Fabric sealing with air-assisted bias

Abstract

A patient interface includes an inflation chamber and a seal-forming structure. The seal-forming structure comprises a support structure arranged to support a seal adapted to sealingly engage a patient's face in use. The seal-forming structure may also include a seal bias configured to inflate when pressurized within a cavity in the gasket assembly in use to extend an extent of the seal and decouple the seal from an external force.

Description

[0001] 1. Related Applications

[0002] This application is a divisional application of patent application No. 202080027780.2, filed on February 11, 2020, entitled "Fabric Sealing with Air-Assisted Bias Section". Application No. 202080027780.2 is an international application (PCT / IB2020 / 051080) that entered the Chinese national phase. 2 Background Technology 2.1 Technical Field

[0003] This technology relates to one or more of the diagnosis, treatment, prevention, and improvement of respiratory-related conditions. This technology also relates to medical devices or equipment and their uses.

[0004] 2.2 Description of relevant technologies

[0005] 2.2.1 The Human Respiratory System and Its Disorders

[0006] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0007] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from inhaled air and carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the airway tubes and do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.

[0008] A range of breathing disorders exist. Some conditions may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0009] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0010] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes the affected patient to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0011] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a dysregulation of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0012] Respiratory failure is a term for a respiratory disorder in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

[0013] Patients with respiratory insufficiency (a form of respiratory failure) may experience unusual shortness of breath during exercise.

[0014] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0015] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0016] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0017] The chest wall is a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0018] A range of treatments have been used to treat or improve these symptoms. Furthermore, other healthy individuals may utilize these treatments to prevent respiratory distress. However, these treatments have many drawbacks.

[0019] 2.2.2 Treatment

[0020] Various treatments, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV), have been used to treat one or more of the above-mentioned respiratory disorders.

[0021] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, or if so, in any of these ways.

[0022] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive disease (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0023] Non-invasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0024] 2.2.3 Treatment System

[0025] These therapies can be provided by treatment systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

[0026] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0027] Another type of treatment system is the mandibular repositioning device.

[0028] 2.2.3.1 Patient Interface

[0029] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway.

[0030] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient.

[0031] Some masks may be clinically disadvantageous for this technology, such as those that block airflow through the nose and only allow it through the mouth.

[0032] If some masks require patients to insert a portion of the mask structure into their mouths to create and maintain a seal through their lips, this may be uncomfortable or impractical for this technology.

[0033] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0034] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head comprises bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during the duration of respiratory therapy.

[0035] Due to these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized face shield can lead to reduced compliance, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those designed for administering anesthetics are acceptable for their original applications, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment, especially if the face shield is worn during sleep.

[0036] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean it, which could affect adherence.

[0037] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0038] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0039] 2.2.3.1.1 Sealing Formation Structure

[0040] Patient interfaces may include seal-forming structures. Because they come into direct contact with the patient's face, the shape and construction of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0041] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0042] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitivity of a patient's face differ. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0043] Certain seal-forming structures can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal. This can lead to patient discomfort.

[0044] A seal that fits one person may not fit another. Furthermore, a design that fits a patient at one pressure or in one location may not be suitable for other pressures or other locations. Some designs may leak when the patient moves, such as while asleep.

[0045] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface and the seal-forming portion engages face-to-face with the patient's face. The seal-forming structure may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0046] Another type of seal-forming structure incorporates a sheet-like seal of thin material surrounding the perimeter of the mask to provide a self-sealing effect on the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may crease or deform during use, leading to leaks.

[0047] In addition, some manufacturing processes can produce unwanted folds, creases, or deformations in the sealed structure, even when not in use.

[0048] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0049] Another form of seal formation can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0050] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0051] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0052] ResMed Ltd. has manufactured the following products that combine a nose pillow: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc.'s SWIFT) TMOther aspects of the LT nose pillow); International patent applications WO 2005 / 063328 and WO 2006 / 130,903 (which describe ResMed Ltd. MIRAGE LIBERTY) TM Other aspects of the full-face mask); International Patent Application WO2009 / 052,560 (which describes ResMed Ltd.'s SWIFT) TM Other aspects of the FX nose pillow).

[0053] 2.2.3.1.2 Positioning and Stability

[0054] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0055] One technique involves using adhesives. See, for example, U.S. Patent Application Publication US2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0056] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: unsuitability, bulkiness, discomfort, and inconvenience of use.

[0057] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0058] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned treatments, for example, by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0059] Pneumatic generators are known in applications such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that more general pneumatic generators cannot meet, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may suffer from drawbacks related to one or more of comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0060] One example of a specific requirement for certain RPT devices is noise.

[0061] A table of noise output levels for existing RPT devices (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0062] RPT device name A-weighted sound pressure level dB(A) Year (approximately) <![CDATA[C Series Tango TM > 31.9 2007 <![CDATA[C-Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[With H4i TM S8 Escape humidifier TM II]]> 31.1 2005 <![CDATA[S9 AutoSet TM ]]> 26.5 2010 <![CDATA[S9 AutoSet with H5i Humidifier TM > 28.6 2010

[0063] One known RPT device for treating sleep-disordered breathing is the ResMed S9 Sleep Therapy System. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar ventilator for adults and children, are also mentioned. TM The series can provide invasive and non-invasive non-dependent ventilation support for a range of patients to treat a variety of conditions, such as, but not limited to, NMD, OHS and COPD.

[0064] Elisée TM 150 ventilator and ResMed VS III TM Ventilators provide support for invasive and non-invasive dependent ventilation for adult or pediatric patients, treating a variety of conditions. These ventilators offer volume-based and pressure-based ventilation modes with single-limb or dual-limb circuits. RPT devices typically include a pressure generator, such as a motor-driven blower or compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The RPT device's outlet is connected via an air circuit to a patient interface such as those described above.

[0065] This provides designers with countless options. Design standards often conflict, meaning that some design choices deviate from the norm or are unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute variations in one or more parameters.

[0066] 2.2.3.3 Humidifier

[0067] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface to generate humidified gas minimizes dryness of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0068] Many artificial humidification devices and systems are known, however, they do not meet the specific requirements of medical humidifiers.

[0069] Medical humidifiers are used to increase the humidity, temperature (or both) of an airflow relative to ambient air, typically when the patient is asleep or resting (e.g., in a hospital). Bedside medical humidifiers can be small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.) can also humidify the air inhaled by the patient; however, these systems also humidify and / or heat the entire room, which can make the occupant uncomfortable. Furthermore, medical humidifiers can have more stringent safety constraints than industrial humidifiers.

[0070] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0071] 2.2.3.4 Data Management

[0072] There are many clinical reasons to obtain data to determine whether a patient is “adhering” to a prescription treatment for respiratory therapy, such as if the patient has used their RPT device according to one or more “adherence rules.” One example of an adherence rule for CPAP therapy is to require the patient to use their RPT device for at least four hours each night for at least 21 or 30 consecutive days to be considered adherent. To determine patient adherence, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s treatment with the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can inform the patient of the third part of adherence.

[0073] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems.

[0074] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0075] 2.2.3.5 Ventilation port technology

[0076] Some forms of therapeutic systems may include a vent to allow the removal of exhaled carbon dioxide. The vent allows gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment.

[0077] The vent may include an opening through which gas can flow during mask use. Many such vents are noisy. Others may become blocked during use, thus providing insufficient clearance. Some vents may, for example, disturb the sleep of the patient or their bed partner by causing noise or congested airflow.

[0078] ResMed has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0079] The noise level of the existing face mask (ISO 17510-2:2007, pressure at 1m and 10cmH2O)

[0080]

[0081] (*Only one sample, measured using the test method specified in ISO 3744 in CPAP mode at 10 cmH2O) The sound pressure levels for various objects are listed below.

[0082]

[0083] 2.2.4 Screening, Diagnosis and Monitoring System

[0084] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves a clinical specialist in its application. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing involves two nights of clinical observation: one night for pure diagnosis and the second night for a clinician to titrate treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0085] Clinicians may be able to adequately diagnose or monitor patients based on visually observed PSG signals. However, there are situations where clinicians may be unavailable or unaffordable. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. 3. Summary of the Invention

[0086] This technology relates to providing medical devices for diagnosing, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0087] The first aspect of this technology relates to devices for diagnosing, improving, treating, or preventing respiratory disorders.

[0088] Another aspect of this technology relates to methods for diagnosing, improving, treating, or preventing respiratory disorders.

[0089] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0090] Another aspect of this technology relates to a sealing structure for a patient interface, the sealing structure comprising a fabric membrane.

[0091] In one form, the fabric membrane is airtight.

[0092] Another aspect of this technology relates to a method for manufacturing a patient interface that utilizes a flat fabric composite material to produce a fabric membrane with a curved shape.

[0093] Another aspect of this technology relates to a sealing structure for a patient interface, the sealing structure comprising a fabric membrane, wherein the sealing structure has no (or very few) wrinkles or creases.

[0094] Another aspect of this technology is a patient interface comprising a fabric membrane, which includes a knitted fabric material.

[0095] In one form, the knitted fabric material is warp-knitted.

[0096] In one form, knitted fabric materials are weft-knitted.

[0097] In one form, the fabric membrane is stretchable in both the vertical and horizontal directions (e.g., equally stretchable).

[0098] In one form, the fabric membrane is more stretchable in the horizontal direction than in the vertical direction.

[0099] Another aspect of this technology relates to a patient interface with a wide range of compatibility.

[0100] Another aspect of this technology relates to a sealing structure for a patient interface, which includes a sealing portion (e.g., comprising a fabric material) that remains taut before use.

[0101] Another aspect of this technology relates to a sealing structure for a patient interface, the sealing structure comprising an unstretched fabric membrane free of creases, wrinkles, folds and / or folds on the outer surface of the fabric membrane.

[0102] Another aspect of this technology relates to a sealing structure for a patient interface, the sealing structure comprising a fabric membrane having bridging portions with loose and / or bent excess material.

[0103] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet to improve sleep-disordered breathing when the patient is asleep, the patient airway inlet including at least an inlet to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in use throughout the patient's respiratory cycle at a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure; the patient interface includes a liner assembly comprising: 1) an inflation chamber that at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure, inflated... The air chamber includes an inlet port for the air chamber, the size and structure of which are designed to receive an airflow at therapeutic pressure for breathing by the patient; and 2) a sealing structure having a fabric membrane constructed and arranged to form a pressure-assisted seal with a region of the patient’s face below the bridge of the nose surrounding the inlet of the patient’s airway, the fabric membrane having pores formed therein such that an airflow at therapeutic pressure is delivered to at least the inlet of the patient’s nostrils, the sealing structure being constructed and arranged to maintain therapeutic pressure within the chamber during use throughout the patient’s respiratory cycle.

[0104] In the example: (a) the sealing-forming structure includes a flexible support structure to hold the fabric membrane in a predetermined curved shape, the fabric membrane being configured to seal against the underside of the patient's nose, the underside of the patient's nose including the patient's subnasal point and the patient's nasal protuberance; (b) the sealing-forming structure includes a sealing bias extending at least in the lateral region of the liner assembly along the periphery of the liner assembly, the sealing bias being less rigid than the adjacent portion of the support structure, such that the sealing bias is configured to inflate when the cavity is pressurized during use, thereby enabling the sealing bias to extend the reach of the fabric membrane and decouple the fabric membrane from external forces applied to the inflation chamber when the sealing bias is active during use; and (c) the sealing bias is configured to extend the reach of the fabric membrane by a greater distance in the lateral region of the liner assembly than in at least a portion of the central region of the liner assembly, such that when the sealing bias is active during use, the central region forms a curved or flexed region, thereby enabling the fabric membrane in the lateral region to lift or clamp the patient's nasal ala.

[0105] In a further example: (a) the fabric membrane in the lateral region is configured to extend in the posterolateral and lateral directions to lift or clamp the patient's nasal ala when the sealing bias is active in use; (b) in use, the fabric membrane is configured to press against the patient's face such that the patient's nose is not received in the cavity; (c) the sealing bias is omitted in at least a portion of the central portion of the pad assembly; (d) the sealing bias extends around the entire periphery of the pad assembly; (e) the size of the sealing bias varies around the periphery of the pad assembly; (f) the sealing bias is larger in the lateral region of the pad assembly and smaller in the central region; and (g) the size of the sealing bias tapers from a larger sealing bias in the lateral region toward a smaller sealing bias in the central region of the pad assembly.

[0106] In further examples: (a) the sealing bias includes a serrated channel or recess; (b) the sealing bias includes an external protrusion; (c) the sealing bias includes at least one fold, pleat, or corrugation; (d) when the sealing bias is active, at least one fold, pleat, or corrugation causes the fabric membrane to stretch toward the patient's face during use; (e) the sealing bias includes multiple folds, pleats, or corrugations; (f) the multiple folds, pleats, or corrugations form a sinusoidal waveform in cross-section; and (g) the sealing bias includes a stepped portion and a wing portion, the stepped portion and the wing portion being angled relative to each other.

[0107] In a further example: (a) a sealing bias is disposed between the support structure and the fabric membrane; (b) a sealing bias is disposed between the inflation chamber and the support structure; (c) the liner assembly includes a shank extending from the inflation chamber to support the sealing formation structure; (d) the sealing bias extends at an angle α through a lateral region of the liner assembly relative to a plane extending along the front side of the liner assembly; and (e) the angle α is between 30° and 60°; (f) the sealing formation structure is arranged such that the fabric membrane has a saddle shape configured to accommodate the lower side of the patient's nose in use.

[0108] In a further example: (a) the support structure and the sealing bias portion comprise silicone; (b) a fabric membrane is attached to the support structure along the periphery of the fabric membrane such that the fabric membrane extends radially inward beyond the support structure; (c) the support structure comprises silicone and the fabric membrane is molded onto the inner edge of the support structure; (d) at least one aperture in the fabric membrane comprises two apertures, and a bridging portion is disposed between the two apertures in the fabric membrane; (e) the fabric membrane comprises a membrane layer applied to a fabric material to make the fabric material substantially airtight; and (f) the air chamber comprises silicone and is integrally formed with the support structure.

[0109] In a further example: (a) the patient interface also includes a positioning and stabilizing structure that provides force to hold the sealing-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tether that is constructed and arranged such that, in use, at least a portion covers an area of ​​the patient's head above the supraaural base point of the patient's head; (b) the patient interface also includes a ventilation structure that allows exhaled air from the cavity to flow continuously to the surrounding environment, the size and shape of the ventilation structure being determined to maintain therapeutic pressure within the cavity in use; and (c) the inflation chamber and the sealing-forming structure form a nasal pad.

[0110] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet to improve sleep-disordered breathing when the patient is asleep, the patient airway inlet including at least an inlet to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in use throughout the patient's respiratory cycle at a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure; the patient interface includes a liner assembly comprising: 1) an inflation chamber that at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure, inflated... The air chamber includes an inlet port for the air chamber, the size and structure of which are designed to receive an airflow at therapeutic pressure for breathing by the patient; and 2) a sealing structure having a sealing portion configured and arranged to form a pressure-assisted seal with a region of the patient’s face below the bridge of the nose surrounding the inlet of the patient’s airway, the sealing portion having an opening formed therein such that an airflow at therapeutic pressure is delivered to at least the inlet of the patient’s nostrils, the sealing structure being configured and arranged to maintain therapeutic pressure within the chamber during use throughout the patient’s respiratory cycle.

[0111] In the example: (a) the sealing forming structure includes a flexible support structure to support the seal, the seal being configured to seal against the underside of the patient's nose, the underside of the patient's nose including the patient's subnasal point and the patient's nasal protuberance; (b) the sealing forming structure includes a sealing bias portion disposed together with the seal along the patient-facing posterior surface of the liner assembly, the sealing bias portion including at least one of a fold, pleat, or corrugation extending between the seal and the support structure; and (c) the sealing bias portion is configured to inflate when the cavity is pressurized during use, thereby causing the seal to extend or stretch beyond other portions of the patient-facing posterior surface of the liner assembly in a direction toward at least a portion of the patient's face.

[0112] In a further example: (a) the sealing bias includes multiple folds, pleats, or corrugations forming a sinusoidal waveform in cross-section; (b) the sealing bias is provided at least in the lateral region of the liner assembly; (c) the sealing portion is configured to extend or extend a greater distance in the lateral region of the liner assembly than in the central region of the liner assembly, such that when the sealing bias moves in use, the central region forms a curved or flexed area, thereby enabling the sealing portion in the lateral region to lift or clamp the patient's nasal ala; (d) the size of the sealing bias varies around the periphery of the liner assembly; (e) the sealing bias is larger in the lateral region of the liner assembly and smaller in the central region; (f) the sealing bias extends around the entire periphery of the liner assembly; (g) the sealing bias is omitted in at least a portion of the central portion of the liner assembly; (h) the support structure and the sealing bias include silicone; and (i) the sealing portion includes a fabric membrane.

[0113] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet to improve sleep-disordered breathing when the patient is asleep, the patient airway inlet including at least an inlet to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in use throughout the patient's respiratory cycle at a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure; the patient interface includes a liner assembly comprising: 1) an inflation chamber that at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure, inflated... The air chamber includes an inlet port for the air chamber, the size and structure of which are designed to receive an airflow at therapeutic pressure for breathing by the patient; and 2) a sealing structure having a sealing portion configured and arranged to form a pressure-assisted seal with a region of the patient’s face below the bridge of the nose surrounding the inlet of the patient’s airway, the sealing portion having an opening formed therein such that an airflow at therapeutic pressure is delivered to at least the inlet of the patient’s nostrils, the sealing structure being configured and arranged to maintain therapeutic pressure within the chamber during use throughout the patient’s respiratory cycle.

[0114] In the example: (a) the sealing structure includes a flexible support structure to support the seal; (b) an air chamber inlet port is formed on the front side of the air chamber, the front side of the air chamber including a connector structure adapted to be connected to an air supply pipe; (c) the front side of the air chamber includes a connector liner, the connector liner including one or more folds, pleats or corrugations adjacent to and extending around the inlet port, the one or more folds, pleats or corrugations being configured to separate the sealing structure from an external force applied to the air supply pipe.

[0115] In a further example: (a) the patient interface also includes an air supply tube connected to the front side of the inflation chamber and in fluid communication with an inlet port; (b) the seal includes a fabric membrane configured to seal against the underside of the patient's nose, the underside of the patient's nose including the patient's subnasal point and the patient's nasal protuberance; and (c) the patient interface also includes a positioning and stabilizing structure that provides forces to hold the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tether configured and arranged such that, in use, at least a portion covers an area of ​​the patient's head above the patient's ear base.

[0116] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet to improve sleep-disordered breathing when the patient is asleep, the patient airway inlet including at least the inlet of the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in use throughout the patient's respiratory cycle at a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure; the patient interface includes: 1) an inflatable chamber that at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure, the inflatable chamber being adapted to receive an airflow at the therapeutic pressure for breathing by the patient; and 2) a sealing formation structure having a fabric membrane constructed and arranged to form a seal with a region of the patient's face surrounding the inlet of the patient's airway, the fabric membrane having pores formed therein such that an airflow at the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the sealing formation structure being constructed and arranged to maintain the therapeutic pressure within the cavity in use throughout the patient's respiratory cycle.

[0117] In the example: (a) the sealing forming structure includes a support structure for supporting the fabric membrane, the support structure being configured to connect to the inflation chamber; and (b) the fabric membrane is attached to the support structure along the periphery of the fabric membrane in such a way that the fabric membrane is in a taut state before use.

[0118] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet to improve sleep-disordered breathing when the patient is asleep, the patient airway inlet including at least the inlet of the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use; the patient interface includes: 1) an inflation chamber that at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure, the inflation chamber including an inflation chamber inlet port, the inflation chamber inlet port being sized and structured to receive an airflow at the therapeutic pressure for breathing by the patient; and 2) a sealing formation structure having a fabric membrane constructed and arranged to form a seal with a region of the patient's face surrounding the inlet of the patient's airway, the fabric membrane having pores formed therein such that an airflow at the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the sealing formation structure being constructed and arranged to maintain the therapeutic pressure within the cavity during the patient's respiratory cycle during use. The sealing structure may include a flexible support structure to support the fabric membrane, the support structure being connected to the inflation chamber and being more rigid than the fabric membrane. In use, the fabric membrane can be configured to press against the patient's face so that the patient's nose is not received within the cavity. The fabric membrane may be attached to the support structure along its periphery, such that the fabric membrane extends radially inward beyond the support structure.

[0119] In the example: (a) the inflatable chamber and support structure comprise silicone and form a one-piece structure having a first lateral support segment of a first thickness and a second centrally arranged nasal base segment of a second thickness less than the first thickness, and the nasal base segment is configured to fold or form a pivot point when the fabric membrane engages with the patient's face, thereby allowing the left and right sides of the support structure to deform inward to support the patient's nose; (b) the support structure comprises a lower liner; (c) the support structure comprises foam; (d) the support structure comprises silicone and the fabric membrane is molded onto the inner edge of the support structure; (e) the fabric membrane has an arched shape in its corner regions; (f) the fabric membrane has a saddle-shaped shape in the lower central region of the fabric membrane, the saddle-shaped shape being configured to seal against the patient's subnasal point during use.

[0120] In a further example: (a) the fabric membrane comprises a membrane layer applied to a fabric material to make the fabric material substantially airtight; (b) the thickness of the fabric membrane is in the range of 0.3 mm to 0.5 mm; (c) the thickness of the membrane layer is in the range of 0.05 mm to 0.1 mm; (d) the fabric material is weft-knitted; (e) the weight of the fabric material is in the range of 105 gsm to 120 gsm; (f) the mechanical properties of the fabric material are in the range of 44 GG to 60 GG; (g) the fabric material has a mixed-color aesthetic; (h) the fabric material has a solid-color aesthetic; (i) the membrane layer comprises silicone; (j) the fabric material comprises nylon, spandex, or polyester; (k) during use, the therapeutic pressure within the cavity pushes the fabric membrane toward the patient's face; (l) the air chamber comprises silicone and is integrally formed with the support structure.

[0121] In a further example: (a) the patient interface also includes a positioning and stabilizing structure that provides forces to hold the sealing-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tether that is constructed and arranged such that, in use, at least a portion covers an area of ​​the patient's head above the supraaural base point of the patient's head; (b) the patient interface also includes a ventilation structure that allows exhaled air from the cavity to flow continuously to the surrounding environment, the size and shape of the ventilation structure being determined to maintain therapeutic pressure within the cavity in use; (c) the inflation chamber and the sealing-forming structure form an oronasal pad assembly; (d) the inflation chamber and the sealing-forming structure form a nasal pad.

[0122] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet to improve sleep-disordered breathing when the patient is asleep, the patient airway inlet including at least the inlet of the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use; the patient interface includes: 1) an inflation chamber that at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure, the inflation chamber including an inflation chamber inlet port, the inflation chamber inlet port being sized and structured to receive an airflow at the therapeutic pressure for breathing by the patient; and 2) a sealing formation structure having a fabric membrane constructed and arranged to form a seal with a region of the patient's face surrounding the inlet of the patient's airway, the fabric membrane having at least one hole formed therein, such that an airflow at the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the sealing formation structure being constructed and arranged to maintain the therapeutic pressure within the cavity during the patient's respiratory cycle during use. The sealing structure may include a flexible support structure to support the fabric membrane, the support structure being rigider than the fabric membrane, and the support structure being connected to the inflation chamber. At the transition section, the fabric membrane may be attached to the support structure along the outer edge of the fabric membrane and the inner edge of the support structure, such that the fabric membrane extends radially inward beyond the support structure. At the transition section, the support structure and the fabric membrane may extend along a curve from the front side of the sealing structure to the patient-facing rear side of the sealing structure.

[0123] In the example: (a) at the transition section, the support structure and the fabric membrane have substantially the same radius of curvature; (b) the fabric membrane extends continuously along the curve from the transition section to the inner edge of the fabric membrane; (c) in use, the fabric membrane can be configured to press against the patient's face such that the patient's nose is not received in the cavity; (d) at least one hole in the fabric membrane includes two holes, and a bridging portion is disposed between the two holes in the fabric membrane; (e) the support structure includes silicone and the fabric membrane is molded onto the inner edge of the support structure; (f) the sealing forming structure has a seamless transition along its outer surface from the support structure to the fabric membrane.

[0124] In a further example: (a) the fabric membrane comprises a fabric material and a membrane layer applied thereon to make the fabric material substantially impermeable; (b) the thickness of the fabric membrane is in the range of 0.3 mm to 0.5 mm; (c) the fabric material is weft-knitted; (d) the membrane layer comprises silicone; (e) the fabric material comprises nylon, spandex, or polyester; (f) in use, therapeutic pressure in the cavity pushes the fabric membrane toward the patient's face; (g) the air chamber and sealing formation form an oropharyngeal pad assembly; (h) the air chamber and sealing formation form a nasal pad.

[0125] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet to improve sleep-disordered breathing when the patient is asleep, the patient airway inlet including at least the inlet of the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use; the patient interface includes: 1) an inflation chamber that at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure, the inflation chamber including an inflation chamber inlet port, the inflation chamber inlet port being sized and structured to receive an airflow at the therapeutic pressure for breathing by the patient; and 2) a sealing formation structure having a fabric membrane constructed and arranged to form a seal with a region of the patient's face surrounding the inlet of the patient's airway, the fabric membrane having at least one hole formed therein, such that an airflow at the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the sealing formation structure being constructed and arranged to maintain the therapeutic pressure within the cavity during the patient's respiratory cycle during use. The fabric membrane may include a fabric material and a membrane layer applied thereon to make the fabric material substantially airtight; the fabric material may be a weft-knitted fabric. The sealing structure may include a flexible support structure for supporting the fabric membrane, the support structure may be connected to an air chamber, and the support structure may be rigider than the fabric membrane. The fabric membrane may be attached to the support structure along its periphery such that the fabric membrane extends radially inward beyond the support structure. In use, the fabric membrane may be configured to press against the patient's face so that the patient's nose is not received in a cavity. The fabric membrane may have an arched shape in the corner regions configured to seal against the patient's nasal alae, and a saddle-shaped shape in the lower central region configured to seal against the patient's subnasal point.

[0126] In the example: (a) during use, therapeutic pressure in the cavity pushes the fabric membrane toward the patient's face to help the fabric membrane form a seal with the patient's face; (b) at least one hole in the fabric membrane includes two holes, and a bridging portion is disposed between the two holes in the fabric membrane, and the bridging portion is fastened with excess material to allow the fabric membrane to expand to accommodate different nasal sizes; (c) the support structure includes silicone and the fabric membrane is molded onto the inner edge of the support structure; (d) the inflation chamber includes silicone and is integrally formed with the support structure; (e) the fabric membrane is attached to the support structure in such a way that the fabric membrane is taut before use; (f) a first region of the fabric membrane is taut before use and a second region of the fabric membrane is not taut before use.

[0127] In a further example: (a) the fabric membrane has four-way elasticity; (b) the fabric membrane has a first elasticity in the lateral left-right direction and a different second elasticity in the vertical direction, wherein the elasticity in the first direction is greater than the elasticity in the second direction; (c) the membrane layer comprises silicone; (d) the fabric material comprises nylon, spandex or polyester; (e) the air chamber and sealing formation structure form the mouth and nose pad assembly; (f) the air chamber and sealing formation structure form the nose pad.

[0128] Another aspect of this technology relates to a method of forming a pad assembly for a patient interface, the pad assembly being configured to seal and deliver an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet to improve sleep-disordered breathing when the patient is asleep, the patient airway inlet including at least the inlet of the patient's nostrils, wherein the pad assembly is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use; the method includes: 1) forming an impermeable fabric composite material by applying an impermeable material to a fabric material having a flat shape; 2) cutting the fabric composite material to a desired size according to a specific type of pad assembly to be used; and 3) overmolding a flexible support structure onto the cut fabric composite material to form a sealing structure having a fabric membrane, such 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. In the overmolding step, the fabric composite material is held in place by vacuum to have a non-flat shape during overmolding, thereby imparting a curved, non-flat shape to the fabric membrane. No wrinkles, creases, folds, and / or deformations are formed in the fabric membrane.

[0129] In the example: (a) the sealing-forming structure has a seamless transition from the support structure to the fabric membrane along its outer surface; (b) at the transition, 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, such that the fabric membrane extends radially inward beyond the support structure, and at the transition, the support structure and the fabric membrane extend along a curve in a direction from the front side of the sealing-forming structure to the patient-facing rear side of the sealing-forming structure; (c) two holes are formed in the fabric membrane, and a bridging portion is disposed between the two holes in the fabric membrane, and the bridging portion is fastened with excess material to allow the fabric membrane to expand to accommodate different sizes of noses; (d) the support structure comprises silicone.

[0130] Another aspect of this technology relates to a sealing structure for a patient interface, the sealing structure including a support structure and a sealing portion, the support structure supporting the sealing portion, wherein the sealing portion is attached to the support structure along the periphery of the sealing portion such that the sealing portion extends radially inward beyond the support structure, and wherein, in use, the sealing portion is configured to press against the patient's face such that the patient's nose is not received in the cavity and the sealing portion is under tension due to the reaction force of the support structure and / or the elastic tensile properties of the fabric, thereby causing the sealing portion to exert force on the patient's face.

[0131] According to another aspect of the present invention, the sealing portion comprises a fabric. In a further example, the patient interface includes an inflatable chamber, and a support structure is configured to connect to the inflatable chamber, the inflatable chamber at least partially forming a cavity pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port, the inlet port being sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient. In a further example, the sealing portion is constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway, the sealing portion having an opening formed therein such that an airflow at the therapeutic pressure is delivered to an inlet at least the patient's nostrils, the sealing forming structure being constructed and arranged to maintain the therapeutic pressure in the cavity throughout the patient's respiratory cycle during use. In a further example, the support structure comprises silicone and / or a thermoplastic elastomer.

[0132] According to another aspect of the present technology, the wall structure of the support structure between the sealing part and the inflation chamber has a first portion with a first thickness and a second portion with a second thickness different from the first thickness.

[0133] Another aspect of this technology relates to a sealing structure for a patient interface, the sealing structure including a support structure and a sealing portion, the support structure supporting the sealing portion, wherein the sealing portion is attached to the support structure along the periphery of the sealing portion in such a way that the sealing portion is in a tensioned state before use.

[0134] According to another aspect of the present invention, the sealing portion comprises a fabric material. In a further example, the patient interface includes an inflatable chamber, and a support structure is configured to connect to the inflatable chamber, the inflatable chamber at least partially forming a cavity pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port, the inlet port being sized and configured to receive an airflow at the therapeutic pressure for patient breathing. In a further example, the sealing portion is constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway, the sealing portion having an opening formed therein such that an airflow at the therapeutic pressure is delivered to an inlet at least the patient's nostrils, the sealing forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use. In a further example, the support structure comprises silicone and / or a thermoplastic elastomer.

[0135] Another aspect of this technology relates to a sealing structure for a patient interface, the sealing structure including a support structure and a sealing portion, the support structure supporting the sealing portion, wherein the sealing portion includes a fabric material and is attached to the support structure along the periphery of the sealing portion, wherein the support structure is more rigid than the sealing portion, and the support structure having a first segment of a first thickness and a second segment of a second thickness different from the first thickness.

[0136] According to another aspect of the present invention, the support structure comprises silicone and / or a thermoplastic elastomer, the patient interface includes an inflatable chamber, and the support structure is configured to connect to the inflatable chamber, the inflatable chamber at least partially forming a cavity pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port, the inlet port being sized and structured to receive an airflow at the therapeutic pressure for patient breathing. In a further example, a seal is constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway, the seal having an opening formed therein such that an airflow at the therapeutic pressure is delivered to at least an inlet to the patient's nostrils, the seal forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0137] Another aspect of this technology is a patient interface, which is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0138] One aspect of this technology is a method of manufacturing the device.

[0139] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for people without medical training, those who are clumsy, have limited vision, or have limited experience in using this type of medical device.

[0140] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing it in soapy water, without the need for specialized cleaning equipment.

[0141] Another aspect of this technology relates to a treatment system for treating sleep-disordered breathing, comprising: 1) a patient interface according to any of the above aspects; 2) a respiratory pressure therapy (RPT) device for supplying breathable gas at positive pressure; and 3) an air delivery tube that delivers breathable gas from the RPT device to the patient interface.

[0142] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0143] Of course, some of these aspects can form sub-aspects of this technology. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0144] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Attached Figure Descriptions

[0145] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including:

[0146] 4.1 Treatment System

[0147] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient sleeps in a supine position.

[0148] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0149] Figure 1CA system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0150] 4.2 Respiratory System and Facial Anatomy

[0151] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0152] Figure 2B This diagram shows a view of the human upper airway, including the nasal chambers, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0153] Figure 2C It is a front view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0154] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. The vertical and anteroposterior directions are also marked.

[0155] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0156] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0157] Figure 2G A side view showing the surface features of the nose.

[0158] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0159] Figure 2IThe diagram shows the medial anatomy of the nose a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0160] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal turbinate bones, as well as the maxilla and mandible, are also labeled.

[0161] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0162] Figure 2L The frontal lateral view of the nose is shown.

[0163] 4.3 Patient Interface

[0164] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0165] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0166] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0167] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0168] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0169] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0170] Figure 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edge of this surface is shown. The vaulted and saddle-shaped areas are shown.

[0171] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edge of this surface is indicated. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and a vaulted area are indicated.

[0172] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0173] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.

[0174] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0175] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0176] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the air bladder is also shown. The inner surface defines two-dimensional openings in the mask.

[0177] Figure 3N Showing through Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0178] Figure 3O The left-hand rule is shown.

[0179] Figure 3P The right-hand rule is shown.

[0180] Figure 3Q The left ear is shown, including the left ear spiral.

[0181] Figure 3R The right ear is shown, including the right ear spiral.

[0182] Figure 3S A right-handed spiral is shown.

[0183] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0184] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0185] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the central contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts, left and right.

[0186] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, said cross-section is in Figure 3V The image shows a section taken at the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of this intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the liner of the inflation chamber at exactly two points on the sagittal plane (upper point 3220 and lower point 3230). Depending on the geometry of the liner in this region, the intermediate contact plane can be a tangent at the upper and lower points.

[0187] Figure 3X It shows Figure 3U The position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 approximately coincides with the midsagittal plane of the face. When the inflation chamber is in the use position, the intermediate contact plane generally corresponds to the 'facial plane'. Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0188] 4.4RPT device

[0189] Figure 4A An RPT device of one form according to the present technology is shown.

[0190] 4.5 Patient Interface According to This Technology

[0191] Figure 5 This is a perspective view of the patient interface based on an example of this technology worn by a patient.

[0192] Figure 6 This is a perspective view of the patient interface based on another example of this technology worn by a patient.

[0193] Figure 7 It is the positioning and stabilizing structure along Figure 6 The cross-sectional view of line 7-7 in the diagram.

[0194] Figure 8 yes Figure 7 An enlarged view of part of the positioning and stabilizing structure.

[0195] Figure 9 yes Figure 7 An enlarged view of part of the positioning and stabilizing structure.

[0196] Figure 10 It is positioned on the patient's face. Figure 5 The main view of the padding component.

[0197] Figure 11 yes Figure 5 The main view of the padding component.

[0198] Figure 12 yes Figure 5 Top perspective view of the padding assembly.

[0199] Figure 13 yes Figure 5 Top view of the padding assembly.

[0200] Figure 14 yes Figure 5 Side view of the padding component.

[0201] Figure 15 yes Figure 5 The main view of the padding component.

[0202] Figure 16 yes Figure 5 Side view of the padding component.

[0203] Figure 17 yes Figure 5 Top view of the padding assembly.

[0204] Figure 18 This is a front view of a padding component positioned on a patient's face, according to another example of this technology.

[0205] Figure 19 yes Figure 18 Top view of the padding assembly.

[0206] Figure 20 yes Figure 18 The main view of the padding component.

[0207] Figure 21 yes Figure 18 A bottom view of the padding assembly.

[0208] Figure 22 yes Figure 18 Side perspective view of the padding assembly.

[0209] Figure 23 This is a front view of a liner component according to another example of this technology.

[0210] Figure 24 yes Figure 23 A bottom perspective view of the padding assembly.

[0211] Figure 25 yes Figure 23 Side perspective view of the padding assembly.

[0212] Figure 26 yes Figure 23 Top perspective view of the padding assembly.

[0213] Figure 27 yes Figure 23 Rear perspective view of the liner assembly.

[0214] Figure 28 This is a top perspective view of a liner assembly according to another example of this technology.

[0215] Figure 29 yes Figure 28 The main view of the padding component.

[0216] Figure 30 yes Figure 28 Side perspective view of the padding assembly.

[0217] Figure 31 yes Figure 28 Rear perspective view of the liner assembly.

[0218] Figure 32 yes Figure 28 A bottom view of the padding assembly.

[0219] Figure 33 This is a front perspective view of a liner assembly according to another example of this technology.

[0220] Figure 33-1 This is a front perspective view of a liner assembly according to another example of this technology.

[0221] Figure 33-2 It is along Figure 33-1 The cross-sectional view of line 33-2 in the diagram.

[0222] Figure 33-3 It is along Figure 33-1 The cross-sectional view of line 33-3—33-3 in the diagram.

[0223] Figure 33-4 It is taken from Figure 33-2 Zoomed-in details.

[0224] Figure 34 yes Figure 33 Cross-sectional view of the gasket assembly.

[0225] Figure 34-37 This is a front perspective view of a padding assembly having gripping pads arranged on a fabric membrane, according to an example of the present technology.

[0226] Figure 38 This is a perspective view of the patient interface based on another example of this technology worn by a patient.

[0227] Figure 39 This is a perspective view of the patient interface according to another example of this technology.

[0228] Figure 40 It is worn by the patient. Figure 39 A perspective view of the patient interface.

[0229] Figure 41 yes Figure 40 A side view of the patient interface.

[0230] Figure 42 yes Figure 40 The main perspective view of the patient interface.

[0231] Figure 43 yes Figure 39 The main view of the padding component of the patient interface.

[0232] Figure 44 yes Figure 39 Top view of the padding assembly.

[0233] Figure 45 yes Figure 39 A bottom view of the padding assembly.

[0234] Figure 46 yes Figure 39 Front perspective view of the liner assembly.

[0235] Figure 47 yes Figure 39 Rear perspective view of the liner assembly.

[0236] Figure 48 yes Figure 39 Side perspective view of the padding assembly.

[0237] Figure 49 yes Figure 39 The front perspective view of the liner assembly shows the interior of the liner assembly.

[0238] Figure 50 yes Figure 39 The front view of the liner assembly shows the interior of the liner assembly.

[0239] Figure 51 This is a rear view of a liner assembly according to an example of this technology.

[0240] Figure 52 yes Figure 51 The main view of the padding component.

[0241] Figure 53 yes Figure 51 Cross-sectional view of the gasket assembly.

[0242] Figures 54-56 This is a front perspective view of a padding assembly having gripping pads arranged on a fabric membrane, according to an example of the present technology.

[0243] Figure 57 This is a perspective view of a patient interface 30000, which is an example of this technology.

[0244] Figure 58 yes Figure 57 The patient interface 30000 is shown in perspective when worn by a patient.

[0245] Figure 59 yes Figure 57 The cross-sectional view of the patient interface 30000 is shown.

[0246] Figure 60 yes Figure 57 The patient interface 30000 is shown in a side view when worn by a patient.

[0247] Figure 61 yes Figure 57 Front perspective view of the liner assembly 30105.

[0248] Figure 62 yes Figure 57 Rear perspective view of the liner assembly 30105.

[0249] Figure 63 yes Figure 57 The main view of frame 30350.

[0250] Figure 64 yes Figure 57 The back view of frame 30350.

[0251] Figure 65 yes Figure 57 The patient interface 30000 is shown from the back when worn by the patient.

[0252] Figure 66 yes Figure 57 The view of the patient interface 30000 positioning and stabilization structure 30300 strap.

[0253] Figure 67 This is a perspective view of the patient interface based on another example of this technology worn by a patient.

[0254] Figure 68 yes Figure 67 A side view of the patient interface.

[0255] Figure 69 yes Figure 67 The exploded view of the patient interface shown illustrates the padding assembly, frame assembly, arm cover, and elbow assembly.

[0256] Figure 70 This is a pre-exploded view of a liner assembly according to an example of this technology.

[0257] Figure 71 yes Figure 70 An exploded view of the gasket assembly.

[0258] Figure 72 yes Figure 67 The main view of the padding component of the patient interface.

[0259] Figure 73 yes Figure 72 Front perspective view of the liner assembly.

[0260] Figure 74 yes Figure 72 Rear perspective view of the liner assembly.

[0261] Figure 75 yes Figure 72 Top perspective view of the padding assembly.

[0262] Figure 76 yes Figure 72 A bottom perspective view of the padding assembly.

[0263] Figure 77 yes Figure 72 Side perspective view of the padding assembly.

[0264] Figure 78 This is a schematic diagram of a method for providing an airtight layer to a fabric material according to an example of the present technology.

[0265] Figure 79 It is a schematic diagram depicting the patient's face being presented to the fabric membrane with slight tension before use.

[0266] Figure 80 This is a schematic diagram illustrating the resultant force exerted on the patient's face by the fabric membrane due to the tensile stress in the fabric membrane.

[0267] Figure 81 This is a schematic diagram of the tension applied to the seal of a gasket assembly according to an example of the present technology.

[0268] Figure 82 This is a schematic diagram of the force exerted on the patient's face by the fabric membrane due to the air pressure within the cavity formed by the liner assembly.

[0269] Figure 83 This is a cross-sectional view of a gasket assembly according to an example of the present technology.

[0270] Figure 84 This is a cross-sectional view of a gasket assembly according to an example of the present technology.

[0271] Figure 85 This is a cross-sectional view of a gasket assembly according to an example of the present technology.

[0272] Figure 86 This is a cross-sectional view of a gasket assembly according to an example of the present technology.

[0273] Figure 87 This is a partial cross-sectional view of the sealing portion and support structure of a gasket assembly with an external sealing bias, according to an example of the present technology.

[0274] Figure 88 This is a partial cross-sectional view of the sealing portion and support structure of a gasket assembly with an internal sealing bias, according to an example of the present technology.

[0275] Figure 89 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0276] Figure 90A This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0277] Figure 90A-1 yes Figure 90A An enlarged view of a portion of the sealing part of the gasket assembly.

[0278] Figure 90B This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0279] Figure 91 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0280] Figure 92 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0281] Figure 93 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0282] Figure 94 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0283] Figure 95 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0284] Figure 96 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0285] Figure 97 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0286] Figure 98 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0287] Figure 99 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0288] Figure 100 This is a partial cross-sectional view of a liner assembly according to an example of the present technology.

[0289] Figure 101 This is a cross-sectional view of a sealing module assembly according to an example of this technology.

[0290] Figure 102 This is a combination of an example based on this technology. Figure 101 A partial cross-sectional view of the gasket assembly of the sealing module component.

[0291] Figure 103 This is a perspective view of a module support structure according to an example of this technology.

[0292] Figure 104 and 105 The process of molding a seal into a support structure according to an example of the present technology is shown.

[0293] Figure 106 Through Figure 104 and 105 A side view of the sealing module assembly formed by the process shown.

[0294] Figure 107 and 108 This illustrates an example of a size suitable for all soft padding components according to this technology.

[0295] Figure 109 and 110 An example of a custom-made pad assembly manufactured according to this technology is shown, which utilizes a three-dimensional contour obtained by scanning a patient’s face.

[0296] Figure 111 This is a front perspective view of a liner assembly according to another example of this technology.

[0297] Figure 112 yes Figure 111 Rear perspective view of the sealing structure of the gasket assembly.

[0298] Figure 113 and Figure 114 It describes the weaving process.

[0299] Figure 115 Examples of warp-knitted fabrics according to this technology are illustrated.

[0300] Figure 116 Examples of weft-knitted fabrics according to this technology are illustrated.

[0301] Figure 117 This is a functional block diagram illustrating a process of overmolding a support structure onto a fabric composite material to form a sealed structure with a fabric membrane, according to an example of the present technology.

[0302] Figures 118A to 118C It is a schematic diagram depicting a pad assembly in use.

[0303] Figure 119A This is a perspective view of a liner assembly according to an example of this technology.

[0304] Figure 119A-1 yes Figure 119A Enlarged details of the sealing bias section.

[0305] Figure 119B yes Figure 119A A perspective view of the gasket assembly shows the seal being pressurized through the cavity of the gasket assembly during use.

[0306] Figure 120 This is a bottom perspective view of a padding assembly according to another example of this technology.

[0307] Figure 121 This is a bottom perspective view of a padding assembly according to another example of this technology.

[0308] Figure 122A This is a top perspective view of a liner assembly according to another example of this technology.

[0309] Figure 122B yes Figure 122A A bottom perspective view of the padding assembly.

[0310] Figure 123A This is a top perspective view of a liner assembly according to another example of this technology.

[0311] Figure 123B yes Figure 123A A bottom perspective view of the padding assembly.

[0312] Figure 124 This is a partial perspective view of a liner assembly according to another example of this technology.

[0313] Figure 125 This is a front perspective view of a liner assembly according to another example of this technology.

[0314] Figure 126 This is a front perspective view of a liner assembly according to another example of this technology.

[0315] Figure 127 This is a front perspective view of a liner assembly according to another example of this technology.

[0316] Figure 128 This is a rear perspective view of a liner assembly according to another example of this technology. 5. Detailed Implementation

[0317] Before describing this technology in more detail, it should be understood that this technology is not limited to the specific examples that may vary as described herein. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0318] The following description provides various examples of things that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. Furthermore, in any example, any single feature or combination of features can form another example.

[0319] 5.1 Treatment

[0320] In one form, the technology includes a method for treating respiratory disorders, the method comprising the step of applying positive pressure to the airway inlet of a patient 1000.

[0321] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0322] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0323] 5.2 Treatment System

[0324] In one form, the technology includes a device or apparatus for treating respiratory disorders. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000, for example, see [link to relevant documentation]. Figures 1A to 1C .

[0325] 5.3 Patient Interface

[0326] According to one aspect of the present technology, a non-invasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0327] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0328] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 6 cmH2O relative to the environment.

[0329] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 10 cmH2O relative to the environment.

[0330] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 20 cmH2O relative to the environment.

[0331] 5.3.1 Inflation Chamber

[0332] In the area formed by the seal during use, the air chamber has a periphery shaped to complement the surface contours of a normal person's face. During use, the boundary edges of the air chamber are positioned very 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 along the entire periphery of the air chamber during use. In some forms, the air chamber and the seal-forming structure are formed from a single sheet of homogeneous material. In one example, the air chamber may be made of a flexible material (e.g., silicone) and may be formed as a single piece with a support structure (e.g., from any material described herein as suitable for the support structure and / or the air chamber). In one example, the seal-forming structure may be an extension of the air chamber or formed as part of the air chamber such that the air chamber surrounds the seal-forming structure. In such examples, the support structure and the fabric membrane may be considered part of the air chamber.

[0333] 5.3.2 Sealing Formation Structure

[0334] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the position of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0335] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0336] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as liquid silicone (LSR) (or "silicone").

[0337] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and resilient material such as silicone.

[0338] In some forms, the sealing structure can be constructed or molded from a single homogeneous sheet of material (e.g., liquid silicone rubber, fabric).

[0339] In some forms, for example in Figures 5 to 77 As shown in the examples, the sealing structure has a sealing portion comprising a fabric material that may cover all or part of the sealing structure. In some forms, the fabric may comprise a material formed of a fiber web and adapted to be airtight. For example, the fabric may have an airtight membrane on at least one surface, thereby forming a fabric membrane or fabric seal.

[0340] In some forms, the fabric membrane can be configured to stretch elastically in at least one dimension. For example, when the fabric membrane is constructed from a fiber network, it is capable of elongating across the fabric membrane in the longitudinal warp and / or transverse weft directions. In some forms, the fabric membrane is configured to stretch elastically to a greater extent than is achievable by conventional silicone sealing structures.

[0341] In some forms, the fabric membrane is configured to be substantially inelastic in at least one dimension. For example, when the fabric membrane is constructed from a woven fabric material, it is capable of substantially resisting elongation in either or both of the longitudinal warp or transverse weft directions across the fabric membrane.

[0342] Fabric films can comprise a single layer or multiple layers. In the case of multiple layers, these individual layers can be formed using the same material or a variety of different materials, each with unique material properties.

[0343] In some forms, the fabric membrane may include at least one layer that exhibits substantially impermeable properties while maintaining the material properties required to provide patient comfort and a point of minimal pressure. For example, such as Figure 78 As shown, in some forms, the fabric membrane may include an impermeable material 10131 formed on the inner surface of the fabric material 10133. In some forms, the impermeable material may be laminated onto the fabric material. The impermeable material and the fabric material may be selected in some forms such that the resulting fabric membrane exhibits a predetermined overall elasticity or resistance to elasticity as needed. For example, adding an impermeable material (or membrane layer) may increase the elasticity (or extensibility) of the fabric material, resulting in an fabric membrane with increased extensibility.

[0344] In some forms, the membrane can exhibit a low spring constant (i.e., high compliance) in both the warp and weft yarns. In this form, unlike conventional designs where a fixed pad may deform 130° of the patient's facial skin to form an effective seal, the fabric material and / or the resulting fabric membrane can have a material spring constant and spring length that makes the fabric membrane more compliant with the patient's skin than the attached fabric membrane. This can advantageously improve the comfort of the mask and reduce the formation of localized pressure "hot spots."

[0345] In some forms, the surface of the fabric material in contact with the patient's face 1300 may have low-friction properties. This can advantageously improve the comfort of the fabric membrane's surface texture and reduce friction relative to the patient's face 1300. The fabric material may have a surface (e.g., herringbone) where the coefficient of friction in a first direction differs from (e.g., greater or less) in a second direction. Conversely, a fabric with higher friction may cause the fabric membrane to clamp or rub against the contact area of ​​the patient's face during use. Such friction or clamping can cause the fabric membrane to deform or warp, thereby reducing the effectiveness of the seal and allowing undesirable air leakage from the device.

[0346] In some forms, the total thickness of the fabric material in the fabric membrane can be 0.275 mm or less.

[0347] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure being configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0348] It should be noted that although this specification may (e.g., by reference symbols) refer to a particular illustrated example or a feature of a particular illustrated example (e.g., sealing formation 3100), such description may apply to other examples and / or features (e.g., sealing formation 5100).

[0349] 5.3.2.1 Sealing Mechanism

[0350] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight seal with the face. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0351] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0352] In one embodiment, a fabric membrane (e.g., comprising nylon, polyester, nylon and polyester blends, microfibers, or polyurethane) is used as the face contact portion of the sealing formation structure 3100 of the CPAP mask. The fabric membrane may have properties that allow it to stretch in at least one dimension. The fabric membrane may be held under tension at both ends of the support structure before and / or during use. Before use, the fabric membrane may be permanently attached (e.g., by molding) or attached to the support structure as a removable module in a pre-tensioned and slightly stretched manner.

[0353] Alternatively, the fabric can be formed into a complex, predetermined three-dimensional shape such that it is unstretched (e.g., loose, relaxed, and / or wrinkle-free) before and / or during use, but without substantially causing leakage that results in wrinkles. Due to manufacturing, the fabric polymer can shrink, causing the inherent pretension in the fabric membrane to be lost; however, the fabric membrane can remain substantially wrinkle-free.

[0354] Figure 79An example is illustrated where the fabric membrane has slight tension in both the X and Y directions across the fabric surface. Before the patient's face 1300 (e.g., the nose) approaches and presses against the fabric membrane 3130, the fabric membrane is adapted to form a constant surface in the fabric material without interruptions such as creases, wrinkles, or creases before contact between the patient's face 1300 and the seal-forming structure 3100. In some forms, this can be achieved by applying slight pretension or by molding the fabric membrane so that it is substantially free of any leakage that would cause wrinkling. This is advantageous in ensuring that the fabric membrane forms a smooth and continuous seal on and around the patient's face 1300. This can provide improved respiratory pressure therapy by reducing the occurrence of folds or wrinkles in the treatment air that could leak from the seal-forming structure 3100. This is also advantageous in ensuring that the fabric membrane remains at a minimum tension threshold when pressed against the patient's face 1300. Figure 80 ).

[0355] In some forms, areas of the fabric membrane may be pre-tensioned and slightly stretched, while other areas of the fabric membrane may remain loose. For example, in some forms, the subnasal region may be pre-tensioned while the area covering the outside of the nostrils and / or the patient's mouth may remain tension-free (e.g., with excess material) to form a saddle-shaped area or valley shape before use. This can advantageously improve sealing efficiency while reducing pressure on areas of the face that extend into or toward the cavity (i.e., "hot spots"). In another example, the sides and / or bridge of the nose may be left untensioned and / or loose before use to provide additional material to accommodate the facial contours of these sensitive facial areas. In yet another example, a bridging portion (e.g., bridging portion 3104) extending between the two nostril openings may be tensioned, loosened, and / or fastened with excess material before use, for example, as shown in the image. Figure 33-1 As shown. A bridging portion with excess material (e.g., 3104) allows the fabric membrane to expand (e.g., in the vertical (height) direction) to accommodate noses of different sizes.

[0356] In some forms, instead of having pre-tensioned areas, the fabric membrane can be formed to be essentially leak-free, causing no wrinkles. This can be advantageous because it can be difficult to form a complex, leak-free three-dimensional shape from a loose fabric membrane or from a fabric membrane that provides excess untensioned material. An untensioned fabric membrane can also be more comfortable in some arrangements because it applies less pressure to the patient's face.

[0357] In some forms, the fabric membrane can be in a substantially tension-free state and formed on a support structure or directly on an inflatable chamber in such a way that it remains unstretched and / or slack. In one example, such a fabric membrane may also remain unprinted to avoid leakage of the seal against the patient's face. In some forms, the unstretched and / or unprinted fabric membrane may utilize padding supports (e.g., a lower pad, a sealing support area (e.g., a support structure)) and / or air pressure within the cavity to enable an effective seal against the patient's face.

[0358] In some forms, the tension and / or wrinkle-free state of the fabric membrane (see...) Figure 80 and 81 A sealed contact with the patient's face can be maintained using one or a combination of the following:

[0359] a) When the patient's face 1300 is engaged with the fabric membrane, the pre-applied tensile stress and additional tensile stress of the fabric membrane;

[0360] b) The preformed state of the fabric membrane is formed as a non-tensioned, but substantially unchanged surface, with no leakage and no leakage that causes interruptions such as creases, folds, deformation or wrinkles in the fabric membrane.

[0361] c) The stiffness of the support structure and / or the air chamber, and the ability of the support structure and / or the air chamber to adapt to and react to the applied tensile stress at the 130° joint with the fabric membrane on the patient's face; and

[0362] d) An additional air pressure load from within the cavity abuts against the inner surface of the fabric membrane. The internal air pressure can apply additional tensile stress to the inner surface of the fabric membrane to further stretch the fabric membrane and stress the patient's face 1300 (e.g., to create a pressure-assisted seal).

[0363] By continuously maintaining the fabric membrane under tensile stress and / or in a wrinkle-free state before and during use, the fabric membrane can conform to the patient's facial contours while minimizing wrinkles and / or bursting of the seal-forming structure. In some forms, this also improves seal performance by maximizing the contact area of ​​the fabric membrane on the patient's face 130°. In some forms, this also improves the performance of the CPAP device when subjected to external lateral or longitudinal forces (e.g., tube tension).

[0364] In some configurations, when the inflatable chamber is pulled a short distance away from the patient's face 1300, the load applied by the air pressure within the inflatable chamber helps the fabric membrane maintain an effective seal. The applied air pressure load is sufficient to elastically stretch the fabric membrane in at least one dimension, causing the fabric membrane to form a "hoverboard" balloon effect on the anthropometric contour of the patient's face 1300, thereby maintaining an effective seal thereon.

[0365] In some forms, the fabric membrane can be held under tension by a relatively rigid support structure. In various forms, the support structure can be formed from, for example, silicone, PU foam, PU solid materials, or other suitable materials. In some forms, the support structure can be relatively rigid than the shell or frame of the inflation chamber.

[0366] In some forms, the magnitude of the tensile stress can be varied on the fabric membrane sealing the structure as needed. For example, there may be stress concentration areas near one or more pores in the fabric membrane through which treatment is performed, or over a wider range of the material.

[0367] In some forms, the sealing formation structure can utilize several different gasket configurations, including a single air-assisted fabric membrane, a dual air-assisted fabric membrane, a fabric membrane with compression support, or a fabric membrane with TPU / TPE / Si support. In some forms, the gasket configuration of the sealing formation structure can be configured to advantageously provide a "one-size-fits-all" solution.

[0368] In the example, the sealing formation structure and the inflation chamber can be applied to nasal pads, nasal supports, nasal and oral pads, ultra-compact full-face masks, full-face masks, and other suitable pad arrangements.

[0369] In some forms, the fabric membrane can be configured to create an effective seal across the patient's anterior nose, for example, as... Figure 58 As shown. In some forms, the fabric membrane can be configured to create an effective seal against the lower portion of the nostrils of the patient's nose, such that the fabric membrane does not engage with the nostrils, for example, as... Figure 40 As shown.

[0370] In some forms, during use, stretching and / or maintaining the wrinkle-reducing state of the fabric membrane to conform to the patient's face 1300 can apply pressure to the walls of the support structure. This stress can pull the walls of the support structure inwards from each other during use. In some forms, the support structure can be adapted to resist the applied stress load to prevent inward deformation. Thus, the rigidity of the support structure can further stress the fabric membrane, which in turn can cause elastic stretching of the fabric membrane during use.

[0371] In some forms, for example Figure 87 and88 As shown, the support structure may include pleats or folds (e.g., sealing biases 10140, 10140') that utilize internal air pressure to dynamically support the fabric membrane. This can advantageously provide further support to the fabric membrane under dynamic loads (e.g., tube traction). In other forms, pleats or folds may utilize internal air pressure to separate dynamic loads (e.g., tube traction) from the sealing formation structure. In some forms, the air pressure within the cavity can load the inner surface of the fabric membrane to generate further tensile stress, such that the fabric membrane substantially fills the concave contour of the patient's face 1300 (e.g., the side around the nose). In some forms, when combined with the applied load of internal air pressure, the elasticity of the fabric membrane can elastically stretch the fabric membrane, thereby forming a larger sealing contact area on the patient's face. This is also advantageous in some forms in providing a continuous seal, even when the mask partially shifts from the optimal interface with the patient's face, because the fabric membrane may be partially inflated due to the reaction force from the internal air pressure (i.e., the "hovercraft effect").

[0372] In some forms, for example Figures 35-37 As shown in Figures 54-56, the fabric membrane may have one or more clamping pads 29150, 31150 disposed thereon. In one example, the clamping pads 29150, 31150 may be configured such that the patient-facing surface of the fabric membrane is substantially flat. In other examples, the clamping pads 29150, 31150 may be embossed such that the clamping pads may form slightly protruding creases or flanges above the surface of the fabric membrane. In some forms, the clamping pads 29150, 31150 may have a high coefficient of friction. In some forms, the clamping pads may have a defined shape (e.g., elliptical, see Figure 54-56). Figure 35 , 37 (54 and 56), circular, square, etc.). In some forms, the clamping pad can be elongated (see...). Figure 35 and 54 In some forms, the clamping pads 29150 and 31150 may be linear. In some forms, the clamping pads may be arranged in a pattern across the surface of the sealing structure 3100. In some forms, the clamping pads may be irregularly arranged on the surface of the sealing structure 3100 (see [reference]). Figure 37 and 56 In some forms, the clamping pads can be arranged to form the periphery of the adjacent fabric membrane (see [reference]). Figure 34 , 35 54 and 55). In some forms, the clamping pads 29150 and 31150 forming the perimeter can be in the form of dashed lines (see 54 and 55). Figure 35 and 54 In some forms, the clamping pads forming the perimeter can be in the form of solid lines (see...). Figure 36 and 55 In some forms, the clamping pads forming the perimeter can be in the form of multi-line, dotted, or solid lines, or combinations thereof. In some forms, the clamping portion helps the fabric membrane hold the patient's face. In one example, the clamping pad is formed as a relatively thin silicone layer applied to the surface of the fabric membrane.

[0373] In some forms, the fabric membrane can be integrated into the support structure by attaching (e.g., molding) the outer edge (e.g., peripheral edge) of the fabric membrane around the lip of the curved edge (i.e., inner edge) of the support structure. In one example, the fabric membrane may be angled slightly "inward" toward the inside of the mask. In one example, the fabric membrane is attached to provide the front of the sealing-forming structure. That is, the support structure forms the curved portion of the sealing-forming structure from the front side to the back contact side of the sealing-forming structure (see...). Figure 11 In this way, the fabric membrane can avoid having a portion that curves from the back to the front. With this arrangement, the fabric membrane can be presented only along the front of the sealing structure, such as, for example... Figure 11-17 As shown in the diagram. This arrangement can be advantageous because the fabric membrane may not require folding or cutting to fuse around the corners of the support structure. This can help reduce protruding folds or wrinkles in the fabric membrane (which can lead to leaks), thereby improving the sealing performance.

[0374] In some forms, the fabric membrane can be attached to the outer edge of the fabric membrane, such that the fabric membrane forms a portion of the portion of the sealing structure that curves from the front side to the back contact side of the sealing structure (see, for example, [reference needed]). Figures 33-1 to 33-4 (73 and 74). This provides more fabric membrane surface (relative to the support structure) for engagement with the patient's face, which can improve comfort. In one example, the fabric membrane is attached to the support structure using a specific process (as described later), which forms the curved portion without creating folds, creases, wrinkles, or deformation in the fabric membrane surface. It can be seen that, in some examples, at the transition portion 36, the support structure and the fabric membrane may both have a radius of curvature (e.g., the same or similar radius of curvature) along curve 35 in the direction from the front side of the sealing-forming structure to the rear side of the sealing-forming structure (see...). Figures 33-1 to 33-4 The fabric membrane may have a predetermined curvature, such that a portion of the unsupported structure directly supporting the fabric membrane extends along curve 35. Figures 33-2 to 33-4 This can help create an arched shape (e.g., a convex arch) in certain areas of the fabric membrane (e.g., the outer surface 3250 and / or corner area 3252), which helps the fabric membrane seal against the contour of the patient's face (e.g., the area below the nasal ala (i.e., the corner of the nasal region, i.e., the area near the nasolabial fold where the nasal ala terminates at the upper lip)). Figure 33-1As shown. The dome shape helps prevent creases, wrinkles, folds, and deformations in the fabric membrane, which helps avoid leakage paths. Furthermore, the dome shape helps the fabric reach hard-to-seal areas of the patient's face, such as the corners of the nasal region. The fabric membrane 29130 may have a saddle shape in the subnasal medial region 3260, configured to seal against the patient's subnasal point, thereby matching the saddle shape formed by the patient's nasolabial angle and upper lip, as... Figure 33-1 As shown. Similarly, the nasal protuberance region 3270 can also have a saddle shape, configured to seal against or below the matching contour presented at the patient's nasal protuberance. The curvature of the fabric membrane in the direction of curve 35 (e.g., the magnitude of the curvature and / or the radius of curvature) can vary along the periphery of the fabric membrane in different areas of the pad assembly. For example, as Figure 33-2 As shown, the fabric membrane 29130 in the medial region 3270 of the nasal protuberance can have a different curvature in the direction of curve 35 than the fabric membrane in the medial subnasal region 3260. Figure 33-2 In one example, the fabric membrane in the medial region 3270 of the nasal protuberance may have a curvature (e.g., a smaller radius) that is relatively larger (e.g., a smaller radius) than the curvature (e.g., a negative curvature in the vertical direction of curve 35) in the medial subnasal region 3260. In another example, the curvature (e.g., magnitude of curvature and / or radius of curvature) at the lateral surface 3250 of the fabric membrane may differ from the curvature at the medial region 3270 of the nasal protuberance and / or the medial subnasal region 3260. For example Figure 43 , 52 The nose portion of the padding assemblies 14105, 30105, and 31105 shown in Figure 61 may have similar dome and saddle-shaped features.

[0375] exist Figure 73 In the example, the curvature of the fabric membrane 16230 from its connection with the support structure 16220 (e.g., at a transition section) can extend to the inner edge of the fabric membrane. For example, at the inner edge of the fabric membrane in certain areas of the padding, the fabric membrane can have a dome shape or a saddle shape.

[0376] In some forms, the fabric membrane may be slightly angled inward or curved inward toward the inside of the mask (e.g., positive curvature in the left-right direction), see [link to relevant documentation]. Figure 11-17 23-26 and 3-37. In some forms, the fabric membrane can be formed into a vault shape on the supporting structure, for example, as... Figure 19-22 As shown in 43-50. It should be noted that, as mentioned above... Figure 33-1Any pad assembly disclosed herein may have a fabric membrane attached to the outer edge of the fabric membrane, such that the fabric membrane forms part of a portion of the sealing formation extending along curve 35 from the front side of the sealing formation to the back contact side, such that the fabric membrane 6130 of, for example, pad assembly 6105 may have a more domed shape due to its more convex shape from one side to the other.

[0377] In some forms where the fabric membrane is not under continuous tension (before and / or during use) or is inelastic, the fabric membrane can form an improved air-assisted seal on the patient's face, which dynamically conforms to change / movement (i.e., the "hovercraft effect"), for example due to the thinner fabric membrane and its lower structural stiffness compared to silicone membranes.

[0378] In some forms, the fabric membrane may be supported by a second or third support structure, which may serve as a padding support or a biasing mechanism that provides pressure assistance and aids in sealing the patient's face. Padding supports offer additional flexibility and can accommodate most patients' faces (one size fits most). The second or third support layer may be formed using fabric membranes, fabrics with PU / Si films, laminated open-cell foams, laminated PU foams, PU moldings, TPU / TPE, or silicone. In some forms, the additional support layer itself may be supported by structural / rigid plastics such as PP / PC / PA / PET or other suitable materials.

[0379] In some forms, 3D printing of the fabric membrane and / or padding support as the "skeleton" can reduce the thickness and thus the weight of the mask.

[0380] In some forms, multiple different layers of the mask can be printed with varying stiffness, hardness, or thickness. For example, the "skeleton" portion can be formed using Si, PU foam, PU solid material, or any suitable plastic material.

[0381] In some forms, pleats or folds can be formed along the padding assembly (e.g., padding assemblies in fabric membranes and / or support structures) to provide dynamic force / support or decoupling areas.

[0382] In one form, the sealing structure may include a compression seal or a gasket seal. In use, the compression seal or the gasket seal is constructed and positioned in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0383] In one embodiment, the seal-forming structure may include a biasing mechanism to help form a seal between the fabric contact portion (seal portion) of the seal-forming structure and the patient's face.

[0384] In one form, the sealing structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0385] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0386] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tensioning portion, and a portion having an adhesive or bonding surface.

[0387] 5.3.2.2 Nasal bridge or nasal ridge area

[0388] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0389] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the bridge or ridge of the nose of a patient's face.

[0390] 5.3.2.3 Upper lip area

[0391] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that, in use, forms a seal on the upper lip region (i.e., the upper lip) of the patient's face.

[0392] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0393] 5.3.2.4 Chin area

[0394] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that, during use, forms a seal on the chin region of the patient's face.

[0395] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on the chin area of ​​a patient's face.

[0396] 5.3.2.5 Forehead area

[0397] In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0398] 5.3.2.6 Nasal pillow

[0399] In one embodiment, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.

[0400] A nasal pillow according to one aspect of the present technology includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow connection structure of the present technology includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of both the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle connection structure.

[0401] 5.3.3 Nasal Liner

[0402] Reference Figure 5-14 The first example of a patient interface 3000, 6000 according to the present technology is shown, which has a liner assembly 3105 including a sealing formation structure 3100 and an inflation chamber 3200. Figure 15-17 A second example of a gasket assembly 5105 according to the present technology is shown, comprising a sealing formation structure 5100 and an inflation chamber 3200. Figure 18-22 A third example of a gasket assembly 6105 according to the present technology is shown, comprising a sealing formation structure 6100 and an inflation chamber 3200. Figure 23-27 A fourth example of a gasket assembly 7105 according to the present technology is shown, comprising a sealing formation structure 7100 and an inflation chamber 3200. See also Figure 28-32 Figure 3 illustrates a fifth example of a liner assembly 8105 according to the present invention, including a sealing formation structure 8100 and an inflation chamber 3200. Figure 3 also illustrates a sixth example of a patient interface 9000 having a liner assembly 9105 including a sealing formation structure 9100 and a frame 9200.

[0403] Figure 11-14 This includes dashed lines that delineate areas of different thicknesses, and it should be understood that these are merely nominal boundaries, not actual structures.

[0404] Examples of the sealing structures 3100, 5100, 6100, 7100, 8100, and 9100 described in the preceding paragraphs can be considered as nasal support pads and are designed to provide a pressurized airflow to the patient's nostrils by at least sealing the lower side of the patient's nose. Exemplary sealing structures may engage the patient's face below the bridge of the nose, and some examples may engage the patient's nose below the nasal protuberance, depending on the size and shape of the patient's nose. Exemplary sealing structures may also engage the patient's face at least above the vermilion border of the upper lip. Thus, exemplary sealing structures can seal against the patient's upper lip during use. Furthermore, the patient's mouth may remain uncovered by the depicted exemplary sealing structures, allowing the patient to breathe freely, i.e., directly into the atmosphere without interference from the sealing structures. The subnasal support may be configured such that it does not have orifices, the size of which is determined for receiving the patient's nose within the cavity. Furthermore, the height of the pad from the lower edge of the fabric membrane in the medial region of the nose to the upper edge of the fabric membrane in the medial region of the nasal protuberance can be less than the width of the pad in the left-right direction from one side edge of the fabric membrane to the other side edge of the fabric membrane (see, for example). Figure 33 and 33-1 ).

[0405] Examples of nasal support pads (e.g., exemplary seal-forming structures) disclosed herein may include an upper saddle-shaped or concave region with positive curvature on the pad. Furthermore, nasal support pads can be understood as having a single targeted seal-forming region or surface, while nasal occipital pads may have two targeted seal-forming regions (one for each nostril). The support pad may also have a posterior wall contacting the upper part of the patient's lips and an upper central surface contacting the lower side of the patient's nose. These two surfaces of the patient's face may form a nasolabial angle between them (see...). Figure 2E The support pad can be shaped to have a nasolabial angle ranging from 90 to 120 degrees.

[0406] Furthermore, the shape and size of the exemplary sealing structure can also be designed such that no part of the sealing structure enters the patient's nostrils during use.

[0407] Inflation chamber

[0408] See Figure 5-17 In the area formed during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a normal person's face. During use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 can extend along the entire periphery of the air chamber 3200 during use.

[0409] In some forms of this technology, the air chamber 3200 is made of a relatively rigid material (e.g., polycarbonate) compared to the sealing-forming structure. Alternatively, the air chamber 3200 may be made of a flexible material (e.g., silicone) and may be formed as a single piece with the support structure (e.g., made of any material described herein as suitable for the support structure and / or the air chamber). In one example, the sealing-forming structure may be an extension of the air chamber or formed as part of the air chamber such that the air chamber surrounds the sealing-forming structure. In such an example, the support structure and the fabric membrane may be considered as part of the air chamber. In another example, the air chamber 3200 may be made of a transparent material, such as transparent polycarbonate. Using a transparent material can reduce the prominence of the patient interface and help improve treatment compliance. Using a transparent material can help clinicians observe how the patient interface is positioned and functions.

[0410] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve compliance with treatment.

[0411] Figure 5 and 10 -17 illustrates an example of a sealing structure 3100 having an inflation chamber 3200. The sealing structure 3100 may include an inflation chamber connection opening, wherein the sealing structure 3100 is sealingly coupled to the inflation chamber 3200. The sealing structure 3100 and the inflation chamber 3200 may at least partially form a cavity 3101 pressurized by an airflow. In the illustrated example, the sealing structure 3100 and the inflation chamber 3200 together form the cavity 3101.

[0412] The connection between the sealing structure 3100 and the inflation chamber 3200 at the inflation chamber connection opening 3106 can be a permanent bond. Alternatively, the connection between the sealing structure 3100 and the inflation chamber 3200 at the inflation chamber connection opening 3106 can be a chemical bond. The sealing structure 3100 can be connected to the inflation chamber 3200 at the inflation chamber connection opening without a mechanical connection. Alternatively, the sealing structure 3100 can be connected to the inflation chamber 3200 at the inflation chamber connection opening via a mechanically removable and detachable connection.

[0413] At each side of the inflation chamber 3200, there may be an inflation chamber side end 3202 in the form of a hollow channel, which forms an inflation chamber inlet port, the size and structure of which are determined to receive airflow. An inflation chamber connector 3204 may also be provided on each side of the inflation chamber 3200, laterally outward from the inflation chamber side end 3202. The inflation chamber connector 3204 may be connected to a corresponding end 3314 of the positioning and stabilizing structure 3300. The connection between the inflation chamber connector 3204 and the corresponding end 3314 of the positioning and stabilizing structure 3300 may be releasable on both sides. In other examples, one side may have a permanent connection while the other side has a releasable connection. In a further example, both connections between the inflation chamber connector 3204 and the corresponding end 3314 of the positioning and stabilizing structure 3300 may be permanent.

[0414] These inflation chamber side ends 3202 can receive pressurized gas flow from positioning and stabilizing structure 3300. The pressurized gas flow can then pass through inflation chamber 3200, then through sealing forming structure 3100, and into the patient's airway for inhalation.

[0415] End 3314 of the positioning and stabilizing structure 3300 can be connected to the side end 3202 of the inflation chamber. Each inflation chamber connector 3204 in these examples may include a slot 3209, a chamfered edge 3208, and a notch 3206 that can be detachably attached to the clip of the positioning and stabilizing structure in a snap-fit ​​manner.

[0416] According to the third, fourth and fifth examples of this technology Figure 18-32 The air chamber 3200 shown can be used with Figure 10-17 The air chamber is similar to or identical to that of the present invention. It should also be understood that one or more aspects of this technology may be combined with one or more aspects of: U.S. Provisional Application No. 62 / 764,992, filed August 20, 2018, entitled “Patient Interface,” or PCT / AU 2019 / 050873, filed August 20, 2019, each of which is incorporated herein by reference in its entirety. For example, the air chamber of this technology may be identical to the air chamber in any embodiment of the '992 or '837 application. Furthermore, the sealing formation structures disclosed herein may replace any sealing formation structures in any patient interface disclosed in the '992 or '873 application, and the sealing formation structures of this technology may include any features of the sealing formation structures in any embodiment of the '992 or '873 application.

[0417] exist Figure 28-32In the example, the inflation chamber 13200 has an inflation chamber side end 3202, an inflation chamber connector 3204, a notch 3206, a chamfered edge 3208, and a slot 3209 similar to the inflation chamber 3200 described above. However, the vent 3400 may be provided by a vent insert 13400, which is removably or permanently attached to the inflation chamber 13200 (e.g., by insertion into an opening in the inflation chamber). It should be noted that any other example may have a vent insert (e.g., Figure 10-27 The vent 3400 in the inflation chamber 3200 can be made of, for example Figure 28-32 The vent insert 13400 shown is provided.

[0418] exist Figure 38 In the example, frame 9200 may include a centrally positioned connection for air circuit 4170. The frame may also include a headband attachment portion 9210 on its side. A sealing formation 9100 may be connected to frame 9200 via spaced-apart connectors 9122, which may include clips on the sealing formation and receiving connectors on the frame.

[0419] The sealing structure of this technology

[0420] The sealing structures 3100, 5100, 6100, 7100, 8100, 9100, and 29100 may each include support structures 3120, 6120, 7120, 8120, 9120, and 29120, respectively, which provide support for the sealing portions 3130, 5130, 6130, 7130, 8130, 9130, and 29130 (e.g., a fabric membrane). The sealing portions are configured to sealably engage with the patient's face. Similarly, based on the size and contour of the patient's nose, in Figure 5-27 In some cases, the support structure can also be sealed to the patient's face.

[0421] Exemplary sealing formation structures 3100, 5100, 6100, 7100, 8100, 9100, and 29100, while differing in various aspects (as will be further described below), each may include a support structure having at least two regions of different thicknesses (e.g., two, three, or four regions). (For example, sealing formation structure 3100 includes a support structure 3120 with a wall structure having a lateral support region 3122 with an increased thickness relative to other portions of the wall structure.) For example, as... Figure 59As shown, portion (d1) of the support structure can be thicker than portion (d2) of the support structure. For example, portion (d1) can be adjacent to or connected to the inflation chamber, and portion (d2) can be adjacent to or connected to the seal to provide structural stability at the connection with the inflation chamber and flexibility at the interface with the patient. Alternatively, these thicker lateral support regions 3122 can be located at corners, for example, in the nasal region of the seal-forming structure (and can be directly connected to the fabric membrane, for example), to ensure adequate sealing in the subnasal region of the patient's face.

[0422] Furthermore, in the depicted example, each seal has two separate nostril openings 3102 corresponding to one of the patient's nostrils, to provide airflow to both nostrils. A bridging portion 3104 may also be provided between the nostril openings 3102. The bridging portion 3104 may help provide a taut fabric membrane before and / or during use. In an alternative example, a single opening may be used to provide airflow to both of the patient's nostrils.

[0423] As described above, the sealing structure 3100 may include an inflation chamber connection opening, wherein the sealing structure 3100 is sealingly coupled to the inflation chamber 3200. Figure 5-38 In the example, support structures 3120, 5120, 6120, 7120, 8120, 9120, and 29120 are directly connected to the inflation chamber or frame. Therefore, the support structure may include an opening in which the support structure is sealed to the inflation chamber 3200.

[0424] The support structure can be less rigid than the air chamber 3200 and can be made of silicone, foam (e.g., polyurethane foam) (see...). Figure 28-32 The seal may be composed of polyurethane solid materials, thermoplastic elastomers (e.g., thermoplastic polyurethane), suitable plastics, or other suitable materials, as described later. Furthermore, the seal may be less rigid than the supporting structure and may be composed of, for example, nylon, polyester, nylon and polyester blends, microfibers, or polyurethane fabric materials, as described in more detail later. The seal described in any example of the invention may be referred to as a fabric seal or fabric membrane and may comprise a fabric material having an impermeable material laminated, coated, or otherwise applied thereto.

[0425] The support structure may have an orifice formed therein, the orifice providing an inner edge of the support structure, and a sealing portion (e.g., the peripheral boundary of the sealing portion) may be attached to the support structure along the inner edge such that the sealing portion extends radially inward from the sealing forming structure beyond the support structure or extends to a extent further than the support structure, for example, as Figure 11-27As shown in Figures 33-38. For example, the seal may be molded around the inner edge of the support structure, or otherwise suitably attached to the support structure, as will be described later. However, in Figure 28-32 In an alternative example, the sealing portion 8130 may be stacked on the support structure 8120 (e.g., foam).

[0426] See Figure 11-14 The sealing forming portion 3100 has a wall structure that may include lateral support regions 3122, which have increased thickness compared to other portions of the wall structure of the support structure 3120. Lateral support regions 3122 may be provided on the outermost sides of each of the sealing forming structures 3100. The sealing forming structure 3100 may include two lateral support regions 3122, each spaced apart from a plane bisecting the sealing forming structure 3100, which will be parallel to the patient's sagittal plane during use. The lateral support regions 3122 may be the thickest portion of the sealing forming structure 3100 to provide resistance to lateral displacement, such as that caused by a patient sleeping with their head turned to the side, causing the pillow to push laterally against the sealing forming structure and providing a firm engagement against the patient's nasal ala. The lateral support regions 3122 may have a thickness of 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 of the sealing structure 3100 in the depicted example, the lateral support region 3122 can also provide the greatest resistance to deformation.

[0427] Additionally, the lateral support regions 3122 can provide sufficient rigidity to ensure adequate sealing in the subnasal region of the patient's face (i.e., the region where the nasal alae terminate at the upper lip near the nasolabial fold), a particularly complex geometric region. The subnasal region of the patient's face exhibits a particularly complex geometry because at least three facial surfaces—the nasal alae, the upper lip, and the cheek—converge in this region. Therefore, sufficient rigidity in the lateral support regions 3122 ensures that the sealing-forming structure 3100 can be advanced into the subnasal region by tension from the positioning and stabilizing structure 3300 without collapsing. These lateral support regions 3122 can be located on the patient's face in the region below the patient's nasal alae, as well as in the region below and laterally on the patient's nose, such as between the nasolabial fold and the upper lip region located below the nasal alae.

[0428] Figure 15-17 The sealing structure 5100 in the example can have the same Figure 11-14The sealing portion 3130 is compared to the expanded sealing portion 5130. That is, the support structure 5120 is reduced and the sealing portion 5130 is expanded within the sealing forming structure 5100, so that the sealing portion 5130 can be configured to engage the subnasal region of the patient's face during use. Therefore, the sealing forming structure 5100 can be more flexible and compliant in order to more easily conform to the patient's facial contours.

[0429] Turning Figure 18-22 In this example, the sealing structure is arranged to provide a larger cavity 3101, such that the sealing portion 6130 protrudes further from the inflation chamber in the direction toward the patient's face during use by generating greater tension within the sealing portion, thereby causing the sealing portion to inflate outwards. In use, the patient's nose can press against the sealing portion 6130 in the direction toward the cavity 3101 and the inflation chamber 3200, causing the sealing portion 6130 to extend and invert, such that the space formed by the cavity 3101 receives the patient's nose, thereby allowing the sealing portion 6130 to seal above the patient's nasal protuberance, as... Figure 18 As shown. Conversely, as Figure 10 As shown, sealing parts 3130 and 5130 are sealed below the patient's anterior nose.

[0430] exist Figure 23-27 In the example, the sealing portion 7130 is also configured to seal above the patient's nasal protuberance due to the height of the liner. The sealing portion 7130 is configured to provide a further seal in the self-sealing direction along the ridge of the nose compared to the sealing portion 6130.

[0431] exist Figure 28-32 In the exemplary padding assembly, the support structure 8120 can be provided by foam material laminated on the inflatable chamber 3200. The sealing portion 8130 can be directly laminated on the support structure. The support structure 8120 can extend through the inflatable chamber connection opening, except for a pair of holes formed therein corresponding to the nostril openings 3102 in the sealing portion 8130. This arrangement provides a compression-type seal against the patient's face, wherein the padding assembly 8105 is pulled toward the patient's face by a headband, such that the seal-forming structure 8100 conforms to the patient's facial contours through the compression of the support structure 8120.

[0432] The pad assembly 8105 is configured to seal against the underside of the patient's nose. The seal-forming structure 8100 includes an end 8122 that curves around the rear of the inflation chamber 3200 and is configured to engage the patient's upper lip in use.

[0433] See Figure 33-37 Gasket assembly 29105 is similar to gasket assembly 3105, but may extend further in the lateral direction. Gasket assembly 29105 includes a seal-forming structure 29100, a support structure 29120, and a seal portion 29130. See also Figure 33-1 The gasket assembly 29105-1 is similar to the gasket assembly 29105, but may have a fabric membrane 29105 formed as part of a portion of a sealing structure that bends from the front side to the back contact side of the sealing structure, as previously described.

[0434] As mentioned above, Figures 35-37 A clamping pad 29150 is shown on the surface of a fabric membrane.

[0435] exist Figure 38 In the example, the sealing part 9130 is arranged to seal above the patient's nasal protuberance.

[0436] 5.3.3.1 Positioning and Stabilizing Structure

[0437] The padding 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 during use by the positioning and stabilizing structure 3300. The padding assembly 9105 of the patient interface 9000 can be held in a sealed position during use by the positioning and stabilizing structure 9300.

[0438] In one configuration, positioning and stabilizing structures 3300, 9300 provide a holding force that is at least sufficient to overcome the positive pressure in cavity 3101 to lift the face away.

[0439] In one form, positioning and stabilizing structures provide holding forces to overcome the effects of gravity on the patient interface.

[0440] In one form, the positioning and stabilizing structure provides holding forces as a safety margin to overcome the potential effects of destructive forces on the patient interface, such as from tube drag or accidental interference with the patient interface.

[0441] In one form of this technology, positioning and stabilizing structures 3300 and 9300 are provided, constructed in a manner consistent with those worn by a patient while sleeping. In one example, the positioning and stabilizing structure has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilizing structure includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0442] In one form of this technology, a positioning and stabilizing structure is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0443] In one form of this technology, a positioning and stabilizing structure is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a side-sleeping position, wherein the lateral area of ​​the patient's head is on the pillow.

[0444] In one form of this technology, the positioning and stabilizing structures 3300, 9300 are provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure. This decoupling portion does not resist compression and may be, for example, a flexible band or soft band. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure and breaking the seal.

[0445] In one form of this technology, the positioning and stabilizing structure includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0446] In some forms of this technology, the positioning and stabilizing structure includes a strap that is extendable, for example, elastically extendable. For instance, the strap may be configured to be taut during use and to guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0447] In one form of this technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the base of the upper ear on the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0448] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap, which is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the base of the lower ear on the patient's head and covers or is located below the occipital bone of the patient's head.

[0449] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap that is configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0450] In some forms of this technology, the positioning and stabilizing structure includes straps that are flexible and, for example, non-rigid. An advantage of this is that the straps make it more comfortable for the patient to lie on them while sleeping.

[0451] In some forms of this technology, the positioning and stabilizing structure includes straps configured as breathable to allow moisture to be transferred through the straps.

[0452] In some forms of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300, 9300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0453] 5.3.3.1.1 Positioning and Stabilization Structure of this Technology

[0454] Figure 5 An example of this technology is depicted, including a positioning and stabilizing structure 3300. In this example, the positioning and stabilizing structure 3300 includes a lateral portion 3302 and an upper portion 3304 in the form of conduits that guide the flow of pressurized gas from a hub 3306 to an end portion 3314. The positioning and stabilizing structure 3300 can be arranged such that the hub 3306 and the decoupling structure 3500 are positioned above the patient's head during use. As described below, the decoupling structure 3500 can rotate within the hub 3306, and when the patient wears the patient interface 3000, such as during treatment, the position of the hub 3306 and the decoupling structure 3500 above the patient's head allows the patient more freedom of movement without becoming entangled with the air circuit 4170.

[0455] The positioning and stabilizing structure 3300 can be made of silicone. For example, the lateral portion 3302, the upper portion 3304, the hub 3306, and the side end 3314 can be constructed or molded from a single piece of silicone.

[0456] The upper portion 3304 of the positioning and stabilizing structure 3300 has ridges and valleys (or folded portions) that allow the upper portion 3304 to conform to the shape of the corresponding portion of the patient's head during use. The ridges and valleys of the upper portion 3304 allow it to extend and contract along its longitudinal axis to accommodate larger or smaller heads. The ridges and valleys of the upper portion 3304 also allow it to bend to different radii of curvature to accommodate patient heads of different shapes and sizes.

[0457] The lateral portion 3302 of the positioning and stabilizing structure 3300 may not be formed together with the ridge and valley of the upper portion 3304. Therefore, the lateral portion 3302 may have less extensibility and flexibility compared to the upper portion 3304, which may be advantageous because the shape and size of the lateral portion of the patient's head are less variable.

[0458] These ends 3314 can be connected to the corresponding inflation chamber side end 3202. As described above, the inflation chamber side end 3202 receives a pressurized gas flow from the positioning and stabilizing structure 3300, which passes through the inflation chamber 3200, through the sealing forming structure 3100, and reaches the patient's airway. As described above, the ends 3314 can be connected to the inflation chamber connector 3204 of the corresponding inflation chamber side end 3202.

[0459] The positioning and stabilizing structure 3300 can be configured and arranged to guide the force / tension provided by the lateral portion 3302 into a partially upward and partially backward force vector applied to the inflation chamber 3200. In particular, the partially upward and partially backward force vector causes the fabric membrane of the sealing forming structure 3100 to make sealing contact with the lower side of the patient's nose, for example at or below the nasal protuberance and at least above the vermilion border of the upper lip.

[0460] These lateral portions 3302 may also each include a tab 3308 for receiving the rear bandage end 3311 of the rear bandage 3310. The rear bandage 3310 may be length-adjustable, for example, by means of hook and loop material arrangements such that one of the rear bandage end 3311 and the remainder of the rear bandage 3310 includes hook material on its exterior, while the other includes loop material on its exterior. The length adjustability of the rear bandage 3310 allows for increased tension on the lateral portions 3302 to pull the sealing structure 3100 into a sealed engagement with the patient's face under desired pressure (i.e., sufficiently tight to avoid leakage, but not too tight to cause discomfort).

[0461] The lateral portion 3302 may also be provided with a sleeve 3312, which cushions the patient's face against the lateral portion 3302. The sleeve 3312 may be made of a breathable fabric material with a soft touch.

[0462] exist Figure 6 In the alternative example shown, the patient interface 6000 includes a positioning and stabilizing structure 6300 having at least one tube 6350 formed of a fabric material (e.g., one or more sheets or layers of fabric material) and receiving 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.

[0463] In some forms, the fabric tube 6350 may be formed with a first side configured to contact the patient. This may be referred to as the inner layer 6352. The fabric tube may also include a second side attached to the inner layer but facing away from the patient; this second side may be referred to as the outer layer 6354. The inner and outer layers may be fastened to each other along their respective edges, such that a channel or passage is formed between these seams of the inner and outer layers. That is, the space between the seams remains unattached and forms an air passage 6372. The inner and outer layers may be joined using various techniques that impart specific properties to the seams or joints. For example, in some forms, ultrasonic welding, radio frequency welding, and cutting and welding techniques are used to form the seams. Heat may be applied to specific areas of the thermosetting or thermoplastic material used in the activated tube 6350. This heat may be used not only to bond the layers together but also to thermoform layers such as the outer layer 6354. Furthermore, in some forms, sutures or adhesives such as glue may be used to bond these layers together. In some forms, sutures are not used. In a further form, the material located outside the layers is not used to connect the inner and outer layers of the tube. For example, in some forms, the inner and outer layers can be formed such that no additional material such as glue or stitching is required to join the inner and outer layers together.

[0464] Each of the inner and outer layers may include an inner surface and an outer surface. The inner surface of the inner layer is the surface facing the outer layer. The inner surface of the outer layer is the surface facing the inner layer. Similarly, the outer surface of the outer layer faces away from the inner layer, and the outer surface of the inner layer faces away from the outer layer. Furthermore, in the form of a single sheet, the inner surface is the inward-facing and self-facing surface of the sheet.

[0465] In some forms, one or more sheets of the tube may include an airtight layer or membrane. In some forms, the inner surface of both layers includes a membrane configured to restrict or confine air from the inner surface to the outer surface through the layer. The airtight layer may be a thin layer less than the thickness of the fabric sheet of the inner or outer layer. In other forms, the airtight layer may be greater than the thickness of the fabric sheet of either layer. The airtight layer or membrane may be completely impermeable to air transfer, or it may be formed to allow a predetermined rate or amount of air transfer at a specific pressure.

[0466] The membrane can be formed from thermoplastic or thermosetting materials, allowing the membrane material to be molded or shaped into a specific form when exposed to a specific temperature, and then cured, hardened, or solidified upon cooling. In some forms, the membrane can be formed from silicone or polyurethane. In some forms, the outer layer 6354 can be pre-formed such that, in an unpressurized or unsupported state, the outer layer 6354 is pre-positioned and pre-formed to extend away from the inner layer 6352 between opposing joints 6312. That is, the outer layer 6354 can support its own weight such that, when not supported by pressurized air or other support mechanisms, the outer layer 6354 remains spaced apart from the inner layer 6352 between the joints 6312.

[0467] Conversely, the inner layer 6352 can be a soft component. The inner layer 6352 can be attached and secured to the edge of the outer layer 6354, such that the inner layer 6352 is a substantially flat layer.

[0468] like Figure 7 And especially Figure 8 As shown, the inner layer 6352 includes a fabric sheet 6360 and a membrane 6362. The fabric sheet 6360 may be formed of felt, foam, woven, knitted, or nonwoven materials or other fiber webs.

[0469] The outer layer 6354 includes a segment 6364 and an outer cover 6366. In some forms, both sides of the segment 6364 may be covered with a membrane. For example... Figure 9 As shown, segment 6364 includes a membrane 6368 exposed to a chamber of tube 6350 and a membrane 6370 along opposing surfaces of segment 6364. Membrane 6368 helps provide a seal between inner layer 6352 and outer layer 6354 and forms an impermeable tube. Membrane 6370 helps connect segment 6364 to outer cover 6366.

[0470] It should also be understood that one or more aspects of this technology may be combined with one or more aspects of: U.S. Provisional Application No. 62 / 821,878, filed March 21, 2019, entitled “Textile Headgear Tubing for a Patient Interface,” or PCT / AU 2019 / 050655, filed June 25, 2019, each of which is incorporated herein by reference in its entirety. For example, the positioning and stabilization structure of this technology may be identical to the positioning and stabilization structure in any embodiment of the '968 or '655 application. Additionally, the padding assembly or sealing formation structure disclosed herein may replace any padding assembly or sealing formation structure in any patient interface disclosed in the '968 or '655 application.

[0471] exist Figure 38In another example shown, the patient interface 9000 includes a positioning and stabilizing structure 9300 having a pair of side portions extending between the patient's eyes and ears on the corresponding sides of the patient's head. These side portions may include holes or other connectors for connection to a headband attachment portion 9210 of the frame 9200. The positioning and stabilizing structure 9300 also includes a rear strap 9310 extending around the back of the patient's head and a crown strap 9312 extending over the crown of the patient's head.

[0472] 5.3.3.2 Vent

[0473] In one form, the patient interface 3000, 6000, 9000 includes a ventilation port 3400 constructed and arranged to allow the clearance of exhaled gases such as carbon dioxide, for example... Figure 5 As shown.

[0474] In some configurations, the airway 3400 is configured to allow continuous ventilation flow from the interior of cavity 3101 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The airway 3400 is configured such that the airway flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0475] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0476] A vent 3400 may be located in an inflation chamber 3200. The vent 3400 may include multiple holes, as described above. The holes of the vent 3400 may be divided into two laterally spaced groups. The axes of the flow paths through each hole of the vent 3400 may be parallel to avoid crossflow and prevent additional noise. These vent holes may be circular.

[0477] These holes in the vent 3400 decrease in radius from the inside to the outside of the air chamber 3200. Each vent has a draft angle. The diameter of each hole at its front end is smaller than its diameter at its rear end. The draft angle means that these holes do not have small cross-sections over the entire chassis thickness, which helps to provide effective carbon dioxide removal at high humidity levels. In addition, a larger draft angle makes the air chamber 3200 easier to manufacture, especially when the air chamber 3200 is formed from injection-molded plastic material. The draft angle allows for thicker vent pins used in the mold, making them easier to eject.

[0478] These vents 3400 can be provided in two sets facing the center of the inflation chamber 3200, and these sets can be symmetrical at both ends of the centerline of the inflation chamber 3200. Providing multiple vents can reduce noise and concentrate diffused flow.

[0479] These holes of the vent 3400 can be placed at an optimal distance from the centerline of the air chamber 3200. Orienting the holes of the vent 3400 towards the centerline advantageously reduces the chance of vent blockage when the patient is sleeping on their side. However, placing these vent holes too close to the center of the air chamber 3200 may result in excessive weakening of the air chamber 3200 at the center, especially since, in the depicted example, the cross-section of the air chamber 3200 is smallest at the center due to the overall shape of the air chamber 3200. The positioning of the holes of the vent 3400 avoids vent blockage during side sleeping while keeping the central portion of the chassis sufficiently strong.

[0480] The size and number of each vent hole can be optimized to achieve a balance between noise reduction and necessary carbon dioxide removal, even under extreme humidification conditions. In the depicted example, the vent holes of vent 3400 may not provide a total amount of ventilation to the system. Decoupling structure 3500 may include decoupling structure vent 3402. Decoupling structure vent 3402 may include one or more holes passing through decoupling structure 3500. Decoupling structure vent 3402 can be used to release excess pressure generated by RPT device 4000 before reaching the patient, while vent 3400 can be used to remove carbon dioxide exhaled by the patient during treatment.

[0481] Figure 31 and 32 An alternative example of a vent 3400 is shown, wherein a hole is provided to a vent insert 13400, the vent insert being detachably or permanently connected to an inflation chamber 3200 at an opening in the vent insert. The vent insert 13400 may be constructed of a material more flexible than that of the inflation chamber 3200.

[0482] 5.3.3.3 Decoupling Structure

[0483] In one form, the patient interface 3000, 6000, 9000 includes at least one decoupling structure, such as a swivel or ball head and ball socket.

[0484] The hub 3306 described above is connected to a decoupling structure 3500, which in these examples is a rotatable elbow. The decoupling structure 3500 can rotate 360° within the hub 3306 during use. The decoupling structure 3500 can be removed from the hub 3306 by manually pressing button 3504 to release a clip (not shown) from within the hub 3306.

[0485] The decoupling structure 3500 may also include a rotary joint 3502 that allows a rotatable connection to the air circuit 4170.

[0486] The rotatability of the decoupling structure 3500 (which is in the form of an elbow) and the rotatability of the rotary joint 3502 on the decoupling structure 3500 can increase the degree of freedom, which in turn reduces the pipe resistance and torque on the patient interface 3000 caused by the connection to the air circuit 4170.

[0487] 5.3.3.4 Connection Port

[0488] Connection port 3600 allows connection to air circuit 4170.

[0489] 5.3.3.5 Forehead Stent

[0490] In one configuration, the patient interface includes a forehead stent 3700.

[0491] 5.3.3.6 Anti-asphyxiation valve

[0492] In one form, the patient interface includes an anti-asphyxiation valve.

[0493] Port 5.3.3.7

[0494] In one embodiment of this technology, patient interfaces 3000, 6000, and 9000 include one or more ports that allow access to a volume within cavity 3101. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows for direct measurement of the properties of the gas within cavity 3101, such as pressure.

[0495] 5.3.4 Full-face padding

[0496] 5.3.4.1 First Illustrative Example

[0497] See Figures 39-50 The patient interface 14000 includes a pad assembly 14105 having a sealing formation structure 14100 configured to seal around the patient's nostrils and mouth, respectively; i.e., an oronasal pad assembly or an ultra-compact full-face mask. According to one example of the present technology, the pad assembly 14105 is at least partially formed by an inflation chamber 14200 and the sealing formation structure 14100 attached to the inflation chamber.

[0498] See Figures 51-56 The image shows a pad assembly 31105. Pad assembly 31105 is similar to pad assembly 14105 and has a sealing formation structure 31100 configured to seal around the patient's nostrils and mouth respectively, i.e., an oronasal pad assembly or an ultra-compact full-face mask. According to one example of the present technology, pad assembly 31105 is at least partially formed by an inflation chamber 31200 and a sealing formation structure 31100 attached to the inflation chamber.

[0499] The padding 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 vent 31400, which are connected to... Figures 39-50 The features described herein are similar and will not be discussed separately. A pair of air chamber openings are configured to receive airflow.

[0500] As mentioned above, Figures 54-56 A clamping pad 31150 is shown on the surface of a fabric membrane.

[0501] Inflation chamber

[0502] In the area formed during use, the air chamber 14200 has a periphery shaped to complement the surface contours of a normal person's face. During use, the boundary edges of the air chamber 14200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 14100. The sealing structure 14100 can extend along the entire periphery of the air chamber 14200 during use.

[0503] In some forms of this technology, the air chamber 14200 is constructed of a relatively rigid material (e.g., polycarbonate) compared to a sealed structure. In another example, the air chamber 14200 may be constructed of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve treatment compliance. Using a transparent material can help clinicians observe how the patient interface is positioned and functions.

[0504] In some forms of this technology, the air chamber 14200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve compliance with treatment.

[0505] An example of the present technology, an inflation chamber 14200, may include an inflation chamber aperture on each side. The inflation chamber aperture may provide pneumatic communication between these catheter connectors 14800 and the lumen 14001, as described in more detail below. A connecting edge portion around each inflation chamber aperture may facilitate mechanical connection with the corresponding catheter connector, e.g., a tight fit or a friction fit. The inflation chamber 14200 may be constructed of a sufficiently rigid material to provide auditory and / or tactile feedback to the patient when the catheter connector 14800 is attached to or removed from the inflation chamber.

[0506] The sealing structure 14100 can be hermetically connected to the inflation chamber 14200. The connection can be permanent or the sealing structure 14100 can be removable from the inflation chamber 14200. The sealing structure 14100 can be overmolded to the inflation chamber 14200. The sealing structure 14100 and the inflation chamber 14200 can be mechanically connected, wherein no chemical bonds are formed between the inflation chamber 14200 and the sealing structure 14100.

[0507] Sealing Formation Structure

[0508] See Figures 39-50 The sealing structure 14100 may include a nasal portion 14101 having a pair of nasal openings 14103 to seal the patient's nostrils. The depicted example provides two separate openings 14103, each corresponding to one of the patient's nostrils, to provide airflow to both nostrils. A bridging portion 14106 may also be provided between the nostril openings 14103. In an alternative example, a single opening may be used to provide airflow to both of the patient's nostrils.

[0509] The sealing structure 14100 may include a mouth portion 14102 having a mouth portion orifice 14104 that seals with the patient’s mouth.

[0510] The sealing structure 14100 can at least partially form a cavity 14001 pressurized by an airflow. An inflation chamber 14200 can be connected to the sealing structure 14100 to further form the cavity 14001.

[0511] The sealing structure 14100 may include a support structure 14120 that provides support for the sealing portion 14130 (e.g., a fabric membrane). The sealing portion is configured to sealably engage with the patient's face. Similarly, the support structure may also sealably engage with the patient's face depending on the size and contour of the patient's nose.

[0512] The support structure 14120 may include a wall structure having at least two regions of different thicknesses (e.g., the portion of the support structure adjacent to or connected to the inflation chamber 14200 may be thicker than the portion of the support structure adjacent to or connected to the seal 14130, in order to provide structural stability at the connection with the inflation chamber 14200 and flexibility at the interface with the patient). Figure 84An example is shown where a portion (d1) of the support structure may be thicker than a portion (d2) of the support structure. For example, portion (d1) may be adjacent to or connected to the air chamber, and portion (d2) may be adjacent to or connected to the seal to provide structural stability at the connection with the air chamber and flexibility at the interface with the patient. Alternatively, these thicker lateral support regions 3122 may be located at corners, for example, in the nasal region and / or in the region of the mouth where the sealing structure forms (and may be directly connected to the fabric membrane, for example), to ensure adequate sealing in the subnasal and / or oral regions of the patient's face.

[0513] As described above, the sealing structure 14100 can be hermetically connected to the inflation chamber 14200. The support structure 14120 may be less rigid than the inflation chamber 14200 and may be constructed of silicone, foam (e.g., polyurethane foam), solid polyurethane 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 of, for example, nylon, polyester, nylon and polyester blends, microfiber, or polyurethane fabric material, as described in more detail later.

[0514] The support structure 14120 may have an orifice formed therein, which provides an inner edge of the support structure. A sealing portion 14130 (e.g., the peripheral boundary of the sealing portion) may be attached to the support structure along the inner edge such that the sealing portion extends radially inward from the sealing forming structure beyond the support structure or extends to a greater extent than the support structure, such as, for example… Figures 43-46 As shown in the diagram. For example, the seal may be molded around the inner edge of the support structure, or attached to the support structure in other suitable ways, as will be described later.

[0515] exist Figure 49 In one example, the support structure 14120 may extend into the cavity 14001 forming the lower gasket 14121 to provide support for the seal 14130. The lower gasket 14121 and the seal 14130 may form a double-walled structure surrounding the periphery of the seal. In an alternative example, a second or third lower gasket layer may be provided to form a three- or four-walled structure. Figure 49 In the example, the underliner is constructed of a foam material (e.g., polyurethane foam). In an alternative example, the underliner 14122 may be constructed of silicone, such as... Figure 50 As shown. However, it will be appreciated that the underliner can be constructed from other suitable materials (e.g., fabric).

[0516] It should also be understood that one or more aspects of this technology may be combined with one or more aspects of U.S. Provisional Application No. 62 / 609,909, filed December 22, 2017, or WO 2019 / 119058, filed December 21, 2018, both entitled "Catheter Head Connector for Patient Interfaces," the entire contents of each of which are incorporated herein by reference. For example, the catheter and positioning and stabilization structure of this technology may be identical to those in any embodiment of the '909 or '058 application. Additionally, the liner assemblies and sealing formation structures disclosed herein may replace any liner assemblies (sealing formation structures and air chambers) and sealing formation structures in any patient interface disclosed in the '909 or '058 application.

[0517] 5.3.4.1.1 Positioning and Stabilizing Structure

[0518] The sealing structure 14100 of the patient interface 14000 of this technology can be kept in a sealed state during use by positioning and stabilizing structure 14300.

[0519] In one configuration, the positioning and stabilizing structure 14300 provides a holding force that is at least sufficient to overcome the positive pressure in the cavity 14001 to lift the face away.

[0520] In one configuration, the positioning and stabilizing structure 14300 provides holding forces to overcome the gravitational effects on the patient interface 14000.

[0521] In one configuration, the positioning and stabilizing structure 14300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 14000, such as from tube drag or accidental interference with the patient interface.

[0522] In one form of this technology, a positioning and stabilization structure 14300 is provided, constructed in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 14300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilization structure 14300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 14300 includes at least one flat strap.

[0523] In one form of this technology, a positioning and stabilizing structure 14300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head is on a pillow.

[0524] In one form of this technology, a positioning and stabilizing structure 14300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a side-sleeping position, wherein the lateral area of ​​the patient's head is on the pillow.

[0525] In one form of this technology, the positioning and stabilizing structure 14300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 14300. This decoupling portion does not resist compression and may be, for example, a flexible band or soft band. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0526] In one form of this technology, the positioning and stabilizing structure 14300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0527] In some forms of this technology, the positioning and stabilizing structure 14300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be taut in use and to guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0528] In one form of this technology, the positioning and stabilizing structure may include a first tether (e.g., upper strap 14302, Figure 41 The first frenulum is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the upper ear base of the patient's head.

[0529] In one form of this technology suitable for full-face masks, the positioning and stabilizing structure includes a second strap (e.g., a lower strap 14303). Figure 41 The second frenulum is constructed and arranged such that, in use, at least a portion of the upper edge of the second frenulum passes below the base of the lower ear of the patient's head and covers or is located below the occipital bone of the patient's head.

[0530] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap (e.g., strap connector 14304). Figure 39 The third lacing band is constructed and arranged to connect the first and second lacing bands to reduce the tendency of the first and second lacing bands to separate from each other.

[0531] In some forms of this technology, the positioning and stabilizing structure 14300 includes straps that are flexible and, for example, non-rigid. An advantage of this is that the straps make it more comfortable for the patient to lie on them while sleeping.

[0532] In some forms of this technology, the positioning and stabilizing structure 14300 includes straps configured to be breathable to allow moisture to be transferred through the straps.

[0533] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 14300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 14300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0534] The positioning and stabilizing structure 14300 may include a clip 14301 to secure a corresponding tether (e.g.) to the catheter connector 14800, such as Figure 39 As shown. Clip 14301 and conduit connector 14800 may each include magnets arranged with opposite polarities to facilitate connection therebetween.

[0535] 5.3.4.1.2 Vent

[0536] In one form, the patient interface 14000 includes a ventilation port 14400 constructed and arranged to allow the clearance of exhaled gases, such as carbon dioxide, as... Figure 39 As shown.

[0537] In some configurations, the airway 14400 is configured to allow continuous ventilation flow from the interior of the inflation chamber 14200 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The airway 14400 is configured such that the airway flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0538] One form of the vent 14400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0539] The vent 3400 can be located in the inflation chamber 14200, such as Figure 47 As shown. Alternatively, the vent 14400 may be located in a decoupling structure, such as a rotary joint.

[0540] Figure 39An example of a vent 14400 (e.g., a rotary elbow) provided on the connection port 14600 is shown. Variations of these examples may exclude the vent 14400 from the connection port 14600.

[0541] These conduit connectors 14800, described in more detail below, may also include a vent feature.

[0542] 5.3.4.1.3 Decoupling Structure

[0543] In one form, the patient interface 14000 includes at least one decoupling structure, such as a spindle or a ball head and a ball socket.

[0544] 5.3.4.1.4 Connection Port

[0545] Connection port 14600 allows connection to air circuit 4170. According to an example of this technology, connection port 14600 can be connected to connection port housing 14903. Connection port 14600 can be rotatable relative to connection port housing 14903, and the connection to air circuit 4170 can also be rotatable.

[0546] The connection port 14600 and the connection port housing 14903 can be positioned above the patient's head during use.

[0547] 5.3.4.1.5 Forehead stent

[0548] Figures 39-50 The example patient interface of this technology shown does not include a forehead stent. Variations of the patient interface of this technology may include a forehead stent.

[0549] 5.3.4.1.6 Catheter

[0550] The patient interface 14000 according to an example of the present technology may include a catheter 14900 to provide a pressurized airflow from a connection port 14600 to a cavity 14001 in an inflation chamber 14200. The catheter 14900 may engage above the patient's head at a connection port housing 14903 and may pass along the side of the patient's head between corresponding counterparts in the patient's eyes and ears. The catheter 14900 may be connected via a catheter connector 14800 to a liner assembly 14105 (e.g., an inflation chamber 14200), as described below, to provide a pressurized airflow to the cavity 14001.

[0551] The catheter 14900 can also stabilize and position the sealing structure 14100 on the patient's face. Therefore, the catheter 14900 can function similarly to the tether of the positioning and stabilizing structure 14300. Thus, the mechanical connection between the catheter 14900 and the catheter connector 14800 is sufficient to allow tension in the catheter 3900 to be transmitted through the catheter connector 14800 to the sealing structure 14100.

[0552] Catheter 14900 may include International Application Publication No. WO 2017 / 124155 A1, which is incorporated herein by reference in its entirety. For example, catheter 14900 of the present technology may include this document. Figure 3A-3L Features of the headband tube 3350 depicted in the text and associated written descriptions.

[0553] The catheter 14900 may also be provided with a sleeve 14901 to cushion the patient's face against the catheter 14900. The sleeve 14901 may be removable. The sleeve 14901 may be made of a breathable material.

[0554] The conduit 14900 may also include a tether connector 14902 for tethering to the positioning and stabilizing structure 14300.

[0555] 5.3.4.1.7 Conduit Connector

[0556] According to an example of this technology, the patient interface 14000 may include a catheter connector 14800 to connect a catheter 14900 to a liner assembly 14105 to provide a pressurized airflow to the cavity 14001. The catheter connectors 14800 may each have a catheter connector housing 14801. The catheter connectors 14800 may provide other functions, as described below, such as ventilation of the inflation chamber 14200, connection to the positioning and stabilization structure 14300, and prevention of asphyxiation by including an anti-asphyxiation valve 14850.

[0557] Figure 43-50 Several views of a catheter connector 14800 of an example patient interface 14000 according to this technology are shown.

[0558] exist Figures 39-50In the diagram, a conduit connector 14800 is shown attached to an inflation chamber 14200 at an inflation chamber orifice (not shown). It can be seen that one conduit connector 14800 is present on each side of the liner assembly 14105, and each conduit connector 14800 connects to an inflation chamber orifice on each corresponding side of the liner assembly 14105. Each conduit connector 14800 may include a conduit connector attachment structure for connecting each of the conduit connectors 14800 to a corresponding inflation chamber orifice at a connecting rim (not shown). The connection can be mechanical, such as an engagement, snap-fit, or friction fit. The connection can also be removable. The materials of the conduit connector 14800 and the inflation chamber 14200 can each be selected to facilitate desired connection features. For example, the materials of the conduit connector 14800 and the inflation chamber 14200 can each be relatively rigid to allow auditory and / or tactile feedback associated with a snap-fit ​​engagement. The materials of the catheter connector 14800 and the inflation chamber 14200 may be different in at least one respect, or these materials may be the same. The catheter connector 14800 may also be permanently attached to the inflation chamber at the inflation chamber orifice. For example, the catheter connector 14800 may be ultrasonically welded to the inflation chamber 14200. The connection between the catheter connector 14800 and the inflation chamber 14200, whether detachable or permanent, may also be designed to be robust enough that tension from the catheter 14900 can be transmitted to the inflation chamber 14200 without interrupting the connection, as described above, the catheter connector 14800 can contribute to the positioning and stability of the sealing formation 14100 on the patient's head.

[0559] The catheter connector 14800 can also be attached to the side of the inflation chamber 14200 to improve the aesthetics of the patient interface 14000. As described above, the inflation chamber 14200 can be made of a transparent or translucent material, which allows for the visibility of the patient's facial features. By laterally positioning the catheter connector 14800 on the inflation chamber, for example, as shown in the described example, more of the patient's face is visible, and this arrangement improves the aesthetics of the patient interface 14000. This contrasts with an alternative design in which elbows and air circuits can be connected to the center of the inflation chamber 14200, thereby obstructing the view of the patient's face.

[0560] The conduit connector 14800 may also each include a conduit connection end 14802 connected to a corresponding 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 orifice 14803 may be formed in the conduit connector housing 14801 at the conduit connection end 14802 to receive a pressurized airflow. The conduit connector 14800 may include a structure (e.g., undercut) facilitating a removable snap-fit ​​connection with the corresponding conduit 14900, and each conduit 14900 may include a relatively rigid structure at its end connected to the conduit connector 14800 for such connection. The conduit connector 14800 may also be connected to the conduit 14900 via a friction fit. As described above again, catheter 14900 can provide positioning and stabilization functions to position the sealing structure in a therapeutically effective sealing position on the patient's face, and thus the connection between catheter 14900 and catheter connector 14800 positioned at catheter connection end 14802 can be secure enough to allow tension from catheter 14900 to be transmitted to catheter connector 14800 without disrupting the connection between catheter 14900 and catheter connector 14800 at catheter connection end 14802.

[0561] The catheter connector 14800 can also provide ventilation functionality for the patient interface 14000. The catheter connector housing 14801 may include a ventilation inlet that is in pneumatic communication with the cavity 14001 when the patient interface 14000 is assembled. The catheter connector housing 14801 may also include at least one catheter connector vent 14831. As can be seen in the depicted example, each catheter connector housing 14801 includes a plurality of catheter connector vent 14831. This ensures adequate mixing of newly introduced air with the air already present in the inflation chamber 14200, which enhances carbon dioxide removal and increases the amount of fresh air provided to the patient for breathing.

[0562] like Figures 39-41 As shown, the catheter connector 3800 can also provide a connection to ties of the positioning and stabilizing structure 3300. These lower ties can be engaged to the catheter connector 3800 using clips 14301. Clips 14301 and the catheter connector 14800 may include magnets of opposite polarities to facilitate connection. The connection between the ties of the positioning and stabilizing structure 14300 and the catheter connector 14800 can be releasable. Tension from the lower ties of the positioning and stabilizing structure 14300 can force the lower portion of the sealing forming structure 14100 to seal against the patient's face (e.g., around the mouth). Alternatively, the structure connecting to clips 14301 can be formed directly on the catheter connector housing 14801.

[0563] 5.3.4.1.8 Anti-asphyxiation valve

[0564] In one configuration, the patient interface 14000 includes an anti-asphyxiation valve. (As in...) Figure 47 and 48 As best shown, each of the catheter connectors 14800 may include an anti-asphyxiation valve assembly 14850. Therefore, the patient interface 14000 may include two anti-asphyxiation valve assemblies 14850. Each of the anti-asphyxiation valve assemblies 14850 can operate independently (i.e., jointly) of each other in response to the cessation of pressurized airflow. For example, if the patient is asleep on his or her side when there is a cessation of pressurized airflow and one of the anti-asphyxiation valve assemblies 14850 is, for example, blocked by a pillow, the other of the anti-asphyxiation valve assemblies 14850 can act to prevent the patient from suffocating.

[0565] Port 5.3.4.1.9

[0566] In one embodiment of this technology, the patient interface 14000 includes one or more ports that allow access to a volume within the inflation chamber 4200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows direct measurement of the properties of the gas within the inflation chamber 14200, such as pressure.

[0567] 5.3.4.2 Second Illustrative Example

[0568] Figures 57 to 66 A patient interface 30000 according to another example of the present technology is shown. The patient interface 30000 includes a pad assembly 30105 having a sealing formation structure 30100 configured to seal around the patient's nostrils and mouth respectively, i.e., an oronasal pad assembly or an ultra-compact full-face mask. According to one example of the present technology, the pad assembly 30105 is at least partially formed by an inflation chamber (or housing) 30200 and the sealing formation structure 30100 attached to the inflation chamber.

[0569] The liner 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 connected to... Figures 39-56 The features described herein are similar and will not be discussed separately. Inlet port 30240 is formed in the inflation chamber and configured to receive airflow for the air circuit.

[0570] 5.3.4.2.1 Positioning and Stabilizing Structure

[0571] Figures 57-66An example of a patient interface 30000 according to the present technology is shown, which has a positioning and stabilization structure 30300 and an inflatable chamber 30200 with a sealing forming structure 30100. The positioning and stabilization structure 30300 in this example includes a frame 30350 and a plurality of headband straps connected to the frame 30350.

[0572] The air chamber 30200 of the patient interface 3000 is connected to the frame 30350. The air chamber 30200 can be connected to the frame 30350 via a snap-fit ​​connection. In other examples, the air chamber can form a different type of removable connection to the frame, snap-fit, removable press-fit, or other means, or it can be permanently connected to the frame.

[0573] The positioning and stabilizing structure 30300 may include multiple straps or strap portions that are attached to the frame 30350 and pass around the patient's head to support the inflatable chamber in a sealed position against the patient's face. It should be understood that a single "strap" may be formed from multiple lengths of material that have been cut or individually formed and then joined together at their ends to form a longer length, or a single "strap" may be a single length of material.

[0574] exist Figures 57-66 In the example shown, the positioning and stabilizing structure 30300 includes a pair of upper straps 30310. Each upper strap is configured to pass between the corresponding eye and ear of the patient. Additionally, the positioning and stabilizing structure includes a pair of lower straps 30320, configured to be positioned below and above the patient's cheek. In this example, the inflatable chamber is held in place via a frame 30350 through a four-point connection with the headband.

[0575] Framework in Figures 63-64 Shown separately. The frame includes a frame inlet connection port 30354. The frame inlet connection port 30354 is configurable to connect to a pressurized breathable gas source, such as air. In one example, the frame inlet connection port 30354 can be configured to connect to a rotary elbow assembly 30610, which provides a connection port 30600 for connection to an air circuit 4170. The frame inlet connection port in this example includes a connection flange 30355. The connection flange 30355 may include a radially outwardly extending flange. The rotary elbow assembly 30610 can form a releasable snap-fit ​​engagement with the connection flange to form a fluid connection between the rotary elbow assembly and the frame. The opposite side of the frame inlet connection port 30354 is configured to be fluidly connected to the inflation chamber. Therefore, the frame 30350 enables a fluid connection between the rotary elbow assembly 30610 and the interior of the inflation chamber 30200.

[0576] Frame 30350 also includes a pair of opposing upper strap connection points 30315 to which upper straps 30310 are connected. In this example, each upper strap connection point includes a hole formed in the frame. Each upper strap 30310 can be connected to the corresponding upper strap connection point 30315 by passing through the hole, looping back onto itself, and fastening itself. Each upper strap can be secured to itself by hooks and loops configured to releasably engage with each other upon contact. In an alternative example, each upper strap 30310 can pass through the corresponding hole, loop back onto itself, and be fastened to itself by a strap, clip, etc. In a further alternative example, the upper straps can be connected to the frame via a side-release buckle connector.

[0577] Frame 30350 also includes a pair of opposing lower strap connection points 30325 to which 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 attracted to the magnet at the lower strap connection point 30325. In this example, each lower strap clip 30326 includes an opening through which the end of the corresponding lower strap can pass and then loop back and secure itself, for example, using hook and loop material, strap, clip, etc. In an alternative example, the lower straps may be connected to a hook via a side release buckle or to the frame via any other suitable connection.

[0578] In one example, frame 30350 and upper strap connection point 30315 are configured and arranged to direct the force / tension provided by upper strap 30310 to a portion of the upper force and a portion of the rear force vector applied to the inflation chamber 30200. The portion of the upper force and the portion of the rear force vector specifically force the nasal portion 30101 of the sealing forming structure 3100 into sealed contact with the lower periphery of the patient's nose and the patient's upper lip.

[0579] The upper bandages 30310 can each be selectively adjustable. For example, the effective length of each upper bandage can be changed by varying how much of the upper bandage passes through the orifice at the corresponding upper bandage connection point 30315 and loops back on itself. Allowing more upper bandage to pass through the orifice effectively reduces the length of the upper bandage, thereby allowing for changes in the force vector and adjustment of the fit at the patient interface.

[0580] In one example, frame 30350 and lower strap connection point 30325 are configured and arranged to direct the force / tension provided by lower strap 30320 to a partial rear force and a partial lower force vector applied to the inflation chamber. The partial rear force and partial lower force vector specifically force the mouth portion 30102 into sealed contact with the patient's face around the periphery of the mouth. The partial lower force applied to the frame by the lower strap can be balanced with the partial upper force applied by the upper strap and any downward-pointing force that the patient's nose can apply to the seal-forming structure.

[0581] The lower bandages 30320 can each be selectively adjustable. For example, the effective length of each lower bandage can be changed by varying how much each lower bandage passes through the orifice in the corresponding lower bandage clip 30326 and loops back on itself. Allowing more of each lower bandage to pass through the orifice effectively reduces the length of the lower bandage, thereby allowing for changes in the force vector and adjustment of the fit at the patient interface.

[0582] The positioning and stabilizing structure 30300 may also include one or more of the following: a top crown bandage 30330, a pair of lateral crown bandages 30332, and a neck bandage 30334. Figures 57-66 In the example shown, the upper bandage 30310 and the lower bandage 30320 are connected to the ends of the top crown bandage 30330. The top crown bandage is configured to wrap around the patient's head and abut against a surface facing upwards and backwards. The top crown bandage 30330 may be configured to cover the parietal bone of the patient's skull. Each end of the top crown bandage is connected to a corresponding one of the upper bandages 30310 and also to a corresponding one of a pair of lateral crown bandages 30332. Each lateral crown bandage is connected between the upper and lower bandages on a corresponding side of the patient's head. The lower ends of the lateral crown bandages 30332 are connected to each other via a neck bandage 30334. The neck bandage may be configured to pass through the sagittal plane and abut against the lower and / or posterior surface of the patient's head or against the back of the patient's neck. The neck bandage may cover the occipital bone of the patient's skull or be located below the occipital bone of the patient's skull.

[0583] The length of the top crown strap 30330 can be selectively adjustable. The top crown strap 30330 is formed by two strap portions connected by a link having a pair of orifices. Each of the two strap portions forming the top crown strap can pass through the corresponding orifice and then loop back and fasten to itself, for example, via a hook and loop material, another clip, a strap, etc. The amount by which each top strap portion passes through the link can be varied to adjust the length of the top crown strap 30330 and thus adjust the fit of the positioning and stabilizing structure.

[0584] Once all headband 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 quickly detach from the lower strap connection point 30325 on the frame 30350, thus allowing the patient interface 30000 to be removed from the patient without adjusting the straps. Similarly, when the patient wears the patient interface again, the lower strap clip can quickly engage at the lower strap connection point to fit the patient interface without adjusting the straps. Further advantages and features, including the positioning and stabilization structure of the magnetic clip, are described in WO 2014 / 110622, the entire contents of which are incorporated herein by reference.

[0585] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0586] Additionally, it should be understood that one or more aspects of this technology may be combined with one or more of the following: PCT / AU 2019 / 050278, filed on March 28, 2019, entitled “Patient Interface,” the entire contents of which are incorporated herein by reference.

[0587] 5.3.4.2.2 Vent

[0588] In one form, the patient interface 30000 includes a ventilation port 30400 constructed and arranged to allow the clearance of exhaled gases such as carbon dioxide.

[0589] In some configurations, the ventilation port 30400 is configured to allow continuous ventilation flow from the interior of the inflation chamber 30200 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The ventilation port is configured such that the ventilation flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0590] One form of the vent according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0591] The vent 30400 may be located in the inflation chamber. Alternatively, the vent may be located in a decoupling structure such as a rotary joint.

[0592] exist Figures 57-66 In the example shown, the patient interface 30000 includes a vent 30400. The vent in this example includes a passageway and a rotating elbow assembly within the frame, through which air can flow from the interior of the inflation chamber to the atmosphere. Figure 59 As shown, air can flow into the rotary elbow assembly 30610 and then out to the atmosphere through an external hole in the rotary elbow assembly that forms part of the vent 30400. The rotary elbow assembly 30610 can be described as in International Publication No. WO 2017 / 049357 A1, the entire contents of which are incorporated herein by reference.

[0593] 5.3.4.2.3 Decoupling Structure

[0594] In one form, the patient interface 30000 includes at least one decoupling structure, such as a spindle or a ball head and a ball socket.

[0595] 5.3.4.2.4 Connection Port

[0596] Connection port 30600 allows connection to air circuit 4170.

[0597] 5.3.4.2.5 Forehead Stent

[0598] In one form, the patient interface 30000 includes, for example, Figure 3A The forehead support 3700 is shown. In other examples, the patient interface may not include a forehead support. Furthermore, the patient interface 30000 can be configured not to contact the patient's forehead at all.

[0599] 5.3.4.2.6 Anti-asphyxiation valve

[0600] In one configuration, the patient interface 30000 includes an anti-asphyxiation valve.

[0601] Port 5.3.4.2.7

[0602] In one embodiment of this technology, the patient interface 30000 includes one or more ports that allow access to the volume within the inflation chamber. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows direct measurement of the properties of the gas within the inflation chamber 302000, such as pressure.

[0603] 5.3.4.3 Third Illustrative Example

[0604] Figures 67 to 77 Another example of a patient interface 16000 according to the present technology is shown. The patient interface includes a frame assembly 16100, a padding assembly 16175 including a sealing forming structure 16200, an air delivery connector (e.g., a bend assembly 16600), and positioning and stabilizing structures (e.g., a headband 16800 including an upper strap 16802, a lower strap 16804, and a crown strap 16806). In use, one form of the sealing forming structure 16200 is arranged around the inlet of the airway of the patient 1000 to facilitate the supply of positive pressure air to the airway. Figures 46-56 In the example shown, the patient interface is a full-face / mouth-to-nose interface type including a sealing formation structure 16200 configured to form a seal around the patient's nose and mouth. However, aspects of this technology can be adapted for use with other suitable interface types, such as nasal interfaces, nasal forks, nasal pillows, etc.

[0605] The sealing structure 16200 is also commonly referred to as a gasket. Figure 67 and 68This is an exemplary view of the patient interface 16000, wherein the arm cover 16750 is used to attach the upper arm 16134 of the frame assembly 16100, and Figure 69 This is an exemplary view of the patient interface 16000, in which the headgear 16800 and arm covers 16750 are removed.

[0606] In this example, the gasket assembly 16175 is connected to the frame assembly 16100 independently of the elbow assembly 16600 (via a first retention feature on the frame assembly), while the elbow assembly 16600 is connected to the frame assembly 16100 independently of the gasket assembly 16175 (via a second retention feature on the frame assembly). That is, the retention connections of the gasket assembly 16175 and the elbow assembly 16600 to the frame assembly 16100 are separate and distinct from each other, allowing for independent engagement / disengagement.

[0607] In the example of patient interface 16000, a first seal for an airflow path is formed between elbow assembly 16600 and frame assembly 16100, and a separate second seal is formed between frame assembly 16100 and gasket assembly 16175. In this example, frame assembly 16100 is disposed in the airflow path. That is, elbow assembly 16600 is configured to establish a hard-to-hard connection and dynamic seal with frame assembly 16100, while gasket assembly 16175 is configured to establish a separate hard-to-hard connection and static seal with frame assembly 16100.

[0608] Furthermore, in the example of patient interface 16000, frame assembly 16100 includes a locking feature along opening 16105, which is configured and arranged to prevent direct connection or insertion of air circuit 4170 (e.g., air delivery tubing). This arrangement requires the use of elbow assembly 16600 to interconnect frame assembly 16100 with air circuit 4170, thereby ensuring the presence of elbow assembly 16600 (and its exhaust and anti-asphyxiation valve (AAV valve)) in the system.

[0609] Framework components

[0610] See also Figures 67-77 The frame assembly 16100 includes a shield or wall member 16110, a pair (i.e., left and right) of upper headband connector arms 16134 (each including two flexible portions 16140, 16145) extending from the respective sides of the upper portion of the shield 16110, and a pair (i.e., right and left) of lower headband connector arms 16154 extending from the respective sides of the lower portion of the shield 16110. Each lower headband connector arm 16154 includes a magnetic connector 16155 (including an encapsulated magnet) configured to be positioned and connected to a headband clip 16160 (including an encapsulated magnet) disposed on a respective lower headband strap 16804 of the headband.

[0611] In the example shown, the opening 16105 of the shield 16110 (e.g., made of a relatively rigid plastic material, such as polycarbonate) is defined by an outer annular flange and an inner annular flange.

[0612] Gasket assembly and elbow assembly

[0613] See Figures 67-77 The gasket assembly 16175 includes a body, a chassis, an inflation chamber or housing 16180, which is connected to or otherwise provided to the sealing formation structure or gasket 16200 (see [link to documentation]). Figure 70 and 71 The housing 16180 may be permanently (e.g., co-molded, overmolded) or removably (e.g., mechanically connected) attached to the gasket 16200. In one example, the gasket 16200 is made of a relatively flexible or tough material and the housing 16180 is made of a relatively rigid material (e.g., polycarbonate). The housing 16180 and the gasket 16200 cooperate to form a cavity 16500 (see, for example, see...). Figure 70 , 71 (and 73). The housing 16180 includes an opening 16305 through which breathable gas is delivered to the cavity 16500. The opening 16305 is defined by an annular flange 16310, which is adapted to connect to the frame assembly 16100.

[0614] The housing 6180 has multiple functions. For example, it at least partially forms an inlet for delivering pressurized gas to the patient's airway. The housing 6180 is a rigid structure that directs forces onto a sealing structure for sealing the patient's face. The forces are provided by the tension generated by tightening the headband straps. These forces are transmitted from a pair of upper and lower headband straps to the corresponding upper and lower arms. In one example, the upper and lower arms are provided with frame assemblies that provide headband tension to the housing 6180.

[0615] The housing 16180 of the gasket assembly 16175 is repeatedly engaged with and removably detached from the shield 16110 of the frame assembly 16100 via a mechanical connection (e.g., a snap-fit ​​connection). An inner annular flange of the shield 16110 extends through an opening 16305 in the housing 16180, and these tabs or hooks of the flange engage or interlock with the rear side of the annular flange 16310 of the housing 16180 to releasably connect the frame assembly 16100 to the gasket assembly 16175. Such a connection remains easy to use, provides a sealed hard-to-hard connection, minimizes vibration and wobbling between components, and reduces the impact on stability. Furthermore, this connection stably holds the gasket assembly 16175 in place while allowing the appropriate force vector to be applied to the gasket assembly 16175 for sealing.

[0616] exist Figure 67 In the example shown, the elbow assembly 16600 includes a first end 16610 and a second end 16620. The first end has a clamping arm 16650 for releasable engagement (and rotatable connection) with the frame assembly 16100, and the second end is adapted to connect to the air circuit 4170 via a rotary connector 16625. The elbow assembly 16600 is configured to establish a hard-to-hard connection and seal with the frame assembly 16100.

[0617] In this example, the first end portion 16610 includes an inner radial wall and an outer radial wall defining a radial passage leading to a plurality of vent holes 16700 to allow exhaust gas to exit from the patient interface.

[0618] Furthermore, it should be understood that one or more aspects of this technology may be combined with one or more of the following: U.S. Application Publication No. 2018 / 0250486, filed March 12, 2018, entitled "Patient Interface," the entire contents of which are incorporated herein by reference. For example, the pad assembly 16175 disclosed herein may replace the pad assembly in any patient interface embodiment disclosed in '486 Publication. Additionally, the seal-forming structure 16200 disclosed herein may replace the seal-forming structure in any patient interface embodiment disclosed in '486 Publication.

[0619] Sealing Formation Structure

[0620] As described above, housing 16180 is hermetically connected to or otherwise disposed to sealing forming structure or gasket 16200, and housing 16180 and gasket 16200 cooperate to form cavity 16500.

[0621] The pad 16200 may include a support structure 16220 that provides support for the seal 16230 (e.g., a fabric membrane). The seal is configured to sealably engage with the patient's face.

[0622] The support structure 16220 may include a wall structure having at least two regions of different thicknesses (e.g., the portion of the support structure adjacent to or connected to the housing 16180 may be thicker than the portion of the support structure adjacent to or connected to the seal 16230, in order to provide structural stability at the connection with the housing 16180 and flexibility at the interface with the patient). Figure 84An example is shown where a portion (d1) of the support structure may be thicker than a portion (d2) of the support structure. For example, portion (d1) may be adjacent to or connected to the air chamber, and portion (d2) may be adjacent to or connected to the seal to provide structural stability at the connection with the frame and flexibility at the interface with the patient. Alternatively, these thicker lateral support regions 3122 may be located, for example, in the lower cheek region of the seal-forming structure (and may be directly connected to the fabric membrane, for example), to ensure adequate sealing in the lower cheek region of the patient's face.

[0623] The support structure 16220 may be less rigid than the housing 16180 and may be constructed of silicone, foam (e.g., polyurethane foam), solid polyurethane 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 of, for example, nylon, polyester, nylon and polyester blends, microfiber, or polyurethane fabric material, as described in more detail later.

[0624] The support structure 16220 may have an orifice formed therein, which provides an inner edge of the support structure. A sealing portion 16230 (e.g., the peripheral boundary of the sealing portion) may be attached to the support structure along the inner edge such that the sealing portion extends radially inward from the sealing forming structure beyond the support structure or extends to a greater extent than the support structure, such as, for example… Figure 71 and 73 As shown in -77. For example, the seal may be molded around the inner edge of the support structure, or otherwise connected to the support structure in a suitable manner, as will be described later.

[0625] The support structure 16220 can extend into the cavity 16500 to form a lower gasket 16221, thereby providing support for the seal 16230, such as Figure 73 and 77 As shown. The lower liner 16221 and the sealing portion 16230 can form a double-walled structure surrounding the periphery of the sealing portion. In alternative examples, a second or third lower liner layer can be provided to form a three- or four-layer wall structure. The lower liner can be made of the same material as the support structure, or it can be made of other suitable materials (e.g., fabric).

[0626] 5.3.4.3.1 Positioning and Stabilizing Structure

[0627] The sealing structure of the patient interface in this technology can be maintained in a sealed state during use by positioning and stabilizing the structure.

[0628] In one form of this technology, a positioning and stabilizing structure is provided, constructed in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilizing structure has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilizing structure includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0629] In one form of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0630] In some forms of this technology, the positioning and stabilizing structure includes a strap that is extendable, for example, elastically extendable. For instance, the strap may be configured to be taut during use and to guide forces to create a sealed contact between the pad and a portion of the patient's face. In one example, the strap may be configured as a tie.

[0631] In some forms of this technology, the positioning and stabilizing structure includes straps that are flexible and, for example, non-rigid. An advantage of this is that the straps make it more comfortable for the patient to lie on them while sleeping.

[0632] In some forms of this technology, the positioning and stabilizing structure provides retention forces configured to correspond to a specific head size and / or facial shape. For example, one form of positioning and stabilizing structure provides retention forces suitable for large-sized heads rather than small-sized heads. In another example, one form of positioning and stabilizing structure provides retention forces suitable for small-sized heads rather than large-sized heads.

[0633] 5.3.4.3.2 Vent

[0634] In one form, the patient interface includes a ventilation port constructed and arranged to allow the clearance of exhaled gases such as carbon dioxide.

[0635] One form of the vent according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0636] The vent can be located in the inflation chamber or the housing. Alternatively, the vent can be located in a decoupling structure such as a rotary joint.

[0637] 5.3.4.3.3 Decoupling Structure

[0638] In one form, the patient interface includes at least one decoupled structure, such as a spindle or a ball head and a ball socket.

[0639] 5.3.4.3.4 Connection Port

[0640] The connection port allows connection to an air circuit.

[0641] 5.3.4.3.5 Forehead Stent

[0642] In the example shown, frame component 6100 does not have a forehead support.

[0643] In another form, the patient interface may include a forehead support; for example, the frame component may include a forehead support.

[0644] 5.3.4.3.6 Anti-asphyxiation valve

[0645] In one form, the patient interface includes an anti-asphyxiation valve.

[0646] Port 5.3.4.3.7

[0647] In one form of this technology, the patient interface includes one or more ports that allow access to the volume within the cavity. In one form, this allows a clinician to supply supplemental oxygen. In another form, this allows for direct measurement of the properties of the gas within the cavity, such as pressure.

[0648] 5.3.5 Arrangement of Support Structure and Sealing Parts

[0649] The support structure and sealing parts in the above example can have many different configurations and arrangements.

[0650] In use, the sealing element (e.g., a fabric membrane) can maintain a sealed contact with the patient's face through: 1) the tension (e.g., light tension) in the fabric membrane and / or the elastic tensile properties (e.g., elasticity) of the sealing element's material (e.g., fabric material, airtight layer material, and / or composite material of fabric membrane); 2) the reaction force of the supporting structure; 3) the pre-formed state of the fabric membrane, resulting in a non-tensioned, but substantially constant surface, without leakage or any interruption in the fabric membrane that would cause creases, folds, deformation, or wrinkles; and / or 4) the air pressure within the cavity against the inner surface of the sealing element. Each of these factors contributes to the sealing element being under constant tension, allowing it to conform to the anthropometric contours of the patient's face, thereby minimizing wrinkles or bursts and maximizing the contact area of ​​the sealing element.

[0651] In some examples, the seal may comprise a relatively thin, flexible, stretchable elastic material, such as a fabric membrane comprising a suitable woven material (e.g., nylon, polyester, nylon and polyester blends, microfibers, or polyurethane). The seal may be held taut and stretched by a support structure before and during use. The seal may be molded or otherwise attached (e.g., bonded, glued) to the support structure, such that the seal is pre-tensioned (slightly stretched), thus eliminating wrinkles in the seal material. This advantageously ensures that the seal forms a smooth and continuous seal on the patient's face without any air leakage through its folds. Furthermore, the seal may be shaped or have a curvature, for example, imparted to it by thermoforming, such that the seal retains its shape. The support structure may also impart curvature to the seal.

[0652] For example, such as Figure 11-17 As shown in Figures 23-37, the sealing portion may have a concave curved profile (e.g., positive curvature in the left-right direction) from the side (right) to the opposite side (left) to support the patient's nose.

[0653] In some forms, such as Figure 10-66 As shown, the patient's nose is not intended to be received within a cavity formed by the inflatable chamber and sealing structure. Instead, unlike conventional masks, the patient's nose is designed to press against a fabric membrane that conforms to the contours of the patient's face to comfortably form a reliable seal with the patient's airway. In this way, the fabric membrane can stretch to fit the patient's face. Bridging portions 3104, 1406 extending between the nostril openings help to hold the fabric membrane in a taut manner before and / or during use. The bridging portions can also be used to help provide a seal by eliminating a central opening in the fabric membrane, which presses against the patient's nose rather than receiving the patient's nose within a cavity. This produces a different sealing experience compared to conventional masks. This sealing experience provides enhanced comfort due to contact with the compliant fabric membrane rather than the more rigid material of conventional masks or conventional sealing arrangements, where the seal has a smaller contact area around the periphery of the nose and / or mouth.

[0654] The sealing element can be constructed from a single layer or multiple layers of material (e.g., fabric material). The fabric membrane (and / or the fabric material of the fabric membrane) can exhibit a low spring constant (i.e., high compliance) in both the warp and weft yarns. Unlike conventional masks where fixed padding can deform the patient's skin to create an effective seal (e.g., silicone sealing films), fabric membranes can have a material spring constant and spring length (i.e., the amount of material available for stretching), making the fabric membrane more compliant than the patient's skin, thus more easily conforming to the patient's facial features. This can improve mask comfort and reduce the formation of localized pressure "hot spots."

[0655] Compared to conventional silicone membranes and compressed foam seals, the seal of this technology has a more flexible structural stiffness and therefore exhibits dynamic rebound characteristics, allowing the seal to recover more quickly when subjected to external forces. Furthermore, due to the lower structural stiffness, a smaller sealing force is required, allowing for a more comfortable seal and fewer facial marks during use.

[0656] Fabric membranes can exhibit variable tension across the material (e.g., lower tension near the pores or over a wider range of stretching in the material). In some forms, the surface of the material of the seal that contacts the patient's face can have low-friction properties (e.g., low-friction finish), which can advantageously improve the material's conformity to the patient's face while also improving patient comfort.

[0657] The fabric membrane may also include at least one layer exhibiting substantially airtight properties while maintaining the elastic tensile properties required for comfort and minimum pressure points. That is, a membrane layer or laminate (e.g., a polymer such as silicone, polyurethane, thermoplastic polyurethane (TPU), polyester, nylon, etc.) can be applied to the fabric material to provide a substantially airtight material. In an alternative example, the fibers of the fabric may be tightly woven to produce a substantially airtight material.

[0658] In some forms, the fabric material of the sealing portion may have a thickness in the range of 0.275 mm or less (e.g., 0.275 mm to 0.075 mm, 0.275 mm to 0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225 mm to 0.09 mm, 0.225 mm to 0.095 mm, 0.225 mm, or 0.25 mm). The membrane layer may have a thickness in the range of 0.03 mm to 0.01 mm (e.g., 0.015 mm, 0.02 mm, or 0.025 mm). The total composite thickness of the fabric material with the sealing layer can be in the range of 0.305 mm or less (e.g., 0.305 mm to 0.085 mm, 0.305 mm to 0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255 mm to 0.10 mm, 0.255 mm to 0.105 mm, 0.25 mm, or 0.275 mm). In one example, the fabric composite material including the microfiber fabric and the polyurethane membrane layer can have these dimensions.

[0659] In another example, the thickness of the fabric material for the sealing portion can be in the range of 0.15 mm to 0.5 mm (e.g., 0.2 mm to 0.4 mm, or 0.3 mm to 0.4 mm, or 0.25 mm, or 0.3 mm, or 0.4 mm). The thickness of the membrane layer can 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 total composite material thickness of the fabric material with the sealing layer can range from 0.18 mm to 0.625 mm (0.25 mm to 0.6 mm, or 0.25 mm to 0.5 mm, or 0.3 mm to 0.5 mm, or 0.35 mm to 0.45 mm, or 0.3 mm, or 0.35 mm, or 0.4 mm, or 0.45 mm, or 0.5 mm). In one example, the fabric composite material comprising nylon or a nylon and polyester blend fabric and a silicone film layer can have these dimensions.

[0660] Due to the rigidity and elasticity of the support structure, tension can also be transmitted to the seal. The support structure can be formed from a variety of materials, including silicone, foam (e.g., polyurethane foam), solid polyurethane materials, thermoplastic elastomers (TPEs) (e.g., thermoplastic polyurethane foam), and suitable plastic materials. The support structure can be configured to produce a number of different gasket configurations, including single air-assisted seals (e.g., fabric membranes) and seals with a lower gasket support layer, such as double air-assisted seals (e.g., double fabric membranes), seals with compression support (e.g., open-cell foam, polyurethane foam, gel), seals with TPU, TPE, or silicone support, or double air-assisted seals with additional support (e.g., double fabric membranes, where the inner membrane has a foam laminate (e.g., open-cell foam, polyurethane) or a TPU, TPE, polyurethane, or silicone molded layer thereon).

[0661] The underlay layer can help optimize the contact surface area between the seal and the patient's face. Furthermore, in examples where the seal is made of a breathable material (e.g., breathable fabric), the underlay layer can provide sufficient contact area behind the seal to adequately seal it to the patient's face and prevent leakage.

[0662] During use, the engagement between the patient's face 1000 and the sealing part 10130 will generate temporary tension, which attempts to pull the walls of the supporting structure 10120 toward each other, such as... Figure 81As shown. The support structure 10120 will respond to the strain force with an outward tensile reaction force. The reaction force transmits greater tension to the seal 10130 by preferentially stretching the more compliant seal, which generates a combined spring force applied to the patient's face within the seal.

[0663] In some examples, the support structure may include a sealing bias that uses internal air pressure to dynamically support the support structure and the seal. This can advantageously provide further support for the seal under dynamic loads (e.g., pipe traction).

[0664] The air pressure within the cavity and acting on the inner surface of the seal also ensures that the fabric membrane is presented to the patient's face without wrinkles, creases, buckles, or folds (e.g., by creating tension in the seal), allowing the seal to substantially fill the concave contours of the patient's face (e.g., around the sides of the nose). This allows the compliant seal to form a larger sealing contact area on the patient's face. The tension in the seal generated by the air pressure within the cavity is also advantageous in providing a continuous seal, even when the mask partially shifts to its optimal position on the patient's face, because the seal may partially inflate due to the reaction force from the internal air pressure (i.e., the "hovercraft effect").

[0665] In examples where the fabric membrane is not under constant tension (and, for example, in inelastic applications), the seal can still maintain sealed contact with the patient's face by the air pressure within the cavity, and form an improved air-assisted seal with the patient's face that dynamically conforms to change / movement (i.e., the "hovercraft effect"), because the seal is thinner and has lower structural stiffness compared to the support structure.

[0666] The seal can be integrated with the support structure by molding or otherwise attaching it to the inner edge of the support structure. Thus, for example, the periphery of the seal can be attached to the inner edge of the support structure such that the seal extends radially inward from the seal-forming structure beyond or into the support structure. The inner edge of the support structure can be curved, allowing the seal to be angled slightly inward toward the inside of the mask. By attaching the seal along the inner edge of the support structure, there is no need to fold or cut the seal to fuse around the corners of the support structure. This advantageously reduces protruding folds or wrinkles in the seal (which could lead to leakage), thereby improving seal performance.

[0667] As previously mentioned, the sealing structure can be removably attached or fixedly attached to the inflation chamber. In some forms, the seal can have a removable or modular structure. For example, the seal can be attached to a support frame structure along its periphery. The support frame can be removably attached to the support structure as a module. The seal can be attached to the support frame to reduce protruding folds or wrinkles in the fabric surface. Modular arrangements can also substantially simplify the manufacture of the seal (e.g., fabric seal), as all complex joining can be accomplished in a simple, stress-free state. While the seal can be treated to have substantially self-cleaning properties, the use of modular seals can also provide a cheaper and more hygienic alternative.

[0668] The support frame can be pre-formed into a flat or three-dimensional shape, such as an arc, to give the seal a curved shape. The support frame can form an airtight seal with the support structure. In some examples, the support frame can be engaged with the support structure via connectors (e.g., convex / concave locating pins / holes, tongues and tenons).

[0669] The seal may have an underlay support layer (e.g., a second, third, or more padding layers) incorporated therein. The underlay layer can provide additional flexibility and allow the padding layer to be adapted for use by most patients' faces (e.g., only one size fits most patients' faces). For example, the seal may be configured as a dual air-assisted seal (e.g., a dual fabric membrane), a seal with a compression support layer (e.g., open-cell foam, polyurethane foam, gel), a seal with a TPU, TPE, or silicone support layer, or a dual air-assisted seal with an additional support layer (e.g., a dual fabric membrane, wherein the inner membrane has a foam laminate (e.g., open-cell foam, polyurethane) or a TPU, TPE, polyurethane, or silicone molding layer thereon).

[0670] In some examples, the support layer can be supported by a rigid structure, such as plastics, for example, polypropylene (PP), polycarbonate (PC), polyamide (PA), or polyethylene terephthalate (PET).

[0671] In some examples, 3D printing of the seals, support layers, and / or support structures that serve as the "skeleton" can reduce the thickness of the structure, thereby reducing the weight of the mask. Additionally, different layers of the mask can be printed with varying stiffness, rigidity, or thickness. For example, the "skeleton" portion can be formed using silicone, foam (e.g., polyurethane foam), polyurethane (e.g., solid polyurethane material), or any suitable plastic material. In some examples, a sealing bias can be formed that provides dynamic support during use.

[0672] 5.3.5.1 Sealing Offset Section

[0673] Figures 118A to 128 Examples of the disclosed technology illustrate a series of different pad assemblies depicting different sealing bias portions 32160 and / or connector liners 32172. The pad assembly is a nasal support pad designed to seal against at least the lower side of the patient's nose, as described above, for example in... Figure 5-37 The features described herein may include any nasal pad features described in another example of this disclosure. For example, the pad assembly disclosed in this section may include pads as described in other examples of nasal support structures. As those skilled in the art will understand, the sealing bias portion 32160 may also be used for other pad types, such as those described in this disclosure (e.g., nose, oronasal, full face, etc.). In the region where the sealing portion 32130 is directly attached to the sealing bias portion 32160, the sealing portion may attach its inner edge to (e.g., mold) the sealing bias portion in the same or similar manner as described in this disclosure regarding the connection of the sealing portion to the support structure.

[0674] As described above, the inflation chamber 3200 can be constructed of a material that is relatively rigid compared to the sealing structure 32100. Alternatively, the inflation chamber 3200 can be constructed of a flexible material (e.g., silicone) and can be formed as a single piece with the support structure 32120 (e.g., the sealing structure can be an extension of the inflation chamber or formed as part of the inflation chamber such that the inflation chamber surrounds the sealing structure, as described above). As such an example, the inflation chamber 3200 can extend seamlessly into the sealing structure 32120, as... Figure 128 As shown.

[0675] In some examples, the support structure 32120 and the sealing portion 32130 may include fabric. In other examples, the sealing portion 32120 may not include fabric (e.g., it may include silicone). The air chamber connector 3204 described in this section may be the same as or similar to the air chamber connector 3204 described elsewhere in this disclosure.

[0676] As described herein, specific manufacturing processes may be required to form circular or curved (e.g., domed) portions of the fabric seal with curvature in two or more directions. Such curved portions allow the patient's face to sink into the fabric membrane for better conformation to facial contours and also tend to provide a more dynamic seal capable of withstanding at least some external forces. A dynamic seal can be considered, for example, a seal that maintains sealing contact with the patient's face as the liner (e.g., air chamber, support structure) and the patient's face move relative to each other. Similarly, it may be particularly advantageous to combine a sealing bias portion 32160, which enhances the dynamic sealing capability of the fabric seal and extends the reach of the seal without requiring such specific manufacturing processes, with the fabric membrane. Even with such a circular portion of the fabric seal, the sealing bias portion 32160 can further enhance the sealing capability of the fabric membrane.

[0677] The reach of the seal 32130 can be considered as, for example, the maximum possible distance between the front side of the inflation chamber 3200 and / or the gasket assembly and the seal 32130. That is, the reach of the seal can be considered as the maximum possible distance by which the gasket assembly (e.g., including the sidewall of the sealing bias portion 32160) protrudes from the front side of the inflation chamber and / or the gasket assembly from the seal 32130. When the cavity is unpressurized, the seal 32130 has a certain maximum possible distance from the front side of the inflation chamber and / or the gasket. When the cavity is pressurized, the sealing bias portion 32160 inflates, and this maximum possible distance changes, possibly depending on the pressurization level in the cavity. Therefore, when the cavity in the gasket assembly is pressurized in use and the sealing bias portion 32160 inflates, thereby increasing the maximum possible distance between the front side of the inflation chamber 3200 and / or the gasket assembly and the seal, the reach of the seal is extended.

[0678] It should be noted that at a first pressurization level sufficient to at least partially inflate the sealing bias portion 32160, the maximum possible distance will be greater than the maximum possible distance when the cavity is not pressurized, but may be less than the maximum possible distance at higher pressurizations, because the first level may not be sufficient to fully extend the sealing bias portion 32160 (e.g., due to thick material). It should also be noted that even at a pressurization level sufficient to fully extend the sealing bias portion 32160, a certain degree of slack may remain in the sealing bias portion due to headband fit, nose size, etc.

[0679] In use, when the sealing bias portion 32160 is inflated, the sealing portion 32130 can move or travel in a direction toward at least a portion of the patient's face. This can help the sealing portion achieve a seal with areas of complex geometry (e.g., the nasal alae and subnasal alae). If the sealing portion 32130 does not move to its maximum distance, a certain degree of slack may remain in the sealing bias portion 32160, thereby allowing the sealing bias portion to absorb dynamic forces applied to the liner assembly while maintaining a sealing contact with the patient's face.

[0680] The sealing structure 32100 may include a structure providing a pressure-assisted biasing mechanism (e.g., a sealing bias portion 32160) that enhances the sealing capability of the sealing portion (e.g., a fabric membrane). In some forms, the sealing bias portion 32160 may be arranged such that, when activated under internal pressure, the active area 32140 of the sealing portion can actively engage with a corresponding area of ​​the patient's face. Figures 118A to 127 As shown, the sealing bias 32160 can be configured to inflate to extend the reach of the sealing 32130, thereby allowing 1) the sealing to better adapt to a range of nasal sizes (e.g., wider and thinner noses) because the inflation of the sealing bias enables the sealing to travel to and seal against a thinner nose; and 2) the sealing to actively and reliably engage with areas on the patient's face that may otherwise be difficult to seal without causing discomfort (e.g., overtightening the headband may cause airway obstruction before pressurized air is introduced).

[0681] For example, sealing bias portion 32160 (e.g., Figure 119A The effective area 32140 of the seal can be extended (e.g., in the lateral area 32136 of the liner assembly, which is arranged to facilitate a seal around and / or under the nasal ala). As further described below, the inactive area 32142 of the seal (e.g., at the central (i.e., middle) area 32138) can represent an area of ​​the seal in which the seal bias 32160 is absent, does not affect the extent of the seal, and / or is present and affects the extent of the seal to a lesser degree than in the active area 32140 of the seal. The central area can be configured to seal against the patient's under-nasal ala and columella to a point located at or above the nasal protuberance but below the bridge of the nose (however, in some examples, the seal can seal below the nasal protuberance). In one example (e.g., Figure 119BThe inactive area 32142 can work together with the active area 32140 to form a support or clamping action that can better seal the nasal alae and under the nasal alae. Therefore, the sealing bias 32160 can improve the dynamic stability of the sealing structure and can further improve the seal in hard-to-reach areas, thereby advantageously forming a more effective and robust seal with the patient's face.

[0682] During treatment, the cavity within the pad assembly is pressurized, which in turn inflates the sealing structure 32100, thereby forcing the sealing bias portion 32160 to extend elastically as a pneumatic spring, allowing the sealing portion 32130 to move in a rearward direction (or in both the rearward and upward directions (e.g., posterosuperior direction)) (i.e., toward the patient's face). The sealing bias portion 32160 can be kept inflated (i.e., biased) during treatment by the pressurized air present in the cavity, thereby effectively forming an air-assisted spring within the pad assembly (e.g., within the sealing structure).

[0683] However, when the padding assembly is configured to achieve the aforementioned support or clamping action (e.g., Figure 119B When inflated, the sealing bias portion 32160 can cause the lateral region 32136 to expand or widen radially inward (e.g., in the left-right direction) toward the center of the liner assembly to press the seal against the side of the nose (e.g., the nostril). To facilitate this supporting or clamping action, at least a portion of the central region 32138 can be used as a hinged, pivoting, and / or bending / flexing region. The supporting or clamping action of the sealing bias portion 32160 during inflation can cause the seal 32130 to move in directions having components in the rearward and upward (e.g., rear-upward) and left-right (in other words, rear-upward and left-right) directions.

[0684] By increasing the pressure within the cavity, the sealing bias portion 32160 can be inflated to a greater extent (reaching its maximum extension length), thereby increasing the force with which the active area 32140 of the sealing portion engages with the patient's face. In this way, the sealing bias portion 32160 can actively extend the patient contact portion of the sealing forming structure 3100. This can increase the range of facial contours that can be adapted to by a single-sized patient interface. As mentioned above, the sealing bias portion 32160 can also improve the efficiency of the seal formed between the sealing portion 32130 and the patient's face by extending the reach of the sealing portion while simultaneously decoupling from external forces. Furthermore, the sealing bias portion 32160 reduces the possibility of occlusion before pressurized air is introduced during treatment (which sometimes occurs, for example, due to overtightening of the headband in an attempt to form a seal with hard-to-reach areas of the patient's face), thereby improving patient comfort.

[0685] See Figure 118AWhen a patient with wider anthropomorphic features (e.g., a wider nose) engages the sealing portion 32130, the active areas of the sealing portions can expand outwards away from each other (i.e., expand apart) to accommodate and seal against the patient's features. Due to intracavitary pressure, the sealing bias portion 32160 can be in a compressed state, thereby applying a small spring force to the wider nose, which can enhance the seal without causing discomfort. Conversely, as Figure 118B As shown, when a patient with narrower anthropomorphic features (e.g., a narrower / thinner nose) wears the patient interface, the active areas can be biased inward toward each other (e.g., supporting, clamping, or locking) when pressure is applied to the cavity in the pad assembly during use, in order to adapt to and seal the unique facial features of a particular patient. That is, due to the pressure in the cavity, the sealing bias 32160 can inflate, thereby causing the sealing portion 32130 to extend, thereby contacting and sealing the surface of the thinner nose.

[0686] In some forms, the sealing bias portion 32160 can mechanically support the active area 32140 of the seal when in use. This can increase the dynamic stability of the seal formed with the patient's face. The sealing bias portion 32160 can be configured (e.g., by being formed of a relatively thin material (e.g., silicone)) to expand easily under pressure. In such examples, the thickness of the sealing bias portion can be thinner than the adjacent portions of the support structure and / or the inflation chamber.

[0687] In the example, the geometry (e.g., shape and thickness) and material properties (e.g., tensile properties of the fabric membrane) of the sealing formation 32100 can be adapted to complement the ability of the sealing bias portion 32160 to elastically extend under pressure. The combined effect of the mechanical support properties of the pneumatic spring and the sealing bias portion 32160 can improve the dynamic stability and support of the sealing portion 32130 in maintaining a sealed contact against the patient's face. That is, the sealing bias portion 32160 can be configured to maintain contact between the sealing portion 32130 and the patient's face when the pad assembly dynamically moves away from the patient's face by a relatively small distance (e.g., 2-7 mm, 3-5 mm) or when it is laterally displaced across the patient's face.

[0688] For example, when a patient sleeps on their side, the padding assembly can withstand forces from the pillow. This dynamic force can cause the padding assembly to move away from or over the patient's face. The sealing bias 32160 can function in conjunction with the geometry and material properties of the sealing forming structure 32100 to help absorb such dynamic forces to maintain continuous contact against the patient's face (and thus maintain a continuous seal), thereby producing a "decoupling effect" that decouples the seal from the dynamic force. That is, the sealing bias 32160 achieves decoupled movement between the seal 32130 and the rest of the padding assembly (e.g., the air chamber, support structure, etc.). For example, as Figure 118C As shown, when a force is applied to the pad assembly that tends to pull the pad assembly away from the patient's face or to cause the pad assembly to shift laterally across the patient's face, the sealing bias region 32160 can be adjusted (e.g., by allowing the sealing forming structure to shift laterally) to maintain pressurized contact of the seal 32130 against the patient's face.

[0689] In some forms, the sealing bias 32160 may provide a dynamic support region that moves when the cavity is pressurized and is primarily designed to help support the seal in maintaining a tight seal with the patient's face without applying any significant biasing force to the seal. In one example, when the sealing bias 32160 is active, the seal 32130 can adequately seal against the patient's face while maintaining a degree of slack in the sealing bias to regulate dynamic forces applied to the liner assembly. In this way, the sealing bias 32160 is designed to primarily absorb external loads applied to the patient interface, thereby decoupling the seal from such external forces.

[0690] See Figures 118A to 127 The sealing bias portion 32160 may be formed of a flexible material (e.g., silicone). The sealing bias portion 32160 may be formed of the same material as the support structure 32120 (e.g., any material described herein as suitable for a support structure). Alternatively, the sealing bias portion 32160 may comprise a fabric (e.g., the same fabric material included in a fabric membrane or the same composite material used as a fabric membrane). As described above, the sealing bias portion is flexible to inflate when the cavity within the pad assembly is pressurized during use. To facilitate inflation of the sealing bias portion 32160, the wall structure of the sealing bias portion may be thinner (or otherwise less rigid, thus easier to inflate) than adjacent portions of the support structure 32120 and / or the inflation chamber 3200.

[0691] The sensitivity and efficiency of the movement of the sealing bias portion 32160 can be adjusted by regulating the wall thickness of the sealing bias portion. That is, a relatively thin wall structure will move more easily under pressure, while a relatively thick wall structure will move less easily. In one example, the wall thickness of the sealing bias portion 32160 (e.g., silicone) can be in the range of 0.2 mm to 0.6 mm (e.g., 0.3 mm to 0.5 mm); however, in other examples, the wall thickness can be thicker (e.g., 0.6 mm to 0.8 mm) or thinner (e.g., 0.1 mm to 0.2 mm).

[0692] In some examples, the thickness of the sealing bias portion 32160 may vary around the periphery of the pad assembly (e.g., the wall thickness in a first region (e.g., the lateral region 32136 of the pad assembly) may differ from the wall thickness in a second region (e.g., the central region 32138 of the pad assembly). In one example, the wall thickness of the sealing bias portion 32160 in the lateral region 32136 may be thinner than that in the central region 32138 to facilitate support or clamping of the sealing portion 32130 against the patient's nose in the subnasal region when the sealing bias portion 32160 is active, so as to form a better sealing contact with the nasal alae and the subnasal region of the patient's face that is difficult to reach.

[0693] In some examples, the sealing bias portion 32160 may be formed as a serrated (or recessed) channel 32165 (e.g., Figure 121 ) or external protrusion 32167 (e.g., Figure 126 (Or, alternatively, a combination of both in a pleated configuration). When inflated, the sealing bias 32160 moves toward the straightened position, thereby extending the possible range of the sealing bias 32130. The sealing bias 32160 may extend along the boundary edge 32122 of the support structure 32120 (e.g., Figure 120 and 121 In this case, the sealing bias portion 32160 can be directly connected to the sealing portion 32130. In another example, the sealing bias portion 32160 can extend along the boundary edge 32125 of the inflation chamber 3200 (e.g., Figures 122A to 123B This allows the support structure 32120 to be directly connected to the sealing portion 32130 (e.g., to provide more support for the sealing portion). Alternatively, the sealing bias portion 32160 can be arranged in the middle portion of the support structure.

[0694] In one example, channel 32165 or protrusion 32167 may form a crease. In some forms, channel 32165 may have a saddle shape (e.g., Figure 121 ), and protrusion 32167 may have a dome shape (e.g., Figure 126 (Or multiple saddle and vault shapes may exist when channels and protrusions are used in combination).

[0695] In example Figure 121 , 123A In the examples shown in 123B and 125-127, the sealing bias portion 32160 can extend around the entire periphery of the gasket assembly.

[0696] The extent of the sealing portion 32130 can be adjusted by regulating the dimensions of the sealing bias portion (e.g., the depth of the channel 32165 or the extent of the protrusion 32167). That is, a deeper channel or a larger protrusion can expand the extent, while a shallower channel or a smaller protrusion can shrink the extent. Furthermore, the depth of the channel 32165 and / or the extent of the protrusion 32167 can vary around the periphery of the gasket assembly. In one example, a relatively deep channel 32165 or a larger protrusion 32167 can be provided in the lateral region 32136 of the gasket assembly, and a relatively shallow channel or a smaller protrusion can be formed in the central region 32138 of the gasket assembly (e.g., Figure 121 This allows the seal 32130 to clamp or support to fit snugly against the patient's nose, and to more effectively form a seal at the nasal alae and the lower part of the nasal alae on the patient's face, which are difficult to reach. In such an example, at least a portion of the central region 32138 can be used as a hinge, pivot, and / or bending / flexing area.

[0697] In addition, such as Figures 121 to 123B As shown, when the sealing bias portion extends around the periphery of the gasket assembly, the sealing bias portion 32160 can taper from a larger (e.g., a deeper channel) sealing bias portion 32160 to a smaller (e.g., a shallower channel) sealing bias portion, or vice versa. That is, for example, as Figures 122A to 123B As shown, the sealing bias portion 32160 can taper 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 the protrusion 32167 can be uniform around the entire periphery or a portion of the periphery of the gasket assembly.

[0698] Furthermore, it should be noted that the sealing bias portion 32160 may be omitted in certain areas of the gasket assembly to change the extent of the sealing portion 32130 around the periphery of the gasket assembly as needed. For example, as Figures 119A to 120 As shown in 122A and 122B, the sealing bias portion 32160 can be omitted in at least a portion of the central region 32138. Therefore, two sealing bias portions 32160 are formed in these lateral regions 32136, each extending partially around the periphery of the liner assembly. This also facilitates the support or bolstering action of the liner assembly to fit snugly against the patient's nose and more effectively forms a seal at the alar and the lower alar portion of the patient's face, which are difficult to access. In other examples, the sealing bias portion 32160 can be omitted in other regions of the liner assembly, such as the lateral region 32136.

[0699] 5.3.5.1.1 Example of top surface sealing offset section

[0700] See Figures 119A to 119B The sealing bias portion 32160 may be arranged along the patient-facing rear surface of the pad assembly. The patient-facing rear surface may be a surface or side of the pad assembly that is directly opposite the patient's face during use, and may include at least a portion of the sealing portion 32130, the sealing bias portion 32160, and / or the support structure 32120. In the illustrated example, the sealing bias portion 32160 includes at least one fold, pleat, or corrugation, such as a plurality of folds, pleats, or corrugations 32162, which form a substantially sinusoidal waveform in cross-section, such as... Figure 119A-1 As shown. Figure 119A As shown, the sealing bias portion 32160 may extend between the sealing portion 32130 and the support structure 32120, such that a first end of the sealing bias portion is connected to the sealing portion and a second end of the sealing bias portion is connected to the support structure. In the region where the sealing portion 32130 is attached to the sealing bias portion 32160, the sealing portion may attach (e.g., mold) its inner edge to the sealing bias portion.

[0701] Before pressurizing the cavity in the gasket assembly, the sealing portion 32130 can be aligned with the rearmost portion of the sealing bias portion 32160 (e.g., Figure 119A and 119A-1 The rearward-facing fold, pleat, or corrugation 32162 shown is substantially flush, i.e. substantially uniform or horizontal. When the cavity is pressurized, the fold, pleat, or corrugation 32162 may straighten (or move toward a straightened position), thereby causing the seal 32130 to extend or stretch beyond the seal bias 32160 and other portions of the patient-facing rear surface in a direction toward at least a portion of the patient's face (e.g., a direction with components in both the posterolateral and lateral directions to support or wrap around the nasal ala under the force exerted by the pressure within the cavity of the liner assembly).

[0702] In the example shown, the sealing bias portion 32160 extends around or is arranged in the lateral region 32136 of the gasket assembly, and is omitted in at least a portion of the central region 32138, thereby providing an active region 32140 of the sealing portion 32130 in the lateral region 32136, and an inactive region of the sealing portion in at least a portion of the central region 32138 of the gasket assembly.

[0703] As previously described, when operating under pressure, the sealing bias portion 32160 can extend the reach of the active area 32140, such as Figure 119BAs shown. This can facilitate clamping or supporting action of the pad assembly (e.g., allowing the seal to wrap around or clamp / support the sides of the nasal ala and / or the lower portion of the nasal ala). In another example, clamping or supporting action can still be provided in a pad assembly having a sealing bias 32160 in the central region 32138 (e.g., a sealing bias extending around the entire periphery (or a seal around the patient-facing posterior surface of the pad assembly)), provided that such a centrally positioned sealing bias is smaller than the sealing bias 32160 in the lateral region 32136. That is, the size of the sealing bias 32160 can vary in different regions around the pad assembly. Furthermore, as previously mentioned, the sealing bias can also be uniform around the entire periphery of the pad assembly.

[0704] 5.3.5.1.2 Example of side surface sealing offset part

[0705] See Figures 120 to 128 The sealing bias portion 32160 may be disposed on or as part of a side surface of the gasket assembly. The side surface may be considered as a sidewall or wall structure extending around the outer periphery of the gasket assembly.

[0706] exist Figure 120 In one example, the sealing bias portion 32160 is arranged on the boundary edge 32122 of the support structure 32120, such that the sealing bias portion is directly connected to the sealing portion 32130. In some examples, the portion of the sealing bias portion 32160 that connects to the sealing portion may be thicker than the other portions of the sealing bias portion to provide a desired level of support to the sealing portion. The support structure 32120 may be arranged between the inflation chamber 3200 and the sealing bias portion 32160.

[0707] exist Figure 120 In the example, the sealing bias portion 32160 may be formed to be less rigid (e.g., thinner) than the adjacent portion of the support structure 32120. Alternatively, the sealing bias portion 32160 may be formed by a serrated channel (or recess), external protrusion, fold, pleat, or corrugation.

[0708] like Figure 120 As shown, the sealing bias portion 32160 may extend around the periphery of the gasket assembly in the lateral region 32136 and may be omitted in at least a portion of the central region 32138 of the gasket assembly. As previously described, this arrangement may extend the reach of the active region 32140 when under pressure, which may facilitate clamping or supporting action of the gasket assembly.

[0709] It should also be noted that the sealing bias portion 32160 may extend at an angle α (e.g., 30°–60°, 45°) across the lateral region 32136 relative to the horizontal plane (or a plane extending along the front side of the liner assembly). This can further position the sealing portion 32130 by promoting the sealing portion to extend inward in the left-right direction during use and better supporting the lower side of the patient's nose at the nasal ala.

[0710] See Figure 121 The sealing bias portion 32160 can extend around the entire periphery of the gasket assembly. The sealing bias portion 32160 can be arranged on the boundary edge 32122 of the support structure 32120 such that the sealing bias portion is directly connected to the sealing portion 32130 (and the support structure 32120 connects the sealing bias portion 32160 to the inflation chamber 3200). See also... Figure 120 As described, in some examples, the thicker portion of the sealing bias portion 32160 can be used to connect to the sealing portion 32130.

[0711] The sealing bias portion 32160 can be formed as a serrated channel 32165, and the size of the sealing bias portion (e.g., the depth of the channel) can taper as it extends along the periphery of the gasket assembly. For example, the sealing bias portion 32160 can taper from a larger sealing bias portion in the lateral region 32136 to a relatively smaller sealing bias portion 32160 in the central region 32138, such as... Figure 121 As shown. This arrangement allows the sealing portion 32130 to extend a greater distance in the lateral region 32136 than the sealing portion in or toward the central region 32138, thereby facilitating the clamping or supporting action of the gasket assembly.

[0712] Turning Figure 122A and 122B The sealing bias portion 32160 can be arranged on the boundary edge 32125 of the inflation chamber 3200, such that the support structure 32120 is arranged between the sealing bias portion 32160 and the sealing portion 32130.

[0713] This arrangement, where the support structure 32120 is directly connected to the sealing part 32130, can be compared to... Figure 120 The arrangement in the example provides more support for the seal.

[0714] Similar to Figure 120 For example, the sealing bias portion 32160 may extend around the periphery of the gasket assembly in the lateral region 32136, and may be omitted in at least a portion of the central region 32138 of the gasket assembly, as shown below. Figure 122A and 122BAs shown. The serrated channel 32165 of the sealing bias portion 32160 can taper from a larger sealing bias portion in the lateral region 32136 toward the central region 32138 to a relatively smaller sealing bias portion 32160 along the periphery of the gasket assembly. Furthermore, as previously described, this sealing bias arrangement can extend the reach of the active area 32140 when operating under pressure, which can facilitate the clamping or supporting action of the gasket assembly.

[0715] refer to Figure 123A and 123B The sealing bias portion 32160 can be arranged on the boundary edge 32125 of the inflation chamber 3200, such that the support structure 32120 is arranged between the sealing bias portion 32160 and the sealing portion 32130.

[0716] and Figure 121 Similarly, the sealing bias portion 32160 can extend around the entire periphery of the gasket assembly. The serrated channel 32165 of the sealing bias portion 32160 can taper from a larger sealing bias portion in the lateral region 32136 to a relatively smaller sealing bias portion 32160 in the central region 32138, as... Figure 123A and 123B As shown.

[0717] As previously described, this arrangement allows the seal 32130 to extend a greater distance in the lateral region 32136 than the seal in or toward the central region 32138, thereby facilitating the clamping or supporting action of the gasket assembly.

[0718] Turning Figure 124 A sealing bias portion 32160 is disposed around the lateral region 32136 of the gasket assembly and is omitted in at least a portion of the central region 32138, thereby forming an active region 32140 and an inactive region 32142. The sealing bias portion 32160 may include a stepped portion 32164 and a wing portion 32166, which extend from the support structure 32120 in a vertical or rearward direction (or in a rearward and upward direction (e.g., rear-upward direction) or in a rear-upward and left-right direction).

[0719] Step portion 32164 is directly connected to support structure 32120. Step portion 32164 may extend from support structure toward the patient's face during use (e.g., along the posterolateral direction and left-right direction) and may be angled relative to support structure. Wing portion 32166 is directly connected to step portion 32164. Wing portion 32166 may be angled relative to step portion 32164, but extends further in the direction toward the patient's face (e.g., along the posterolateral direction and left-right direction). The angled arrangement of step portion 32164 and wing portion 32166 may create one or more folds, creases, pleats or full folds in the material of sealing bias portion 32160, the material of sealing bias portion 32160 may straighten (or move toward a straightened position) when inflated to extend the reach of sealing portion 32160, and also forms a decoupling arrangement to decouple external forces from the sealing portion.

[0720] The step portion 32164 and / or the wing portion 32166 may include a material that is relatively thinner (or otherwise less rigid) than the support structure 32120, such that the sealing bias portion 32160 can move when the cavity within the gasket assembly is pressurized.

[0721] As previously described, the arrangement having a sealing bias portion 32160 in the lateral region 32136 while omitting it in at least a portion of the central region 32138 can extend the reach of the lateral region when under pressure, which can facilitate the clamping or supporting action of the gasket assembly. It should also be noted that in other examples, the sealing bias portion 32160 may extend around the entire periphery of the gasket assembly, and the size of the sealing bias portion may vary around the periphery (e.g., smaller in the central region (smaller step and / or wing portions) and larger in the lateral regions (larger step and / or wing portions).

[0722] 5.3.5.1.2.1 Example of a sealing bias portion for a handle support

[0723] See Figures 125 to 127 The gasket assembly has a sealing portion 32130, which is connected to the inflation chamber via a support structure 32120, the support structure 32120 including a handle 32135 extending from the inflation chamber (not shown). A sealing bias portion 32160 may extend around the periphery of the gasket assembly. The sealing bias portion is less rigid (e.g., thinner) than the adjacent portion of the support structure, such that the sealing bias portion 32160 can extend the reach of the sealing portion 32130 and also decouple the sealing portion from external forces applied to the inflation chamber when the cavity within the gasket assembly is pressurized.

[0724] The sealing bias portion 32160 can support the sealing portion 32130 via a universal joint or ball joint, thereby achieving mobility and flexibility in multiple directions. In this way, the sealing bias portion 32160 is configured to substantially isolate the sealing portion 32130 and prevent dynamic impacts encountered by the inflation chamber from affecting the efficiency of the sealing portion, in a manner similar to that typically experienced in force-absorbing suspension systems.

[0725] In one example, the sealing bias portion 32160 can be formed as an external protrusion 32167, such as Figure 126 As shown. In Figure 127 In one example, the sealing bias portion 32165 is formed as a serrated (e.g., recessed or concave) channel 32165. In other examples, the sealing bias portion 32160 may include multiple protrusions and / or channels.

[0726] The dimensions of the sealing bias portion 32160 (e.g., the channel or protrusion may be larger or smaller) may vary around the periphery of the gasket assembly and may be omitted in certain areas, as described above in other examples. The sealing bias portion 32160 may also taper around the periphery of the gasket assembly as described above.

[0727] As previously described, the arrangement of having a sealing bias portion 32160 in the lateral region 32136 while omitting (or minimizing) it in at least a portion of the central region 32138 can extend the reach of the lateral region during pressurized movement, which can facilitate the clamping or supporting action of the pad assembly. Additionally, the seal-forming structure 32100 is arranged such that the seal portion 32130 has a saddle shape to accommodate the underside of the patient's nose. As mentioned above, due to the saddle shape, the seal portion may also tend to support the patient's nose simply by inflating towards the patient's face during intracavitary pressurization.

[0728] Furthermore, the size of the sealing bias portion 32160 can be selected based on the length of the handle portion 32135. For example, a larger sealing bias portion 32160 can allow the use of a shorter handle portion 32135, because the sealing bias portion will allow the sealing portion 32130 to fully reach the patient's sealing area when in motion.

[0729] 5.3.5.1.3 Connector Liner

[0730] like Figure 128 As shown, the air duct connection of the padding assembly includes an inlet port 32170, which is configured to receive airflow from an air supply duct (e.g., a bend assembly connected to the air supply duct, as those skilled in the art will understand). For example, the inlet port 32170 may be formed in the front side of the inflation chamber, such as... Figure 128 As shown. The inflation chamber may include a connector structure for connection to an air supply pipe (e.g., via a bend assembly).

[0731] The air duct connection may include connector liner 32172, configured to absorb dynamic forces (e.g., external forces applied to the air supply duct, i.e., duct resistance). Connector liner 32172 may include one or more folds, pleats, and / or corrugations formed along the front wall portion of the inlet chamber adjacent to the inlet port. Figure 128 As shown, the connector liner surrounds the inlet port such that folds, pleats, or corrugations form a circular arrangement extending around the entire periphery of the air chamber adjacent to the inlet port, thereby being substantially coaxial with the inlet port. In other examples, the connector liner 32172 may not extend completely around the gasket assembly and may be discontinuous (e.g., the connector liner may have diameter-dimensioned portions extending around the inlet port, these portions being interrupted by segments without folds, pleats, or corrugations). In one example, the connector liner 32172 may have a corrugated configuration.

[0732] The connector liner 32172 is configured to absorb dynamic forces applied to the supply tube and decouple these forces from the sealing structure (e.g., the seal), thereby enhancing the dynamic stability of the seal 32130 in use.

[0733] 5.3.5.2 Fabric Membrane

[0734] According to one example of the disclosed technology, the sealing structure may include a fabric membrane comprising a fabric material. The fabric material may have an airtight membrane / film or layer coated or otherwise applied thereto to create an air-retaining fabric composite. The fabric composite may be cut (e.g., die-cut, ultrasonic, laser, or RF) to a desired shape and then attached to a support structure. The resulting fabric seal (or fabric membrane) may be attached to the support structure (e.g., silicone, TPE), for example, by overmolding or injection molding. In another example, the fabric seal may be thermally welded at its edges (peripherals) to the support structure material (e.g., silicone, TPE).

[0735] Fabrics are materials comprising at least one natural or man-made fiber (e.g., yarn or thread). Fibers can be filaments (monofilaments or multifilaments), plied yarns, silk threads, or twisted yarns. Fibers can include animal-based materials such as wool or silk, plant-based materials such as linen and cotton, and synthetic materials such as polyester and rayon. Fabrics can be formed using various techniques such as weaving, knitting, crocheting, knotting, woven, bonding, felting, tufting, or braiding, and can include, for example, woven and nonwoven materials, such as by interlacing or weaving one or more fibers.

[0736] In one example, the fabric material is a knitted material. Knitted materials are preferred because they provide elasticity (e.g., stretch) to the fabric, particularly compared to woven materials. This is advantageous in providing comfort to the patient, as described below. The elasticity can be in all directions (e.g., four-way stretch / elasticity, or substantially equal in all directions), and at least in the left-right transverse direction of the fabric membrane. For example, the fabric material can have a weft-knitted or warp-knitted structure. Since weft-knitted fabrics are more elastic than warp-knitted fabrics, a weft-knitted structure may be more desirable.

[0737] Figure 113 This describes the direction in which the longitudinal loop 70 of the weft-knitted fabric, or the loop of one yarn joins with the loop of another yarn. Figure 114 The direction of the coil rows 80, or the coil of a single strand, is shown. Figure 115 This illustrates a basic closed-loop warp-knitted fabric 90, in which the longitudinal and transverse loops are parallel to each other. Figure 116 This describes the weft-knitted fabric 100 in which the longitudinal coil 70 extends perpendicularly to the transverse coil 80.

[0738] 5.3.5.2.1 Manufacturing

[0739] In one example, an overmolding process can be used to construct a seal-forming structure having a flexible support structure (e.g., silicone) attached to a fabric membrane.

[0740] like Figure 117 As shown, in step 10, the impermeable fabric composite material can be formed by combining a fabric material with an impermeable material. For example, such as... Figure 78 As shown, an impermeable layer can be attached to a fabric material using a heating process. The fabric composite material can have a flat shape (e.g., sheet-like).

[0741] In step 12, the fabric composite material can be cut into the desired shape according to the specific padding component to be used.

[0742] In step 14, a support structure (e.g., silicone) can be overmolded onto the fabric composite to form a seal-forming structure with the fabric membrane. The fabric composite can be held in place by vacuum to have a non-flat, predefined shape in this overmolding process. That is, a planar fabric composite can be overmolded with the support structure to impart curvature to the fabric composite, thereby forming a fabric membrane that can have curvature without wrinkles, folds, creases, and / or deformation within the fabric membrane. Figure 33-1 As shown, the fabric membrane can extend along curve 35 from the front side of the sealing structure to the rear side of the sealing structure. In one example, as... Figure 33-1As shown, both the support structure and the fabric membrane can have a radius of curvature along curve 35 (e.g., the same or similar radius of curvature). The fabric membrane can have a predetermined curvature imposed thereon, such that a portion of the fabric membrane not directly supported by the support structure extends along curve 35. Figures 33-2 to 33-4 As previously discussed, the fabric membrane may also have curvature in other areas, for example, in the form of vaults and saddles. The fabric membrane may have a concave curved profile (e.g., positive curvature in a left-right direction) from one side (right) to the opposite side (left), which may be imparted during the overmolding process and held to a support structure by connection (see, for example...). Figure 11-17 (23-27 and 33-37). In another example, the fabric film may have a negative curvature in the bottom-top direction, which can be imparted during the overmolding process and maintained by attachment to a support structure (see, for example, 23-27 and 33-37). Figure 18-22 ).

[0743] The support structure can be molded onto the fabric composite material, so that the outer surface of the sealing structure is smooth and seamless during the transition from the support structure to the fabric membrane (see [link]). Figure 33-4 The support structure can be integrated into the impermeable material of the fabric membrane. While the outer surface of the seal-forming structure can be smooth and seamless, steps may exist on the inner surface of the seal-forming structure if the thickness of the support structure is different from (e.g., greater than) the thickness of the impermeable layer.

[0744] The overmolding process creates a sealed structure without producing any wrinkles, folds, creases and / or deformations in the fabric membrane, while also imparting curvature to the fabric membrane.

[0745] 5.3.5.2.2 Example of fabric membrane

[0746] Below are exemplary properties and structural arrangements of fabric composite materials used as fabric membrane materials.

[0747] 5.3.5.2.2.1 Fabric composite material structure

[0748] Various combinations of fabric materials and film / film layers can be used. In one example, a three-layer arrangement is used, comprising a thermoplastic polyurethane (TPU) film disposed between two fabric layers (e.g., nylon, a nylon and polyester blend, a nylon and spandex blend, a polyester and spandex blend, or a nylon / polyester / spandex blend). An additional fabric layer is required to protect the TPU film from breakage (e.g., during washing).

[0749] In another example, a two-layer arrangement is used, comprising a siloxane layer (e.g., nylon, a nylon and polyester blend, a nylon and spandex blend, a polyester and spandex blend, or a nylon / polyester / spandex blend). This composite material is cheaper than the three-layer arrangement described above because it requires only one layer of fabric.

[0750] In another example, a fabric material (e.g., microfiber or polyurethane material) can be coated with a polyurethane film to form a two-layer arrangement.

[0751] 5.3.5.2.2.2 Fabric Materials

[0752] As mentioned above, a variety of fabric materials can be used to form the sealing part, such as nylon, polyester, spandex, nylon, nylon and polyester blends, nylon and spandex blends, polyester and spandex blends, nylon / polyester / spandex blends, microfibers, or polyurethane.

[0753] In one example, nylon is used. Nylon offers the benefit of patient comfort because it is softer than polyester. Nylon is also more durable than polyester, thus improving lifespan and longevity. Furthermore, nylon has a higher melt temperature compared to polyester, allowing it to withstand higher temperature manufacturing conditions.

[0754] In another example, a blend of nylon and polyester is used. This material may be more ideal because the addition of polyester makes it less absorbent of moisture, thus reducing irritation to the patient. The nylon and polyester blend is also cheaper than nylon alone.

[0755] 5.3.5.2.2.3 Fabric material thickness

[0756] In one example, the thickness of the fabric material for the sealing portion can be in the range of 0.15 mm to 0.5 mm (e.g., 0.2 mm to 0.4 mm, or 0.3 mm to 0.4 mm, or 0.25 mm, or 0.3 mm, or 0.4 mm). This thickness is suitable for nylon materials or nylon and polyester blends.

[0757] In another example, the thickness of the fabric material for the sealing portion can be in the range of 0.275 mm or less (0.275 mm to 0.075 mm, 0.275 mm to 0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225 mm to 0.09 mm, 0.225 mm to 0.095 mm, 0.225 mm or 0.25 mm). This thickness can be suitable for microfiber fabric materials or polyurethane fabric materials.

[0758] 5.3.5.2.2.4 Thickness of the air-impermeable layer

[0759] In examples where silicone is used as a film / layer, the silicone can have a thickness ranging 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). A thinner silicone layer (e.g., 0.05 mm) may be more desirable because it provides a lighter product and also provides more stretch than a thicker silicone layer (e.g., 0.1 mm). However, a thicker silicone layer (e.g., 0.1 mm) is more durable than a thinner silicone layer (e.g., 0.05 mm thick).

[0760] In another example, where a polyurethane membrane is used as the membrane layer, the thickness of the polyurethane membrane can be in the range of 0.03 mm to 0.01 mm (e.g., 0.015, 0.02 mm or 0.025 mm).

[0761] 5.3.5.2.2.5 Total thickness of fabric composite materials

[0762] In examples where the fabric material is coated with a silicone film / film layer, the overall thickness of the composite material can be in the range of 0.18 mm to 0.625 mm (e.g., 0.25 mm to 0.6 mm, or 0.25 mm to 0.5 mm, or 0.3 mm to 0.5 mm, or 0.35 mm to 0.45 mm, or 0.3 mm, or 0.35 mm, or 0.4 mm, or 0.45 mm, or 0.5 mm).

[0763] Thicker fabric films (e.g., 0.5 mm) can be stronger and provide less brittle indentations. These fabric films may also be easier to handle during manufacturing because they are less likely to tip over.

[0764] Medium-thickness ranges (e.g., 0.35 mm to 0.45 mm) can provide a flexible, lightweight structure that is relatively easy to handle during manufacturing and can offer patients more comfort than thicker fabric membranes.

[0765] Thinner fabric membranes offer a very lightweight structure that provides a soft and comfortable feel for patients, but offer lower durability compared to thicker fabric membranes.

[0766] In examples where the fabric material is coated with a polyurethane film, the overall thickness of the composite material can be in the range of 0.305 mm or less (e.g., 0.305 mm to 0.085 mm, 0.305 mm to 0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255 mm to 0.10 mm, 0.255 mm to 0.105 mm, 0.25 mm or 0.275 mm).

[0767] 5.3.5.2.2.6 Knitted Structure

[0768] The fabric material of the fabric membrane can have, for example, a weft-knitted structure, or optionally a warp-knitted structure. Weft-knitted fabrics may be more desirable because they can provide a material with greater elasticity compared to warp-knitted fabrics. This can be advantageous because it can provide greater comfort to the patient by stretching when the patient's face engages with the fabric membrane, thereby reducing the force exerted on the patient's face by the fabric membrane.

[0769] In one example, because the weft direction can have greater elasticity or elongation, the weft direction (the direction of the transverse loop 80) can extend in the nose width direction of the fabric film. Alternatively, the weft direction can extend in the nose length direction (up-down direction).

[0770] Furthermore, weft knitting is better suited for producing relatively thin materials, such as those disclosed herein. Moreover, weft knitting is generally less expensive than warp knitting.

[0771] However, in some cases, warp knitting may be necessary because it offers a smaller shrinkage rate than weft knitting materials.

[0772] 5.3.5.2.2.7 Knitting Machines

[0773] Weft-knitted fabrics can have a single-jersey plain knit structure that provides different appearances for the fabric front and fabric back. A single-jersey plain knit can be formed using a set of needles, and knitted loops can be provided on the fabric front (the front side) and purl loops on the fabric back. In one example, the fabric front can form the outer surface of a fabric membrane, and an airtight membrane can be attached to the fabric back. Alternatively, the fabric front can be oriented towards the inner surface of the fabric membrane, and the membrane can be attached thereto.

[0774] In an example where the fabric membrane includes an impermeable membrane sandwiched between two fabric layers, the process front side of each fabric material can form the exposed surface of the fabric membrane.

[0775] 5.3.5.2.2.8 Fabric weight

[0776] The weight of the fabric material can range from 95 grams per square meter (gsm) to 130 gsm (e.g., 105 gsm to 120 gsm, or 110 gsm to 115 gsm, or 105 gsm, or 110 gsm, or 120 gsm). Due to the weight / thickness of the fabric, heavier fabrics (e.g., 120 gsm) can provide a desirable comfortable fabric feel even after lamination and coating. Lighter fabrics (e.g., 105 gsm) may be desirable because they provide a lighter product.

[0777] 5.3.5.2.2.9 Machine Specifications

[0778] The machine specifications (i.e., the number of stitches per inch) of the fabric material can vary. For example, the machine specifications can range from 35Gg to 70Gg (e.g., 44Gg to 60Gg, or 50Gg to 55Gg, or 55Gg to 60Gg, or 44Gg, or 50Gg, or 55Gg, or 60Gg).

[0779] Using a relatively large glyph material (e.g., 44GG) may be desirable, as it provides a wider range of options for the mix. However, a finer glyph material (e.g., 60GG) may be desirable, as this softer material can enhance patient comfort.

[0780] 5.3.5.2.2.10 Aesthetically pleasing

[0781] Fabric materials can possess either a solid color aesthetic or a mixed color aesthetic. Mixed-color materials can be considered materials already made using textiles / fabrics / yarns of different colors, or materials made from different textiles / fabrics / yarns that have been individually dyed in more than one color. Mixed-color materials may be desirable because they may have a greater ability to conceal dirt or grime, thus making it easier to improve the cleanliness of the product. Mixed-color materials can also offer benefits during the manufacturing process, as it makes it easier to visually align the knitted structure of the fabric during cutting and / or overmolding.

[0782] However, solid-color materials may be desirable because they offer a greater selection of finer-sized materials that are softer and therefore more comfortable for patients (e.g., Provich, 55GG+).

[0783] 5.3.5.3 shows an example of the arrangement of the support structure and sealing parts.

[0784] Figure 81-112 Several different liner assembly configurations are shown, including different support structures and sealing arrangements and / or processes. Note that these examples can be applied to any patient interface and / or liner assembly described in this disclosure. Furthermore, any feature of any example can be applied to different examples and / or used with different features. The inflation chambers, support structures, and seals shown in these figures can be made of any suitable materials described above. It should also be noted that components, such as support structures, can include more than one material. For example, the lower liner of the support structure can include a different material than other parts of the support structure.

[0785] Reference Figure 83The support structure 10120 is removably connected to the air chamber 10200 via a clip 10126 on the support structure and a connector 10210 on the air chamber to form a cavity 10001. In some examples, the clip 10126 may be formed of polyurethane, polypropylene (PP), or polyethylene terephthalate (PET). The air chamber 10200 may be made of a more rigid material than the clip, such as polycarbonate or polyurethane having a higher Shore A hardness than the clip. The support structure 10120 and the sealing portion 10130 are configured as a gasket arrangement with a single air-assisted sealing portion 10130 (e.g., a fabric membrane).

[0786] The connection between the peripheral edge (or outer edge) of the fabric membrane and the inner edge of the supporting structure can be formed in many different ways. For example... Figure 83 and 85 As shown, the connection can form an overlap, where the edge portion of the fabric membrane overlaps with the edge portion of the support structure. In one example, the attachment portion 10122 of the support structure can form a recessed portion to receive the seal 10130, such that the support structure and the seal form a smooth outer surface, as... Figure 83 As shown. This overlap can be minimal and only provided for manufacturing purposes (i.e., necessary for attaching the seal and support structure), for example, by overmolding and / or injection molding. This is in contrast to conventional arrangements, in which the overlap area can be arranged to provide additional support (e.g., stiffness) to the seal due to the presence of the support structure. (In such arrangements, the overlap can vary around the periphery of the seal-forming structure to change the level of support or stiffness (e.g., less overlap, less support, more flexibility, less tension in the sensitive bridge area).

[0787] In contrast to the lap joints described above, the connection between the fabric membrane and the supporting structure can form an end-to-end joint (e.g., a butt joint), such as... Figure 84 As shown. Due to manufacturing techniques (e.g., overmolding, injection molding, etc.), end-to-end joints may have some overlap; however, this overlap is negligible and constant around the periphery of the seal at the connection with the support structure. In other words, as described above, any overlap between the support structure and the fabric membrane is not designed to modulate stiffness, tension, flexibility, or support in different areas of the face (e.g., less overlap, less support, more flexibility, less tension in the sensitive nasal bridge area).

[0788] Conversely, whether an overlap joint or an end-to-end joint is provided, this arrangement allows the compliant fabric membrane to appropriately adapt to the patient's facial features. That is, the sealing-forming structure is designed to allow the patient's facial features (e.g., the nose) to sink into the fabric membrane that compliantly receives the patient's face.

[0789] The seal may be glued, molded (e.g., overmolded or injection molded), or otherwise attached to the support structure. In an alternative example, the recessed portion may be removed and the attachment portion 10122 may be used to attach the seal 10130 and the support structure 10120 end-to-end, as shown. Figure 84 As shown. Furthermore, Figure 84 It is also explained that the portion (d1) of the support structure 10120 adjacent to or connected to the inflation chamber 10200 may be thicker than the portion (d2) of the support structure 10120 adjacent to or connected to the sealing portion 10130, in order to provide structural stability at the connection with the inflation chamber and flexibility at the interface with the patient.

[0790] exist Figure 85 In the support structure 10120, a lower gasket 10121 is included. The support structure also includes a sealing lip 10124 to seal the interface between the inflation chamber 10200 and the support structure 10120. The attachment portion 10122 of the support structure can be configured such that the end of the sealing portion is clamped between opposing sections of the attachment portion 10122.

[0791] In another example, the air chamber 11200 may have a lower liner 11121 attached to its interior portion, such as Figure 86 As shown. In this way, the lower liner 11121 can be permanently attached to the inflation chamber 11200, while the support structure 10120 and the sealing part 10130 can be removably connected to the inflation chamber via the clip 10126 and the connector 10210.

[0792] See Figure 87 and 88 The support structure 10120 may have an external sealing bias portion 10140 or an internal sealing bias portion 10140', which can dynamically support the support structure and the sealing portion 10130 using the internal air pressure in the cavity. The support structure 10120 may include an inwardly bent end portion 10142, thereby forming an air-assisted support region 10144, which can optimize the forces acting on the support structure and the sealing portion due to the air pressure in the cavity to promote a sealing contact between the sealing portion and the patient's face.

[0793] Turning Figure 89 The support structure 12120 includes a lower liner 12121. The support structure and / or the lower liner may be formed, for example, from molded polyurethane. In this example, the seal 10130 is adhered to the support structure by an adhesive 10150 (e.g., heat-activated polyurethane, tape, glue, etc.).

[0794] exist Figure 90AIn this configuration, the support structure 15120 is removably connected to the air chamber 10200. The support structure includes a lower liner 15121. In this example, the support structure is formed of foam (e.g., molded from polyurethane foam), but it can also be formed of TPE, TPU, or any other suitable material. The sealing portion 10130 may have a membrane layer or membrane laminate 10131 to provide a substantially airtight material, such as... Figure 90A-1 As shown. Alternatively, the support structure 15120 may be glued, bonded or otherwise attached to the inflation chamber 10200.

[0795] Figure 90B It shows something similar to Figure 90A Examples, however Figure 90B The sealing portion 10130 is directly connected to the inflation chamber 10200 and can form a seamless cover on the lower liner 15121. The sealin...

Claims

1. A patient interface for sealingly delivering a flow of air to an airway entrance of a patient at a continuous positive pressure relative to ambient air pressure to improve sleep-disordered breathing when the patient is sleeping, the airway entrance of the patient comprising at least an entrance to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's breathing cycle in use; The patient interface comprises: A cushion assembly, the cushion assembly comprising: a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure having a sealing portion constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway below a nasal bridge area of ​​the patient's face, the sealing portion having an aperture formed therein so that a flow of air at the treatment pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure being constructed and arranged to, in use, maintain the treatment pressure within the cavity throughout the patient's breathing cycle, wherein the seal-forming structure comprises a flexible support structure to support the sealing portion, the sealing portion being configured to seal with the underside of the patient's nose, the underside of the patient's nose comprising the patient's subnasal point and the patient's pronasal point, wherein the seal-forming structure includes a seal biasing portion such that the seal and the seal biasing portion are both disposed along a rear surface of the cushion assembly that faces the patient, the seal biasing portion including at least one of a fold, pleat, or corrugation extending between the seal and the support structure, and Wherein, the sealing bias portion is configured to inflate when the cavity is pressurized during use, thereby causing the sealing portion to extend or telescope in a direction toward at least a portion of the patient's face beyond other portions of the rear surface of the cushion assembly facing the patient.

2. A patient interface as described in claim 1, wherein the sealing bias portion includes a plurality of folds, pleats or corrugations, which form a sinusoidal waveform in cross-section.

3. A patient interface as described in claim 1, wherein the sealing bias portion is disposed at least in a lateral region of the cushion assembly.

4. A patient interface as described in claim 3, wherein the sealing portion is configured to extend or retract a greater distance in the lateral regions of the cushion assembly than in the central region of the cushion assembly, so that when the sealing bias portion moves during use, the central region forms a bending or flexing area, thereby enabling the sealing portion in the lateral region to support or clamp the patient's nose.

5. A patient interface as described in any of Claims 1, wherein the size of the sealing bias portion varies around the periphery of the cushion assembly.

6. A patient interface as described in any one of claims 1 to 5, wherein the sealing bias portion is larger in the lateral regions of the cushion assembly and smaller in the central region.

7. A patient interface as described in any one of Claims 1 to 5, wherein the sealing bias portion extends around the entire periphery of the cushion assembly.

8. A patient interface as described in any one of Claims 1 to 5, wherein the sealing bias portion is omitted in at least a portion of the central portion of the cushion assembly.

9. A patient interface as claimed in any one of claims 1 to 5, wherein the support structure and the seal bias comprise silicone.

10. A patient interface as claimed in any one of claims 1 to 5, wherein the sealing portion comprises a fabric membrane.

11. A patient interface for sealingly delivering a flow of air to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure when the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of 4 cmH2O to 30 cmH2O above ambient air pressure throughout the patient's breathing cycle in use; The patient interface comprises: A cushion assembly, the cushion assembly comprising: a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure having a fabric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the fabric membrane having apertures formed therein so that a flow of air at the treatment pressure is delivered to the patient's airway, the seal-forming structure constructed and arranged to, in use, maintain the treatment pressure within the cavity throughout the patient's breathing cycle, wherein the seal-forming structure comprises a flexible support structure to maintain the fabric membrane in a predetermined curved shape, the fabric membrane being configured to seal with the underside of the patient's nose, the underside of the patient's nose comprising the patient's subnasal point and the patient's pronasal point, wherein the seal forming structure comprises a seal biasing portion extending along the periphery of the cushion assembly at least in a lateral region of the cushion assembly, the seal biasing portion being formed of a material different from that of the fabric membrane, the seal biasing portion being configured to inflate when the cavity is pressurized during use, thereby enabling the seal biasing portion to extend the reach of the fabric membrane and to relieve external forces applied to the inflatable chamber from the fabric membrane when moving during use, and Wherein, the sealing bias portion is configured so that the reach of the fabric membrane extends a greater distance in the lateral region of the cushion assembly than in at least a portion of the central region of the cushion assembly, so that when the sealing bias portion moves during use, the central region forms a bending or flexing region, thereby enabling the fabric membrane in the lateral region to lift or clamp the patient's nose.

12. A patient interface as described in claim 11, wherein the fabric membrane in the lateral region is configured to extend in a superior-posterior direction and a left-right direction so as to hold or clamp the patient's nose when the sealing biasing portion is activated in use.

13. A patient interface as claimed in claim 11, wherein: In use, the fabric membrane is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity.

14. A patient interface as described in claim 11, wherein the sealing bias portion is omitted in at least a portion of the central portion of the cushion assembly.

15. A patient interface as described in Claim 11, wherein the sealing bias portion extends around the entire periphery of the cushion assembly.

16. A patient interface as described in Claim 11, wherein the size of the sealing bias portion varies around the periphery of the cushion assembly.

17. A patient interface as described in Claim 11, wherein the sealing bias portion is larger in the lateral regions of the cushion assembly and smaller in the central region.

18. A patient interface as claimed in any one of claims 11 to 16, wherein the size of the sealing offset portion tapers from a larger sealing offset portion in the lateral region to a smaller sealing offset portion towards a central region of the cushion assembly.

19. A patient interface as claimed in any one of claims 11 to 16, wherein the seal bias comprises a serrated channel or recess.

20. A patient interface as claimed in any one of claims 11 to 16, wherein the seal bias comprises an external protrusion.

21. A patient interface as claimed in any one of claims 11 to 16 wherein the seal bias comprises at least one fold, pleat or corrugation.

22. A patient interface as claimed in claim 21 wherein when the sealing bias is activated, the at least one fold, pleat or corrugation causes the fabric membrane to telescope towards the patient's face in use.

23. A patient interface as described in claim 21, wherein the sealing bias portion includes a plurality of folds, pleats or corrugations.

24. A patient interface as claimed in claim 23, wherein the plurality of folds, pleats or corrugations form a sinusoidal waveform in cross-section.

25. A patient interface as claimed in any one of claims 11 to 16, wherein the seal bias comprises a step and a wing, the step and wing being angled relative to each other.

26. A patient interface as claimed in any one of claims 11 to 16, wherein the sealing bias is arranged between the support structure and the fabric membrane.

27. A patient interface as claimed in any one of claims 11 to 16, wherein the seal bias is arranged between the plenum chamber and the support structure.

28. A patient interface as claimed in any one of claims 11 to 16, wherein the cushion assembly includes a handle extending from the inflation chamber to support the seal-forming structure.

29. A patient interface as claimed in any one of claims 11 to 16, wherein the sealing bias extends across the lateral region of the cushion assembly at an angle α relative to a plane extending along the front side of the cushion assembly.

30. A patient interface as claimed in claim 29, wherein the angle α is between 30° and 60°.

31. A patient interface as claimed in any one of claims 11 to 16, 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 in use.

32. A patient interface as claimed in any one of claims 11 to 16 wherein the support structure and the seal bias comprise silicone.

33. A patient interface as claimed in any one of claims 11 to 16, wherein the fabric membrane is attached to the support structure along a periphery of the fabric membrane such that the fabric membrane extends radially inwardly beyond the support structure.

34. A patient interface as claimed in any one of claims 11 to 16 wherein the support structure comprises silicone and the fabric membrane is moulded onto an inner edge of the support structure.

35. A patient interface as claimed in any one of claims 11 to 16, wherein the at least one hole in the fabric membrane comprises two holes, and a bridge is arranged between the two holes in the fabric membrane.

36. A patient interface as claimed in any one of claims 11 to 16 wherein the fabric membrane comprises a membrane layer applied to a fabric material to render the fabric material substantially air impermeable.

37. A patient interface as claimed in any one of claims 11 to 16 wherein the plenum comprises silicone and is formed integrally with the support structure.

38. A patient interface as described in any one of claims 11 to 16, further comprising a positioning and stabilizing structure which provides a force to maintain the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a strap which is constructed and arranged so that when in use at least a portion covers an area of ​​the patient's head above a base point above the patient's ear.

39. A patient interface as described in any one of claims 11 to 16, further comprising a ventilation structure which allows gas exhaled by the patient to flow continuously from the interior of the cavity to the surrounding environment, the size and shape of the ventilation structure being determined to maintain a therapeutic pressure in the cavity during use.

40. A patient interface as claimed in any one of claims 11 to 16 wherein the plenum chamber and the seal-forming structure form a nasal cushion.

41. A treatment system for treating sleep apnea, comprising: A patient interface according to any one of claims 11 to 16; Respiratory pressure therapy devices for supplying breathable gas at a positive pressure; as well as An air delivery tube communicates the breathable gas from the respiratory pressure therapy device to the patient interface.

42. A patient interface for sealingly delivering a flow of air to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure while the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's breathing cycle in use; The patient interface comprises: A cushion assembly, the cushion assembly comprising: a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure having a sealing portion constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway below a nasal bridge area of ​​the patient's face, the sealing portion having an aperture formed therein so that a flow of air at the treatment pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure being constructed and arranged to, in use, maintain the treatment pressure within the cavity throughout the patient's breathing cycle, wherein the plenum inlet port is formed on a front side of the plenum, the front side of the plenum comprising a connector structure adapted to be connected to an air supply pipe, and Wherein, the front side of the inflation chamber includes a connector gasket, which includes one or more folds, pleats or corrugations adjacent to the inlet port and extending around the inlet port, and the one or more folds, pleats or corrugations are configured to separate the sealing forming structure from external forces applied to the air supply pipe.

43. A patient interface as claimed in Claim 42, further comprising an air supply tube connected to the front side of the plenum chamber and in fluid communication with the inlet port.

44. A patient interface as claimed in any one of claims 42 and 43, wherein the connector gasket may have a pleated configuration.

45. A patient interface as described in claim 42, further comprising a positioning and stabilizing structure which provides a force to maintain the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a strap which is constructed and arranged so that in use at least a portion covers an area of ​​the patient's head above the base point of the patient's ear.

46. ​​A patient interface for sealingly delivering a flow of air to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure while the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's breathing cycle in use; The patient interface comprises: A cushion assembly, the cushion assembly comprising: a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure having a sealing portion constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the sealing portion having an aperture formed therein such that a flow of air at the treatment pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure being constructed and arranged to, in use, maintain the treatment pressure within the cavity throughout the patient's breathing cycle, wherein the seal forming structure comprises a flexible support structure to support the sealing portion, the support structure comprising a handle protruding from the inflation chamber, Wherein, the sealing bias portion extends around the periphery of the gasket assembly between the sealing portion and the handle portion, supporting the sealing portion in the manner of a universal joint, and the sealing bias portion is configured to extend the reach of the sealing portion during use and separate the sealing portion from external forces applied to the inflation chamber.

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