Patient interface

Abstract

The patient interface includes a support structure and a seal-forming structure. The support structure is arranged to support the seal and is configured to be connected to the frame. The seal includes a fabric and is attached to the support structure along a periphery of the seal such that, in use, the seal may be under tension due to a reaction force of the support structure and / or an elastic tensile property of the fabric such that the seal exerts a force on a patient's face.

Description

[0001] This application is a divisional application of the patent application with application number 201980082087.2, application date October 16, 2019, and invention name “Patient Interface”. The patent application with application number 201980082087.2 is the Chinese national phase application of the PCT application with application number PCT / IB2019 / 058832.

[0002] 1 Cross-reference to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 805,147, filed on February 13, 2019, and also claims the benefit of Australian Provisional Application Nos. AU2018904886, filed on December 21, 2018, and AU2018903752, filed on October 16, 2018, respectively, the entire contents of which are incorporated herein by reference. 2 Background technology 2.1 Technical Field

[0005] The present technology relates to one or more of the diagnosis, treatment, prevention and improvement of respiratory-related diseases. The present technology also relates to medical devices or equipment and their uses.

[0006] 2.2 Description of related technologies

[0007] 2.2.1 Human respiratory system and its disorders

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

[0009] The airway includes a series of branching tubes, which become narrower, shorter and more numerous as the branching tracheae penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the inhaled air and expel carbon dioxide in the opposite direction. The trachea is divided into the left main bronchi and the right main bronchi, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branches of the airway lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. See "Respiratory Physiology", 9th edition, published by John B. West, Lippincott Williams & Wilkins in 2012.

[0010] There is a range of breathing disorders. Some conditions can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[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 including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. Comorbid symptoms are common disorders, 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 disorder of the patient's respiratory controller in which there are rhythmic alternating cycles of boom-and-bust ventilation called CSR cycles. CSR is characterized by repeated hypoxia and reoxygenation of arterial blood. CSR can be harmful because of the repeated lack of oxygen. In some patients, CSR is associated with repeated arousals from sleep, which leads 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 cannot take in 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 abnormal shortness of breath during exercise.

[0016] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness in the absence of 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 have certain common features. These diseases include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0018] Neuromuscular disease (NMD) is a broad term that covers many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, which leads to loss of walking ability, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in 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, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0019] The chest wall is a group of deformities of the thorax that result in an inefficient connection between the respiratory muscles and the thorax. These disorders are usually characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0020] A range of treatments have been used to treat or ameliorate such conditions. In addition, such treatments can be used to prevent breathing disorders in otherwise healthy individuals. However, these treatments have a number of disadvantages.

[0021] 2.2.2 Treatment

[0022] Various therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV) have been used to treat one or more of the above-mentioned breathing disorders.

[0023] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA treated by CPAP can be voluntary, so if the patient finds the device used to provide such treatment to be any one or more of: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0024] Non-invasive ventilation (NIV) provides ventilation support to patients through the upper airway to help them breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure in the form of OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0025] Non-invasive ventilation (IV) provides ventilation support to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0026] 2.2.3 Treatment system

[0027] These therapies can be provided by a therapeutic system or device.Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

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

[0029] Another form of treatment system is a mandibular repositioning device.

[0030] 2.2.3.1 Patient interface

[0031] The patient interface can be used to engage the respiratory apparatus to its wearer, for example by providing an air flow to the entrance of the airway. The air flow 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 of ​​the patient's face, for example, to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (e.g., a positive pressure of approximately 10 cm H2O relative to the ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cm H2O to the airway.

[0032] Certain other mask systems may not be functionally suitable for use in this field. For example, a purely decorative mask may not be able to maintain appropriate pressure. A mask system for underwater swimming or diving may be configured to prevent the entry of water from a higher pressure outside, but not to maintain the internal air at a pressure higher than the ambient pressure.

[0033] Certain masks may be clinically undesirable for the present technology, for example where they block airflow through the nose and only allow it through the mouth.

[0034] If certain masks require the patient to insert a portion of the mask structure into their mouth to create and maintain a seal with their lips, this may be uncomfortable or impractical with the present technology.

[0035] Certain masks may not be feasible for use while sleeping, such as when sleeping on one's side in bed with the head on a pillow.

[0036] The design of a patient interface presents many 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 is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during a respiratory therapy session.

[0037] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for a long time or when the patient is not familiar with the system. A mask of the wrong size may lead to reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original applications, but such masks are not as comfortable as ideal for long periods of time (e.g., several hours). This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0038] CPAP therapy is very effective in treating certain breathing disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean their mask, which may affect patient compliance.

[0039] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed for treating sleep-disordered breathing may be suitable for use in other applications.

[0040] For these reasons, patient interfaces for delivering CPAP during sleep have emerged as a distinct field.

[0041] 2.2.3.1.1 Sealing structure

[0042] The patient interface may include a seal-forming structure. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0043] The patient interface can be characterized in part according to the design intent of the seal-forming structure to engage with the face when in use. In one form of patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils when in use. This single element may be designed to, for example, cover the upper lip area and the bridge of the nose area of ​​the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth area when in use, for example, by forming a seal on the lower lip area of ​​the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth area when in 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 seal-forming structure that may be effective in one area of ​​a patient's face may not be suitable in another area, for example, because the shape, structure, variability, and sensitive areas of the patient's face are different. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on the patient's nose.

[0045] Certain seal-forming structures may be designed for mass manufacturing so that one design is suitable, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must adapt to form a seal. This may result in patient discomfort.

[0046] A seal-forming structure that works for one person may not work for another. Also, a design that works for a patient at one pressure or in one position may not work for another pressure or position. Some designs may leak when the patient moves, such as when asleep.

[0047] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface while the seal-forming portion is in facing engagement with the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inadequate, there will be a gap 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 incorporates a sheet seal of thin material around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous types of seal-forming portions, if the fit between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal-forming structure does not match the shape of the patient, it may crease or deform during use, causing leaks.

[0049] Additionally, some manufacturing processes can create undesirable folds, creases or deformations in the seal-forming structure even when not in use.

[0050] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these uncomfortable.

[0051] Another form of seal-forming structure can use adhesive to achieve the seal. Some patients may find it inconvenient to frequently apply and remove adhesive from their face.

[0052] A series of patient interface seal forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0053] One form of nasal pillow is 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 Inc. already manufactures the following products in combination with nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TMFX Nasal Pillows Mask and 0043MIRAGE LIBERTY TM Full face mask. The following patent applications assigned to ResMed describe examples of nasal pillow masks: International Patent Application WO 2004 / 073,778 (which describes ResMed's SWIFT TM Other aspects of nasal pillows), U.S. Patent Application 2009 / 0044808 (which describes ResMed's SWIFT TM LT nasal pillow); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed's MIRAGE LIBERTY TM Aspects of full face masks); International patent application WO 2009 / 052,560 (which describes the ResMed SWIFT TM Other aspects of the FX pillows).

[0055] 2.2.3.1.2 Positioning and stabilization

[0056] The seal-forming structure of the patient interface for positive air pressure therapy is subjected to the corresponding force of the air pressure that will destroy the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0057] One technique is to use an adhesive. See, for example, US Patent Application Publication No. US2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0058] Another technique is to use one or more straps and / or stabilizing harnesses.Many of these harnesses suffer from one or more of being ill-fitting, bulky, uncomfortable, and inconvenient to use.

[0059] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0060] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the above-mentioned therapies, for example by operating the device to generate an air flow for delivery to an airway interface. The air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0061] Air pressure generators are known in the context 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 reliability, size and weight requirements for medical devices. Furthermore, even devices designed for medical use may suffer from disadvantages, related to one or more of comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost and reliability.

[0062] One example of a special requirement for certain RPT devices is noise.

[0063] Table of noise output levels of existing RPT devices (one sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744).

[0064] RPT device name A-weighted sound pressure level dB(A) Years (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 S9 sleep therapy system manufactured by ResMed. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar ventilator for adults and pediatrics TM series, which can provide invasive and non-invasive non-dependent ventilatory support to a range of patients to treat a variety of conditions such as but not limited to NMD, OHS and COPD.

[0066] ResMed Elisée TM 150 ventilator and ResMed VS III TM Ventilators can provide support for invasive and non-invasive dependent ventilation for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide volumetric ventilation modes and pressure ventilation modes with single-limb circuits or double-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 an air flow to the patient's airway. In some cases, the air flow can be provided to the patient's airway at a positive pressure. The outlet of the RPT device is connected to a patient interface such as those described above via an air circuit.

[0067] Numerous options are available to the designer of the device. Design criteria often conflict, which means that certain design choices are far from conventional or unavoidable. Furthermore, certain aspects of comfort and efficacy may be highly sensitive to small subtle changes in one or more parameters.

[0068] 2.2.3.3 Humidifier

[0069] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air, which is often applied to the facial area in and around the patient interface, is more comfortable than cold air.

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

[0071] Medical humidifiers are used to increase the humidity, temperature (or both) of an air stream relative to ambient air when needed, typically while the patient is asleep or resting (e.g., in a hospital). Medical humidifiers placed at the bedside can be small. Medical humidifiers can be configured to humidify and / or heat only the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.) can also humidify the air inhaled by the patient, however these systems also humidify and / or heat the entire room, which can be uncomfortable for the occupants. In addition, medical humidifiers can have more stringent safety constraints than industrial humidifiers.

[0072] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification and may be difficult or inconvenient for some patients to use.

[0073] 2.2.3.4 Data Management

[0074] There may be many clinical reasons to obtain data that determines whether a patient being treated with a prescribed respiratory therapy is "compliant," such as if the patient has used their RPT device in accordance with one or more "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours each night for at least 21 or 30 consecutive days in order for the patient to be considered compliant. To determine the patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate usage over a predetermined time period and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform the patient of the third part of compliance.

[0075] There are other aspects of patient treatment that may benefit from the communication of treatment data to third parties or external systems.

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

[0077] 2.2.3.5 Ventilation technology

[0078] Some forms of therapeutic systems may include a vent to allow clearance of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (eg, a plenum) of the patient interface to a space outside the patient interface, such as to the environment.

[0079] The vent may include an orifice through which gas may flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, thereby providing insufficient clearance. Some vents may disturb the sleep of the patient's 1000 bed partner 1100, for example, by making noise or by collecting airflow.

[0080] Resmed Limited has developed many 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; U.S. Patent Application Publication No. 2009 / 0044808.

[0081] Noise table of existing masks (ISO 17510-2:2007, pressure of 10cmH2O at 1m)

[0082]

[0083] (*One sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744)

[0084] The sound pressure values ​​for various objects are listed below

[0085]

[0086] 2.2.4 Screening, diagnosis and surveillance systems

[0087] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves clinical experts to apply the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. The PSG of sleep-disordered breathing involves observing the patient for two nights in the clinic, one night of pure diagnosis and the second night of clinician titration of treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0088] A clinical expert may be able to adequately diagnose or monitor a patient based on visually observed PSG signals. However, there are situations where a clinical expert may not be available or may not be affordable. Different clinical experts may disagree on a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. 3. Summary of the invention

[0089] The present technology is directed to providing medical devices for diagnosing, ameliorating, treating or preventing breathing disorders with improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0090] A first aspect of the present technology relates to an apparatus for diagnosing, ameliorating, treating or preventing a respiratory disorder.

[0091] Another aspect of the present technology relates to methods for diagnosing, ameliorating, treating or preventing breathing disorders.

[0092] One aspect of some forms of the present technology is for providing methods and / or apparatus for improving patient compliance with respiratory therapy.

[0093]

[0013] Another aspect of the present technology relates to a seal-forming structure of a patient interface, the seal-forming structure comprising a fabric membrane.

[0094] In one form, the fabric membrane is air impermeable.

[0095] Another aspect of the present technology relates to a method of manufacturing a patient interface that utilizes a flat fabric composite material to create a fabric membrane having a curved shape.

[0096] Another aspect of the present technology relates to a seal-forming structure of a patient interface, the seal-forming structure comprising a fabric membrane, wherein the seal-forming structure has no (or almost no) wrinkles or folds.

[0097]

[0013] Another aspect of the present technology is a patient interface comprising a fabric membrane comprising a knitted fabric material.

[0098] In one form, the knitted textile material is warp knitted.

[0099] In one form, the knitted textile material is weft knitted.

[0100] In one form, the fabric membrane is stretchable in both vertical and horizontal directions (eg, equally stretchable).

[0101] In one form, the fabric membrane is more stretchable in the horizontal direction than in the vertical direction.

[0102] Another aspect of the present technology relates to a patient interface having a wide fit range.

[0103]

[0013] Another aspect of the present technology relates to a seal-forming structure of a patient interface that includes a sealing portion (eg, including a fabric material) that is maintained tensioned prior to use.

[0104]

[0013] Another aspect of the present technology relates to a seal-forming structure of a patient interface that includes an untensioned fabric membrane that is free of folds, wrinkles, wrinkles, and / or creases in an outer surface of the fabric membrane.

[0105] Another aspect of the present technology relates to a seal-forming structure of a patient interface that includes a fabric membrane having a bridge portion that is slack and / or bent with excess material.

[0106] Another aspect of the present technology relates to a patient interface for sealingly delivering an air flow to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure while the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance including at least an entrance to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's breathing cycle; the patient interface includes: 1) an inflatable chamber, the inflatable chamber at least partially forming a cavity that can be pressurized to a therapeutic pressure of at least 6 cm H2O above the ambient air pressure, the inflatable chamber being suitable for receiving an air flow at a therapeutic pressure for breathing by the patient; and 2) a seal-forming structure having a fabric membrane that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's airway entrance, the fabric membrane having holes formed therein so that the air flow at the therapeutic pressure is delivered to at least the entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle in use.

[0107] In an embodiment: (a) the seal-forming structure includes a support structure 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 periphery of the fabric membrane in such a manner that the fabric membrane is in a tensioned state before use.

[0108] Another aspect of the present technology relates to a patient interface for sealingly delivering an air flow to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure when the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's breathing cycle; the patient interface comprises: 1) an inflatable chamber, which at least partially forms a pressure that can be pressurized to at least 6 cm above the ambient air pressure; 1) a chamber for a patient to breathe in a therapeutic pressure of H2O, the chamber comprising a chamber inlet port, the chamber inlet port being sized and configured to receive a flow of air at a therapeutic pressure for breathing by a patient; and 2) a seal-forming structure having a fabric membrane constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the fabric membrane having holes formed therein so that the flow of air at the therapeutic pressure is delivered to at least the entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the chamber throughout the patient's breathing cycle in use. The seal-forming structure may include a flexible support structure to support the fabric membrane, the support structure being connected to the chamber, the support structure being harder than the fabric membrane. In use, the fabric membrane may be configured to press against the patient's face so that the patient's nose is not received in the chamber. The fabric membrane may be attached to the support structure along the periphery of the fabric membrane so that the fabric membrane extends radially inwardly beyond the support structure.

[0109] In an embodiment: (a) the inflatable chamber and the support structure include 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 is configured to fold or form a pivot point when the fabric membrane is engaged with the patient's face, thereby allowing the left and right sides of the support structure to deform inwardly to support the patient's nose; (b) the support structure includes an underpad; (c) the support structure includes foam; (d) the support structure includes silicone and the fabric membrane is molded to the inner edge of the support structure; (e) the fabric membrane has a dome shape in its corner regions; (f) the fabric membrane has a saddle shape in the lower central region of the fabric membrane, and the saddle shape is configured to seal against the patient's subnasal point during use.

[0110] In further examples: (a) the fabric membrane includes a membrane layer applied to the fabric material to make the fabric material substantially impermeable to air; (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 a weft knitted fabric; (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 44GG to 60GG; (g) the fabric material has a mixed aesthetic; (h) the fabric material has a solid color aesthetic; (i) the membrane layer includes silicone; (j) the fabric material includes nylon, spandex or polyester; (k) when in use, the treatment pressure in the cavity pushes the fabric membrane toward the patient's face; (1) the inflatable chamber includes silicone and is integrated with the support structure.

[0111] In a further example: (a) the patient interface also includes a positioning and stabilizing structure that provides a force to maintain the sealing forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap, the strap being constructed and arranged so that in use at least a portion covers an area of ​​the patient's head that is above a base point on the patient's ear; (b) the patient interface further includes a ventilation structure to allow gas exhaled by the patient to continuously flow from the interior of the cavity to the surrounding environment, the ventilation structure being sized and shaped to maintain a therapeutic pressure in the cavity during use; (c) the inflatable chamber and the sealing forming structure form an oral and nasal cushion assembly; (d) the inflatable chamber and the sealing forming structure form a nasal cushion.

[0112] Another aspect of the present technology relates to a patient interface for sealingly delivering an air flow to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure when the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's breathing cycle; the patient interface comprises: 1) an inflatable chamber, which at least partially forms a pressure that can be pressurized to at least 6 cm above the ambient air pressure; 1) a chamber for a therapeutic pressure of H2O, the plenum chamber including a plenum chamber inlet port, the plenum chamber inlet port being sized and configured to receive a flow of air at a therapeutic pressure for breathing by the patient; and 2) a seal-forming structure having a fabric membrane, the fabric membrane being constructed and arranged to form a seal with an area of ​​the patient's face, the area of ​​the patient's face surrounding the entrance to the patient's airway, the fabric membrane having at least one hole formed therein so that the flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's nostril, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the chamber throughout the patient's breathing cycle in use, the seal-forming structure may include a flexible support structure to support the fabric membrane, the support structure being harder than the fabric membrane, the support structure being connected to the plenum chamber. At a transition portion, the fabric membrane may be attached to the support structure along an outer edge of the fabric membrane and an inner edge of the support structure, so that the fabric membrane extends radially inwardly beyond the support structure. At the transition portion, the support structure and the fabric membrane may extend along a curve in a direction from a front side of the seal-forming structure to a rear side of the seal-forming structure facing the patient.

[0113] In an embodiment: (a) at a 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 an inner edge of the fabric membrane; (c) 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; (d) at least one hole on the fabric membrane includes two holes, and a bridge portion is arranged between the two holes in the fabric membrane; (e) the support structure includes silicone, and the fabric membrane is molded onto an inner edge of the support structure; (f) the seal-forming structure has a seamless transition from the support structure to the fabric membrane along its outer surface.

[0114] In a further embodiment: (a) the fabric membrane comprises a fabric material and a membrane layer applied thereto so that the fabric material is substantially impermeable to air; (b) the thickness of the fabric membrane is in the range of 0.3 mm to 0.5 mm; (c) the fabric material is a weft knitted fabric; (d) the membrane layer comprises silicone; (e) the fabric material comprises nylon, spandex or polyester; (f) in use, the treatment pressure in the cavity pushes the fabric membrane toward the patient's face; (g) the inflatable chamber and the sealing forming structure constitute an oral and nasal cushion assembly; (h) the inflatable chamber and the sealing forming structure form a nasal cushion.

[0115] Another aspect of the present technology relates to a patient interface for sealingly delivering an air flow to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure when the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's breathing cycle; the patient interface comprises: 1) an inflatable chamber, which at least partially forms a pressure that can be pressurized to at least 6 cm above the ambient air pressure; 1) a chamber for treating a patient's breathing with a therapeutic pressure of H2O, the chamber comprising a chamber inlet port, the chamber inlet port being sized and configured to receive a flow of air at a therapeutic pressure for breathing by the patient; and 2) a seal-forming structure having a fabric membrane, the fabric membrane being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the fabric membrane having at least one hole formed therein so that the flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the chamber throughout the patient's breathing cycle in use, the fabric membrane comprising a fabric material and a film layer applied thereto to make the fabric material substantially airtight, the fabric material being a weft knitted fabric. The seal-forming structure may comprise a flexible support structure for supporting the fabric membrane, the support structure being connectable to the chamber, and the support structure being harder than the fabric membrane. The fabric membrane may be attached to the support structure along the periphery of the fabric membrane so that the fabric membrane extends radially inwardly beyond the support structure. In use, the fabric membrane can be configured to be pressed against the patient's face so that the patient's nose is not received in the cavity. The fabric membrane can have a dome shape in the corner regions of the fabric membrane configured to seal against the patient's nose wing, and a saddle shape at the lower central region of the fabric membrane configured to seal against the patient's lower nose point.

[0116] In an embodiment: (a) in use, the 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, and a bridge portion is arranged between the two holes of the fabric membrane, and the bridge portion is snapped with excess material to allow the fabric membrane to unfold to accommodate noses of different sizes; (c) the support structure includes silicone, and the fabric membrane is molded to the inner edge of the support structure; (d) the inflatable chamber includes silicone and is integrally formed with the support structure; (e) the fabric membrane is attached to the support structure in a manner that causes the fabric membrane to be in a tensioned state before use; (f) a first area of ​​the fabric membrane is in a tensioned state before use, and a second area of ​​the fabric membrane is not tensioned before use.

[0117] In a further embodiment: (a) the fabric membrane has four-way elasticity; (b) the fabric membrane has a first elasticity in the lateral left and right directions, and has a different second elasticity in the up and down directions, wherein the elasticity in the first direction is greater than the elasticity in the second direction; (c) the membrane layer includes silicone; (d) the fabric material includes nylon, spandex or polyester; (e) the inflatable chamber and the sealing structure form an oral and nasal pad assembly; (f) the inflatable chamber and the sealing structure form a nasal pad.

[0118] Another aspect of the present technology relates to a method for forming a cushion assembly for a patient interface, wherein the cushion assembly is configured to seal and deliver an air flow to the patient's airway entrance at a continuous positive pressure relative to the ambient air pressure when the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance including at least the entrance of the patient's nostrils, wherein the cushion assembly is configured to maintain a therapeutic pressure in the range of about 4 cm H2O to about 30 cmH2O above the ambient air pressure in use throughout the patient's breathing cycle; the method comprising: 1) forming an airtight fabric composite material by applying an airtight material to a fabric material, the fabric composite material having a flat shape; 2) cutting the fabric composite material into desired sizes according to the specific type of cushion assembly to be used; and 3) overmolding a flexible support structure onto the cut fabric composite material to form a sealing forming structure having a fabric membrane, so that the fabric membrane is attached to the support structure along the outer edge of the fabric membrane and the inner edge of the support structure, and in the overmolding step, the fabric composite material is held in place by a vacuum to have a non-flat shape during overmolding, thereby imparting a curved non-flat shape to the fabric membrane. No wrinkles, creases, folds and / or deformations are formed in the fabric film.

[0119] In an embodiment: (a) the seal-forming structure has a seamless transition from the support structure to the fabric membrane along its outer surface; (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, so that the fabric membrane extends radially inward beyond the support structure, and at the transition portion, the support structure and the fabric membrane both extend along a curve in a direction from the front side of the seal-forming structure to the rear side of the seal-forming structure facing the patient; (c) two holes are provided in the fabric membrane, and a bridge portion is arranged between the two holes of the fabric membrane, and the bridge portion is buckled with excess material to allow the fabric membrane to unfold to accommodate noses of different sizes; (d) the support structure includes silicone.

[0120] Another aspect of the present technology relates to a seal-forming structure of a patient interface, the seal-forming structure comprising a support structure and a sealing portion, wherein the support structure supports the sealing portion, wherein the sealing portion is attached to the support structure along a 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 in tension due to a reaction force of the support structure and / or the elastic stretch properties of the fabric, thereby causing the sealing portion to apply force to the patient's face.

[0121] According to another aspect of the present technology, the sealing portion includes fabric. In another embodiment, the patient interface includes an inflatable chamber and the support structure is configured to be connected to the inflatable chamber, the inflatable chamber at least partially forming a cavity that can be pressurized to a therapeutic pressure of at least 6cm H2O above ambient air pressure, the inflatable chamber including an inlet port of the ...

[0122] According to another aspect of the present technology, a wall structure of the support structure between the seal and the plenum has a first portion of a first thickness and a second portion of a second thickness different from the first thickness.

[0123] Another aspect of the present technology relates to a seal-forming structure of a patient interface, the seal-forming structure comprising a support structure and a sealing portion, wherein the support structure supports the sealing portion, wherein the sealing portion is attached to the support structure along a periphery of the sealing portion in a manner such that the sealing portion is in a tensioned state prior to use.

[0124] According to another aspect of the present technology, the sealing portion includes a fabric material. In another embodiment, the patient interface includes an inflatable chamber and the support structure is configured to be connected to the inflatable chamber, the inflatable chamber at least partially forming a cavity that can be pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the inflatable chamber including an inlet port of the ...

[0125] Another aspect of the present technology relates to a sealing forming structure of a patient interface, the sealing forming structure comprising a support structure and a sealing portion, the support structure supporting the sealing portion, wherein the sealing portion comprises a fabric material and is attached to the support structure along the periphery of the sealing portion, wherein the support structure is more rigid than the sealing portion, the support structure having a first section of a first thickness and a second section of a second thickness different from the first thickness.

[0126] According to another aspect of the present technology, the support structure includes silicone and / or a thermoplastic elastomer, the patient interface includes an inflatable chamber and the support structure is configured to be connected to the inflatable chamber, the inflatable chamber at least partially forming a cavity that can be pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the inflatable chamber including an inlet port of the inlet port, the size and structure of the inlet port ...

[0127] Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured to have a peripheral shape that is complementary to the peripheral shape of the intended wearer.

[0128] One aspect of one form of the present technology is a method of making the device.

[0129] One aspect of some forms of the present technology is an easy to use medical device, for example for a person with no medical training, a person with clumsiness, limited vision or a person with limited experience in using this type of medical device.

[0130] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0131] Another aspect of the present 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 a positive pressure; and 3) an air delivery tube that transmits the breathable gas from the RPT device to the patient interface.

[0132] The described methods, systems, devices and apparatus may be implemented to improve the functionality of a processor, such as a processor of a dedicated computer, a respiratory monitor and / or a respiratory therapy device. In addition, the described methods, systems, devices and apparatus may provide improvements in the art of automated management, monitoring and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0133] Of course, a part of these aspects may form a sub-aspect of the present technology. Each aspect and / or each of the aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0134] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. 4. Description of the drawings

[0135] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to like elements, including:

[0136] 4.1 Treatment system

[0137] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows receiving a supply of air under positive pressure from an RPT device 4000. 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 partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0138] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0139] Figure 1CA system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a supply of air under positive pressure from an RPT device 4000. 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 sleeping position.

[0140] 4.2 Respiratory system and facial anatomy

[0141] Figure 2A Shown is a schematic diagram of the human respiratory system including the nasal and oral chambers, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0142] Figure 2B A view of the human upper airway including the nasal chamber, 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 is shown.

[0143] Figure 2C is a front view of the face with several surface anatomical features labeled, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal wing, nasolabial fold, and corner of mouth. The superior, inferior, radially inward, and radially outward directions are also labeled.

[0144] Figure 2D It is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge point, nasal prominence point, subnasal septum point, upper lip, lower lip, supramental point, nasal ridge, nasal apex, supra-auricular base point, and subauricular base point. The superior-inferior and anterior-posterior directions are also labeled.

[0145] Figure 2E This is another lateral view of the head. The approximate location of the Frankfort horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0146] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, nasal process point, long axis of the nostrils, and midsagittal plane.

[0147] Figure 2G A side view of the nasal surface features is shown.

[0148] 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.

[0149] Fig.2IThe medial anatomy of the nose is shown approximately a few millimeters from the mid-sagittal plane, showing, among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0150] Figure 2J A front view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates are also labeled, as are the maxilla and mandible.

[0151] Figure 2K A side view of the skull is shown with the outline of the head surface and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also labeled. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0152] Figure 2L An anterolateral view of the nose is shown.

[0153] 4.3 Patient Interface

[0154] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0155] Figure 3B A schematic diagram of a cross section through 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 is Figure 3C The curvature magnitude shown is relatively large in comparison.

[0156] Figure 3C A schematic diagram of a cross section through 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 is Figure 3B The curvature magnitude shown is relatively small in comparison.

[0157] Figure 3D A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0158] Figure 3E A schematic diagram of a cross section through 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 is Figure 3F The curvature magnitude shown is relatively small in comparison.

[0159] Figure 3F A schematic diagram of a cross section through 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 is Figure 3E The curvature magnitude shown is relatively large in comparison.

[0160] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edge of this surface is shown. The dome and saddle areas are shown.

[0161] Figure 3H A cushion for a mask is shown. The outer surface of the cushion is indicated. The edge of the surface is shown. The path on the surface between points A and B is indicated. The straight line distance between A and B is indicated. The two saddle areas and the vault area are indicated.

[0162] Fig. 3I A surface having a structure with a one-dimensional hole on the surface is shown. The plane curves shown form the boundaries of the one-dimensional hole.

[0163] Figure 3J Shown through Fig. 3I The surface shown is in Fig. 3I A two-dimensional hole is defined in the structure.

[0164] Figure 3K Shows Fig. 3I A perspective view of the structure of includes two-dimensional holes and one-dimensional holes. Also shown is the Fig. 3I The surface of the two-dimensional holes is defined in the structure.

[0165] Figure 3L A mask with an inflatable bladder as cushion is shown.

[0166] Figure 3M Shown through Figure 3L A cross section of a mask of FIG. 1 and showing the inner surface of the airbag. The inner surface defines a two-dimensional hole in the mask.

[0167] Figure 3N Shown by Figure 3L Another cross section of the mask. The inner surface is also indicated.

[0168] Fig.3O The left hand rule is shown.

[0169] Figure 3P The right hand rule is shown.

[0170] Figure 3Q The left ear is shown, including the left ear helix.

[0171] Figure 3R The right ear is shown, including the right ear helix.

[0172] Figure 3S A right-hand helix is ​​shown.

[0173] Figure 3T Views of a mask are shown including symbols for the twisting of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0174] Figure 3U A view of the plenum chamber 3200 is shown, showing the sagittal plane and the medial contact plane.

[0175] Figure 3V Shows Figure 3U A view of the rear portion of the plenum chamber. The view is oriented perpendicular to the median contact plane. Figure 3V The sagittal plane divides the air chamber into two equal parts: left and right sides.

[0176] Figure 3W Shown through Figure 3V The cross section of the gas-filled chamber is Figure 3V 32. The middle contact plane is perpendicular to the sagittal plane. The orientation of the middle contact plane corresponds to the orientation of the chord 3210, which lies on the sagittal plane and contacts the liner of the plenum at just two points on the sagittal plane, the upper point 3220 and the lower point 3230. Depending on the geometry of the liner in this area, the middle contact plane can be a tangent at the upper point and the lower point.

[0177] Figure 3X Shows Figure 3U The inflatable chamber 3200 is in the position of use on the face. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 substantially coincides with the mid-sagittal plane of the face. When the inflatable chamber is in the use position, the middle contact plane generally corresponds to the 'facial plane'. Figure 3X In FIG. 3 , the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3220 is approximately located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0178] 4.4RPT device

[0179] Figure 4A One form of RPT device according to the present technology is shown.

[0180] 4.5 Patient Interface According to the Present Technology

[0181] Figure 5 is a perspective view of an example patient interface according to the present technology worn by a patient.

[0182] Figure 6 is a perspective view of a patient interface according to another example of the present technology worn by a patient.

[0183] Figure 7 is to position and stabilize the structure along Figure 6 Cross-sectional view along line 7-7.

[0184] Figure 8 yes Figure 7 An enlarged view of a portion of the positioning and stabilizing structure.

[0185] Fig. 9 yes Figure 7 An enlarged view of a portion of the positioning and stabilizing structure.

[0186] Fig.10 Positioned on the patient's face Figure 5 Front view of the gasket assembly.

[0187] Fig.11 yes Figure 5 Front view of the gasket assembly.

[0188] Fig.12 yes Figure 5 A top perspective view of a gasket assembly.

[0189] Fig.13 yes Figure 5 A top view of a gasket assembly.

[0190] Fig.14 yes Figure 5 Side view of a gasket assembly.

[0191] Fig.15 yes Figure 5 Front view of the gasket assembly.

[0192] Fig.16 yes Figure 5 Side view of a gasket assembly.

[0193] Fig.17 yes Figure 5 A top view of a gasket assembly.

[0194] Fig.18 is a front view of a cushion assembly positioned on a patient's face according to another example of the present technology.

[0195] Fig.19 yes Fig.18 A top view of a gasket assembly.

[0196] Fig. 20 yes Fig.18 Front view of the gasket assembly.

[0197] Fig.21 yes Fig.18 Bottom view of the gasket assembly.

[0198] Fig. 22 yes Fig.18 A side perspective view of a gasket assembly.

[0199] Fig.23 is a front view of a cushion assembly according to another example of the present technology.

[0200] Fig.24 yes Fig.23 A bottom perspective view of a gasket assembly.

[0201] Fig.25 yes Fig.23 A side perspective view of a gasket assembly.

[0202] Fig.26 yes Fig.23 A top perspective view of a gasket assembly.

[0203] Fig. 27 yes Fig.23 A rear perspective view of a cushion assembly.

[0204] Fig.28 is a top perspective view of a cushion assembly according to another example of the present technology.

[0205] Fig.29 yes Fig.28 Front view of the gasket assembly.

[0206] Fig.30 yes Fig.28 A side perspective view of a gasket assembly.

[0207] Fig.31 yes Fig.28 A rear perspective view of a cushion assembly.

[0208] Fig.32 yes Fig.28 Bottom view of the gasket assembly.

[0209] Fig.33 is a front perspective view of a cushion assembly according to another example of the present technology.

[0210] Figure 33-1 is a front perspective view of a cushion assembly according to another example of the present technology.

[0211] Figure 33-2 It is along Figure 33-1 Cross-sectional view along line 33-2—33-2.

[0212] Figure 33-3 It is along Figure 33-1 Cross-sectional view along line 33-3—33-3.

[0213] Figure 33-4 It is taken from Figure 33-2 Zoomed in details.

[0214] Fig.34 yes Fig.33 A cross-sectional view of a gasket assembly.

[0215] Figure 34-37 is a front perspective view of a cushion assembly having a grip pad disposed on a fabric membrane according to an example of the present technology.

[0216] Fig.38 is a perspective view of a patient interface according to another example of the present technology worn by a patient.

[0217] Fig.39 is a perspective view of a patient interface according to another example of the present technology.

[0218] Fig.40 It is worn by the patient Fig.39 Perspective view of a patient interface.

[0219] Fig.41 yes Fig.40 Side view of the patient interface.

[0220] Fig.42 yes Fig.40 Front perspective view of the patient interface.

[0221] Fig.43 yes Fig.39 Front view of the cushion assembly of the patient interface.

[0222] Fig.44 yes Fig.39 A top view of a gasket assembly.

[0223] Fig.45 yes Fig.39 Bottom view of the gasket assembly.

[0224] Fig.46 yes Fig.39 Front perspective view of a gasket assembly.

[0225] Fig.47 yes Fig.39 A rear perspective view of a cushion assembly.

[0226] Fig.48 yes Fig.39 A side perspective view of a gasket assembly.

[0227] Fig.49 yes Fig.39 A front perspective view of a cushion assembly showing the interior of the cushion assembly.

[0228] Fig.50 yes Fig.39 A front view of a gasket assembly showing the interior of the gasket assembly.

[0229] Fig.51 is a rear view of a cushion assembly according to an example of the present technology.

[0230] Fig.52 yes Fig.51 Front view of the gasket assembly.

[0231] Fig.53 yes Fig.51 A cross-sectional view of a gasket assembly.

[0232] Figure 54-56 is a front perspective view of a cushion assembly having a grip pad disposed on a fabric membrane according to an example of the present technology.

[0233] Fig.57 Depicted is a perspective view of a patient interface 30000 according to an example of the present technology.

[0234] Fig.58 yes Fig.57 A perspective view of the patient interface 30000 as worn by a patient.

[0235] Fig.59 yes Fig.57 A cross-sectional view of patient interface 30000 is shown.

[0236] Fig.60 yes Fig.57 Side view of the patient interface 30000 when worn by a patient.

[0237] Fig.61 yes Fig.57 Front perspective view of the cushion assembly 30105.

[0238] Fig.62 yes Fig.57 Rear perspective view of the cushion assembly 30105.

[0239] Fig.63 yes Fig.57 Front view of frame 30350.

[0240] Fig.64 yes Fig.57 Rear view of frame 30350.

[0241] Fig.65 yes Fig.57 Back view of the patient interface 30000 when worn by a patient.

[0242] Fig.66 yes Fig.57 View of the straps of the positioning and stabilizing structure 30300 of the patient interface 30000.

[0243] Fig.67 is a perspective view of a patient interface according to another example of the present technology worn by a patient.

[0244] Fig.68 yes Fig.67Side view of the patient interface.

[0245] Fig.69 yes Fig.67 An exploded view of the patient interface shown, illustrating the cushion assembly, frame assembly, arm cover, and elbow assembly;

[0246] Fig.70 is a front exploded view of a cushion assembly according to an example of the present technology.

[0247] Fig.71 yes Fig.70 Rear exploded view of the gasket assembly.

[0248] Fig.72 yes Fig.67 Front view of the cushion assembly of the patient interface.

[0249] Fig.73 yes Fig.72 Front perspective view of a gasket assembly.

[0250] Fig.74 yes Fig.72 A rear perspective view of a cushion assembly.

[0251] Fig.75 yes Fig.72 A top perspective view of a gasket assembly.

[0252] Fig.76 yes Fig.72 A bottom perspective view of a gasket assembly.

[0253] Fig.77 yes Fig.72 A side perspective view of a gasket assembly.

[0254] Fig.78 is a schematic diagram of a method of providing an air-impermeable layer to a fabric material according to an example of the present technology.

[0255] Fig.79 is a schematic diagram depicting a patient's face presented to the fabric membrane with slight tension prior to use.

[0256] Fig.80 is a schematic diagram showing the resultant force exerted by the fabric membrane on the patient's face due to tensile stress in the fabric membrane.

[0257] Fig.81 is a schematic diagram of tension applied to a sealing portion of a gasket assembly according to an example of the present technology.

[0258] Fig.82 is a schematic diagram of the forces exerted by the fabric membrane on the patient's face due to air pressure within the cavity formed by the cushion assembly.

[0259] Fig.83 is a cut-away cross-sectional view of a cushion assembly according to an example of the present technology.

[0260] Fig.84 is a cross-sectional view of a cushion assembly according to an example of the present technology.

[0261] Fig.85 is a cross-sectional view of a cushion assembly according to an example of the present technology.

[0262] Fig.86 is a cut-away cross-sectional view of a cushion assembly according to an example of the present technology.

[0263] Fig.87 is a partial cross-sectional view of a sealing portion and a support structure of a cushion assembly having an external offset portion according to an example of the present technology.

[0264] Fig.88 is a partial cross-sectional view of a sealing portion and a support structure of a cushion assembly having an internal offset portion according to an example of the present technology.

[0265] Fig.89 is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0266] Fig.90A is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0267] Figure 90A-1 yes Fig.90A An enlarged view of a portion of the sealing portion of the gasket assembly.

[0268] Fig.90B is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0269] Fig.91 is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0270] Fig.92 is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0271] Fig.93 is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0272] Fig.94 is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0273] Fig.95 is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0274] Fig.96is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0275] Fig.97 is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0276] Fig.98 is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0277] Fig.99 is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0278] Fig.100 is a partial cross-sectional view of a cushion assembly according to an example of the present technology.

[0279] Fig.101 is a cross-sectional view of a seal module assembly according to one example of the present technology.

[0280] Fig.102 is a combination of an example according to the present technology Fig.101 A partial cross-sectional view of a gasket assembly of a sealing portion module assembly.

[0281] Fig.103 is a perspective view of a module support structure according to one example of the present technology.

[0282] Fig.104 and 105 A process of molding a seal to a support structure according to one example of the present technology is shown.

[0283] Fig.106 is through Fig.104 and 105 A side view of a seal module assembly formed by the process shown.

[0284] Fig.107 and 108 A one size fits all soft cushion assembly according to one example of the present technology is described.

[0285] Fig.109 and 110 A custom cushion assembly is shown manufactured according to an example of the present technology by utilizing a three-dimensional contour obtained by scanning a patient's face.

[0286] Fig.111 is a front perspective view of a cushion assembly according to another example of the present technology.

[0287] Fig.112 yes Fig.111 A rear perspective view of the seal-forming structure of the gasket assembly.

[0288] Fig.113 and Fig.114 Depicts the craft of weaving.

[0289] Fig.115 A warp knitted fabric according to an example of the present technology is described.

[0290] Fig.116 A weft knitted fabric according to an example of the present technology is described.

[0291] Fig.117 is a functional block diagram illustrating a process for overmolding a support structure onto a fabric composite material to form a seal with a fabric membrane according to one example of the present technology. 5. Specific implementation methods

[0292] Before describing the present technology in more detail, it should be understood that the present technology is not limited to the specific examples described herein, which can be varied. It should also be understood that the terminology used in the present disclosure is only for the purpose of describing the specific examples described herein, and is not intended to be limiting.

[0293] The following description is provided about various examples that can share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. In addition, in any one of the examples, any single feature or combination of features can constitute another example.

[0294] 5.1 Treatment

[0295] In one form, the present technology includes a method for treating a breathing disorder, the method comprising the step of applying positive pressure to an airway entrance of a patient 1000 .

[0296] In certain examples of the present technology, a supply of air at a positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0297] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0298] 5.2 Treatment system

[0299] In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000, e.g., see Figures 1A to 1C .

[0300] 5.3 Patient Interface

[0301] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of 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, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0302] If a 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.

[0303] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 6 cm H2O relative to ambient.

[0304] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 10 cm H20 relative to ambient.

[0305] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 20 cm H20 relative to ambient.

[0306] 5.3.1 Inflatable chamber

[0307] In the area where the seal is formed in use, the plenum has a perimeter shaped to complement the surface contour of an average human face. In use, the boundary edge of the plenum is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure. The seal-forming structure may extend along the entire perimeter of the plenum in use. In some forms, the plenum and the seal-forming structure are formed by a single homogeneous sheet of material.

[0308] 5.3.2 Sealing structure

[0309] In one form of the present 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 sealing is likely to occur. The area where sealing actually occurs - the actual sealing surface - can vary from day to day and from patient to patient within a given course of treatment, depending on a range of factors including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0310] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0311] In some forms of the present technology, the seal-forming structure 3100 is comprised of a biocompatible material such as liquid silicone rubber (LSR) (or "silicone").

[0312] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible and resilient material such as silicone.

[0313] In some forms, such as Figures 5 to 77 In some embodiments, the seal-forming structure has a seal portion including a fabric material that can cover all or part of the seal-forming structure. In some forms, the fabric can include a material formed from a fiber mesh and adapted so that it is airtight. For example, the fabric can have an airtight film on at least one surface thereof, thereby forming a fabric membrane or a fabric seal portion.

[0314] In some forms, the fabric membrane can be configured to elastically stretch in at least one dimension. For example, when the fabric membrane is constructed from a fiber network, the fabric membrane can be stretched in the longitudinal warp direction and / or the transverse weft direction across the fabric membrane. In some forms, the fabric membrane is configured to elastically stretch to a greater extent than can be achieved by conventional silicone seal forming structures.

[0315] In some forms, the fabric membrane is constructed to be substantially inelastic in at least one dimension. For example, when the fabric membrane is constructed of a woven fabric material, the fabric membrane can substantially resist elongation in either or both of the longitudinal warp and transverse weft directions across the fabric membrane.

[0316] The fabric membrane may comprise a single layer or multiple layers. In the case of using multiple layers, these individual layers may be formed using the same material or a variety of different materials each having unique material properties.

[0317] In some forms, the fabric membrane may include at least one layer that exhibits substantially air-impermeable properties while maintaining the material properties necessary to provide comfort and minimize pressure points for the patient. Fig.78 As shown, in some forms, the fabric membrane may include an airtight material 10131 formed on the inner surface of the fabric material 10133. In some forms, the airtight material may be laminated to the fabric material. The airtight material and the fabric material may be selected in some forms so that the resulting fabric membrane may exhibit a predetermined overall elasticity or resistance to elasticity as desired. For example, adding an airtight material (or film layer) may increase the elasticity (or ductility) of the fabric material, so that the resulting fabric membrane has increased ductility.

[0318] In some forms, the membrane may exhibit low spring constants (i.e., high compliance) in both the warp and weft yarns. In such forms, unlike conventional designs where a fixed cushion may deform the skin of the patient's face 1300 to form an effective seal, the fabric material and / or resulting fabric membrane may have a material spring constant and spring length such that the fabric membrane is more compliant than the patient's skin to which it engages. This may advantageously improve the comfort of the mask and reduce the formation of localized pressure "hot spots."

[0319] In some forms, the surface of the fabric material that contacts the patient's face 1300 can have low friction properties. This can advantageously improve the comfort of the surface texture of the fabric membrane and reduce friction relative to the patient's face 1300. The fabric material can have a surface (e.g., a herringbone) that can have a first coefficient of friction in a first direction that is different (e.g., greater or smaller) than the coefficient of friction in a second direction. Conversely, a higher friction fabric can cause the fabric membrane to clamp or rub against the contact area of ​​the patient's face during use. Such friction or clamping can cause the fabric membrane to deform or deform, thereby reducing the effectiveness of the seal and allowing air to leak from the device undesirably.

[0320] In some forms, the total thickness of the fabric material of the fabric membrane may be 0.275 mm or less.

[0321] In some forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large-sized heads but not for small-sized heads, and another form that is suitable for small-sized heads but not for large-sized heads.

[0322] It should be noted that although this description may (e.g., by reference notations) refer to a particular described example or features of a particular described example (e.g., seal-forming structure 3100), such description may apply to other examples and / or features (e.g., seal-forming structure 5100).

[0323] 5.3.2.1 Sealing mechanism

[0324] In one form, the seal forming structure includes a sealing flange that utilizes a pressure assisted sealing mechanism. In use, the sealing flange can easily respond to the system positive pressure inside the inflatable chamber 3200 acting on its bottom surface, so that it forms a tight sealing engagement with the face. The pressure assist mechanism can work together with the elastic tension in the positioning and stabilizing structure.

[0325] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm, such as about 0.25 mm to about 0.45 mm, which extends around the periphery of the plenum 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the plenum 3200 and extends around at least a portion of the path of the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange to prevent it from bending during use.

[0326] In one form, a fabric membrane (e.g., comprising nylon, polyester, a nylon and polyester blend, microfiber, or polyurethane) is used as the face contacting portion of the seal-forming structure 3100 of the CPAP mask. The fabric membrane may have properties that enable it to stretch in at least one dimension. The fabric membrane may be held under tension at both ends of the support structure before and / or during use. Prior to use, the fabric membrane may be permanently attached (e.g., by molding) or attached to the support structure as a removable module in a pre-tensioned and slightly stretched manner.

[0327] Alternatively, the fabric can be formed into a complex three-dimensional predetermined shape so that it is untensioned (e.g., loose, relaxed and / or wrinkle-free) before and / or during use, but substantially free of wrinkle-inducing leakage. Due to manufacturing, the fabric polymer can shrink so that the inherent pre-tension in the fabric membrane is lost, yet the fabric membrane can remain substantially wrinkle-free.

[0328] Fig.79 An example is illustrated in which the fabric membrane has slight tension in both the X and Y directions across the fabric surface. Before the patient's face 1300 (e.g., nose) approaches and presses the fabric membrane 3130, the fabric membrane is adapted to form a constant surface without interruptions such as creases, wrinkles, or wrinkles in the fabric material before contact between the patient's face 1300 and the seal-forming structure 3100. In some forms, this can be achieved by applying a slight pre-tension or by molding the fabric membrane so that it is substantially free of any wrinkle-causing leaks. This is advantageous in ensuring that the fabric membrane forms a smooth and continuous seal on and around the patient's face 1300. This can provide improved respiratory pressure therapy by reducing the presence of folded or wrinkled portions of the seal-forming structure 3100 that may leak therapeutic air. This is also advantageous in ensuring that the fabric membrane remains below a minimum tension threshold when the fabric membrane is pressed against the patient's face 1300 ( Fig.80 ).

[0329] In some forms, areas of the fabric membrane may be pre-tensioned and slightly stretched, while other areas of the fabric membrane may be held relaxed. For example, in some forms, the under-nose region may be pre-tensioned while areas covering the outside of the nostrils and / or the patient's mouth may be held tension-free (e.g., with excess material) to form a saddle-like region or valley shape prior to use. This may advantageously improve sealing efficiency while reducing pressure on areas of the face that anthropometrically extend into the cavity or toward the cavity a greater distance (i.e., "hot spots"). In another example, the sides of the nasal region and / or the bridge of the nose region may be held untensioned and / or relaxed prior to use to provide additional material to accommodate the facial contours of these sensitive facial areas. In another example, a bridge portion extending between the two nostril openings (e.g., bridge portion 3104) may be de-tensioned, relaxed, and / or buckled with excess material prior to use, such as Figure 33-1 A bridge portion (eg, 3104) having excess material may allow the fabric membrane to expand (eg, in the up-down (height) direction) to accommodate noses of varying sizes.

[0330] In some forms, instead of having pre-tensioned areas, the fabric membrane can be formed to be substantially free of leaks that cause wrinkles. This can be advantageous because it can be difficult to form a substantially leak-free complex three-dimensional shape from a slack fabric membrane or from a fabric membrane provided with excess untensioned material. An untensioned fabric membrane can be more comfortable for some arrangements because it can apply less pressure to the patient's face.

[0331] In some forms, the fabric membrane can be in a substantially tension-free state and formed on a support structure or directly on an inflatable chamber in a manner such that it remains untensioned and / or relaxed. In one example, such a fabric membrane can remain unprinted to avoid leaking a seal with the patient's face. In some forms, the untensioned and / or unprinted fabric membrane can utilize a cushion support (e.g., a lower cushion, a seal support area (e.g., a support structure), and / or air pressure within the cavity to enable an effective seal to be formed with the patient's face.

[0332] In some forms, the tensioned and / or wrinkled state in the fabric film (see Fig.80 and 81 ) may be maintained in order to maintain sealing contact with the patient's face 1300 by one or a combination of the following:

[0333] a) pre-applied tensile stress and additional applied tensile stress of the fabric membrane when the patient's face 1300 is engaged with the fabric membrane;

[0334] b) The preformed state of the fabric membrane is formed as a non-tensioned, but substantially unchanged surface, free of leaks, free of leakage causing discontinuities such as creases, folds, deformations or wrinkles in the fabric membrane.

[0335] c) the stiffness of the support structure and / or plenum, and the ability of the support structure and / or plenum to accommodate and react to tensile stresses applied when the patient's face 1300 engages the fabric membrane; and

[0336] d) Additional applied air pressure load from within the cavity against the inner surface of the fabric membrane. The internal air pressure can apply additional tensile stress to the inner surface of the fabric membrane to further stretch the fabric membrane and apply stress to the patient's face 1300 (e.g., create a pressure-assisted seal).

[0337] By continuously maintaining the fabric membrane under tensile stress and / or in a de-wrinkled state prior to and during use, the fabric membrane can conform to the patient's facial contours while minimizing wrinkling and / or bursting of the seal-forming structure. In some forms, this can also improve sealing performance by maximizing the contact area of ​​the fabric membrane on the patient's face 1300. In some forms, this can also improve the performance of the CPAP device when the CPAP device is impacted by external lateral or longitudinal forces (e.g., tube tension).

[0338] In some forms, the applied load from the air pressure within the plenum chamber can help the fabric membrane maintain an effective seal when the plenum chamber is pulled a short distance away from the patient's face 1300. The applied load of air pressure can be sufficient to elastically stretch the fabric membrane in at least one dimension such that the fabric membrane forms a "hovercraft"-like balloon effect over the anthropometric contours of the patient's face 1300, thereby maintaining an effective seal thereon.

[0339] In some forms, the fabric membrane may be held under tension by a relatively stiff support structure. In various forms, the support structure may be formed of, for example, silicone, PU foam, PU solid material, or any other suitable material. In some forms, the support structure may be relatively stiffer than the housing or frame of the plenum.

[0340] In some forms, the magnitude of the tensile stress may be varied as desired across the fabric membrane of the seal-forming structure. For example, there may be a stress concentration region close to one or more holes in the fabric membrane through which treatment is applied or over a wider range of the material.

[0341] In some forms, the seal-forming structure may utilize a plurality of different cushion configurations, including a single air-assisted fabric membrane, a dual air-assisted fabric membrane, a fabric membrane with compression support, or a fabric membrane with TPU / TPE / Si support. In some forms, the cushion configuration of the seal-forming structure may be formed such that it may advantageously provide a "one size fits most" solution.

[0342] In examples, the seal-forming structure and the plenum chamber may be applied to nasal cushions, nasal brackets, oronasal cushions, ultra-compact full-face masks, full-face masks, and other suitable cushion arrangements.

[0343] In some forms, the fabric membrane can be configured to create an effective seal across the patient's anterior nose, e.g. Fig.58 In some forms, the fabric membrane may be configured to create an effective seal against the lower nares of the patient's nose such that the fabric membrane does not engage the nares, e.g. Fig.40 shown.

[0344] In some forms, stretching and / or maintaining the wrinkled state of the fabric membrane to conform to the patient's face 1300 can exert pressure on the walls of the support structure during use. This stress can pull the walls of the support structure inwardly toward each other during use. In some forms, the support structure can be adapted to resist the applied stress load to prevent inward deformation. Therefore, the rigidity of the support structure can further exert stress on the fabric membrane, which in turn can cause elastic stretching of the fabric membrane during use.

[0345] In some forms, for example Fig.87 and 88 As shown, the support structure may include pleats, folds or gussets (e.g., seal biasing portions 10140, 10140') that utilize internal air pressure to dynamically support the fabric membrane. This can advantageously provide further support for the fabric membrane when under dynamic loads (e.g., tube traction). In other forms, the pleats, folds or gussets can utilize internal air pressure to separate dynamic loads (e.g., tube traction) from the seal-forming structure. In some forms, the air pressure within the cavity can apply a load to the inner surface of the fabric membrane to generate further tensile stresses, so that the fabric membrane substantially fills the concave contour of the patient's face 1300 (e.g., around the sides of the nose). In some forms, when combined with the applied load of the internal air pressure, the elasticity of the fabric membrane can elastically stretch the fabric membrane so that it forms a larger sealing contact area on the patient's face. This is also advantageous in providing a continuous seal in some forms, even when the mask is partially displaced from the optimal interface with the patient's face, because the fabric membrane may be partially inflated (i.e., the "hovercraft effect") due to the reaction force from the internal air pressure.

[0346] In some forms, for example Figure 35-37As shown in Figures 54-56, the fabric membrane can have one or more clamping pads 29150, 31150 disposed thereon. In one example, the clamping pads 29150, 31150 can be configured to be substantially flat along the patient-facing surface of the fabric membrane. In other examples, the clamping pads 29150, 31150 can be embossed so that the clamping pads can form a curled edge or rim that protrudes slightly above the surface of the fabric membrane. In some forms, the clamping pads 29150, 31150 can have a high coefficient of friction. In some forms, the clamping pads can have a definite shape (e.g., an elliptical shape (see Figure 54-56)). Fig.35 , 37 , 54 and 56), round, square, etc.). In some forms, the clamping pad can be elongated (see Fig.35 and 54 ). In some forms, the clamping pads 29150, 31150 may be linear. In some forms, the clamping pads may be arranged in a pattern across the surface of the seal-forming structure 3100. In some forms, the clamping pads may be arranged irregularly on the surface of the seal-forming structure 3100 (see Fig.37 and 56 In some forms, the clamping pads may be arranged to form a perimeter adjacent to the peripheral edge of the fabric membrane (see Fig.34 , 35 , 54 and 55). In some forms, the clamping pads 29150, 31150 forming the perimeter may be in the form of dashed lines (see Fig.35 and 54 ). In some forms, the clamping pads forming the perimeter may be in the form of a solid line (see Fig.36 and 55 ). In some forms, the clamping pad forming the perimeter can be in the form of multiple lines, dotted lines or solid lines or a combination thereof. In some forms, the clamping portion can help the fabric membrane grip the patient's face. In one example, the clamping pad is formed as a relatively thin silicone layer applied to the surface of the fabric membrane.

[0347] In some forms, the fabric membrane can be integrated to the support structure by attaching (e.g., molding) the outer edge (e.g., perimeter edge) of the fabric membrane around a lip of the curved edge (i.e., inner edge) of the support structure. In one example, the fabric membrane can be angled slightly "inward" toward the interior of the mask. In one example, the fabric membrane is attached so as to provide a front face of the seal-forming structure. That is, the support structure forms a portion of the seal-forming structure that curves from the front side of the seal-forming structure to the back contact side (see Fig.11 ). In this way, the fabric membrane can avoid having a portion that is bent from the rear side to the front side. With this arrangement, the fabric membrane can be presented only along the front side of the seal-forming structure, such as for example Figure 11-17This arrangement may be advantageous because the fabric membrane may not need to be folded or cut to fuse around the corners of the support structure. This may be advantageous in reducing the occurrence of prominent folds or wrinkles in the fabric membrane (which may cause leakage), thereby improving the performance of the seal.

[0348] In some forms, the fabric membrane may be attached to the outer edge of the fabric membrane so that the fabric membrane forms part of the portion of the seal-forming structure that curves from the front side of the seal-forming structure to the back contact side (see, for example, Figures 33-1 to 33-4 , 73 and 74). This can provide more fabric membrane surface (opposite the support structure) for engaging with the patient's face, which can improve comfort. In one example, the fabric membrane is attached to the support structure by a specific process (as will be described later) that can form a 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, the support structure and the fabric membrane can both have a radius of curvature (e.g., the same or similar radius of curvature) along the curve 35 in the direction from the front side of the seal-forming structure to the back side of the seal-forming structure (see Figures 33-1 to 33-4 The fabric membrane may have a predetermined curvature imparted thereto, such that a portion of the fabric membrane that is not directly supported by the support structure extends along a curve 35 ( Figure 33-2 to Figure 33-4 ). This can help create a dome shape (e.g., a convex dome) in certain areas of the fabric membrane (e.g., the outer side 3250 and / or the corner area 3252) that can help the fabric membrane seal against the contours of the patient's face (e.g., the alar region of the patient's face (i.e., the corner of the nasal region, i.e., the area where the nose near the nasolabial groove ends at the upper lip)), such as Figure 33-1 As shown. The dome shape can help prevent creases, wrinkles, folds and deformations from forming in the fabric membrane, which can help avoid creating leak paths. In addition, the dome shape can help the fabric reach difficult-to-seal areas of the patient's face, such as the corners of the nasal area. The fabric membrane 29130 can have a saddle shape at the under-nasal medial area 3260 that is configured to seal against the patient's under-nasal point, thereby matching the saddle shape formed by the patient's nasolabial angle and upper lip, as shown. Figure 33-1 Similarly, the nasal prominence region 3270 may also have a saddle shape that is configured to seal against a matching contour presented at or below the nasal prominence of the patient. The curvature of the fabric membrane in the direction of curve 35 (e.g., the magnitude of the curvature and / or the radius of curvature) may vary along the perimeter of the fabric membrane in different areas of the cushion assembly. For example, Figure 33-2 As shown, the fabric membrane 29130 in the inner region 3270 of the nose protrusion may have a different curvature in the direction of the curve 35 than the fabric membrane in the inner region 3260 of the nose protrusion. Figure 33-2In an example, the fabric membrane in the inner nasal protrusion area 3270 may have a curvature (e.g., a negative curvature in the upper and lower directions along the curve 35) that is relatively larger (e.g., a smaller radius) than the curvature in the inner nasal protrusion area 3260 (e.g., a negative curvature in the upper and lower directions along the curve 35). In one example, the curvature (e.g., the curvature size and / or the curvature radius) at the outer side 3250 of the fabric membrane may be different from the curvature at the inner nasal protrusion area 3270 and / or the inner nasal protrusion area 3260. For example Fig.43 , 52 The nose portions of the cushion assemblies 14105, 30105, 31105 shown in and 61 can have similar arch and saddle features.

[0349] exist Fig.73 In the example of, the curvature of the fabric membrane 16230 from the connection with the support structure 16220 (e.g., at the transition portion) can continue to the inner edge of the fabric membrane. For example, at the inner edge of the fabric membrane in certain areas of the cushion, the fabric membrane can have a dome shape or a saddle shape.

[0350] In some forms, the fabric membrane may be angled or curved slightly inwardly toward the interior of the mask (e.g., a positive curvature in the left-right direction), see Figure 11-17 , 23-26 and 3-37. In some forms, the fabric membrane can be formed into a dome shape on a support structure, such as Figure 19-22 It should be noted that, as shown in the above reference Figure 33-1 As discussed, any cushioning assembly disclosed herein may have a fabric membrane attached to an outer edge of the fabric membrane such that the fabric membrane forms a portion of a seal-forming textile membrane forming a seal-forming structure extending along curve 35 from a front side of the seal-forming structure to a back contact side, such that, for example, the fabric membrane 6130 of cushioning assembly 6105 may have a more dome shape due to a more convex shape from one side to the other.

[0351] In some forms where the fabric membrane is not under continuous tension (before and / or during use) or is inelastic, the fabric membrane can form an improved air-assisted seal on the patient's face that dynamically conforms to changes / movements (i.e., a "hovercraft effect"), for example because the fabric membrane is thinner and has a lower structural stiffness than a silicone membrane.

[0352] In some forms, the fabric membrane may be supported by a second or third support structure that may serve as a cushion support. The cushion support may provide additional flexibility and may be adapted to fit most patients' faces (one size fits most). The second or third support layer may be formed using a fabric membrane, a fabric with a PU / Si membrane, a laminated open cell foam, a laminated PU foam, a PU molding, TPU / TPE, or silicone. In some forms, the additional support layer itself may be supported by a structural / rigid plastic such as PP / PC / PA / PET or other suitable material.

[0353] In some forms, 3D printing of a fabric membrane and / or cushion support as a "skeleton" can reduce the thickness and, therefore, the weight of the mask.

[0354] In some forms, multiple different layers of the mask layer can be printed with different stiffness, hardness or thickness. For example, the "skeleton" part can be formed using Si, PU foam, PU solid material or any suitable plastic material.

[0355] In some forms, pleats or folded sections may be formed along a cushion component (eg, a cushion component in a fabric membrane and / or a support structure) that may provide dynamic force / support or decoupling regions.

[0356] In one form, the seal-forming structure may comprise a compression seal or a gasket seal. In use, the compression seal or the gasket seal is constructed and arranged to be in a compressed state, for example as a result of elastic tension in the positioning and stabilising structure.

[0357] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is held in tension, for example, by an adjacent region of the sealing flange.

[0358] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0359] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tensioning portion, and a portion having a tacky or adhesive surface.

[0360] 5.3.2.2 Nose bridge or nasal ridge area

[0361] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the nasal bridge or nasal ridge region of the patient's face.

[0362] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over a nasal bridge region or a nasal ridge region of the patient's face.

[0363] 5.3.2.3 Upper lip area

[0364] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region (ie, upper lip) of the patient's face when in use.

[0365] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.

[0366] 5.3.2.4 Chin area

[0367] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the chin region of the patient's face when in use.

[0368] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on a chin area of ​​a patient's face.

[0369] 5.3.2.5 Forehead area

[0370] In one form, the seal-forming 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.

[0371] 5.3.2.6 Nasal pillows

[0372] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each of which is constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0373] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal on the bottom surface of the patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible region can work together to facilitate a universal engagement structure that can accommodate relative movement of both displacement and angle between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0374] 5.3.3 Nasal pads

[0375] Reference Figure 5-14 , shows a patient interface 3000 , 6000 according to a first example of the present technology, which has a cushion assembly 3105 including a seal-forming structure 3100 and an inflatable chamber 3200 . Figure 15-17A cushion assembly 5105 including a seal-forming structure 5100 and a plenum chamber 3200 is shown according to a second example of the present technology. Figure 18-22 A cushion assembly 6105 including a seal-forming structure 6100 and a plenum chamber 3200 is shown according to a third example of the present technology. Figure 23-27 A cushion assembly 7105 including a seal-forming structure 7100 and an inflatable chamber 3200 is shown according to a fourth example of the present technology. Figure 28-32 , shows a cushion assembly 8105 including a seal-forming structure 8100 and an inflatable chamber 3200 according to a fifth example of the present technology. FIG3 shows a patient interface 9000 having a cushion assembly 9105 including a seal-forming structure 9100 and a frame 9200 according to a sixth example of the present technology.

[0376] Figure 11-14 Dashed lines are included to demarcate regions of varying thickness, and it should be understood that these are merely nominal boundaries and not actual structures.

[0377] The examples of seal-forming structures 3100, 5100, 6100, 7100, 8100, 9100 described in the preceding paragraphs can be considered as nose bridge cushions and are intended to provide a pressurized gas flow to the patient's nostrils by sealing at least the underside of the patient's nose. Exemplary seal-forming structures can 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 can engage the patient's nose below the nasal protrusion. Exemplary seal-forming structures can also engage the patient's face at least above the upper vermilion. Thus, the exemplary seal-forming structure can seal against the patient's upper lip during use. In addition, the patient's mouth can remain uncovered by the seal-forming structure of the depicted example, so that the patient can breathe freely, i.e., breathe directly into the atmosphere without interference from the seal-forming structure. The under-nose nose bridges can be configured so that they do not have an orifice, the size of the orifice being determined to receive the patient's nose within the cavity. In addition, the height of the cushion from the lower edge of the fabric membrane at the inner side of the nose to the upper edge of the fabric membrane at the inner side of the nasal protrusion may be smaller than the width of the cushion in the left-right direction from the side edge of the fabric membrane to the other side edge of the fabric membrane (see, for example, Fig.33 and 33-1 ).

[0378] Examples of nasal support cushions disclosed herein (e.g., exemplary seal-forming structures) may include an upper saddle-shaped or concave region on the cushion having a positive curvature. Moreover, a nasal support cushion may be understood to have a single targeted seal-forming region or surface, while a nasal pillow cushion may have two targeted seal-forming regions (one for each nostril). The support cushion may also have a posterior wall that contacts the upper portion of the patient's lips and an upper center surface that contacts the underside of the patient's nose. These two surfaces of the patient's face may form a nasolabial angle therebetween (see Figure 2E ). The support cushion can be formed to have a nasolabial angle in the range of 90 degrees to 120 degrees.

[0379] Additionally, the shape and size of the exemplary seal-forming structure may also be designed such that no portion of the seal-forming structure enters the patient's nostrils during use.

[0380] Inflatable room

[0381] See also Figure 5-17 In the area where the seal is formed in use, the plenum 3200 has a perimeter shaped to complement the surface contour of an average human face. In use, the boundary edge of the plenum 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend along the entire perimeter of the plenum 3200 in use.

[0382] In certain forms of the present technology, the plenum chamber 3200 is constructed of a relatively rigid material (e.g., polycarbonate) compared to the seal-forming structure. Alternatively, the plenum chamber 3200 can be constructed of a flexible material (e.g., silicone) and can be formed as a single-piece structure with the support structure (e.g., of any material described herein as being suitable for the support structure and / or the plenum chamber). In one example, the seal-forming structure can be an extension of the plenum chamber or formed as a part of the plenum chamber such that the plenum chamber surrounds the seal-forming structure. In such an example, the support structure and the fabric membrane can be considered to be part of the plenum chamber. In another example, the plenum chamber 3200 can be constructed of a transparent material, such as transparent polycarbonate. The use of a transparent material can reduce the protrusion of the patient interface and help improve compliance with treatment. The use of a transparent material can help clinicians observe how the patient interface is positioned and functions.

[0383] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0384] Figure 5 and 10 -17 shows an example of a seal-forming structure 3100 with a plenum 3200. The seal-forming structure 3100 may include a plenum connection opening, wherein the seal-forming structure 3100 is sealingly coupled to the plenum 3200. The seal-forming structure 3100 and the plenum 3200 may at least partially form a cavity 3101 that is pressurized by an air flow. In the example shown, the seal-forming structure 3100 and the plenum 3200 together form the cavity 3101.

[0385] The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 may be a permanent bond. The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 may be a chemical bond. The seal-forming structure 3100 may be connected to the plenum chamber 3200 at the plenum chamber connection opening without requiring a mechanical connection. Alternatively, the seal-forming structure 3100 may be coupled to the plenum chamber 3200 at the plenum chamber connection opening by a mechanically removable, detachable connection.

[0386] At each side of the plenum 3200, there may be a plenum side end 3202 in the form of a hollow channel, which forms a plenum inlet port, the size and structure of which are determined to receive air flow. A plenum connector 3204 may also be provided on each side of the plenum 3200, laterally outward of the plenum side end 3202. The plenum connector 3204 may be connected to the respective ends 3314 of the positioning and stabilizing structure 3300. The connection between the plenum connector 3204 and the respective ends 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 a further example, the two connections between the plenum connector 3204 and the respective ends 3314 of the positioning and stabilizing structure 3300 may be permanent.

[0387] These plenum side ends 3202 can receive a flow of pressurized gas from the positioning and stabilizing structure 3300. The flow of pressurized gas can then pass through the plenum 3200, then through the seal-forming structure 3100, and into the patient's airway for inhalation.

[0388] The end 3314 of the positioning and stabilizing structure 3300 can be connected to the plenum side end 3202. Each plenum connector 3204 in these examples can include a slot 3209, a chamfered edge 3208, and a notch 3206 that can be removably connected to a clip of the positioning and stabilizing structure with a snap fit.

[0389] According to the third, fourth and fifth examples of the present technology Figure 18-32 The plenum chamber 3200 shown may be used with Figure 10-17It should also be understood that one or more aspects of the present technology may be combined with one or more of the following: U.S. Provisional Application No. 62 / 764,992, entitled “PATIENT INTERFACE,” filed on August 20, 2018, or PCT / AU 2019 / 050873, filed on August 20, 2019, each of which is incorporated herein by reference in its entirety. For example, the inflatable chamber of the present technology may be the same as the inflatable chamber in any embodiment of the '992 or '837 applications. In addition, the seal-forming structure disclosed herein may replace any seal-forming structure in any patient interface disclosed in the '992 or '873 applications, and the seal-forming structure of the present technology may include any features of the seal-forming structure in any embodiment of the '992 or '873 applications.

[0390] exist Figure 28-32 In the example of , the plenum 13200 has a plenum side 3202, a plenum connector 3204, a notch 3206, a chamfered edge 3208, and a slot 3209 similar to the plenum 3200 described above. However, the vent 3400 can be provided by a vent insert 13400 that is removably or permanently attached to the plenum 13200 (e.g., by being inserted into an opening in the plenum). It should be noted that any other examples can have a vent insert (e.g., Figure 10-27 The vent 3400 in the plenum 3200 may be formed by Figure 28-32 The vent insert 13400 shown is provided).

[0391] exist Fig.38 In the example of FIG. 4 , the frame 9200 may include a centrally located connection for the air circuit 4170. The frame may also include headband attachment portions 9210 at its sides. The seal-forming structure 9100 may be connected to the frame 9200 by spaced-apart connectors 9122, which may include a clip on the seal-forming structure and a receiving connector on the frame.

[0392] The seal forming structure of the present technology

[0393] The seal-forming structures 3100, 5100, 6100, 7100, 8100, 9100, 29100 may each include a support structure 3120, 6120, 7120, 8120, 9120, 29120 that provides support for a sealing portion 3130, 5130, 6130, 7130, 8130, 9130, 29130 (e.g., a fabric membrane). The sealing portion is configured to sealingly engage the patient's face. Similarly, depending on the size and contour of the patient's nose, the ... Figure 5-27 In the example of FIG. 1 , the support structure may also sealingly engage the patient's face.

[0394] Exemplary seal-forming structures 3100, 5100, 6100, 7100, 8100, 9100, 29100, while different in various aspects (as further described below), can each include a support structure having at least two regions of different thicknesses (e.g., two, three, or four regions) (e.g., seal-forming structure 3100 includes support structure 3120 having a wall structure having lateral support regions 3122 having increased thickness relative to other portions of the wall structure). For example, as Fig.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 plenum chamber, and portion (d2) can be adjacent to or connected to the seal portion to provide structural stability at the connection with the plenum chamber and flexibility at the interface with the patient. Alternatively, these thicker lateral support areas 3122 can be located, for example, at the corners of the nasal area of ​​the seal-forming structure (and, for example, can be directly connected to the fabric membrane) to ensure adequate sealing in the subalanar area of ​​the patient's face.

[0395] In addition, in the depicted example, each seal has two separate nostril openings 3102, each corresponding to one of the patient's nostrils, to provide air flow to both nostrils of the patient. A bridge 3104 may also be provided between the nostril openings 3102. The bridge 3104 may help provide a taut fabric membrane before and / or during use. In an alternative example, a single hole may be used to provide air flow to both nostrils of the patient.

[0396] As described above, the seal-forming structure 3100 may include a plenum connection opening, wherein the seal-forming structure 3100 is sealingly coupled to the plenum 3200. Figure 5-38 In the example of the embodiment of the present invention, the support structure 3120, 5120, 6120, 7120, 8120, 9120, 29120 is directly connected to the inflatable chamber or the frame. Therefore, the support structure can include an opening, wherein the support structure is sealingly coupled to the inflatable chamber 3200.

[0397] The support structure can be less rigid than the plenum 3200 and can be made of silicone, foam (e.g., polyurethane foam) (see Figure 28-32), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic or other suitable material, as will be described later. In addition, the sealing portion can be less rigid than the support structure and can be composed of a fabric material such as nylon, polyester, a nylon and polyester blend, microfiber or polyurethane, as will be described in more detail later. The sealing portion described in any example of the present invention may be referred to as a fabric sealing portion or a fabric membrane and may include a fabric material having an airtight material laminated, coated or otherwise applied thereto.

[0398] The support structure may have an aperture formed therein, the aperture providing an inner edge of the support structure, and the seal portion (e.g., a peripheral edge of the seal portion) may be attached to the support structure along the inner edge so that the seal portion extends radially inward from the seal-forming structure beyond the support structure or to a greater extent than the support structure, such as Figure 11-27 For example, the seal may be molded around the inner edge of the support structure, or connected to the support structure in other suitable ways, as will be described later. Figure 28-32 In an alternative example, the sealing portion 8130 can be laminated onto a support structure 8120 (eg, foam).

[0399] See also Figure 11-14 , the seal-forming portion 3100 has a wall structure that may include a lateral support region 3122 having an increased thickness compared to other portions of the wall structure of the support structure 3120. At each outermost side of the seal-forming structure 3100, a lateral support region 3122 may be provided. The seal-forming structure 3100 may include two lateral support regions 3122, each spaced apart from a plane bisecting the seal-forming structure 3100, which plane will be parallel to the patient's sagittal plane in use. The lateral support regions 3122 may be the thickest portion of the seal-forming structure 3100 to provide resistance to lateral displacement, for example, caused by a patient sleeping on the side of their head, causing the pillow to push laterally against the seal-forming structure, and provide a secure engagement against the patient's nose. The lateral support regions 3122 may have a thickness of about 0.9 mm to about 1.5 mm, or about 1.3 mm to about 1.4 mm, or about 1.3 mm, or about 1 mm to about 1.5 mm. Since the lateral support regions 3122 are the thickest regions of the seal-forming structure 3100 in the depicted example, the lateral support regions 3122 may also provide the greatest resistance to deformation.

[0400] In addition, the lateral support regions 3122 can provide sufficient rigidity to ensure adequate sealing (e.g., via the lateral support regions 3122) in the subalar region of the patient's face (i.e., the region where the ala terminates at the upper lip near the nasolabial groove), which is a particularly complex geometric region. The subalar region of the patient's face presents a particularly complex geometry because at least three facial surfaces - the ala, upper lip, and cheek converge in this region. Thus, sufficient rigidity in the lateral support regions 3122 can ensure that the seal-forming structure 3100 can be pushed into the subalar region by tension from the positioning and stabilizing structure 3300 without collapsing. These lateral support regions 3122 can be located on the patient's face in the region below the patient's ala and in the region below and laterally outward of the patient's nose, such as between the nasolabial groove and the upper lip region located below the ala.

[0401] Figure 15-17 The seal forming structure 5100 in the example of Figure 11-14 The support structure 5120 is reduced and the sealing portion 5130 is expanded in the seal-forming structure 5100, so that the sealing portion 5130 can be configured to engage the subalanar region of the patient's face during use. Therefore, the seal-forming structure 5100 can be more flexible and compliant so as to more easily conform to the facial contours of the patient.

[0402] Steering Figure 18-22 , the seal-forming structure in this example is arranged to provide a larger cavity 3101 so that the seal portion 6130, in use, protrudes further from the plenum chamber in a direction toward the patient's face by creating greater tension in the seal portion, thereby causing the seal portion to inflate outwardly. In use, the patient's nose can press against the seal portion 6130 in a direction toward the cavity 3101 and the plenum chamber 3200, causing the seal portion 6130 to stretch and invert so that the space formed by the cavity 3101 receives the patient's nose, thereby allowing the seal portion 6130 to seal above the patient's nasal prominence, as shown. Fig.18 On the contrary, Fig.10 As shown, the sealing portions 3130, 5130 seal below the front nose of the patient.

[0403] exist Figure 23-27 The sealing portion 7130 in the example of is also configured to seal above the nasal prominence of the patient due to the height of the cushion. The sealing portion 7130 is configured to seal further in the self-sealing direction along the ridge of the nose than the sealing portion 6130.

[0404] exist Figure 28-32In an exemplary cushion assembly of FIG. 8105 , the support structure 8120 can be provided by a foam material laminated on the plenum 3200. The sealing portion 8130 can be laminated directly on the support structure. The support structure 8120 can extend through the plenum 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-type seal against the patient's face, wherein the cushion assembly 8105 is pulled toward the patient's face by the headgear so that the seal-forming structure 8100 conforms to the contours of the patient's face through compression of the support structure 8120.

[0405] The cushion assembly 8105 is configured to seal against the underside of the patient's nose. The seal-forming structure 8100 includes an end 8122 that curves around the rear of the plenum 3200 and is configured to engage the patient's upper lip in use.

[0406] See also Figure 33-37 , cushion assembly 29105 is similar to cushion assembly 3105, but can extend further in the lateral left-right direction. Cushion assembly 29105 includes a seal forming structure 29100, a support structure 29120, and a sealing portion 29130. See Figure 33-1 , cushion assembly 29105-1 is similar to cushion assembly 29105, but may have a fabric membrane 29105 formed so that the fabric membrane forms a portion of a portion of a seal-forming structure that curves from a front side of the seal-forming structure to a back contact side, as previously described.

[0407] As mentioned earlier, Figure 35-37 A gripping pad 29150 is shown on the fabric membrane surface.

[0408] exist Fig.38 In the example of FIG. 9A , the sealing portion 9130 is arranged to seal above the nasal prominence of the patient.

[0409] 5.3.3.1 Positioning and stabilizing the structure

[0410] The cushion assembly 3105, 5105, 6105, 7105, 8105, 29105 of the patient interface 3000, 6000 of the present technology may be maintained in a sealed position during use by the positioning and stabilizing structure 3300. The cushion assembly 9105 of the patient interface 9000 may be maintained in a sealed position during use by the positioning and stabilizing structure 9300.

[0411] In one form, the positioning and stabilising structure 3300, 9300 provides a retaining force that is at least sufficient to overcome the positive pressure in the cavity 3101 to lift off the face.

[0412] In one form, the positioning and stabilising structure provides a retaining force to overcome the effects of gravity on the patient interface.

[0413] In one form, the positioning and stabilizing structure provides a retaining force as a safety margin to overcome the potential effects of damaging forces on the patient interface, such as from tube drag or accidental interference with the patient interface.

[0414] In one form of the present technology, a positioning and stabilizing structure 3300, 9300 is provided that is constructed in a manner consistent with being 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 sensed or actual volume of the instrument. In one example, the positioning and stabilizing structure includes at least one strap that is rectangular in cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0415] In one form of the present technology, a positioning and stabilizing structure is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back area of ​​the patient's head on a pillow.

[0416] In one form of the present technology, a positioning and stabilizing structure is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side sleeping position with the side area of ​​the patient's head on a pillow.

[0417] In one form of the present technology, the positioning and stabilizing structure 3300, 9300 is provided with a decoupling portion located between the front of the positioning and stabilizing structure and the back of the positioning and stabilizing structure. The decoupling portion does not resist compression and may be, for example, a flexible band or soft strap. The decoupling portion is constructed and arranged such that when a patient lies their head on the pillow, the presence of the decoupling portion prevents forces acting on the back from being transmitted along the positioning and stabilizing structure and disrupting the seal.

[0418] In one form of the present technology, the positioning and stabilizing structure includes a strap constructed from a laminate of a fabric patient contacting layer, a foam 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 engaging with a hook material portion.

[0419] In some forms of the present technology, the positioning and stabilizing structure includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state when in use and to direct a force to cause the seal-forming structure to seal with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0420] In one form of the present technology, the positioning and stabilizing structure includes a first strap, which is constructed and arranged so that in use, at least a portion of the lower edge of the first strap passes through the upper ear base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0421] In one form of the present technology applicable to a nasal-only mask or to a full-face mask, the positioning and stabilizing structure includes a second strap, which is constructed and arranged so that in use, at least a portion of the upper edge of the second strap passes under the inferior ear base of the patient's head and covers the occipital bone of the patient's head or is located below the occipital bone of the patient's head.

[0422] In one form of the present technology suitable for use with a nasal-only mask or with a full-face mask, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to separate from each other.

[0423] In some forms of the present technology, the positioning and stabilizing structure comprises a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0424] In some forms of the present technology, the positioning and stabilizing structure includes a strap configured to be breathable to allow moisture vapor to be transmitted through the strap,

[0425] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, 9300, each positioning and stabilizing structure configured to provide a retention force to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure that is suitable for large-sized heads but not small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not large-sized heads.

[0426] 5.3.3.1.1 Positioning and stable structure of this technology

[0427] 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 lateral portions 3302 and an upper portion 3304 in the form of conduits that direct the flowing pressurized gas from a hub 3306 to an end 3314. The positioning and stabilizing structure 3300 can be arranged so that the hub 3306 and the decoupling structure 3500 are positioned above the patient's head in use. As described below, the decoupling structure 3500 can rotate within the hub 3306, and when the patient interface 3000 is worn by the patient, such as during treatment, the position of the hub 3306 and the decoupling structure 3500 above the patient's head allows the patient to move more freely without becoming entangled with the air circuit 4170.

[0428] The positioning and stabilizing structure 3300 can be constructed from silicone. For example, the lateral portion 3302, the upper portion 3304, the hub 3306, and the side end 3314 can be constructed or molded from a single piece of silicone.

[0429] The upper portion 3304 of the positioning and stabilizing structure 3300 has ridges and valleys (or folded portions) that allow the upper portion 3304 to conform to the shape of a corresponding portion of a patient's head during use. The ridges and valleys of the upper portion 3304 allow the upper portion 3304 to extend and contract along the longitudinal axis to accommodate larger or smaller heads. The ridges and valleys of the upper portion 3304 allow the upper portion 3304 to bend to different radii of curvature to accommodate patient heads of different shapes and sizes.

[0430] The lateral portions 3302 of the positioning and stabilizing structure 3300 may not be formed with the ridges and valleys of the upper portion 3304. Thus, the lateral portions 3302 may be less malleable and flexible than the upper portion 3304, which may be advantageous because there is less variability in the shape and size of the lateral portions of a patient's head.

[0431] These ends 3314 can be connected to the corresponding plenum side ends 3202. As described above, the plenum side ends 3202 receive a flow of pressurized gas from the positioning and stabilizing structure 3300, which passes through the plenum 3200, through the seal-forming structure 3100, and to the patient's airway. As described above, the ends 3314 can be connected to the plenum connectors 3204 of the corresponding plenum side ends 3202.

[0432] The positioning and stabilizing structure 3300 can be constructed and arranged to direct the force / tension provided by the lateral portion 3302 into a partially upward and partially backward force vector applied to the plenum 3200. In particular, the partially upward and partially backward force vector urges the fabric membrane of the seal-forming structure 3100 into sealing contact with the underside of the patient's nose, such as at or below the prona and at least above the upper vermilion.

[0433] These lateral portions 3302 may also each include a tab 3308 that receives a rear strap end 3311 of the rear strap 3310. The rear strap 3310 may be adjustable in length, for example, by a hook and loop material arrangement such that one of the rear strap end 3311 and the remainder of the rear strap 3310 includes a hook material on its exterior and the other includes a loop material on its exterior. The length adjustability of the rear strap 3310 allows the tension on the lateral portions 3302 to be increased to pull the seal-forming structure 3100 into sealing engagement with the patient's face at a desired pressure (i.e., sufficiently tight to avoid leaks, while not too tight to cause discomfort).

[0434] The lateral portion 3302 may also be provided with a sleeve 3312 that cushions the patient's face against the lateral portion 3302. The sleeve 3312 may be constructed of a breathable fabric material having a soft touch.

[0435] exist Figure 6 In the illustrated alternative example, the patient interface 6000 includes a positioning and stabilizing structure 6300 having at least one tube 6350 formed of a fabric material (e.g., one or more sheets or layers of fabric material) and receiving pressurized air from an air delivery tube 6348 via a connection port 6600. The tube 6350 includes a left arm 6305 and a right arm 6307.

[0436] 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 conduit may also include a second side, which is attached to the inner layer, but away from the patient, and the second side may be referred to as the outer layer 6354. The inner layer and the outer layer may each be fastened to each other along the edges of the inner layer and the outer layer so that a channel or passage is formed between these seams of the inner layer and the outer layer. That is, the space between the seams remains unattached and forms an air passage 6372. The inner layer and the outer layer may be connected using various techniques that impart specific properties to the seams or joints. For example, in some forms, seams are formed using ultrasonic welding, radio frequency welding, and cutting and welding techniques. Heat may be applied in specific areas of the thermosetting or thermoplastic material used in the activated tube 6350. The heat may be used not only to combine the layers together, but also to thermoform layers such as the outer layer 6354. In addition, in some forms, stitching or adhesives such as glue may be used to combine the layers together. In some forms, stitching is not used. In further forms, material outside the layer is not used to connect the inner and outer layers of the tube. For example, in some forms, the inner and outer layers may be formed such that no additional material such as glue or stitching is required to connect the inner and outer layers together.

[0437] Each of the inner layer and the outer layer 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. Likewise, 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. In addition, in a form comprising a single sheet, the inner surface is the surface of the sheet facing inward and facing itself.

[0438] In some forms, one or more sheets of the tube may include an air-impermeable layer or membrane. In some forms, the inner surface of both layers includes a membrane configured to limit or restrict air from passing through the layer from the inner surface to the outer surface. The impermeable layer may be a thin layer that is less than the thickness of the fabric sheet of the inner or outer layer. In other forms, the impermeable layer may be greater than the thickness of the fabric sheet of either layer. The impermeable layer or membrane or film may be completely impermeable to air transfer, or may be formed to allow a predetermined rate or air transfer and a specific pressure.

[0439] The film can be formed of a thermoplastic or thermosetting material so that when exposed to a specific temperature, the film material can be molded or formed into a specific form, and then solidify or harden or solidify when cooled. In some forms, the film can be formed of silicone or polyurethane. In some forms, the outer layer 6354 can be preformed so that in an unpressurized or supported state, the outer layer 6354 is pre-positioned and pre-formed to extend away from the inner layer 6352 between the relative joints 6312. That is, the outer layer 6354 can support its own weight so that when not supported by pressurized air or other supporting mechanisms, the outer layer 6354 is kept spaced apart from the inner layer 6352 between the joints 6312.

[0440] 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 so that the inner layer 6352 is a substantially flat layer.

[0441] like Figure 7 , and especially Figure 8 As shown, the inner layer 6352 includes a fabric sheet 6360 and a membrane 6362. The fabric sheet 6360 may be formed from felt, foam, woven, knitted, or nonwoven material or other web.

[0442] The outer layer 6354 includes a tube sheet 6364 and an outer cover 6366. In some forms, both sides of the tube sheet 6364 can be covered with a film. Fig. 9 As shown, the tube sheet 6364 includes a film 6368 exposed to the chamber of the tube 6350 and a film 6370 along the opposite surface of the tube sheet 6364. The film 6368 can help provide a seal between the inner layer 6352 and the outer layer 6354 and form an airtight tube. The film 6370 can help connect the tube sheet 6364 to the outer cover 6366.

[0443] It should also be understood that one or more aspects of the present technology may be combined with one or more aspects of the following: U.S. Provisional Application No. 62 / 821,878, filed on March 21, 2019, entitled "Textile Headgear Tubing for a Patient Interface," or PCT / AU 2019 / 050655, filed on June 25, 2019, each of which is incorporated herein by reference in its entirety. For example, the positioning and stabilizing structures of the present technology may be the same as the positioning and stabilizing structures in any embodiment of the '968 or '655 applications. In addition, the cushioning assembly or seal-forming structure disclosed herein may replace any cushioning assembly or seal-forming structure in any patient interface disclosed in the '968 or '655 applications.

[0444] exist Fig.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 the ears on the corresponding sides of the patient's head. These side portions may include holes or other connectors for connecting with the headband attachment portion 9210 of the frame 9200. The positioning and stabilizing structure 9300 also includes a rear strap 9310 extending around the back of the patient's head, and a crown strap 9312 extending over the crown of the patient's head.

[0445] 5.3.3.2 Ventilation

[0446] In one form, the patient interface 3000, 6000, 9000 includes a vent 3400 constructed and arranged to allow clearance of exhaled gases, such as carbon dioxide, e.g. Figure 5 shown.

[0447] In some forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the cavity 3101 to the surrounding environment while the pressure within the plenum is positive relative to the surrounding environment. The vent 3400 is configured so that the vent flow has a sufficient amplitude to reduce the patient's rebreathing of exhaled CO2 while maintaining a therapeutic pressure in the plenum during use.

[0448] One form of a vent 3400 in accordance with the present technology includes a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0449] The vent 3400 may be located in the plenum 3200. The vent 3400 may include a plurality of holes, as described above. The holes of the vent 3400 may be divided into two groups spaced laterally apart. The axes of the flow paths through each hole of the vent 3400 may be parallel so that cross flow is avoided to prevent the generation of additional noise. The vents may be circular.

[0450] The holes of the vent 3400 may decrease in radius from the inside to the outside of the plenum 3200. Each vent hole has a draft angle. Each hole has a smaller diameter at its front end than at its rear end. The draft angle means that the holes do not have a small cross-section through the thickness of the chassis, which helps provide effective carbon dioxide removal at high humidification levels. In addition, a larger draft angle can result in the plenum 3200 being easier to manufacture, particularly when the plenum 3200 is formed from an injection molded plastic material. The draft angle allows the vent pins used in the mold to be thicker and easier to eject.

[0451] The holes of the vent 3400 may be provided in two groups toward the middle of the plenum 3200 and the groups may be symmetrical across the centerline of the plenum 3200. Providing a pattern of multiple vent holes may reduce noise and diffuse flow concentration.

[0452] The holes of vent 3400 may be placed at an optimal distance away from the centerline of plenum chamber 3200. Placing the holes of vent 3400 toward the centerline may advantageously reduce the chance of the vent holes becoming blocked when the patient is sleeping on their side. However, placing the vent holes too close to the middle of plenum chamber 3200 may result in excessive weakening of plenum chamber 3200 at the center, especially since the cross-section of plenum chamber 3200 is smallest at the center in the depicted example due to the overall shape of plenum chamber 3200. The location of the holes of vent 3400 may avoid blockage of the holes during side sleeping while keeping the middle portion of the chassis sufficiently strong.

[0453] The size of each vent hole and the number of vent holes can be optimized to achieve a balance between noise reduction while achieving necessary carbon dioxide removal, even during extreme humidification. In the depicted example, the vent holes of vent 3400 may not provide the total amount of ventilation for the system. The decoupling structure 3500 may include a decoupling structure vent 3402. The decoupling structure vent 3402 may include a hole or multiple holes through the decoupling structure 3500. The decoupling structure vent 3402 can be used to vent excess pressure generated by the RPT device 4000 before reaching the patient, while the vent 3400 can be used to remove carbon dioxide exhaled by the patient during treatment.

[0454] Fig.31 and 32An alternative example of a vent 3400 is shown where the apertures are provided to a vent insert 13400 that is removably or permanently connected to the plenum 3200 at the vent insert opening. The vent insert 13400 may be constructed of a material that is more flexible than the material of the plenum 3200.

[0455] 5.3.3.3 Decoupling structure

[0456] In one form, the patient interface 3000, 6000, 9000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0457] The hub 3306 described above is connected to the decoupling structure 3500, which is a rotatable elbow in these examples. The decoupling structure 3500 can be rotated 360° in the hub 3306 during use. The decoupling structure 3500 can be removable from the hub 3306 by manually pressing the button 3504 to release the catch (not shown) from the hub 3306.

[0458] The decoupling structure 3500 may also include a swivel joint 3502 that allows for a rotatable connection to the air circuit 4170 .

[0459] The rotatability of the decoupling structure 3500, which is in the form of an elbow, and the rotatability of the swivel joint 3502 on the decoupling structure 3500, can both increase the degrees 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.

[0460] 5.3.3.4 Connection Port

[0461] The connection port 3600 allows connection to the air circuit 4170 .

[0462] 5.3.3.5 Forehead support

[0463] In one form, the patient interface comprises a forehead support 3700 .

[0464] 5.3.3.6 Anti-asphyxia valve

[0465] In one form, the patient interface includes an anti-asphyxia valve.

[0466] 5.3.3.7 Ports

[0467] In one form of the present technology, the patient interface 3000, 6000, 9000 includes one or more ports that allow access to the volume within the cavity 3101. In one form, this allows a clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the cavity 3101, such as pressure.

[0468] 5.3.4 Full face padding

[0469] 5.3.4.1 First illustrative example

[0470] See also Figure 39-50 , the patient interface 14000 includes a cushion assembly 14105 having a seal-forming structure 14100 configured to seal around the patient's nostrils and mouth, respectively, i.e., an oronasal cushion assembly or an ultra-compact full-face mask. According to one example of the present technology, the cushion assembly 14105 is at least partially formed by an inflatable chamber 14200 and a seal-forming structure 14100 attached to the inflatable chamber.

[0471] See also Figure 51-56 , a cushion assembly 31105 is shown. Cushion assembly 31105 is similar to cushion assembly 14105 and has a seal-forming structure 31100 configured to seal around the patient's nostrils and mouth, respectively, i.e., an oronasal cushion assembly or an ultra-compact full face mask. According to one example of the present technology, cushion assembly 31105 is at least partially formed by an inflatable chamber 31200 and a seal-forming structure 31100 attached to the inflatable chamber.

[0472] The cushion assembly 31105 includes a nose portion 31101, a nose portion aperture 31103, a mouth portion 31102, a mouth portion aperture 31104, a cavity 31001, a support structure 31120, a sealing portion 31130 and a vent 31400, which are connected to the nose portion 31101. Figure 39-50 The features described in are similar and will not be discussed separately. A pair of plenum holes are configured to receive an air flow.

[0473] As mentioned earlier, Figure 54-56 A gripping pad 31150 is shown on the fabric membrane surface.

[0474] Inflatable room

[0475] In the area where the seal is formed in use, the plenum 14200 has a perimeter shaped to complement the surface contour of an average human face. In use, the boundary edge of the plenum 14200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 14100. The seal-forming structure 14100 may extend along the entire perimeter of the plenum 14200 in use.

[0476] In some forms of the present technology, the plenum 14200 is comprised of a relatively rigid material (e.g., polycarbonate) compared to the seal-forming structure. In another example, the plenum 14200 can be comprised of a transparent material, such as transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with treatment. The use of a transparent material can help a clinician observe how the patient interface is positioned and functioning.

[0477] In some forms of the present technology, the plenum chamber 14200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0478] The plenum chamber 14200 according to an example of the present technology can include a plenum hole on each side. The plenum hole can provide pneumatic communication between these catheter connectors 14800 and cavity 14001 described in more detail below. The connecting edge portion around each plenum hole can promote mechanical connection with the corresponding catheter connector, for example, a tight fit or a friction fit. The plenum chamber 14200 can be constructed of sufficiently rigid materials to provide auditory and / or tactile feedback to the patient when the catheter connector 14800 is connected to the plenum chamber 14200 or removed from the plenum chamber.

[0479] The seal-forming structure 14100 may be sealingly connected to the plenum 14200. The connection may be permanent or the seal-forming structure 14100 may be removable from the plenum 14200. The seal-forming structure 14100 may be overmolded to the plenum 14200. The seal-forming structure 14100 and the plenum 14200 may be connected by a mechanical connection, wherein no chemical bond is formed between the plenum 14200 and the seal-forming structure 14100.

[0480] Sealing structure

[0481] See also Figure 39-50 , the seal-forming structure 14100 may include a nasal portion 14101 having a pair of nasal apertures 14103 to seal the patient's nostrils. The depicted example provides two separate apertures 14103, each corresponding to one of the patient's nostrils, to provide air flow to both nostrils of the patient. A bridge 14106 may also be provided between the nostril openings 14103. In an alternative example, a single aperture may be used to provide air flow to both nostrils of the patient.

[0482] The seal-forming structure 14100 may include a mouth portion 14102 having a mouth portion aperture 14104 that seals with the patient's mouth.

[0483] The seal-forming structure 14100 can at least partially form a cavity 14001 that is pressurized by the air flow. A plenum 14200 can be connected to the seal-forming structure 14100 to further form the cavity 14001.

[0484] The seal-forming structure 14100 may include a support structure 14120 that provides support for a sealing portion 14130 (e.g., a fabric membrane). The sealing portion is configured to sealably engage the patient's face. Similarly, depending on the size and contour of the patient's nose, the support structure may also sealably engage the patient's face.

[0485] The support structure 14120 may include a wall structure having at least two regions of different thicknesses (e.g., a portion of the support structure adjacent to or connected to the inflatable chamber 14200 may be thicker than a portion of the support structure adjacent to or connected to the sealing portion 14130 so as to provide structural stability at the connection with the inflatable chamber 14200 and flexibility at the interface with the patient). Fig.84 An example is shown where portion (d1) of the support structure may be thicker than portion (d2) of the support structure. For example, portion (d1) may be adjacent to or connected to the plenum chamber, and portion (d2) may be adjacent to or connected to the seal portion to provide structural stability at the connection with the plenum chamber and flexibility at the interface with the patient. Alternatively, these thicker lateral support areas 3122 may be located, for example, at the corners of the nasal region and / or at the region of the mouth of the seal-forming structure (and, for example, may be directly connected to the fabric membrane) to ensure adequate sealing in the subalaural region and / or mouth region of the patient's face.

[0486] As described above, the seal-forming structure 14100 can be sealingly connected to the inflatable chamber 14200. The support structure 14120 can be less rigid than the inflatable chamber 14200 and can be constructed of silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic or other suitable material, as will be described later. In addition, the sealing portion 14130 can be less rigid than the support structure 14120 and can be constructed of a fabric material such as nylon, polyester, a nylon and polyester blend, microfiber or polyurethane, as will be described in more detail later.

[0487] The support structure 14120 can have an orifice formed therein that provides an inner edge of the support structure along which a seal 14130 (e.g., a peripheral edge of the seal) can be attached to the support structure such that the seal extends radially inward from the seal-forming structure beyond the support structure or to a greater extent than the support structure, such as, for example Figure 43-46For example, the seal may be molded around the inner edge of the support structure, or connected to the support structure in other suitable ways, which will be described later.

[0488] exist Fig.49 In the example of, the support structure 14120 can extend into the cavity 14001 forming the lower liner 14121 to provide support for the sealing portion 14130. The lower liner 14121 and the sealing portion 14130 can form a double-walled structure around the periphery of the sealing portion. In an optional example, a second or third lower liner layer can be provided to form a three-layer or four-layer wall structure. Fig.49 In the example of, the lower pad is constructed of a foam material (e.g., polyurethane foam). In an optional example, the lower pad 14122 can be constructed of silicone, such as Fig.50 However, it will be appreciated that the lower pad may be constructed of other suitable materials (eg, fabric).

[0489] It should also be understood that one or more aspects of the present technology may be combined with one or more aspects of the following: U.S. Provisional Application No. 62 / 609,909 filed on December 22, 2017, or WO2019 / 119058 filed on December 21, 2018, both of which are entitled "Catheter Headgear Connector for Patient Interface", the entire contents of each of which are hereby incorporated by reference into this document. For example, the conduit and positioning and stabilizing structures of the present technology can be the same as the conduit and positioning and stabilizing structures in any embodiment of the '909 or '058 applications. In addition, the cushion assembly and seal-forming structure disclosed herein can replace any cushion assembly (seal-forming structure and inflation chamber) and seal-forming structure in any patient interface disclosed in the '909 or '058 applications.

[0490] 5.3.4.1.1 Positioning and stabilizing the structure

[0491] The seal-forming structure 14100 of the patient interface 14000 of the present technology may be maintained in a sealed state during use by the positioning and stabilizing structure 14300 .

[0492] In one form, the positioning and stabilising structure 14300 provides a retaining force that is at least sufficient to overcome the positive pressure in the cavity 14001 to lift off the face.

[0493] In one form, the positioning and stabilising structure 14300 provides a retaining force to overcome the effects of gravity on the patient interface 14000 .

[0494] In one form, the positioning and stabilising structure 14300 provides a retaining force as a safety margin to overcome the potential effects of damaging forces on the patient interface 14000, such as from tube drag or accidental interference with the patient interface.

[0495] In one form of the present technology, a positioning and stabilizing structure 14300 is provided that is constructed in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 14300 has a small side or cross-sectional thickness to reduce the sensed or actual volume of the instrument. In one example, the positioning and stabilizing structure 14300 includes at least one strap that is rectangular in cross-section. In one example, the positioning and stabilizing structure 14300 includes at least one flat strap.

[0496] In one form of the present technology, a positioning and stabilizing structure 14300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back area of ​​the patient's head on a pillow.

[0497] In one form of the present technology, a positioning and stabilizing structure 14300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side sleeping position with the side area of ​​the patient's head on a pillow.

[0498] In one form of the present technology, the positioning and stabilising structure 14300 is provided with a decoupling portion located between the front of the positioning and stabilising structure 14300 and the back of the positioning and stabilising structure 14300. The decoupling portion does not resist compression and may be, for example, a flexible band or soft strap. The decoupling portion is constructed and arranged such that when a patient lies their head on a pillow, the presence of the decoupling portion prevents forces acting on the back from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0499] In one form of the present technology, the positioning and stabilizing structure 14300 comprises a strap constructed from a laminate of a fabric patient contacting 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 comprises a loop material for engaging with a hook material portion.

[0500] In some forms of the present technology, the positioning and stabilizing structure 14300 includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state when in use and to direct a force to cause the seal-forming structure to seal with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0501] In one form of the present technology, the positioning and stabilizing structure may include a first strap (e.g., upper strap 14302, Fig.41 )), the first strap is constructed and arranged so that in use at least a portion of a lower edge of the first strap passes over the upper ear base of the patient's head.

[0502] In one form of the present technology suitable for a full face mask, the positioning and stabilizing structure includes a second strap (e.g., lower strap 14303 ( Fig.41 )), the second strap is constructed and arranged so that in use at least a portion of the upper edge of the second strap passes under the lower ear base of the patient's head and covers the occipital bone of the patient's head or is located below the occipital bone of the patient's head.

[0503] In one form of the present technology suitable for a nasal mask only or for a full face mask, the positioning and stabilizing structure includes a third strap (e.g., strap connector 14304 ( Fig.39 )), the third strap is constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to separate from each other.

[0504] In some forms of the present technology, the positioning and stabilizing structure 14300 comprises a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0505] In some forms of the present technology, the positioning and stabilizing structure 14300 includes a strap configured to be breathable to allow moisture to be transmitted through the strap.

[0506] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 14300, each positioning and stabilizing structure configured to provide retention forces to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 14300 that is 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.

[0507] The positioning and stabilizing structure 14300 may include a clip 14301 to secure a corresponding strap (for example) to the catheter connector 14800, such as Fig.39 The clip 14301 and the catheter connector 14800 may each include magnets arranged to have opposite polarities to facilitate connection therebetween.

[0508] 5.3.4.1.2 Ventilation

[0509] In one form, the patient interface 14000 includes a vent 14400 constructed and arranged to allow clearance of exhaled gases, such as carbon dioxide, such as Fig.39 shown.

[0510] In some forms, the vent 14400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 14200 to the surrounding environment while the pressure within the plenum chamber is positive relative to the surrounding environment. The vent 14400 is configured so that the vent flow has a sufficient amplitude to reduce the patient's rebreathing of exhaled CO2 while maintaining a therapeutic pressure in the plenum chamber during use.

[0511] One form of a vent 14400 in accordance with the present technology comprises a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0512] The vent 3400 may be located in the plenum 14200, such as Fig.47 Alternatively, the vent 14400 is located in a decoupling structure, such as a rotary joint.

[0513] Fig.39 Examples of vents 14400 (eg, swivel elbows) disposed on connection port 14600 are shown. Variations of these examples may exclude vents 14400 from connection port 14600.

[0514] These catheter connectors 14800, described in more detail below, may also include a vent feature.

[0515] 5.3.4.1.3 Decoupling structure

[0516] In one form, the patient interface 14000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0517] 5.3.4.1.4 Connection Port

[0518] The connection port 14600 allows connection to the air circuit 4170. The connection port 14600 according to an example of the present technology may be connected to the connection port housing 14903. The connection port 14600 may be rotatable relative to the connection port housing 14903 and the connection to the air circuit 4170 may also be rotatable.

[0519] The connection port 14600 and the connection port housing 14903 can be positioned above the patient's head during use.

[0520] 5.3.4.1.5 Forehead support

[0521] Figure 39-50 The example of a patient interface of the present technology shown does not include a forehead support. Variations of a patient interface of the present technology may include a forehead support.

[0522] 5.3.4.1.6 Catheter

[0523] A patient interface 14000 according to an example of the present technology can include a conduit 14900 to provide a pressurized air flow from a connection port 14600 to a cavity 14001 in a plenum 14200. The conduit 14900 can be engaged above the patient's head at a connection port housing 14903 and can be passed along the side of the patient's head between the patient's eyes and ears. The conduit 14900 can be connected to a cushion assembly 14105 (e.g., a plenum 14200) via a conduit connector 14800, as described below, to provide a pressurized air flow to the cavity 14001.

[0524] The conduit 14900 may also stabilize and position the seal-forming structure 14100 on the patient's face. Thus, the conduit 14900 may function similarly to the tether of the positioning and stabilizing structure 14300. Thus, the mechanical connection of the conduit 14900 to the conduit connector 14800 may be sufficient to transfer tension in the conduit 3900 through the conduit connector 14800 to the seal-forming structure 14100.

[0525] The catheter 14900 may include the invention disclosed in International Application Publication No. WO 2017 / 124155 A1, which is incorporated herein by reference in its entirety. For example, the catheter 14900 of the present technology may include the invention disclosed in International Application Publication No. WO 2017 / 124155 A1, which is incorporated herein by reference in its entirety. Figures 3A-3L Features of the headband tube 3350 depicted in and an associated written description.

[0526] The catheter 14900 may also be provided with a sleeve 14901 to cushion the patient's face against the catheter 14900. The sleeve 14901 may be removable. The sleeve 14901 may be made of a breathable material.

[0527] The catheter 14900 may also include a strap connector 14902 to facilitate connection to the strap of the positioning and stabilizing structure 14300.

[0528] 5.3.4.1.7 Catheter connector

[0529] According to an example of the present technology, the patient interface 14000 can include a conduit connector 14800 to connect the conduit 14900 to the cushion assembly 14105 to provide a pressurized air flow to the cavity 14001. The conduit connectors 14800 can each be formed with a conduit connector housing 14801. The conduit connectors 14800 can provide other functions, as described below, such as ventilation of the plenum chamber 14200, connection to the positioning and stabilizing structure 14300, and prevention of asphyxia by including an anti-asphyxia valve 14850.

[0530] Figure 43-50 Several views of a catheter connector 14800 of a patient interface 14000 are shown in accordance with examples of the present technology.

[0531] exist Figure 39-50 In the embodiment of the present invention, the conduit connector 14800 is shown as being attached to the plenum chamber 14200 at the plenum chamber hole (not shown). It can be seen that there is a conduit connector 14800 on each side of the cushion assembly 14105, and each conduit connector 14800 is connected to the plenum chamber hole on each corresponding side of the cushion assembly 14105. The conduit connectors 14800 can each include a conduit connector attachment structure, which is used to connect each of the conduit connectors 14800 to the corresponding plenum chamber hole at the connection rim (not shown). The connection can be mechanical, such as an engagement fit, a snap fit, or a friction fit. The connection can also be removable. The material of the conduit connector 14800 and the material of the plenum chamber 14200 can each be selected to facilitate the desired connection feature. For example, the material of the conduit connector 14800 and the material of the plenum chamber 14200 can each be relatively rigid to allow auditory and / or tactile feedback associated with the snap fit. The material of the conduit connector 14800 and the material of the plenum chamber 14200 may be different in at least one aspect or these materials may be the same. The conduit connector 14800 may also be permanently connected to the plenum chamber at the plenum chamber hole. For example, the conduit connector 14800 may be ultrasonically welded to the plenum chamber 14200. The connection between the conduit connector 14800 and the plenum chamber 14200, whether removable or permanent, may also be designed to be sufficiently strong so that tension from the conduit 14900 may be transferred to the plenum chamber 14200 without interrupting the connection, because, as described above, the conduit connector 14800 may contribute to the positioning and stabilization of the seal-forming structure 14100 on the patient's head.

[0532] The conduit connector 14800 may also be connected to the side of the plenum chamber 14200 to improve the aesthetics of the patient interface 14000. As described above, the plenum chamber 14200 may be constructed of a transparent or translucent material, which may allow visibility of the patient's facial features. By positioning the conduit connector 14800 laterally on the plenum chamber, for example, as shown in the described example, more of the patient's face is visible, and this arrangement may improve the aesthetics of the patient interface 14000. This is in contrast to an alternative design in which the elbow and air circuit may be connected to the center of the plenum chamber 14200, thereby blocking the view of the patient's face.

[0533] 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 hole 14803 may be formed in the conduit connector housing 14801 at the conduit connection end 14802 to receive a pressurized air flow. The conduit connector 14800 may include a structure (e.g., undercut) that is convenient for being connected to a removable snap fit with the corresponding conduit 14900, and each conduit 14900 may include a relatively rigid structure at the end that is connected to the conduit connector 14800 to facilitate such connection. The conduit connector 14800 may also be connected to the conduit 14900 by friction fit. Again as described above, the catheter 14900 can provide a positioning and stabilizing function to position the seal-forming structure in a therapeutically effective sealing position on the patient's face, and thus the connection between the catheter 14900 and the catheter connector 14800 at the catheter connection end 14802 can be sufficiently tight to allow tension from the catheter 14900 to be transferred to the conduit connector 14800 without disrupting the connection between the conduit 14900 and the conduit connector 14800 at the catheter connection end 14802.

[0534] The conduit connector 14800 can also provide ventilation functionality for the patient interface 14000. The conduit connector housing 14801 can include a ventilation inlet that is in pneumatic communication with the cavity 14001 when the patient interface 14000 is assembled. The conduit connector housing 14801 can also include at least one conduit connector vent hole 14831. As can be seen in the depicted example, each conduit connector housing 14801 includes a plurality of conduit connector vent holes 14831. This ensures that the newly introduced air is fully mixed with the air already present in the plenum 14200, which can enhance the removal of carbon dioxide and increase the amount of fresh air provided to the patient for breathing.

[0535] like Figure 39-41 As shown, the catheter connector 3800 can also provide a connection with the laces of the positioning and stabilizing structure 3300. These lower laces can be engaged to the pipeline connector 3800 with a clip 14301. The clip 14301 and the catheter connector 14800 can include magnets with opposite polarities to facilitate connection. The connection between the laces of the positioning and stabilizing structure 14300 and the catheter connector 14800 can be releasable. The tension of the lower laces from the positioning and stabilizing structure 14300 can force the lower portion of the seal-forming structure 14100 to seal and engage with the patient's face (e.g., around the mouth). Alternatively, the structure connected to the clip 14301 can be directly formed on the catheter connector housing 14801.

[0536] 5.3.4.1.8 Anti-asphyxia valve

[0537] In one form, the patient interface 14000 includes an anti-asphyxia valve. Fig.47 and 48 As best shown in , the catheter connectors 14800 can each include an anti-asphyxia valve assembly 14850. Thus, the patient interface 14000 can include two anti-asphyxia valve assemblies 14850. Each of the anti-asphyxia valve assemblies 14850 can operate independently of each other (i.e., collectively) in response to a cessation of the pressurized air flow. For example, if a patient falls asleep on his or her side when there is a cessation of the pressurized air flow and one of the anti-asphyxia valve assemblies 14850 is blocked by, for example, a pillow, the other of the anti-asphyxia valve assemblies 14850 can function to prevent the patient from suffocating.

[0538] 5.3.4.1.9 Ports

[0539] In one form of the present technology, the patient interface 14000 includes one or more ports that allow access to the volume within the plenum chamber 4200. In one form, this allows a clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 14200, such as pressure.

[0540] 5.3.4.2 Second illustrative example

[0541] Figures 57 to 66 A patient interface 30000 according to another example of the present technology is shown. The patient interface 30000 includes a cushion assembly 30105 having a seal-forming structure 30100 configured to seal around the patient's nostrils and mouth, respectively, i.e., an oronasal cushion assembly or an ultra-compact full face mask. According to one example of the present technology, the cushion assembly 30105 is at least partially formed by an inflatable chamber (or shell) 30200 and a seal-forming structure 30100 attached to the inflatable chamber.

[0542] The cushion assembly 30105 includes a nose portion 30101, a nose hole 30103, a mouth portion 30102, a mouth hole 30104, a cavity 30001, a support structure 30120 and a sealing portion 30130, which are connected to the nose portion 30101, and the mouth portion 30102 is connected to the mouth portion 30104. Figure 39-56 The features described in are similar and are not discussed separately. Inlet port 30240 is formed in the plenum and is configured to receive an air flow for the air circuit.

[0543] 5.3.4.2.1 Positioning and stabilizing the structure

[0544] Figure 57-66A patient interface 30000 is shown having a positioning and stabilizing structure 30300 and a plenum chamber 30200 having a seal-forming structure 30100 in accordance with one example of the present technology. The positioning and stabilizing structure 30300 in this example includes a frame 30350 and a plurality of headgear straps connected to the frame 30350.

[0545] The plenum 30200 of the patient interface 30000 is connected to the frame 30350. The plenum 30200 can be connected to the frame 30350 via a snap-fit ​​connection. In other examples, the plenum can form a different type of removable connection to the frame, a snap fit, a removable press fit, or other means, or can be permanently connected to the frame.

[0546] The positioning and stabilizing structure 30300 may include a plurality of straps or strap portions that are connected to the frame 30350 and passed around the patient's head to support the inflatable chamber in a sealed position against the patient's face. It should be understood that a single "strap" may be formed from multiple lengths of material that have been cut or formed individually and then joined together at their ends to form a longer length, or a single "strap" may be a single length of material.

[0547] exist Figure 57-66 In the example shown, the positioning and stabilizing structure 30300 includes a pair of upper straps 30310. Each upper strap is configured to pass between the patient's respective eyes and ears. In addition, the positioning and stabilizing structure includes a pair of lower straps 30320, which are configured to be positioned above the patient's cheeks below the patient's cheeks. In this example, the inflatable chamber is held in place via a four-point connection to the headband via the frame 30350.

[0548] Framework in Figure 63-64 30354. The frame inlet connection port 30354 can be configured to be connected to a source of pressurized breathable gas, such as air. In one example, the frame inlet connection port 30354 can be configured to be connected to a swivel elbow assembly 30610, which provides a connection port 30600 for connecting to the air circuit 4170. The frame inlet connection port in this example includes a connection flange 30355. The connection edge 30355 can include a flange extending radially outward. The swivel elbow assembly 30610 can form a releasable snap fit with the connection flange, thereby forming a fluid connection between the swivel elbow assembly and the frame. The opposite side of the frame inlet connection port 30354 is configured to be fluidly connected to the plenum chamber. Therefore, the frame 30350 is capable of achieving a fluid connection between the swivel elbow assembly 30610 and the interior of the plenum chamber 30200.

[0549] The frame 30350 also includes a pair of opposing upper strap connection points 30315 to which the upper straps 30310 are connected. In this example, each upper strap connection point includes an aperture formed in the frame. Each upper strap 30310 can be connected to a corresponding upper strap connection point 30315 by passing through the aperture, looping back on itself and fastening to itself. Each upper strap can be secured to itself by a hook and loop material configured to releasably engage with each other when in contact. In an optional example, each upper strap 30310 can pass through a corresponding aperture, loop back on itself and fasten to itself by a strap, clip, etc. In a further optional example, the upper strap can be connected to the frame by a side release buckle connector.

[0550] The frame 30350 also includes a pair of opposing lower strap connection points 30325 to which the lower strap 30320 is connected. In this example, each lower strap connection point includes a magnet. Each lower strap includes a lower strap clip 30326, which includes a magnet or material that is attracted to the magnet at the lower strap connection point 30325. In this example, each lower strap clip 30326 includes an aperture through which the end of the corresponding lower strap can pass and then be looped back and secured to itself, such as using hook and loop material, a strap, a clip, etc. In alternative examples, the lower straps can be connected to the frame via a side release buckle connection, to a hook, or via any other suitable connection.

[0551] In one example, the frame 30350 and upper strap connection points 30315 are constructed and arranged to direct the force / tension provided by the upper strap 30310 into a partial upper force and partial rearward force vector applied to the plenum chamber 30200. The partial upper force and partial rearward force vectors, among other things, force the nasal portion 30101 of the seal-forming structure 3100 into sealing contact with the lower periphery of the patient's nose and the patient's upper lip.

[0552] The upper straps 30310 can each be selectively adjustable. For example, the effective length of each upper strap can be changed by changing how much of the upper strap is passed through the aperture at the corresponding upper strap connection point 30315 and looped back on itself. Passing more of the upper strap through the aperture effectively reduces the length of the upper strap, thereby allowing the force vector to be changed and the fit of the patient interface to be adjusted.

[0553] In one example, the frame 30350 and lower strap connection points 30325 are constructed and arranged to direct the force / tension provided by the lower strap 30320 to a partial rearward force and a partial downward force vector applied to the plenum chamber. The partial rearward force and the partial downward force vector, among other things, urge the mouth portion 30102 into sealing contact with the patient's face around the periphery of the patient's mouth. The partial downward force applied to the frame by the lower strap can be balanced with the partial upward force applied by the upper strap and any downwardly directed force that the patient's nose may apply to the seal-forming structure.

[0554] The lower straps 30320 can each be selectively adjustable. For example, the effective length of each lower strap can be changed by changing how much each lower strap passes through the aperture in the corresponding lower strap clip 30326 and loops back on itself. Passing more of each lower strap through the aperture effectively reduces the length of the lower strap, thereby allowing the force vector to be changed and the fit of the patient interface to be adjusted.

[0555] The positioning and stabilizing structure 30300 may also include one or more of a top crown strap 30330, a pair of side crown straps 30332, and a neck strap 30334. Figure 57-66 In the example shown, the upper strap 30310 and the lower strap 30320 are connected to the ends of the top crown strap 30330. The top crown strap is configured to pass around the patient's head and rest against the upper and rear facing surfaces. The top crown strap 30330 can be configured to cover the parietal bone of the patient's skull. Each end of the top crown strap is connected to a corresponding one of the upper straps 30310 and is also connected to a corresponding one of a pair of side crown straps 30332. Each side crown strap is connected between the upper strap and the lower strap on the corresponding side of the patient's head. The lower ends of the side crown straps 30332 are connected to each other by a neck strap 30334. The neck strap can be configured to pass through the sagittal plane and rest against the lower and / or rear surface of the patient's head or against the back of the patient's neck. The neck strap can cover the occipital bone of the patient's skull or be located below the occipital bone of the patient's skull.

[0556] The length of the top crown strap 30330 may be selectively adjustable. The top crown strap 30330 is formed of two strap portions connected by a link having a pair of apertures. Each of the two strap portions forming the top crown strap can be passed through a respective one of the apertures and then looped back and secured to itself, e.g., via hook and loop material, another clip, a strap, etc. The amount of each top strap portion that passes through the link can be varied to adjust the length of the top crown strap 30330 and thereby adjust the fit of the positioning and stabilizing structure.

[0557] Once all headgear straps have been adjusted and the desired fit of the patient interface 30000 has been achieved, the magnetic clip connection provided by the lower strap clip 30326 enables the lower strap 30320 to be quickly disengaged from the lower strap connection point 30325 on the frame 30350, thereby allowing the patient interface 30000 to be removed from the patient without adjusting the straps. Similarly, when the patient interface is again donned by the patient, the lower strap clip can be quickly engaged at the lower strap connection point to fit the patient interface without the need to adjust the straps. Additional advantages and features of positioning and stabilizing structures including magnetic clips are described in WO 2014 / 110622, the entire contents of which are incorporated herein by reference.

[0558] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure, each positioning and stabilizing structure being configured to provide a retention force to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure that is 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.

[0559] In addition, it should be understood that one or more aspects of the present technology may be combined with one or more aspects of the following: PCT / AU 2019 / 050278, filed on March 28, 2019 and entitled "PATIENT INTERFACE", the entire contents of which are incorporated herein by reference in their entirety.

[0560] 5.3.4.2.2 Ventilation

[0561] In one form, the patient interface 30000 includes a vent 30400 constructed and arranged to allow clearance of exhaled gases, such as carbon dioxide.

[0562] In some forms, the vent 30400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 30200 to the surrounding environment while the pressure within the plenum chamber is positive relative to the surrounding environment. The vent is configured so that the vent flow has a sufficient amplitude to reduce the patient's rebreathing of exhaled CO2 while maintaining a therapeutic pressure in the plenum chamber during use.

[0563] One form of vent according to the present technology includes a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0564] The vent 30400 may be located in the plenum chamber. Alternatively, the vent is located in a decoupling structure such as a swivel joint.

[0565] exist Figure 57-66 In the example shown, the patient interface 30000 includes a vent 30400. The vent in this example includes a passageway and a swivel elbow assembly within the frame through which air can flow from the interior of the plenum chamber to the atmosphere. Fig.59 As shown, air can flow into the swivel elbow assembly 30610 and then flow out to the atmosphere through an external hole of the swivel elbow assembly that forms part of the vent 30400. The swivel elbow assembly 30610 can be substantially as described in International Publication No. WO2017 / 049357 A1, the entire contents of which are incorporated herein by reference.

[0566] 5.3.4.2.3 Decoupling structure

[0567] In one form, the patient interface 30000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0568] 5.3.4.2.4 Connection Port

[0569] The connection port 30600 allows connection to the air circuit 4170 .

[0570] 5.3.4.2.5 Forehead support

[0571] In one form, the patient interface 30000 includes such Figure 3A Forehead support 3700 is shown. In other examples, the patient interface may not include a forehead support. In addition, the patient interface 30000 may be configured not to contact the patient's forehead at all.

[0572] 5.3.4.2.6 Anti-asphyxia valve

[0573] In one form, patient interface 30000 includes an anti-asphyxia valve.

[0574] 5.3.4.2.7 Ports

[0575] In one form of the present technology, the patient interface 30000 includes one or more ports that allow access to the volume within the plenum chamber. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 302000, such as pressure.

[0576] 5.3.4.3 Third illustrative example

[0577] Figures 67 to 77 A patient interface 16000 according to another example of the present technology is shown. The patient interface includes a frame assembly 16100, a cushion assembly 16175 including a seal-forming structure 16200, an air delivery connector (e.g., an elbow assembly 16600), and a positioning and stabilizing structure (e.g., a headband 16800, including upper side straps 16802, lower side straps 16804, and a crown strap 16806). In use, a form of the seal-forming structure 16200 is arranged to surround the entrance of the airway of the patient 1000 to facilitate the supply of positive pressure air to the airway. Figure 46-56 In the example shown, the patient interface is a full face / oral-nasal interface type that includes a seal-forming structure 16200 that is configured to form a seal around the patient's nose and mouth. However, aspects of the present technology may be adapted for use with other suitable interface types, such as nasal interfaces, nasal prongs, nasal pillows, etc.

[0578] The seal-forming structure 16200 may also be generally referred to as a gasket. Fig.67 and 68is an exemplary view of a patient interface 16000 in which an arm cover 16750 is used to attach an upper arm 16134 of a frame assembly 16100, and Fig.69 is an exemplary view of the patient interface 16000 with the headgear 16800 and arm covers 16750 removed.

[0579] In this example, the pad assembly 16175 is connected to the frame assembly 16100 (via a first retention feature on the frame assembly) independently of the elbow assembly 16600, and the elbow assembly 16600 is connected to the frame assembly 16100 (via a second retention feature on the frame assembly) independently of the pad assembly 16175. That is, the retention connections of the pad assembly 16175 and the elbow assembly 16600 to the frame assembly 16100 are separate and distinct from each other and allow for independent engagement / disengagement.

[0580] In the example of the patient interface 16000, a first seal for the airflow path is formed between the elbow assembly 16600 and the frame assembly 16100, and a separate second seal is formed between the frame assembly 16100 and the cushion assembly 16175. In this example, the frame assembly 16100 is disposed in the airflow path. That is, the elbow assembly 16600 is configured to establish a hard-to-hard connection and a dynamic seal with the frame assembly 16100, while the cushion assembly 16175 is configured to establish a separate hard-to-hard connection and a static seal with the frame assembly 16100.

[0581] Additionally, in the example of patient interface 16000, frame assembly 16100 includes a locking feature along opening 16105 that is constructed and arranged to prevent direct connection or insertion of air circuit 4170 (e.g., an air delivery tube). This arrangement requires the use of elbow assembly 16600 to interconnect frame assembly 16100 with air circuit 4170, thereby ensuring that elbow assembly 16600 (and its vent and anti-asphyxia valve (AAV valve)) is present in the system.

[0582] Framework components

[0583] Still see Figures 67-77 , the frame assembly 16100 includes a shield or wall member 16110, a pair (i.e., left and right) of upper headband connector arms 16134 (each including two flexible portions 16140, 16145) extending from respective sides of an upper portion of the shield 16110, and a pair (i.e., right and left) of lower headband connector arms 16154 extending from respective sides of a lower portion of the shield 16110. Each lower headband connector arm 16154 includes a magnetic connector 16155 (including an encapsulated magnet) configured to locate and connect to a headband clip 16160 (including an encapsulated magnet) provided to a corresponding lower headband strap 16804 of the headband.

[0584] In the example shown, the opening 16105 of the shroud 16110 (eg, constructed of a relatively hard plastic material such as polycarbonate) is defined by an outer annular flange and an inner annular flange.

[0585] Gasket Assemblies and Elbow Assemblies

[0586] See also Figures 67-77 , the cushion assembly 16175 includes a body, chassis, plenum or housing 16180 that is connected or otherwise provided to a seal forming structure or cushion 16200 (see Fig.70 and 71 ). The housing 16180 can be permanently (e.g., co-molded, overmolded) or removably (e.g., mechanically connected) connected to the liner 16200. In one example, the liner 16200 is composed of a relatively flexible or pliable material and the housing 16180 is composed of a relatively rigid material (e.g., polycarbonate). The housing 16180 and the liner 16200 cooperate to form the cavity 16500 (e.g., see Fig.70 , 71 16305 . The housing 16180 includes an opening 16305 through which breathable gas is delivered to the chamber 16500 . The opening 16305 is defined by an annular flange 16310 that is adapted to be connected to the frame assembly 16100 .

[0587] The housing 6180 has multiple functions. For example, it at least partially forms a cavity for delivering pressurized gas to the entrance of the patient's airway. The housing 6180 is a rigid structure that directs force to a seal-forming structure for sealing the patient's face. The force is provided by the tension generated by tightening the headgear straps. These forces are transmitted from a pair of upper and lower headgear straps to the corresponding upper and lower arms. In one example, the upper and lower arms are provided with a frame assembly that provides headgear tension to the housing 16180.

[0588] The housing 16180 of the cushion 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). The inner annular flange of the shield 16110 extends through the opening 16305 of the housing 16180, and the tabs or hooks 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 cushion assembly 16175. Such a connection remains easy to use, provides a sealed hard-to-hard connection, minimizes trembling and rocking motion between components, and reduces the impact on stability. In addition, such a connection stably holds the cushion assembly 16175 in place while allowing the appropriate force vector to be applied to the cushion assembly 16175 to seal.

[0589] exist Fig.67 In the example shown, elbow assembly 16600 includes a first end 16610 having a clamping arm 16650 for releasably engaging (and rotating in connection with) frame assembly 16100 and a second end 16620 adapted to connect to air circuit 4170 via a rotating connector 16625. Elbow assembly 16600 is configured to establish a hard-to-hard connection and seal with frame assembly 16100.

[0590] In this example, the first end 16610 includes inner and outer radial walls that define a radial passageway leading to a plurality of vent holes 16700 to allow exhaust gases to escape from the patient interface.

[0591] In addition, it should be understood that one or more aspects of the present technology can be combined with one or more aspects of the following: U.S. Application Publication No. 2018 / 0250486, filed on March 12, 2018 and entitled "PATIENT INTERFACE," the entire contents of which are incorporated herein by reference in their entirety. For example, the cushion assembly 16175 disclosed herein can replace the cushion assembly in any patient interface embodiment disclosed in the '486 publication. In addition, the seal-forming structure 16200 disclosed herein replaces the seal-forming structure in any patient interface embodiment disclosed in the '486 publication.

[0592] Sealing structure

[0593] As described above, the housing 16180 is sealingly connected or otherwise configured to the seal-forming structure or gasket 16200, and the housing 16180 and gasket 16200 cooperate to form the cavity 16500.

[0594] The cushion 16200 can include a support structure 16220 that provides support for a sealing portion 16230 (eg, a fabric membrane). The sealing portion is configured to sealingly engage the patient's face.

[0595] The support structure 16220 may include a wall structure having at least two regions of different thicknesses (e.g., a portion of the support structure adjacent to or connected to the shell 16180 may be thicker than a portion of the support structure adjacent to or connected to the seal 16230) so as to provide structural stability at the connection with the shell 16180 and flexibility at the interface with the patient. Fig.84An example is shown where portion (d1) of the support structure may be thicker than portion (d2) of the support structure. For example, portion (d1) may be adjacent to or connected to the plenum chamber and portion (d2) may be adjacent to or connected to the seal to provide structural stability at the connection with the frame and flexibility at the interface with the patient. Alternatively, these thicker lateral support areas 3122 may be located, for example, at the lower cheek region of the seal-forming structure (and, for example, may be directly connected to the fabric membrane) to ensure adequate sealing in the lower cheek region of the patient's face.

[0596] The support structure 16220 can be less rigid than the housing 16180 and can be constructed of silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastics, or other suitable materials, as will be described later. In addition, the sealing portion 16230 can be less rigid than the support structure 16220 and can be constructed of a fabric material such as nylon, polyester, a nylon and polyester blend, microfiber, or polyurethane, as will be described in more detail later.

[0597] The support structure 16220 can have an orifice formed therein that provides an inner edge of the support structure, and the sealing portion 16230 (e.g., a peripheral boundary of the sealing portion) can be attached to the support structure along the inner edge so that the sealing portion extends radially inward from the seal-forming structure beyond the support structure or to a greater extent than the support structure, such as, for example Fig.71 and 73 -77. For example, the seal may be molded around the inner edge of the support structure, or connected to the support structure in other suitable ways, as will be described later.

[0598] The support structure 16220 can extend into the cavity 16500 to form a lower liner 16221 to provide support for the sealing portion 16230, such as Fig.73 and 77 As shown. The lower pad 16221 and the sealing portion 16230 can form a double-walled structure around the periphery of the sealing portion. In an optional example, a second or third lower pad layer can be provided to form a three-layer or four-layer wall structure. The lower pad can be made of the same material as the support structure, and can also be made of other suitable materials (e.g., fabric).

[0599] 5.3.4.3.1 Positioning and stabilizing the structure

[0600] The seal-forming structure of the patient interface of the present technology can be maintained in a sealed state by positioning and stabilizing the structure during use.

[0601] In one form of the present technology, a positioning and stabilizing structure is provided that is configured in a manner consistent with being 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 sensed or actual volume of the instrument. In one example, the positioning and stabilizing structure includes at least one strap that is rectangular in cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0602] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a strap constructed from a laminate of a fabric patient contacting 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 comprises a loop material for engaging with a hook material portion.

[0603] In some forms of the present technology, the positioning and stabilizing structure includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state when in use and to direct a force to seal the cushion to a portion of the patient's face. In one example, the strap can be configured as a tie.

[0604] In some forms of the present technology, the positioning and stabilizing structure comprises a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0605] In some forms of the present technology, the positioning and stabilizing structure provides a retention force that is configured to correspond to a specific size and / or facial shape of the head. For example, one form of the positioning and stabilizing structure provides a retention force that is suitable for a large-sized head but not a small-sized head. In another example, one form of the positioning and stabilizing structure provides a retention force that is suitable for a small-sized head but not a large-sized head.

[0606] 5.3.4.3.2 Ventilation

[0607] In one form, the patient interface includes a vent constructed and arranged to allow clearance of exhaled gases, such as carbon dioxide.

[0608] One form of vent according to the present technology includes a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0609] The vent may be located in the plenum or housing. Alternatively, the vent is located in a decoupling structure such as a swivel joint.

[0610] 5.3.4.3.3 Decoupling structure

[0611] In one form, the patient interface includes at least one decoupling structure, such as a swivel or a ball and socket.

[0612] 5.3.4.3.4 Connection Port

[0613] The connection port allows connection to the air circuit.

[0614] 5.3.4.3.5 Forehead support

[0615] In the example shown, the frame assembly 6100 is not provided with a forehead support.

[0616] In another form, the patient interface may include a forehead support, for example, the frame assembly may include the forehead support.

[0617] 5.3.4.3.6 Anti-asphyxia valve

[0618] In one form, the patient interface includes an anti-asphyxia valve.

[0619] 5.3.4.3.7 Ports

[0620] In one form of the present technology, the patient interface includes one or more ports that allow access to the volume within the cavity. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the cavity, such as pressure.

[0621] 5.3.5 Support structure and sealing arrangement

[0622] The support structures and seals in the examples described above may have many different configurations and arrangements.

[0623] In use, the seal (e.g., fabric membrane) can be maintained in sealing contact with the patient's face by: 1) tension in the fabric membrane (e.g., light tension) and / or elastic stretch properties (e.g., elasticity) of the seal's material (e.g., fabric material, airtight layer material, and / or a composite of fabric membranes); 2) the reaction force of the support structure; 3) the pre-formed state of the fabric membrane to form a non-tensioned, but substantially unchanging surface, without leaks, without leakage that causes interruptions such as creases, folds, deformations, or wrinkles in the fabric membrane; and / or 4) air pressure within the cavity against the inner surface of the seal. Each of these factors can contribute to the seal being under constant tension so that the seal conforms to the anthropometric contours of the patient's face, thereby minimizing wrinkles or blowouts and maximizing the contact area of ​​the seal.

[0624] In some examples, the seal can include a relatively thin, compliant, stretchable elastic material, such as a fabric film including a suitable fabric material (e.g., nylon, polyester, a mixture of nylon and polyester, microfiber, or polyurethane). The seal can be held taut and tensioned by the support structure before and during use. The seal can be molded or otherwise attached (e.g., bonded, glued) to the support structure so that the seal is pre-tensioned (slightly stretched) so that there are no wrinkles in the material of the seal. This can advantageously ensure that the seal forms a smooth and continuous seal on the patient's face without any folded portions through which air can leak. In addition, the seal can be shaped or have a curvature, such as given by thermoforming, so that the seal maintains its own shape. The support structure can also give the seal a curvature.

[0625] For example, Figure 11-17 As shown in FIGS. 23-37 , the sealing portion can have a concave curved profile (eg, a positive curvature in the left-right direction) from the side (right) to the opposite side (left) to support the patient's nose.

[0626] In some forms, such as Figure 10-66 As shown, the patient's nose is not intended to be received in the cavity formed by the inflatable chamber and the seal forming structure. On the contrary, unlike traditional masks, the patient's nose is intended to be pressed against the fabric membrane, which in turn adapts to the contour of the patient's face to comfortably form a reliable seal with the patient's airway. In this way, the fabric membrane can be stretched to adapt to the patient's face. The bridge 3104, 1406 extending between the nostril openings can help to keep the fabric membrane in a tightened manner before and / or during use. The bridge can also be used to help provide a sealing portion by eliminating the central opening in the fabric membrane, which is pressed against the patient's nose instead of receiving the patient's nose in the cavity. Compared with traditional masks, this produces a different sealing experience. Due to contact with a more rigid material of a compliant fabric membrane rather than a traditional mask or a traditional sealing arrangement, this sealing experience can provide enhanced comfort, in which the sealing portion has a smaller contact area around the periphery of the nose and / or mouth.

[0627] The sealing portion can be composed of a single layer or multiple layers of material (e.g., a fabric material). The fabric membrane (and / or the fabric material of the fabric membrane) can exhibit a low spring constant (i.e., high compliance) in both the warp and weft. In traditional masks, the fixed cushion may deform the patient's skin to form an effective seal. Unlike traditional masks (e.g., silicone sealing membranes), the fabric membrane can have a material spring constant and spring length (i.e., the amount of material available for stretching) so that the fabric membrane is more compliant than the patient's skin so as to conform to the patient's facial features more easily. This can improve the comfort of the mask and reduce the formation of local pressure "hot spots".

[0628] Compared to conventional silicone membranes and compressed foam seals, the seal of the present technology has a more flexible structural rigidity and therefore has a dynamic rebound characteristic that enables the seal to recover faster when disturbed by external forces. In addition, due to the lower structural rigidity, less sealing force is required, allowing the seal to be more comfortable and produce fewer facial marks during use.

[0629] The fabric membrane can exhibit variable tension across the material (e.g., less tension near the apertures or over a wider stretch range of the material). In some forms, the surface of the material of the seal that contacts the patient's face can have low friction properties (e.g., a low friction finish), which can advantageously improve conformability of the material to the patient's face while also improving patient comfort.

[0630] The fabric membrane may also include at least one layer that exhibits substantially air-impermeable properties while maintaining the elastic stretch properties required for comfort and minimal pressure points. That is, a film layer or laminated film layer (e.g., a polymer such as silicone, polyurethane, thermoplastic polyurethane (TPU), polyester, nylon, etc.) may be applied to the fabric material to provide a substantially air-impermeable material. In an alternative example, the fibers of the fabric may be tightly woven to produce a substantially air-impermeable material.

[0631] In some forms, the fabric material of the sealing portion can have a thickness in the range of 0.275 or less (e.g., 0.275 to 0.075 mm, 0.275 to 0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225 to 0.09 mm, 0.225 to 0.095 mm, 0.225 mm, or 0.25 mm). The membrane layer can have a thickness in the range of 0.03 to 0.01 mm (e.g., 0.015, 0.02 mm, or 0.025 mm). The total composite thickness of the fabric material of the sealing portion with the film layer can be in the range of 0.305 mm or less (e.g., 0.305 to 0.085 mm, 0.305 to 0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255 to 0.10 mm, 0.255 to 0.105 mm, 0.25 mm, or 0.275 mm). In one example, the fabric composite material including the microfiber fabric and the polyurethane film layer can have these dimensions.

[0632] In another example, the thickness of the fabric material of the sealing portion can be in the range of 0.15 mm to 0.5 mm (e.g., 0.2 mm to 0.4 mm, or 0.3 mm to 0.4 mm, or 0.25 mm, or 0.3 mm, or 0.4 mm). The thickness of the membrane layer can be in the range of 0.03 mm to 0.125 mm (e.g., 0.05 mm to 0.1 mm, or 0.075 mm to 0.1 mm, or 0.05 mm to 0.075 mm, or 0.05 mm, or 0.075 mm, or 0.1 mm). The total composite thickness of the fabric material of the sealing portion with the membrane layer can be in the range of 0.18mm to 0.625mm (0.25mm to 0.6mm, or 0.25mm to 0.5mm, or 0.3mm to 0.5mm, or 0.35mm to 0.45mm, or 0.3mm, or 0.35mm, or 0.4mm, or 0.45mm, or 0.5mm). In one example, a fabric composite material including a nylon or nylon and polyester blend fabric and a silicone membrane layer can have these dimensions.

[0633] Due to the rigidity and elasticity of the support structure, tension can also be transmitted to the sealing portion. The support structure can be formed of a variety of materials, including silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (TPE) (e.g., thermoplastic polyurethane foam), and suitable plastic materials. The support structure can be configured to produce a plurality of different cushion configurations, including a single air-assisted seal (e.g., a fabric membrane) and a seal with a lower cushion support layer, such as a double air-assisted seal (e.g., a double fabric membrane), a seal with compression support (e.g., open-cell foam, polyurethane foam, gel), a seal with TPU, TPE or silicone support, or a double air-assisted seal with additional support (e.g., a double fabric membrane, wherein the inner membrane has a foam laminate layer (e.g., open-cell foam, polyurethane) or a TPU, TPE, polyurethane or silicone molded layer thereon).

[0634] The lower cushioning layer can help optimize the contact surface area of ​​the seal with the patient's face. In addition, in examples where the seal is composed of a breathable material (e.g., a breathable fabric), the lower cushioning layer can provide sufficient contact area behind the seal to adequately seal the seal to the patient's face and prevent leakage.

[0635] In use, the engagement of the patient's face 1000 with the sealing portion 10130 will create a temporary tension that attempts to pull the walls of the support structure 10120 toward each other, such as Fig.81As shown. The support structure 10120 will respond to the strain force with an outward pulling reaction force. The reaction force transmits greater tension to the seal portion 10130 by preferentially stretching the more compliant seal portion, which creates a resultant spring force in the seal portion that is applied to the patient's face.

[0636] In some examples, the support structure may include a biasing portion that utilizes internal gas pressure to dynamically support the support structure and the seal. This may advantageously provide further support for the seal when under dynamic loads (eg, tube traction).

[0637] The air pressure within the cavity and acting on the inner surface of the seal can also ensure that no wrinkles, folds, buckles or folds of the fabric membrane are presented to the patient's face (e.g., by creating tension in the seal), so that the seal can substantially fill the concave contours of the patient's face (e.g., around the sides of the nose). This can enable the compliant seal to form a larger sealing contact area on the patient's face. The tension in the seal created by the air pressure within the cavity is also advantageous in providing a continuous seal, even when the mask is partially displaced in an optimal position on the patient's face, because the seal may be partially inflated due to the reaction force from the internal air pressure (i.e., the "hovercraft effect").

[0638] In examples where the fabric membrane is not under constant tension (and, for example, in non-elastic applications), the sealing portion can still be maintained in sealing contact with the patient's face by the air pressure within the cavity and form an improved air-assisted seal with the patient's face that dynamically conforms to changes / movements (i.e., a "hovercraft effect") because the sealing portion is thinner and has lower structural stiffness than the supporting structure.

[0639] The seal can be integrated with the support structure by molding or otherwise attaching the seal to the inner edge of the support structure. Thus, for example, the periphery of the seal can be attached to the inner edge of the support structure so that the seal extends radially inward from the seal-forming structure beyond or beyond the support structure. The inner edge of the support structure can be curved so that the seal can be slightly angled inward toward the interior of the mask. By attaching the seal along the inner edge of the support structure, there is no need to fold or cut the seal to fuse around the corner of the support structure. This can advantageously reduce the occurrence of protruding folds or wrinkles in the seal (which may cause leakage), thereby improving the performance of the seal.

[0640] As previously mentioned, the seal forming structure can be removably connected or fixedly attached to the plenum. In some forms, the seal can have a removable or modular structure. For example, the seal can be attached to the support frame structure along its periphery. The support frame can be removably attached to the support structure as a module. The seal can be attached to the support frame to reduce the folds or wrinkles that appear prominently in the fabric surface. The modular arrangement can also substantially simplify the manufacture of the seal (e.g., fabric seal) because all complex combinations can be completed in a simple stress-free state. Although the seal can be treated to have a substantially self-cleaning property, the use of modular seals can also provide a cheaper and more hygienic alternative.

[0641] The support frame can be preformed to have a flat or three-dimensional shape, such as an arc, to impart a curved shape to the sealing portion. The support frame can form an airtight seal with the support structure. In some examples, the support frame can engage the support structure via a connector (e.g., male / female dowel pins / holes, tongue and groove).

[0642] The seal can have an undercushion support layer incorporated therein (e.g., a second, third, or more cushion layers). The undercushion layer can provide additional flexibility and allow the cushion layer to be adapted for use by most patient faces (e.g., only one size fits most patient faces). For example, the seal can be constructed as a dual air-assisted seal (e.g., a dual fabric membrane), a seal with a compression support layer (e.g., open-cell foam, polyurethane foam, gel), a seal with a TPU, TPE, or silicone support layer, or a dual air-assisted seal with an additional support layer (e.g., a dual fabric membrane with an inner membrane having a foam laminate layer (e.g., open-cell foam, polyurethane) or a TPU, TPE, polyurethane, or silicone molded layer thereon).

[0643] In some examples, the support layer can be supported by a rigid structure, such as a plastic, for example, polypropylene (PP), polycarbonate (PC), polyamide (PA), or polyethylene terephthalate (PET).

[0644] In some examples, 3D printing of the sealing portion, support layer, and / or support structure as a "skeleton" can reduce the thickness of the structure, thereby reducing the weight of the mask. In addition, different layers of the mask can be printed with different stiffness, hardness, or thickness. For example, the "skeleton" portion can be formed using silicone, foam (e.g., polyurethane foam), polyurethane (e.g., polyurethane solid material), or any suitable plastic material. In some examples, a biasing portion can be formed that can provide dynamic support during use.

[0645] 5.3.5.1 Fabric membrane

[0646] According to an example of the disclosed technology, the seal forming structure can include a fabric membrane, and the fabric membrane includes a fabric material. The fabric material can have a coating or otherwise applied thereto to produce an airtight film / membrane or layer of an air-retaining fabric composite material. The fabric composite material can be cut (e.g., die-cut, ultrasound, laser, or RF) to a desired shape and then attached to a supporting structure. The resulting fabric seal (or fabric membrane) can be attached to a supporting structure (e.g., silicone, TPE) by, for example, overmolding or injection molding. In another example, the fabric seal can be heat-welded to a supporting structure material (e.g., silicone, TPE) at its edge (periphery).

[0647] A fabric is a material comprising at least one natural or artificial fiber (e.g., yarn or thread). The fibers may be filaments (monofilament or multifilament), strands, threads or twisted threads). The fibers may include animal-based materials such as wool or silk, plant-based materials such as linen and cotton, and synthetic materials such as polyester and rayon. Fabrics may be formed by various techniques such as weaving, knitting, crocheting, knotting, weaving, bonding, felting, tufting or braiding, and may include, for example, woven and nonwoven materials, for example, by interlacing or interweaving one or more fibers.

[0648] In one example, the fabric material is a knitted material. Knitted material can be preferred because it provides elasticity (e.g., ductility) to fabric, particularly compared with woven materials. As described below, this is advantageous in providing comfort to the patient. Elasticity can be in all directions (e.g., four-way stretch / elasticity, e.g., substantially equal in all directions), and at least in the transverse left and right directions of the fabric membrane. For example, the fabric material can have a weft knitted fabric structure or a warp knitted fabric structure. Because the elasticity of the weft knitted fabric is higher than the elasticity of the warp knitted fabric, the weft knitted fabric structure may be more desirable.

[0649] Fig.113 A wale 70 of a weft knitted fabric, or the direction in which the loops of one yarn engage with the loops of another yarn, is illustrated. Fig.114 The course 80, or direction of the coils of the individual strands, is shown. Fig.115 A basic closed loop warp knitted fabric 90 is illustrated wherein the longitudinal and transverse loops are parallel to one another. Fig.116 A weft-knitted material 100 is illustrated in which the longitudinal loops 70 extend perpendicularly to the transverse loops 80 .

[0650] 5.3.5.1.1 Manufacturing

[0651] In one example, an overmolding process may be used to construct a seal-forming structure having, for example, a flexible support structure (eg, silicone) attached to a fabric membrane.

[0652] like Fig.117 As shown, in step 10, an airtight fabric composite material can be formed by combining a fabric material with an impermeable material. Fig.78 As shown, a heating process may be used to attach the impermeable layer to the fabric material. The fabric composite material may have a flat shape (eg, a sheet).

[0653] In step 12, the fabric composite material may be cut into a desired shape depending on the particular cushion component to be used.

[0654] In step 14, a support structure (e.g., silicone) can be overmolded onto the fabric composite to form a seal with the fabric membrane. The fabric composite can be held in place by a vacuum so as to have a non-flat predefined shape during this overmolding process. That is, a planar fabric composite can be overmolded with a support structure to impart a curvature to the fabric composite, thereby forming a fabric membrane, and the fabric membrane can have a curvature without forming wrinkles, folds, creases, and / or deformations in the fabric membrane. Figure 33-1 As shown, the fabric membrane can extend from the front side of the seal-forming structure to the back side of the seal-forming structure along curve 35. In one example, as shown in FIG. Figure 33-1 As shown, both the support structure and the fabric membrane may have a radius of curvature (e.g., the same or similar radius of curvature) along curve 35. The fabric membrane may have a predetermined curvature imparted thereon, such that a portion of the fabric membrane that is not directly supported by the support structure extends along curve 35 ( Figure 33-2 to Figure 33-4 As previously discussed, the fabric membrane may also have curvatures in other areas of the fabric membrane, for example in the manner of a dome and a saddle. The fabric membrane may have a concave curved profile from one side (right) to the opposite side (left) (e.g., a positive curvature in the left-right direction), which may be imparted during the overmolding process and retained by connection to a support structure (see, e.g., Figure 11-17 , 23-27 and 33-37). In another example, the fabric membrane can have a negative curvature in the inferior-superior direction, which can be imparted during the overmolding process and maintained by connection to the support structure (see, for example, Figure 18-22 ).

[0655] The support structure can be molded onto the fabric composite material so that the outer surface of the seal-forming structure is smooth and seamless in the transition from the support structure to the fabric membrane (see Figure 33-4 ). The support structure can be bonded to the impermeable material of the fabric membrane. Although the outer surface of the seal-forming structure can be smooth and seamless, there may be a step on the inner surface of the seal-forming structure if the thickness of the support structure is different from (e.g., greater than) the thickness of the impermeable layer.

[0656] The overmolding process forms a seal-forming structure without creating any wrinkles, folds, creases and / or deformations in the fabric membrane, while also imparting curvature to the fabric membrane.

[0657] 5.3.5.1.2 Fabric membrane example

[0658] The following are exemplary properties and structural arrangements of textile composite materials useful as textile membrane materials.

[0659] 5.3.5.1.2.1 Fabric composite material structures

[0660] Various combinations of fabric materials and membrane / film layers can be used. In one example, a three-layer arrangement is used that includes a thermoplastic polyurethane (TPU) film disposed between two fabric layers (e.g., nylon, nylon and polyester blends, nylon and spandex blends, polyester and spandex blends, or nylon / polyester / spandex blends). The additional fabric layer is needed to protect the TPU film from rupture (e.g., during cleaning).

[0661] In another example, a two-layer arrangement including a silicone layer (e.g., nylon, a nylon and polyester blend, a nylon and spandex blend, a polyester and spandex blend, or a nylon / polyester / spandex blend) is used. This composite material can be cheaper than the three-layer arrangement described above because only one layer of fabric is required.

[0662] In another example, a textile material (eg, microfiber or polyurethane material) may be coated with a polyurethane film to form a two-layer arrangement.

[0663] 5.3.5.1.2.2 Fabric materials

[0664] As described above, a variety of fabric materials may be used to form the seal, such as nylon, polyester, spandex, nylon, nylon and polyester blends, nylon and spandex blends, polyester and spandex blends, nylon / polyester / spandex blends, microfibers, or polyurethane.

[0665] In one example, a nylon material is used. Nylon can provide comfort benefits to the patient because it is softer than polyester. Nylon is also more durable than polyester, thus improving longevity and durability. In addition, nylon has a higher melting temperature than polyester, thus being able to withstand higher temperature manufacturing conditions.

[0666] In another example, a nylon and polyester blend is used. This material may be more desirable because it does not absorb moisture as easily due to the addition of polyester, thus reducing irritation to the patient. Nylon and polyester blends are also less expensive than nylon.

[0667] 5.3.5.1.2.3 Fabric material thickness

[0668] In one example, the thickness of the fabric material of the sealing portion may be in the range of 0.15 mm to 0.5 mm (eg, 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 thickness may be suitable for nylon material or nylon and polyester mixed material.

[0669] In another example, the thickness of the fabric material of the sealing portion can be in the range of 0.275 or less (0.275 to 0.075 mm, 0.275 to 0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225 to 0.09 mm, 0.225 to 0.095 mm, 0.225 mm, or 0.25 mm). This thickness may be suitable for microfiber fabric materials or polyurethane fabric materials.

[0670] 5.3.5.1.2.4 Thickness of airtight layer

[0671] In examples where silicone is used as a film / membrane layer, the silicone may have a thickness in the range of 0.03 mm to 0.125 mm (e.g., 0.05 mm, 0.05 mm to 0.1 mm, or 0.05 mm to 0.075 mm, or 0.075 mm to 0.1 mm, or 0.1 mm). A thinner silicone layer (e.g., 0.05 mm) may be more desirable because it provides a lighter weight product and also provides more stretch than a thicker silicone layer (e.g., 0.1 mm). However, a thicker silicone layer (e.g., 0.1 mm) is more durable than a thinner silicone layer (e.g., 0.05 mm thick).

[0672] In another example, in the case where a polyurethane film is used as the film layer, the thickness of the polyurethane film may be in the range of 0.03 to 0.01 mm (eg, 0.015, 0.02 mm, or 0.025 mm).

[0673] 5.3.5.1.2.5 Total thickness of fabric composite material

[0674] In the example where the fabric material is coated with a silicone film / membrane layer, the thickness of the entire composite material can be in the range of 0.18 mm to 0.625 mm (e.g., 0.25 mm to 0.6 mm, or 0.25 mm to 0.5 mm, or 0.3 mm to 0.5 mm, or 0.35 mm to 0.45 mm, or 0.3 mm, or 0.35 mm, or 0.4 mm, or 0.45 mm, or 0.5 mm).

[0675] Thicker fabric membrane thicknesses (e.g., 0.5 mm) can be stronger and provide less fragile indentations. These fabric membranes may be easier to handle during the manufacturing process because they are less likely to fall around.

[0676] An intermediate range of thicknesses (eg, 0.35 mm to 0.45 mm) may provide a flexible, lightweight structure that is relatively easy to handle during manufacturing and may provide more comfort to the patient than thicker fabric membranes.

[0677] A thinner fabric membrane may provide a very lightweight structure that provides a soft, comfortable touch to the patient, but may provide less durability than a thicker fabric membrane.

[0678] In examples where the fabric material is coated with a polyurethane film, the thickness of the entire composite material can be in the range of 0.305 mm or less (e.g., 0.305 to 0.085 mm, 0.305 to 0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255 to 0.10 mm, 0.255 to 0.105 mm, 0.25 mm, or 0.275 mm).

[0679] 5.3.5.1.2.6 Knitted structure

[0680] The fabric material of the fabric membrane may have, for example, a weft knitted fabric structure, or an optional warp knitted fabric structure. A weft knitted fabric may be more desirable because this may provide a material with a higher elasticity than a warp knitted fabric. This may be advantageous because it may provide more comfort to the patient by stretching when the patient's face engages with the fabric membrane, thereby reducing the force applied to the patient's face by the fabric membrane.

[0681] In one example, since the weft direction can have greater elasticity or elongation, the weft direction (the direction of the transverse coil 80) can extend in the nose width direction of the fabric membrane. Alternatively, the weft direction can extend in the nose length direction (up-down direction).

[0682] In addition, weft knitting is more suitable for producing relatively thin materials, such as disclosed herein. Moreover, compared with warp knitting, weft knitting is generally less expensive.

[0683] However, in some examples, warp knitting may be desirable because it provides less shrinkage than weft knitted materials.

[0684] 5.3.5.1.2.7 Knitting machines

[0685] The weft knitted fabric material can have a single jersey fabric structure that provides a technical front and a technical back with different appearances. The single jersey fabric can be formed by a set of needles, and a knitted loop can be provided on the technical front (front) and a purl loop can be provided on the technical back. In one example, the technical front can form the outer surface of the fabric membrane and the airtight membrane can be attached to the technical back. Alternatively, the technical front can be oriented toward the inner surface of the fabric membrane and the membrane can be attached thereto.

[0686] In examples where the fabric membrane comprises an air-impermeable membrane sandwiched between two fabric layers, the technical face side of each fabric material may form an exposed surface of the fabric membrane.

[0687] 5.3.5.1.2.8 Fabric weight

[0688] The weight of the fabric material can range from 95 grams per square meter (gsm) to 130 gsm (e.g., 105 gsm to 120 gsm, or 110 gsm to 115 gsm, or 105 gsm, or 110 gsm, or 120 gsm). Due to the weight / thickness of the fabric, a heavier weight fabric (e.g., 120 gsm) can provide a desirable comfortable fabric feel even after coating with a laminate layer. A lighter weight fabric (e.g., 105 gsm) may be desirable because it provides a lighter product.

[0689] 5.3.5.1.2.9 Machine specifications

[0690] The machine gauge (i.e., the number of stitches per inch) of the fabric material can vary. For example, the machine gauge can be in the range of 35GG to 70GG (e.g., 44GG to 60GG, or 50GG to 55GG, or 55GG to 60GG, or 44GG, or 50GG, or 55GG, or 60GG).

[0691] It may be desirable to use a relatively large gauge material (e.g., 44GG) because it provides a greater choice of blends. However, a finer gauge material (e.g., 60GG) may be desirable because such a softer material may enhance patient comfort.

[0692] 5.3.5.1.2.10 Aesthetics

[0693] Fabric materials may have a solid color aesthetic or a heathered color aesthetic. Heathered color materials may be considered to be materials that have been made by using textiles / fabrics / yarns of different colors, or materials made with different textiles / fabrics / yarns that are then individually dyed to more than one color. Heathered color materials may be desirable because they may have a greater ability to hide dirt or grime, thereby more easily improving the clean feel of the product. Heathered color materials may also provide benefits during the manufacturing process because it is easier to visually correctly align the fabric knit structure during the cutting and / or overmolding process.

[0694] However, a solid color material may be desirable because it provides a greater choice of finer gauge materials (eg, Provich, 55GG+) that are softer and therefore more comfortable to the patient.

[0695] 5.3.5.2 shows the arrangement of the support structure and the sealing part arrangement

[0696] Figure 81-112 A number of different cushion assembly configurations are shown, including different support structure and seal arrangements and / or processes. Note that these examples can be applied to any patient interface and / or cushion assembly described in this disclosure. In addition, any feature of any example can be applied to a different example and / or used with different features. The inflatable chambers, support structures, and seals shown in these figures can be constructed of any suitable material as previously described. It should also be noted that a component, such as a support structure, can include more than one material. For example, the lower cushion of a support structure can include a different material than other portions of the support structure.

[0697] Reference Fig.83 , support structure 10120 is removably connected to inflatable chamber 10200 via clip 10126 on the support structure and connector 10210 on the inflatable chamber to form cavity 10001. In some examples, clip 10126 can be formed of polyurethane, polypropylene (PP), or polyethylene terephthalate (PET). Inflatable chamber 10200 can be made of a more rigid material than the clip, such as polycarbonate or polyurethane having a higher Shore A hardness than the clip. Support structure 10120 and seal 10130 are configured as a cushion arrangement with a single air-assisted seal 10130 (e.g., a fabric membrane).

[0698] The connection between the peripheral edge (or outer edge) of the fabric membrane and the inner edge of the support structure can be formed in many different ways. Fig.83 and 85 As shown, the connection can form an overlap, wherein the edge portion of the fabric membrane overlaps the edge portion of the support structure. In one example, the attachment portion 10122 of the support structure can form a recessed portion to receive the sealing portion 10130, so that the support structure and the sealing portion form a smooth outer surface, such as Fig.83 As shown. The overlap may be minimal and provided only for manufacturing purposes (i.e., necessary for attaching the seal portion and the support structure), for example by overmolding and / or injection molding. This is in contrast to conventional arrangements in which the overlapping region may be arranged to provide additional support (e.g., stiffness) to the seal portion due to the presence of the support structure (in such arrangements, the overlap may vary around the periphery of the seal-forming structure to vary the level of support or stiffness (e.g., less overlap, less support, more flexibility, less tension in the sensitive bridge of the nose region).

[0699] In contrast to the lap joint described above, the connection between the fabric membrane and the support structure may form an end-to-end joint (e.g., a butt joint), such as Fig.84As shown. Due to manufacturing techniques (e.g., overmolding, injection molding, etc.), the end-to-end joint may have some overlap, however this overlap is negligible and constant around the perimeter of the seal at the connection to the support structure. In other words, as described above, any overlap of the support structure and the fabric membrane is not designed to adjust stiffness, tension, flexibility, or support in different areas of the face (e.g., less overlap, less support, more flexibility, less tension in the sensitive nose bridge area).

[0700] On the contrary, whether providing lap joints or end-to-end joints, the present arrangement allows the conformable fabric membrane to properly adapt to the patient's facial features. That is, the seal-forming structure is designed to allow the patient's facial features (e.g., nose) to sink into the fabric membrane that conformably receives the patient's face.

[0701] The seal may be glued, molded (e.g., overmolded or injection molded), or otherwise attached to the support structure. In an alternative example, the recessed portion may be removed and the attachment portion 10122 may be used to attach the seal 10130 and the support structure 10120 end to end, such as Fig.84 In addition, Fig.84 It is also described that the portion (d1) of the support structure 10120 adjacent to or connected to the inflatable chamber 10200 can be thicker than the portion (d2) of the support structure 10120 adjacent to or connected to the sealing portion 10130 so as to provide structural stability at the connection with the inflatable chamber and flexibility at the interface with the patient.

[0702] exist Fig.85 , the support structure 10120 includes a lower gasket 10121. The support structure also includes a sealing lip 10124 to seal the interface between the plenum 10200 and the support structure 10120. The attachment portion 10122 of the support structure can be configured so that the end of the sealing portion is clamped between opposite sections of the attachment portion 10122.

[0703] In another example, the plenum 11200 can have a lower liner 11121 attached to an interior portion thereof, such as Fig.86 In this way, the lower cushion 11121 can be permanently attached to the inflatable chamber 11200, while the support structure 10120 and the sealing portion 10130 can be removably connected to the inflatable chamber via the clip 10126 and the connector 10210.

[0704] See also Fig.87 and 88, the support structure 10120 can have an external biasing portion 10140 or an internal biasing portion 10140', which can utilize the internal air pressure in the cavity to dynamically support the support structure and the sealing portion 10130. The support structure 10120 can include an inwardly curved end 10142 to form an air-assisted support area 10144, which can optimize the force acting on the support structure and the sealing portion due to the air pressure in the cavity to urge the sealing portion into sealing contact with the patient's face.

[0705] Steering Fig.89 , the support structure 12120 includes a lower pad 12121. The support structure and / or the lower pad can 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, etc.).

[0706] exist Fig.90A 10200. The support structure 15120 is removably connected to the inflatable chamber 10200. The support structure includes a lower cushion 15121. In this example, the support structure is formed of foam (e.g., molded from polyurethane foam), but can also be formed of TPE, TPU, or any other suitable material. The sealing portion 10130 can have a film layer or film laminate layer 10131 to provide a substantially airtight material, such as Figure 90A-1 Alternatively, support structure 15120 can be glued, bonded, or otherwise attached to plenum 10200 .

[0707] Fig.90B Shows something like Fig.90A example, however Fig.90B The seal 10130 in the embodiment of the present invention is directly connected to the inflatable chamber 10200 and can form a seamless cover on the lower cushion 15121. The seal 10130 and the lower cushion 15121 can be glued or otherwise bonded to the inflatable chamber 10200. Alternatively, the seal 10130 and / or the lower cushion 15121 can be removably connected to the inflatable chamber.

[0708] refer to Fig.91 , support structure 17120 includes a first portion 17123 and a lower pad 17121. The first portion 17123, which may be connected to the inflatable chamber, may be constructed of a material that is more rigid than the material of the lower pad 17121. For example, both the first portion 17123 and the lower pad may be constructed of polyurethane, but the polyurethane material of the first portion may have a higher hardness than the material of the lower pad. A reinforcing member 17125 may extend along the perimeter of the pad, bridging the intersection between the first portion 17123 and the lower pad 17121 to provide structural support.

[0709] like Fig.92As shown, the support structure 23120 may include a lower pad 23121 (e.g., constructed of TPU) having a U-shaped or hook-shaped shape. The lower pad may include a clip 23126 for removably connecting to the pad (e.g., a frame, an inflatable chamber, or other portion of the support structure). Alternatively, the sealing portion 10130 may be attached to the support structure 23120 as a removable module that can be removably connected to the pad (e.g., a frame, an inflatable chamber, or other portion of the support structure) as a unit. The sealing portion 10130 can be attached to the lower pad 23121, for example, by thermoforming. The lower pad can also be formed by thermoforming.

[0710] The support structure 24120 may include a rigid clip 24126 supporting the lower pad 24121, such as Fig.93 As shown. The lower pad 24121 may include an outer fabric layer 10132 and an inner layer (e.g., constructed of foam) encapsulated by the fabric layer and the clip. The support structure 24120 can be removably connected to the pad (e.g., a frame, an inflatable chamber, or other part of the support structure). Alternatively, the sealing portion 10130 can be attached to the support structure 24120 as a removable module, which can be removably connected to the pad (e.g., a frame, an inflatable chamber, or other part of the support structure) as a unit. The sealing portion 10130 can be attached to the lower pad 24121, for example, by thermoforming. The lower pad can also be formed by thermoforming.

[0711] See also Fig.94 , the support structure 18120 can include a rigid clip 18126 that supports a lower pad 18121 (e.g., a pad constructed of a foam material). The support structure 18120 can be removably connected to the pad (e.g., a frame, an inflatable chamber, or other portion of the support structure). Alternatively, the sealing portion 10130 can be attached to the support structure 18120 as a removable module that can be removably connected to the pad (e.g., a frame, an inflatable chamber, or other portion of the support structure) as a unit. The sealing portion 10130 can be attached to the lower pad 18121, for example, by thermoforming. The lower pad can also be formed by thermoforming.

[0712] Steering Fig.95 , support structure 19120 includes a first portion 19123 and a lower cushion 19121. The first portion 19123, which may be connected to the inflatable chamber, may be made of a material that is more rigid than the material of the lower cushion 19121. For example, the first portion may be made of polyurethane, and the lower cushion may be made of foam.

[0713] refer to Fig.96, the support structure 20120 includes a first portion 20123 and a lower cushion 20121. The first portion 20123, which may be connected to the inflatable chamber, may be constructed of a material having a different stiffness or Shore A hardness than the material of the lower cushion. For example, the first portion 20123 and the lower cushion 20121 may both be constructed of polyurethane, while the first portion 20123 may be less or more rigid or have a higher or lower Shore A hardness than the lower cushion 20121. In an alternative example, the first portion 20123 and the lower cushion 20121 may be constructed of the same material and may have the same stiffness or Shore A hardness.

[0714] Fig.97 The support structure 21120 includes a first portion 21123 and a lower liner 21121, and is similar to the support structure 20120 described above, except that the liner includes a second sealing layer (e.g., fabric layer 10132) forming a double fabric membrane. The lower liner 21121 can be molded or otherwise attached to the underside of the fabric layer 10132.

[0715] refer to Fig.98 , support structure 22120 includes a first portion 22123 and a lower pad 22121 and is similar to the support structure 21120 described above, except that the lower pad 22121 is a foam layer laminated or otherwise attached to the underside of the fabric layer 10132.

[0716] Steering Fig.99 , the cushion assembly shown includes a double seal structure without a cushion support member located underneath. The cushion assembly includes a first fabric layer 10130 and a second fabric layer 10132 connected to a support structure 10120.

[0717] Fig.100 The gasket components in Fig.99 The cushion assembly of FIG. 10120 is similar to that of FIG. 10121 , except that the sealing portion includes a support section 10135 from which the first fabric layer 10130 and the second fabric layer 10132 extend. The support section 10135 can be made of TPU or foam (e.g., polyurethane foam molded foam). The support section 10135 can increase the elasticity of the sealing portion and allow the fabric layers to rebound faster from external forces. The support section 10135 can be removably connected to the support structure 10120 with these fabric layers as a modular unit. In an alternative example, the support section 10135 is removably connected to the inflatable chamber.

[0718] Steering Fig.101 and 102, the seal module assembly 26400 can be permanently or removably connected (e.g., by mechanical clips) to the support structure 26120 (or alternatively to the inflatable chamber 10200). The seal module assembly can include a skeleton support frame 26450 having a seal 10130 attached thereto. The seal 10130 can be, for example, thermoformed or insert molded to attach the seal to the support frame 26450. The thermoforming or molding process and / or the support frame itself can form and maintain the seal into a curved or three-dimensional shape. For example, the support structure 26120 can be composed of insert molded polyurethane.

[0719] exist Fig.103 In the example of FIG. 101 , the fabric membrane 10130 and / or the support structure can be configured to be removable or modular. Fig.103 As shown, the fabric membrane 10130 can be attached to the module support structure 26480 around its perimeter. The module support structure 26480 can then be removably coupled to the plenum as a module. The module form can advantageously reduce the occurrence of prominent folds or wrinkles in the fabric membrane surface.

[0720] In some forms, the fabric membrane may be a sleeve or tube adapted to cover and remain over the plenum or support structure.

[0721] Modular fabric membrane seals can also substantially simplify manufacturing, as all complex bonding can be accomplished in a simple stress-free state. While some fabrics can be treated to have substantially self-cleaning properties, the use of modular fabric membranes can also advantageously provide a cheaper and more sanitary alternative. In some forms, the fabric membrane or support structure can be a removable and / or replaceable subassembly attached to the plenum, support structure, or frame assembly.

[0722] In the form of a support frame in which the fabric membrane is attached to the module support structure 26480, the support frame can be pre-formed into a flat (eg Fig.103 as shown) or 3D structures such as arcs.

[0723] In some forms, the modular support structure 26480 may engage the plenum chamber via corresponding male / female locating pins / holes. In some forms, the modular support structure may utilize a tongue-and-groove arrangement around the perimeter side of the structure to form an effective airtight seal with the plenum chamber. The modular support structure 26480 may be formed, for example, from a plastic material, polyurethane, or similar material.

[0724] Steering Figures 104-106 , describes a process of insert molding a sealing portion (e.g., a fabric material) as an in-mold decoration (IMD). Fig.104 and 105As shown, the first mold 26500 can contact the second mold 26550 to attach the seal 10130 to the support frame 26450 while also imparting curvature to the seal. The molding process can also stretch the seal 10130 so that the attachment of the seal to the support frame 26450 keeps the seal under tension before use.

[0725] See also Fig.107 and 108 , showing a one size fits all cushion assembly 27105. The cushion assembly 27105 can include a seal 10130 attached to the upper support frame portion 27202 and the lower support frame portion 27204. The upper support frame portion 27202 can be spaced apart from the lower support frame portion 27204 to form an elastic region 27108 in which the seal can extend to space the upper support frame portion 27202 and the lower support frame portion 27204 to accommodate a range of patient face sizes.

[0726] The patient's face can be scanned to create a custom mask, e.g. Fig.109 and 110 As shown. A three-dimensional profile can be obtained through facial scanning to generate a cushion assembly 28105 including a sealing portion 10130 attached to a support frame 28200. The support frame 28200 may include a relatively rigid support element (e.g., a polyurethane molding) and a cushioning element (e.g., foam) located between the support element and the sealing portion. Fig.84 As shown, the cushion assembly can be arranged to stretch to accommodate different patient face sizes.

[0727] In some examples of nasal pads, such as Fig.111 and 112 As shown, the support structure 3120 can actually be configured to deform inwardly at certain fold or pivot points. For example, thinner areas of the support structure can be designed to create fold or pivot points. In one example, the bottom central portion of the support structure 3120 (e.g., the nasal base region 3112) can have a relatively reduced thickness so that when stress is applied to the walls of the support structure due to the engagement of the patient's face, the bottom central portion of the support structure can create a pivot point, thereby allowing the left and right sides of the support structure to deform inwardly to support the patient's face (e.g., nose), thereby accommodating the patient's engagement. The upper front region 3109 can also have a reduced thickness compared to the lateral support regions 3122 to create a fold or pivot point.

[0728] Therefore, in Fig.111 and 112In an example, the support structure 3120 can have three regions of different hardness (e.g., by having different thicknesses). The upper front region 3109 can have a thickness that is the same as or greater than the thickness of the nasal base region 3112. The thickness of the lateral support region 3122 can be greater than the thickness of the upper front region 3109 and the nasal base region 3112. Therefore, the lateral support region can be harder than the upper front region 3109, and the upper front region can be harder than the nasal base region 3112. Note that both the inflatable chamber and the support structure can be formed of a flexible material (e.g., silicone) and can form a single-piece structure (e.g., molded together). This can help the cushion assembly bend / fold / pivot to adapt to the patient's facial features. In one example, the seal-forming structure can be an extension of the inflatable chamber or formed as a part of the inflatable chamber, so that the inflatable chamber surrounds the seal-forming structure. In such an example, the support structure and the fabric membrane can be considered to be part of the inflatable chamber.

[0729] 5.4RPT device

[0730] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to execute one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to generate an air flow for delivery to the airway of a patient, such as for treating one or more respiratory conditions described elsewhere in this document.

[0731] In one form, the RPT device 4000 is constructed and arranged to deliver air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cm H2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0732] The RPT device can have an outer housing 4010 that is constructed in two parts: an upper portion 4012 and a lower portion 4014. In addition, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0733] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator capable of supplying air at a positive pressure (e.g., a blower 4142), an outlet muffler 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0734] One or more air path items may be disposed within a removable separate structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by, or forms part of, the chassis 4016.

[0735] The RPT device 4000 may have a power source 4210, one or more input devices 4220, a central controller, a treatment device controller, a pressure generator, one or more protection circuits, a memory, a converter, a data communication interface, and one or more output devices. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0736] 5.5 Glossary

[0737] For purposes of this technical disclosure, one or more of the following definitions may apply in certain forms of the technology. In other forms of the technology, alternative definitions may apply.

[0738] 5.5.1 General

[0739] Air: In some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0740] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0741] For example, the ambient humidity relative to the humidifier may be the humidity of the air directly surrounding the humidifier, such as the humidity within the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0742] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0743] In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0744] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum limit, e.g., with each breath, depending on whether there is an indication of an SBD event.

[0745] Continuous Positive Airway Pressure (CPAP) therapy: A breathing pressure therapy in which the therapy pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

[0746] Flow: Volume (or mass) of air delivered per unit time. Flow may refer to an instantaneous quantity. In some cases, reference to flow will be to a scalar quantity, i.e. a quantity having only magnitude. In other cases, reference to flow will be to a vector quantity, i.e. a quantity having both magnitude and direction. Flow may be given by the symbol Q. 'Flow' is sometimes simply abbreviated to 'flow' or 'air flow'.

[0747] In the example of a patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. The total flow, Qt, is the flow of air leaving the RPT device. The ventilation flow, Qv, is the flow of air leaving the vent to allow for clearance of exhaled gases. The leakage flow, Ql, is the leakage flow from the patient interface system or elsewhere. The respiratory flow, Qr, is the flow of air received into the patient's respiratory system.

[0748] Humidifier: The term humidifier shall be deemed to refer to a humidifying device constructed and arranged or configured with a physical structure capable of providing therapeutically beneficial amounts of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0749] Leakage: The word leakage is to be considered as undesired air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in the return bend to the surrounding environment.

[0750] Noise, conducted (acoustic): Conducted noise in this document refers to the noise brought to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0751] Noise, radiated (acoustic): Radiated noise in this document refers to the noise that is brought to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0752] Noise, Ventilatory (Acoustic): Ventilatory noise in this document refers to the noise generated by the flow of air through any vent, such as the vent of a patient interface.

[0753] Patient: A person, whether or not they have a respiratory condition.

[0754] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 , hectopascal. 1cmH2O is equal to 1g-f / cm 2 And about 0.98 hectopascal. In this specification, unless otherwise specified, the pressure is given in cmH2O.

[0755] The pressure in the patient interface is given the symbol Pm, while the therapy pressure is given the symbol Pt, which represents the target value to be achieved by the mask pressure Pm at the current moment.

[0756] Respiratory Pressure Therapy (RPT): The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0757] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0758] 5.5.1.1 Materials

[0759] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0760] Polycarbonate: A transparent thermoplastic polymer of bisphenol A carbonate.

[0761] 5.5.1.2 Mechanical properties

[0762] Resilience: The ability of a material to absorb energy when elastically deformed and release that energy when unloaded.

[0763] Elastic: Will release substantially all of its energy when unloaded. Includes, for example, certain silicones and thermoplastic elastomers.

[0764] Hardness: The ability of a material to resist deformation inherently (as described, for example, by Young's modulus or the indentation hardness scale measured on a standardized sample size).

[0765] "Soft" materials may include silicone or thermoplastic elastomers (TPEs), and may deform easily, for example, under finger pressure.

[0766] "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example, under finger pressure.

[0767] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending, or torsion. The structure or component may offer different resistance in different directions.

[0768] Flexible structure or component: A structure or component that will change shape (eg, bend) when made to support its own weight for a relatively short period of time, such as within 1 second.

[0769] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads normally encountered in use. An example of such use may be to place and maintain a patient interface in sealing relationship with the entrance to a patient's airway, for example at a pressure of about 20 to 30 cmH2O.

[0770] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction than in a second orthogonal direction. In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

[0771] 5.5.2 Breathing cycle

[0772] Apnea: According to some definitions, an apnea is considered to occur when flow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air to flow despite the patient's efforts. Central apnea is considered to occur when apnea is detected due to a decrease or absence of respiratory effort despite a patent airway. Mixed apnea is considered to occur when a decrease or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0773] Respiratory Rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0774] Duty cycle: the ratio of inspiratory time Ti to total breathing time Ttot.

[0775] Effort (breathing): The work done by a spontaneous breather in an attempt to breathe.

[0776] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0777] Flow Limitation: Flow limitation is to be considered a state in the patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. Where flow limitation occurs during the inspiratory portion of the breathing cycle, it may be described as inspiratory flow limitation. Where flow limitation occurs during the expiratory portion of the breathing cycle, it may be described as expiratory flow limitation.

[0778] Types of flow-limited inspiratory waveforms:

[0779] (ii) Flattened: having an ascent followed by a relatively flat section and then a descent.

[0780] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat portion between the two peaks.

[0781] (ii) Chair shape: has a single local peak at the leading edge followed by a relatively flat section.

[0782] (ii) Reverse chair shape: has a relatively flat section followed by a single local peak located at the trailing edge.

[0783] Hypopnea: According to some definitions, hypopnea is considered a decrease in flow rather than a cessation of flow. In one form, hypopnea is considered to occur when flow decreases below a threshold for a sustained period of time. Central hypopnea is considered to occur when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following may be considered hypopnea:

[0784] (ii) The patient's respiration decreases by 30% for at least 10 seconds with an associated 4% desaturation; or

[0785] (ii) The patient has a decrease in breathing (but less than 50%) lasting at least 10 seconds with an associated desaturation or arousal of at least 3%.

[0786] Hyperpnea: Increased air flow to above normal levels.

[0787] Inspiratory portion of the respiratory cycle: The period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0788]

[00136] Patency (airway): The degree to which an airway is open or the degree to which an airway is open. An open airway is open. Airway patency can be quantified, for example with a value (1) for open, and a value of zero (0) for closed (obstructed).

[0789] Positive End Expiratory Pressure (PEEP): The pressure above atmospheric pressure that exists in the lungs at the end of exhalation.

[0790] Peak Flow (Q Peak): The maximum value of the flow during the inspiratory portion of the respiratory flow waveform.

[0791] Respiratory flow, patient air flow, respiratory air flow (Qr): These synonymous terms may be understood to refer to the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow", which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0792] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no additional effort is exerted. In principle, the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined to be equal to either volume. In practice, the tidal volume Vt is estimated as some combination of the inspiratory volume Vi and the expiratory volume Ve, such as an average.

[0793] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0794] (Expiratory) Time (Te): Duration of the expiratory portion of the respiratory flow waveform.

[0795] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0796] Typical Recent Ventilation: The ventilation value around which recent values ​​of ventilation Vent tend to cluster over some predetermined time scale, ie a measure of the central tendency of recent values ​​of ventilation.

[0797] Upper airway obstruction (UAO): includes partial and total upper airway obstruction. This may be associated with a state of flow limitation, where flow increases only slightly, or even decreases, as the pressure difference across the upper airway increases (Starling impedance behavior).

[0798] Ventilation (Vent): A measure of the rate of gas exchanged by a patient's respiratory system. Measurements of ventilation may include one or both of inspiratory and expiratory flow (per unit time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation is sometimes given simply as volume, and is understood to be the volume per minute.

[0799] 5.5.3 Ventilation

[0800] Adaptive servo ventilator (ASV): A servo ventilator with a variable rather than fixed target ventilation. The variable target ventilation may be derived from some characteristics of the patient, such as the patient's breathing characteristics.

[0801] Backup Rate: A parameter of a ventilator that determines the minimum rate of breaths (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by a spontaneous respiratory effort.

[0802] Cyclic: The termination of the inspiratory phase of a ventilator. When a ventilator is delivering a breath to a spontaneously breathing patient, at the end of the inspiratory portion of the respiratory cycle, the ventilator is considered to cycle to stop delivering a breath.

[0803] Expiratory Positive Airway Pressure (EPAP): The base pressure to which the intra-breath varying pressures are added to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0804] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion. If the pressure waveform template is zero at the end of exhalation, that is, when , then EEP is equal to EPAP.

[0805] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of a breath.

[0806] Pressure Support: A number that indicates the increase in pressure during ventilator inspiration over the pressure during ventilator expiration, and usually means the difference in pressure between the maximum during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference that the ventilator aims to achieve, rather than the difference that is actually achieved.

[0807] Servomotor: A ventilator that measures patient ventilation, has a target ventilation and adjusts the level of pressure support to bring the patient's ventilation to the target ventilation.

[0808] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically initiate the delivery of a breath.

[0809] Swing: A term equivalent to pressure support.

[0810] Triggered: When the ventilator delivers breathed air to a spontaneously breathing patient, it is considered to be triggered at the beginning of the breath portion of the breathing cycle through the patient's effort.

[0811] 5.5.4 Anatomy

[0812] 5.5.4.1 Facial anatomy

[0813] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0814] Nose angle:

[0815] Alar tip: The outermost point on the wing of the nose.

[0816] Alar bend (or alar apex) point: The most posterior point in the base line of the curvature of each ala, found in the crease formed by the union of the ala and cheek.

[0817] Auricle: The entire external visible part of the ear.

[0818] (Nose) Framework: The nasal framework includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0819] (Nose) Soft skeleton: The nasal soft skeleton includes the septal, lateral, major and minor cartilages.

[0820] Columella: The strip of skin that separates the nostrils and extends from the nasal prominence to the upper lip.

[0821] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (where both lines intersect at the lower point of the nasal septum).

[0822] Frankfurt horizontal plane: A line extending from the lowest point of the orbital rim to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0823] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0824] External nasal cartilage: A cartilaginous plate that is essentially triangular in shape. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the greater alar cartilage.

[0825] Lip, lower (midpoint of lower lip):

[0826] Lip, upper (midpoint of upper lip):

[0827] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the alar.

[0828] Nare: A roughly oval hole that forms the entrance to the nasal cavity. The singular form of nare is naris. The nostrils are separated by the nasal septum.

[0829] Nasolabial Folds or Nasolabial Wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0830] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0831] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0832] Auricular base: The highest point where the auricle attaches to the facial skin.

[0833] Nasal prominence: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0834] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0835] Mental point: The midpoint of the frontmost part of the chin located on the soft tissue.

[0836] Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protuberance point.

[0837] Sagittal plane: A vertical plane that runs from anterior (front) to posterior (back). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0838] Nasal point: The most concave point on the soft tissue covering the frontonasal suture area.

[0839] Septal Cartilage (Nose): The septal cartilage forms part of the septum and divides the front of the nasal chambers.

[0840] Subalanal: The point at the lower edge of the ala base where the ala base joins the skin of the upper (superior) lip.

[0841] Subnasal point: The point on the soft tissue where the columella meets the upper lip in the midsagittal plane.

[0842] Mandibular alveolar seat point: the point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue

[0843] 5.5.4.2 Anatomy of the skull

[0844] Frontal Bone: The frontal bone includes a large vertical portion (the squama) which corresponds to the area called the forehead.

[0845] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0846] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0847] Nasal Bones: The nasal bones are two small oval bones that vary in size and form in different individuals; they lie side by side in the middle and upper part of the face and form the "bridge" of the nose at their junction.

[0848] Nasal root: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0849] Occipital Bone: The occipital bone is located at the back and lower part of the skull. It contains an oval hole (foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0850] Orbit: The bony cavity in the skull that holds the eyeball.

[0851] Parietal bones: The parietal bones are the bones that when joined together form the roof and sides of the skull.

[0852] Temporal Bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0853] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the prominence of the cheeks.

[0854] 5.5.4.3 Anatomy of the respiratory system

[0855] Diaphragm: A sheet of muscle that extends across the base of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0856] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0857] Lung: The respiratory organ of humans. The conducting zone of the lungs contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

[0858] Nasal Chamber: The nasal chamber (or nasal fossa) is a large air-filled space above and behind the nose in the middle of the face. The nasal chamber is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal chamber are three horizontal branches called the nasal conchae (singular "concha") or turbinates. The front of the nasal chamber is the nose, while the back joins into the nasopharynx via the internal nostrils.

[0859] Pharynx: The portion of the throat located just below (under) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (nasal portion of the pharynx), the oropharynx (mesopharynx) (oral portion of the pharynx), and the hypopharynx (hypopharynx).

[0860] 5.5.5 Patient interface

[0861] Anti-Asphyxia Valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0862] Elbow: An elbow is an example of a structure that directs the axis of an air flow traveling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a cross-section that is approximately circular. In another form, the elbow may have an elliptical or rectangular cross-section. In some forms, the elbow may be rotatable relative to a mating component, such as approximately 360 degrees. In some forms, the elbow may be removable from a mating component, such as via a snap connection. In some forms, the elbow may be assembled to a mating component via a one-time snap during manufacturing, but may not be removed by the patient.

[0863] Frame: A frame will be considered to mean the mask structure that carries the tensile load between two or more connection points to the headgear. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.

[0864] Functional dead space:

[0865] Headband: A headband will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, a headband may include a collection of one or more support bars, straps, and reinforcements configured to position and maintain a patient interface in position on the patient's face for delivery of respiratory therapy. Some straps are formed of soft, flexible, resilient materials, such as a laminate composite of foam and fabric.

[0866] Membrane: Membrane means a thin structural element having:

[0867] Stretch resistance; and

[0868] There is essentially no resistance to bending.

[0869] The membrane may be curved.

[0870] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls at least partially enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The housing may form part of the wall of the mask plenum.

[0871] Seal: can be a noun form referring to a structure (seal) or a verb form referring to the effect (seal). Two elements can be constructed and / or arranged to 'seal' or achieve a 'seal' between them without the need for a separate 'seal' element itself.

[0872] Shell: Shell will be taken to mean a curved and relatively thin structural element having bendable, stretchable and compressible stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be air-impermeable. In some forms, the shell may not be air-impermeable.

[0873] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0874] Braces: Braces will be considered to be structural components designed to increase the compression resistance of another component in at least one direction.

[0875] Swivel: (noun) A subassembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of the component preferably comprises a pair of matching cylindrical conduits. There may be little or no air flow leakage from the swivel when in use.

[0876] Tie(noun: a structure used to resist tension.

[0877] Vent: (noun): A structure that allows air flow from the interior of a mask or duct to ambient air, e.g., for effective clearance of exhaled gases. For example, clinically effective clearance may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the therapy pressure.

[0878] 5.5.6 Shape of the structure

[0879] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or a thruster. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relative surface orientation, position, function, or some other feature. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

[0880] To help describe the shape of three-dimensional structures and surfaces, first consider a cross section through a point p on the surface of the structure, cf. FIG. 3B to FIG. 3F , which show a cross section at a point p on the surface and an example of the resulting plane curve. Figures 3B to 3FThe outward normal vector at p is also shown. The outward normal vector at p points away from the surface. In some examples, the surface is described from the point of view of an imaginary person standing upright on the surface.

[0881] 5.5.6.1 One-dimensional curvature

[0882] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the inverse of the radius of a circle that touches the curve only at p).

[0883] Positive curvature: If the curve at p turns toward the outward normal, then the curvature at that point will be positive (if the imaginary person leaves point p, they must be walking uphill). Figure 3B (and Figure 3C Compared with the relatively large positive curvature) and Figure 3C (and Figure 3B This type of curve is often called concave.

[0884] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally without going up or down). Figure 3D .

[0885] Negative curvature: If the curve at p turns away from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary person leaves point p, they must be walking downhill). Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E This type of curve is often called convex.

[0886] 5.5.6.2 Curvature of two-dimensional surfaces

[0887] A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. Multiple cross sections may cut the surface in a plane including an outward normal ("normal plane"), and each cross section may be taken in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each curvature at the point has a quantity, such as a relatively small quantity. Figures 3B to 3F The plane curve in may be an example of such multiple sections at specific points.

[0888] Principal curvatures and principal directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values ​​are called principal directions. FIG. 3B to FIG. 3F In the example, the maximum curvature occurs at Figure 3B The minimum curvature occurs in Figure 3F Therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0889] Region of a surface: A connected set of points on a surface. The set of points in a region can have similar characteristics, such as curvature or sign.

[0890] Saddle region: A region where at each point the principal curvatures have opposite signs, ie one sign is positive and the other sign is negative (depending on the direction the imagined individual is turning, they can be walking up or down).

[0891] Dome region: The region where at every point the principal curvatures have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0892] Cylindrical region: A region where one of the principal curvatures is zero (or is zero, for example, within manufacturing tolerances) and the other principal curvature is non-zero.

[0893] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0894] Edge of a surface: The boundary or limit of a surface or area.

[0895] Path: In some forms of the present technology, 'path' will be taken to mean a path in a mathematical-topological sense, e.g. a continuous spatial curve from f(0) to f(1) on a surface. In some forms of the present technology, a 'path' may be described as a route or journey, comprising, e.g., a set of points on a surface. (A hypothetical person's path is where they walk on a surface, and is similar to a garden path).

[0896] Path length: In some forms of the present technology, 'path length' will be considered to be the distance along the surface from f(0) to f(1), i.e. the distance along a path on the surface. There may be more than one path between two points on the surface, and such paths may have different path lengths. (The path length of an imaginary person would be the distance they would have to walk along a path on the surface.

[0897] Straight-line distance: Straight-line distance is the distance between two points on a surface, but regardless of the surface. On a planar area, there will be a path on the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there may not be a path that has the same path length as the straight-line distance between two points. (For an imaginary individual, straight-line distance would correspond to the distance as a 'straight line'.

[0898] 5.5.6.3 Space curve

[0899] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be closed, i.e., have no endpoints. Space curves can be thought of as one-dimensional segments of three-dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear includes a helix, which is a left-handed helix, see Figure 3Q The typical human right ear includes a helix that is a right-handed helix, see Figure 3R . Figure 3S A right-handed spiral is shown. The edge of a structure, such as the edge of a membrane or impeller, can follow a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and a magnitude. The twist at a point on a space curve can be characterized with reference to the tangent vector, normal vector, and binormal vector at that point.

[0900] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction from that point as well as the magnitude. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If an imaginary person were flying along the curve and fell from her aircraft at a particular point, the direction of the tangent vector is the direction she would be traveling.

[0901] Unit Normal Vector: This tangent vector itself changes as the imaginary person moves along the curve. The unit vector pointing in the direction of the tangent vector change is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0902] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see Figure 3P ) or alternatively by the left-hand rule ( Fig.3O ) to determine.

[0903] Oscillating plane: The plane containing the unit tangent vector and the unit principal normal vector. Fig.3O and 3P .

[0904] Torsion of a space curve: The torsion of a space curve at a point is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane. A space curve that lies within the plane has zero torsion. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torsion (e.g., a gently inclined spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torsion (e.g., a sharply inclined spiral path). See Figure 3S Since T2>T1, the twist near the top coil of the spiral in Figure 3 is greater than Figure 3SThe amount of twist in the bottom coil of the helix.

[0905] Reference Figure 3P According to the right-hand rule, a space curve with a right-hand binormal can be considered to have a right-hand positive twist (e.g., Figure 3S A space curve that turns away from the right-handed binormal direction can be considered to have right-handed negative twist (e.g., a left-handed helix).

[0906] Similarly, referring to the left-hand rule (see Fig.3O ), a space curve oriented in the direction of the left-handed binormal can be considered to have a left-handed positive twist (e.g., a left-handed helix). Thus left-handed positive is equivalent to right-handed negative. See Figure 3T .

[0907] 5.5.6.4 Holes

[0908] A surface may have one-dimensional pores, for example pores defined by planar curves or by spatial curves. A thin structure (e.g., a membrane) having pores may be described as having one-dimensional pores. See, for example Fig. 3I A one-dimensional hole in a surface bounded by a planar curve for the structure shown.

[0909] A structure can have a two-dimensional hole, such as a hole defined by a surface. For example, a pneumatic tire has a two-dimensional hole defined by the inner surface of the tire. In another example, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, Figure 3L The padding and the Figure 3M and Figure 3N , showing an inner surface defining a two-dimensional hole. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or at its outlet) and a two-dimensional hole defined by the inner surface of the conduit. See also Figure 3K A two-dimensional hole in the shown structure bounded by the shown surface.

[0910] 5.6 Other notes

[0911] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, a...

Claims

1. A patient interface for sealingly delivering an air flow to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure when the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of 4 cmH2O to 30 cmH2O above the ambient air pressure in use throughout the patient's breathing cycle; the patient interface comprising: a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure having a fabric membrane constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the fabric membrane having at least one aperture formed therein such that a flow of air at the treatment pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure being constructed and arranged to, in use, maintain the treatment pressure within the cavity throughout the patient's breathing cycle, wherein the seal-forming structure comprises a flexible support structure to support the fabric membrane, the support structure being harder than the fabric membrane, The inflatable chamber and the support structure are integrally formed of silicone to form a one-piece structure. wherein, in use, the fabric membrane is configured to be pressed against the face of the patient such that the patient's nose is not received in the cavity, wherein, at a transition portion, the fabric membrane is attached to the support structure along an outer edge of the fabric membrane and an inner edge of the support structure such that the fabric membrane extends radially inwardly beyond the support structure along a rear patient contacting side of the seal-forming structure, and Therein, in the cross-sectional view, at the transition portion, the support structure and the fabric membrane extend along a curve in a direction from the front side of the seal-forming structure to the rear side of the seal-forming structure facing the patient.

2. A patient interface as claimed in claim 1, wherein: At the transition portion, the support structure and the fabric membrane have substantially the same radius of curvature.

3. A patient interface as described in claim 1, wherein the fabric membrane extends continuously along the curve from the transition portion to the inner edge of the fabric membrane.

4. A patient interface as described in Claim 1, wherein the at least one hole in the fabric membrane comprises two holes, and a bridge portion is arranged between the two holes in the fabric membrane.

5. A patient interface as claimed in claim 4, wherein the bridge portion is snapped with excess material to allow the fabric membrane to expand to accommodate noses of different sizes.

6. A patient interface as described in Claim 1 wherein the support structure comprises silicone and the fabric membrane is molded onto an inner edge of the support structure.

7. A patient interface as described in claim 1, wherein the seal-forming structure has a seamless transition from the support structure to the fabric membrane along its outer surface.

8. A patient interface as claimed in any one of claims 1 to 7, wherein the fabric membrane comprises a fabric material and a film layer applied to the fabric material to render the fabric material substantially air impermeable.

9. A patient interface as claimed in any one of claims 1 to 7, wherein the fabric membrane has a given curvature such that a portion of the fabric membrane not directly supported by the support structure extends along the curve.

10. A patient interface as described in claim 8, wherein the fabric material is a weft knitted fabric.

11. A patient interface according to claim 8, wherein the membrane layer comprises silicone.

12. A patient interface as described in claim 8, wherein the fabric material comprises nylon, spandex, or polyester.

13. A patient interface as claimed in any one of claims 1 to 7, wherein in use, treatment pressure in the cavity pushes the fabric membrane towards the patient's face.

14. A patient interface as claimed in any one of claims 1 to 7, wherein the inflatable chamber and seal-forming structure form an oral and nasal cushion assembly.

15. A patient interface as claimed in any one of claims 1 to 7, wherein the plenum chamber and seal-forming structure form a nasal cushion.

16. A treatment system for treating sleep apnea, comprising: A patient interface according to any one of claims 1 to 7; Respiratory pressure therapy (RPT) devices for supplying breathable gas at a positive pressure; and An air delivery tube that communicates the breathable gas from the RPT device to the patient interface.

17. A patient interface for sealingly delivering a flow of air to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure when the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of 4 cm H2O to 30 cm H2O above the ambient air pressure in use throughout the patient's breathing cycle; the patient interface comprising: a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure having a fabric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, the fabric membrane having at least one aperture formed therein so that a flow of air at the treatment pressure is delivered to at least the entrance to the patient's nostril, the seal-forming structure being constructed and arranged to, in use, maintain the treatment pressure within the cavity throughout the patient's breathing cycle, wherein the sealing forming structure comprises a flexible silicone support structure to maintain the fabric membrane in a predetermined curved shape, the fabric membrane comprises a nasal protrusion inner side region, the outer surface of the nasal protrusion inner side region has a predetermined curved shape with a positive curvature in the left-right direction, the fabric membrane comprises a subnasal point inner side region, the outer surface of the subnasal point inner side region has a predetermined curved shape with a positive curvature in the left-right direction, wherein the plenum chamber comprises silicone and the seal-forming structure is integrally formed as a one-piece structure with the plenum chamber, wherein, in use, the fabric membrane is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity, and Wherein the fabric membrane is attached to the support structure along a periphery of the fabric membrane such that the fabric membrane extends radially inwardly beyond the support structure.

18. A patient interface as described in claim 17, wherein the plenum 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 disposed nasal base section having a second thickness less than the first thickness, and Wherein the nasal base section is configured to fold or form a pivot point when the fabric membrane is engaged with the patient's face, thereby allowing the left and right sides of the support structure to deform inwardly to support the patient's nose.

19. A patient interface as described in claim 17, wherein the support structure includes an underpad.

20. A patient interface as described in Claim 17, wherein the support structure comprises foam.

21. A patient interface as described in Claim 17, wherein the fabric membrane is molded onto an inner edge of the support structure.

22. A patient interface as described in claim 17, wherein the fabric membrane has a dome shape in the corner area of ​​the fabric membrane.

23. A patient interface as claimed in claim 17, wherein the fabric membrane has a saddle shape in a lower central region of the fabric membrane, the saddle shape being configured to seal against the subnasal point of the patient in use.

24. A patient interface as claimed in claim 17, wherein the fabric membrane comprises a film layer applied to the fabric material to render the fabric material substantially impermeable to air.

25. A patient interface as claimed in claim 17, wherein the fabric membrane has a thickness in the range of 0.3 mm to 0.5 mm.

26. A patient interface as claimed in claim 24, wherein the membrane layer has a thickness in the range of 0.05mm to 0.1mm.

27. A patient interface as described in claim 24, wherein the fabric material is a weft knitted fabric.

28. A patient interface as claimed in claim 24, wherein the weight of the fabric material is in the range of 105 gsm to 120 gsm.

29. A patient interface as claimed in claim 24, wherein the machine gauge of the fabric material is in the range of 44GG to 60GG.

30. A patient interface as described in claim 24, wherein the fabric material has a heathered aesthetic.

31. A patient interface as described in claim 24, wherein the fabric material has a solid color aesthetic.

32. A patient interface according to claim 24, wherein the membrane layer comprises silicone.

33. A patient interface as described in claim 24, wherein the fabric material comprises nylon, spandex, or polyester.

34. A patient interface as claimed in any one of claims 17 to 33, wherein in use, treatment pressure in the cavity pushes the fabric membrane towards the patient's face.

35. A patient interface as claimed in any one of claims 17 to 33, wherein the at least one hole in the fabric membrane comprises two holes, and a bridge is arranged between the two holes in the fabric membrane.

36. A patient interface as described in any one of claims 17 to 33, further comprising a positioning and stabilizing structure which provides a force to maintain the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap which is constructed and arranged so that in use at least a portion covers an area of ​​the patient's head above the base point of the patient's ear.

37. A patient interface as described in any one of claims 17 to 33, further comprising a ventilation structure that allows gas exhaled by the patient to flow continuously from the interior of the cavity to the surrounding environment, the size and shape of the ventilation structure being determined to maintain a therapeutic pressure in the cavity during use.

38. A patient interface as claimed in any one of claims 17 to 33, wherein the inflatable chamber and seal-forming structure form an oral and nasal cushion assembly.

39. A patient interface as claimed in any one of claims 17 to 33, wherein the inflatable chamber and seal-forming structure form a nasal cushion.

40. A treatment system for treating sleep apnea, comprising: A patient interface according to any one of claims 17 to 33; Respiratory pressure therapy (RPT) devices for supplying breathable gas at a positive pressure; and An air delivery tube that communicates the breathable gas from the RPT device to the patient interface.

41. A patient interface for sealingly delivering a flow of air to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure while the patient is sleeping to improve sleep-disordered breathing, the patient's airway entrance comprising at least an entrance to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cm H2O to about 30 cm H2O above the ambient air pressure in use throughout the patient's breathing cycle; the patient interface comprising: a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure having a fabric membrane constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the fabric membrane having at least one aperture formed therein so that a flow of air at the treatment pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the treatment pressure within the cavity throughout the patient's breathing cycle, wherein the fabric membrane comprises a fabric material and a membrane layer applied thereto to make the fabric material substantially air-impermeable, the fabric material being a weft-knitted fabric, wherein the seal-forming structure comprises a flexible support structure to support the fabric membrane, the support structure comprising silicone and connected to the plenum chamber, the support structure being harder than the fabric membrane, The plenum chamber comprises silicone and the seal-forming structure is integrally formed as a one-piece structure with the plenum chamber, wherein the textile membrane is attached to the support structure along a periphery of the textile membrane such that the textile membrane extends radially inwardly beyond the support structure, wherein, in use, the fabric membrane is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity, and The fabric membrane has a dome shape in a corner region of the fabric membrane configured to seal against the patient's nose wing, and has a saddle shape at a lower central region of the fabric membrane configured to seal against the patient's subnasal point.

42. A patient interface as claimed in claim 41, wherein: In use, the treatment 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.

43. A patient interface as claimed in any one of claims 41 and 42, wherein the at least one hole in the fabric membrane comprises two holes, and a bridge portion is arranged between the two holes in the fabric membrane. The bridge portion is snapped with excess material to allow the fabric membrane to expand to accommodate noses of different sizes.

44. A patient interface as claimed in any one of claims 41 to 43 wherein the support structure comprises silicone and the fabric membrane is moulded onto an inner edge of the support structure.

45. A patient interface as claimed in any one of claims 41 to 44, wherein the fabric membrane has a dome shape in a corner region of the fabric membrane.

46. ​​A patient interface as claimed in any one of claims 41 to 45, wherein the fabric membrane is attached to the support structure in such a manner that the fabric membrane is in tension prior to use.

47. A patient interface as claimed in any one of claims 41 to 46 wherein a first region of the fabric membrane is in a tensioned state prior to use and a second region of the fabric membrane is not tensioned prior to use.

48. A patient interface as claimed in any one of claims 41 to 47 wherein the fabric membrane has four-way elasticity.

49. A patient interface as claimed in any one of claims 41 to 47, wherein the fabric membrane has a first elasticity in a lateral left-right direction and a different second elasticity in an up-down direction, wherein the elasticity in the first direction is greater than the elasticity in the second direction.

50. A patient interface according to any one of claims 41 to 49 wherein the membrane layer comprises silicone.

51. A patient interface as claimed in any one of Claims 41 to 50, wherein the fabric material comprises nylon, spandex, or polyester.

52. A patient interface as claimed in any one of claims 41 to 51, wherein the inflatable chamber and seal-forming structure form an oral and nasal cushion assembly.

53. A patient interface as claimed in any one of claims 41 to 52, wherein the inflatable chamber and seal-forming structure form a nasal cushion.

54. A treatment system for treating sleep apnea, comprising: A patient interface according to any one of claims 41 to 50; Respiratory pressure therapy (RPT) devices for supplying breathable gas at a positive pressure; and An air delivery tube that communicates the breathable gas from the RPT device to the patient interface.

55. A method of forming a cushion assembly for a patient interface, the cushion assembly being configured to deliver a flow of air to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure to improve sleep-disordered breathing while the patient is sleeping, the patient's airway entrance comprising at least an entrance to the patient's nares, wherein the cushion assembly is configured to maintain a therapeutic pressure in the range of about 4 cm H2O to about 30 cm H2O above ambient air pressure in use throughout the patient's breathing cycle; the method comprising: forming an air-impermeable textile composite material by applying an air-impermeable material to a textile material, the textile composite material having a flat shape; cutting the fabric composite material into desired sizes depending on the particular cushion component type to be used; molding an inflatable chamber and a flexible support structure from a silicone material to form a one-piece structure, the inflatable chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure; and overmolding a flexible support structure onto the cut fabric composite material to form a seal-forming structure with a fabric membrane such that the fabric membrane is attached to the support structure along an outer edge of the fabric membrane and an inner edge of the support structure, wherein, in the overmolding step, the fabric composite material is held in place by vacuum to have a non-flat shape during overmolding, thereby imparting a curved non-flat shape to the fabric film, wherein no wrinkles, creases or folds are formed in the fabric membrane, and Wherein, in use, the fabric membrane is configured to be pressed against the patient's face so that the patient's nose is not received in the cavity.

56. The method of claim 55, wherein the seal-forming structure has a seamless transition along its outer surface from the support structure to the fabric membrane.

57. The method of any one of claims 55 and 56, wherein at the transition portion, the fabric membrane is attached to the support structure along an outer edge of the fabric membrane and an inner edge of the support structure such that the fabric membrane extends radially inwardly beyond the support structure, and in, At the transition portion, the support structure and the fabric membrane extend along a curve in a direction from a front side of the seal-forming structure to a rear side of the seal-forming structure facing the patient.

58. The method of any one of claims 55 to 57, wherein two holes are formed in the fabric membrane and a bridge is arranged between the two holes in the fabric membrane, The bridge portion is snapped with excess material to allow the fabric membrane to expand to accommodate noses of different sizes.

59. A method as claimed in any one of claims 55 to 58, wherein the support structure comprises silicone.

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