structure having a fabric membrane constructed and positioned to form a pressure-assist seal over a region of the patient's face surrounding the entrance to the patient's airway below the nasal bridge region of the patient's face, wherein the fabric membrane has holes formed therein so that airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the cavity throughout the patient's entire respiratory cycle during use, The seal-forming structure includes a flexible support structure for holding the fabric membrane in a predetermined curved shape, and the fabric membrane is configured to seal the underside of the patient's nose, including the subnasal point and the nasal tip. The seal-forming structure includes a seal biasing portion that extends along the periphery of the cushion assembly, at least in the lateral region of the cushion assembly, and since the seal biasing portion has lower rigidity than the adjacent portion of the support structure, the seal biasing portion is configured to expand when the cavity is pressurized during use, so that the seal biasing portion extends over the entire area of ​​the woven film and that the woven film is released from the external force applied to the plenum chamber when activated during use. The configuration of the sealing biasing portion is such that the coverage area of ​​the fabric membrane extends over a distance longer than at least a portion of the central region of the cushion assembly within the lateral region of the cushion assembly. Therefore, when the sealing biasing portion is activated during use, a bending region or a flexible region is formed by the central region, making it possible for the fabric membrane in the lateral region to cradle or pinch the patient's nostrils, thus providing a patient interface.

2. The patient interface according to claim 1, wherein the fabric membrane in the lateral region extends in a posterior-upward and lateral direction, and is configured to facilitate cradle holding or pinching of the patient's nasal ala when the sealing biasing portion is activated during use.

3. The patient interface according to claim 1 or 2, wherein, during use, the fabric membrane is configured to be pressed against the patient's face so that the patient's nose is not received in the cavity.

4. The patient interface according to any one of claims 1 to 3, wherein the sealing biasing portion is omitted in at least a portion of the central part of the cushion assembly.

5. The patient interface according to any one of claims 1 to 3, wherein the sealing biasing portion extends around the entire periphery of the cushion assembly.

6. The size of the seal biasing portion varies around the cushion assembly, according to any one of claims 1 to 5.

7. The patient interface according to any one of claims 1 to 3, 5, and 6, wherein the sealing biasing portion is larger in the lateral region and smaller in the central region of the cushion assembly.

8. The size of the sealing biasing portion is tapered such that it is larger in the lateral region and becomes smaller towards the central region of the cushion assembly, according to any one of claims 1 to 7.

9. The patient interface according to any one of claims 1 to 8, wherein the sealing biasing portion includes a concave channel or recess.

10. The patient interface according to any one of claims 1 to 8, wherein the sealing biasing portion includes an externally protruding portion.

11. The patient interface according to any one of claims 1 to 8, wherein the sealing biasing portion includes at least one fold, pleat or ridge.

12. The patient interface according to claim 11, wherein the at least one fold, pleat or ridge allows the fabric membrane to move in a nesting manner toward the patient's face when the sealing biasing portion is activated.

13. The patient interface according to claim 11 or 12, wherein the sealing biasing portion includes a plurality of folds, pleats, or ridges.

14. The patient interface according to claim 13, wherein a sinusoidal shape is formed in cross-section by the plurality of folds, pleats or ridges.

15. The patient interface according to any one of claims 1 to 8, wherein the sealing biasing portion includes a step and a wing, the step and the wing being at an angle to each other.

16. The patient interface according to any one of claims 1 to 15, wherein the sealing biasing portion is disposed between the support structure and the fabric membrane.

17. The patient interface according to any one of claims 1 to 15, wherein the sealing biasing portion is disposed between the plenum chamber and the support structure.

18. The patient interface according to any one of claims 1 to 10, wherein the cushion assembly includes a stem protruding from the plenum chamber to a support seal forming structure.

19. The patient interface according to any one of claims 1 to 14 and 16, wherein the sealing biasing portion extends through the lateral region of the cushion assembly at an angle α with respect to a plane extending along the front side of the cushion assembly.

20. The patient interface according to claim 19, wherein the angle α is between 30° and 60°.

21. The patient interface according to any one of claims 1 to 20, wherein the seal-forming structure is arranged such that the fabric membrane has a saddle shape configured to accommodate the underside of the patient's nose when in use.

22. The patient interface according to any one of claims 1 to 21, wherein the support structure and the sealing biasing portion include silicone.

23. The patient interface according to any one of claims 1 to 15 and 18 to 22, wherein the woven membrane is attached to a support structure along the outer circumference of the woven membrane, thereby extending radially inward beyond the support structure.

24. The patient interface according to any one of claims 1 to 15 and 18 to 23, wherein the support structure comprises silicone, and the fabric membrane is formed on the inner edge of the support structure.

25. The patient interface according to any one of claims 1 to 24, wherein at least one hole of the woven membrane comprises two holes, and a bridge portion is disposed between the two holes of the woven membrane.

26. The patient interface according to any one of claims 1 to 25, wherein the woven film includes a film layer added to the woven material to make the woven material substantially air-impermeable.

27. The patient interface according to any one of claims 1 to 26, wherein the plenum chamber comprises silicone and is formed as a single piece with the support structure.

28. A positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure further comprises a tie, the tie being constructed and positioned so that at least a portion of it rests on a region of the patient's head above the upper earlobe point when in use, according to any one of claims 1 to 27.

29. A patient interface according to any one of claims 1 to 28, further comprising a ventilation structure that allows gas exhaled by a patient to flow continuously from inside a cavity to the surroundings, wherein the ventilation structure is sized and shaped to maintain therapeutic pressure inside the cavity during use.

30. The plenum chamber and seal-forming structure form a nasal cushion, according to any one of claims 1 to 29.

31. A treatment system used for the treatment of sleep-disordered breathing, A patient interface according to any one of claims 1 to 30; Respiratory pressure therapy (RPT) devices that supply breathable gas under positive pressure; and A therapeutic system including an air delivery tube for passing a breathable gas from the RPT device to the patient interface.

32. A patient interface for delivering airflow in a sealed manner to the entrance of the patient's airway, including at least the nostril entrance, at a continuous positive pressure relative to the ambient air pressure, wherein the patient interface is used during the patient's sleep and throughout the patient's respiratory cycle at a pressure higher than the ambient air pressure of approximately 4 cmH ２ O ~ approx. 30cmH ２ The patient interface is configured to maintain a therapeutic pressure in the range of O to improve sleep-disordered breathing, and the patient interface includes a cushion assembly. The aforementioned cushion assembly is: At least 6 cmH above ambient air pressure ２ A plenum chamber that forms at least partially a cavity pressurized to a therapeutic pressure of O, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at therapeutic pressure for the patient's respiration, A seal-forming structure having a sealing portion constructed and positioned to form a pressure-assist seal over a region of the patient's face surrounding the entrance to the patient's airway below the nasal bridge region of the patient's face, wherein the sealing portion has holes formed therein so that airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the cavity throughout the patient's entire respiratory cycle during use, The seal-forming structure includes a flexible support structure that supports the sealing portion, and the sealing portion is configured to seal the underside of the patient's nose, including the subnasal point and the nasal tip. The seal-forming structure includes a seal-biasing portion disposed together with the sealing portion along the rear patient-facing surface of the cushion assembly, the seal-biasing portion includes at least one fold, pleat or ridge extending between the sealing portion and the support structure, The sealing biasing portion is configured to expand due to the pressurization of the cavity during use, thereby extending the sealing portion beyond other parts of the patient-facing surface at the rear of the cushion assembly to at least a portion of the patient's face, or to operate in a nested manner, as a patient interface.

33. The patient interface according to claim 32, wherein the sealing biasing portion includes a plurality of folds, pleats, or ridges that form a sinusoidal shape in cross-section.

34. The patient interface according to claim 32 or 33, wherein the sealing biasing portion is located at least within the lateral region of the cushion assembly.

35. The patient interface according to claim 34, wherein the sealing portion is configured to extend over a longer distance in the lateral region of the cushion assembly than in the central region of the cushion assembly, or to operate in a nested manner, so that when the sealing biasing portion is activated during use, the central region forms a bent or flexible region, thereby allowing the sealing portion in the lateral region to cradle or pinch the patient's nasal ala.

36. The size of the seal biasing portion varies around the cushion assembly, according to any one of claims 32 to 35.

37. The patient interface according to any one of claims 32 to 36, wherein the sealing biasing portion is larger in the lateral region of the cushion assembly and smaller in the central region of the cushion assembly.

38. The patient interface according to any one of claims 32 to 37, wherein the sealing biasing portion extends around the entire periphery of the cushion assembly.

39. The patient interface according to any one of claims 32 to 36, wherein the sealing biasing portion is omitted in at least a portion of the central part of the cushion assembly.

40. The patient interface according to any one of claims 32 to 39, wherein the support structure and the sealing biasing portion include silicone.

41. The patient interface according to any one of claims 32 to 40, wherein the sealing portion includes a woven fabric membrane.

42. A patient interface for delivering airflow in a sealed manner to the entrance of the patient's airway, including at least the nostril entrance, at a continuous positive pressure relative to the ambient air pressure, wherein the patient interface is used during the patient's sleep and throughout the patient's respiratory cycle at a pressure higher than the ambient air pressure of approximately 4 cmH ２ O ~ approx. 30cmH ２ The patient interface is configured to maintain a therapeutic pressure in the range of O to improve sleep-disordered breathing, and the patient interface includes a cushion assembly. The aforementioned cushion assembly is: Pressurizable to a therapeutic pressure of at least 6 cmH ２ A plenum chamber that at least partially forms a cavity pressurizable to a therapeutic pressure exceeding the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for the patient's respiration, the plenum chamber, A seal-forming structure having a sealing portion constructed and positioned to form a pressure-assist seal over a region of the patient's face surrounding the entrance to the patient's airway below the nasal bridge region of the patient's face, wherein the sealing portion has holes formed therein so that airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the cavity throughout the patient's entire respiratory cycle during use, The seal-forming structure includes a flexible support structure that supports the sealing portion. The plenum chamber inlet port is formed on the front side of the plenum chamber, and a connector structure adapted for connection to an air supply pipe is provided on the front side of the plenum chamber. The front of the plenum chamber includes a connector gusset, pleat, or ridge with one or more folds, the connector gusset, pleat, etc., which is configured to be adjacent to or extending around the plenum chamber inlet port, and to disengage the seal-forming structure from external forces acting on the air supply tube, a patient interface.

43. The patient interface according to claim 42, further comprising an air supply pipe connected to the front of the plenum chamber and in fluid communication with the plenum chamber inlet port.

44. The patient interface according to claim 42 or 43, wherein the sealing portion includes a fabric membrane configured to seal the underside of the patient's nose, including the subnasal point and the nasal tip.

45. A positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure further comprises a tie, the tie being constructed and positioned so that at least a portion of it rests on a region of the patient's head above the upper earlobe point when in use, according to claim 42.

46. A treatment system used for the treatment of sleep-disordered breathing, The patient interface according to any one of claims 42 to 45; Respiratory pressure therapy (RPT) devices that supply breathable gas under positive pressure; and A therapeutic system including an air delivery tube for passing a breathable gas from the RPT device to the patient interface.

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