Patient interface with seal-forming structure of variable configuration

Abstract

The patient interface includes a seal-forming structure that includes a textile membrane and a support structure that supports the textile membrane. The seal-forming structure can have varying configurations in order to accommodate different areas and varying contours of the patient’s face, ensuring a robust and comfortable seal. The air-impermeable layer of the textile membrane can have varying thicknesses in different portions of the textile membrane and / or different areas of the cushion assembly. Furthermore, the seal-forming structure can include an undercushion, the arrangement of the textile membrane and the undercushion and / or the configuration of the undercushion can vary in different areas of the cushion assembly to optimize patient comfort and effectiveness of the seal in different areas of the patient’s face.

Description

[0001] 1. Cross-references to related applications

[0002] This application claims the rights of U.S. Provisional Application No. PCT / IB2019 / 058832, filed October 16, 2019, and Australian Provisional Application No. AU2019903201, filed August 30, 2019, and AU2019902729, filed July 31, 2019, the entire contents of which are incorporated herein by reference. 2 Background Technology 2.1 Technical Field

[0005] 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.

[0006] 2.2 Description of relevant technologies

[0007] 2.2.1 The Human Respiratory System and Its Disorders

[0008] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0009] 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.

[0010] A range of breathing disorders exist. Some conditions may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0011] 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.

[0012] 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).

[0013] 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).

[0014] 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.

[0015] Patients with respiratory insufficiency (a form of respiratory failure) may experience unusual shortness of breath during exercise.

[0016] 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.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 2.2.2 Treatment

[0022] 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.

[0023] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure 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.

[0024] 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.

[0025] 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.

[0026] 2.2.3 Treatment System

[0027] These treatments 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.

[0028] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0029] Another type of treatment system is the mandibular repositioning device.

[0030] 2.2.3.1 Patient Interface

[0031] 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 deliver gas at a positive pressure of approximately 10 cmH2O into the airway.

[0032] 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.

[0033] Some masks may be clinically disadvantageous for this technology, for example, in cases where they block airflow through the nose and only allow it through the mouth.

[0034] If certain masks require patients to insert a portion of the mask structure into their mouths to form and maintain a seal through their lips, they may be uncomfortable or not feasible for this technology.

[0035] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0036] The design of the patient interface presents several 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 bones, cartilage, and soft tissues, 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 a breathing therapy session.

[0037] Due to these challenges, some masks 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. Wrongly sized masks can cause reduced compliance, decreased comfort, and adverse patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for administering anesthetics are acceptable for their original purpose, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the mask is worn during sleep.

[0038] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. However, patient adherence may occur if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, patients may be unable to clean their masks if they are difficult to clean (e.g., difficult to assemble or disassemble), which could affect adherence.

[0039] 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.

[0040] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0041] 2.2.3.1.1 Sealing Formation Structure

[0042] 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.

[0043] 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 and a second sub-part, the first sub-part forming a seal around the left nostril and the 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.

[0044] 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 sensitive areas of a patient's face differ. For instance, a seal on swimming goggles that cover a patient's forehead may not be suitable for use on a patient's nose.

[0045] 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.

[0046] 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.

[0047] 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 gasket, or a molded or shaped surface of a resilient sealing element made of an elastomer (e.g., 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.

[0048] Another type of seal-forming structure includes a wing-shaped seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. 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 wrinkle or buckle during use, causing leakage.

[0049] In addition, some manufacturing processes can produce unwanted wrinkles, creases or creases in the sealing structure even when it is not in use.

[0050] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0051] 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.

[0052] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO2006 / 074,513; WO 2010 / 135,785.

[0053] 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.

[0054] 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 describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (which describes ResMed's SWIFT...) TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (which describes ResMed SWIFT) TMOther aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed's MIRAGE LIBERTY) TM (Regarding full-face masks); International Patent Application WO 2009 / 052,560 (which describes ResMed's SWIFT...) TM Other aspects of the FX nose pillow).

[0055] 2.2.3.1.2 Positioning and Stability

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0060] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned therapies, 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.

[0061] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, 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 the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0062] An example of a specific requirement for certain RPT devices is noise.

[0063] Noise output level table for existing RPT devices (for one sample only, measured at 10 cmH2O using the test method specified in ISO 3744 in CPAP mode).

[0064] 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

[0065] 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.

[0066] Elisée TM 150 ventilator and ResMed VS III TM Ventilators provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients to treat 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 a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow can be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0067] The designer of a device may be presented with an infinite number of options. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute variations in one or more parameters.

[0068] 2.2.3.3 Humidifier

[0069] 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.

[0070] Many artificial humidification devices and systems are known, however, they do not meet the specific requirements of medical humidifiers.

[0071] When needed, medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to the ambient air, typically in areas where patients may sleep or rest (e.g., in hospitals). 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 may make the occupant uncomfortable. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0072] 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.

[0073] 2.2.3.4 Data Management

[0074] 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.

[0075] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems.

[0076] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0077] 2.2.3.5 Ventilation port technology

[0078] Some forms of patient interface systems may include exhaust vents to allow the flushing of exhaled carbon dioxide. Vents allow 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.

[0079] Vents may include orifices through which gas can flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents can, for example, disturb the sleep of the patient's bed partner by causing noise or congested airflow.

[0080] ResMed has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0081] The noise level of the existing face mask (ISO 17510-2:2007, pressure at 1m and 10cmH2O)

[0082]

[0083] (Only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0084] The sound pressure levels for various objects are listed below.

[0085]

[0086] 2.2.4 Screening, Diagnosis and Monitoring System

[0087] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves specialized clinical healthcare professionals applying the system. 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 of the patient: one night for pure diagnosis and the second night for the 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.

[0088] 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

[0090] 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.

[0091] The first aspect of this technology relates to devices for diagnosing, improving, treating, or preventing respiratory disorders.

[0092] Another aspect of this technology relates to methods for diagnosing, improving, treating, or preventing respiratory disorders.

[0093] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0094] Another aspect of this technology relates to a sealing structure for a patient interface, the sealing structure comprising a fabric membrane.

[0095] In one form, the fabric membrane is airtight.

[0096] 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.

[0097] 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.

[0098] Another aspect of this technology is a patient interface comprising a fabric membrane, which includes a knitted fabric material.

[0099] In one form, the knitted fabric material is warp-knitted.

[0100] In one form, knitted fabric materials are weft-knitted.

[0101] In one form, the fabric membrane is stretchable in both the vertical and horizontal directions (e.g., equally stretchable).

[0102] In one form, the fabric membrane is more stretchable in the horizontal direction than in the vertical direction.

[0103] Another aspect of this technology relates to a patient interface with a wide range of compatibility.

[0104] Another aspect of this technology relates to a sealing structure for a patient interface, the sealing structure including a sealing portion (e.g., comprising a fabric material) that remains taut before use.

[0105] 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.

[0106] 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.

[0107] 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 the range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's respiratory cycle; the patient interface includes: 1) an air chamber at least partially formed capable of being pressurized to at least 6 cm H2O above the ambient air pressure. A chamber for therapeutic pressure H2O, the inflation chamber including an inflation chamber inlet port, the inlet port being sized and structured to receive an airflow at therapeutic pressure for patient breathing; 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 surrounding an inlet to the patient's airway below a nasal region of the patient's face, 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 the therapeutic pressure within the chamber throughout the patient's respiratory cycle during use.

[0108] In the embodiments: (a) the sealing structure includes a flexible support structure attached to and supporting the fabric membrane; (b) the fabric membrane includes a fabric material and an airtight layer applied to the fabric material, the airtight layer having a first thickness at a first location on the fabric membrane and a second thickness different from the first thickness at a second location on the fabric membrane; (c) the first thickness of the airtight layer is less than the second thickness.

[0109] In other examples: (a) the tensile strength of the fabric membrane at the first location is greater than the tensile strength of the fabric membrane at the second location; (b) the stiffness of the fabric membrane at the first location is less than the stiffness of the fabric membrane at the second location; (c) the first location on the fabric membrane is in the bridge of the nose region of the sealing structure, and the second location on the fabric membrane is in the cheek region of the sealing structure; (d) the first location on the fabric membrane is in the chin region of the sealing structure, and the second location on the fabric membrane is in the cheek region of the sealing structure; (e) the thickness of the impermeable layer is... (f) The thickness of the impermeable layer in the bridge of the nose region of the sealing structure is less than the thickness of the impermeable layer in the cheek region of the sealing structure; (g) The thickness of the impermeable layer in the chin region of the sealing structure is less than the thickness of the impermeable layer in the cheek region of the sealing structure; (h) In a cross-sectional view, the thickness of the impermeable layer decreases toward the inner edge of the fabric film, such that the first position on the fabric film is radially more inward than the second position on the fabric film.

[0110] In other examples: (a) In a cross-sectional view, the thickness of the impermeable layer decreases toward the inner edge of the fabric membrane, such that the first position on the fabric membrane is radially more inward than the second position on the fabric membrane; (b) The support structure comprises silicone, and the fabric membrane is molded to the inner edge of the support structure; (c) The fabric membrane is saddle-shaped in the bridge of the nose region of the liner assembly; (d) The fabric material is weft-knitted; (e) The fabric material includes nylon, spandex, or polyester; (f) The impermeable layer comprises silicone; (f) In use, the therapeutic pressure in the cavity pushes the fabric membrane toward the patient's face;

[0111] 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 configured 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 further includes a ventilation structure to allow continuous flow of exhaled gas from the interior of the cavity to the surrounding environment, the size and shape of the ventilation structure being determined to maintain therapeutic pressure within the cavity in use; (c) an inflation chamber forms a full-face padding assembly with the sealing-forming structure; (d) in use, the patient's nose is configured to be received within the cavity.

[0112] 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 the range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's respiratory cycle; the patient interface includes: 1) an air chamber at least partially formed capable of being pressurized to at least 6 cm H2O above the ambient air pressure. A chamber for therapeutic pressure H2O, the inflation chamber including an inflation chamber inlet port, the inlet port being sized and structured to receive an airflow at therapeutic pressure for patient breathing; 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 surrounding an inlet to the patient's airway below a nasal region of the patient's face, 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 the therapeutic pressure within the chamber throughout the patient's respiratory cycle during use.

[0113] In an embodiment: (a) the sealing structure includes a flexible support structure attached to and supporting the fabric membrane, the support structure including a lower liner supporting the fabric membrane; (b) in a cross-sectional view, the length of the fabric membrane loosely covering the lower liner in a first region of the sealing structure is different from the length of the fabric membrane loosely covering the lower liner in a second region of the sealing structure; (c) the length of the fabric membrane bonded to the lower liner in the first region of the sealing structure is different from the length of the fabric membrane bonded to the lower liner in the second region of the sealing structure; (d) the length of the fabric membrane bonded to the lower liner in the first region of the sealing structure is shorter than the length of the fabric membrane bonded to the lower liner in the second region of the sealing structure; (e) the length of the fabric membrane loosely covering the lower liner in the first region of the sealing structure is longer than the length of the fabric membrane loosely covering the lower liner in the second region of the sealing structure.

[0114] In a further example: (a) in the first region of the sealing structure, the fabric membrane is substantially not partially bonded to the lower liner; (b) in the first region of the sealing structure, multiple portions of the fabric membrane loosely cover the lower liner, and other portions of the fabric membrane are bonded to the lower liner; (c) in the second region of the sealing structure, the fabric membrane is bonded to at least a portion of the outer-facing sidewall of the lower liner; (d) in the second region of the sealing structure, the fabric membrane is bonded to the lower liner at least at its upper outer edge. (e) In the second region of the sealing structure, the fabric membrane is bonded to at least a portion of the patient-facing surface of the underliner; (f) In the second region of the sealing structure, the fabric membrane is bonded to the patient-facing surface of the underliner up to the inner edge of the underliner; (g) In the second region of the sealing structure, multiple portions of the fabric membrane loosely cover the underliner, and other portions of the fabric membrane are bonded to the underliner; (h) In the second region of the sealing structure, the fabric membrane substantially does not loosely cover the underliner.

[0115] In other examples: (a) the first region of the sealing structure is the bridge of the nose region of the sealing structure; (b) the first region of the sealing structure is the chin region of the sealing structure; (c) the first region of the sealing structure is the side of the nose region of the sealing structure; (d) the second region of the sealing structure is the cheek region of the sealing structure; (e) the cheek region is the lower cheek region of the sealing structure.

[0116] In other examples: (a) the cross-section of the underliner is configured to vary in different regions surrounding the periphery of the sealing structure; (b) the cross-sectional configuration of the underliner in the side portion of the nose region of the sealing structure differs from the cross-sectional configuration of the underliner in the chin region of the sealing structure; (c) the underliner has a radially flat region in at least a portion of the sealing structure that is inclined inward relative to the intermediate contact plane of the sealing structure; (d) the underliner comprises a compressible material; (e) the underliner comprises a foam material; (f) the underliner comprises polyurethane foam.

[0117] In a further example: (b) the fabric membrane includes a fabric material and an airtight layer applied to the fabric material; (c) the airtight layer has a first thickness at a first location on the fabric membrane and a second thickness different from the first thickness at a second location on the fabric membrane; (d) the support structure includes silicone, and the fabric membrane is molded to the inner edge of the support structure; (e) the fabric material is a weft-knitted fabric; (f) the fabric material includes nylon, spandex, or polyester; (g) the airtight layer includes silicone; (c) in use, therapeutic pressure in the cavity pushes the fabric membrane and the underlay towards the patient's face;

[0118] 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 configured 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 further includes a ventilation structure to allow continuous flow of exhaled gas from the interior of the cavity to the surrounding environment, the size and shape of the ventilation structure being determined to maintain therapeutic pressure within the cavity in use; (c) an inflation chamber forms an oronasal liner assembly with the sealing-forming structure; (d) in use, the patient's nose is configured to be received within the cavity.

[0119] 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 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's respiratory cycle; the patient interface includes: 1) an inflatable chamber that at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cm H2O above the 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-forming structure having a fabric membrane constructed and arranged to form a seal with a region of the patient's face surrounding the patient airway inlet, the fabric membrane having pores formed therein such that the airflow at the therapeutic pressure is delivered to at least the inlet of 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 in use.

[0120] In the embodiments: (a) the sealing forming structure includes a support structure for supporting the fabric membrane, the support structure being configured to be connected to the inflation chamber; and (b) the fabric membrane is attached to the support structure along the outer periphery of the fabric membrane such that the fabric membrane is in a taut state before use.

[0121] 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 the range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's respiratory cycle; the patient interface includes: 1) an air chamber at least partially formed capable of being pressurized to at least 6 cm H2O above the ambient air pressure. A cavity for therapeutic pressure H2O, the inflation chamber including an inflation chamber inlet port sized and structured to receive an airflow at therapeutic pressure for patient breathing; and 2) a sealing-forming structure having a fabric membrane constructed and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, 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-forming structure being constructed and arranged to maintain therapeutic pressure in the cavity throughout the patient's respiratory cycle during use. The sealing-forming structure may include a flexible support structure to support the fabric membrane, the support structure being connected to the inflation chamber, the support structure being rigider than the fabric membrane. In use, the fabric membrane may be configured to press against the patient's face such that the patient's nose is not received in the cavity. The fabric membrane may be attached to the support structure along its outer periphery such that the fabric membrane extends radially inward beyond the support structure.

[0122] In the embodiments: (a) the inflatable chamber and the support structure comprise silicone and form a one-piece structure having a first lateral support section of a first thickness and a second centrally arranged nasal base section of a second thickness less than the first thickness, and the nasal base section being 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 includes a lower liner; (c) the support structure includes 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 region; (f) the fabric membrane has a saddle shape in the lower central region of the fabric membrane, the saddle shape being configured to seal against the patient's subnasal point during use.

[0123] 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 machine specification of the fabric material is in the range of 44 GG to 60 GG; (g) the fabric material has a mixed 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 in the cavity pushes the fabric membrane toward the patient's face; (1) the air chamber comprises silicone and is integral with the support structure.

[0124] In a further example: (a) the patient interface further 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 configured 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 further includes a ventilation structure to allow continuous flow of exhaled gas from the interior of the cavity to the surrounding environment, the size and shape of the ventilation structure being determined to maintain therapeutic pressure within the cavity in use; (c) an 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.

[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 an inlet to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's respiratory cycle; the patient interface includes: 1) an air chamber at least partially formed capable of being pressurized to at least 6 cm H2O above the ambient air pressure. A chamber for therapeutic pressure of H2O, the inflation chamber including an inflation chamber inlet port, the inlet port being sized and structured to receive an airflow at therapeutic pressure for patient breathing; and 2) a sealing forming structure having a fabric membrane constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway, the fabric membrane having at least one hole formed therein such that an airflow at therapeutic pressure is delivered to an inlet at least the patient's nostril, the sealing forming structure being constructed and arranged to maintain the therapeutic pressure within the chamber during use throughout the patient's respiratory cycle, the sealing forming structure including a flexible support structure to support the fabric membrane, the support structure being rigider than the fabric membrane, the support structure being connected to the inflation chamber. At a transition portion, 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 portion, the support structure and the fabric membrane may extend along a curve from the front side of the sealing forming structure to the patient-facing rear side of the sealing forming structure.

[0126] In the embodiments: (a) at the transition portion, 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 portion 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 on the fabric membrane comprises two holes, and a bridging portion is disposed between the two holes in the fabric membrane; (e) the support structure comprises 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.

[0127] In a further embodiment: (a) the fabric membrane includes a fabric material and a membrane layer applied thereon 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 fabric material is weft-knitted; (d) the membrane layer includes silicone; (e) the fabric material includes 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 the sealing formation constitute an oropharyngeal pad assembly; (h) the air chamber and the sealing formation constitute a nasal pad.

[0128] 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 the range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's respiratory cycle; the patient interface includes: 1) an air chamber at least partially formed capable of being pressurized to at least 6 cm H2O above the ambient air pressure. A chamber for treating H2O pressure, the inflation chamber including an inflation chamber inlet port sized and structured to receive an airflow at the treatment pressure for patient breathing; and 2) a sealing-forming structure having a fabric membrane constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway, the fabric membrane having at least one hole formed therein such that an airflow at the treatment pressure is delivered to an inlet at least one of the patient's nostrils, the sealing-forming structure being constructed and arranged to maintain the treatment pressure within the chamber during use throughout the patient's respiratory cycle, the fabric membrane comprising a fabric material and a membrane layer applied thereon to make the fabric material substantially airtight, the fabric material being a weft-knitted fabric. The sealing-forming structure may include a flexible support structure for supporting the fabric membrane, the support structure being connectable to the inflation chamber, and the support structure being rigider than the fabric membrane. The fabric membrane may be attached to the support structure along its outer periphery such that the fabric membrane extends radially inward beyond the support structure. In use, the fabric membrane can be configured to press against the patient's face so that the patient's nose is not received in the cavity. The fabric membrane may have a dome shape in the corner region configured to seal against the patient's nasal base, and a saddle shape in the lower central region configured to seal against the patient's subnasal point.

[0129] In the embodiments: (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 on the fabric membrane includes two holes, a bridging portion is disposed between the two holes of the fabric membrane, the bridging portion fastens with excess material to allow the fabric membrane to unfold to accommodate noses of different sizes; (c) a support structure includes silicone, and the fabric membrane is molded to the inner edge of the support structure; (d) an inflation chamber, the inflation chamber including silicone and 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 in a taut state before use; (f) a first region of the fabric membrane is in a taut state before use, and a second region of the fabric membrane is not taut before use.

[0130] In a further embodiment: (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 the sealing structure form a mouth and nose pad assembly; (f) the air chamber and the sealing structure form a nose pad.

[0131] 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 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's respiratory cycle; the method comprising: 1) forming an airtight fabric composite material having a flat shape by applying an impermeable material to a fabric material; 2) cutting the fabric composite material to a desired size according to a specific type of pad assembly to be used; and 3) secondary molding a flexible support structure onto the cut fabric composite material to form a sealed forming 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, wherein, in the secondary molding step, the fabric composite material is held in place by vacuum to have a non-flat shape during secondary molding, thereby imparting a curved non-flat shape to the fabric membrane. No wrinkles, creases, folds, and / or deformations are formed in the fabric membrane.

[0132] In the embodiments: (a) the sealing-forming structure has a seamless transition along its outer surface from the support structure to the fabric membrane; (b) at the transition portion, 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 portion, both the support structure and the fabric membrane extend along curves in a direction from the front side of the sealing-forming structure to the patient-facing rear side of the sealing-forming structure; (c) the fabric membrane has two holes, and a bridging portion is disposed between the two holes of the fabric membrane, the bridging portion fastening with excess material to allow the fabric membrane to unfold to accommodate noses of different sizes; (d) the support structure comprises silicone.

[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 outer 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.

[0134] According to another aspect of the present technology, the sealing portion comprises fabric. In another embodiment, the patient interface includes an inflatable chamber and a support structure is configured to connect to the inflatable chamber, which at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cm H2O higher than ambient air pressure. The inflatable chamber includes an inflatable chamber inlet port, the size and structure of which are designed to receive an airflow at the therapeutic pressure for patient breathing. In another embodiment, 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 has 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 structure is constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use. In another embodiment, the support structure comprises silicone and / or a thermoplastic elastomer.

[0135] According to another aspect of the present technology, the wall structure of the support structure between the sealing portion 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.

[0136] 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 outer periphery of the sealing portion in such a way that the sealing portion is in a tensioned state before use.

[0137] According to another aspect of the present technology, the sealing portion comprises a fabric material. In another embodiment, the patient interface includes an inflatable chamber and a support structure is configured to connect to the inflatable chamber, which at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cm H2O higher than ambient air pressure. The inflatable chamber includes an inflatable chamber inlet port, the size and structure of which are designed to receive an airflow at the therapeutic pressure for patient breathing. In another embodiment, 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 has 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 structure is constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use. In another embodiment, the support structure comprises silicone and / or a thermoplastic elastomer.

[0138] 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 outer periphery of the sealing portion, wherein the support structure is more rigid than the sealing portion, and the support structure has a first segment of a first thickness and a second segment of a second thickness different from the first thickness.

[0139] According to another aspect of the present technology, 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, which at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cmH2O above ambient pressure. The inflatable chamber includes an inflatable chamber inlet orifice, the size and structure of which are designed to receive an airflow at the therapeutic pressure for the patient to breathe. In another embodiment, a 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 has an orifice formed therein, such that an airflow at the therapeutic pressure is delivered to an inlet at least the patient's nostrils. The sealing structure is constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0140] 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.

[0141] One aspect of this technology is a method of manufacturing the device.

[0142] 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.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] 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.

[0147] 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

[0149] 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:

[0150] 4.1 Treatment System

[0151] 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.

[0152] 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.

[0153] 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.

[0154] 4.2 Respiratory System and Facial Anatomy

[0155] 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.

[0156] 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.

[0157] 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.

[0158] 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.

[0159] 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.

[0160] 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.

[0161] Figure 2G A side view showing the surface features of the nose.

[0162] 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.

[0163] 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.

[0164] 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.

[0165] 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.

[0166] Figure 2L The frontal lateral view of the nose is shown.

[0167] 4.3 Patient Interface

[0168] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0169] 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.

[0170] 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.

[0171] 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.

[0172] 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.

[0173] 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.

[0174] Figure 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are shown. The vaulted and saddle-shaped areas are shown.

[0175] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edges of the surface are shown. The path on the surface between point A and point B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and a dome-shaped area are indicated.

[0176] 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.

[0177] 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.

[0178] 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.

[0179] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0180] 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.

[0181] Figure 3N Showing through Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0182] Figure 3O The left-hand rule is shown.

[0183] Figure 3P The right-hand rule is shown.

[0184] Figure 3Q The left ear is shown, including the left ear spiral.

[0185] Figure 3R The right ear is shown, including the right ear spiral.

[0186] Figure 3S A right-handed spiral is shown.

[0187] Figure 3T A view of the face mask is shown, which includes torsion marks of spatial curves defined by the edges of sealing membranes in different areas of the face mask.

[0188] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0189] 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.

[0190] 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 the intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the gasket of the inflation chamber at two points on the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the gasket in this region, the intermediate contact plane can be a tangent at the upper and lower points.

[0191] Figure 3X It shows Figure 3U The air chamber 3200 is positioned for use on the face. When the air chamber is in the use position, the sagittal plane of the air chamber 3200 approximately coincides with the midsagittal plane of the face. When the air 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.

[0192] 4.4RPT device

[0193] Figure 4A An RPT device of one form according to the present technology is shown.

[0194] 4.5 Patient Interface According to This Technology

[0195] Figure 5 This is a perspective view of the patient interface based on an example of this technology worn by a patient.

[0196] Figure 6 This is a perspective view of the patient interface based on another example of this technology worn by a patient.

[0197] Figure 7 It is the positioning and stabilization structure along Figure 6 The cross-sectional view of line 7-7 in the diagram.

[0198] Figure 8 yes Figure 7An enlarged view of part of the positioning and stabilizing structure.

[0199] Figure 9 yes Figure 7 An enlarged view of part of the positioning and stabilizing structure.

[0200] Figure 10 It is positioned on the patient's face. Figure 5 The main view of the padding component.

[0201] Figure 11 yes Figure 5 The main view of the padding component.

[0202] Figure 12 yes Figure 5 Top perspective view of the padding assembly.

[0203] Figure 13 yes Figure 5 Top view of the padding assembly.

[0204] Figure 14 yes Figure 5 Side view of the padding component.

[0205] Figure 15 yes Figure 5 The main view of the padding component.

[0206] Figure 16 yes Figure 5 Side view of the padding component.

[0207] Figure 17 yes Figure 5 Top view of the padding assembly.

[0208] Figure 18 This is a front view of a padding component positioned on a patient's face, according to another example of this technology.

[0209] Figure 19 yes Figure 18 Top view of the padding assembly.

[0210] Figure 20 yes Figure 18 The main view of the padding component.

[0211] Figure 21 yes Figure 18 A bottom view of the padding assembly.

[0212] Figure 22 yes Figure 18 Side perspective view of the padding assembly.

[0213] Figure 23 This is a front view of a padding component according to another example of this technology.

[0214] Figure 24 yes Figure 23 A bottom perspective view of the padding assembly.

[0215] Figure 25 yes Figure 23 Side perspective view of the padding assembly.

[0216] Figure 26 yes Figure 23 Top perspective view of the padding assembly.

[0217] Figure 27 yes Figure 23 Rear perspective view of the liner assembly.

[0218] Figure 28 This is a top perspective view of a liner assembly according to another example of this technology.

[0219] Figure 29 yes Figure 28 The main view of the padding component.

[0220] Figure 30 yes Figure 28 Side perspective view of the padding assembly.

[0221] Figure 31 yes Figure 28 Rear perspective view of the liner assembly.

[0222] Figure 32 yes Figure 28 A bottom view of the padding assembly.

[0223] Figure 33 This is a front perspective view of a liner assembly according to another example of this technology.

[0224] Figure 33-1 This is a front perspective view of a liner assembly according to another example of this technology.

[0225] Figure 33-2 It is along Figure 33-1 The cross-sectional view of line 33-2 in the diagram.

[0226] Figure 33-3 It is along Figure 33-1 The cross-sectional view of line 33-3—33-3 in the diagram.

[0227] Figure 33-4 It is taken from Figure 33-2 Zoomed-in details.

[0228] Figure 34 yes Figure 33 Cross-sectional view of the gasket assembly.

[0229] Figure 34-37This is a front perspective view of a liner assembly having a gripping pad disposed on a fabric membrane, according to an example of the present technology.

[0230] Figure 38 This is a perspective view of the patient interface based on another example of the technology worn by the patient.

[0231] Figure 39 This is a perspective view of the patient interface according to another example of this technology.

[0232] Figure 40 It is worn by the patient. Figure 39 A perspective view of the patient interface.

[0233] Figure 41 yes Figure 40 A side view of the patient interface.

[0234] Figure 42 yes Figure 40 The main perspective view of the patient interface.

[0235] Figure 43 yes Figure 39 The main view of the padding component of the patient interface.

[0236] Figure 44 yes Figure 39 Top view of the padding assembly.

[0237] Figure 45 yes Figure 39 A bottom view of the padding assembly.

[0238] Figure 46 yes Figure 39 Front perspective view of the liner assembly.

[0239] Figure 47 yes Figure 39 Rear perspective view of the liner assembly.

[0240] Figure 48 yes Figure 39 Side perspective view of the padding assembly.

[0241] Figure 49 yes Figure 39 The front perspective view of the liner assembly shows the interior of the liner assembly.

[0242] Figure 50 yes Figure 39 The front view of the liner assembly shows the interior of the liner assembly.

[0243] Figure 51 This is a rear view of a liner assembly according to an example of this technology.

[0244] Figure 52 yes Figure 51 The main view of the padding component.

[0245] Figure 53 yes Figure 51 Cross-sectional view of the gasket assembly.

[0246] Figures 54 to 56 This is a front perspective view of a liner assembly having a gripping pad disposed on a fabric membrane, according to an example of the present technology.

[0247] Figure 57 This is a perspective view of the patient interface 30000, an example of this technology.

[0248] Figure 58 yes Figure 57 The patient interface 30000 is shown in perspective when worn by a patient.

[0249] Figure 59 yes Figure 57 The patient interface 30000 shown is a cross-sectional view.

[0250] Figure 60 yes Figure 57 The patient interface 30000 is shown in a side view when worn by a patient.

[0251] Figure 61 yes Figure 57 Front perspective view of the liner assembly 30105.

[0252] Figure 62 yes Figure 57 Rear perspective view of the liner assembly 30105.

[0253] Figure 63 yes Figure 57 The main view of frame 30350.

[0254] Figure 64 yes Figure 57 The rear view of frame 30350.

[0255] Figure 65 yes Figure 57 The patient interface 30000 is shown from the back when worn by the patient.

[0256] Figure 66 yes Figure 57 The view of the patient interface 30000 positioning and stabilization structure 30300 strap.

[0257] Figure 67 This is a perspective view of the patient interface based on another example of this technology worn by a patient.

[0258] Figure 68 yes Figure 67 A side view of the patient interface.

[0259] Figure 69 yes Figure 67 The exploded view of the patient interface shown illustrates the padding assembly, frame assembly, arm cover, and elbow assembly.

[0260] Figure 70 This is a front exploded view of a liner assembly according to an example of this technology.

[0261] Figure 71 yes Figure 70 An exploded view of the gasket assembly.

[0262] Figure 72 yes Figure 67 The main view of the padding component of the patient interface.

[0263] Figure 73 yes Figure 72 Front perspective view of the liner assembly.

[0264] Figure 74 yes Figure 72 Rear perspective view of the liner assembly.

[0265] Figure 75 yes Figure 72 Top perspective view of the padding assembly.

[0266] Figure 76 yes Figure 72 A bottom perspective view of the padding assembly.

[0267] Figure 77 yes Figure 72 Side perspective view of the padding assembly.

[0268] 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.

[0269] Figure 79 It is a schematic diagram depicting the patient's face being presented to the fabric membrane with slight tension before use.

[0270] Figure 80 This is a schematic diagram showing the resultant force exerted on the patient's face by the fabric membrane due to the tensile stress in the fabric membrane.

[0271] Figure 81 This is a schematic diagram illustrating the tension applied to the sealing portion of the gasket assembly according to an example of this technology.

[0272] 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.

[0273] Figure 83This is a cross-sectional view of a liner assembly according to an example of this technology.

[0274] Figure 84 This is a cross-sectional view of a liner assembly according to an example of this technology.

[0275] Figure 85 This is a cross-sectional view of a liner assembly according to an example of this technology.

[0276] Figure 86 This is a cross-sectional view of a liner assembly according to an example of this technology.

[0277] Figure 87 This is a partial cross-sectional view of the sealing portion and support structure of a gasket assembly with an external bias portion, according to an example of the present technology.

[0278] Figure 88 This is a partial cross-sectional view of the sealing portion and support structure of a gasket assembly with an internal bias portion, according to an example of the present technology.

[0279] Figure 89 This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0280] Figure 90A This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0281] Figure 90A-1 yes Figure 90A An enlarged view of a portion of the sealing part of the gasket assembly.

[0282] Figure 90B This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0283] Figure 91 This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0284] Figure 92 This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0285] Figure 93 This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0286] Figure 94 This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0287] Figure 95 This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0288] Figure 96 This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0289] Figure 97This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0290] Figure 98 This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0291] Figure 99 This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0292] Figure 100 This is a partial cross-sectional view of a gasket assembly according to an example of this technology.

[0293] Figure 101 This is a cross-sectional view of a modular assembly of a sealing portion according to an example of this technology.

[0294] Figure 102 Examples of this technology include Figure 101 A partial cross-sectional view of the gasket assembly of the modular sealing component.

[0295] Figure 103 This is a perspective view of a modular support structure based on an example of this technology.

[0296] Figure 104 and 105 The process of molding a sealing portion into a support structure according to an example of this technology is shown.

[0297] Figure 106 Through Figure 104 and 105 The process shown presents a side view of the modular assembly of the sealed section.

[0298] Figure 107 and 108 A general-purpose gasket assembly according to this technology is shown as an example.

[0299] Figure 109 and 110 An example of a custom-made pad assembly manufactured using a three-dimensional profile obtained by scanning a patient’s face, according to the present technology, is shown.

[0300] Figure 111 This is a front perspective view of a liner assembly according to another example of this technology.

[0301] Figure 112 yes Figure 111 Rear perspective view of the sealing structure of the gasket assembly.

[0302] Figure 113 and 114 The knitting process is described.

[0303] Figure 115An example of a warp-knitted fabric according to this technology is shown.

[0304] Figure 116 An example of a weft-knitted fabric according to this technology is shown.

[0305] Figure 117 This is a functional block diagram illustrating an example of the process of overmolding a support structure onto a fabric composite material to form a sealed structure using a fabric membrane, according to an example of the present technology.

[0306] Figure 118A This is a front perspective view of a liner assembly according to another example of this technology.

[0307] Figure 118B This is a front perspective view of a liner assembly according to another example of this technology.

[0308] Figure 119 Various regions of a sealing formation structure according to an example of this technology are depicted.

[0309] Figures 120-1 to 120-6 Different examples according to this technology are shown. Figure 118A A cross-sectional view of the padding component in the image.

[0310] Figure 121 yes Figure 120-1 Magnified details of the fabric membrane. 5. Detailed Implementation

[0312] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this invention is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0313] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features may constitute another example.

[0314] 5.1 Treatment

[0315] 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.

[0316] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0317] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0318] 5.2 Treatment System

[0319] 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 .

[0320] 5.3 Patient Interface

[0321] According to one aspect of the present technology, the noninvasive 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 positively pressurized air to the airway.

[0322] 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.

[0323] 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 cm H2O relative to the environment.

[0324] 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 cm H2O relative to the environment.

[0325] 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 cm H2O relative to the environment.

[0326] 5.3.1 Inflation Chamber

[0327] In the area formed by the seal during use, the air chamber has a periphery shaped to complement the surface contours of a typical human 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. Alternatively, the air chamber may be made of a flexible material (e.g., silicone) and may be formed as a one-piece structure with a support structure (e.g., any material suitable for a support structure and / or air chamber as described herein). In examples, 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.

[0328] 5.3.2 Sealing Formation Structure

[0329] 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.

[0330] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0331] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as liquid silicone (LSR) (or "silicone").

[0332] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and resilient material such as silicone.

[0333] In some forms, such as in Figures 5 to 77 In the forms shown, 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 network 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 sealing portion.

[0334] In some forms, the fabric membrane can be configured to stretch elastically in at least one dimension. For example, when the fabric membrane is composed of a fiber network, it is capable of stretching along the longitudinal warp and / or transverse weft directions throughout the entire fabric membrane. In some forms, the fabric membrane is configured to stretch elastically to a greater extent than is achievable with conventional silicone sealant formation structures.

[0335] In some forms, the fabric membrane is constructed to be substantially inelastic in at least one dimension. For example, when the fabric membrane is made of woven fabric material, it is able to substantially resist elongation in either or both of the longitudinal warp or transverse weft directions of the fabric membrane.

[0336] Fabric membranes can be single-layered or multi-layered. In multi-layered forms, the individual layers can be formed using the same material or various different materials, each with unique material properties.

[0337] In some forms, the fabric membrane may include at least one layer that exhibits substantially impermeable properties while retaining the material properties necessary 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. In some forms, the impermeable material and the fabric material may be selected such that the resulting fabric membrane exhibits a predetermined overall elasticity or elastic resistance as needed. For example, the addition of an impermeable material (or membrane layer) may increase the elasticity (or tensile strength) of the fabric material, thereby increasing the tensile strength of the resulting fabric membrane.

[0338] In some forms, the membrane can exhibit a low spring constant (i.e., high compliance) in both the warp and weft yarns. In such forms, unlike conventional designs where fixing pads can result in a skin torque of 1300 on the patient's face 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 a fabric membrane bonded together. This can advantageously improve the comfort of the mask and reduce the formation of localized pressure "hot spots."

[0339] 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 pattern) with a first coefficient of friction in a first direction that is different (e.g., greater than or less than) the coefficient of friction in a second direction. Conversely, in use, a fabric with higher friction may cause the fabric membrane to grip or rub against the contact area of ​​the patient's face. Such friction or gripping may cause the fabric membrane to twist or deform, thereby reducing the effectiveness of the seal and allowing undesirable air leakage from the device.

[0340] In some forms, the fabric material of the fabric membrane can have a total thickness of 0.275 mm or less.

[0341] 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.

[0342] It should be noted that although the specification may refer to (e.g., by reference characters) a particular illustrated example or a feature of a particular illustrated example (e.g., sealing formation 3100), such discussion may apply to other examples and / or features (e.g., sealing formation 5100).

[0343] 5.3.2.1 Sealing Mechanism

[0344] 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.

[0345] 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.

[0346] 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 through a support structure before and / or during use. Before use, the fabric membrane may be permanently attached (e.g., molded) or attached to the support structure as a removable module, such that it is pre-tensioned and slightly stretched.

[0347] Alternatively, the fabric can be formed into a complex, predetermined three-dimensional shape such that the fabric is not taut (e.g., loose, relaxed, and / or wrinkled) before and / or during use, but without substantial leakage causing wrinkles. Due to manufacturing, the fabric polymer can shrink, resulting in the loss of the pre-tension inherent in the fabric membrane; however, the fabric membrane can remain substantially wrinkle-free.

[0348] Figure 79 An example is shown in which the fabric membrane has slight tension in both the X and Y directions on the fabric surface. Before the patient's face 1300 (such as the nose) approaches and presses against the fabric membrane 3130, the fabric membrane is adapted to form a constant surface without creating interruptions in the fabric material, such as wrinkles, creases, or folds, before the patient's face 1300 contacts 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 essentially free of any leakage that would cause wrinkling. This can be 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 folded or wrinkled portions of the seal-forming structure 3100 through which therapeutic air can leak. It can also be advantageous in ensuring that the fabric membrane remains at a minimum tension threshold as it is pressed against the patient's face 1300. Figure 80 ).

[0349] In some forms, areas of the fabric membrane can be pre-tensioned and slightly stretched, while other areas of the fabric membrane can remain loose. For example, in some forms, the subnasal region can be pre-tensioned, while the region covering the nostrils and / or the outside of the patient's mouth can remain untensioned (e.g., due to excess material) to form a saddle-shaped or valley-shaped area before use. This can advantageously improve sealing efficiency while reducing pressure on areas protruding into or towards the cavity (i.e., "hot spots") in facial anthropometric measurements. In another example, the sides of the nose region and / or bridge of the nose region can remain untensioned and / or loose before use to provide additional material to accommodate the facial contours of these sensitive facial areas. In yet another example, the bridging portion extending between the two nostril openings (e.g., bridging portion 3104) can be tensioned, loosened due to excess material, and / or bent before use, as shown in the example... Figure 33-1 As shown. The 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.

[0350] In some configurations, instead of having pre-tensioned areas, the fabric membrane can be formed to be essentially leak-free and without 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 with excess untensioned material. In some arrangements, an untensioned fabric membrane may be more comfortable because it applies less pressure to the patient's face.

[0351] In some forms, the fabric membrane can be in a substantially tension-free state and formed on the support structure or directly on the air chamber in a manner that keeps it unstressed and / or relaxed. In one example, such a fabric membrane can remain wrinkle-free to avoid leakage in the seal with the patient's face. In some forms, the unstressed and / or wrinkle-free fabric membrane can utilize padding supports (e.g., a lower pad, a seal support area (e.g., a support structure) and / or air pressure within the cavity) to enable an effective seal with the patient's face.

[0352] In some forms, the fabric membrane can be kept taut and / or wrinkle-free (see [reference]). Figure 80 and 81 ), so as to maintain a sealed contact with the patient's face 1300 by one or a combination of the following:

[0353] a) The pre-applied tensile stress of the fabric membrane and the additional tensile stress applied when the fabric membrane is joined to the patient's face at 130°.

[0354] 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.

[0355] 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 respond to applied tensile stress when the patient's face is 130° engaged with the fabric membrane; and

[0356] d) Additional load exerted on the inner surface of the fabric membrane by air pressure from the cavity. The internal air pressure can exert additional tensile stress on the inner surface of the fabric membrane to further stretch and stress the fabric membrane against the patient's face 1300 (e.g., to create a pressure-assisted seal).

[0357] By continuously maintaining the fabric membrane under tension 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 blowouts in 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 can also improve the performance of the CPAP device when it is subjected to external lateral or longitudinal forces (e.g., tube resistance).

[0358] In some configurations, the applied load of air pressure from the air chamber helps the fabric membrane maintain an effective seal when the inflatable chamber is pulled a short distance away from the patient's face 1300. The applied load of air pressure may be sufficient to cause the fabric membrane to stretch elastically in at least one dimension, creating a balloon-like "air cushion boat" effect on the anthropometric contours of the patient's face 1300, thus maintaining an effective seal thereon.

[0359] 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 any material, such as silicone, PU foam, PU solids, or other suitable materials. In some forms, the support structure can be relatively less rigid than the shell or frame of the inflation chamber.

[0360] In some forms, the magnitude of the tensile stress can be varied across the entire fabric membrane forming the seal structure as needed. For example, stress concentration areas may exist near one or more holes in the fabric membrane (through which treatment is performed) or in wider stretches of the material.

[0361] In some forms, the sealing formation structure can utilize a number of different gasket configurations, including a single air-assisted fabric membrane, a dual air-assisted fabric membrane, a fabric membrane with a compression support, or a fabric membrane with a TPU / TPE / Si support. In some forms, the gasket configuration of the sealing formation structure can be configured to advantageously provide a "universal size" solution.

[0362] In the example, the sealing structure and inflation chamber can be applied to nasal pads, nasal supports, mouth and nose pads, ultra-compact full-face masks, full-face masks, and other suitable pad arrangements.

[0363] In some forms, the fabric membrane can be configured to create an effective seal at the patient's nasal protuberance, for example, as... Figure 58 As shown. In some forms, the fabric membrane can be configured to create an effective seal against the lower point of the nasal septum of the patient's nose, such that the fabric membrane does not engage with the nasal protuberance, for example, as... Figure 40 As shown.

[0364] In some forms, during use, stretching the fabric membrane and / or maintaining its wrinkle-free state to conform to the patient's face 1300 can apply stress to the walls of the support structure. During use, this stress can pull the walls of the support structure inwards towards each other. In some forms, the support structure can be adapted to resist applied stress loads to prevent inward deformation. Therefore, during use, the rigidity of the support structure can apply further stress to the fabric membrane, which in turn can cause elastic stretching of the fabric membrane.

[0365] In some forms, such as in Figure 87 and 88 In the illustrated form, the support structure may include pleats, creases, or gussets (e.g., sealing bias portions 10140, 10140') that dynamically support the fabric membrane using internal air pressure. This can advantageously provide further support to the fabric membrane under dynamic loads (e.g., tube resistance). In other forms, the pleats, creases, or gussets may utilize internal air pressure to separate the dynamic load (e.g., tube resistance) from the sealing formation structure. In some forms, the air pressure within the cavity may apply a load to the inner surface of the fabric membrane to create further tensile stress, such that the fabric membrane substantially fills the concave contour of the patient's face 1300 (e.g., around the side of the nose). In some forms, the elasticity of the fabric membrane, combined with the load applied by the internal air pressure, can elastically stretch the fabric membrane, thereby creating a larger sealing contact area on the patient's face. In some forms, this can also help provide a continuous seal even when the mask is removed from the part that best fits the patient's face, because the fabric membrane may partially expand due to the reaction force generated by the internal air pressure (i.e., the "air cushion boat effect").

[0366] In some forms, such as in Figures 35 to 37 In the forms shown in 54 to 56, the fabric membrane may have one or more gripping pads 29150, 31150 disposed thereon. In one example, the gripping pads 29150, 31150 may be configured to be substantially flat along the patient-facing surface of the fabric membrane. In other examples, the gripping pads 29150, 31150 may be embossed such that the gripping pads may form beads or edges that slightly protrude above the surface of the fabric membrane. In some forms, the gripping pads 29150, 31150 may have a high coefficient of friction. In some forms, the gripping pads may have a defined shape (e.g., oval (see...)). Figure 35 , 37 (54 and 56), circular, square, etc.). In some forms, the gripping pad can be elongated (see...). Figure 35 and 54 In some forms, the gripping pads 29150 and 31150 may be linear. In some forms, the gripping pads may be arranged in a certain pattern on the surface of the sealing structure 3100. In some forms, the gripping pads may be arranged sporadically on the surface of the sealing structure 3100 (see...). Figure 37 and 56 In some forms, the gripping pads can be arranged to form around the periphery near the outer edge of the fabric membrane (see [reference]). Figure 34 , 35 54 and 55). In some forms, the gripping 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 gripping pads forming the perimeter can be in the form of solid lines (see...). Figure 36 and 55 In some forms, the gripping pads forming the perimeter can be in the form of multiple lines, dotted lines, or solid lines, or a combination thereof. In some forms, the gripping action helps the fabric membrane grip the patient's face. In one example, the gripping pads are formed as a relatively thin silicone layer applied to the surface of the fabric membrane.

[0367] In some forms, the fabric membrane can be integral with the support structure by attaching (e.g., molding) the outer edge (e.g., outer periphery) of the fabric membrane to the support structure via a lip around 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 a portion of the sealing-forming structure that bends from the front side of the sealing-forming structure toward the rear surface contact side (see...). Figure 11In this way, the fabric membrane can avoid having sections that bend from the back to the front. With this arrangement, the fabric membrane can be presented only along the front side of the sealing structure, for example, as... Figures 11 to 17 As shown. 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 leakage), thereby improving the sealing performance.

[0368] 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 sealing structure that bends from the front side of the sealing structure to the rear contact side (see example...). Figures 33-1 to 33-4 (73 and 74). This allows for more fabric membrane surface (rather than the support structure) to engage 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 deformations in the fabric membrane surface. It can be seen that, in some examples, at the transition portion 36, both the support structure and the fabric membrane can have radii of curvature (e.g., the same or similar radii of curvature) along curve 35 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 contours of the patient's face (e.g., the subnasal region of the patient's face (i.e., the corner of the nasal region, i.e., the area near the nasolabial fold where the alar of the nose terminates at the upper lip)), such as... Figure 33-1 As shown. The dome shape helps prevent creases, wrinkles, folds, and deformations in the fabric membrane, which can help avoid leakage paths. Similarly, the dome shape helps the fabric enter difficult-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 medial subnasal 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 acupoint region 3270 may also have a saddle shape, which is configured to seal against or below the matching contour presented at the nasal acupoint of the patient. The curvature (e.g., magnitude and / or radius of curvature) of the fabric membrane in the direction of curve 35 may vary along the outer periphery of the fabric membrane in different regions of the pad assembly. For example, as Figure 33-2As 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 As shown in Figures 61 and 61, the noses of the padding assemblies 14105, 30105, and 31105 may have similar dome and saddle-shaped features.

[0369] exist Figure 73 In the example, the curvature of the fabric membrane 16230, which begins at its connection with the support structure 16220 (e.g., at a transition), can continue to the inner edge of the fabric membrane. For example, the fabric membrane can have a dome or saddle shape at the inner edge of the fabric membrane in certain areas of the padding.

[0370] In some forms, the fabric membrane can be slightly tilted inward or curved inward towards the inside of the mask (positive curvature in the left-right direction), for example... Figures 11 to 17 As shown in Figures 23-26 and 3-37. In some forms, the fabric membrane can be formed into a dome shape above the supporting structure, for example, as shown in Figures 23-26 and 3-37. Figures 19 to 22 As shown in Figures 43 to 50. Note that any gasket 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 sealing-forming structure, as referenced above. Figure 33-1 As discussed, the fabric membrane 6130 of the sealing structure extends along curve 35 from the front side to the rear contact surface, such that the fabric membrane 6130 of, for example, the gasket assembly 6105 can be dome-shaped to a greater extent by means of a greater degree of convexity from one side to the other.

[0371] In some forms, if the fabric membrane is not subjected to continuous tension (before and / or during use) or is not elastic, the fabric membrane can form an improved air-assisted seal on the patient's face, thereby dynamically conforming to changes / movements caused by the fabric membrane being thinner than silicone membranes and having lower structural stiffness (e.g., "air-cushioned boat effect").

[0372] In some forms, the fabric membrane can be supported by a second or third support structure that can be used as a padding support. Padding supports provide additional flexibility and can be fitted to most patient faces (universal sizes). The second or third support layer can 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 can be supported by structural / rigid plastics such as PP / PC / PA / PET or other suitable materials.

[0373] In some forms, 3D printing fabric membranes and / or padding supports as a “skeleton” can reduce thickness and thus reduce the weight of the mask.

[0374] In some forms, multiple different layers of the mask can be printed with varying rigidity, hardness, or thickness. For example, the "skeleton" portion can be formed using Si, PU foam, PU solid material, or any suitable plastic material.

[0375] 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.

[0376] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and positioned in a compressed state, for example as a result of elastic tension in the positioning and stabilizing structure.

[0377] 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.

[0378] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0379] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0380] 5.3.2.2 Nasal bridge or nasal ridge area

[0381] 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.

[0382] 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.

[0383] 5.3.2.3 Upper lip area

[0384] 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.

[0385] In one embodiment, the sealing structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0386] 5.3.2.4 Chin area

[0387] 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.

[0388] 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.

[0389] 5.3.2.5 Forehead area

[0390] 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.

[0391] 5.3.2.6 Nasal pillow

[0392] 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.

[0393] 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.

[0394] 5.3.3 Nasal Liner

[0395] refer to Figures 5 to 14 The image shows a patient interface 3000, 6000 with a liner assembly 3105 according to the first example of the present technology, the liner assembly including a sealing formation structure 3100 and an inflation chamber 3200. Figures 15 to 17A second example of a liner assembly 5105 according to the present technology is shown, which includes a sealing forming structure 5100 and an inflation chamber 3200. Figures 18 to 22 A third example of a liner assembly 6105 according to the present technology is shown, which includes a sealing forming structure 6100 and an inflation chamber 3200. Figures 23 to 27 A fourth example of a gasket assembly 7105 according to the present technology is shown, which includes a sealing forming structure 7100 and an inflation chamber 3200. Reference Figures 28 to 32 Figure 3 illustrates a fifth example of a liner assembly 8105 according to the present technology, which includes a sealing forming structure 8100 and an inflation chamber 3200. Figure 3 also illustrates a sixth example of a patient interface 9000 according to the present technology, which includes a liner assembly 9105 and a frame 9200.

[0396] Figures 11 to 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.

[0397] Examples of the sealing structures 3100, 5100, 6100, 7100, 8100, and 9100 described above can be considered as nasal pads and are designed to provide pressurized airflow to the patient's nostrils by sealing against at least the lower side of the patient's nose. Exemplary sealing structures may engage the patient's face below the bridge of the nose, and depending on the size and shape of the patient's nose, some examples may engage the patient's nose below the nasal protuberance. Exemplary sealing structures may also engage the patient's face at least above the upper vermilion portion. Thus, exemplary sealing structures may seal against the patient's upper lip during use. Furthermore, the patient's mouth may remain uncovered by the depicted example sealing structures, allowing the patient to breathe freely, i.e., directly into the atmosphere without interference from the sealing structures. The subnasal pads may be configured such that they do not have openings sized to receive 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 ).

[0398] 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.

[0399] 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.

[0400] Inflation chamber

[0401] 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.

[0402] In some forms of this technology, the air chamber 3200 is made of a relatively rigid material (e.g., polycarbonate) compared to the sealing structure. Alternatively, the air chamber 3200 may be made of a flexible material (e.g., silicone) and may be formed as a one-piece structure with a support structure (e.g., formed of any material suitable for a support structure and / or air chamber as described herein). In examples, the sealing 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 structure. In such examples, 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 (e.g., 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.

[0403] 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.

[0404] Figure 5 and 10 Examples of a sealing structure 3100 having an inflation chamber 3200 are shown up to 17. The sealing structure 3100 may include an inflation chamber connection opening, wherein the sealing structure 3100 is sealingly connected 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 example shown, the sealing structure 3100 and the inflation chamber 3200 together form the cavity 3101.

[0405] 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. Optionally, the sealing structure 3100 can be connected to the inflation chamber 3200 at the inflation chamber connection opening via a mechanically removable detachable connection.

[0406] On each side of the inflation chamber 3200, there may be an inflation chamber side end 3202 in the form of a hollow channel forming an inflation chamber inlet orifice, the size and structure of which are designed to receive airflow. An inflation chamber connector 3204 may also be provided on each side of the inflation chamber 3200, laterally outside 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 may have a releasable connection. In yet another example, both connections between the inflation chamber connector 3204 and the corresponding end 3314 of the positioning and stabilizing structure 3300 may be permanent.

[0407] The side end 3202 of the inflation chamber can receive pressurized airflow from the positioning and stabilizing structure 3300. The pressurized airflow can then pass through the inflation chamber 3200, then through the sealing forming structure 3100, and into the patient's airway for inhalation.

[0408] End 3314 of the positioning and stabilizing structure 3300 can be connected to the lateral end 3202 of the inflation chamber. In these examples, each inflation chamber connector 3204 may include a slot 3209, a chamfered edge 3208, and a notch 3206, which can be removably connected to the clamp of the positioning and stabilizing structure by a snap-fit ​​engagement.

[0409] Figures 18 to 32 The air chamber 3200 shown in the third, fourth, and fifth examples according to this technology can be used with Figures 10 to 17The air chamber is similar to or identical to that of the present invention. It should also be understood that one or more aspects of the present invention may be combined with one or more of the following: U.S. Provisional Application No. 62 / 764,992, filed August 20, 2018, entitled “Patient Interface,” or PCT / AU2019 / 050873, filed August 20, 2019, the entire contents of which are incorporated herein by reference. For example, the air chamber of the present invention 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 the present invention may include any features of the sealing formation structures in any embodiment of the '992 or '873 application.

[0410] exist Figures 28 to 32 In the example, similar to the inflation chamber 3200 described above, 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. However, the vent 3400 can 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). Note that any other example may have a vent insert (e.g., Figures 10 to 27 The vent 3400 in the inflation chamber 3200 can be made of, for example, Figures 28 to 32 The vent insert 13400 shown is provided.

[0411] exist Figure 38 In the example, frame 9200 may include a central 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 a spaced-apart connector 9122, which may include a clamp on the sealing formation and a receiving connector on the frame.

[0412] The sealing structure of this technology

[0413] The sealing structures 3100, 5100, 6100, 7100, 8100, 9100, and 29100 may each include support structures 3120, 6120, 7120, 8120, 9120, and 29120, which provide support to 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. Furthermore, depending on the size and contour of the patient's nose, in Figures 5 to 27 In the example, the support structure can also be sealed to the patient's face.

[0414] Exemplary sealing structures 3100, 5100, 6100, 7100, 8100, 9100, and 29100, while differing in various aspects further described below, each may include a support structure having at least two regions (e.g., two, three, or four regions) of varying thicknesses. (For example, sealing structure 3100 includes a support structure 3120 with a wall structure, the thickness of which is increased relative to the other portions of the wall structure for its lateral support region 3122.) For example, as... Figure 59 As 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 sealing portion 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, for example, at the corners of the nasal region of the sealing formation (and can be directly connected to the fabric membrane, for example), to ensure adequate sealing in the subnasal region of the patient's face.

[0415] Furthermore, in the depicted example, each sealing portion has two separate nostril openings 3102, each corresponding to one of the patient's nostrils, to provide airflow to both nostrils. A bridging portion 3104 may be located between the nostril openings 3102. The bridging portion 3104 may assist in providing a taut fabric membrane before and / or during use. In an alternative example, airflow may be provided to both of the patient's nostrils using a single opening.

[0416] The sealing structure 3100 described above may include an inflation chamber connection opening, wherein the sealing structure 3100 is sealingly connected to the inflation chamber 3200. Figures 5 to 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 through which it is sealed to the inflation chamber 3200.

[0417] The rigidity of the support structure can be less than that of the air chamber 3200, and it can be made of silicone, foam (e.g., polyurethane foam) (see...). Figures 28 to 32The sealing portion may be composed of polyurethane solid materials, thermoplastic elastomers (e.g., thermoplastic polyurethane), suitable plastics, or other suitable materials as described below. Furthermore, the rigidity of the sealing portion may be less than that of the supporting structure, and it may be composed of fabric materials such as nylon, polyester, nylon and polyester blends, microfibers, or polyurethane, as will be described in more detail later. The sealing portion described in any example of the invention may be referred to as a fabric sealing portion or a fabric membrane, and may comprise a fabric material having an impermeable material laminated, coated, or otherwise applied thereon.

[0418] The support structure may have pores formed therein, providing an inner edge for the support structure. A sealing portion (e.g., the outer periphery of the sealing portion) may be attached to the support structure along this inner edge, such that the sealing portion extends radially inward from the support structure beyond the support structure or extends to a degree greater than the support structure, for example, as... Figures 11 to 27 As shown in Figures 33 to 38. For example, the sealing portion may be molded around the inner edge of the support structure or otherwise suitably attached to the support structure, as described later. However, in Figures 28 to 32 In an alternative example, the sealing portion 8130 may be laminated onto the support structure 8120 (e.g., foam).

[0419] refer to Figures 11 to 14 The sealing forming portion 3100 has a wall structure that may include a lateral support region 3122, the thickness of which is increased compared to other portions of the wall structure of the support structure 3120. A lateral support region 3122 may be provided on each of the outermost sides of the sealing forming structure 3100. The sealing forming structure 3100 may include two lateral support regions 3122, each spaced apart distally from the plane bisecting the sealing forming structure 3100, which will be parallel to the patient's sagittal plane in use. The lateral support region 3122 may be the thickest portion of the sealing forming structure 3100 to provide resistance to lateral displacement, for example, caused by the patient sleeping on their side, allowing the nasal pillow to laterally press against the sealing forming structure and providing a firm engagement with the patient's nasal ala. The lateral support region 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.

[0420] Additionally, the lateral support region 3122 can provide sufficient rigidity to ensure adequate sealing in the subnasal region of the patient's face (i.e., the region where the alar terminates 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 alar, the upper lip, and the cheek—converge in this region. Therefore, sufficient rigidity in the lateral support region 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. The lateral support region 3122 can be located on the patient's face, in the region below the patient's alar and in the region below and laterally lateral to the patient's nose, for example, between the nasolabial fold and the region of the upper lip located below the alar.

[0421] Figures 15 to 17 The sealing structure 5100 in the example can have the same Figures 11 to 14 The 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. As a result, the sealing forming structure 5100 can be more flexible and compliant, making it easier to conform to the patient's facial contours.

[0422] Turn Figures 18 to 22 In this example, the sealing structure is arranged to provide a larger cavity 3101, causing the sealing portion 6130 to protrude further from the inflation chamber in the direction toward the patient's face during use by creating greater tension within the sealing portion, thereby causing the sealing portion to expand outward. 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 stretch and invert, such that the space formed by the cavity 3101 accommodates the patient's nose, thereby allowing the sealing portion 6130 to seal above the patient's nasal protuberance, as... Figure 18 As shown. In contrast, as Figure 10 As shown, sealing parts 3130 and 5130 are sealed below the patient's nasal protrusion.

[0423] exist Figures 23 to 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 pad. The sealing portion 7130 is configured to provide a further seal along the upper lip vermilion direction along the bridge of the nose compared to the sealing portion 6130.

[0424] exist Figures 28 to 32In the exemplary pad assembly, the support structure 8120 may be provided by foam material laminated onto the inflation chamber 3200. The sealing portion 8130 may be laminated directly onto the support structure. The support structure 8120 may extend through the inflation chamber connection opening, except for a pair of holes formed therein (corresponding to the nostril openings 3102 in the sealing portion 8130). This arrangement can provide a compression seal against the patient's face, wherein the pad assembly 8105 is pulled toward the patient's face by a headband, thereby causing the seal-forming structure 8100 to conform to the patient's facial contours through compression of the support structure 8120.

[0425] The liner assembly 8105 is configured to seal against the underside of the patient's nose. The seal-forming structure 8100 includes an end portion 8122 that curves around the rear of the inflation chamber 3200 and is configured to engage the patient's upper lip in use.

[0426] refer to Figures 33 to 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 sealing portion 29130. (Reference) Figure 33-1 The gasket assembly 29105-1 is similar to the gasket assembly 29105, but may have a formed fabric membrane 29105 such that the fabric membrane forms a portion of the sealing structure that bends from the front side of the sealing structure to the rear contact side (as previously described).

[0427] As mentioned above, Figures 35 to 37 The gripping pad 29150 on the surface of the fabric membrane is shown.

[0428] exist Figure 38 In the example, the sealing portion 9130 is arranged to seal above the patient's nasal protuberance.

[0429] 5.3.3.1 Positioning and Stabilizing Structure

[0430] 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.

[0431] In one configuration, positioning and stabilizing structures 3300, 9300 provide at least sufficient holding force to overcome the positive pressure in cavity 3101 to elevate away from the face.

[0432] In one form, positioning and stabilizing structures provide holding forces to overcome the effects of gravity on the patient interface.

[0433] In one form, the positioning and stabilizing structure provides holding forces as a safety margin to overcome the potential effects of destructive forces acting on the patient interface, such as those from tube resistance or accidental interference with the patient interface.

[0434] 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.

[0435] In one form of this technology, a positioning and stabilizing structure is provided, configured not to be too large or bulky to prevent the patient from lying in a supine position, wherein the posterior region of the patient's head rests on a pillow.

[0436] 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.

[0437] 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.

[0438] 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.

[0439] In some forms of this technology, the positioning and stabilizing structure includes a strap that is extendable, such as elastically stretchable. For example, the strap may be configured to withstand tensile forces 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.

[0440] In one form of the present 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.

[0441] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that 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.

[0442] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap 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.

[0443] 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.

[0444] 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.

[0445] In some forms of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300, 9300, each positioned and stabilizing structure 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.

[0446] 5.3.3.1.1 Positioning and Stabilization Structure of this Technology

[0447] Figure 5 An example of the present technology is depicted, including a positioning and stabilizing structure 3300. In this example, the positioning and stabilizing structure 3300 includes a transverse portion 3302 and an upper portion 3304 in the form of a conduit, which guides 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 such, the decoupling structure 3500 can rotate within the hub 3306, and when the patient wears the patient interface 3000, for example, 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.

[0448] 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 lateral end 3314 can be constructed or molded from a single piece of silicone.

[0449] The upper portion 3304 of the positioning and stabilizing structure 3300 has ridges and valleys (or convection sections) 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.

[0450] The transverse portion 3302 of the positioning and stabilizing structure 3300 may not form the ridge and valley of the upper portion 3304. Therefore, the transverse 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 side of the patient's head are less variable.

[0451] End 3314 can be connected to the corresponding inflation chamber side end 3202. As described above, the inflation chamber side end 3202 receives pressurized airflow 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, end 3314 can be connected to the inflation chamber connector 3204 of the corresponding inflation chamber side end 3202.

[0452] The positioning and stabilizing structure 3300 can be constructed and arranged to guide the force / tension provided by the transverse portion 3302 into the force vector applied to the upper and lower portions of the pressurization chamber 3200. In particular, the force vectors on the upper and lower portions cause the fabric membrane of the sealing forming structure 3100 to make sealing contact with the lower side of the nose that contacts the patient's nose, for example, at or below the nasal protuberance and at least above the upper nasal protuberance.

[0453] The transverse portion 3302 may also each include a tab 3308 that receives the rear strap end 3311 of the rear strap 3310. The rear strap 3310 may be length-adjustable, for example, having a hook-and-loop material arrangement, whereby one of the rear strap end 3311 and the remainder of the rear strap 3310 includes hook material on its exterior, while the other includes loop material on its exterior. The length adjustability of the rear strap 3310 allows for increased tension on the transverse portion 3302 to pull the sealing structure 3100 into a sealed engagement with the patient's face under the desired pressure (i.e., tight enough to avoid leakage without being too tight to cause discomfort).

[0454] The transverse portion 3302 may also be provided with a sleeve 3312, which cushions the patient's face against the transverse portion 3302. The sleeve 3312 may be made of a breathable fabric material with a soft touch.

[0455] exist Figure 6 In the alternative example shown, the patient interface 6000 includes a positioning and stabilization 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 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.

[0456] 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 each be secured 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 special 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, thereby activating the thermosetting or thermoplastic material used in the tube 6350. Heat may be used not only to join 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 join these layers together. In some forms, sutures are not used. In a further form, the material beyond the inner layer is not used for connecting the inner and outer layers of the tube. For example, in some forms, inner and outer layers can be formed so that no additional material such as glue or stitching is needed to join the inner and outer layers together.

[0457] 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.

[0458] In some forms, one or more sheets of the tube may include an airtight layer or membrane. In some forms, the inner surfaces of both layers include a membrane configured to restrict or confine air from the inner surface to the outer surface through the layers. The airtight layer may be a thin layer less than the thickness of these fabric sheets of the inner or outer layers. In other forms, the airtight layer may be greater than the thickness of the fabric sheet of either layer. The airtight layer, diaphragm, or membrane may be completely impermeable to air transfer, or may be formed to allow a predetermined rate or amount of air transfer at a specific pressure.

[0459] The diaphragm can be formed from a thermoplastic or thermosetting material, allowing the diaphragm material to be molded or shaped into a specific form when exposed to a specific temperature, and then cured, solidified, 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-shaped to extend away from the inner layer 6352 between the opposing joints 6312. That is, the outer layer 6354 can support its own weight such that, when not supported by compressed air or other support mechanisms, the outer layer 6354 remains spaced apart from the inner layer 6352 between the joints 6312.

[0460] In contrast, 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.

[0461] like Figure 7 As shown, especially Figure 8 As shown, the inner layer 6352 includes a fabric sheet 6360 and a diaphragm 6362. The fabric sheet 6360 may be formed of felt, foam, woven, knitted or nonwoven materials or other fiber networks.

[0462] The outer layer 6354 includes a tube sheet 6364 and an outer covering 6366. In some forms, the tube sheet 6364 may be covered with membranes on both sides. Figure 9 As shown, the tube sheet 6364 includes a membrane 6368 exposed to the chamber of the tube 6350 and a membrane 6370 along the opposite surface of the tube sheet 6364. The membrane 6368 helps provide a seal between the inner layer 6352 and the outer layer 6354, and also helps form an airtight tube. The membrane 6370 helps connect the tube sheet 6364 to the outer cover 6366.

[0463] It should also be understood that one or more aspects of this technology may be combined with one or more of the following: U.S. Provisional Application No. 62 / 821,878, filed March 21, 2019, entitled “Textile Headgear Tubing for a Patient Interface,” or PCT / AU2019 / 050655, filed June 25, 2019, the entire contents of which are incorporated herein by reference. 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.

[0464] exist Figure 38 In 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 corresponding sides of the patient's head. The 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 coronal portion of the patient's head.

[0465] 5.3.3.2 Vent

[0466] In one embodiment, the patient interface 3000, 6000, 9000 includes a ventilation port 3400, which is configured and arranged to allow the expulsion of exhaled gases, such as carbon dioxide, as exemplified by Figure 5 As shown.

[0467] 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.

[0468] 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.

[0469] A vent 3400 may be located within an inflation chamber 3200. As described above, the vent 3400 may include a plurality of holes. 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.

[0470] The radius of the orifice 3400 decreases from the inside to the outside of the air chamber 3200. Each vent has a draft angle. The diameter of each orifice at its front end is smaller than its diameter at its rear end. This draft angle means that these orifices do not have small cross-sections across the entire chassis thickness, which helps to provide effective carbon dioxide flushing at high humidity levels. Additionally, the 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 and easier ejection.

[0471] The vents 3400 can be arranged in two sets facing the center of the inflation chamber 3200, and these sets can be symmetrical along the center line of the inflation chamber 3200. Providing a pattern of multiple vent holes can reduce noise and concentrate diffused flow.

[0472] The vent 3400 can be positioned at an optimal distance from the centerline of the air chamber 3200. Orienting 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 vent 3400 prevents blockage during side-lying sleep while ensuring sufficient rigidity in the central portion of the chassis.

[0473] The size and number of each vent hole can be optimized to achieve a balance between noise reduction and necessary carbon dioxide flushing, even under extreme humidification. In the depicted example, the vent hole of vent 3400 may not provide the full 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.

[0474] Figure 31 and 32An alternative example of an vent 3400 is shown, wherein a hole is provided in the vent insert 13400, which is removably or permanently attached to the inflation chamber 3200 at the opening of the vent insert. The vent insert 13400 may be made of a material that is more flexible than the material of the inflation chamber 3200.

[0475] 5.3.3.3 Decoupling Structure

[0476] 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.

[0477] 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.

[0478] The decoupling structure 3500 may also include a rotating shaft 3502, which allows for a rotatable connection to the air circuit 4170.

[0479] The rotatability of the decoupling structure 3500, the elbow-shaped form of the decoupling structure 3500, and the rotatability of the rotating shaft 3502 on the decoupling structure 3500 can increase the degree of freedom, which in turn reduces the tube resistance and torque on the patient interface 3000 caused by the connection to the air circuit 4170.

[0480] 5.3.3.4 Connection Port

[0481] Connection port 3600 allows connection to air circuit 4170.

[0482] 5.3.3.5 Forehead Stent

[0483] In one configuration, the patient interface includes a forehead stent 3700.

[0484] 5.3.3.6 Anti-asphyxiation valve

[0485] In one form, the patient interface includes an anti-asphyxiation valve.

[0486] Port 5.3.3.7

[0487] In one embodiment of this technology, the patient interface 3000, 6000, 9000 includes one or more ports that allow access to the 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.

[0488] 5.3.4 Full-face padding

[0489] 5.3.4.1 Example shown in the first example

[0490] refer to Figures 39 to 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 an 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.

[0491] refer to Figures 51 to 56 The diagram illustrates 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 an 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.

[0492] The liner assembly 31105 includes similar to Figures 39 to 50 The features described herein, but not discussed separately, include the nose 31101, nasal opening 31103, oral cavity portion 31102, oral cavity opening 31104, cavity 31001, support structure 31120, sealing portion 31130, and vent 31400. A pair of inflation chamber openings are configured to receive airflow.

[0493] As mentioned above, Figures 54 to 56 The gripping pad 31150 on the surface of the fabric membrane is shown.

[0494] Inflation chamber

[0495] 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.

[0496] 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 (e.g., 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.

[0497] 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.

[0498] An example of the present technology, the inflation chamber 14200, may include an inflation chamber aperture on each side. The inflation chamber aperture provides pneumatic communication between the catheter connector 14800 and the lumen 14001, which will be described in more detail below. A connecting edge portion surrounding each inflation chamber aperture may facilitate a mechanical connection with the corresponding catheter connector, such as a snap-fit ​​or 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 14200.

[0499] 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 removed from the inflation chamber 14200. The sealing structure 14100 can be overmolded into the inflation chamber 14200. The sealing structure 14100 and the inflation chamber 14200 can be connected by a mechanical connection, wherein no chemical bond is formed between the inflation chamber 14200 and the sealing structure 14100.

[0500] Sealing Formation Structure

[0501] refer to Figures 39 to 50 The sealing structure 14100 may include a nose portion 14101 having a pair of nasal openings 14103 for sealing with a 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 of both patients. A bridging portion 14106 may be located 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.

[0502] The sealing structure 14100 may include an oral portion 14102 having an oral portion hole 14104 for sealing with the patient's mouth.

[0503] The sealing structure 14100 can at least partially form a cavity 14001, which is pressurized by an airflow. An inflation chamber 14200 can be connected to the sealing structure 14100 to further form the cavity 14001.

[0504] 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 seal against the patient's face. Furthermore, depending on the size and contour of the patient's nose, the support structure may also seal against the patient's face.

[0505] The support structure 14120 may include wall structures in at least two regions with 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 sealing portion 14130 in order to provide structural stability at the connection with the inflation chamber 14200 and flexibility at the interface with the patient). Figure 84 An example is shown in which 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 inflation chamber, and portion (d2) may be adjacent to or connected to the sealing portion 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 may be located at, for example, the corners of the nasal region and / or the areas 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.

[0506] As described above, the sealing structure 14100 can be hermetically connected to the inflation chamber 14200. The rigidity of the support structure 14120 can be less than that of the inflation chamber 14200, and it can be made of silicone, foam (e.g., polyurethane foam), solid polyurethane material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable materials as described below. Furthermore, the rigidity of the sealing portion 14130 can be less than that of the support structure 14120, and it can be made of fabric materials such as nylon, polyester, nylon and polyester blends, microfibers, or polyurethane, as will be described in more detail later.

[0507] The support structure 14120 may have a pore formed therein, which provides an inner edge of the support structure. A sealing portion 14130 (e.g., the outer periphery of the sealing portion) may be attached to the support structure along this inner edge, such that the sealing portion extends radially inward from the support structure beyond the support structure or extends to a degree greater than the support structure, for example, as... Figures 43 to 46As shown. For example, the sealing portion may be molded around the inner edge of the support structure or otherwise suitably attached to the support structure, as described later.

[0508] exist Figure 49 In one example, the support structure 14120 may extend into the cavity 14001 to form a lower liner 14121, providing support for the sealing portion 14130. The lower liner 14121 and the sealing portion 14130 may form a double-walled structure around the periphery of the sealing portion. In an alternative example, a second or third lower liner layer may be provided to form a three- or four-walled structure. Figure 49 In the example, the underliner is made 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 recognized that the underliner can be made of other suitable materials (e.g., fabric).

[0509] It should also be understood that one or more aspects of this technology may be combined with one or more of the following: U.S. Provisional Application No. 62 / 609,909, filed December 22, 2017, or WO 2019 / 119058, filed December 21, 2018, both entitled “Conduit Headgear Connector for Patient Interface,” each of which is incorporated herein by reference. For example, the catheter and positioning and stabilization structure of this technology may be identical to the catheter and positioning and stabilization structure in any embodiment of the '909 or '058 application. Additionally, the padding assemblies and sealing formation structures disclosed herein may replace any padding assemblies (sealing formation structures and air chambers) or sealing formation structures in any patient interface disclosed in the '909 or '058 application.

[0510] 5.3.4.1.1 Positioning and Stabilizing Structure

[0511] 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.

[0512] 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.

[0513] In one configuration, the positioning and stabilizing structure 14300 provides holding forces to overcome the effects of gravity on the patient interface 14000.

[0514] In one form, the positioning and stabilizing structure 14300 provides a holding force as a safety margin to overcome the potential impact of destructive forces on the patient interface 14000, such as destructive forces caused by tube resistance or accidental interference with the patient interface.

[0515] 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 device. 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.

[0516] 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.

[0517] 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.

[0518] In one embodiment of this technology, the positioning and stabilizing structure 14300 is configured to have a decoupling portion between its front and rear portions. This decoupling portion does not resist compression and may be, for example, a flexible 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.

[0519] 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.

[0520] 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.

[0521] In one form of this technology, the positioning and stabilizing structure may include a first tether (e.g., upper strap 14302, Figure 41The 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.

[0522] 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 tether is constructed and arranged such that, in use, at least a portion of the upper edge of the second tether 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.

[0523] 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.

[0524] 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.

[0525] In some forms of this technology, the positioning and stabilizing structure 14300 includes a strap that is configured to be breathable to allow moisture to be transferred through the strap.

[0526] In some forms of this technology, a system is provided comprising 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.

[0527] Positioning and stabilizing structure 14300 may include clip 14301 to secure a corresponding tether, for example, to catheter connector 14800, such as Figure 39 As shown. Clip 14301 and conduit connector 14800 may each include a magnet arranged with opposite polarities to facilitate connection between them.

[0528] 5.3.4.1.2 Vent

[0529] In one form, the patient interface 14000 includes a ventilation port 14400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide, as... Figure 39 As shown.

[0530] 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.

[0531] One form of vent 14400 according to the present technology includes a plurality of holes, such as about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0532] The vent 3400 can be located in the inflation chamber 14200, such as Figure 47 As shown. Optionally, the vent 14400 is located in a decoupling structure, for example, a rotating shaft.

[0533] Figure 39 An example of a vent 14400 provided on a connection port 14600 (e.g., a rotating shaft bend) is shown. Variations of these examples may exclude the vent 14400 from the connection port 14600.

[0534] The catheter connector 14800, which will be described in more detail below, may also include a vent feature.

[0535] 5.3.4.1.3 Decoupling Structure

[0536] 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.

[0537] 5.3.4.1.4 Connection Port

[0538] 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 rotate relative to connection port housing 14903, and the connection to air circuit 4170 can also be rotatable.

[0539] In use, the connection port 14600 and the connection port housing 14903 can be positioned above the patient's head.

[0540] 5.3.4.1.5 Forehead support

[0541] Figures 39 to 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.

[0542] 5.3.4.1.6 Catheter

[0543] The patient interface 14000 according to an example of the present technology may include a catheter 14900 to provide a flow of compressed air from a connection port 14600 to a cavity 14001 in an inflation chamber 14200. The catheter 14900 may be connected at a connection port housing 14903 above the patient's head and may pass along the side of the patient's head between corresponding objects 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 flow of pressurized air to the cavity 14001.

[0544] 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 a tether for positioning and stabilizing structure 14300. Thus, the mechanical connection between the catheter 14900 and the catheter connector 14800 may be sufficient to allow tension in the catheter 3900 to be transmitted through the catheter connector 14800 to the sealing structure 14100.

[0545] Catheter 14900 may include features of a similar catheter disclosed in International Application Publication No. WO 2017 / 124155 A1, the entire contents of which are incorporated herein by reference. For example, catheter 14900 of this technology may include features described in this document. Figures 3A to 3L Features of the headband tube 3350 as described in Chinese and related written descriptions.

[0546] The catheter 14900 may also be provided with a sleeve 14901 to cushion the patient's face against the catheter 14900. The sleeve 14901 is removable. The sleeve 14901 may be made of a breathable material.

[0547] The conduit 14900 may also include a tether connector 14902 to facilitate connection with the tether of the positioning and stabilizing structure 14300.

[0548] 5.3.4.1.7 Conduit Connector

[0549] Patient interface 14000 according to an example of the present technology may include catheter connector 14800 to connect catheter 14900 to liner assembly 14105 to provide pressurized airflow to cavity 14001. Catheter connector 14800 may each be formed with catheter connector housing 14801. Catheter connector 14800 may provide other functions, as described below, such as venting of inflation chamber 14200, connection to positioning and stabilizing structure 14300, and prevention of asphyxiation by including anti-asphyxiation valve 14850.

[0550] Figures 43 to 50 Several views of a catheter connector 14800 of an example patient interface 14000 according to this technology are shown.

[0551] exist Figures 39 to 50 In the diagram, a conduit connector 14800 is shown attached to an air chamber 14200 at an air chamber orifice (not shown). It can be seen that there is one conduit connector 14800 on each side of the liner assembly 14105, and each conduit connector 14800 is connected to an air chamber orifice on each corresponding side of the liner assembly 14105. Each conduit connector 14800 may include a conduit connector attachment structure to connect each conduit connector 14800 to a corresponding air chamber orifice at a connection edge (not shown). This connection may be mechanical, such as a snap-fit ​​or friction fit. The connection may also be removable. The materials of the conduit connector 14800 and the air chamber 14200 may be selected respectively to facilitate desired connection features. For example, the materials of the conduit connector 14800 and the air chamber 14200 may each be relatively rigid to allow auditory and / or tactile feedback associated with a snap-fit ​​engagement. At least in one respect, the materials of the catheter connector 14800 and the inflation chamber 14200 may be different or the same. The catheter connector 14800 may also be permanently connected 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 removable or permanent) may also be designed to be strong enough that tension from the catheter 14900 can be transferred to the inflation chamber 14200 without interrupting the connection, because, as explained above, the catheter connector 14800 can facilitate the positioning and stability of the sealing structure 14100 on the patient's head.

[0552] 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 explained above, the inflation chamber 14200 can be made of a transparent or translucent material, which allows the patient's facial features to be visible. By laterally positioning the catheter connector 14800 on the inflation chamber, for example, as shown in the illustrated 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 the bend and air circuit can be connected to the center of the inflation chamber 14200, thereby obscuring the patient's view of their face.

[0553] 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 pressurized airflow. The conduit connector 14800 may include, for example, an undercut structure to facilitate a removable, snap-fit ​​connection with the corresponding conduit 14900, and each conduit 14900 may include a relatively rigid structure at the end connected to the conduit connector 14800 to facilitate such a connection. The conduit connector 14800 may also be connected to the conduit 14900 by a friction fit. Furthermore, as explained above, catheter 14900 provides positioning and stabilization functions to position the sealing structure in a therapeutically effective sealing position on the patient's face, so the connection between catheter 14900 and catheter connector 14800 at catheter connection end 14802 is strong 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.

[0554] The catheter connector 14800 also provides ventilation functionality for the patient interface 14000. The catheter connector housing 14801 may include a vent inlet that is pneumatically connected to 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 from the depicted example, each catheter connector housing 14801 includes multiple catheter connector vents 14831. This ensures adequate mixing of newly introduced air with the air already present in the inflation chamber 14200, which enhances carbon dioxide flushing and increases the amount of fresh air provided to the patient for breathing.

[0555] like Figures 39 to 41 As shown, the catheter connector 3800 can also provide a connection to a tether of the positioning and stabilizing structure 3300. The lower tether can be connected to the catheter connector 3800 via a clip 14301. The clip 14301 and the catheter connector 14800 may include magnets of opposite polarities to facilitate connection. The connection between the tether of the positioning and stabilizing structure 14300 and the catheter connector 14800 can be releasable. Tension from the lower tether of the positioning and stabilizing structure 14300 can cause the lower part of the sealing forming structure 14100 to seal against the patient's face, for example, around the mouth. Alternatively, a structure for connection to the clip 14301 can be formed directly on the catheter connector housing 14801.

[0556] 5.3.4.1.8 Anti-asphyxiation valve

[0557] In one configuration, the patient interface 14000 includes an anti-asphyxiation valve. For example... Figure 47 and 48 As best shown, each catheter connector 14800 may include an anti-asphyxiation valve assembly 14850. Therefore, the patient interface 14000 may include two anti-asphyxiation valve assemblies 14850. Each anti-asphyxiation valve assembly 14850 may operate independently of the other (i.e., in response to cessation of airflow pressurization). For example, if the patient is sleeping on their side when airflow pressurization ceases, and one of the anti-asphyxiation valve assemblies 14850 is blocked by a pillow, the other anti-asphyxiation valve assembly 14850 may be used to prevent the patient from suffocating.

[0558] Port 5.3.4.1.9

[0559] In one embodiment of this technology, the patient interface 14000 includes one or more ports that allow access to the volume within the inflation chamber 4200. 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 the inflation chamber 14200, such as pressure.

[0560] Example 2 shown in 5.3.4.2

[0561] 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 the 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.

[0562] Gasket assembly 30105 includes similar Figures 39 to 56 The features described herein, but not discussed separately, include the nose 30101, nose hole 30103, oral cavity portion 30102, oral cavity hole 30104, cavity 30001, support structure 30120, and sealing portion 30130. An inlet hole 30240 is formed in the inflation chamber and configured to receive airflow for the air circuit.

[0563] 5.3.4.2.1 Positioning and Stabilizing Structure

[0564] Figures 57 to 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 having a sealing forming structure 30100. In this example, the positioning and stabilization structure 30300 includes a frame 30350 and a plurality of headband straps connected to the frame 30350.

[0565] 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 and the frame can form different types of removable connections, snap-fit ​​connections, removable press-fit connections, or others, or it can be permanently connected to the frame.

[0566] The positioning and stabilizing structure 30300 may include multiple straps or strap sections that are attached to the frame 30350 and travel 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, which may be cut or formed individually and then joined together at their ends to create a longer length, or a single "strap" may be a single length of material.

[0567] exist Figures 57 to 66 In the example shown, the positioning and stabilizing structure 30300 includes a pair of upper straps 30310. Each upper strap is configured to travel between the corresponding eye and ear of the patient. Additionally, the positioning and stabilizing structure includes a pair of lower straps 30320, which are configured to be positioned on the patient's cheek below the cheekbone. In this example, the inflatable chamber is held in place via a four-point connection to the headband straps through a frame 30350.

[0568] The framework is Figures 63 to 64 Shown separately. The frame includes a frame inlet connection port 30354. The frame inlet connection port 30354 can be configured 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 bend assembly 30610, which provides a connection port 30600 for connection to the air circuit 4170. In this example, the frame inlet connection port includes a connection edge 30355. The connection edge 30355 may include a radially outwardly extending flange. The rotary bend assembly 30610 can form a releasable snap-fit ​​engagement with the connection edge, thereby forming a fluid connection between the rotary bend assembly and the frame. The opposite side of the frame inlet connection port 30354 is configured to be fluidly connected to the inflation chamber. Thus, the frame 30350 achieves a fluid connection between the rotary bend assembly 30610 and the interior of the inflation chamber 30200.

[0569] 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 notch formed in the frame. Each upper strap 30310 can be connected to the corresponding upper strap connection point 30315 by passing through the notch, looping back to itself, and securing itself. Each upper strap can be secured to itself via a hook-and-loop material configured to releasably bind to each other upon contact. In an alternative example, each upper strap 30310 can pass through the corresponding notch, loop back to itself, and be secured to itself with a strap, clip, etc. In another alternative example, the upper straps can be connected to the frame via a side-release hook-and-loop fastener.

[0570] 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 by a magnet at the lower strap connection point 30325. In this example, each lower strap clip 30326 includes a aperture through which the end of the corresponding lower strap can pass and then be looped back and secured to itself, for example, by hook and loop material, strap, clip, etc. In an alternative example, the lower straps may be connected to the frame via a side-release hook and loop connection, to a hook, or to the frame via any other suitable connection.

[0571] In one example, the frame 30350 and the upper strap connection point 30315 are structured and arranged to guide the force / tension provided by the upper strap 30310 to force vectors applied to a portion of the upper and rear portions of the inflation chamber 30200. The force vectors in the upper portion and the rear portion, in particular, cause the nose portion 30101 of the sealing structure 3100 to make sealing contact with the lower periphery of the patient's nose and the patient's upper lip.

[0572] The upper bandages 30310 can be selectively adjusted individually. For example, the effective length of each upper bandage can be changed by varying how much of the upper bandage passes through the aperture at the corresponding upper bandage connection point 30315 and circulates back to itself. Allowing the upper bandage to pass through the aperture more effectively reduces the length of the upper bandage, thereby allowing modification of the force vector and adjustment of the patient interface fit.

[0573] In one example, the frame 30350 and the lower strap connection point 30325 are structured and arranged to guide the force / tension provided by the lower strap 30320 to a force vector applied to the rear and lower portions of the inflation chamber. The rear and lower force vectors specifically cause the oral cavity portion 30102 to seal against the patient's face around the periphery of the patient's mouth. The lower portion of the force applied to the frame by the lower strap can balance the upper portion of the force applied by the upper strap and any lower directional forces that the patient's nose may apply to the seal-forming structure.

[0574] The lower bandages 30320 can be selectively adjusted individually. For example, the effective length of each lower bandage can be changed by varying how much each lower bandage passes through the aperture at the corresponding lower bandage connection point 30326 and loops back to itself. Allowing each lower bandage to pass through the aperture more extensively effectively reduces the length of the lower bandage, thereby allowing modification of the force vector and adjustment of the patient interface fit.

[0575] The positioning and stabilizing structure 30300 may also include a top crown strap 30330, a pair of transverse crown straps 30332, and a neck strap 30334. Figures 57 to 66 In the example shown, the upper bandage 30310 and lower bandage 30320 are connected to the ends of the top coronal bandage 30330. The top coronal bandage is configured to wrap around the patient's head and rest against the upper and posterior surfaces. The top coronal bandage 30330 may be configured to cover the parietal bone of the patient's skull. Each end of the top coronal bandage is connected to a corresponding upper bandage 30310 and also to a corresponding transverse coronal bandage in a pair of transverse coronal bandages 30332. Each transverse coronal bandage is connected between the upper and lower bandages on a corresponding side of the patient's head. The lower ends of the transverse coronal 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 rest against the lower and / or posterior surfaces of the patient's head or against the posterior part 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.

[0576] The length of the top crown strap 30330 can be selectively adjusted. The top crown strap 30330 is formed by two strap sections connected by links having a pair of apertures. Each of the two strap sections forming the top crown strap can pass through a corresponding aperture and then be looped back and secured to itself, for example, via hook and loop material, another clip, strap, etc. The amount of each top strap section passing through the links can be varied to adjust the length of the top crown strap 30330, thereby adjusting the fit of the positioning and stabilizing structure.

[0577] Once all headband straps have been adjusted and the patient interface 30000 is properly fitted, 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 puts the patient interface back on, 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.

[0578] 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.

[0579] Furthermore, it should be understood that one or more aspects of this technology may be combined with one or more of the following: PCT / AU2019 / 050278 entitled “Patient Interface”, submitted on March 28, 2019, the entire contents of which are incorporated herein by reference.

[0580] 5.3.4.2.2 Vent

[0581] In one embodiment, the patient interface 30000 includes a ventilation port 30400, which is configured and arranged to allow the expulsion of exhaled gases, such as carbon dioxide.

[0582] 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.

[0583] One type of vent according to the present technology includes a plurality of holes, such as about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0584] 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.

[0585] exist Figures 57 to 66In the example shown, the patient interface 30000 includes a vent 30400. In this example, the vent includes channels within the frame and rotating bend assembly 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 bend assembly 30610 and then out to the atmosphere through the outer hole of the rotary bend assembly (forming part of the vent 30400). The rotary bend assembly 30610 can be substantially as described in International Publication No. WO 2017 / 049357 A1, the entire contents of which are incorporated herein by reference.

[0586] 5.3.4.2.3 Decoupling Structure

[0587] 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.

[0588] 5.3.4.2.4 Connection Port

[0589] Connection port 30600 allows connection to air circuit 4170.

[0590] 5.3.4.2.5 Forehead Stent

[0591] 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.

[0592] 5.3.4.2.6 Anti-asphyxiation valve

[0593] In one configuration, the patient interface 30000 includes an anti-asphyxiation valve.

[0594] Port 5.3.4.2.7

[0595] 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 one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 302000, such as pressure.

[0596] 5.3.4.3 Third Illustrative Example

[0597] Figures 67 to 77Another example of a patient interface 16000 according to the present technology is shown. The patient interface includes a frame assembly 16100, a liner assembly 16175 including a sealing formation 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 bandage 16802, a lower bandage 16804, and a crown bandage 16806). In use, one form of the sealing formation 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 to 56 In the example shown, the patient interface is a full-face / oronasal interface type, which includes a seal-forming structure 16200 structured 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 plugs, nasal pillows, etc.

[0598] The sealing structure 16200 can also be commonly referred to as a gasket. Figure 67 and 68 This is an exemplary view of the patient interface 16000, in which an arm cover 16750 is attached to the upper arm 16134 for the frame assembly 16100, and Figure 69 This is an exemplary view of the patient interface 16000, in which the headband 16800 and arm cover 16750 have been removed.

[0599] In this example, the gasket assembly 16175 is connected to the frame assembly 16100 independently of the bend assembly 16600 (via a first retaining feature on the frame assembly), and the bend assembly 16600 is connected to the frame assembly 16100 independently of the gasket assembly 16175 (via a second retaining feature on the frame). That is, the retaining connections of the gasket assembly 16175 and the bend assembly 16600 to the frame assembly 16100 are separate and distinct from each other, allowing for independent engagement / disengagement.

[0600] In the example of patient interface 16000, a first seal for an airflow path is formed between the bend assembly 16600 and the frame assembly 16100, and a separate second seal is formed between the frame assembly 16100 and the gasket assembly 16175. In this example, the frame assembly 16100 is disposed in the airflow path. That is, the bend assembly 16600 is structured to establish a hard-on-hard connection and dynamic seal with the frame assembly 16100, while the gasket assembly 16175 is structured to establish a separate hard-on-hard connection and static seal with the frame assembly 16100.

[0601] 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 bend assembly 16600 to interconnect frame assembly 16100 and air circuit 4170, thereby ensuring the presence of bend assembly 16600 (and its vent and anti-asphyxiation valve (AAV)) in the system.

[0602] Framework components

[0603] Still referencing Figures 67 to 77 The frame assembly 16100 includes: a shield or wall member 16110; a pair (i.e., left and right) upper headband connector arms 16134 (each including two flexible portions 16140, 16145) extending from a corresponding side of the upper portion of the shield 16110; and a pair (i.e., right and left) lower headband connector arms 16154 extending from a corresponding side of the lower portion of the shield 16110. Each lower headband connector arm 16154 includes a magnetic connector 16155 (including an encapsulated magnet) structured to be positioned and connected to a headband clip 16160 (including an encapsulated magnet) disposed on a corresponding lower headband strap 16804 of the headband.

[0604] In the example shown, the opening 16105 of the cover 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.

[0605] Gasket assembly & bend assembly

[0606] refer to Figures 67 to 77 The gasket assembly 16175 includes a body, a chassis, an inflation chamber or housing 16180, which is connected or otherwise disposed to the sealing formation or gasket 16200 (see [reference]). 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 soft material, while 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 (e.g., see [link]). 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 adapted to connect to the frame assembly 16100.

[0607] The housing 6180 has multiple functions. For example, it at least partially forms a cavity for delivering pressurized gas to the patient's airway inlet. The housing 6180 is a rigid structure that directs forces onto the sealing structure to seal against the patient's face. This force is provided by the tension caused by tightening the headband straps. These forces are transferred from a pair of upper and lower headband straps to 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.

[0608] The housing 16180 of the gasket assembly 16175 is repeatedly engaged with and removably disengaged from the shield 16110 of the frame assembly 16100 via a mechanical connection (e.g., a snap-fit ​​connection). An internal annular flange of the shield 16110 extends through an opening 16305 in the housing 16180, and tabs or clips of the flange engage or interlock on the rear side of the annular flange 16310 of the housing 16180 to releasably connect the frame assembly 16100 to the gasket assembly 16175. This connection maintains ease of use, provides a hard-on-hard seal, minimizes clicking and wobbling movement 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.

[0609] exist Figure 67 In the example shown, the bend assembly 16600 includes: a first end 16610 having a clamping arm 16650 for releasably engaging (and rotatably connecting) with the frame assembly 16100; and a second end 16620 adapted to connect, for example, via a swivel connector 16625, to an air circuit 4170. The bend assembly 16600 is structured to establish a hard-on-hard connection and seal with the frame assembly 16100.

[0610] In this example, the first end portion 16610 includes an inner radial wall and an outer radial wall that define radial channels leading to a plurality of vent holes 16700 to allow exhaust gas to exit from the patient interface.

[0611] Furthermore, it should be understood that one or more aspects of this technology can be combined with one or more aspects of 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 can replace the pad assembly in any patient interface embodiment disclosed in the '486 disclosure. Additionally, the seal-forming structure 16200 disclosed herein replaces the seal-forming structure in any patient interface embodiment disclosed in the '486 disclosure.

[0612] Sealing Formation Structure

[0613] As described above, housing 16180 is hermetically connected to or otherwise provided to sealing forming structure or gasket 16200, and housing 16180 and gasket 16200 cooperate to form cavity 16500.

[0614] The pad 16200 may include a support structure 16220 that provides support for the sealing portion 16230 (e.g., a fabric membrane). The sealing portion is configured to sealably engage with the patient's face.

[0615] The support structure 16220 may include wall structures in at least two regions with 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 sealing portion 16230 in order to provide structural stability at the connection with the housing 16180 and flexibility at the interface with the patient). Figure 84 An example is shown in which 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 sealing portion to provide structural stability at the connection with the frame and flexibility at the interface with the patient. Optionally, the thicker lateral support region 3122 may be located, for example, in the mandibular region of the sealing formation structure (and may be directly connected to the fabric membrane, for example), to ensure adequate sealing in the mandibular region of the patient's face.

[0616] The rigidity of the support structure 16220 may be less than that of the housing 16180, and it may be made of silicone, foam (e.g., polyurethane foam), solid polyurethane material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable materials as described below. Furthermore, the rigidity of the sealing portion 16230 may be less than that of the support structure 16220, and it may be made of fabric materials such as nylon, polyester, nylon and polyester blends, microfibers, or polyurethane, as will be described in more detail later.

[0617] The support structure 16220 may have a pore formed therein, which provides an inner edge of the support structure. A sealing portion 16230 (e.g., the outer periphery of the sealing portion) may be attached to the support structure along this inner edge, such that the sealing portion extends radially inward from the support structure beyond the support structure or extends to a degree greater than the support structure, for example, as... Figure 71 and 73 As shown in Figure 77. For example, the sealing portion may be molded around the inner edge of the support structure or otherwise suitably attached to the support structure, as described later.

[0618] The support structure 16220 can extend into the cavity 16500 to form a lower gasket or support flange 16221, providing support for the sealing portion 16230, such as Figure 73 and 77 As shown. The lower liner 16221 and the sealing portion 16230 can form a double-wall structure around 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).

[0619] 5.3.4.3.1 Positioning and Stabilizing Structure

[0620] 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.

[0621] 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.

[0622] In one form of this technology, the positioning and stabilizing structure 3300 includes a band 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 band. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0623] In some forms of this technology, the positioning and stabilizing structure includes a strap that is extendable, such as elastically stretchable. For example, the strap may be configured to be taut in 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.

[0624] 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.

[0625] In some forms of this technology, the positioning and stabilizing structure provides a holding force configured to correspond to a specific head size and / or facial shape. For example, one form of positioning and stabilizing structure provides a holding force suitable for large heads but not for small heads. In another example, one form of positioning and stabilizing structure provides a holding force suitable for small heads but not for large heads.

[0626] 5.3.4.3.2 Vent

[0627] In one form, the patient interface includes a ventilation port constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0628] One type of vent according to the present technology includes a plurality of holes, such as about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0629] 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.

[0630] 5.3.4.3.3 Decoupling Structure

[0631] In one form, the patient interface includes at least one decoupled structure, such as a spindle or a ball head and a ball socket.

[0632] 5.3.4.3.4 Connection Port

[0633] The connection port allows connection to an air circuit.

[0634] 5.3.4.3.5 Forehead Stent

[0635] In the example shown, frame component 6100 does not have a forehead support.

[0636] In another form, the patient interface may include a forehead support; for example, the frame component may include a forehead support.

[0637] 5.3.4.3.6 Anti-asphyxiation valve

[0638] In one form, the patient interface includes an anti-asphyxiation valve.

[0639] Port 5.3.4.3.7

[0640] 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.

[0641] 5.3.5 Arrangement of Support Structure and Sealing Parts

[0642] The support structure and sealing components in the above example can have many different configurations and arrangements.

[0643] In use, the sealing portion (e.g., a fabric membrane) can maintain 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 material (e.g., fabric material, impermeable 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 forming a non-tensioned, but substantially constant surface, without leakage, and without any interruption of leakage in the fabric membrane such as creases, folds, deformation, or wrinkles; and / or 4) the air pressure within the cavity against the inner surface of the sealing portion. Each of these factors can result in the sealing portion being under constant tension, such that the sealing portion conforms to the anthropometric contours of the patient's face, thereby minimizing wrinkles or blowouts and maximizing the contact area of ​​the sealing portion.

[0644] In some examples, the sealing portion may comprise a relatively thin, compliant, stretchable, elastic material, such as a fabric membrane comprising a suitable woven material (e.g., nylon, polyester, nylon and polyester blends, microfibers, or polyurethane). Before and during use, the sealing portion can be stretched and taut by a support structure. The sealing portion may be molded or otherwise attached (e.g., adhesive, glued) to the support structure such that the sealing portion is pre-tensioned (slightly stretched) to prevent wrinkles in the material of the sealing portion. This can be advantageous in ensuring that the sealing portion forms a smooth and continuous seal on the patient's face without any folds that could allow air leakage. Furthermore, the sealing portion may be shaped, for example, by thermoforming or given curvature, such that the sealing portion retains its own shape. The support structure may also impart curvature to the sealing portion.

[0645] For example, such as Figure 11-17 As shown in Figures 23-37, the sealing portion may have a concave curved profile from one side (right) to the opposite side (left) (e.g., positive curvature in the left-right direction) to support the patient's nose.

[0646] In some forms, such as Figures 10 to 66As shown, the patient's nose is not intended to be contained within a cavity formed by an inflatable chamber and a sealing structure. Instead, unlike conventional masks, the patient's nose is designed to rest 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. Incidentally, the fabric membrane can be stretched to fit the patient's face. Bridging portions 3104, 1406 extending between the nostrils can help maintain the fabric membrane in a taut manner before and / or during use. The bridging portions can also be used to help provide a sealing portion by eliminating a central opening on the fabric membrane, which rests against the patient's nose rather than containing it within a cavity. This creates a different sealing experience compared to conventional masks. This sealing experience provides enhanced comfort due to contact with a conforming fabric membrane, rather than with the harder material in conventional masks or conventional sealing arrangements where the sealing portion has a smaller contact area around the nose and / or mouth.

[0647] The sealing element can be constructed from a single layer or multiple layers of material (e.g., fabric material). Fabric membranes (and / or the fabric material of the fabric membrane) can exhibit low spring constants (i.e., high compliance) in both the warp and weft yarns. Unlike conventional masks (e.g., silicone sealing films) where fixing pads may cause the patient's skin to twist to form an effective seal, fabric membranes may have a material spring constant and spring length (i.e., the amount of stretchable material) that makes them more compliant than the patient's skin, allowing for easier conformation to the patient's facial features. This improves mask comfort and reduces the formation of localized pressure "hot spots."

[0648] Compared to conventional silicone membranes and compressed foam seals, the sealing element of this technology has a more flexible structural stiffness, thus exhibiting dynamic rebound characteristics. This dynamic rebound characteristic allows the sealing element to recover more quickly when subjected to external forces. Furthermore, due to the lower structural stiffness, less sealing force is required, allowing for a more comfortable seal and less facial indentation during use.

[0649] Fabric membranes can exhibit variable tension throughout the material (e.g., lower tension near the pores or in wider stretches of the material). In some forms, the surface of the material in contact with the patient's face in the sealing portion can have low-friction properties (e.g., low-friction finish), which can advantageously improve the material's compliance with the patient's face while also improving patient comfort.

[0650] The fabric membrane may also include at least one layer that exhibits substantially airtight properties while maintaining the elastic tensile properties necessary for comfort and minimum pressure points. That is, a membrane layer or laminated membrane layer (e.g., polymers such as silicone, polyurethane, thermoplastic polyurethane (TPU), polyester, nylon, etc.) may be applied to a 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.

[0651] In some forms, the thickness of the fabric material for the sealing portion can be 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 thickness of the membrane layer can be 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 material thickness of the fabric material with the sealing portion of the membrane 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.

[0652] 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, 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 thickness of the fabric material in the sealing portion with the membrane layer can range from 0.18 mm to 0.625 mm (e.g., 0.25 mm to 0.6 mm, or 0.25 mm to 0.5 mm, or 0.3 mm to 0.5 mm, or 0.35 mm to 0.45 mm, or 0.3 mm, or 0.35 mm, or 0.4 mm, or 0.45 mm, or 0.5 mm). In one example, the fabric composite comprising a nylon or nylon and polyester blend fabric and a silicone membrane layer can have these dimensions.

[0653] Due to the stiffness and elasticity of the support structure, tensile forces can also be transferred to the sealing portion. 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 (TPU)), and suitable plastic materials. The support structure can be configured to form a number of different liner configurations, including a single air-assisted sealing portion (e.g., a fabric membrane) and a sealing portion with a lower liner support layer (such as a double air-assisted sealing portion (e.g., a double fabric membrane)), a sealing portion with a compression support (e.g., open-cell foam, polyurethane foam, gel), a sealing portion with a TPU, TPE, or silicone support, or a double air-assisted sealing portion with an additional support (e.g., a double fabric membrane, wherein the inner membrane has a foam laminate layer (e.g., open-cell, polyurethane) or a TPU, TPE, polyurethane, or silicone molding layer thereon).

[0654] The underlay layer can help optimize the contact surface area between the sealing portion and the patient's face. Furthermore, in examples where the sealing portion is made of a breathable material (e.g., breathable fabric), the underlay layer can provide sufficient contact area behind the sealing portion to adequately seal it against the patient's face and prevent leakage.

[0655] During use, the engagement of the patient's face 1000 with the sealing portion 10130 will generate a temporary strain force that attempts to pull the walls of the supporting structure 10120 toward each other, such as... Figure 81 As shown. The support structure 10120 will respond to the strain force using an outward pulling reaction force. The reaction force transfers more tension to the sealing portion 10130 by preferentially stretching the more compliant sealing portion, which generates a synthetic elastic force in the sealing portion that is applied to the patient's face.

[0656] In some examples, the support structure may include a biasing portion that uses internal air pressure to dynamically support both the support structure and the sealing portion. This can advantageously provide further support for the sealing portion under dynamic loads (e.g., pipe resistance).

[0657] The air pressure within the cavity and acting on the inner surface of the seal also ensures that the surface of the fabric membrane is free of wrinkles, creases, bends, or folds (e.g., by creating tension in the seal) on the patient's face, 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 created by the air pressure within the seal, even if the mask is partially displaced when optimally positioned on the patient's face, can also contribute to providing a continuous seal because the seal may partially expand due to the reaction force generated by the internal air pressure (i.e., the "air-cushioned boat effect").

[0658] In examples where the fabric membrane is not under constant tension (e.g., and is not elastic), the sealing portion can still maintain sealed contact with the patient's face by the air pressure within the cavity, forming an improved air-assisted seal with the patient's face. Because the sealing portion is thinner and has lower structural stiffness than the supporting structure, the air-assisted seal dynamically adapts to changes / movements (i.e., the "air-cushioned boat effect").

[0659] The sealing element can be integrally formed with the support structure by molding or otherwise attaching it to the inner edge of the support structure. Thus, for example, the outer periphery of the sealing element can be attached to the inner edge of the support structure such that the sealing element extends radially inward beyond the support structure or extends radially greater than the support structure. The inner edge of the support structure can be curved, allowing the sealing element to be slightly angled inward toward the inside of the mask. By attaching the sealing element along the inner edge of the support structure, it is not necessary to fold or cut the sealing element to fuse around the corners of the support structure. This helps reduce the occurrence of protruding creases or wrinkles in the sealing element (which can cause leakage), thereby improving the sealing performance.

[0660] As previously mentioned, the sealing structure can be removably attached or fixedly attached to the inflation chamber. In some forms, the sealing portion can have a removable or modular structure. For example, the sealing portion 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 sealing portion can be attached to the support frame to reduce the occurrence of creases or wrinkles protruding in the fabric surface. Modular arrangements can also significantly simplify the manufacture of the sealing portion (e.g., fabric sealing portion), as all complex connections can be completed in a simple, stress-free state. Although the sealing portion can be treated to have basic self-cleaning properties, the use of modular sealing portions can also provide a cheaper and more hygienic alternative.

[0661] The support frame can be pre-formed with a flat or three-dimensional shape, such as an arc, to allow the sealing portion to have 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., male / female locating pins / holes, tongues and tenons).

[0662] The sealing portion may have an under-liner support layer (e.g., a second, third, or more liner layers) incorporated therein. The under-liner layer provides additional flexibility and allows the liner to fit most patients' faces (e.g., universal size). For example, the sealing portion may be structured as a dual air-assisted sealing portion (e.g., a dual fabric membrane), a sealing portion with a compression support layer (e.g., open-cell foam, polyurethane foam, gel), a sealing portion with a TPU, TPE, or silicone support layer, or a dual air-assisted sealing portion with an additional support layer (e.g., a dual fabric membrane, wherein the inner membrane has a foam laminate layer (e.g., open-cell, polyurethane) or a TPU, TPE, polyurethane, or silicone molding layer thereon).

[0663] In some examples, the support layer may be supported by a rigid structure such as a plastic, for example, polypropylene (PP), polycarbonate (PC), polyamide (PA), or polyethylene terephthalate (PET).

[0664] In some examples, 3D printing of the sealing portions, support layers, and / or support structures that serve as the "skeleton" can reduce the thickness of the structure, thus reducing the weight of the mask. Furthermore, different layers of the mask can be printed with varying rigidity, stiffness, 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, bias portions can be formed to provide dynamic support during use.

[0665] 5.3.5.1 Fabric Membrane

[0666] According to examples of the disclosed techniques, the sealing structure may include a fabric membrane comprising a fabric material. The fabric material may have an airtight diaphragm / membrane or layer coated or otherwise applied thereon to create an airtight fabric composite. The fabric composite may be cut (e.g., die-cut, ultrasonic, laser, or RF cut) into the desired shape and then attached to a support structure. The resulting fabric sealing portion (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 sealing portion may be thermally welded to the support structure material (e.g., silicone, TPE) at its edges (outer periphery).

[0667] Fabrics are materials comprising at least one natural or man-made fiber (e.g., yarn or silk thread). Fibers can be filaments (single or multiple strands), ply yarns, or ropes. Fibers can include animal-based materials (such as wool or silk), plant-based materials (such as flax and cotton), and synthetic materials (such as polyester and rayon). Fabrics can be formed using various techniques such as weaving, knitting, crocheting, braiding, woven, bonding, felting, tufting, or braiding, and can include, for example, woven and non-woven materials, such as by interlacing or cross-linking one or more fibers.

[0668] In one example, the fabric material is a knitted material. Knitted materials are often preferred over braided materials because they provide elasticity (e.g., stretchability) to the fabric. This can be advantageous in providing comfort to the patient, as described below. The elasticity can be in all directions (e.g., four-way stretch / elasticity, where elasticity is substantially equal in all directions), and at least in the left-right transverse direction of the fabric membrane. The fabric material can have, for example, a weft-knitted or warp-knitted structure. A weft-knitted structure is often preferred because weft-knitted fabrics are more elastic than warp-knitted fabrics.

[0669] Figure 113 This shows the warp 70 of the weft-knitted fabric, or the direction in which the loops of one row of yarns connect to the loops of another row of yarns. Figure 114 The direction of the coils is shown in the 80th row or from a single row of wires. 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.

[0670] 5.3.5.1.1 Manufacturing

[0671] 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, for example, a fabric membrane.

[0672] like Figure 117 As shown, in step 10, an airtight fabric composite material can be formed by combining a fabric material with an airtight material. For example, such as Figure 78 As shown, a non-breathable layer can be attached to a fabric material using thermal processing. The fabric composite material can have a flat shape (e.g., sheet-like).

[0673] In step 12, the fabric composite material can be cut into the desired shape according to the specific padding component to be used.

[0674] In step 14, a support structure (e.g., silicone) can be overmolded onto the fabric composite material to form a seal-forming structure with the fabric membrane. The fabric composite material can be held in place by vacuum to have a non-planar predetermined shape during the overmolding process. That is, a planar fabric composite material can be overmolded with the support structure to impart curvature to the fabric composite material, thereby forming a fabric membrane that can have curvature without wrinkles, folds, creases, and / or deformation within the fabric membrane. Figure 33-1 As can be seen, 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, such as Figure 33-1 As shown, both the support structure and the fabric membrane can have radii of curvature (e.g., the same or similar radii of curvature) along curve 35. 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 ).

[0675] The support structure can be molded onto the fabric composite material, so that the outer surface of the sealed structure has a smooth and seamless transition from the support structure to the fabric membrane (see [link]). Figure 33-4 The support structure can be incorporated into the impermeable material of the fabric membrane. Although other surfaces of the seal-forming structure can be smooth and seamless, there may be stepped sections on the inner surface of the seal-forming structure, where the thickness of the support structure is different from (e.g., greater than) the thickness of the impermeable layer.

[0676] 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.

[0677] 5.3.5.1.2 Example of fabric membrane

[0678] The following are exemplary properties and structural arrangements of fabric composite materials used as fabric membrane materials.

[0679] 5.3.5.1.2.1 Fabric Composite Structure

[0680] Various combinations of fabric materials and diaphragm / membrane layers can be used. In one example, a three-layer arrangement is used, comprising a thermoplastic polyurethane (TPU) membrane 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). Additional fabric layers are required to protect the TPU membrane from breakage (e.g., during cleaning).

[0681] In another example, a two-layer arrangement is used, which includes a fabric (e.g., nylon, a nylon and polyester blend, a nylon and spandex blend, a polyester and spandex blend, or a nylon / polyester / spandex blend) having a silicone layer (e.g., coated thereon). This composite material can be cheaper than the three-layer arrangement discussed above because only one layer of fabric is required.

[0682] 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.

[0683] 5.3.5.1.2.2 Fabric Materials

[0684] As mentioned above, a variety of fabric materials can be used to form the sealing parts, such as nylon, polyester, spandex, nylon and polyester blends, nylon and spandex blends, polyester and spandex blends, nylon / polyester / spandex blends, fibers, or polyurethane.

[0685] In one example, nylon is used. Because nylon is softer than polyester, it provides comfort for the patient. Nylon is also more durable than polyester, thus extending its lifespan and overall durability. Furthermore, nylon has a higher melting point than polyester, allowing it to withstand higher-temperature manufacturing conditions.

[0686] 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 blend of nylon and polyester is also cheaper than nylon alone.

[0687] 5.3.5.1.2.3 Fabric material thickness

[0688] 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). Such a thickness can be suitable for nylon materials or blends of nylon and polyester.

[0689] In another example, the thickness of the fabric material for the sealing portion can be 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). Such a thickness can be suitable for microfiber fabric materials or polyurethane fabric materials.

[0690] 5.3.5.1.2.4 Thickness of the air-impermeable layer

[0691] In examples where silicone is used as a separator / membrane layer, the silicone thickness can range from 0.03 mm to 0.125 mm (e.g., 0.05 mm, 0.05 mm to 0.1 mm, or 0.05 mm to 0.075 mm, or 0.075 mm to 0.1 mm, or 0.1 mm). A thinner silicone layer (e.g., 0.05 mm) may be more desirable because it provides a lighter product weight and greater tensile strength compared to a thicker silicone layer (e.g., 0.1 mm). However, a thicker silicone layer (e.g., 0.1 mm) is more durable than a thinner layer (e.g., 0.05 mm).

[0692] In another example, when a polyurethane membrane is used as the separator layer, the thickness of the polyurethane membrane can be in the range of 0.03 mm to 0.01 mm (e.g., 0.015 mm, 0.02 mm, or 0.025 mm).

[0693] 5.3.5.1.2.5 Total thickness of fabric composite materials

[0694] In examples where the fabric material is coated with a silicone diaphragm / film layer, the total composite material thickness 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).

[0695] Thicker fabric films (e.g., 0.5 mm) may be stronger and offer less fragility. These fabric films may also be easier to handle during manufacturing because they are less likely to be flipped.

[0696] Medium-thickness ranges (e.g., 0.35 mm to 0.45 mm) can provide a flexible and lightweight structure that is relatively easy to handle during manufacturing and can provide greater comfort to patients compared to thicker fabric membranes.

[0697] Thinner fabric membranes offer a very lightweight structure that provides a soft and comfortable feel for patients, but they are less durable compared to thicker fabric membranes.

[0698] In examples where the fabric material is coated with a polyurethane film, the total composite thickness 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).

[0699] 5.3.5.1.2.6 Knitted Structure

[0700] The fabric material of the fabric membrane can have, for example, a weft-knitted structure or optionally a warp-knitted structure. Weft-knitted fabric may be more desirable because it provides greater elasticity to the material compared to warp-knitted fabric. This can be advantageous because it can provide greater comfort to the patient by stretching when the patient's face is in contact with the fabric membrane, thereby reducing the force exerted on the patient's face by the fabric membrane.

[0701] 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 (vertical direction).

[0702] In addition, weft knitting is better suited for producing relatively thin materials, such as those disclosed in this article. Moreover, compared to warp knitting, weft knitting is generally significantly less expensive.

[0703] However, in some cases, warp knitting may be ideal because it provides less shrinkage than weft knitting.

[0704] 5.3.5.1.2.7 Knitting Machines

[0705] Weft-knitted materials can have a single plain knit structure, providing a process front and process back with different appearances. A single-sided plain knit fabric can be formed using a set of needles, and knitted loops can be provided on the process front (front) and purl loops on the process back. In one example, the process front can form the outer surface of a fabric membrane, and an airtight membrane can be attached to the process back. Alternatively, the process front can be oriented towards the inner surface of the fabric membrane, and a diaphragm can be attached thereto.

[0706] In an example where the fabric membrane includes an impermeable membrane sandwiched between two fabric layers, the process face of each fabric material can form the exposed surface of the fabric membrane.

[0707] 5.3.5.1.2.8 Fabric weight

[0708] The weight of the fabric material can range from 95 grams (gsm) to 130 gsm per square meter (e.g., 105 gsm to 120 gsm, or 110 gsm to 115 gsm, or 105 gsm, or 110 gsm, or 120 gsm). Heavier fabrics (e.g., 120 gsm) can provide the desired comfortable fabric feel even after being coated with a laminate due to their weight / thickness. Lighter fabrics (e.g., 105 gsm) may be ideal because they offer a lighter product.

[0709] 5.3.5.1.2.9 Machine Specifications

[0710] The machine specifications (i.e., the number of needles 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).

[0711] Using relatively large-gauge materials (e.g., 44GG) may be ideal, as this provides more options for mixing materials. However, smaller-gauge materials (e.g., 60GG) may be ideal, as this softer material can improve patient comfort.

[0712] 5.3.5.1.2.10 Aesthetics

[0713] Fabric materials can possess either a solid color aesthetic or a mixed aesthetic. Mixed materials can be considered as materials made from fabrics / textiles of more than one color using different colored fabrics / yarns, or materials made from different fabrics / yarns and then dyed separately. Mixed materials can be ideal because they can have a greater ability to conceal dust or dirt, thus making it easier to improve the cleanliness of the product. Mixed materials can also offer benefits during manufacturing, as it makes it easier to visually align the fabric knit structure correctly during cutting and / or overmolding.

[0714] However, solid-color materials may be ideal because they offer more options for finer gauge materials (e.g., 55GG+), which are softer and therefore more comfortable for patients.

[0715] 5.3.5.2 Sealing Formation Structure with Variable Construction

[0716] See Figure 118A The diagram illustrates another example of a gasket assembly 16175-1 according to the present technology. Gasket assembly 16175-1 is similar to the one described above. Figures 67-77The described pad assembly 16175 can be used with Figures 67-77 It is used together with the frame component 16100, positioning and stabilizing structures (e.g., headband 16800), etc., as described herein. (See reference...) Figure 118B The padding assembly 16175-2 is similar to the padding assembly 16175-1, but has a larger fabric portion that extends further toward the front side of the padding assembly, which will be described in more detail later.

[0717] The liner assembly 16175-1 may include a seal-forming structure 16200-1 having a fabric sealing portion (or fabric membrane 16230-1) connected to the support structure 16220. The fabric membrane 16230-1 may be configured to form a seal around the periphery of the patient's airway. The seal may be formed around the patient's nose (e.g., a nasal liner) or around the patient's nose and mouth (e.g., a full-face liner where the patient's nose is received within a cavity). The fabric membrane 16230-1 may be configured to avoid contact with the wing seal, for example, by being sufficiently far outwardly spaced relative to the wing to avoid or minimize contact with the wing.

[0718] Compared to elastomeric materials (such as silicone), fabrics can have greater flexibility and / or less resilience. Therefore, to maintain the shape of the fabric membrane and / or provide air impermeability, the fabric membrane may include a substrate support layer (e.g., an elastomeric material such as silicone), an air-impermeable laminate, or other such layers. Additional layers can increase the stiffness of the fabric material (while reducing its flexibility). However, it should be noted that in some examples, the fabric membrane is air-permeable and does not include an air-impermeable layer.

[0719] The total thickness of the fabric membrane 16230-1 can be in the range of less than 1.25 mm (e.g., 0.15 mm to 1.0 mm, 0.15 mm to 0.8 mm, 0.2 mm to 0.7 mm, 0.2 mm to 0.5 mm, 0.25 mm to 0.45 mm, 0.3 mm to 0.4 mm, 0.25 mm, 0.3 mm, 0.35 mm, or 0.45 mm). However, it should be noted that the fabric membrane can have the thickness of other examples described in other parts of the invention.

[0720] In use, as described in other parts of the invention, the fabric membrane 16230-1 can be inflated toward the patient's face by the force applied to the fabric membrane due to pressurization in the cavity of the liner assembly, so as to create a pressure-assisted seal with the patient's face. In some examples, the fabric membrane can be configured to stretch when inflated, which can improve the conformity of the fabric membrane to the patient's facial contours and thus improve the efficiency of the seal created with the patient's face.

[0721] The seal-forming structure can have a variable construction to adapt to different areas and varying contours of the patient's face, thereby ensuring a robust and comfortable seal. For example, the impermeable material of the fabric membrane can have a varying thickness in different sections of the fabric membrane and / or in different areas of the padding assembly, while the thickness of the fabric material remains constant. In another example, the fabric membrane may be provided with an underliner (e.g., a compressible underliner, such as a foam material). The arrangement of the fabric membrane and the underliner and / or the construction of the underliner can be varied in different areas of the padding assembly to optimize patient comfort and seal effectiveness in different areas of the patient's face.

[0722] As those skilled in the art will appreciate, variations in the sealing structure can also be used for other gasket types, such as those described in this invention (e.g., nose (e.g., subnasal type), oronasal type, etc.).

[0723] Figures 120-1 to 120-6 Different examples according to this technology are shown. Figure 118A The cross-section of the gasket assembly 16175-1. It should be noted that, in Figure 118A The points on the cross-section of the liner assembly 16175-1 are exemplary, and these cross-sectional views can represent any point around the liner assembly.

[0724] 5.3.5.2.1 Air-impermeable materials with variable thickness

[0725] See Figure 120-1 and 121 The fabric membrane 16230-1 may include multiple layers, including a fabric material 33133 that contacts the patient's face and an impermeable material (forming an impermeable layer 33131) that provides impermeability to the fabric material, as described in other parts of the invention. As mentioned above, the impermeable layer can provide rigidity to the fabric membrane.

[0726] In the example, such as Figure 121 As shown, the thickness of the impermeable layer 33131 can be varied throughout the fabric membrane to alter the fabric membrane's flexibility in different areas of the fabric membrane and / or in different areas of the padding assembly. Figure 121As shown, the thickness d1 of the impermeable layer 33131 at a first location on the fabric membrane 16230-1 can differ from the thickness d2 of the impermeable layer 33131 at a second location on the fabric membrane. By changing the thickness of the impermeable layer 33131, several properties of the fabric membrane, such as tensile strength, elasticity, and / or stiffness, can be altered, which may affect the fabric membrane's ability to conform to the patient's facial features and the patient's comfort. Therefore, a portion of the fabric membrane with a thinner impermeable layer 33131 can have increased flexibility, tensile strength, and compliance compared to a portion of the fabric membrane with a thicker impermeable layer. Similarly, a thicker portion of the fabric membrane can have increased stiffness, rigidity, and resilience compared to a thinner portion of the fabric membrane.

[0727] For example, the thickness of the non-breathable layer 33131 can vary in different areas of the liner assembly, such as around the periphery of the liner assembly. In this example, the non-breathable layer 33131 can be thinner in sensitive areas (e.g., the bridge of the nose area) than in other areas (e.g., the cheek area) to increase compliance and reduce the stiffness of the fabric membrane, thereby adapting to patient comfort. Furthermore, the non-breathable layer 33131 can be thinner in areas where increased stretchability of the fabric membrane is needed (e.g., thinner in the bridge of the nose, sides of the nose, and / or chin area than in the cheek area) to conform to facial contours (or stretch around facial contours) without causing discomfort.

[0728] In addition, such as Figure 121 As shown in the cross-sectional view, the thickness of the impermeable layer 33131 can vary toward the inner edge 33134 of the fabric membrane 16230-1. That is, the more radially outer portion of the fabric membrane (e.g., the portion more toward the front side of the padding assembly) can have an impermeable layer 33131 that is thicker than the impermeable layer of the more radially inner portion of the fabric membrane. In this way, the more radially outer portions of the fabric membrane can provide structural support to the more radially inner portion of the fabric membrane through their increased rigidity.

[0729] In this example, the impermeable layer 33131 comprises silicone. However, as discussed elsewhere in this invention, the impermeable layer 33131 may comprise other materials. The impermeable layer 33131 may have a Shore A hardness in the range of 15 to 45 (e.g., 20 to 40, 25 to 35, 20, 25, 30, or 35). Additionally, the impermeable layer 33131 may have a thickness of 0.015 mm to 0.085 mm across the fabric membrane to vary the compliance of the fabric membrane (e.g., 0.02 mm to 0.07 mm, 0.03 mm to 0.04 mm, 0.02 mm to 0.04 mm, 0.025 mm to 0.035 mm, 0.04 mm to 0.07 mm, 0.02 mm, 0.025 mm, 0.03 mm, 0.035 mm, 0.04 mm, or 0.06 mm). However, because the impermeable layer 33131 penetrates into the fabric material during curing, the thickness of the impermeable layer 33131 may not be completely uniform in any particular area. The impermeable layer 33131 may have a weight in the range of 90 grams per square meter (gsm) to 215 gsm (e.g., 100 gsm to 200 gsm, 120 gsm to 180 gsm, 135 gsm to 165 gsm, 110 gsm, 120 gsm, 150 gsm or 180 gsm).

[0730] The fabric material 33133 may have a thickness in the range of 0.135 mm to 0.985 mm (e.g., 0.18 mm to 0.73 mm, 0.2 mm to 0.535 mm, 0.28 mm to 0.485 mm, 0.4 mm to 0.7 mm, 0.22 mm, 0.25 mm, 0.3 mm, 0.5 mm, or 0.7 mm).

[0731] Figure 119 Various regions of the sealing structure 16200-1 are shown, with patterns representing regions of similar wall thickness in the sealing structure. Since the thickness of the fabric material 33133 is constant, these patterns show regions of similar thickness in the impermeable layer 33131 and / or the support structure 16220.

[0732] In the example, the regions defining the holes in the sealing forming structure 16200-1, such as regions 33180B, 33180F and 33180G, can typically correspond to the fabric membrane 16175-1, while regions 33180A, 33180C, 33180D and 33180E can typically correspond to the support structure.

[0733] Region 33180A (e.g., support structure 16220) may be a relatively thin region of the sealing forming structure 16200-1, for example, with a wall thickness of approximately 0.3 mm. This region may be thin for comfort and compliance at the bridge of the nose.

[0734] Region 33180B can be a very thin region of the sealing structure 16200-1. This reduction in thickness relative to region 33180A can significantly reduce tension, which can produce minimal or no facial marks at the bridge of the nose. The bridge of the nose is quite firm for most patients, and therefore sensitive and prone to discomfort. Furthermore, region 3180A can extend from region 33180B to the mask housing 16180, which is connected to the front side of the sealing structure 16200-1.

[0735] Regions 33180A and 33180B can both straddle the sagittal plane 33185, which can divide the seal forming structure 16200-1 into left and right sides.

[0736] A portion of region 33180B can also be configured to seal against the sides of the nose against the nasal bone and / or lateral cartilage, and can also seal against a portion of the upper cheek area. This portion of region 33180B can be configured to contact the sides of the nose and / or lateral cartilage before the fabric membrane contacts other parts of the face to form a seal during use. This portion of region 33180B can also be very thin to prevent excessive force and clamping at the sides of the nose, thereby avoiding airway obstruction.

[0737] Region 33180C can be a semi-thin region of the sealing formation 16200-1, for example, approximately 0.85 mm. This region can be semi-thin to prevent clamping at the side of the nose. Furthermore, region 33180C can be adjacent to both regions 33180A and 33180B.

[0738] Region 33180D can be a transitional region where the wall thickness changes. Specifically, the wall thickness of the sealing structure 16200-1 (e.g., support structure 16220) in region 33180D can decrease in the direction toward the inner edge 33134. For example, the wall thickness can decrease from about 2.0 mm to 1.3 mm. The change in wall thickness can be gradual or abrupt. Furthermore, region 33180D can border regions 33180A and 33180C.

[0739] Region 33180E (e.g., support structure 16220) can be a thicker region, for example, with a wall thickness of approximately 2.0 mm. This thicker peripheral region provides a more rigid outer wall to support the more inner portion of the liner. Region 33180E can be used as a lower liner in existing double-layer liner designs; for example, region 33180E can support the portion of the sealing formation 16200-1 that contacts the patient's face. Furthermore, region 33180E can border regions 33180D and 33180A.

[0740] Region 33180F can be a semi-thick region of the sealing formation 16200-1 (e.g., thicker than region 33180B). This region can be sealed on the cheek next to the mouth (e.g., the lower cheek area). This region on the face is typically wider than the sides of the nose or bridge of the nose, which allows for the application of a relatively greater sealing force without causing discomfort. The semi-thick region can also provide greater structural rigidity than the thinner region.

[0741] Region 33180G may be a thin region of the sealing structure 16200-1 (e.g., thinner than region 33180F). The portion sealed below the lower lip (e.g., the chin region) may be thinner to allow jaw movement. This thinner region also provides less load on the patient's gums for comfort. Region 33180G can maintain a seal against minor changes in facial contours and movements during sleep. Furthermore, region 33180G may extend from its inner edge 33134 to the mask housing 16180, which is connected to the front side of the sealing structure 16200-1. Region 33180G may also border regions 33180D, 33180E, and 33180F.

[0742] Although different lines are shown between regions 33180, regions can transition smoothly from one region to another in relative thickness, so the boundaries between regions are approximate. However, different transitions can also be provided.

[0743] In addition, it should be noted that the thickness of the airtight layer 33131 and / or the support structure 16200-1 may vary in each region.

[0744] See Figure 118A Regions 33180B, 33180F and 33180G are typically positioned to contact the patient’s face and, as described above, may correspond to fabric membrane 16230-1, while regions 33180A, 33180C, 33180D and 33180E may correspond to support structure 16200-1.

[0745] However, in such Figure 118B In other examples of the padding assembly 16175-2, one or more of regions 33180A, 33180C, 33180D, and 33180E may also include fabric material. The presence of fabric material is aesthetically pleasing to the patient even if all or part of these regions do not contact the patient's face. For example, one or more of regions 33180A, 33180C, 33180D, and 33180E may include a fabric membrane 16230-2, thereby reducing the extent of the support structure 16200-2. In such examples, the thickness of the impermeable layer 33131 in these regions may correspond to the thickness of the support structure as described above with reference to the padding assembly 16175-1.

[0746] That is, in the example, the support structure 16200-2 can extend to a lesser extent toward the rear of the padding assembly, thereby providing a larger fabric portion. However, the sections of the fabric membrane 16230-2 facing the front of the padding assembly (e.g., regions 33180A, 33180C, 33180D, and / or 33180E) can have an air-impermeable layer with a greater thickness than the rearward sections to provide sufficient structural support for the fabric membrane. The thickness of the air-impermeable layer in this front portion can be similar to that described above. Figure 118A The thickness of the support structure in the same section of the example. In practice, in regions 33180A, 33180C, 33180D and / or 33180E, the fabric material 33133 can simply be placed on the support structure, which will serve as an impermeable layer for the fabric material.

[0747] It should be noted that the connection between the fabric membrane 16230-1 and the support structure 16200-1 can form an overlapping joint, wherein the edge portion of the fabric membrane overlaps with the edge portion of the support structure, thereby potentially creating areas where the thickness of the elastomeric material (impermeable layer 33131 and / or support structure 16200-1) is increased. It should be noted that the varying thickness of the impermeable layer 33131 across the fabric membrane, as described herein, is not present outside any such connection or overlapping areas.

[0748] Note that regions 33180A to 33180G have various curvatures. For example, at least a portion of region 33180A can be a dome-shaped region, while region 33180B can be saddle-shaped. Furthermore, portions of regions 33180C, 33180D, 33180E, and 33180F can be saddle-shaped, dome-shaped, or cylindrical. Additionally, region 33180G can be saddle-shaped.

[0749] Fabric membranes can be elastically held in the desired shape with minimal undesirable folds and creases through the structure of the fabric membrane and / or the support structure.

[0750] In another example, the support structure 16220 may also include the following pad 16221, such as Figure 120-2 As shown. The lower liner 16221 may be disposed in at least one region of the liner assembly, and in some examples, may extend around the entire periphery of the liner assembly. In the examples, the lower liner 16221 may be thicker than the fabric film.

[0751] The lower liner 16221 may provide a spring-like element for supporting the fabric membrane 16230-1 and preventing it from bending during use. In an example, the fabric membrane 16230-1 may loosely cover the lower liner 16221, allowing the fabric membrane and the lower liner to respond independently to forces applied to their respective undersides due to the pressurization chamber within the liner assembly. In some examples, the fabric membrane 16230-1 may be coupled to the lower liner 16221, such that the fabric membrane and the lower liner respond uniformly to the forces of the pressurization chamber.

[0752] It should also be understood that one or more aspects of this technology may be combined with one or more aspects of WO 2017 / 049361, filed September 23, 2016, entitled “Patient Interface with a Seal-Forming Structure having Varying Thickness,” which is incorporated herein by reference. For example, the thickness distribution of the impermeable layer and / or support structure may be the same as the thickness distribution of the seal-forming structure in any embodiment of the `361 application. For example, the thickness distribution of the impermeable layer may correspond to the thickness distribution of the seal-forming structure in any embodiment of the `361 application. Furthermore, the padding assemblies and seal-forming structures disclosed herein may replace any padding assemblies (seal-forming structures and air chambers) or seal-forming structures in any patient interface disclosed in the `361 application.”

[0753] 5.3.5.2.2 Fabric film with underlay

[0754] refer to Figures 120-3 to 120-6 The support structure 16220 may be provided with an underliner (e.g., a compressible underliner, such as foam underliner 33121) to provide support for the membrane 16230-1. The underliner may be formed of foamed silicone material, foamed fabric material, polyurethane foam, spacer fabric, TPU, TPE, or any material suitable for an underlying buffer layer as described elsewhere in this invention. In the example shown, the underliner 33121 is formed of a polymer-based foam, such as polyurethane foam.

[0755] The foam underliner 33121 may be at least partially supported by a liner connecting portion 33150, which extends below the foam underliner and connects to the lower surface of the foam underliner. The liner connecting portion 33150 may be part of the support structure 16220 and may be integral with the support structure. The liner connecting portion 33150 may be in the form of an outer peripheral lip that connects to the foam underliner to form an effective cantilever extension.

[0756] The foam underlayment 33121 may be attached to the underlayment connection portion 33150 by means of, for example, adhesives (e.g., glue and / or tape); flame lamination; molding (e.g., molding the foam onto the underlayment connection portion, or vice versa); welding; mechanical connection between the foam and the underlayment connection portion; and / or sewing; etc.

[0757] The pad connection 33150 can help the foam under the pad 33121 to fit tightly against the patient's face by responding to the force generated in the pressurized chamber in the pad assembly, thereby pushing the foam (and fabric film) under the pad 33121 toward the patient's face.

[0758] In some examples, the padding connection portion 33150 provides a cantilever spring force that is soft enough to allow the nose to be pressed firmly into the fabric membrane and foam underliner without obstructing the nostrils. Conversely, the spring force of the padding connection portion 33150 can provide a reaction force sufficient to press the foam underliner 33121 into all sealing areas of the mask. This can be important for areas such as the sides of the nose.

[0759] The arrangement of the fabric membrane 16230-1 and the foam underliner 33121 and / or the construction of the foam underliner can be varied in different areas of the liner assembly to optimize patient comfort and sealing effectiveness in different areas of the patient's face.

[0760] See Figure 120-3 In the example, fabric membrane 16230-1 may loosely cover the foam underliner 33121 without being bonded to it. The fabric membrane may be attached to and protrude from the edge 33102 of the support structure 16220. Reference character 33146 indicates the length of the fabric membrane 16230-1 loosely covering the foam underliner 33121 without being bonded to it (e.g., from the edge 33102 (or the lower outer edge of the foam underliner) to the inner edge 33134 of the fabric membrane). In use, the fabric membrane may expand by forces generated in the pressure chamber, thereby pushing the fabric membrane toward the patient's face so that the fabric membrane at least partially conforms to the patient's facial contours. In some forms, the fabric membrane may also elastically stretch when expanded by forces within the pressure chamber.

[0761] It should be noted that the length of the fabric film 16230-1 loosely covering the foam underliner 33121 refers to a portion of the fabric film extending over the foam underliner to the inner edge 33108 of the foam underliner, and not any portion of the fabric film extending radially inward beyond the inner edge 33108 of the foam underliner.

[0762] See Figure 120-4In the example, the fabric membrane 16230-1 may loosely cover a portion of the foam underlayment 33121, while also being bonded to a portion of the foam underlayment. For example, as... Figure 120-4 As shown, the fabric membrane can be attached to the outward-facing sidewall of the foam underlayment 33121 from the edge 33102 of the support structure 16220 (or the lower outer edge of the foam underlayment) to the upper outer edge 33104 of the foam underlayment. The remaining length 33146 of the fabric membrane can loosely cover the foam underlayment 33121.

[0763] Reference character 33148 indicates the length of the fabric film 16230-1 bonded to the foam underliner (e.g., from the edge 33102 (or the lower outer edge of the foam underliner) to the inner edge 33134 of the fabric film). It should be noted that the fabric film can be bonded to any desired length of foam underliner. The expansion capacity of the fabric film 16230-1 can be inversely proportional to the length of the fabric film bonded to the foam underliner 33121 (consider the length of the fabric film loosely covering the foam underliner). Thus, Figure 120-3 The fabric membrane 16230-1 in the middle can have a higher density than... Figure 120-4 The fabric membrane inside has a larger capacity to inflate the patient's face.

[0764] See Figure 120-5 In this example, the fabric membrane 16230-1 may be bonded to the outward-facing sidewalls of the foam underliner 33121 and a portion of the patient-facing surface of the foam underliner 33121. The fabric membrane may be bonded to the foam underliner along the patient-facing surface up to a midpoint 33106. It should be noted that the midpoint 33106 may be anywhere along the patient-facing surface of the foam underliner up to and including the inner edge 33108 of the foam underliner, such that the bond length 33148 may terminate at any point along the patient-facing surface of the foam underliner.

[0765] because Figure 120-5 The length of the fabric membrane loosely covering the foam padding is 33146 times that of the previous one. Figure 120-4 The length of the fabric membrane loosely covering the foam padding is 33146, which is short. Figure 120-4 The fabric membrane 16230-1 ratio Figure 120-5 The fabric membrane in the middle has a greater ability to inflate the patient's face.

[0766] See Figure 120-6In this example, the fabric membrane 16230-1 is bonded to the patient-facing surface of the foam underliner 33121, with substantially no loose extension of the fabric membrane across or from the foam underliner. It should be noted that the bonding length 33148 may terminate at any point along the patient-facing surface of the foam underliner, up to and including the inner edge 33108 of the foam underliner.

[0767] because Figure 120-6 The length of the fabric membrane loosely covering the foam padding is 33146 times that of the previous one. Figure 120-5 The length of the fabric membrane loosely covering the foam padding is 33146, which is short. Figure 120-5 The fabric membrane 16230-1 ratio Figure 120-6 The fabric membrane in the middle has a greater ability to inflate the patient's face.

[0768] In the example, it might be desirable to vary how much the fabric membrane 16230-1 can move relative to the foam beneath the pad 33121 in different areas surrounding the periphery of the pad assembly (e.g., by inflating due to forces in the pressurized chamber). For example, it might be desirable to have more relative movement in the bridge of the nose area than in the cheek area (e.g., the lower cheek area). As described above, the relative movement between the fabric membrane and the foam underpad can be varied by adjusting the length of the fabric membrane attached to the foam underpad relative to the length of the fabric membrane loosely covering the foam underpad.

[0769] In some examples, the degree of bonding (e.g., length) between the covering fabric membrane and the foam beneath the pad 33121 can be configured to vary in different regions along the periphery of the pad assembly. For example, there may be some regions of the seal-forming structure 16200-1 (e.g., the bridge of the nose) where an air-assisted inflation seal formed by a fabric membrane, which is compliant and adaptable to the facial curvature at the bridge of the nose, may be more necessary, while in other regions (e.g., the cheek region, such as the lower cheek region), a compression seal simply formed by the foam pad, with or without a fabric membrane bonded thereto, may be required. Thus, in the examples, the fabric membrane can be configured such that the fabric membrane loosely covering the foam pad has a relatively longer length in the bridge of the nose region than in the cheek region. That is, in the example, both the bridge of the nose region and the cheek region (e.g., the lower cheek region) can have multiple portions of a fabric membrane loosely covering the foam underliner and multiple portions of a fabric membrane bonded to the foam underliner; however, in the bridge of the nose region, the fabric membrane can have a relatively longer length of loosely covering the foam underliner compared to the cheek region.

[0770] In another example, the fabric membrane 16230-1 in the nasal bridge region may be substantially without a portion of the fabric membrane attached to the foam underliner 33121, such that substantially the entire portion of the fabric membrane covering the foam underliner is movable relative to the foam underliner. This allows the fabric membrane to bend (and / or stretch) to conform to the curvature of the patient's nasal bridge. The relative movement between the fabric membrane and the foam underliner allows the fabric membrane to bend (and / or stretch) around the patient's nasal bridge before engaging the foam underliner located beneath the fabric membrane.

[0771] In some examples, the fabric membrane in the cheek area (e.g., the lower cheek area) can be fully bonded to the foam underliner, such that the fabric membrane essentially does not loosely cover the foam underliner. This arrangement allows the foam underliner to apply force to the patient's face immediately upon engagement with the fabric membrane. This arrangement can produce a compression-type seal against the patient's face, where the foam underliner compresses as the seal-forming structure engages with the patient's face. The cheek area, particularly the lower cheek area, is typically wider than the sides of the nose or bridge of the nose, allowing for the application of a relatively greater sealing force without discomfort. This sealing force in this area can create a stable point for the underliner against the patient's face.

[0772] On the sides of the nasal region of the liner assembly, similar to the bridge of the nose region in the example above, the fabric membrane may be substantially unbonded to the fabric membrane portion of the foam underliner. Note that the bridge of the nose region and the sides of the nasal region may also have a similar arrangement, where in both regions, a portion of the fabric membrane is bonded to the foam underliner, while the remaining portion of the fabric membrane loosely covers the foam underliner. This allows the fabric membrane to expand while also allowing the foam underliner to press into the patient's face for a better conformation to the contours of these areas.

[0773] However, in the lateral part of the nose region, compared to the bridge of the nose region, it may be desirable to have less fabric film loosely covering the foam underliner, allowing the fabric film to still expand while also increasing the ability of the foam underliner to press into the lateral part of the nose region to better conform to the contours of that region. In another example, the fabric film in the lateral part of the nose region may have a loosely overlapping portion with virtually no fabric film, in order to allow only a compression seal.

[0774] In the chin region of the padding assembly, compared to the cheek region (e.g., the lower cheek region), it may be desirable to have a more loosely covering fabric membrane over the foam underliner, allowing the fabric membrane in the chin region to move relative to the foam underliner to inflate toward the patient's face during use. In the example, on the side of the nasal region of the padding assembly, similar to the bridge of the nose region in the example above, the fabric membrane may be substantially not bonded to the fabric membrane portion of the foam underliner.

[0775] In another example, a portion of the fabric membrane in the chin area may be bonded to a foam underliner, while other portions of the fabric membrane may loosely cover the foam underliner. This allows the fabric membrane to expand and bend (and / or stretch) around the curvature passing through the chin area, while also allowing the foam underliner to press into the patient's face to exert a stabilizing force.

[0776] In the example, the fabric membrane 16230-1 may not extend on the patient-facing surface of the foam underlay in some areas surrounding the periphery of the pad assembly, such that the fabric membrane is configured to engage the patient's face in some areas, and the foam underlay is configured to engage the patient's face in other areas. For example, it may be desirable for the foam underlay to directly contact the patient's face in the cheek area of ​​the pad assembly, where a compression seal may be desired.

[0777] It should also be noted that the cross-sectional configuration of the foam underlay can vary around the periphery of the pad assembly. That is, the cross-sectional configuration of the foam underlay in the side portion of the nasal region of the pad assembly can differ from the cross-sectional configuration of the foam underlay in the cheek region (e.g., the lower cheek region), bridge of the nose region, or chin region of the pad assembly.

[0778] In the example, the height of the foam underlay can be approximately 8mm-16mm. The width of the foam underlay can be approximately 12mm to 30mm, preferably approximately 15-20mm.

[0779] It should be noted that the fabric membrane 16230-1 with an impermeable layer 33131 of varying thickness can be used with... Figures 120-3 to 120-6 Used together with the underliner described herein.

[0780] In some forms of this technology, the foam underlay 33121 may include a radially flat region having a three-dimensional surface profile arranged such that the radially flat region in at least a portion of the underlay assembly is inclined inward relative to the intermediate contact plane of the underlay assembly to surround and conform to the shape of the patient's face in use. In some forms, the radially flat region may be located on one or both of the sides of the mouth region (e.g., the lower cheek region) and the sides of the nose region, or it may extend around the entire periphery of the underlay assembly.

[0781] In some forms, at least a portion of the foam underliner 33121 may include a flat surface area that slopes inward relative to the median plane of the patient interface, for use to surround and conform to the shape of the patient’s face.

[0782] It should also be understood that one or more aspects of this technology may be combined with one or more aspects of US 2017 / 0128689, entitled “Respiratory Apparatus,” filed November 16, 2016, which is incorporated herein by reference in its entirety. For example, the liner connection portion and the foam subliner of this technology may be identical to the liner connection portion and the foam subliner in any embodiment of the `689 application. Additionally, the liner assemblies and sealing formation structures disclosed herein may replace any liner assemblies (sealing formation structures and inflation chambers) or sealing formation structures in any patient interface disclosed in the `689 application. Furthermore, the foam subliner may have the same physical properties and / or the same physical construction as the foam liner in any example of the `689 application. For example, foam properties, such as permeability, hardness, compressive stress-strain, apparent density, dynamic coefficient of friction, compressive deformation, tensile strength, elongation at break, and / or tear strength, may be identical to the foam liner in any embodiment of the `689 application. Furthermore, the cross-sectional configuration of the foam liner in different regions of the liner assembly can be the same as that in any embodiment of the '689 application.

[0783] 5.3.5.3 Example of the arrangement of support structure and sealing parts

[0784] Figures 81 to 112 Numerous different pad assembly configurations are illustrated, including various support structures and sealing arrangements and / or processes. Note that these examples can be applied to any patient interface and / or pad assembly described in this invention. Furthermore, any feature of any example can be applied to different examples and / or used with different features. The inflation chambers, support structures, and sealing portions shown in these figures can be made of any suitable materials described above. It should also be noted that, for example, components of the support structure may include more than one material. For instance, the lower pad of the support structure may include a different material than other parts of the support structure.

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

[0786] The connection between the outer periphery (or outer edge) of the fabric membrane and the inner edge of the supporting structure can be formed in a variety of different ways. For example... Figure 83 and 85 As shown, this connection can form an overlap joint in which the edge portion of the fabric membrane overlaps with the edge portion of the supporting structure. In one example, such as Figure 83 As shown, the attachment portion 10122 of the support structure can form a recessed portion to accommodate the sealing portion 10130, such that the support structure and the sealing portion form a smooth outer surface. The overlap can be minimal and provided only for manufacturing purposes (i.e., necessary for attaching the sealing portion and the 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 sealing portion due to the presence of the support structure (in such arrangements, the overlap can vary around the periphery of the sealing forming structure to change the level of support or stiffness (e.g., less overlap, less support, more flexibility, less tension in the sensitive columella region)).

[0787] In contrast to the above-mentioned lap joints, such as Figure 84 As shown, the connection between the fabric membrane and the support structure can form an end-to-end joint (e.g., a butt joint). Due to manufacturing techniques (e.g., overmolding, injection molding), the end-to-end joint may have a certain overlap; however, this overlap is negligible and constant around the periphery of the sealing portion 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 adjust the 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 or abutment joint is provided, the current 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., nose) to sink into the fabric membrane that compliantly accommodates the patient's face.

[0789] The sealing portion may be glued, molded (e.g., overmolded or injection molded), or otherwise attached to the support structure. In alternative examples, such as... Figure 84 As shown, the recessed portion can be removed, and the sealing portion 10130 and the support structure 10120 can be attached end-to-end using the attachment portion 10122. Furthermore, Figure 84 It is also shown 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 this configuration, the support structure 10120 includes a lower gasket 10121. The support structure also includes a sealing lip 10124 to seal the interface between the inflation chamber 10200 and the support structure 10120. An attachment portion 10122 of the support structure can be configured to clamp the end of the sealing portion between opposing portions of the attachment portion 10122.

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

[0792] refer to Figure 87 and 88 The support structure 10120 may have an external bias portion 10140 or an internal 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 10142, thus forming an air-assisted support region 10144, which can optimize the forces generated by the air pressure in the cavity acting on the support structure and the sealing portion to promote the sealing contact between the sealing portion and the patient's face.

[0793] Go to 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 sealing portion 10130 is adhered to the support structure by an adhesive 10150 (e.g., heat-activated polyurethane, tape, glue).

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

[0796] refer to Figure 91 The support structure 17120 includes a first portion 17123 and a lower liner 17121. The first portion 17123, which can be connected to the inflation chamber, can be made of a material harder than the material of the lower liner 17121. For example, both the first portion 17123 and the lower liner can be made of polyurethane, but the polyurethane material of the first portion can have a higher rigidity than the material of the lower liner. A reinforcing member 17125 can extend along the outer periphery of the liner to bridge the intersection between the first portion 17123 and the lower liner 17121 to provide structural support.

[0797] like Figure 92 As shown, the support structure 23120 may include a lower liner 23121 (e.g., made of TPU) having a U-shape or hook shape. The lower liner may include clips 23126 for removably attaching to the liner (e.g., a frame, an air chamber, or other part of the support structure). Optionally, a sealing portion 10130 may be attached to the support structure 23120 as a removable module, which can be removably attached to the liner (e.g., a frame, an air chamber, or other part of the support structure) as a unit. The sealing portion 10130 may be attached to the lower liner 23121, for example, by thermoforming. The lower liner may also be formed by thermoforming.

[0798] The support structure 24120 may include a rigid clip 24126 that supports the lower liner 24121, such as Figure 93 As shown. The lower liner 24121 may include an outer fabric layer 10132 and an inner layer (e.g., made of foam) surrounded by the fabric layer and clips. The support structure 24120 may be removably attached to the liner (e.g., a frame, an air chamber, or other part of the support structure). Optionally, the sealing portion 10130 may be attached to the support structure 24120 as a removable module, which can be removably attached to the liner (e.g., a frame, an air chamber, or other part of the support structure) as a unit. The sealing portion 10130 may be attached to the lower liner 24121, for example, by thermoforming. The lower liner may also be formed by thermoforming.

[0799] refer to Figure 94The support structure 18120 may include rigid clips 18126 supporting the lower liner 18121 (e.g., made of foam). The support structure 18120 may be removably attached to the liner (e.g., a frame, an air chamber, or other part of the support structure). Optionally, a sealing portion 10130 may be attached to the support structure 18120 as a removable module, which can be removably attached to the liner (e.g., a frame, an air chamber, or other part of the support structure) as a unit. The sealing portion 10130 may be attached to the lower liner 18121, for example, by thermoforming. The lower liner may also be formed by thermoforming.

[0800] Go to Figure 95 The support structure 19120 includes a first part 19123 and a lower liner 19121.

[0801] The first part 19123, which can be connected to the air chamber, can be made of a material that is harder than the material of the lower liner 19121. For example, the first part can be made of polyurethane, while the lower liner can be made of foam.

[0802] refer to Figure 96 The support structure 20120 includes a first part 20123 and a lower liner 20121.

[0803] The first portion 20123, which can be connected to the inflation chamber, can be made of a material with a different rigidity or Shore A hardness than the material of the lower liner. For example, both the first portion 20123 and the lower liner 20121 can be made of polyurethane, and the first portion 20123 can have less or greater rigidity or a higher or lower Shore A hardness compared to the lower liner 20121. In an alternative example, the first portion 20123 and the lower liner 20121 can be made of the same material and can have the same rigidity or Shore A hardness.

[0804] Figure 97 The support structure 21120 includes a first p...

Claims

1. A patient interface for sealingly delivering an airflow to a patient airway inlet at a continuous positive pressure relative to ambient air pressure when the patient is asleep, to improve sleep-disordered breathing, 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 within a range of 4 cm H2O to 30 cm H2O above the ambient air pressure in use throughout the patient's respiratory cycle; the patient interface comprising: An air chamber, which at least partially forms a cavity pressurizable to a therapeutic pressure at least 6 cm H2O higher than ambient air pressure, the air chamber including an air chamber inlet port, the size and structure of which are designed to receive an airflow at the therapeutic pressure for breathing by the patient; as well as A sealing structure comprising a fabric membrane configured and arranged to form a pressure-assisted seal with a region of the patient's face surrounding the inlet of the patient's airway below the nasal bridge region of the patient's face, the fabric membrane having pores formed therein such that an airflow under the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use. The sealing structure includes a flexible support structure comprising silicone attached to and supporting the fabric membrane. The flexible support structure and the fabric membrane form an overlap joint, wherein, in the overlapping region, the edge portion of the fabric membrane overlaps with the edge portion of the support structure. The fabric membrane includes a fabric material and an airtight layer applied to the fabric material to make the fabric material airtight. The airtight layer has a first thickness at a first location on the fabric membrane and a second thickness different from the first thickness at a second location on the fabric membrane, the first location and the second location being outside the overlapping area.

2. The patient interface of claim 1, wherein the first thickness of the airtight layer is less than the second thickness.

3. The patient interface of claim 1, wherein the stretchability of the fabric membrane at the first position is greater than the stretchability of the fabric membrane at the second position.

4. The patient interface of claim 1, wherein the stiffness of the fabric membrane at the first position is less than the stiffness of the fabric membrane at the second position.

5. The patient interface of claim 1, wherein the first position on the fabric membrane is in the nasal region of the sealing structure, and the second position on the fabric membrane is in the cheek region of the sealing structure.

6. The patient interface of claim 1, wherein the first position on the fabric membrane is in the chin region of the sealing structure, and the second position on the fabric membrane is in the cheek region of the sealing structure.

7. The patient interface of claim 1, wherein the thickness of the impermeable layer varies in different regions around the periphery of the sealing structure to alter the compliance of the fabric membrane in those different regions.

8. The patient interface of claim 7, wherein the thickness of the impermeable layer in the nasal region of the sealing structure is less than the thickness of the impermeable layer in the cheek region of the sealing structure.

9. The patient interface of claim 7, wherein the thickness of the impermeable layer in the chin region of the sealing structure is less than the thickness of the impermeable layer in the cheek region of the sealing structure.

10. The patient interface of claim 1, wherein, in a cross-sectional view, the thickness of the impermeable layer decreases toward the inner edge of the fabric membrane, such that the first position on the fabric membrane is radially more inward than the second position on the fabric membrane.

11. The patient interface of any one of claims 1 to 10, wherein the support structure includes a lower liner that supports the fabric membrane in use.

12. The patient interface of any one of claims 1 to 10, wherein the fabric membrane is molded onto the inner edge of the support structure.

13. The patient interface of any one of claims 1 to 10, wherein the fabric membrane has a saddle shape in the nasal bridge region of the sealing structure.

14. The patient interface as claimed in any one of claims 1 to 10, wherein the fabric material is a weft-knitted fabric.

15. The patient interface of any one of claims 1 to 10, wherein the fabric material comprises nylon, spandex, or polyester.

16. The patient interface of any one of claims 1 to 10, wherein the airtight layer comprises silicone.

17. The patient interface of any one of claims 1 to 10, wherein, in use, therapeutic pressure in the cavity pushes the fabric membrane toward the patient's face.

18. The patient interface of any one of claims 1 to 10, further comprising a positioning and stabilizing structure that provides a force for holding the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a tether configured and arranged such that, in use, at least a portion covers an area of ​​the patient's head above the supraauricular base point of the patient's head.

19. The patient interface of any one of claims 1 to 10, further comprising a ventilation structure that allows exhaled gas from the patient to flow continuously from the interior of the cavity to the surrounding environment, the ventilation structure being sized and shaped to maintain therapeutic pressure in the cavity during use.

20. The patient interface of any one of claims 1 to 10, wherein the air chamber and sealing formation form a full-face pad assembly.

21. The patient interface of any one of claims 1 to 10, wherein in use, the patient's nose is configured to be received in the cavity.

22. A treatment system for treating sleep-disordered breathing, comprising: Patient interface according to any one of claims 1 to 10; Respiratory pressure therapy (RPT) devices used to supply breathable gases with positive pressure; as well as An air delivery tube that delivers the breathable gas from the respiratory pressure therapy device to the patient interface.

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