Elastic sealing forming structure with multiple curvatures

Abstract

A patient interface comprising a seal-forming structure having an elastic membrane having at least one aperture such that a flow of air at a therapeutic pressure is delivered to at least the entrance of a patient's nostrils and / or the entrance of a patient's mouth. In use, the seal-forming structure is constructed and arranged to maintain a therapeutic pressure within the plenum cavity throughout the patient's breathing cycle. The elastic membrane comprises a first portion that is maintained in a relaxed state and a second portion that is maintained in a taut state. The elastic membrane is molded to include a three-dimensional shape having multiple curvatures. The at least one aperture comprises an arch on a side of the at least one aperture and is in a relaxed state prior to use. The arch is configured to move to a substantially taut state during use.

Description

[0001] 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, as it appears in the Patent Office patent file or records, but otherwise reserves all copyright rights whatsoever.

[0002] 1 Cross-reference to related applications

[0003] This application claims priority to international application No. PCT / AU2020 / 051109, filed on October 15, 2020, which claims priority to Australian provisional application No. 2020902371, filed on July 9, 2020, and to U.S. application No. 16 / 850,803, filed on April 16, 2020, which is a continuation-in-part of international application No. PCT / IB2019 / 058832, filed on October 16, 2019, the entire contents of which are incorporated herein by reference. 2 Background Technology 2.1 Technical Field

[0006] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and improvement of respiratory-related disorders. The present technology also relates to medical devices or equipment and their uses.

[0007] 2.2 Description of Related Technologies

[0008] 2.2.1 Human respiratory system and its disorders

[0009] The human respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0010] The airway comprises a series of branch tubes, and when the branch trachea penetrates deeper into the lungs, it becomes narrower, shorter and more numerous. The main function of the lungs is gas exchange, thereby allowing oxygen to enter the venous blood from the inhaled air and allowing carbon dioxide to move in the opposite direction. The trachea is divided into the left main bronchus and the right main bronchus, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branches of the airway lead to the respiratory bronchioles and eventually lead to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. Referring to " Respiratory Physiology (Respiratory Physiology)" published by John B.West, Lippincott Williams & Wilkins in 2012, the 9th edition.

[0011] There are a range of breathing disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[0012] Examples of respiratory 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.

[0013] 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. Complications are common disorders, especially in middle-aged overweight men, but those affected may not be aware of the problem. Referring to U.S. Patent No. 4,944,310 (Sullivan).

[0014] Respiratory failure is an umbrella term for respiratory disorders in which the lungs cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may include some or all of the following disorders.

[0015] People with respiratory insufficiency (a form of respiratory failure) may become abnormally short of breath during exercise.

[0016] A range of treatments have been used to treat or ameliorate these conditions. Furthermore, such treatments can be used to prevent respiratory distress in otherwise healthy individuals. However, these treatments have a number of drawbacks.

[0017] 2.2.2 Treatment

[0018] Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high flow therapy (HFT), have been used to treat one or more of the above-mentioned respiratory disorders.

[0019] 2.2.2.1 Respiratory pressure therapy

[0020] Respiratory pressure therapy is the supply of air to the airway entrance at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a tank ventilator or cuirass).

[0021] 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 with CPAP can be voluntary, so if a 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.

[0022] 2.2.2.2 Flow treatment

[0023] Not all respiratory therapies are designed to provide a prescribed therapeutic pressure. The goal of some respiratory therapies is to deliver a prescribed respiratory volume by delivering an inspiratory air flow rate profile over a target duration, possibly superimposed on a positive baseline pressure. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy may only be able to supplement the patient's own spontaneous breathing with conditioned or enriched gas. In one example, high flow therapy (HFT) is to provide a continuous flow of heated, humidified air to the airway entrance through an unsealed or open patient interface at a "therapeutic flow rate" that remains substantially constant throughout the respiratory cycle. The nominal therapeutic flow rate should be set to exceed the patient's maximum inspiratory air flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD and other respiratory diseases. One mechanism of action is that the high flow rate of air at the airway entrance improves ventilation efficiency by flushing or washing out expired CO2 in the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (DST). Other benefits may include increased warmth and humidification (which may aid secretion management) and the potential for a modest increase in airway pressure.As an alternative to a constant flow rate, the therapeutic flow rate may follow a profile that varies during the respiratory cycle.

[0024] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician may prescribe a continuous flow of oxygen-enriched air delivered to a patient's airway at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) with a specified oxygen concentration (ranging from 21% to 100% oxygen fraction in ambient air).

[0025] 2.2.2.3 Supplemental oxygen

[0026] For some patients, oxygen therapy can be combined with respiratory pressure therapy, or HFT, by adding supplemental oxygen to the pressurized air flow. When oxygen is added to respiratory pressure therapy, it is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0027] 2.2.3 Respiratory therapy system

[0028] These respiratory therapies can be provided by a respiratory therapy system or device.Such systems and devices can also be used to screen for, diagnose, or monitor a condition without treating it.

[0029] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0030] 2.2.3.1 Patient interface

[0031] The patient interface can be used to couple 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, for example, an area of ​​the patient's face to facilitate the delivery of gas at a pressure sufficiently different from the ambient pressure (for example, a positive pressure of approximately 10 cmH2O 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 cmH2O to the airway. For flow treatments such as nasal HFT, the patient interface is configured to insufflate the nostrils, but a complete seal is explicitly avoided. An example of such a patient interface is a nasal cannula.

[0032] Some other mask systems may not be functionally suitable for this application. For example, a purely decorative mask may not be able to maintain the appropriate pressure. Mask systems used for underwater swimming or diving may be configured to prevent water from flowing in from high pressure outside, rather than maintaining air at a higher pressure than the ambient pressure inside.

[0033] Certain masks may be clinically unfavorable for the present technology, for example if they block air flow through the nose and only allow it through the mouth.

[0034] Certain masks may be uncomfortable or impossible with the present technology if they require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal through their lips.

[0035] Certain masks may not be practical 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 several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly from person to person. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The mandible or lower jaw can move relative to the other bones of the skull. The entire head can move during a period of respiratory therapy.

[0037] Due to these challenges, some masks face one or more of the following problems: being 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. The wrong mask size can lead to reduced compliance, reduced comfort, and poor patient outcomes. For example, masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for applying anesthetics are acceptable for their original applications, but for long periods of time (e.g., several hours), such masks are not as comfortable as ideal. This discomfort may lead to reduced patient compliance with therapy. This is even more true if the mask is worn during sleep.

[0038] CPAP therapy is very effective in treating certain breathing disorders, assuming patient compliance. If the mask is uncomfortable or difficult to use, patients may not comply with treatment. Since patients are often advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their masks, 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 to treat sleep-disordered breathing may be suitable for other applications.

[0040] For these reasons, a diverse field has emerged for patient interfaces used to deliver CPAP during sleep.

[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 may 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 the 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 the patient interface, the seal-forming structure may include a single element that surrounds both nostrils when in use. Such a single element may be determined to cover, for example, the upper lip region and the bridge of the nose region of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth region when in use, for example, by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region when in use. These different types of patient interfaces may be referred to by 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 sensitivity of the patient's facial areas are different. For example, a seal on swimming goggles that covers the patient's forehead may not be suitable for use on the patient's nose.

[0045] Certain seal-forming structures can 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.

[0046] 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 and the seal-forming structure engages face-to-face 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, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0047] Another type of seal-forming structure incorporates a sheet-like seal of thin material positioned 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 forms of seal-forming portions, if the fit between the face and the mask is poor, excessive force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or bend during use, causing leaks.

[0048] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these uncomfortable.

[0049] Another form of seal-forming structure may use an adhesive to achieve the seal. Some patients may find it inconvenient to constantly apply and remove adhesive to their face.

[0050] A range 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; and WO 2010 / 135,785.

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

[0052] ResMed Ltd. 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 TM FX Nasal Pillows Mask and MIRAGE LIBERTY TM Full face mask. The following patent application assigned to ResMed Ltd. describes an example of a nasal pillow mask: International Patent Application WO 2004 / 073,778 (which describes the ResMed Ltd. SWIFT TM Other aspects of nasal pillows); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc. SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe the MIRAGE LIBERTY TM Other aspects of full-face masks); International patent application WO 2009 / 052,560 (which describes ResMed Ltd. SWIFT TM Other aspects of the FX Nasal Pillows).

[0053] 2.2.3.1.2 Positioning and stabilization

[0054] 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.

[0055] One technique is to use adhesives. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0056] Another technique is to use one or more straps and / or stabilizing harnesses.Many of these harnesses suffer from one or more of poor fit, bulk, discomfort, and awkwardness to use.

[0057] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0058] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to provide one or more of the various therapies described above, such as by operating the device to generate an air flow for delivery to an airway interface. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Thus, an RPT device can also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0059] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as reliability, size, and weight requirements for medical devices. Furthermore, even devices designed for medical use may have drawbacks related to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

[0060] An example of a special requirement for certain RPT devices is noise.

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

[0062] 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

[0063] One known RPT device for treating sleep-disordered breathing is the S9 sleep therapy system manufactured by ResMed Limited. Another example of an RPT device is a ventilator. A ventilator such as the ResMed Stellar TMThe range of adult and pediatric ventilators can provide support for invasive and non-invasive independent ventilation for a range of patients for the treatment of a variety of conditions such as, but not limited to, NMD, OHS and COPD.

[0064] ResMed Elisée TM 150 ventilator and ResMed VS III TM Respirators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide volume and air pressure ventilation modes with single or double limb circuits. RPT devices typically include a pressure generator, such as a blower driven by an electric motor 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 supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface such as described above via an air circuit.

[0065] The designer of a device may be presented with an infinite number of choices that can be made. Design criteria often conflict, which means that some design choices are far from conventional or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

[0066] 2.2.3.3 Air circuit

[0067] An air circuit is a conduit or tube constructed and arranged to allow air flow to flow between two components of a respiratory therapy system, such as an RPT device and a patient interface. In some cases, separate branches of the air circuit can handle both inspiration and exhalation. In other cases, a single branch air circuit can be used for both inspiration and exhalation.

[0068] 2.2.3.4 Humidifier

[0069] Delivering an air stream without humidification can lead to 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, typically applied to the facial area in and around the patient interface, is more comfortable than cold air.

[0070] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of a medical humidifier.

[0071] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to the ambient air when needed, typically where the patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. A medical humidifier can be configured to only humidify and / or heat the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, but these systems also humidify and / or heat the entire room, which may cause discomfort to the occupants. In addition, medical humidifiers may have stricter safety restrictions 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 some may be difficult or inconvenient to use by patients.

[0073] 2.2.3.5 Data Management

[0074] There may be many clinical reasons to obtain data to determine whether a patient being treated with a prescribed respiratory therapy is "compliant," such as whether the patient has used their RPT device in accordance with one or more "compliance rules." One example of an 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 patient 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 it 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 component 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] 2.2.3.6 Mandibular reduction

[0078] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other provider, that holds the lower jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and then removes it after falling asleep. Therefore, an MRD is not designed to be worn all the time. An MRD can be custom made or produced in a standard form and includes a bite impression portion that is determined to fit over the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, putting tension on the pharyngeal walls, which reduces collapse of the airway and reduces vibration of the palate.

[0079] In some examples, the mandibular advancement device may include an upper plate designed to engage or mate with teeth on the upper jaw or maxilla, and a lower plate designed to engage or mate with teeth below the upper jaw or mandible. The upper and lower plates are laterally connected by a pair of connecting rods. The pair of connecting rods are symmetrically secured to the upper and lower plates.

[0080] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible is held in a forward position. The length of the connecting rod can be adjusted to change the protrusion level of the mandible. The dentist can determine the protrusion level of the mandible, which will determine the length of the connecting rod.

[0081] Some MRDs are constructed to push the mandible relative to the maxilla, while others, such as the ResMed Narval CC TM Other MADs, such as the MRD, are designed to hold the mandible in a forward position. The device also reduces or minimizes side effects on the teeth and the temporomandibular joint (TMJ). Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0082] 2.2.3.7 Vent Technology

[0083] Some forms of therapy systems may include a vent to allow exhaled carbon dioxide to be flushed out. The vent may allow gas to flow from an interior space (eg, a plenum) of the patient interface to a space external to the patient interface, such as to the environment.

[0084] The vent may include an orifice through which air can flow when the mask is in use. Many such vents are noisy. Other vents may become blocked during use, thereby providing insufficient airflow. Some vents may disrupt the sleep of the patient's 1000 bed partner 1100, for example, by making noise or converging airflow.

[0085] ResMed Inc. 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. US2009 / 0050156; and U.S. Patent Application Publication No. US2009 / 0044808.

[0086] Noise table of existing masks (ISO 17510-2:2007, pressure of 10cmH2O at 1m)

[0087]

[0088] (*One sample only, measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O).

[0089] The sound pressure values ​​of various objects are shown below

[0090]

[0091]

[0092] 2.2.4 Screening, diagnosis and surveillance systems

[0093] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and typically involves specialized clinical staff using the system. PSG typically 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. PSG for sleep apnea involves observing the patient clinically for two nights: one night for pure diagnosis and the second night for the clinician to titrate treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep apnea.

[0094] Screening and diagnosis generally describe the identification of a disorder based on symptoms and signs. Screening typically provides a yes / no result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis may yield clinically useful information. Screening and diagnosis are often one-time procedures, while monitoring for disease progression can continue indefinitely. Some screening / diagnostic systems are suitable only for screening / diagnosis, while others can also be used for monitoring.

[0095] Clinical experts can appropriately screen, diagnose, or monitor patients based on visual inspection of 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. In addition, a given clinical expert may apply different criteria at different times. 3 Summary of the invention

[0097] The present technology is intended to provide medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders with improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0098] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0099] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0100] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0101] One form of the present technology is a seal-forming structure for use with a patient interface, the seal-forming structure for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the seal-forming structure comprising:

[0102] An elastic membrane is coupled to a flexible support structure in a relaxed state, and a bridging portion of the elastic membrane is held under greater tension than a remainder of the elastic membrane.

[0103] One form of the present technology is a seal-forming structure for use with a patient interface, the seal-forming structure for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the seal-forming structure comprising:

[0104] A fabric membrane is coupled to a flexible support structure in a relaxed state, with a bridging portion of the fabric membrane held under greater tension than the remainder of the fabric membrane.

[0105] One form of the present technology is a seal-forming structure for use with a patient interface, the seal-forming structure for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the seal-forming structure comprising:

[0106] A membrane is cut from a sheet of material using ultrasonic cutting so that the perimeter of the membrane is substantially free of abrasion, the membrane being constructed of a textile material and / or an air-impermeable material (eg, silicone).

[0107] One form of the present technology is a seal-forming structure for use with a patient interface, the seal-forming structure for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the seal-forming structure comprising:

[0108] A fabric layer forms an air-impermeable layer configured to allow air flow through and absorb moisture for the patient's skin.

[0109] One form of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an airway entrance of a patient, including at least the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure, when in use, within a range of about 4 cmH2O to about 30 cmH2O above the ambient air pressure used throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing; the patient interface comprising:

[0110] a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0111] Seal to form a structure.

[0112] One form of the present technology includes a fabric seal-forming structure having a bridge portion between a first aperture and a second aperture, the bridge portion being crimped to be held at a greater tension than a remainder of the fabric membrane.

[0113] One form of the present technology includes a resilient seal-forming structure having a bridge portion between a first aperture and a second aperture, the bridge portion being crimped to maintain greater tension than the remainder of the elastic membrane.

[0114] One form of the present technology includes a fabric seal-forming structure having a bridge portion between a first aperture and a second aperture, the bridge portion being crimped to maintain a greater tension than a remainder of the fabric membrane.

[0115] One form of the present technology includes a resilient seal-forming structure having a bridge portion between a first aperture and a second aperture, the bridge portion being generally planar. The tension in the bridge may be greater than, less than, or equal to that in the remainder of the resilient membrane.

[0116] One form of the present technology is a seal-forming structure constructed from a fabric material and / or an elastic material.

[0117] In some aspects, a) the seal-forming structure is cut from a sheet of material using ultrasonic cutting; and / or b) a perimeter of the seal-forming structure is configured to be substantially free of wear due to ultrasonic cutting.

[0118] In some aspects, a) the seal-forming structure includes an air-impermeable layer; b) the air-impermeable layer is constructed of the elastomeric material; c) the seal-forming structure includes a breathable layer exposed around at least a portion of the periphery of the hole in the seal-forming structure; d) the breathable layer is configured to receive a portion of the air flow that exits the inflatable chamber through the at least one hole in the fabric material; e) the first layer is configured to be positioned between the patient's skin and the air-impermeable layer; f) the breathable layer is configured to cause the air flow to bounce between the patient's skin and the air-impermeable layer; and / or g) the breathable layer is configured to allow moisture on the patient's skin to be wicked away due to air flowing through the breathable layer.

[0119] Another aspect of one form of the present technology is a seal-forming structure having a fabric membrane coupled to a flexible support structure in a relaxed state, with bridging portions of the fabric membrane crimped and held under greater tension than the remainder of the fabric membrane.

[0120] Another aspect of one form of the present technology is a seal-forming structure having an elastic membrane coupled to a flexible support structure in a relaxed state, with a bridging portion of the elastic membrane held under greater tension than the remainder of the elastic membrane.

[0121] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an airway entrance of a patient including at least the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above the ambient air pressure used during use throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing; the patient interface comprising:

[0122] a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0123] A seal-forming structure, the seal-forming structure having:

[0124] a fabric membrane constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's airway entrance below the nasal bridge area of ​​the patient's face, the fabric membrane having a portion, the seal-forming structure constructed and arranged to maintain the treatment pressure in the cavity throughout the patient's breathing cycle during use,

[0125] in:

[0126] The fabric membrane remains in a relaxed state, and

[0127] This portion is held under greater tension than the rest of the fabric membrane.

[0128] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the entrance including at least the entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising:

[0129] a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0130] A seal forming structure having:

[0131] an elastic 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 elastic membrane having a portion, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the cavity throughout the patient's respiratory cycle,

[0132] in:

[0133] maintaining the elastic membrane in a relaxed state, and

[0134] This portion maintains a greater tension than the rest of the elastic membrane.

[0135] In some aspects, the elastic membrane has at least one aperture or two apertures formed therein such that the flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's airway.

[0136] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an airway entrance of a patient including at least the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above the ambient air pressure used during use throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing; the patient interface comprising:

[0137] a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0138] A seal-forming structure, the seal-forming structure having:

[0139] 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 below an area of ​​the nasal bridge of the patient's face, the fabric membrane having at least one aperture such that a flow of air at the therapeutic pressure is delivered to the entrance of at least one of the patient's nostrils, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle during use,

[0140] in:

[0141] The fabric membrane includes a first portion maintained in a relaxed state and a second portion maintained in a taut state, the taut state of the second portion being configured to allow the seal-forming structure to include a three-dimensional shape having a plurality of curvatures.

[0142] In some aspects, a) the area of ​​the first portion is greater than the area of ​​the second portion; b) the at least one aperture includes a first aperture and a second aperture, each aperture being configured to be positioned adjacent one of the patient's nostrils when in use, and wherein a bridging portion is disposed between the first aperture and the second aperture; c) the bridging portion is the second portion and is maintained in a taut state; d) the bridging portion is curled to be maintained under a greater tension than the first portion of the fabric membrane; e) the bridging portion includes a first segment and a second segment, the first segment being substantially flat and configured to contact the patient when in use, the second segment extending into the inflatable chamber; f) the bridging portion is curled using ultrasonic welding and / or adhesive; and / or g) ultrasonic welding and / or adhesive is applied to the second segment.

[0143] In some aspects, the sealing forming structure also includes a flexible support structure for maintaining the fabric membrane in a three-dimensional shape; b) the sealing forming structure includes a single wall, and wherein one end of the flexible support structure contacts the fabric membrane; c) the sealing forming structure includes a pair of walls, wherein the flexible support structure includes a free end, and the fabric membrane is connected to the flexible support structure at the distal end of the free end, and wherein the free end is spaced apart from the fabric membrane so that the fabric membrane is radially arranged outside the free end; d) the flexible support structure is connected to the fabric membrane using injection molding; and / or e) the bridging portion is a positioning pin after being curled.

[0144] In some aspects, a) the fabric membrane includes a first curvature about a first axis intersecting the first hole and the second hole, and wherein, before being curled, the bridging portion includes a bridging curvature about the first axis in a direction opposite to the rest of the fabric membrane; b) a second axis is transverse to the first axis and extends along the bridging portion, and the fabric membrane includes a second curvature about the second axis; c) the second curvature has one of a dome area and a saddle area, and the first curvature has the other of the dome area and the saddle area; d) the second curvature is configured to contact the patient's subnasal point when in use; e) a third axis extends transverse to the second axis and is inclined relative to the first axis, and the fabric membrane includes a third curvature about the third axis; f) the third curvature is configured to contact the patient's upper lip when in use; g) a fourth axis is transverse to the second axis and the third axis and extends parallel to the first axis, and the fabric membrane includes a fourth curvature about the fourth axis; h) the fourth curvature includes a variable radius of curvature; and / or i) the fourth curvature extends into the main curvature of an edge adjacent to the fabric membrane.

[0145] In some aspects, a) a portion of the first hole away from the bridging portion is movable between a first position and a second position; b) the first position is a natural state, and the fabric membrane is moved to the second position due to an external force; c) in the second position, a portion of the first hole extends into the inflatable chamber; d) the first hole comprises a generally teardrop shape in the second position; e) in the second position, the first hole is configured to contact around the entrance of one of the patient's nostrils, adjacent to the alar rim; and / or f) the portion of the second hole away from the bridging portion is movable between the first position and the second position.

[0146] In some aspects, a) the fabric membrane includes a fabric layer and a silicone layer coupled to the fabric layer, the silicone layer having an impermeable property; b) the thickness of the silicone layer is approximately 0.5 mm; c) the silicone layer is disposed within the cavity and is configured not to contact the patient's skin when in use; d) the silicone layer has a low hardness property, and the fabric membrane has a high stretchability when coupled to a flexible support structure.

[0147] In some aspects, a) the length of the bridging portion is directly related to the size of the first hole and the size of the second hole; b) due to the tensioned state of the second portion, the fabric membrane is configured to bend about at least two non-parallel axes to form a three-dimensional shape; c) the fabric membrane includes a multi-layer fabric material and a silicone layer connected to the multi-layer fabric material; d) the multi-layer fabric material includes a first layer, a second layer and a third layer, the silicone layer only contacts the first layer, and wherein the third layer is configured to contact the patient's face when in use; e) the first layer and the third layer are composed of nylon, wherein the second layer is composed of spandex; f) the thickness of the fabric membrane is approximately 0.35 mm to 0.45 mm; and / or g) when in use, the patient's nose and upper lips only contact the fabric membrane.

[0148] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an airway entrance of a patient, including at least a nares of the patient, wherein the patient interface is configured to maintain a therapeutic pressure, when in use, within a range of about 4 cm HO to about 30 cm HO above the ambient air pressure used throughout the patient's breathing cycle while the patient is sleeping to improve sleep-disordered breathing; the patient interface comprising:

[0149] a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0150] A seal-forming structure, the seal-forming structure having:

[0151] a resilient membrane constructed and arranged to form a pressure-assisted seal with a region of the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, the resilient membrane having at least one aperture such that a flow of air at the therapeutic pressure is delivered to the at least one entrance to the patient's nostril, the seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle,

[0152] in:

[0153] The elastic membrane includes a first portion maintained in a relaxed state and a second portion maintained in a taut state, the taut state of the second portion being configured to allow the seal-forming structure to include a three-dimensional shape having multiple curvatures.

[0154] In some aspects, a) the area of ​​the first portion is greater than the area of ​​the second portion; b) the at least one aperture comprises a first aperture and a second aperture, each aperture being configured to be positioned adjacent one of the patient's nostrils in use, and wherein the bridging portion is disposed between the first aperture and the second aperture; c) the bridging portion is the second portion and is maintained in a taut state; and / or d) the bridging portion comprises a first portion and a second portion, the first portion being substantially flat and configured to contact the patient in use, and the second portion extending into the plenum chamber.

[0155] In some aspects a) the seal-forming structure further includes a flexible support structure; b) the seal-forming structure includes a single wall, and wherein one end of the flexible support structure contacts the elastic membrane; c) the seal-forming structure includes a pair of walls, wherein the flexible support structure includes a free end, and the elastic membrane is connected to the flexible support structure distal to the free end, and wherein the free end is spaced apart from the elastic membrane so that the elastic membrane is radially arranged outside the free end; and / or d) the flexible support structure is connected to the elastic membrane using injection molding.

[0156] In some aspects a) the elastic membrane includes a first curvature about a first axis intersecting the first and second apertures; b) a second axis transverse to the first axis and extending along the bridging portion, the elastic membrane including a second curvature about the second axis; c) the second curvature has one of a dome region and a saddle region, the first curvature having the other of a dome region and a saddle region; d) the second curvature is configured to contact the patient's subnasal point during use; e) a third axis extending transverse to the second axis and tilted relative to the first axis, the elastic membrane including a third curvature about the third axis; f) the third curvature is configured to contact the patient's upper lip during use; g) a fourth axis transverse to the second and third axes and extending parallel to the first axis, the elastic membrane including a fourth curvature about the fourth axis; h) the fourth curvature includes a variable radius of curvature; and / or i) the fourth curvature extends into the main curvature near the edge of the elastic membrane.

[0157] In some aspects, a) a portion of the first hole away from the bridging portion is movable between a first position and a second position; b) the first position is a natural state, and the elastic membrane is moved to the second position due to an external force; c) the portion of the first hole extends into the inflatable chamber in the second position; d) the first hole comprises a generally teardrop shape in the second position; e) in the second position, the first hole is configured to contact a periphery of the inlet, which is proximate to a ledge of one of the patient's nostrils; and / or f) a portion of the second hole of the second hole is movable between a first position and a second position.

[0158] In some aspects a) the elastic membrane comprises a silicone layer having an impermeable property; b) the silicone layer is about (or between about) 0.25 mm and about (or about) 0.3 mm thick; c) the silicone layer has a low hardness characteristic d) the silicone layer has a 40 Shore A durometer hardness; e) the silicone layer is molded with a lower hardness silicone (e.g., 20 Shore A); f) the elastic membrane includes curling to selectively apply local tension; and / or g) the elastic membrane includes a fabric layer connected to the silicone layer.

[0159] In some aspects a) the length of the bridging portion is directly related to the size of the first hole and the size of the second hole; and / or b) due to the tensioned state of the second portion, the elastic membrane is configured to bend about at least two non-parallel axes to form the three-dimensional shape.

[0160] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the entrance including at least the entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising:

[0161] a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0162] A seal forming structure having:

[0163] a fabric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​a patient's face surrounding an entrance to the patient's airway below an area of ​​the patient's nose bridge, the fabric membrane having a first aperture and a second aperture, and a bridging portion disposed between the first aperture and the second aperture, the first aperture and the second aperture formed therein enabling a flow of air at the therapeutic pressure to be delivered at least to the entrance of the patient's nostril, the seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure within the cavity throughout the patient's breathing cycle, and

[0164] a flexible support structure for holding the fabric membrane in a predetermined shape;

[0165] in:

[0166] The fabric membrane is coupled to a flexible support structure in a relaxed state, and

[0167] The bridging portion is crimped and thereby held under greater tension than the remainder of the fabric membrane.

[0168] In some aspects, a) the fabric membrane is configured to include bending about at least two non-parallel axes due to the bridging portion being curled; b) the bridging portion is curled using ultrasonic welding and / or adhesive; c) the length of the bridging portion is directly related to the size of the first hole and the size of the second hole; d) the bridging portion includes a first portion and a second portion; e) the first section is substantially flat and configured to contact the patient in use, and the second section extends into the inflatable chamber; and / or f) ultrasonic welding and / or adhesive is applied to the second section.

[0169] In some aspects, a) the seal-forming structure includes a single wall; b) one end of the flexible support structure contacts the fabric membrane; c) the seal-forming structure includes a pair of walls; d) the flexible support structure includes a free end; e) the fabric membrane is connected to the flexible support structure away from the free end; f) the free end is spaced apart from the fabric membrane so that the fabric membrane is radially disposed outside the free end; g) the flexible support structure is connected to the fabric membrane using injection molding; and / or h) the bridging portion is a curled positioning pin.

[0170] In some aspects, a) the fabric membrane includes a fabric layer and a silicone layer coupled to the fabric layer; b) the silicone layer has an impermeable property; c) the silicone layer is about (or between about) 20 microns and about (or about) 100 microns thick; d) the fabric membrane includes a multi-layer fabric material and a silicone layer coupled to the multi-layer fabric material; e) the multi-layer fabric material includes a first layer, a second layer, and a third layer, the silicone layer only contacts the first layer, and the third layer is configured to contact the patient's face during use; f) the first layer and the third layer are composed of nylon, and wherein the second layer is composed of spandex; and / or g) the silicone layer is disposed within the cavity and is configured not to contact the patient's skin during use.

[0171] In some aspects, a) the silicone layer has low durometer properties; b) the fabric membrane comprises a high stretchability when coupled to the flexible support structure; and / or c) the fabric membrane is about 0.6 mm to about 0.8 mm thick.

[0172] In some aspects, a) the fabric membrane includes a first curvature about a first axis intersecting the first opening and the second opening; b) before curling, the bridging portion includes a bridging curvature about the first axis in a direction opposite to the rest of the fabric membrane; c) a second axis that is transverse to the first axis and extends along the bridging portion; d) the fabric membrane includes a second curvature about the second axis; e) the second curvature has a concavity opposite to the first curvature; f) the second curvature is configured to contact the patient's subnasal point during use; g) a third axis that extends transverse to the second axis and is inclined relative to the first axis; h) the fabric membrane includes a third curvature about the third axis; i) the third curvature is configured to contact the patient's upper lip during use; j) a fourth axis extends transverse to the second axis and the third axis and is parallel to the first axis; k) the fabric membrane includes a fourth curvature about the fourth axis; l) the fourth curvature includes a variable radius of curvature; and / or m) the fourth curvature extends into the main curvature of the edge of the fabric membrane.

[0173] In some aspects, a) a portion of the first hole away from the bridging portion is movable between a first position and a second position; b) the first position is a natural state, and the fabric membrane is moved to the second position due to an external force; c) the portion of the first hole extends into the inflatable chamber in the second position; d) the first hole includes a roughly teardrop shape in the second position; e) in the second position, the first hole is configured to contact the periphery of the inlet, which is close to the edge of one of the patient's nostrils; f) the portion of the second hole away from the bridging portion is movable between the first position and the second position; g) the patient's nose and upper lip are configured to contact only the fabric membrane during use; and / or h) the patient interface is a nasal pad, a nose pad, a mouth-nose pad, an ultra-compact full-face mask, or a full-face mask.

[0174] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the entrance including at least the entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising:

[0175] a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0176] A seal forming structure having:

[0177] a resilient membrane constructed and arranged to form a pressure-assisted seal with a region of the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, the resilient membrane having a first aperture and a second aperture and a bridging portion disposed between the first aperture and the second aperture, the first aperture and the second aperture formed therein such that a flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nostril, the seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle, and

[0178] a flexible support structure for maintaining the fabric membrane in a predetermined shape;

[0179] in:

[0180] The elastic membrane is molded to the flexible support structure in a relaxed state, and

[0181] The bridge portion is molded at a greater tension than the remainder of the elastic membrane.

[0182] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air to a patient's nares and a patient's mouth at a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure, when in use, within a range of about 4 cm HO to about 30 cm HO above the ambient air pressure used throughout the patient's breathing cycle while the patient is sleeping to improve sleep-disordered breathing; the patient interface comprising:

[0183] a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0184] A seal-forming structure comprising a resilient membrane constructed and arranged to form a pressure-assisted seal with an area of ​​a patient's face surrounding an entrance to the patient's nostrils and an entrance to the patient's mouth, the seal structure comprising:

[0185] a nose portion configured to at least partially surround an entrance to a patient's nostril, and

[0186] an oral portion configured to at least partially surround an entrance to the patient's mouth,

[0187] wherein the elastic membrane has at least one aperture such that a flow of air at the therapeutic pressure is delivered to at least the entrance of the patient's nostrils and / or the entrance of the patient's mouth, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's breathing cycle, in use,

[0188] The elastic membrane includes a first portion maintained in a relaxed state and a second portion maintained in a tensioned state, the tensioned state of the second portion being configured to allow the seal-forming structure to include a three-dimensional shape having multiple curvatures.

[0189] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an inlet of a patient's airway, the inlet including at least an inlet of the patient's nares, wherein the patient interface is configured to, in use, maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing; the patient interface comprising:

[0190] a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0191] A seal forming structure having:

[0192] a resilient membrane constructed and arranged to form a pressure-assisted seal with a region of the patient's face below the nasal bridge region of the patient's face around the entrance to the patient's airway, the resilient membrane having at least one aperture such that a flow of air at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle,

[0193] wherein the elastic membrane comprises a three-dimensional shape having a plurality of curvatures;

[0194] The at least one hole comprises an arch on a lateral side of the at least one hole, the arch being in a relaxed state before use, and the arch being configured to move to a substantially taut state during use.

[0195] In some aspects, a) the elastic membrane comprises a first layer and a second layer coupled to the first layer; b) the first layer is coupled to the second layer with an adhesive; c) the first layer is substantially uniform and the second layer is formed from a non-uniform matrix structure configured to render the elastic membrane anisotropic; and / or d) the second layer is formed from a plurality of spaced-apart spherical or cylindrical structures.

[0196] In some aspects, a) the at least one opening is partially arranged in a common plane as a bridging portion configured to contact the nasal bridge region of the patient; or b) the at least one opening is partially arranged completely out of plane, with a bridging portion configured to contact the nasal bridge region of the patient.

[0197] In some aspects, a) the at least one aperture comprises: a nostril opening configured to be positioned adjacent to a nostril of the patient; and an oral portion aperture configured to be positioned adjacent to the patient's mouth in use; b) the bridge portion extends across the nostril opening and divides the nostril opening into a first aperture and a second aperture, each of the first aperture and the second aperture being configured to be adjacent to one of the patient's nostrils in use; and / or c) the bridge portion is the second portion and is maintained in a taut state.

[0198] In some aspects, a) the first portion at least partially includes an oral portion; b) the first portion includes the oral portion and a section of the nose; c) the seal-forming structure also includes a flexible support structure for maintaining the elastic membrane in a three-dimensional shape; d) the flexible support structure includes at least one support rib that engages with the oral portion within the inflatable chamber cavity; e) the flexible support structure also includes a second rib disposed within the cavity, the support rib extending between the second rib and the oral portion; f) the oral portion is bent about at least two non-parallel axes; and / or g) the elastic membrane includes a silicone layer having an impermeable property.

[0199] In some aspects, a) the seal-forming structure is formed of a resilient membrane having a first segment and a second segment spaced apart from the first segment; b) the seal-forming structure further comprises a flexible support portion formed of a material other than the resilient membrane, the flexible support portion being formed of a greater thickness than the resilient membrane, the flexible support portion being disposed between the first segment and the second segment; c) in use, the second segment is positioned higher than the first segment; d) the second segment is at least partially disposed between ends of the first segment; e) at least one aperture comprises a nostril opening configured to be positioned adjacent to a patient's nostril and a nostril opening configured to be positioned adjacent to a patient's nostril. an oral cavity portion aperture positioned proximate to the patient's mouth, wherein the first segment completely forms a perimeter of the oral cavity portion aperture; and the second segment completely forms a perimeter of a nostril opening; f) at least one aperture includes a nostril opening configured to be positioned adjacent to the patient's nostril, and an oral cavity portion aperture configured to be positioned adjacent to the patient's mouth, wherein the second segment completely forms a perimeter of the nostril opening; and the perimeter of the oral cavity portion aperture is at least partially formed by a combination of the first segment and the second segment; g) the first segment forms at least a portion of the oral cavity portion and includes a ring shape; and / or h) the second segment constitutes at least a portion of the oral cavity portion and includes a U-shape.

[0200] In some aspects, a) the length of the bridging portion is directly related to the size of the first hole and the size of the second hole; b) the seal-forming structure includes a single wall; c) one end of the flexible support structure contacts the elastic membrane; d) the seal-forming structure includes a pair of walls; e) the flexible support structure includes a free end, and the elastic membrane is connected to the flexible support structure at the distal end of the free end; and / or f) the free end is spaced apart from the elastic membrane so that the elastic fabric membrane is arranged radially outside the free end.

[0201] In some aspects, a) the flexible support structure is coupled to the elastic membrane using injection molding; and / or b) the elastic membrane is about (or between about) 20 microns to about (approximately) 100 microns thick.

[0202] In some aspects, a) the elastic membrane includes a first curvature about a first axis intersecting the first and second openings; b) a second axis transverse to the first axis and extending along the bridge portion; c) the elastic membrane includes a second curvature about the second axis; d) the second axis is offset relative to the first axis; e) the elastic membrane includes a second curvature about the second axis; f) in use, the second curvature is configured to contact an upper lip of a patient; g) a third axis transverse to the second axis and extending parallel to the first axis, the elastic membrane including a third curvature about the third axis; h) the third curvature includes a variable radius of curvature; and / or i) the third curvature extends into the main curvature proximate an edge of the elastic membrane.

[0203] In some aspects, a) a portion of the first aperture away from the bridging portion is movable between a first position and a second position; b) the first position is a natural state, and the elastic membrane is moved to the second position due to an external force; c) a portion of the first aperture extends into the plenum chamber in the second position; d) the first aperture comprises a generally teardrop shape in the second position; e) in the second position, the first aperture is configured to contact the periphery of the entrance of one of the patient's nostrils, near the alar rim; f) a portion of the second aperture away from the bridging portion is movable between the first position and the second position; g) the first aperture is further movable to a third position due to additional external force; and / or h) the generally sharp corners of the teardrop-shaped first aperture are extended and rounded in the third position.

[0204] In certain aspects, the patient interface is a nasal cushion, a nasal support, an oronasal cushion, an ultra-compact full face mask, or a full face mask.

[0205] In some aspects, a) the at least one aperture includes an arch on a lateral side of the at least one aperture; b) the arch is a saddle-shaped region; c) the arch is in a relaxed state prior to use; d) the arch is configured to invert into the cavity after contact with the patient's nostril; e) the arch remains in the relaxed state after being inverted into the cavity; f) the arch has a teardrop shape after being inverted into the cavity; g) during use, corners of the teardrop shape extend into a rounded shape; and / or h) the rounded shape is generally taut.

[0206] In some aspects, a) the elastic membrane includes curling to selectively apply local tension; b) the elastic membrane includes a fabric layer coupled to a silicone layer; c) the fabric layer is configured to be cut from a sheet of material using ultrasonic cutting; d) the fabric layer is a breathable material and is configured to allow air flow through and contact the patient's skin to provide cooling and / or moisture wicking; e) the elastic membrane forming the periphery of the at least one aperture forms a saddle-shaped area in a relaxed state; f) the elastic membrane forming the periphery of the at least one aperture forms a saddle-shaped area in a taut state; and / or g) the orientation of the saddle-shaped area in the relaxed state is substantially the same as the orientation of the saddle-shaped area in the taut state.

[0207] In some forms, a) the elastic membrane forms a perimeter proximate to the at least one hole, the perimeter forming a dome region or a saddle region in a non-use state of the patient interface; b) the elastic membrane forming the perimeter of the at least one hole forms the saddle region in the non-use state; c) the elastic membrane forms a perimeter proximate to the at least one hole, the at least one hole forming a dome region or a saddle region in the operative state of the patient interface; d) the elastic membrane forming the perimeter of the at least one hole forms the saddle region in the operative state; and / or e) the orientation of the saddle region in the non-use state is substantially the same as the orientation of the saddle region in the operative state.

[0208] In some forms, a) the arch of the first hole is movable between a first position and a second position; b) the first position is a natural state; c) the elastic membrane is moved to the second position due to an external force; d) the arch of the first hole extends into the inflatable chamber in the second position; e) the first hole includes a generally teardrop shape in the second position; f) due to additional external force, the arch of the first hole is further movable to a third position; g) the corners of the generally teardrop shape extend to a generally circular periphery in the third position; h) in the second position, the first hole is configured to contact the periphery of the entrance, which is proximate to the rim of one of the patient's nostrils; i) the arch of the second hole is movable between a first position and a second position; j) before contacting the patient's face, the first hole includes a generally teardrop shape in the first position; and / or k) when in use, the corners of the generally teardrop shape extend to a generally circular periphery in the second position.

[0209] In some forms, a) the elastic membrane includes a silicone layer having impermeable properties; b) the elastic membrane includes a fabric layer coupled to the silicone layer; c) the fabric layer is configured to be cut from a sheet of material using ultrasonic cutting; d) the fabric layer is configured to allow air flow through to provide cooling and / or moisture wicking to the patient; e) the silicone layer includes a first sublayer and a second sublayer; f) the first sublayer is substantially uniform and the second sublayer is non-uniform; and / or g) the second sublayer is formed from a plurality of spaced-apart structures configured to provide anisotropic properties to the elastic membrane.

[0210] Some forms include a method of constructing a patient interface, the method comprising:

[0211] providing a mold having a shape corresponding to any of the above-described forms of elastic membrane;

[0212] introducing a liquid material into the mold to form the three-dimensional shape of the elastic membrane; and

[0213] The mold is separated.

[0214] In some forms, the method further comprises applying a fabric layer to at least a portion of the elastic membrane after separating the mold.

[0215] In some forms, the method further includes providing a sheet of fabric material and cutting the sheet of fabric material into a shape corresponding to the elastic membrane using ultrasonic cutting to form the fabric layer.

[0216] In some forms, the method further comprises curling the bridge portion of the elastic film after applying the fabric layer to form the fabric layer in a three-dimensional shape that generally corresponds to the shape of the elastic film.

[0217] In another aspect of the present invention, a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the patient's airway including at least the entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising:

[0218] a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0219] a seal-forming structure having a resilient 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 resilient membrane having a first aperture and a second aperture and a bridging portion disposed between the first aperture and the second aperture, the first aperture and the second aperture formed therein such that a flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nostril, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle,

[0220] in:

[0221] the elastic membrane being molded to the flexible support structure of the seal-forming structure in a predetermined curved shape, the elastic membrane including a first curvature about a first axis and a second curvature about a second axis generally transverse to the first axis, the first axis being configured generally transverse to a sagittal plane of the patient's head such that the first curvature includes an apex in a posterior direction such that the first curvature passes about the nasolabial groove of the patient's nose, and the second axis being configured generally parallel to the sagittal plane such that the second curvature includes an apex in an inferior direction such that the second curvature is a saddle-shaped region and has a generally positive curvature relative to the patient's upper lip in use,

[0222] The bridge portion has a third curvature opposite to the first curvature,

[0223] The elastic membrane is molded to the flexible support structure in a relaxed state,

[0224] In use, the elastic membrane is configured to press against the patient's face so that the patient's nose is not received in the cavity, and the elastic membrane is attached to the flexible support structure along the periphery of the fabric membrane so that the elastic fabric membrane extends radially inward beyond the support structure.

[0225] In some aspects, the elastic membrane is substantially air impermeable.

[0226] In some aspects, the elastic membrane includes a silicone layer and / or a TPE layer having impermeable properties.

[0227] In some aspects, the silicone layer and / or TPE layer is about (or between about) 0.25 mm to about (or about) 0.3 mm thick.

[0228] In some aspects, the silicone layer and / or the TPE layer has low durometer properties.

[0229] In some aspects, the seal-forming structure comprises a single wall, and wherein one end of the flexible support structure contacts the elastic membrane.

[0230] In some aspects, the seal formation includes a pair of walls, wherein the flexible support structure includes a free end, and the elastic membrane is connected to the flexible support structure distal to the free end, and wherein the free end is spaced apart from the elastic membrane such that the elastic membrane is arranged radially outside the free end.

[0231] In some aspects, the first aperture includes a first arched portion generally having a first curvature, and the first arched portion is configured to be positioned within a first nostril of the patient.

[0232] In some aspects, the first arched portion is configured to flip from having generally the first curvature to having generally the third curvature after being positioned within a first nostril of the patient, the arched portion being configured to wrap around a perimeter of an entrance of the first nostril.

[0233] In some aspects, the second aperture includes a second arched portion generally having a first curvature, and the second arched portion is configured to be positioned within a second nostril of the patient.

[0234] In some aspects, the first aperture comprises a generally circular shape and is configured to comprise a generally teardrop shape upon contact with the patient's face.

[0235] In some aspects, the flexible support is coupled to the elastic membrane using injection molding.

[0236] In some aspects, the elastic membrane includes a fourth curvature about a fourth axis, the fourth curvature being generally a saddle-shaped region having a positive curvature relative to a subnasal point of the patient in use, and the fourth axis being generally transverse to the first and second axes.

[0237] In some aspects, the area affected by the second curvature is formed by a generally rectangular area surrounding the first and second apertures, the generally rectangular area having a generally tangential relationship with respect to the first and second apertures, wherein the generally tangential relationship limits a crease in the elastic membrane.

[0238] In another aspect of the present technology, a patient interface is provided for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an inlet of a patient's airway, the inlet including at least an inlet of the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing; the patient interface comprising:

[0239] a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0240] a seal-forming structure having a resilient 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 resilient membrane having a first aperture and a second aperture and a bridging portion disposed between the first aperture and the second aperture, the first aperture and the second aperture formed therein such that a flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nostril, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle,

[0241] in:

[0242] the elastic membrane being molded to the flexible support structure of the seal-forming structure in a predetermined curved shape, the elastic membrane including a first curvature about a first axis and a second curvature about a second axis generally transverse to the first axis, the first axis being configured generally transverse to a sagittal plane of the patient's head such that the first curvature includes an apex in a posterior direction such that the first curvature, in use, is generally a negative dome curvature relative to the patient's upper lip, and the second axis being configured generally parallel to the sagittal plane such that the second curvature includes an apex in an inferior direction such that the second curvature is generally a saddle-shaped region and, in use, is a positive curvature relative to the patient's forehead,

[0243] The bridge portion has a third curvature opposite to the first curvature,

[0244] The elastic membrane is molded to the flexible support structure in a relaxed state,

[0245] In use, the elastic membrane is configured to press against the patient's face so that the patient's nose is not received in the cavity, and the elastic fabric membrane is attached to the flexible support structure along the periphery of the elastic membrane so that the elastic membrane extends radially inward beyond the support structure.

[0246] In some aspects, the elastic membrane includes a fourth curvature about a fourth axis configured substantially parallel to the first axis such that the fourth curvature includes an apex in a posterior direction such that the fourth curvature passes around a nasolabial canal of the patient's nose.

[0247] In some aspects, the elastic membrane is substantially air impermeable.

[0248] In some aspects, the elastic membrane includes a silicone layer and / or a TPE layer having impermeable properties.

[0249] In some aspects, the silicone layer and / or TPE layer is about (or between about) 0.25 mm to about (or about) 0.3 mm thick.

[0250] In some aspects, the silicone layer and / or the TPE layer has low durometer properties.

[0251] In some aspects, the seal-forming structure comprises a single wall, and wherein one end of the flexible support structure contacts the elastic membrane.

[0252] In some aspects, the seal formation includes a pair of walls, wherein the flexible support structure includes a free end, and the elastic membrane is connected to the flexible support structure distal to the free end, and wherein the free end is spaced apart from the elastic membrane such that the elastic membrane is arranged radially outside the free end.

[0253] In some aspects, the first aperture includes a first arched portion generally having a first curvature, and the first arched portion is configured to be positioned within a first nostril of the patient.

[0254] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the entrance including at least the entrance to the patient's nares, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising:

[0255] a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0256] A seal forming structure having:

[0257] an elastic 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 elastic membrane having a portion, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the cavity throughout the patient's respiratory cycle,

[0258] The elastic membrane is kept in a tensioned state.

[0259] One form of the present technology includes a fabric seal-forming structure having a bridge portion between a first aperture and a second aperture, the entire resilient seal-forming structure being held in a taut state.

[0260] Another aspect of one form of the present technology is a seal-forming structure having an elastic membrane coupled to a flexible support structure under tension, with a bridging portion of the elastic membrane being generally flat due to the tension.

[0261] Another aspect of one form of the present technology is a seal-forming structure having an elastic membrane coupled to a flexible support structure in a taut condition prior to use, the elastic membrane having a generally flat surface in at least one direction in the taut condition prior to use.

[0262] In another aspect of the present invention, a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an airway entrance of a patient, including at least a narial entrance of the patient, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above the ambient air pressure used during the patient's breathing cycle while the patient is sleeping, to improve sleep-disordered breathing; the patient interface comprising:

[0263] a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0264] A seal-forming structure having a fabric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​a patient's face surrounding an entrance to the patient's airway below an area of ​​the nasal bridge of the patient's face, the fabric membrane having a first aperture and a second aperture, and a bridging portion disposed between the first aperture and the second aperture, the first aperture and the second aperture being formed therein such that a flow of air at the therapeutic pressure is delivered at least to the entrance of the patient's nostril, the seal-forming structure being constructed and arranged to, when in use, maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle,

[0265] in:

[0266] The seal-forming structure includes a flexible support structure to maintain a fabric membrane in a predetermined curved shape, the fabric membrane including a first curvature about a first axis and a second curvature about a second axis, the second curvature being generally transverse to the first axis, the first axis being configured generally transverse to a sagittal plane of the patient's head such that the first curvature includes an apex in a posterior direction such that the first curvature passes about a nasolabial groove of the patient's nose, and the second axis being configured generally parallel to the sagittal plane such that the second curvature includes an apex in an inferior direction such that, in use, the second curvature is a saddle-shaped region and has a generally positive curvature relative to an upper portion of the patient's lip.

[0267] The bridging portion has a third curvature opposite to the first curvature, the third curvature of the bridging portion limiting creases along the surface of the fabric membrane,

[0268] The fabric membrane is connected to a flexible support structure in a relaxed state.

[0269] In use, the fabric membrane is configured to be pressed against the patient's face so that the patient's nose is not received within the cavity; and

[0270] The fabric membrane may be attached to the flexible support structure along an outer periphery of the fabric membrane such that the fabric membrane extends radially inward beyond the support structure.

[0271] In some aspects, a) the bridge portion is crimped to maintain the third curvature and restrict rollover to the first curvature; and / or b) the bridge portion is crimped using ultrasonic welding and / or adhesives.

[0272] In some aspects, a) the fabric membrane is substantially impermeable to air; b) the fabric membrane includes a fabric layer and a silicone layer coupled to the fabric layer, the silicone layer having an impermeable property; c) the silicone layer is about (or between about) 20 microns and about (or about) 100 microns thick; and / or d) the silicone layer is disposed within the cavity and is configured not to contact the patient's skin when in use.

[0273] In some aspects, a) the silicone layer has low durometer properties; b) the fabric layer includes high stretchability when coupled to a support structure; and / or c) the fabric membrane has a thickness of about 0.6 mm to about 0.8 mm.

[0274] In some aspects, a) the seal-forming structure includes a single wall; b) one end of the flexible support structure contacts the fabric membrane; c) the seal-forming structure includes a pair of walls; d) the flexible support structure includes a free end, and the fabric membrane is connected to the flexible support structure at the distal end of the free end; and / or e) the free end is spaced apart from the fabric membrane so that the fabric membrane is arranged radially outside the free end.

[0275] In some aspects, a) the first aperture includes a first arched portion having generally the first curvature and being configured to be positioned within the patient's first nostril; b) the first arched portion is configured to flip from having generally the first curvature to having generally the third curvature after being positioned within the patient's first nostril; c) the arched portion is configured to wrap around a periphery of the entrance of the first nostril; d) the second aperture includes a second arched portion; e) the second arched portion has generally the first curvature; f) the second arched portion is configured to be positioned within the patient's second nostril; and / or g) the first aperture includes a generally circular shape and is configured to include a generally teardrop shape upon contacting the patient's face.

[0276] In some aspects, a) the fabric membrane is configured to contact only the patient's upper lip, subnasal point, and nasal protuberance when in use; b) the flexible support is coupled to the fabric membrane using injection molding; c) the fabric membrane includes a fourth curvature about a fourth axis; d) the fourth curvature is a generally saddle-shaped area having a positive curvature relative to the patient's subnasal point when in use; e) the fourth axis is generally transverse to the first axis and the second axis; f) the area affected by the second curvature is formed by a generally rectangular area surrounding the first aperture and the second aperture; g) the generally rectangular area has a generally tangential relationship relative to the first aperture and relative to the second aperture; h) the generally tangential relationship limits creases in the fabric membrane.

[0277] In another aspect of the present technology, a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an airway entrance of a patient including at least a nares of the patient, wherein the patient interface is configured to maintain a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above the ambient air pressure used throughout the patient's breathing cycle while the patient is sleeping to improve sleep-disordered breathing; the patient interface comprising:

[0278] a plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0279] A seal-forming structure having a fabric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​a patient's face surrounding an entrance to the patient's airway below an area of ​​the nasal bridge of the patient's face, the fabric membrane having a first aperture and a second aperture, and a bridging portion disposed between the first aperture and the second aperture, the first aperture and the second aperture being formed therein such that a flow of air at the therapeutic pressure is delivered at least to the entrance of the patient's nostril, the seal-forming structure being constructed and arranged to, when in use, maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle,

[0280] in:

[0281] The seal-forming structure includes a flexible support structure to maintain the fabric membrane in a predetermined curved shape, the fabric membrane including a first curvature about a first axis and a second curvature about a second axis, the second curvature being generally transverse to the first axis, the first axis being configured generally transverse to a sagittal plane of the patient's head such that the first curvature includes an apex in a posterior direction such that, in use, the first curvature has a generally negative dome curvature relative to an upper portion of the patient's lip, and the second axis of curvature being configured generally parallel to the sagittal plane such that the second curvature includes an apex in an inferior direction such that, in use, the second curvature has a generally saddle-shaped region and a positive curvature relative to a nasal protuberance of the patient,

[0282] The bridging portion has a third curvature opposite to the first curvature, the third curvature of the bridging portion limiting creases along the surface of the fabric membrane,

[0283] The fabric membrane is connected to a flexible support structure in a relaxed state.

[0284] In use, the fabric membrane is configured to be pressed against the patient's face so that the patient's nose is not received within the cavity, and

[0285] The fabric membrane is attached to the flexible support structure along an outer periphery of the fabric membrane such that the fabric membrane extends radially inward beyond the support structure.

[0286] In some aspects, a) the fabric membrane includes a fourth curvature about a fourth first axis, the fourth curvature being configured substantially parallel to the first axis such that the fourth curvature includes an apex in a posterior direction such that the fourth curvature passes around the nasolabial groove of the patient's nose; b) the bridging portion is curled to maintain the third curvature and limit flipping to the first curvature; and / or c) the bridging portion is curled using ultrasonic welding and / or adhesive.

[0287] In some aspects, a) the fabric membrane is substantially air-impermeable; b) the fabric membrane comprises a fabric layer and a silicone layer coupled to the fabric layer, the silicone layer having an impermeable property; c) the silicone layer is about (or between about) 20 microns and about (or about) 100 microns thick; d) the silicone layer is disposed within the cavity and is configured not to contact the patient's skin when in use.

[0288] In some aspects, a) the silicone layer has a low hardness property; b) the fabric layer includes a high stretchability when coupled to the support structure; c) the fabric membrane has a thickness of approximately 0.6 mm to approximately 0.8 mm; d) the seal forming structure includes a single wall, and wherein one end of the flexible support structure contacts the fabric membrane; e) the seal forming structure includes a pair of walls; f) the flexible support structure includes a free end, and the fabric membrane is coupled to the flexible support structure distally of the free end; and / or g) the free end is spaced apart from the fabric membrane such that the fabric membrane is radially arranged outside the free end.

[0289] In some aspects, a) the first aperture includes a first arcuate portion; b) the first arcuate portion generally has a first curvature; and / or c) the first arcuate portion is configured to be positioned within a first nostril of the patient.

[0290] In one aspect of the present technology, a seal-forming structure has:

[0291] a fabric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​a patient's face surrounding an entrance to the patient's airway below an area of ​​the nasal bridge of the patient's face, the fabric membrane having a first aperture and a second aperture, and a bridging portion disposed between the first aperture and the second aperture, the first aperture and the second aperture being formed therein such that a 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, in use, maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle, and

[0292] a flexible support structure for holding the fabric membrane in a predetermined shape;

[0293] in:

[0294] The fabric membrane is coupled to a flexible support structure in a relaxed state, and

[0295] The bridging portion is crimped and thereby held under greater tension than the remainder of the fabric membrane.

[0296] Another aspect of the present technology is a fabric membrane for use as a seal-forming structure in a patient interface, the fabric membrane configured to provide sealed delivery of an air flow at a continuously positive pressure relative to ambient air pressure to an entrance to a patient's airway, the patient's airway including at least an entrance to the patient's nares, wherein the patient interface is configured to maintain, in use, a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is asleep, to improve sleep-disordered breathing; the fabric membrane comprising:

[0297] fabric material;

[0298] an elastic material connected to the fabric material, the elastic material forming an air-impermeable layer;

[0299] Wherein at least the perimeter of the textile material is formed using ultrasonic cutting.

[0300] Another aspect of the present technology is a fabric membrane for use as a seal-forming structure in a patient interface, the fabric membrane configured to provide sealed delivery of an air flow at a continuously positive pressure relative to ambient air pressure to an entrance to a patient's airway, the patient's airway including at least an entrance to the patient's nares, wherein the patient interface is configured to maintain, in use, a therapeutic pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is asleep, to improve sleep-disordered breathing; the fabric membrane comprising:

[0301] a fabric material configured to contact the patient's skin;

[0302] an elastic material coupled to the fabric material, the elastic material being configured to form a surface of a pressurized volume of the patient interface;

[0303] wherein the elastic material is configured as an air impermeable layer, and wherein the fabric material is configured to allow air flow therethrough.

[0304] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an inlet of a patient's airway, the inlet including at least an inlet of the patient's nares, wherein the patient interface is configured to, in use, maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing; the patient interface comprising:

[0305] a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; and

[0306] A seal forming structure having:

[0307] a fabric membrane constructed and arranged to form a pressure-assisted seal with a region of the patient's face below the nasal bridge region of the patient's face around the entrance to the patient's airway, the fabric membrane having at least one aperture such that a flow of air at the therapeutic 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 therapeutic pressure in the cavity throughout the patient's breathing cycle, the fabric membrane comprising:

[0308] a first layer constructed of a fabric material and configured to contact the patient's face,

[0309] a second layer connected to the first layer, the second layer being constructed of an elastic material and forming a wall of the cavity;

[0310] wherein the fabric membrane comprises a three-dimensional shape having a plurality of curvatures;

[0311] wherein the elastic material of the second layer is configured to block air flow; and

[0312] Wherein the fabric material is configured to allow air flow to pass therethrough and provide a cooling effect to the patient's skin contacting the first layer.

[0313] In some aspects, a) at least the fabric material of the fabric membrane is cut from the sheet of material using ultrasonic cutting; b) the entire fabric membrane is cut from the sheet of material using ultrasonic cutting; and / or c) the periphery of the first layer is constructed to be substantially free of wear due to ultrasonic cutting.

[0314] In some aspects, a) the second layer is an airtight layer; b) the first layer is a airtight layer; c) the first layer is exposed at least a portion of the periphery of the at least one hole in the fabric membrane; d) the first layer is configured to receive a portion of the air flow that exits the plenum through the at least one hole in the fabric membrane; e) the first layer is configured to be positioned between the patient's skin and the second layer; f) the first layer is configured to cause the air flow to bounce between the patient's skin and the second layer; and / or g) the first layer is configured to allow moisture on the patient's skin to be wicked away due to air flowing through the first layer.

[0315] In some aspects, a) the second layer is about (or between about) 20 microns and about (or about) 100 microns thick; b) the first layer is about (or between about) 0.6 mm to about (or about) 0.8 mm thick; c) the fabric membrane includes a first portion maintained in a relaxed state and a second portion maintained in a taut state; d) the taut state of the second portion is configured to allow the seal-forming structure to include a three-dimensional shape having multiple curvatures; e) the second portion is a bridging portion between a first hole and a second hole formed in the at least one hole of the elastic membrane; and / or f) the bridging portion is curled.

[0316] In some aspects, a) the at least one aperture includes an arch on a lateral side of the at least one aperture; b) the arch is in a relaxed state prior to use; c) the arch is configured to move to a substantially taut state during use; and / or d) the patient interface is a nasal pad, a nose pad, an oronasal pad, an ultra-compact full-face mask, or a full-face mask.

[0317] In some aspects, a) the second layer includes a first sublayer and a second sublayer coupled to the first sublayer; b) the first sublayer is coupled to the second sublayer with an adhesive; c) the first sublayer is substantially uniform and the second sublayer is formed from a non-uniform matrix structure configured to render the elastic material anisotropic; and / or d) the second sublayer is formed from a plurality of spaced-apart spherical or cylindrical structures.

[0318] In some aspects, a) the first sublayer has a thickness of about (or between about) 0.01 mm and about (or about) 0.05 mm; b) the second sublayer has a thickness approximately equal to the thickness of the first sublayer; c) the second sublayer has a thickness less than the thickness of the first sublayer; d) the first sublayer has a porosity of about (or approximately) 30 gsm to about (or approximately) 50 gsm; and / or e) the second sublayer has a lower porosity than the first sublayer.

[0319] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed to have a perimeter shape that complements the anatomy of the intended wearer.

[0320] One aspect of one form of the present technology is a method of manufacturing a device.

[0321] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, a person with limited dexterity, limited vision, or a person with limited experience using this type of medical device.

[0322]

[0011] An aspect of one form of the present technology is a portable RPT device that can be carried by a person, such as around the person's home.

[0323] An aspect of one form of the present technology is a patient interface that can be rinsed in a patient's home (e.g., in soapy water) without the need for specialized cleaning equipment. An aspect of one form of the present technology is a humidifier canister that can be rinsed in a patient's home (e.g., in soapy water) without the need for specialized cleaning equipment.

[0324] One aspect of one form of the present technology is a method of constructing a patient interface, the method comprising: providing a mold having a three-dimensional shape; introducing a liquid material into the mold to form an elastic membrane having the three-dimensional shape; and separating the mold.

[0325] Some aspects further include applying a fabric layer to at least a portion of the elastic membrane after separating the mold.

[0326] Some aspects further include curling the bridge portion of the elastic film after applying the fabric layer to form the fabric layer in a three-dimensional shape that generally corresponds to the shape of the elastic film.

[0327] The described methods, systems, devices, and apparatus can be implemented to improve the functionality of a processor, such as a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. Furthermore, the described methods, systems, devices, and apparatus can provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0328] Of course, a part of these aspects may form a sub-aspect of the present technology. Moreover, each aspect of the sub-aspects and / or aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0329] Other features of the technology will become apparent upon consideration of the information contained in the following detailed description, abstract, drawings, and claims. 4 Description of the accompanying drawings

[0331] 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:

[0332] 4.1 Respiratory therapy system

[0333] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows and receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient is sleeping in a supine position.

[0334] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0335] Figure 1C A 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 at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. The patient is sleeping on his side.

[0336] 4.2 Respiratory system and facial anatomy

[0337] Figure 2A Shown is a schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0338] Figure 2B A view of the human upper airway is shown, including the nasal cavity, 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.

[0339] Figure 2C It is a frontal view of the face with several surface anatomical features identified, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal ala, nasolabial folds, and corners of the mouth. The directions of superior, inferior, radially inward, and radially outward are also indicated.

[0340] Figure 2DA side view of the head with several surface anatomical features identified, including the glabella, nasal bridge, nasal prominence, subnasal point, upper lip, lower lip, supramental point, nasal ridge, apex of the nose, and upper and lower ear bases. The superior-inferior and anterior-posterior directions are also indicated.

[0341] Figure 2E This is another lateral view of the head. The Frankfort horizontal plane and the approximate location of the nasolabial angle are indicated. The coronal plane is also indicated.

[0342] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, inferior nasal point, columella, pronasal point, long axis of the nostrils, and midsagittal plane.

[0343] Figure 2G A side view of the nasal surface features is shown.

[0344] 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 bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0345] Figure 2I The medial anatomy of the nose is shown approximately a few millimeters from the midsagittal plane, showing, among other things, the septal cartilage and the medial crus of the greater alar cartilage.

[0346] Figure 2J Shown is a frontal view of the skull, including the frontal, nasal, and zygomatic bones. The nasal turbinates, as well as the maxilla and mandible, are also labeled.

[0347] Figure 2K A side view of the skull is shown, showing the outline of the head surface and several muscles. The following bones are shown: the frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also labeled. The following muscles are shown: the digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0348] Figure 2L An anterolateral view of the nose is shown.

[0349] 4.3 Patient Interface

[0350] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0351] 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 when compared to Figure 3C The curvature magnitude shown is relatively large in comparison.

[0352] 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 when compared to Figure 3B The curvature magnitude shown is of relatively small magnitude in comparison.

[0353] Figure 3D A schematic diagram of a cross section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0354] 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 when compared to Figure 3F The curvature magnitude shown is of relatively small magnitude in comparison.

[0355] 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 when compared to Figure 3E The curvature magnitude shown is relatively large in comparison.

[0356] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0357] Figure 3H A cushion for a face mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle areas and one dome area are indicated.

[0358] Figure 3I A surface of a structure is shown with a one-dimensional hole in the surface. The plane curve shown forms the boundary of the one-dimensional hole.

[0359] Figure 3J Shown through Figure 3I The surface shown is in the cross section of the structure. Figure 3I Two-dimensional pores are defined in the structure.

[0360] Figure 3K Shown Figure 3I A perspective view of a structure comprising two-dimensional holes and one-dimensional holes is also shown. Figure 3I The surface defining the two-dimensional pores in the structure.

[0361] Figure 3L A mask with an inflatable bladder as a cushion is shown.

[0362] Figure 3M Shown through Figure 3L A cross-section of a mask with the inner surface of the airbag shown. The inner surface defines a two-dimensional hole in the mask.

[0363] Figure 3N Shown through Figure 3L Another cross section of a mask. The inner surface is also indicated.

[0364] Figure 3O The left-hand rule is shown.

[0365] Figure 3P The right-hand rule is shown.

[0366] Figure 3Q The left ear is shown including the left ear helix.

[0367] Figure 3R The right ear including the right ear helix is ​​shown.

[0368] Figure 3S A right-hand helix is ​​shown.

[0369] Figure 3T Shown are views of a mask including symbols for the twisting of the spatial curve defined by the edge of the sealing membrane in different areas of the mask.

[0370] Figure 3U A view of the plenum chamber 3200 is shown, illustrating the sagittal plane and the medial contact plane.

[0371] Figure 3V Shown Figure 3U View of the rear of the plenum chamber. The view is perpendicular to the median contact plane. Figure 3V The mid-sagittal plane divides the air chamber into left and right sides.

[0372] Figure 3W Shown through Figure 3V The cross section of the gas-filled chamber is Figure 3V The 'mid-contact' plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The direction of the mid-contact plane corresponds to the direction of chord 3210, which lies in the sagittal plane and just contacts the lining of the plenum chamber at two points in the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the lining in this area, the mid-contact plane may be tangent at both the upper and lower points.

[0373] Figure 3X Shown Figure 3UThe inflatable chamber 3200 is in the use position on the face. When the inflatable chamber 3200 is in the use position, the sagittal plane of the inflatable chamber generally coincides with the mid-sagittal plane of the face. When the inflatable chamber is in the use position, the median contact plane generally corresponds to the 'facial plane'. Figure 3X In FIG, the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3220 is located approximately on the bridge of the nose, while the lower point 3230 is located on the upper part of the lip.

[0374] 4.4RPT device

[0375] Figure 4A One form of RPT device according to the present technology is shown.

[0376] Figure 4B is a schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. Upstream and downstream directions are indicated with reference to the blower and the patient interface. The blower is defined as upstream of the patient interface, and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any particular moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0377] 4.5 Respiratory waveform

[0378] Figure 5 A typical breathing waveform model of a person during sleep is shown.

[0379] 4.6 Patient interface based on current technology

[0380] Figure 6 is a perspective view of a patient interface according to an example of the present technology worn by a patient and illustrating force vectors when the patient is in an upright position.

[0381] Figure 6 -1 is based on Figure 6 A perspective view of the patient interface is shown, and the force vectors are shown when the patient is lying supine.

[0382] Figure 6 -2 is based on Figure 6 A perspective view of the patient interface is shown, and the force vectors are shown when the patient is lying on his side.

[0383] Figure 7 is a perspective view of another example patient interface worn by a patient in accordance with the present technology.

[0384] Figure 8 It is along Figure 7 A cross-sectional view of the positioning and stabilizing structure along line 8-8.

[0385] Figure 9 yes Figure 8An enlarged view of a portion of the positioning and stabilization structure.

[0386] Figure 10 yes Figure 8 An enlarged view of a portion of the positioning and stabilization structure.

[0387] Figure 11 Positioned on the patient's face Figure 6 Front view of the gasket assembly.

[0388] Figure 12 is a front perspective view of a cushion assembly according to an example of the present technology.

[0389] Figure 13 yes Figure 12 Front view of the gasket assembly.

[0390] Figure 14 yes Figure 12 A top perspective view of the gasket assembly.

[0391] Figure 15 yes Figure 12 A top view of the gasket assembly.

[0392] Figure 16 It is along Figure 12 Cross-section along midline 16-16.

[0393] Figure 17 It is along Figure 12 Sectional view along midline 17-17.

[0394] Figure 18 Is from Figure 16 Zoomed in details.

[0395] Figures 19 to 21 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.

[0396] Figure 22 is a perspective view of a patient interface according to another example of the present technology.

[0397] Figure 23 Worn by the patient Figure 22 A perspective view of the patient interface.

[0398] Figure 24 yes Figure 23 Side view of the patient interface.

[0399] Figure 25 yes Figure 23 Front perspective view of the patient interface.

[0400] Figure 26 is a front view of a cushion assembly of a patient interface according to an example of the present technology.

[0401] Figure 27 yes Figure 26 A top view of the gasket assembly.

[0402] Figure 28 yes Figure 26 Bottom view of the gasket assembly.

[0403] Figure 29 yes Figure 26 Front perspective view of the liner assembly.

[0404] Figure 30 yes Figure 26 Rear perspective view of the liner assembly.

[0405] Figure 31 yes Figure 26 A side perspective view of a gasket assembly.

[0406] Figure 32 yes Figure 26 A front perspective view of a cushion assembly showing the interior of the cushion assembly.

[0407] Figure 33 yes Figure 26 A front view of a liner assembly showing the interior of the liner assembly.

[0408] Figure 33-1 is a rear perspective view of a cushion assembly according to an example of the present technology.

[0409] Figure 33-2 is a rear perspective view of a cushion assembly according to an example of the present technology.

[0410] Figure 33-3 is a rear perspective view of a cushion assembly according to an example of the present technology, wherein the sealing portion is constructed from a single piece of fabric material.

[0411] Figure 33-4 yes Figure 33-3 A rear perspective view of the cushion assembly of , showing a more positive arch curvature of the sealing portion at a position configured to contact the upper lip of the patient.

[0412] Figure 33-5 yes Figure 33-4 A top view of the gasket assembly.

[0413] Figure 33-6 yes Figure 33-3 A side perspective view of the liner assembly showing the support ribs.

[0414] Figure 33-7 yes Figure 33-3 A side perspective view of the liner assembly showing the Figure 33-6 Compared to the larger support ribs.

[0415] Figure 33-8 yes Figure 33-3 A rear perspective view of a cushion assembly having thicker corners of the nose area to provide a narrower space to accommodate the patient's nose.

[0416] Figure 33-9 yes Figure 33-8 A top view of the gasket assembly.

[0417] Figure 33-10 yes Figure 33-3 A front view of the liner assembly, showing the Figure 24 The patient interface is elevated compared to the catheter connector portion.

[0418] Figure 33-11 yes Figure 33-3 A rear perspective view of a cushion assembly showing the foam inserts configured to contact the corners of the patient's nose area.

[0419] Figure 34 is with Figure 22 Rear view of the cushion assembly for use with a patient interface.

[0420] Figure 35 yes Figure 34 Front view of the gasket assembly.

[0421] Figure 36 Observed along line 36-36 Figure 34 A cross-sectional view of a gasket assembly.

[0422] Figures 37 to 39 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.

[0423] Figure 40 is a schematic diagram of a process for providing a fabric material with an air-impermeable layer according to an example of the present technology.

[0424] Figure 40-1 is a schematic diagram of a process of providing an air-impermeable layer to a fabric material according to another example of the present technology.

[0425] Figure 41 is a schematic diagram depicting presenting a patient's face with slight tension to the fabric membrane prior to use.

[0426] Figure 42 is a schematic diagram illustrating the resultant force exerted by the fabric membrane on the patient's face due to tensile stress in the fabric membrane.

[0427] Figure 43 is a schematic diagram of tension applied to a sealing portion of a gasket assembly according to an example of the present technology.

[0428] Figure 44 is a schematic diagram of the forces exerted by the fabric membrane on the patient's face due to the air pressure within the cavity formed by the cushion assembly.

[0429] Figure 45 and 46 Depicts the knitting process.

[0430] Figure 47 A warp knitted fabric according to an example of the present technology is shown.

[0431] Figure 48 A weft-knitted fabric according to an example of the present technology is shown.

[0432] Figure 49 is a perspective view of a fabric material bent or folded about a first axis.

[0433] Figure 50 is bent or folded about a first axis and a second axis Figure 49 The second axis is not parallel to the first axis, and bending or folding about the second axis creates creases and / or wrinkles in the fabric material.

[0434] Figure 51 A perspective view of a fabric material used as a seal-forming structure. The fabric material is bent or folded about three non-parallel axes and manipulated to limit the creation of creases and / or wrinkles.

[0435] Figure 52 yes Figure 49 A perspective view of a fabric material having a pair of openings cut into the material and a bridging portion located between the two openings.

[0436] Figure 53 yes Figure 52 A perspective view of a fabric material showing the bridging portion flipped about a second axis parallel to the first axis.

[0437] Figure 54 yes Figure 53 A perspective view of a fabric material showing a bridging portion under tension via a crimping process.

[0438] Figure 55 yes Figure 53 A perspective view of a fabric material being bent or folded about non-parallel axes. The folded bent or bridging portions limit the formation of creases and / or wrinkles in the fabric material.

[0439] Figure 56 yes Figure 55 Detailed view of a fabric material, showing the curvature about different axes.

[0440] Figure 57Ais a detail of the fabric material showing the perimeter of the opening, which can vary depending on the length of the bridge portion that is curled.

[0441] Figure 57B is a detailed view showing a fabric material around an opening according to another example.

[0442] Figure 57-1A is a detailed view of the elastic material showing the perimeter of the opening. The elastic material can be molded into a shape similar to the fabric material in Figure 57.

[0443] FIG57-1B is a detailed view showing an elastic material of a perimeter of an opening according to another example.

[0444] FIG57-1C is a detailed view showing an elastic material of a perimeter of an opening according to another example.

[0445] Figure 58 is Figure 54 A cross-sectional view of a cushion assembly formed of a fabric material. A flexible support structure is in contact with the fabric material to form a single wall.

[0446] Figure 58 -1 is used Figure 54 A cross-sectional view of an alternative embodiment of a cushion assembly formed of a fabric material. The fabric material includes an arcuate portion that partially surrounds an opening.

[0447] Figure 58 -2 is moved to the operating position Figure 58 -1 is a cross-sectional view of the gasket assembly.

[0448] Figure 59 is Figure 54 A portion of the flexible support structure is spaced apart from the fabric material to form two walls.

[0449] Figure 60 is Figure 54 A perspective view of a cushion assembly formed of a fabric material. The fabric material includes an arched portion that partially surrounds an opening.

[0450] Figure 60 -1 Yes Figure 60 A side perspective view of a cushion assembly showing the nostril openings oriented generally vertically.

[0451] Figure 61 yes Figure 60 A perspective view of a gasket assembly showing the arcuate portions turned inwardly such that the opening comprises a generally teardrop shape.

[0452] Figure 61 -1 Yes Figure 60A rear perspective view of the cushion assembly of , showing the arched portions of both nostril openings turned inwardly such that the openings comprise a generally torn shape.

[0453] Figure 61 -2 is Figure 60 A perspective view of a gasket assembly showing the arched portion expanding from a teardrop shape to form a circular perimeter.

[0454] Figure 62 is a perspective view of a gasket assembly formed from the resilient material of Figure 57-1. The resilient material includes an arcuate portion partially surrounding an opening.

[0455] Figure 62 -1 Yes Figure 62 A side perspective view of a cushion assembly showing the nostril openings oriented generally vertically.

[0456] Figure 63 yes Figure 62 A perspective view of a liner assembly is shown showing the arched portion turned inwardly such that the opening comprises a generally torn shape.

[0457] Figure 63 -1 Yes Figure 60 A rear perspective view of the cushion assembly of , showing the arched portions of both nostril openings turned inwardly such that the openings comprise a generally torn shape.

[0458] Figure 64 yes Figure 63 A perspective view of a gasket assembly showing the arched portion expanding from a teardrop shape to form a circular perimeter.

[0459] Figure 65 yes Figure 63 A perspective view of a cushion assembly showing the arched portions of both nostril openings expanding from a teardrop shape to form a circular perimeter.

[0460] Figure 66 It is wearable Figure 60 A perspective view of a patient with a cushion assembly, wherein the arch of the cushion assembly is shown in a first position.

[0461] Figure 67 The patient takes it off Figure 60 A perspective view of a cushion assembly showing the arch in the second position before returning to the first position.

[0462] Figure 68 Yes, I wore it Figure 60 Perspective view of a patient with a cushion assembly.

[0463] Figure 69 It is used for manufacturing Figure 62 Schematic diagram of the mold of the liner assembly.

[0464] Figure 70 is a schematic cross-sectional view of a seal-forming structure according to another example, showing a multi-layer impermeable portion coupled to a fabric material.

[0465] Figure 70 -1 is a schematic cross-sectional view of a seal-forming structure according to another example, showing the multi-layer impermeable portion without the fabric material.

[0466] Figure 71 yes Figure 70 A plan view of one layer of a multi-layer impermeable portion.

[0467] Figure 72 yes Figure 70 Plan view of the two floors of the multi-layer impermeable part.

[0468] Figure 73 is a schematic diagram of a patient wearing a pad assembly having a breathable and / or moisture-wicking fabric. 5. Specific Implementation Methods

[0470] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0471] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any of the examples, any single feature or combination of features may constitute another example.

[0472] 5.1 Treatment

[0473] In one form, the present technology comprises a method for treating a breathing disorder comprising applying positive pressure to an airway entrance of a patient 1000 .

[0474] In some examples of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0475] In some examples of the present technology, mouth breathing is restricted, limited, or prevented.

[0476] 5.2 Respiratory therapy system

[0477] In one form, the present technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0478] 5.3 Patient Interface

[0479] The 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 to the patient's airway so as to maintain a positive pressure at the entrance to the airway of the patient 1000. The sealed patient interface 3000 is thereby suitable for delivering positive pressure therapy.

[0480] If a patient interface is unable to comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0481] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide a supply of air at a positive pressure of at least 6 cmH20 relative to ambient.

[0482] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide a supply of air at a positive pressure of at least 10 cmH20 relative to ambient.

[0483] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide a supply of air at a positive pressure of at least 20 cmH20 relative to ambient.

[0484] 5.3.1 Sealing structure

[0485] 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—may vary from day to day during a given treatment session and from patient to patient, depending on a number of factors, including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0486] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0487] In some forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, such as silicone rubber.

[0488] The seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, elastic material such as silicone.

[0489] In some forms, such as Figures 6 to 39 In the illustrated form, the seal-forming structure 3100, 6100, 9100 has a sealing portion comprising a fabric material that may cover all or a portion of the seal-forming structure 3100, 6100, 9100. In some forms, the fabric may comprise a material formed from a network of fibers and adapted to be air-impermeable. For example, the fabric may have an air-impermeable membrane on at least one surface thereof, thereby forming a fabric membrane or a fabric sealing portion.

[0490] Although the following description relates to a seal-forming structure constructed at least partially of fabric, the description is equally applicable to a seal-forming structure constructed solely of elastic materials (e.g., silicone, TPE, etc.). The shapes and characteristics of the fabric seal-forming structure described below are all applicable to seal-forming structures constructed solely of elastic materials. Some similarities and differences may be specifically noted throughout this specification.

[0491] In some embodiments, the fabric membrane can be configured to elastically stretch in at least one dimension. For example, when the fabric membrane is formed from a fiber network, the fabric membrane can be stretched longitudinally and / or transversely across the entire fabric membrane. In some embodiments, the fabric membrane is configured to elastically stretch to a greater extent than can be achieved with conventional silicone seal-forming structures.

[0492] In some forms, the fabric membrane is constructed to be substantially inelastic in at least one dimension.For example, when the fabric membrane is composed of a woven fabric material, the fabric membrane can substantially resist elongation in either or both of the longitudinal warp and transverse weft directions on the fabric membrane.

[0493] The fabric membrane can comprise a single layer or multiple layers. In the form of utilizing multiple layers, the same material or various different materials each having unique material properties can be used to form each layer.

[0494] 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. Figure 40As shown, in some forms, the fabric membrane may include an airtight material 10131 (e.g., a silicone layer, a polyurethane coating, or a film) formed on one surface of a fabric material 10133. In some forms, the airtight material 10131 may be laminated to the fabric material 10133. In some forms, the airtight material 10131 and the fabric material 10133 may be selected so that the resulting fabric membrane 10135 exhibits a predetermined overall elasticity or elastic resistance as desired. In some forms, applying a force of about (or approximately) 2N to about (or approximately) 15N may result in about 50% of the maximum displacement of the fabric membrane 10135. In some forms, applying a force of about 5N to about 40N may result in about 100% of the maximum displacement of the fabric membrane 10135. The airtight material 10131 may also have a low hardness property so as not to interfere with the elasticity of the fabric material 10133. In other words, the fabric membrane 10135 will have an elasticity that is substantially the same as the elasticity that the fabric material 10133 alone has, such that the addition of the air-impermeable material 10131 will not substantially reduce the elasticity (or stretchability) of the fabric material 10133 .

[0495] The thickness of the air-impermeable material 10131 can be substantially less than the thickness of the fabric material 10133. For example, the thickness of the air-impermeable material 10131 can be about (or approximately) 1 micron to about (or approximately) 1 mm thick. In some forms, the thickness of the air-impermeable material can be about (or between about) 5 microns to about (or approximately) 0.5 mm thick. In some forms, the thickness of the air-impermeable material 10131 can be about (or between about) 20 microns to about (or approximately) 100 microns thick. This can help maintain a generally lightweight fabric membrane 10135, as the relatively small thickness of the air-impermeable material 10131 may not significantly increase the weight of the fabric material 10133. A patient interface having a fabric membrane 10135 including the air-impermeable material 10131 will not feel noticeably heavier than a patient interface including only the fabric material 10133.

[0496] In some examples, the thickness of the fabric material 10133 is between about (or about) 0.1 mm and about (or about) 2 mm. In some examples, the thickness of the fabric material 10133 is between about (or about) 0.25 mm and about (or about) 1 mm. In some examples, the thickness of the fabric material 10133 is between about (or about) 0.4 mm and about (or about) 0.9 mm. In some examples, the thickness of the fabric material 10133 is between about (or about) 0.6 mm and about (or about) 0.8 mm.

[0497] In some examples, the thickness of the air-impermeable membrane 10131 is about (or between about) 0.01 mm to about (or about) 0.10 mm. In some examples, the thickness of the air-impermeable membrane 10131 is about (or between about) 0.02 mm to about (or about) 0.8 mm. In some examples, the thickness of the air-impermeable membrane 10131 is about (or between about) 0.03 mm to about (or about) 0.7 mm. In some examples, the thickness of the air-impermeable membrane 10131 is about (or between about) 0.04 mm to about (or about) 0.6 mm. In some examples, the thickness of the air-impermeable membrane 10131 is about (or approximately) 0.05 mm. The air-impermeable membrane 10131 can be substantially thin, such that the thickness of the fabric membrane 10135 (e.g., the combined thickness of the air-impermeable membrane 10131 and the fabric material 10133) can be substantially similar to the thickness of the fabric material 10133.

[0498] In some forms, the fabric material 10133 can be formed as multiple layers of fabric. In some forms, the fabric material 10133 can be formed as multiple layers of fabric. The fabric material 10133 can be woven in a single process (e.g., using double jersey, double knit, and / or double jersey fabric). Figure 40-1 As shown, the fabric material 10133 can be composed of two layers (although any number of layers can be used). The second layer 10133b of the fabric material 10133 can be sandwiched between the first layer 10133a and the third layer 10133c. In the example shown, the second layer 10133b (i.e., the middle layer) is composed of spandex, and the first layer 10133a and the third layer 10133c (i.e., the inner and outer layers) are composed of nylon. However, other materials can be used without departing from the scope and spirit of these embodiments (e.g., the material can be any combination of spandex, nylon, and polyester). ). In addition, the first layer 10133a and the third layer 10133c can be formed of different materials (i.e., different materials).

[0499] In some forms, the overall composition of the fabric material 10133 can be at least 50% nylon and at most 50% spandex. In some forms, the overall composition of the fabric material 10133 can be between about (or about) 60% and about (or about) 90% nylon and between about (or about) 10% and about (or about) 40% spandex. In some forms, the overall composition of the fabric material 10133 can be between about (or about) 70% and about (or about) 85% nylon and between about (or about) 15% and about (or about) 30% spandex. In certain forms, the overall composition of the fabric material 10133 can be about (or about) 82% nylon and about (or about) 18% spandex.

[0500] In some embodiments, the layered structure can provide the fabric material 10133 with a spongy feel. In other words, the fabric material 10133 can be compliant and deform upon contact with the patient's face. Specifically, when force is applied, the thickness of the fabric material 10133 can decrease, and when the force is removed, the thickness of the fabric material 10133 can return to its original shape. Thus, the fabric material 10133 can act like a sponge because it can at least partially absorb the applied force. Specifically, the spandex layer 10133b of the fabric material 10133 can provide a spongy feel (e.g., due to its elastic properties). The spongy feel of the fabric material 10133 can help improve comfort against the patient's skin (e.g., because the fabric material 10133 can conform to a variety of facial contours). The spongy feel of the fabric material 10133 can also help improve the seal against the patient's face. In particular, due to the applied forces (e.g., via the positioning and stabilizing structure 3300), the fabric material 10133 may be able to deform into crevices on the patient's face (e.g., the area between the nose and the nasolabial grooves) without wrinkling and forming locations where air could leak. This can help the patient establish a seal between their skin and the fabric membrane 10135 without requiring the fabric membrane 10135 to contact the exact same location (e.g., this can make wearing the seal-forming structure 3100 easier). This can also allow the seal-forming structure 3100, 6100, 9100 to move and / or shift as it is worn without creating leaks, as the sponge-like properties help maintain the necessary contact with the patient's skin.

[0501] In some embodiments, the fabric material 10133 is coated (e.g., laminated) with an air-impermeable layer 10131 (e.g., liquid silicone rubber) to form a fabric membrane 10135 having impermeable properties. In the example shown, the air-impermeable layer 10131 is applied to a single side of the fabric material 10133. In other words, the air-impermeable layer 10131 may be applied to the first layer 10133a, but not to the second layer 10133b or the third layer 10133c. When the fabric membrane 10135 is configured to seal the structure 3100, 6100, or 9100, the first layer 10133a is configured to be positioned within the cavity 3101, 6001, or 9001, such that the third layer 10133c is configured to face and contact the patient.

[0502] In one form, the fabric material 10133 is formed from a finely knitted fabric. Specifically, the first layer 10133a and the third layer 10133c are constructed as a finely knitted fabric. This may be a fabric of less than about 100 denier. This may be a fabric of less than about 50 denier. This may be a fabric of about 20 denier. This may be a fabric of about 15 denier. The fine knit of the fabric, particularly in the third layer 10133c, provides a smooth feel against the patient's skin, which may promote patient compliance (e.g., due to increased comfort).

[0503] like Figure 70 As shown, the fabric membrane can include multiple layers that exhibit substantially air-impermeable properties while maintaining the material properties required to provide comfort and minimize pressure points on the patient. For example, the fabric membrane can include two air-impermeable layers 10131 (e.g., silicone layers, polyurethane coatings or films, etc.) formed on one surface of a fabric material 10133. In other examples not shown, any number of air-impermeable layers 10131 can be used. In some embodiments, the air-impermeable material 10131 can be attached to the fabric material 10133 using any number of methods (e.g., using an adhesive, using a laminate, etc.).

[0504] In some forms, the air-impermeable layer 10131 may be comprised of the same material. In other words, separate layers of the same material may be attached to one another to form multiple layers of air-impermeable material 10131. In certain forms, each layer of air-impermeable material 10131 may also have substantially the same shape. In other words, there may be no discernible differences between the different layers of air-impermeable material 10131.

[0505] In other forms, at least one layer of air-impermeable material 10131 may be different from the other layers. For example, Figure 71 and 72 A substantially solid and / or uniform first impermeable layer 10137 is shown, as well as an intermittent or discontinuous second impermeable layer 10139. The second layer 10139 can be formed from a plurality of structures 10140. The structures 10140 can be equally spaced (see, e.g., Figure 71 ), or they may be variably spaced (not shown). In the illustrated example, the second impermeable layer 10139 may be formed from a plurality of spaced-apart spherical or cylindrical structures 10140 (e.g., dots). In other examples (not shown), the structures 10140 may be formed from different shapes (e.g., having triangular, rectangular, elliptical, or other similar cross-sections). Other examples may include a second impermeable layer 10139 having structures 10140 having a variety of cross-sections (e.g., only a portion being circular).

[0506] In some forms, the first impermeable layer 10137 can have a substantially uniform distribution of pressure from the interior of the plenum 3200 (e.g., Figure 16 3101 in the cavity) to the second impermeable layer 10139 (e.g., in the Figure 70 and 70 -1). In some forms, the thickness of the first impermeable layer 10137 may be about (or between about) 0.0001 mm to about (or about) 10 mm. In some forms, the thickness of the first impermeable layer 10137 may be about (or between about) 0.001 mm to about (or about) 1 mm. In some forms, the thickness of the first impermeable layer 10137 may be about (or between about) 0.005 mm to about (or about) 0.1 mm. In some forms, the thickness of the first impermeable layer 10137 may be about (or between about) 0.01 mm to about (or about) 0.05 mm.

[0507] In some forms, the first impermeable layer 10137 may have a density of about (or between about) 0.1 grams per square meter (gsm) to about (or about) 1000 gsm. In some forms, the first impermeable layer 10137 may have a density of about (or between about) 1 gsm to about (or about) 100 gsm. In some forms, the first impermeable layer 10137 may have a density of about (or between about) 10 gsm to about (or about) 75 gsm. In some forms, the first impermeable layer 10137 may have a density of about (or between about) 30 gsm to about (or about) 50 gsm.

[0508] In some forms, each structure 10140 in the plurality of structures 10140 may have a width of approximately (or between approximately) 0.001 mm or approximately (or approximately) 10 mm (e.g., Figure 71 and 72 ). In some forms, each structure 10140 can be between about (or approximately) 0.005 mm and about (or approximately) 1 mm. In some forms, each structure 10140 can be between about (or approximately) 0.01 mm and about (or approximately) 0.5 mm.

[0509] In some forms, the spacing between each structure 10140 can be between about (or approximately) 0.001 mm and about (or approximately) 10 mm.

[0510] In some forms, the spacing between each structure 10140 may be between about (or approximately) 0.005 mm and about (or approximately) 1 mm. In some forms, the spacing between each structure 10140 may be between about (or approximately) 0.01 mm and about (or approximately) 0.5 mm.

[0511] In some forms, the second impermeable layer 10139 may have a lower density than the first impermeable layer 10137 due to discontinuities (eg, spacing) between the plurality of structures 10140 in the second layer 10139 .

[0512] like Figure 71 As shown, the rows of structures 10140 can be offset from one another. For example, the second air-impermeable layer 10139 can be formed from a varying (e.g., alternating) pattern of structures 10140 (although in other examples, the pattern need not alternate). The varying pattern can create different spacing between the structures 10140 (e.g., structures 10140 in adjacent rows can be closer together than adjacent structures 10140 in the same row). The varying pattern can provide the second air-impermeable layer with anisotropy. Figure 70 As shown, the cross section is non-uniform along the length of the fabric membrane 10135. The cross section along the other direction may also be non-uniform and may be different from the Figure 70 The cross-sections shown are not identical. The anisotropic fabric membrane 10135 can provide varying material properties along the length of the fabric membrane 10135. For example, the fabric membrane 10135 can have greater curvature in one direction and can be stiffer in another (e.g., perpendicular) direction. Alternatively or additionally, the fabric membrane 10135 can have curvature that varies along a single direction. For example, a length of the fabric membrane 10135 can be less bendable or flexible (i.e., stiffer) around its edges and more bendable or flexible around its center (or vice versa).

[0513] In certain embodiments, the shape of the structure 10140 can affect the flexibility of the fabric membrane 10135. For example, a similar pattern of circular shapes (e.g., similar to Figure 71 ) can be more flexible than angled shapes.

[0514] like Figure 72As shown, first and second air-impermeable layers 10137, 10139 (or any other number of layers in other examples) are joined together to form the air-impermeable material 10131. In the example shown, the second air-impermeable layer 10139 can be an adhesive layer. For example, an adhesive layer can be applied to a surface of the structure 10140. The adhesive can allow for bonding between the first and second air-impermeable layers 10137, 10139. The adhesive can also be applied to the opposite side of the structure 10140 (i.e., opposite the side secured to the first air-impermeable layer 10137). The adhesive on the opposite side can be used to couple the second air-impermeable layer 10137 to the fabric material 10133 (e.g., having any of the properties described). The fabric membrane 10135 can be formed with all three (or any other number) layers (i.e., the fabric material 10133, the first air-impermeable material 10137, and the second air-impermeable material 10139) at once.

[0515] like Figure 70 As shown in FIG. 1 , the air-impermeable material 10133 (e.g., first and second layers 10137, 10139) may not be attached to the textile material 10133 and may form an air-impermeable or elastic membrane on its own. The matrix construction of the second air-impermeable layer 10139 may still provide anisotropic properties. In this example, the first and second air-impermeable layers 10137, 10139 may be attached to the third impermeable layer 10141, such that the second air-impermeable layer 10139 remains as an intermediate layer. Alternatively, the air-impermeable material 10133, and therefore the air-impermeable membrane, may consist solely of the first and second air-impermeable layers 10137, 10139.

[0516] like Figure 73 As shown, the fabric material 10133 can be a breathable fabric. The breathable fabric material 10133 can allow air flow to reach the patient's skin to improve the patient's cooling comfort.

[0517] In some forms, the breathable fabric material 10133 may have a porosity sufficient to allow pressurized air to pass through to provide a cooling effect. In some forms, the porosity may be between about (or about) 0.01 L / min and about (or about) 10 L / min. In some forms, the porosity may be between about (or about) 0.05 L / min and about (or about) 8 L / min. In some forms, the porosity may be between about (or about) 0.1 L / min and about (or about) 5 L / min. In some forms, the porosity may be between about (or about) 0.5 L / min and about (or about) 2 L / min.

[0518] In some forms, the porosity can be achieved at a positive pressure of at least about 4 cmH2O, or at least about 6 cmH2O, or at least about 10 cmH2O, or at least about 20 cmH2O.

[0519] As described above, the fabric membrane 10135 can be composed of an air-impermeable material 10131 and a fabric material 10133. The air-impermeable material 10131 can face the cavity 3101. The air-impermeable material 10131 can block pressurized air from exiting the cavity 3101 and direct the pressurized air back into the cavity 3101. This can create a sealing portion 3130 that seals the cushion assembly 3105 against the patient's face.

[0520] The fabric material 10133 may not be impermeable and may allow pressurized air to flow through the material. Because the fabric material 10133 is coated with the air-impermeable material 10131, the pressurized air generally does not come into contact with the fabric material 10133 and cannot escape the cavity 3101. In other words, the back wall of the cavity 3101 may be at least partially formed by the air-impermeable material 10131 forming part of the fabric membrane 11035, and the fabric material 10133 may be external to the cavity 3101. However, as Figure 73 As shown, the air flow may not be completely straight through (i.e., perpendicular to) the nostril openings 3102 (or otherwise referred to as nasal openings and / or apertures). The steam line can be directed toward the periphery of the nostril openings 3102 (and / or the periphery of the oral aperture, as shown). Figure 26 This may cause the compressed air to contact the fabric material 10133 instead of entering the patient's nostrils. Once within the fabric material 10133, the pressurized air is able to escape into the surrounding environment.

[0521] In the example shown, pressurized air can enter the fabric material 10133 at an angle (i.e., not perpendicular to the thickness of the fabric material 10133). The air flow can pass through the fabric material 10133 and contact the patient's nose. The solid surface can redirect the air flow back into the fabric material 10133, where it can travel until it reaches the air-impermeable membrane 10131. Just as the air-impermeable membrane 10131 can restrict air from escaping from the cavity 3101, the air-impermeable membrane 10131 can also restrict air from entering the cavity 3101. The air flow can continue to alternate between contacting the patient's nose and the air-impermeable material 10131 until the air flows out of the patient's nose and escapes into the surrounding environment.

[0522] In some forms, the backing has Figure 70 The fabric material 10133 of the air-impermeable material 10131 described in the accompanying drawings can provide increased breathability. For example, because the second impermeable layer 10139 forms discontinuities between the structures 10140, leakage of the impermeable material into the fabric material 10133 may be reduced.

[0523] As air moves between the patient's nose and the airtight material 10131, the air flow can provide cooling and / or breathability to the patient. For example, the patient can experience air flow across their skin, which can make wearing the cushion assembly 3105 more comfortable. Additionally, the patient may sweat while wearing the cushion assembly 3105. The air flow through the fabric material 10133 can provide forced convection and cooling to the patient. The air flow (along with the fabric material 10133) can help draw moisture away from the patient's skin and into the surrounding environment, rather than allowing sweat or other moisture to penetrate the fabric material 10133, which could irritate the patient. In other words, the air flow through the fabric material 10133 can simulate evaporative cooling and can remove moisture from the patient's skin to cool the patient. This can improve patient comfort and provide a more breathable and / or more absorbent cushion assembly 3105.

[0524] The fine knit of the fabric can also prevent the air-impermeable layer 10131 from seeping through the fabric layers 10133 (e.g., during the manufacturing process). For example, the fine knit of the first layer 10133a can restrict all seepage, or it can allow some seepage but substantially limit seepage into the other layers 10133b, 10133c. In other words, the first layer 10133a acts as a barrier and substantially limits the air-impermeable layer 10131 from contacting and / or coating the second layer 10133b or the third layer 10133c. Because the first layer 10133a does not contact the patient, some seepage can be permitted, as the relative stiffness of the first layer 10133a is less critical to patient comfort than the relative stiffness of the third layer 10133c (i.e., directly contacting the patient's skin). Consequently, the spandex does not lose its elasticity due to contact with the air-impermeable layer 10131. Additionally, the third layer 10133c may not lose its smooth texture due to being impregnated by the air-impermeable layer 10131. And because only one surface of the fabric material 10133 needs to be coated with the air-impermeable material 10131 (ie, in order for the fabric membrane 10135 to have air-impermeable properties), the air-impermeable membrane 10135 can be constructed to generally not restrict patient comfort.

[0525] In some embodiments, coating the fabric material 10133 with an air-impermeable material does not substantially affect the material properties of the fabric membrane 10133. For example, because the air-impermeable material 10131 is substantially prevented from reaching the second layer 10133b, the spandex forming the second layer 10133b does not significantly reduce its elasticity. This allows the fabric membrane 10135 to continue to stretch as a whole due to applied forces. Furthermore, if the third layer 10133c were impregnated with the air-impermeable layer 10131, it could lose its drape and become stiff. This could reduce the ability of the third layer 10133c to seal against the patient's face. Therefore, in addition to providing comfort, isolating the air-impermeable layer 10131 from the third layer 10133c also allows the third layer 10133c to remain substantially relaxed and capable of sealing against the patient's face.

[0526] In some embodiments, the air-impermeable layer 10131 comprises a thickness T of no greater than about 500 microns. I1 In some embodiments, the air-impermeable layer 10131 comprises a thickness T between about (or between about) 4 microns and about (or about) 400 microns. I1 In some embodiments, the air-impermeable layer 10131 comprises a thickness T between about (or between about) 8 microns and about (or between about) 300 microns. I1 In some embodiments, the air-impermeable layer 10131 comprises a thickness T between about (or between about) 12 microns and about (or between about) 200 microns. I1 In some embodiments, the air-impermeable layer 10131 comprises a thickness T between about (or between about) 16 microns and about (or between about) 100 microns. I1 In some embodiments, the air-impermeable layer 10131 comprises a thickness T between about (or between about) 20 microns and about (or between about) 70 microns. I1 In some embodiments, the air-impermeable layer 10131 comprises a thickness T of approximately (or between approximately) 40 microns. I1 .

[0527] In some embodiments, the actual thickness T of the airtight layer 10131 in the fabric membrane 10135 is I2 It can be less than the thickness T of the airtight layer 10131 before being coated on the fabric material 10133. I1 (Although this is not always the case.) In other words, if the air-impermeable material 10131 penetrates the first layer 10133a, the thickness T of the air-impermeable layer 10131 is I1 Partially overlaps with the thickness of the first layer 10133a so that the thickness T measured from the outer surface of the first layer 10133a (i.e., the surface facing the cavity) to the exposed surface of the airtight layer 10131 (i.e., the surface facing the cavity) is I2 Less than the total thickness T of the airtight layer 10131 I1 .

[0528] Even if the thickness T of the airtight layer 10131 is I2In some embodiments, the air-impermeable layer 10131 has a density of about (or about) 5 GSM to about (or about) 400 GSM. In some embodiments, the air-impermeable layer 10131 has a density of about (or about) 50 GSM to about (or about) 300 GSM. In some embodiments, the air-impermeable layer 10131 has a density of about (or about) 100 GSM to about (or about) 200 GSM. In some embodiments, the air-impermeable layer 10131 has a density of about (or about) 110 GSM to about (or about) 130 GSM. In some embodiments, the air-impermeable layer 10131 has a density of about (or about) 120 GSM.

[0529] The fabric membrane 10135 provides various benefits by maintaining separation between the air-impermeable layer 10131 and the second layer 10133b (i.e., the intermediate layer) and the third layer 10133c (i.e., the patient-contacting layer). As described above, the material properties of the fabric material 10133 are substantially not sacrificed to achieve the impermeable membrane 10135. In particular, the third layer 10133 maintains a smooth surface texture to provide comfort to the patient, while the second layer 10133b does not substantially lose its elasticity. The first layer 10133a, the third layer 10133c, and the air-impermeable layer 10131 can also be elastic, allowing them to stretch along with the second layer 10133b. In particular, the air-impermeable layer can have a low hardness (e.g., between about (or about) 20 and about (or about) 40, for example, about 30), which can provide it with greater stretchability compared to the air-impermeable layer 10131 having a greater hardness (e.g., it does not generally limit the stretchability of the fabric material 10133).

[0530] In other examples, the fabric membrane 10135 is comprised entirely of the fabric material 10133. The fabric material 10133 can include an air-impermeable thread that imparts impermeability to the fabric membrane 10135. No additional layer of air-impermeable material 10131 is required, which can allow the fabric membrane 10135 to be thinner (i.e., only the thickness of the fabric material). The air-impermeable thread can have similar elasticity to a non-air-impermeable thread, such that the fabric membrane 10135 having the air-impermeable thread does not lose stretchability.

[0531] In yet another example, the membrane is constructed entirely of an elastomeric material (e.g., silicone and / or TPE). The elastic-only membrane can be configured to have similar properties and / or structure to any of the fabric membranes 10135 described above. For example, the overall thickness of the elastic-only membrane can be substantially similar to the thickness, hardness, and / or stretchability of the fabric membrane 10135.

[0532] In some forms, the thickness of the elastic-only film is from about (or between about) 0.1 mm to about (or about) 0.55 mm. In some instances, the thickness of the elastic-only film is from about (or between about) 0.15 mm to about (or about) 0.45 mm. In some instances, the thickness of the elastic-only film is from about (or between about) 0.2 mm to about (or about) 0.35 mm. In some instances, the thickness of the elastic-only film is from about (or between about) 0.25 mm to about (or about) 0.3 mm.

[0533] In some forms, the elastic-only membrane has a durometer hardness of at least 20 Shore A. In some forms, the elastic-only membrane has a durometer hardness of at least 35 Shore A. In some forms, the elastic-only membrane has a durometer hardness of 40 Shore A. This hardness can provide the elastic-only membrane with flexibility and drape (e.g., a low drape coefficient) to form complex curvatures and a seal against the patient's face. In some forms, the elastic-only membrane can have a lower drape coefficient than the fabric membrane 10135.

[0534] In some forms, an elastic-only membrane can be coupled (e.g., molded) to a lower durometer silicone. For example, 40 Shore A durometer silicone can be molded into 20 Shore A durometer silicone. This can further increase the drape of the elastomeric-only membrane (e.g., compared to an elastic-only membrane constructed solely of 40 Shore A durometer silicone).

[0535] In some forms, the fabric membrane 10135 can exhibit a low spring constant (i.e., high compliance) in both the warp and weft yarns. In some forms, the fabric membrane 10135 can exhibit a low spring constant (i.e., high compliance) in both the warp and weft yarns. In some forms, applying a force of about (or approximately) 0.5 N to about (or approximately) 10 N can result in about 50% of the maximum displacement of the fabric membrane 10135. In some forms, applying about 2 N to about 25 N can result in about 100% of the maximum displacement of the fabric membrane 10135. In such forms, unlike conventional designs in which securing a cushion may result in torqueing of the skin of the patient's face 1300 to form an effective seal, the fabric material 10133 and / or the resulting fabric membrane 10135 can have a material spring constant and spring length such that the fabric membrane 10135 is more compliant than the patient's skin to which the fabric membrane 10135 is engaged. This can advantageously improve the comfort of the mask and reduce the development of localized pressure “hot spots,” or locations that may cause irritation due to contact with the seal-forming structure 3100 , 6100 , 9100 .

[0536] In some embodiments, the surface of the fabric material 10133 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 10135 and reduce friction relative to the patient's face 1300. The fabric material 10133 can have a surface (e.g., a herringbone pattern) that has a first coefficient of friction in a first direction that is different from (e.g., greater than or less than) the coefficient of friction in a second direction. Conversely, during use, a higher-friction fabric can cause the fabric membrane 10135 to grip or rub against the contact area of ​​the patient's face. Such friction or gripping can cause the fabric membrane 10135 to distort or deform, thereby reducing the effectiveness of the seal and allowing air to undesirably leak from the device.

[0537] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 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 heads but not for small heads, while another form of seal-forming structure is suitable for small heads but not for large heads.

[0538] It should be noted that although the description may refer (e.g., by reference characters) to a particular illustrated example or feature of a particular illustrated example (e.g., seal-forming structure 3100), such discussion may apply to other examples and / or features (e.g., seal-forming structures 6100, 9100).

[0539] 5.3.1.1 Sealing mechanism

[0540] In one form, the seal-forming structure includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum 3200, acting on its underside to urge the sealing flange into tight sealing engagement with the face. The pressure-assisted mechanism can act in conjunction with the elastic tension in positioning and stabilizing the structure.

[0541] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange comprises a relatively thin member having a thickness of less than about 1 mm, for example, about 0.25 mm to about 0.45 mm, that extends around the perimeter 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 perimeter. The support flange is or comprises a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0542] In one form, a fabric membrane 3130 (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 3130 can be biocompliant and can provide a generally smooth and comfortable surface for the patient, which can improve patient compliance (e.g., because they are not wearing an irritating device). The fabric membrane 3130 can have properties that enable it to stretch in at least one dimension. Prior to use, the fabric membrane 3130 can be permanently attached (e.g., molded) or attached to a support structure (e.g., a flexible support structure 3120) as a removable module.

[0543] In one embodiment, the fabric membrane 3130 can be formed into a complex, three-dimensional, predetermined shape, such that the fabric is not taut (e.g., loose, sagging, and / or wrinkling) before and / or during use, but is free of substantial leakage-inducing wrinkling. When attached to the support structure 3120, the fabric membrane 3130 can include one or more curvatures, which can help it conform to the various contours of the patient's face. Before the patient's face (e.g., the nose) approaches and presses against the fabric membrane 3130, the fabric membrane 3130 is adapted to form a consistent surface without interruptions such as wrinkles, creases, or folds. In some embodiments, this can be achieved by molding the fabric membrane 3130 so that it is substantially free of any wrinkling-inducing leaks. This can help ensure that the fabric membrane 3130 forms a smooth, continuous seal on and around the patient's face. This can provide improved respiratory pressure therapy by reducing the presence of folded or wrinkled portions of the seal-forming structure 3100, through which therapeutic air can leak.

[0544] In some embodiments, regions of the fabric membrane 3130 can be pre-tensioned (e.g., placed in a tensioned state prior to contact with the patient's face) and slightly stretched, while other regions of the fabric membrane 3130 can remain relaxed. In other words, the entire fabric membrane 3130 cannot be pre-tensioned. Fabric membranes 3130 with varying tensions can advantageously improve sealing efficiency while reducing pressure on areas of the face where anthropometric features protrude a greater distance into or toward the cavity 3101 (i.e., "hot spots"). In some examples, prior to use, the sides of the nose region (e.g., sides 3250 and / or corner regions 3252) can remain untensioned and / or relaxed to provide additional material to accommodate the facial contours of these sensitive facial areas. When the cushion assembly 3105 contacts the patient's face in the use position, the lateral sides 3250 and / or corner regions 3252 can intersect a plane that is generally perpendicular to the sagittal plane (e.g., generally parallel to the coronal plane). In some examples, the bridge portion 3104 can extend between the two nostril openings 3102 and can be tensioned, e.g. Figures 12 to 21As shown. The tension applied to the bridge portion 3104 can be one possible way to allow the fabric membrane 3130 to include a complex shape (e.g., multiple curvatures) to better conform to the patient's facial contours while including significantly less tension in the remainder of the fabric membrane 3130 (e.g., compared to the bridge portion 3104). In some arrangements, a wide, untensioned fabric membrane 3130 may be more comfortable because the untensioned fabric may exert less pressure on the patient's face.

[0545] By continuously maintaining the fabric membrane 3130 in an unwrinkled state before and during use, the fabric membrane 3130 can conform to the contours of the patient's face while minimizing wrinkling and / or blowing out of the seal-forming structure. In some forms, this can also improve sealing performance by maximizing the contact area of ​​the fabric membrane 3130 on the patient's face. In some forms, this can also improve the performance of the CPAP device when it is subjected to external lateral or longitudinal forces (e.g., tube resistance).

[0546] In some versions, the applied load from the air pressure within the plenum 3200 can help the fabric membrane 3130 maintain an effective seal when the plenum 3200 is pulled a short distance away from the patient's face. The applied load of the air pressure can be sufficient to elastically stretch the fabric membrane 3130 in at least one dimension such that it forms a "hovercraft" effect like a balloon over the anthropometric contours of the patient's face 1300, thereby maintaining an effective seal thereon.

[0547] In some forms, the fabric membrane 3130 can be held under tension by a relatively stiff support structure 3120. In various forms, the support structure 3120 can be formed from any of a material such as silicone, PU foam, PU solid material, or other suitable material. Although the support structure 3120 is stiffer than the fabric membrane 3130, it can still be described as flexible and can bend or flex due to applied tension. In some forms, the support structure 3120 can be relatively less stiff than the shell or frame of the inflatable chamber 3200 (e.g., made of a hard plastic). In other forms, the inflatable chamber 3200 does not include a shell or frame, but is instead composed entirely of the fabric membrane 3130 and the support structure 3120.

[0548] In some embodiments, the amount of tensile stress can vary as desired across the fabric membrane 3130 of the seal-forming structure 3100. The bridge portion 3104 can remain taut, and the remainder of the fabric membrane 3130 can be understood as being unstretched compared to the bridge portion 3104. The bridge portion 3104 is shown in the central portion of the fabric membrane 3130. However, the bridge portion 3104 (or any similar feature that selectively applies tension) can be located anywhere across the fabric membrane 3130. However, different locations on the fabric membrane 3130 can include different degrees of tension (i.e., but all less than the bridge portion 3104). For example, areas of stress concentration may exist near one or more apertures (e.g., nostril openings 3102) in the fabric membrane 3130 through which treatment is administered, or within a wider stretch of material. In some examples, with the exception of the bridging portion 3104 (which may include the highest tension), areas of the fabric membrane 3130 directly connected to the support structure 3120 (e.g., the periphery) may maintain greater tension than the radially inner portion of the fabric membrane 3130.

[0549] In some forms, the seal-forming structure 3100 may utilize a number of different cushion configurations, including a single air-assisted fabric membrane 3130, a dual air-assisted fabric membrane 3130, a fabric membrane with a compression scaffold 3130, or a fabric membrane with a TPU / TPE / Si scaffold 3130. In some forms, the cushion configuration of the seal-forming structure 3100 may be formed such that it may advantageously provide a "one size fits all" solution.

[0550] In an example, the seal structure 3100 and the plenum chamber 3200 may be applied to nose pads, nose supports, oronasal pads, ultra-compact full-face masks, full-face masks, and other suitable cushion arrangements.

[0551] In some forms, the fabric membrane 3130 can be configured to create an effective seal against the subnasal point of the patient's nose such that the fabric membrane 3130 does not engage the pronasal point, e.g. Figure 23 In some forms, the fabric membrane can be configured to create an effective seal over the patient's nasal protuberance (not shown).

[0552] In some forms, the air pressure within the cavity 3101 can apply a load to the inner surface of the fabric membrane (e.g., the air-impermeable layer 10131) to create further tensile stress, causing the fabric membrane 3130 to generally fill the concave contours of the patient's face 1300 (e.g., around the nose, adjacent to the alar rims). In some forms, the elasticity of the fabric membrane 3130, when combined with the applied load of the internal air pressure, can elastically stretch the fabric membrane 3130, causing it to form a larger sealing contact area on the patient's face. In some forms, this can also help provide a continuous seal even if the mask moves away from optimal engagement with the patient's face, as the fabric membrane 3130 may partially expand due to the reaction force generated by the internal air pressure (i.e., a "hovercraft effect").

[0553] In some forms, such as Figures 19 to 21 37 to 39, the fabric membrane 3130, 9130 may have one or more gripping pads 3150, 9150 disposed thereon. In one example, the gripping pads 3150, 9150 may be configured to be generally flat along the patient-facing surface of the fabric membrane 3130, 9130. In other examples, the gripping pads 3150, 9150 may be embossed such that the gripping pads 3150, 9150 may form a bead or edge that protrudes slightly above the surface of the fabric membrane 3130, 9130. In some forms, the gripping pads 3150, 9150 may have a high coefficient of friction. In some forms, the gripping pads 3150, 9150 may have a defined shape (e.g., an oval (see FIG. 20 )). Figure 19 、 21 , 37 and 39), round, square, etc.). In some forms, the grip pads 3150, 9150 may be elongated (see Figure 19 and 37 In some forms, the gripping pads 3150, 9150 may be linear. In some forms, the gripping pads 3150, 9150 may be arranged in a pattern on the surface of the seal-forming structure 3100, 9100. In some forms, the gripping pads 3150, 9150 may be arranged sporadically on the surface of the seal-forming structure 3100, 9100 (see Figure 21 and 39 In some forms, the grip pads 3150, 9150 may be arranged to form a perimeter around the peripheral edge of the fabric membrane 3130, 9130 (see Figure 19 、 20 , 37 and 38). In some forms, the gripping pads 3150, 9150 forming the perimeter may be in the form of dotted lines (see Figure 19 and 37 In some forms, the gripping pads 3150, 9150 forming the perimeter may be in the form of a solid line (see Figure 20 and 38 ). In some forms, the gripping pads 3150, 9150 forming the perimeter can be in the form of multiple lines, dotted lines, or solid lines, or a combination thereof. In some forms, the gripping pads 3150, 9150 can help the fabric membrane 3130, 9130 grip the patient's face. In one example, the gripping pads 3150, 9150 are formed as a relatively thin silicone layer applied to the surface of the fabric membrane 3130, 9130. In any of the above configurations, the gripping pads 3150, 9150 can provide other materials (e.g., fabric and silicone) that come into contact with the patient's face. While it may not provide the comfort that an entire fabric surface can provide (e.g., only where the fabric material of the fabric membrane contacts the patient's nose), including the gripping pads 3150, 9150 on the fabric membrane 3130, 9130 may provide benefits in helping to ensure that the seal-forming structure 3100, 9100 remains in place (e.g., to transmit therapeutic pressure to the patient). Additionally, having only a small area covered with silicone (or other gripping material), as compared to a relatively large area of ​​fabric (or all of silicone), may be more comfortable to the patient than forming the entire seal-forming structure 3100, 9100 from silicone (or other similar material).

[0554] In some embodiments, the fabric membrane 3130 can be integral with the support structure 3120 by attaching (e.g., molding) the outer edge (e.g., outer periphery) of the fabric membrane 3130 with a lip around the curved edge (e.g., inner edge) of the support structure 3120. In one example, the fabric membrane 3130 is attached so as to provide the front face of the seal-forming structure 3100. The fabric membrane 3130 also extends in a forward direction, such that the fabric membrane 3130 curves away from the front face. In other words, the fabric membrane 3130 is curved so as to extend beyond the front face and provide additional surface area of ​​fabric material exposed to the patient. This arrangement can be advantageous because substantially all of the patient's face that contacts the seal-forming structure 3100 contacts the fabric membrane 3130. This can be beneficial for improving patient compliance because contact with the fabric membrane 3130 can be more comfortable. Therefore, the patient is more likely to wear the patient interface 3000 incorporating the fabric membrane 3130 than a patient interface 3000 that includes at least some other material (e.g., silicone) in the face-contacting area.

[0555] In one example, the fabric membrane 3130 is attached to the support structure 3120 by a specific process (as described later), which may form a curved portion without forming creases, wrinkles, folds, or bends in the fabric membrane surface 3130. It can be seen that in some examples, at the transition portion 36, the support structure 3120 and the fabric membrane 3130 may 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 3100 to the back side of the seal-forming structure (see Figures 16 to 18 The fabric membrane 3130 may have a predetermined curvature imparted thereto such that a portion of the fabric membrane 3130 that is not directly supported by the support structure 3120 extends along the curve 35 ( Figures 16 to 18 ). The fabric membrane 3130 can be held slightly taut against the support structure 3120, but the fabric membrane 3130 that is not directly supported by (e.g., not in direct contact with) the support structure 3120 can be considered to be generally relaxed (e.g., under less tension than the bridge portion 3104). This can help form a dome shape (e.g., a convex dome) in certain areas of the fabric membrane 3130 (e.g., the sides 3250 and / or the corner areas 3252), which can help the fabric membrane 3130 seal against the contours of the patient's face (e.g., the subnasal point of the patient's face (i.e., the corners of the nasal region (i.e., the area where the nose ends at the upper lip near the nasolabial groove)), for example. Figure 12 As shown. The dome shape can help prevent wrinkles, folds, creases, and bends from forming in the fabric membrane 3130, which can help avoid the formation of leak paths. Likewise, the dome shape can help the fabric membrane 3130 enter difficult-to-seal areas of the patient's face, such as the corners of the nasal area. The fabric membrane 3130 can have a saddle shape at the middle subnasal point area 3260 that is configured to seal against the patient's subnasal point, thereby matching the saddle shape formed by the patient's nasolabial angle and upper lip, as shown. Figure 12 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 patient's nasal prominence. In the direction of curve 35, the curvature of the fabric membrane 3130 (e.g., the magnitude of the curvature and / or the radius of curvature) may vary in different areas of the cushion assembly along the periphery of the fabric membrane 3130. For example, as Figure 16 As shown, the fabric membrane 3130 in the middle pronasal point area 3270 may have a different curvature in the direction of the curve 35 than the fabric membrane 3130 in the middle subnasal point area 3260. In one example, the curvature (e.g., the magnitude of the curvature and / or the radius of curvature) at the side 3250 of the fabric membrane 3130 may be different from the curvature of the middle pronasal point area 3270 and / or the middle subnasal point area 3260.

[0556] In some forms, the fabric membrane 3130 can be slightly angled or curved inwardly toward the interior of the mask (e.g., a positive arch curvature in the left-right direction), such as Figures 12 to 21 In some forms, the fabric membrane 3130 may be formed into a dome shape over the support structure 3120, such as Figures 26 to 33 Note that any of the cushion assemblies 6105, 9105 disclosed herein can have a fabric membrane 6130, 9130 attached to the outer edge of the support structure 6120, 9120 such that the fabric membrane 6130, 9130 forms part of the portion of the seal-forming structure 6100, 9100 described above with reference to FIG. Figure 12 As discussed, the fabric membrane 6130 of the cushion assembly 6105 may be more dome-shaped by virtue of a negative curvature from one side to the other (e.g., as shown in FIG. Figure 26 In other words, because the fabric membrane 6130 is attached to the support structure 6120 with curvatures in different directions and / or about different axes, the fabric membrane 6130 can be formed to have an inward curvature and a dome shape. In one example, the majority of the fabric membrane 6130 includes a positive (e.g., inward) curvature that can support a portion of the patient's face, and only the periphery (e.g., the area near the support structure) is dome-shaped (e.g., includes a negative curvature).

[0557] In some embodiments, the central portion of the fabric membrane 3130 has a saddle shape. In other words, the periphery of the fabric membrane 3130 can be shaped to have a negative arch curvature (e.g., relative to a patient's face during use), and the central portion includes a positive arch curvature (e.g., around the bridge portion 3104), so that the central portion (e.g., near the bridge portion 3104) can be considered a minimum-maximum point (e.g., relative to a patient's face during use), and thus can be considered a saddle.

[0558] In some forms, if the fabric membrane 3130 is not under continuous tension (before and / or during use) or is not elastic, the fabric membrane 3130 can form an improved air-assisted seal against the patient's face, dynamically conforming to changes / movements caused by the fabric membrane 3130 being thinner than the support structure 3120 (e.g., a silicone membrane) and its lower structural stiffness (e.g., a "hovercraft effect").

[0559] In some forms, the fabric membrane 3130 can be supported by a second or third support structure that can serve as a cushion support. The cushion support can provide additional flexibility and can fit most patient faces (universal size). The second or third support layer can be formed using a fabric membrane, a fabric with a PU / Si film, a laminated open-cell foam, a laminated PU foam, a PU molded, TPU / TPE, or silicone. In some forms, the additional support layer itself can be supported by a structural / rigid plastic such as PP / PC / PA / PET or other suitable material.

[0560] In some versions, 3D printing the fabric membrane and / or cushion support as a "skeleton" can reduce the thickness and therefore the weight of the mask.

[0561] In some forms, multiple different layers of the mask layer can be printed with different rigidity, hardness or thickness. For example, the "skeleton" part can be formed using Si, PU foam, PU solid material or any suitable plastic material.

[0562] In one form, the seal-forming structure may comprise a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged to be in a compressed state, for example due to elastic tension in the positioning and stabilizing structure.

[0563] In one form, the seal-forming structure includes a tensioning portion. The tensioning portion can be located at any number of discrete locations throughout the seal-forming structure. When in use, the tensioning portion is maintained in tension, for example, by an adjacent area of ​​the sealing flange.

[0564] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0565] In certain forms of the present technology, the seal-forming structure may include one or more of: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having a tacky or adhesive surface.

[0566] 5.3.1.2 Nose bridge area

[0567] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the columella or bridge of the nose region of the patient's face.

[0568] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over a columella or bridge of the nose region of the patient's face in use.

[0569] 5.3.1.3 Upper lip area

[0570] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.

[0571] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.

[0572] 5.3.1.4 Chin area

[0573] 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.

[0574] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on a chin region of a patient's face in use.

[0575] 5.3.1.5 Forehead area

[0576] In one form, the seal-forming structure forms a seal on the forehead area of ​​the patient's face when in use. In such a form, the inflatable chamber can cover the eyes when in use.

[0577] 5.3.1.6 Nasal pillows

[0578] In one form, the seal-forming portion of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0579] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal against the bottom surface of a 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. Additionally, 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 regions can cooperate to facilitate a universal joint structure that can adapt to relative movement of both the 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.

[0580] 5.3.2 Nose pad

[0581] refer to Figures 6 to 21 , shows a patient interface 3000 having a cushion assembly 3105 including a seal-forming structure 3100 and an inflatable chamber 3200 according to a first example of the present technology.

[0582] The examples of the seal-forming structure 3100 described in the preceding paragraph may be considered nose pad cushions and are intended to provide a pressurized air flow to the patient's nostrils by sealing against at least the underside of the patient's nose. The exemplary seal-forming structure 3100 may engage the patient's face below the columella, and depending on the size and shape of the patient's nose, some examples may engage the patient's nose below the pronasal point. The exemplary seal-forming structure 3100 may also engage the patient's face at least above the vermilion of the upper lip. Thus, the exemplary seal-forming structure 3100 may seal against the upper portion of the patient's lip when in use. Furthermore, the patient's mouth may remain uncovered by the seal-forming structure 3100 of the depicted example, such that the patient may breathe freely, i.e., directly into the atmosphere, without interference from the seal-forming structure 3100. The under-nose nose pads may be configured such that they do not have an aperture sized to accommodate the patient's nose within a cavity. In addition, the height of the pad 3105 from the lower edge of the fabric membrane at the middle subnasal point area to the upper edge of the fabric membrane 3130 at the middle protruding nose area may be smaller than the width of the pad 3105 in the left-right direction from the side edge of the fabric membrane 3130 to the other side edge of the fabric membrane 3130 (for example, see Figure 12 ).

[0583] Examples of nose pads 3105 (e.g., the exemplary seal-forming structures 3100 disclosed herein) can include an upper saddle-shaped or concave region having a positive curvature across the entire cushion. Furthermore, the nose pads 3105 can be understood as having a single targeted seal-forming region or surface, whereas the nasal pillow pads can have two targeted seal-forming regions (one for each nostril). The nose pads 3105 can also have a posterior wall that contacts the upper portion of the patient's lips and an upper central surface that contacts the underside of the patient's nose (e.g., the patient's subnasal point and / or columella). A nasolabial angle can be formed between these two surfaces of the patient's face (see Figure 2E ). The nose pad 3105 can be shaped to have a nasolabial angle in the range of 90 degrees to 120 degrees.

[0584] Furthermore, the exemplary seal-forming structure 3100 can also be shaped and sized such that during use, no portion of the seal-forming structure 3100 substantially enters the patient's nostrils. In other words, a portion of the seal-forming structure 3100 may contact the flange in certain directions and extend slightly internally, but the seal-forming structure 3100 does not substantially seal within the nasal passages (e.g., as opposed to a nasal pillows-type mask).

[0585] 5.3.2.1 Inflatable chamber

[0586] refer to Figures 6 to 12, the plenum 3200 has a perimeter that is shaped to complement the surface contours of an average person's face in the area where it will form a seal when in use. When in use, the edge of the plenum 3200 is positioned very close to the adjacent surface of the face. The seal-forming structure 3100 provides actual contact with the face. The seal-forming structure 3100 can extend around any portion of the perimeter of the plenum 3200 when in use (e.g., around the entire perimeter, around a majority of the perimeter, etc.).

[0587] In certain forms of the present technology, the plenum 3200 can be constructed of a flexible material (e.g., silicone) and can be formed as a one-piece structure with the support structure 3120 (e.g., formed of any material described herein as suitable for the support structure 3120 and / or the plenum 3200). In some examples, the seal-forming structure 3100 can be an extension of the plenum 3200 or formed as a portion of the plenum 3200 such that the plenum 3200 surrounds the seal-forming structure 3100. In such examples, the support structure 3120 and the fabric membrane 3130 can be considered to be part of the plenum 3200 (e.g., the seal-forming structure 3100 at least partially forms the interior volume of the plenum 3200). In some examples, the plenum 3200 can be constructed of a transparent material (e.g., transparent silicone). The use of a transparent material can reduce obstructive properties of the patient interface 3000 and help improve compliance with therapy. The use of transparent materials can help the clinician (or patient) observe how the patient interface is positioned and functions (e.g., to ensure a proper seal), as well as observe the cleanliness of the patient interface 3000. Transparent materials can allow the clinician or patient to observe the accumulation of debris (e.g., dust, mold, etc.) within the plenum 3200, so that the patient interface 3000 can be cleaned or replaced. This can give the patient a sense of cleanliness when wearing the patient interface and can help ensure that the patient does not inhale harmful substances. Both of these help improve compliance with treatment. Instead of or in addition to transparent materials, translucent materials can also be used, which can provide similar benefits to patients. Optionally, the plenum 3200 is made of a relatively rigid material (e.g., polycarbonate) compared to the seal-forming structure 3100. The rigid material can also be made of transparent and / or translucent materials (e.g., transparent polycarbonate, etc.) to achieve similar benefits of flexible transparent materials (e.g., allowing observation). In the embodiment where the seal-forming structure 3100 is a membrane that is solely elastic, the plenum chamber 3200 and the seal-forming structure 3100 can be constructed of the same or similar materials (e.g., both can be at least partially constructed of silicone). However, the thickness of the plenum chamber 3200 can be greater than the thickness of the seal-forming structure 3100 because the plenum chamber 3200 does not come into direct contact with the patient's face and may not require as much flexibility.

[0588] In some embodiments, the seal-forming structure 3100 can include an opening connecting the plenum 3200, wherein the seal-forming structure 3100 is sealingly connected to the plenum 3200. The seal-forming structure 3100 and the plenum 3200 can at least partially form a cavity 3101 that is pressurized by the air flow. In the example shown, the seal-forming structure 3100 and the plenum 3200 together form the cavity 3101. At least one opening in the seal-forming structure (e.g., a pair of nostril openings 3102) can allow fluid communication between the cavity 3101 and the patient's nostrils. However, the nostril openings 3102 are not large enough to allow the patient's nose (e.g., the pronasal point) to enter the cavity 3101.

[0589] The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 can be a permanent bond. The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 can be a chemical bond. The seal-forming structure 3100 can be connected to the plenum chamber 3200 at the plenum chamber connection opening without requiring a mechanical connection. Alternatively, the seal-forming structure 3100 can be connected to the plenum chamber 3200 at the plenum chamber connection opening via a mechanically removable, detachable connection.

[0590] On each side of the plenum 3200 (e.g., Figure 13 The plenum connector 3204 may also be provided on each side of the plenum 3200, laterally outward from the plenum side end 3202. The plenum connector 3204 may be connected to a respective end 3314 of the positioning and stabilizing structure 3300. The connection between the plenum connector 3204 and the respective end 3314 of the positioning and stabilizing structure 3300 may be releasable on both sides. In other examples, one side may have a permanent connection and the other side may have a releasable connection. In further examples, both connections between the plenum connector 3204 and the respective end 3314 of the positioning and stabilizing structure 3300 may be permanent.

[0591] The plenum side end 3202 can receive a pressurized air flow from a positioning and stabilizing structure 3300 (e.g., a catheter headgear). The pressurized air flow can then pass through the plenum 3200, then through the seal-forming structure 3100, and into the patient's airway for inspiration.

[0592] An end 3314 of the positioning and stabilizing structure 3300 (e.g., an opening of a corresponding conduit) can be connected to the plenum lateral end 3202. In these examples, each plenum connector 3204 can include a slot 3209, a chamfered edge 3208, and a notch 3206 that can be removably connected to a clamp of the positioning and stabilizing structure via a snap fit.

[0593] 5.3.2.2 Sealing structure of this technology

[0594] The seal-forming structures 3100 can each include a support structure 3120 that provides support for a sealing portion 29130 (e.g., a fabric membrane) that creates a seal with the patient's face. The sealing portion 29130 is configured to sealingly engage the patient's face (e.g., when pressurized air is supplied to the plenum chamber 3200). Alternatively or additionally, the support structure 3120 can be molded onto the elastic-only membrane. The support structure 3120 can have a different thickness than the elastic-only membrane (e.g., it can be thicker) to support the elastic-only membrane in its molded position.

[0595] In one example, the seal-forming structure 3100 may include a support structure having at least two regions (e.g., two, three, four, etc. regions) of different thicknesses (e.g., the seal-forming structure 3100 includes a support structure 3120 having a wall structure having a lateral support region 3122 with an increased thickness relative to other portions of the wall structure). For example, Figure 58 and 59 As shown, some portions 3123 of the support structure 3120 can be thicker than other portions 3124, 3126 of the support structure 3120. For example, the thicker portion 3123 can be adjacent to or connected to the plenum 3200, and the portions 3124, 3126 can be adjacent to or connected to the fabric membrane 3130 to provide structural stability at the connection with the plenum 3200 and flexibility at the interface with the patient. Optionally, thicker lateral support regions 3122 can be located, for example, at the corners of the nasal region of the seal-forming structure (and, for example, can be directly connected to the fabric membrane) to ensure that an adequate seal is formed in the upper rear side panel region of the patient's face.

[0596] Furthermore, in the depicted example, each fabric membrane (e.g., a sealing portion) can have two separate nostril openings 3102, one corresponding to each nostril of the patient, to provide air flow to both nostrils of the patient. A bridge portion 3104 can be located between the nostril openings 3102. The bridge portion 3104 can help maintain the desired shape of the fabric membrane before and / or during use.

[0597] The sealing portion 3130 can be less rigid than the support structure 3120 and can be made 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 3130 described in any example of the present disclosure can be referred to as a fabric sealing portion or a fabric membrane and can include a fabric material having airtight properties (e.g., laminated, coated, or otherwise applied thereto).

[0598] The support structure 3120 can have an aperture formed therein that provides an inner edge of the support structure 3120 along which the sealing portion 3130 (e.g., an outer periphery of the sealing portion 3130) can be attached to the support structure 3120 such that the sealing portion 3130 extends radially inward from the support structure 3120 beyond the support structure or to an extent greater than the support structure, e.g., as Figures 12 to 21 For example, the sealing portion 3130 can be molded around the inner edge of the support structure 3120 or connected to the support structure 3120 in other suitable ways, as will be described later.

[0599] refer to Figures 12 to 15 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. A lateral support region 3122 may be provided on each of the lateral sides of the seal-forming structure 3100. The seal-forming structure 3100 may include two lateral support regions 3122, each spaced distally from a plane bisecting the seal-forming structure 3100, which plane, when in use, will be parallel to the patient's sagittal plane. The lateral support regions 3122 may be the thickest portion of the seal-forming structure 3100 to provide resistance to lateral displacement (e.g., caused by a patient sleeping on their side, causing nasal pillows to push laterally against the seal-forming structure) and to provide secure engagement against the patient's nasal ala. The lateral support regions 3122 may have a thickness of approximately 0.9 mm to approximately 1.5 mm, or approximately 1.3 mm to approximately 1.4 mm, or approximately 1.3 mm, or approximately 1 mm to approximately 1.5 mm. Since the lateral support region 3122 is the thickest region of the seal-forming structure 3100 in the depicted example, the lateral support region 3122 may also provide the greatest resistance to deformation.

[0600] The fabric membrane 3130 can be formed such that it forms part of the portion of the seal-forming structure 3100 that curves from the anterior side of the seal-forming structure 3100 to the posterior face-contacting side, as previously described. Specifically, the fabric membrane 3130 contacts the support structure 3120 in the transition portion 36, so that the fabric membrane portion 3130 can be configured to engage the posterior superior side panel region of the patient's face (i.e., the region where the nasal ala terminates at the upper portion of the lip near the nasolabial groove), which is a particularly complex geometric region. The posterior superior side panel region of the patient's face exhibits a particularly complex geometry because at least three facial surfaces (the nasal ala, the upper portion of the lip, and the cheek) converge in this region. Consequently, the seal-forming structure 3100 can be more flexible and conformable (e.g., not in tension near the periphery of the fabric membrane 3130) to more easily conform to the patient's facial contours.

[0601] As mentioned earlier, Figures 19 to 21 A grip pad 3150 is shown on the surface of the fabric membrane 3130.

[0602] 5.3.2.3 Positioning and stabilizing the structure

[0603] The seal-forming structure 3100 of a patient interface 3000 of the present technology may be maintained in a sealed position during use by a positioning and stabilising structure 3300 .

[0604] In one form, the positioning and stabilizing structure 3300 provides a retaining force at least sufficient to overcome the positive pressure in the plenum 3200 to lift off the face.

[0605] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface.

[0606] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential impact of damaging forces on the patient interface 3000, such as those caused by resistance from tubing or accidental interference with the patient interface.

[0607] In one form of the present technology, a positioning and stabilizing structure 3300 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 3300 has a small side or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0608] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured not to be too large and bulky to prevent a patient from lying in a supine sleeping position and resting the back region of the patient's head on a pillow.

[0609] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured not to be too large and bulky to prevent a patient from lying in a side sleeping position and resting the side region of the patient's head on a pillow.

[0610] In one form of the present technology, the positioning and stabilizing structure 3300 has a decoupling portion located between the front of the positioning and stabilizing structure 3300 and the back of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible strap or soft band. The decoupling portion is constructed and arranged such that when a patient lays their head on the pillow, the presence of the decoupling portion prevents forces at the back from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0611] 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 to engage with a hook material portion.

[0612] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state during use and to direct a force to seal the seal-forming structure 3100 against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0613] In one form of the present technology, the positioning and stabilizing structure includes a first strap that is constructed and arranged so that, when in use, at least a portion of its lower edge passes above the supra-auricular base of the patient's head and covers a portion of the parietal bone, but not the occipital bone.

[0614] In one form of the present technology applicable to a nasal-only mask or a full-face mask, the positioning and stabilizing structure includes a second strap that is constructed and arranged so that, when in use, at least a portion of its upper edge passes below the subauricular base of the patient's head and covers or lies below the occipital bone of the patient's head.

[0615] In one form of the present technology applicable to a nasal-only mask or 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 move apart from each other.

[0616] In some forms of the present technology, the positioning and stabilizing structure 3300 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.

[0617] In some forms of the present technology, the positioning and stabilising structure 3300 comprises a strap that is configured to be breathable to allow moisture vapor to be transferred through the strap.

[0618] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure 3300 configured to provide a retaining force corresponding to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large heads but not for small heads, while another form of seal-forming structure is suitable for small heads but not for large heads.

[0619] 5.3.2.3.1 Positioning and stabilization structure of this technology

[0620] Figure 6 An example of the present technology is depicted that includes a positioning and stabilizing structure 3300. In this example, the positioning and stabilizing structure 3300 includes a lateral portion 3302 and an upper portion 3304 in the form of a conduit that directs flowing pressurized gas from a hub 3306 to an end 3314. The positioning and stabilizing structure 3300 can be arranged so that, when in use, the hub 3306 and the decoupling structure 3500 are positioned above the patient's head. As described below, the decoupling structure 3500 can rotate within the hub 3306, and when the patient interface 3000 is worn by the patient, for example, 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.

[0621] The positioning and stabilizing structure 3300 can be constructed from silicone. For example, the lateral portion 3302, upper portion 3304, hub 3306, and side ends 3314 can be constructed or molded from a single piece of silicone.

[0622] The upper portion 3304 of the positioning and stabilizing structure 3300 has ridges and valleys (or a hexagonal cross-section) 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.

[0623] The lateral portion 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 portion 3302 may be less extensible and flexible than the upper portion 3304, which is advantageous because there is less variability in the shape and size of the side of a patient's head.

[0624] The end portions 3314 can be connected to the corresponding plenum side ends 3202. As described above, the plenum side ends 3202 receive a flow of pressurized air 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 end portions 3314 can be connected to the plenum connector 3204 of the corresponding plenum side ends 3202.

[0625] 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 superior and partially posterior force vector applied to the plenum 3200. In particular, the partially superior and partially posterior force vectors urge the fabric membrane of the seal-forming structure 3100 into sealing contact with the underside of the patient's nose, e.g., at or below the prona and at least above the vermilion of the upper lip.

[0626] The 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 length-adjustable, for example, having a hook-and-loop material arrangement whereby one of the rear strap end 3311 and the remainder of the rear strap 3310 includes hook material on its exterior and the other includes loop material on its exterior. The length adjustability of the rear strap 3310 allows for increasing the tension on the lateral portions 3302 to pull the seal-forming structure 3100 into sealing engagement with the patient's face at a desired amount of pressure (i.e., tight enough to prevent leakage but not too tight to cause discomfort).

[0627] The transverse portion 3302 may also be provided with a sleeve 3312 that holds the patient's face against the transverse portion 3302. The sleeve 3312 may be constructed of a breathable fabric material having a soft feel. After the end 3314 is removed from the plenum side end 3202, the sleeve 3312 may be removed from the transverse portion 3302.

[0628] like Figures 6 to 6 As shown in FIG. 2 , the positioning and stabilizing structure 3300 provides a force F that holds the inflatable chamber 3200 in a sealed position on the patient's face. PSS Positioning and stabilizing force F PSS The force F may be the resultant of various force vectors from different elements of the positioning and stabilizing structure 3300. For example, each lateral portion 3302 may provide a force F directed in the rear and corresponding lateral directions. 导管 , so as to hold the seal-forming structure 3100 against the patient's face (entering the upper lip and sealing under the nose) and to oppose the action of the positive pressure in the inflatable chamber 3200 to lift the seal away from the face (i.e., F 充气 ). Guided force F 导管 It can also be guided at least partially upwards in order to overcome the force of gravity F gGravity F g Specific illustrations may be made with respect to the seal-forming structure 3100 and the plenum chamber 3200, but gravity will act on the entire patient interface 3000 (ie, at a level comparable to the illustrated gravity F). g in the same direction).

[0629] Gravity F g Can be combined with the friction force F f On the contrary, the friction force F f Can act on the gravity F g In the directly opposite direction. When gravity pulls the seal forming structure 3100 and the inflatable chamber 3200 downward (as Figure 6 As shown), friction force F f For example, the patient may experience a friction force F above their lips (and / or other surface of the patient's face that contacts the seal-forming structure 3100). f , to resist movement in the downward direction (this can help stabilize the pad in place). Although the friction force F f Specifically shown is the gravity F with the seal forming structure 3100 and the plenum 3200 g Conversely, however, a component of the overall friction force (not shown) will also be associated with the weight force F associated with the positioning and stabilising structure 3300 (eg, the lateral portions 3302) and any other portions of the patient interface 3000. g On the contrary. Frictional forces may act anywhere along the patient interface 3000 where it contacts the patient's skin (or hair). f Along gravity F g in the opposite direction of the skin (or hair) of the patient.

[0630] There may also be an additional component of friction (not shown) that opposes the tension applied by the positioning and stabilizing structure 3300. When tension is applied to each individual element of the positioning and stabilizing structure 3300 (e.g., each lateral portion 3302, the upper portion 3304, the rear strap 3310, etc.), friction may oppose the tension at the location of the individual element. In other words, the patient may experience these tensions along his skin (or hair) in a direction directly opposite to the tension. The friction force may be directed in an anterior and / or inferior direction, or in an opposite direction to the rear and / or superior direction of the tension of the lateral portion 3302. The friction force may also be directed in an superior and / or anterior direction, or in an opposite direction to the tension F of the rear strap 3310. US The lower and / or rear parts are in opposite directions.

[0631] In some forms, when the lateral portion 3302 is formed as an air delivery conduit, the lateral portion 3302 can provide a force F directed toward the patient's head. TP Force F TPThis force may be caused by expansion of the catheter during normal use. In some forms, the force F TP The transverse portion 3302 can be designed to limit expansion of the catheter to prevent over-clamping of the patient's head.

[0632] The position of the patient's head can also change the force F TP For example, if the patient is sleeping (e.g. Figure 6 -2), the weight of the patient's head may compress one conduit, and the other conduit (e.g., the lateral portion 3302 not between the patient's head and the sleeping surface, like a pillow) may additionally expand (and cause a greater F TP ) in order to maintain approximately the same flow rate of pressurized air.

[0633] In some forms, an air delivery conduit (not shown) attached to the decoupling structure 3500 may provide a tube resistance F TD Because the decoupling structure 3500 can be pivotable, and because the patient's position can change during sleep (e.g., rolling over), the tube resistance F TD The direction of the light can change throughout the night or between nights.

[0634] In some forms, the sum of the various forces may equal zero, such that the patient interface 3000 is in equilibrium (eg, does not move along the patient's face when in use). Specifically, the gravity force F g and blowing force F 充气 Tends to move the seal-forming structure 3100 away from the desired sealing position. Applying a positioning and stabilizing force F PSS In order to counteract gravity F g and blowing force F 充气 (and any friction F f ) and maintain the seal forming structure 3100 properly positioned. Although the positioning and stabilizing force F PSS The force F may exceed the sum of the other forces and still maintain the seal-forming structure 3100 in the proper sealing position, but patient comfort may be sacrificed. PSS When just strong enough to achieve this, maximum patient comfort can be achieved. As described below, various positions of the patient's head when using the patient interface 3000 can determine the positioning and stabilizing force F required to achieve balance. PSS .

[0635] like Figure 6 As shown, the gravity F of the patient interface 3000 g The force F can be roughly perpendicular to the air chamber 充气 and / or positioning and stabilizing force F PSSIn this orientation, the patient can be in an upright position (e.g. sitting in bed). As described above, the positioning and stabilizing force F PSS The force of gravity F must be counteracted g and the chamber force F 充气 .

[0636] like Figure 6 -1, the gravity F of the patient interface 3000 g Can be roughly parallel to the chamber force F 充气 and / or positioning and stabilizing force F PSS In this orientation, the patient can be in a reclined position (e.g., supine). In this case, gravity F g can be directed into the patient's face (e.g., upper lip) and can counteract the chamber force F 充气 In other words, the positioning and stabilizing force F PSS and gravity F g can be directed into the patient's face and can counteract the chamber force F 充气 In other words, a lower positioning and stabilizing force F may be required PSS to hold the seal-forming structure 3100 in a sealed position (and to achieve equilibrium) because gravity F g Complementarily act to counteract the chamber force F 充气 .

[0637] like Figure 6 -2, the gravity F of the patient interface 3000 g The force F can be roughly perpendicular to the air chamber 充气 and / or positioning and stabilizing force F PSS In this orientation, the patient can lie on his side. As described above, the positioning and stabilizing force F PSS The force of gravity F must be counteracted g and the chamber force F 充气 Furthermore, the plenum 3200 and / or the positioning and stabilising structure 3300 may tend to be in compression on the underside and in tension on the upper side.

[0638] In some forms (e.g., see Figure 7 and Figure 8), the positioning and stabilizing structure 6300 may include a fabric tube 6350 having a left arm 6305 and a right arm 6307. The fabric tube 6350 may be formed with a first side configured to contact the patient. This may be referred to as an inner layer 6352. The fabric tube may also include a second side that is attached to the inner layer 6352 but faces away from the patient, which may be referred to as an outer layer 6354. The inner layer 6352 and the outer layer 6354 may each be secured to one another along the edges of the inner layer 6352 and the outer layer 6354 so that a channel (or passageway) is formed between the seams of the inner layer 6352 and the outer layer 6354. That is, the space between the seams remains unattached and forms an air passage 6372. The inner layer 6352 and the outer layer 6354 may be joined using various techniques that impart special properties to the seam or joint. For example, in some forms, the seam is formed using ultrasonic welding, radio frequency welding, and cutting and welding techniques. Heat can be applied to specific areas to activate the thermosetting or thermoplastic materials used in the tube 6350. This heat can be used not only to join the layers together, but also to heat-form thermoformed layers, such as the outer layer 6354. Additionally, in some forms, stitching or an adhesive such as glue can be utilized to join the layers together. In some forms, stitching is not used. In still further forms, material beyond the material within the layers is not used to join the inner and outer layers 6352, 6354 of the tube. For example, in some forms, the inner and outer layers 6352, 6354 can be formed such that no additional material, such as glue, or stitching is required to join the inner and outer layers 6352, 6354 together.

[0639] Each of the inner layer 6352 and the outer layer 6354 may include an inner surface and an outer surface. The inner surface of the inner layer 6352 is the surface facing the outer layer 6354. The inner surface of the outer layer 6354 is the surface facing the inner layer 6352. Similarly, the outer surface of the outer layer 6354 faces away from the inner layer 6352, while the outer surface of the inner layer 6352 faces away from the outer layer 6354. Furthermore, in a form comprising a single sheet, the inner surface is the surface of the sheet that faces inward and toward itself.

[0640] In some embodiments, one or more sheets of the tube may comprise an air-impermeable layer or membrane. In some embodiments, the inner surface of both layers comprises a membrane configured to restrict or inhibit air from passing through the layer from the inner surface to the outer surface. The air-impermeable layer may be a thin layer that is less than the thickness of the fabric sheet of either the inner or outer layer. In other embodiments, the impermeable layer may be greater than the thickness of the fabric sheet of either layer. The air-impermeable layer, membrane, or membrane may be completely impermeable to air transfer, or may be formed to allow a predetermined rate or air transfer and a specific pressure.

[0641] The diaphragm can be formed from a thermoplastic or thermosetting material such that when exposed to a specific temperature, the diaphragm material can be molded or formed into a specific form and then solidify or cure or set upon cooling. In some forms, the diaphragm can be formed from silicone or polyurethane. In some forms, the outer layer 6354 can be pre-formed such that in an unpressurized or supported state, the outer layer 6354 is pre-positioned and pre-shaped to extend away from the inner layer 6352 between the opposing joints 6312. That is, the outer layer 6354 can support its own weight such that when not supported by pressurized air or other supporting mechanisms, the outer layer 6354 remains spaced apart from the inner layer 6352 between the joints 6312.

[0642] In contrast, the inner layer 6352 can be a soft component. The inner layer 6352 can be attached and fixed to the edge of the outer layer 6354 so that the inner layer 6352 is a generally flat layer.

[0643] like Figure 8 As shown, especially Figure 9 As shown, the inner layer 6352 includes a fabric sheet 6360 and a membrane 6362. The fabric sheet 6360 can be formed from felt, foam, woven, knitted or nonwoven material or other fiber network.

[0644] The outer layer 6354 includes a tube sheet 6364 and an outer covering 6366. In some forms, both sides of the tube sheet 6364 can be covered with a membrane. Figure 10 As shown, tube sheet 6364 includes a diaphragm 6368 exposed to the chamber of tube 6350 and a diaphragm 6370 along an opposing surface of tube sheet 6364. Diaphragm 6368 can help provide a seal between inner layer 6352 and outer layer 6354 and form an airtight tube. Diaphragm 6370 can help connect tube sheet 6364 to outer cover 6366.

[0645] 5.3.2.4 Ventilation

[0646] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the flushing of exhaled gases, such as carbon dioxide.

[0647] In some forms, the vent 3400 is configured to allow continuous vent flow from the plenum chamber 3200 to the environment while the pressure in the plenum chamber is positive relative to the environment. The vent 3400 is configured to provide a vent flow rate of sufficient magnitude to reduce rebreathing of CO2 exhaled by the patient while maintaining a therapeutic pressure in the plenum chamber during use.

[0648] 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.

[0649] The vent 3400 can be located in the plenum 3200. As described above, the vent 3400 can include a plurality of holes. The holes of the vent 3400 can be divided into two laterally spaced groups. The axes of the flow paths through each hole of the vent 3400 can be parallel to avoid cross flow and prevent the generation of additional noise. The vent can be circular.

[0650] The radius of the hole of the vent 3400 can decrease from the inside to the outside of the inflation chamber 3200. Each vent is provided with a draft angle. The front diameter of each hole is smaller than the rear diameter. The draft angle means that the hole does not have a small cross-section throughout the thickness of the chassis, which helps to provide effective carbon dioxide flushing at high levels of humidity. In addition, the larger draft angle can cause the inflation chamber 3200 to be easier to manufacture, especially when the inflation chamber 3200 is formed from an injection molded plastic material. The draft angle allows relatively thick vent pins to be used in the mold and are easier to eject.

[0651] The holes of the vent 3400 may be arranged in two groups toward the middle of the plenum 3200, and the groups may be symmetrical about the centerline of the plenum 3200. Providing a pattern of multiple ventilation holes may reduce noise and disperse flow concentrations.

[0652] The hole of the vent 3400 can be placed at an optimal distance from the centerline of the plenum 3200. Placing the hole of the vent 3400 toward the centerline can advantageously reduce the chance of the vent hole being blocked when the patient sleeps on their side. However, placing the vent too close to the middle of the plenum 3200 can cause the plenum 3200 to be excessively weakened in the center, particularly since the cross-section of the plenum 3200 is smallest in the center due to the overall shape of the plenum 3200 in the depicted example. The location of the hole of the vent 3400 can avoid blockage of the hole during side sleeping while leaving the middle portion of the chassis sufficiently strong.

[0653] The size of each vent and the number of vents can be optimized to achieve a balance between reducing noise and achieving necessary carbon dioxide flushing even with extreme humidification. In the depicted example, the vents of vent 3400 may not provide the full ventilation capacity of 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 it reaches the patient, and the vent 3400 can be used to flush out carbon dioxide exhaled by the patient during treatment.

[0654] In some examples, a vent insert (not shown) is removably or permanently attached to the plenum chamber 3200 at the vent insert opening. The vent insert can be made of a material that is more flexible than the material of the plenum chamber 3200. In one example, a heat and moisture exchange (HME) material (e.g., foam) is contained in the removable vent to humidify the air inhaled by the patient without the need for a separate humidifier. The vent insert can be removable to allow the patient to replace the HME material with a fresh, clean sheet of HME material after a certain period of time has passed. In addition, the entire vent structure can be replaceable (e.g., in contrast to a separate HME material).

[0655] 5.3.2.5 Decoupling Structure

[0656] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0657] The hub 3306, as described above, is connected to the decoupling structure 3500, which in these examples is a rotatable elbow. In use, the decoupling structure 3500 can be rotated 360° within the hub 3306. The decoupling structure 3500 can be removed from the hub 3306 by manually depressing the button 3504 to release a clip (not shown) from within the hub 3306.

[0658] The decoupling structure 3500 may also include a swivel 3502 that allows for rotatable connection to the air circuit 4170 .

[0659] The rotatability of the decoupling structure 3500, the curved tubing form of the decoupling structure 3500, and the rotatability of the swivel 3502 on the decoupling structure 3500 all increase the degrees of freedom, thereby reducing the drag and torque on the patient interface 3000 caused by the tubing connection to the air circuit 4170.

[0660] 5.3.2.6 Connection Port

[0661] The connection port 3600 allows connection to the air circuit 4170 .

[0662] 5.3.2.7 Forehead support

[0663] In one form, the patient interface 3000 includes a forehead support 3700 .

[0664] 5.3.2.8 Anti-suffocation valve

[0665] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0666] 5.3.2.9 Port

[0667] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. 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 3200, such as pressure.

[0668] 5.3.3 Full-surface padding

[0669] refer to Figures 26 to 33 , the patient interface 6000 includes a cushion assembly 6105 having a seal-forming structure 6100 that is configured to seal around the patient's nostrils and mouth, respectively (e.g., an oronasal cushion assembly or an ultra-compact full-face mask). According to an example of the present technology, the cushion assembly 6105 is at least partially formed by an inflatable chamber 6200 and the seal-forming structure 6100 attached to the inflatable chamber.

[0670] refer to Figures 22 to 25 34 to 39, cushion assembly 9105 is shown. Cushion assembly 9105 is similar to cushion assembly 6105 and has a seal-forming structure 9100 that is configured to seal around the patient's nostrils and mouth, respectively (e.g., an oronasal cushion assembly or an ultra-compact full-face mask). According to an example of the present technology, cushion assembly 9105 is at least partially formed by an inflatable chamber 9200 and a seal-forming structure 9100 attached to the inflatable chamber.

[0671] The pad assembly 9105 includes a Figures 26 to 33 The nose 9101, nose hole 9103, oral portion 9102, oral portion hole 9104, cavity 9001, support structure 9120, sealing portion 9130 and vent 9400 of the features described in. Figures 26 to 33 The description can be roughly applied to Figures 22 to 25 and 34 to 39, and various similarities and differences not discussed separately. A pair of plenum apertures is configured to receive an air flow.

[0672] Due to the connection to the support structure 9120, the cushion component 9105 (e.g., specifically, the nose 9101) can include at least one curved surface. The curved surface can extend from the front side to the back side of the cushion component 9105 (e.g., see Figure 24 ). Similar curvature may be present on the pad component 6105 (see, for example, Figure 30 and 31). However, unlike cushion assembly 6105, cushion assembly 9105 (e.g., specifically, nose 9101) can include at least one curved surface, which can be the result of curling in nose 9101, as will be described in more detail below (although a curved surface can be formed using a membrane that is only elastic without curling). When cushion assembly 9105 is used, the curved surface of cushion assembly 9105 resulting from the curling can extend in a lateral direction (e.g., a left-right direction) of the patient's face. For example, the curved surface of cushion assembly 9105 resulting from the curling can be bent about an axis that is perpendicular to the axis passing through section line 36--36 (e.g., see Figure 34 ), and / or bend about a third axis 13000 (described in detail below). The curved surface produced by the curling may also have a positive curvature relative to the patient's face.

[0673] As reference Figure 23 and 24 As described, the positioning and stabilizing structure 9300 provides a force F that holds the cushion assembly 9105 in a sealed position on the patient's face. PSS Positioning and stabilizing force F PSS The force F may be the resultant of various force vectors from different elements of the positioning and stabilizing structure 9300. For example, each catheter 9900 may provide a force F directed in a posterior direction and a corresponding lateral direction. 导管 , so as to hold the seal-forming structure 9100 against the patient's face and to oppose the effect of the positive pressure in the plenum 9200 to lift the seal away from the face (i.e., F 充气 ). Guided force F 导管 It can also be guided at least partially upwards in order to overcome the force of gravity F g Positioning and stabilizing force F PSS Also included is the force F from the lower strap 9303 LS (e.g., generally in a rearward direction) and / or a force F from the upper strap 9302 US (eg, generally pointing in a rearward and downward direction).

[0674] Gravity F in Patient Interface 9000 g The source can be similarly Figure 6 to Figure 6 -2 changes depending on the orientation of the patient wearing the patient interface 9000. Figures 6 to 6 - Positioning and stabilizing force F as described in 2 PSS Can be set so that the patient interface 9000 has zero net force (ie, all forces cancel out). Lower strap force F LS and / or upper strap force F US The tightness of the pillow can depend on the patient's preferred sleeping orientation.

[0675] As described above, the patient may experience frictional forces due to contact with various components of the patient interface 9000. Figure 23 and 24 FIG. 1 shows the gravity F of the sealing structure 9100 and the plenum 9200. g The opposite friction force F f Other components of the total friction force are not shown, but will oppose other forces acting on the patient interface 9000. Because the patient interface 9000 is a full face cushion, a larger surface area will be subject to the weight force F with the seal forming structure 9100 and the plenum chamber 9200. g The opposite friction force F f For example, except for the upper part of the lip, the friction force F shown in the figure is f Can be used on the lower lip and / or nasolabial folds, among other areas.

[0676] As mentioned earlier, Figures 37 to 39 A gripping pad 9150 is shown on the surface of the fabric membrane. The gripping pad 9150 can be on the first sealing portion 9131 and / or the second sealing portion 9132. Although shown with the cushion assembly 9105, the gripping pad 9150 can also be incorporated into the cushion assembly 6105.

[0677] refer to Figure 33-1 , patient interface 21000 includes a cushion assembly 21105 having a seal-forming structure 21100 that is configured to seal around the patient's nostrils and mouth (e.g., an oronasal cushion assembly or an ultra-compact full-face mask). Cushion assembly 21105 is similar to cushion assemblies 6105 and 9105. According to an example of the present technology, cushion assembly 21105 is at least partially formed by an inflatable chamber 21200 and a seal-forming structure 21100 attached to the inflatable chamber. Seal-forming structure 21100 may also include a curved surface similar to nose 9101.

[0678] refer to Figure 33-2 , patient interface 23000 includes a cushion assembly 23105 having a seal-forming structure 23100 that is configured to seal around the patient's nostrils and mouth (e.g., an oronasal cushion assembly or an ultra-compact full-face mask). Cushion assembly 23105 is similar to cushion assemblies 6105 and 9105. According to an example of the present technology, cushion assembly 23105 is at least partially formed by an inflatable chamber 23200 and a seal-forming structure 23100 attached to the inflatable chamber. Seal-forming structure 23100 may also include a curved surface similar to nose 9101.

[0679] refer to Figures 33-3 to 33-11, patient interface 25000 includes a cushion assembly 25105 having a seal-forming structure 25100 that is configured to seal around the patient's nostrils and mouth (e.g., an oronasal cushion assembly or an ultra-compact full-face mask). Cushion assembly 25105 is similar to cushion assemblies 6105 and 9105. According to an example of the present technology, cushion assembly 25105 is at least partially formed by an inflatable chamber 25200 and a seal-forming structure 25100 attached to the inflatable chamber. Seal-forming structure 25100 may also include a curved surface similar to nose 9101.

[0680] Figures 22 to 39 The full face cushion of the present invention may have some similarities with the nose cushion 3000 described above. For example, the seal-forming structure described in more detail below may have selectively applied tension to help form the final shape (e.g., a two-dimensional shape or a three-dimensional shape). Various similarities and differences between the full face cushion and the nose cushion 3000 are described below. In addition, various features of the fabric full face cushion described below are applicable to the full face cushion having only an elastic membrane.

[0681] 5.3.3.1 Inflatable chamber

[0682] The plenum 6200 has a perimeter that is shaped to complement the surface contours of an average person's face in the area where it will form a seal during use. During use, the edge of the plenum 6200 is positioned very close to the adjacent surface of the face. The seal-forming structure 6100 provides actual contact with the face. The seal-forming structure 6100 can extend around the entire perimeter of the plenum 6200 during use.

[0683] In some forms of the present technology, the plenum 6200 is constructed of a relatively rigid material (e.g., polycarbonate) compared to the seal-forming structure 6100. In another example, the plenum 6200 can be constructed of a flexible material (e.g., silicone, fabric, etc.) and can have a similar hardness as the seal-forming structure 6100. In another example, the plenum 6200 can be constructed of a transparent material (e.g., clear polycarbonate). The use of a transparent material can reduce the obstructive nature of the patient interface 6000 and help improve compliance with treatment. The use of a transparent material can help the clinician observe how the patient interface 6000 is positioned and functioning, and / or observe the accumulation of debris (e.g., dust, mold, etc.).

[0684] In some forms of the present technology, the plenum chamber 6200 is constructed of a translucent material. The use of a translucent material can reduce obstruction of the patient interface 6000 and help improve compliance with therapy.

[0685] A plenum 6200 according to an example of the present technology may include a plenum 6201 on each side (e.g., Figure 26The plenum 6200 may be provided with a plurality of plenum holes (on the left and right sides of the bridging portion 6106 in the embodiment of the present invention). The plenum holes may provide pneumatic communication between the catheter connector 6800 and the cavity 6001, which will be described in more detail below. The connection edge portion around each plenum hole may facilitate mechanical connection with the corresponding catheter connector, such as a snap fit or friction fit. The plenum 6200 may be made of sufficiently rigid material to provide auditory and / or tactile feedback to the patient when the catheter connector 6800 is connected to the plenum 6200 or when the catheter connector 6800 is removed therefrom.

[0686] The seal-forming structure 6100 can be sealingly connected to the plenum 6200. The connection can be permanent, or the seal-forming structure 6100 can be removable from the plenum 6200. The seal-forming structure 6100 can be molded (e.g., overmolded, injection molded, etc.) to the plenum 6200. The seal-forming structure 6100 and the plenum 6200 can be connected by a mechanical connection, wherein no chemical bond is formed between the plenum 6200 and the seal-forming structure 6100.

[0687] 5.3.3.2 Sealing structure

[0688] refer to Figures 26 to 33 , the seal-forming structure 6100 may include a nose portion 6101 having at least one aperture (e.g., a pair of nostril openings 6103) to seal with the patient's nostrils and deliver pressurized air to the patient's nostrils. The depicted example provides two separate apertures 6103, each corresponding to one nostril of the patient, to provide air flow to both nostrils of two patients. A bridging portion 6106 may be located between the nostril openings 6103. In an alternative example, a single aperture may be used to provide air flow to both nostrils of the patient. Another alternative may include three or more apertures. Unlike the bridging portion 3104, the bridging portion 6106 may not be selectively tensioned. For example, the bridging portion 6106 and the surrounding material of the nose portion 6101 may be held together under tension, rather than applying tension only to the bridging portion 6106.

[0689] Brief reference Figures 22 to 25 and 34 to 39, the bridge portion 9106 can be selectively tensioned in a similar manner as the bridge portion 3104. For example, the bridge portion 9106 can be tensioned more than the surrounding first sealing portion 9131.

[0690] Continue to refer Figures 26 to 33, the seal-forming structure 6100 can include an oral portion 6102 having an oral portion aperture 6104 for sealing with the patient's mouth. In some examples, when not in use (i.e., when not in contact with the patient's face), the oral portion 6102 is at least partially maintained in tension (e.g., at any number of discrete locations). For example, the oral portion can be in tension at its connection to the support structure 6120, but relaxed at an exposed sealing edge (e.g., an inner edge near the opening of the cavity 6001). In some examples, when not in use, the oral portion 6102 is completely relaxed. In any example, contact with the patient's face may cause the oral portion 6102 to stretch, thereby placing the oral portion in tension when in use.

[0691] The seal-forming structure 6100 can at least partially form a cavity 6001 that is pressurized by the air flow. A plenum 6200 can be connected to the seal-forming structure 6100 to further form the cavity 6001.

[0692] The seal-forming structure 6100 may include a support structure 6120 that provides support for a sealing portion 6130 (e.g., a fabric membrane). The sealing portion is configured to sealingly engage the patient's face. The sealing portion 6130 is sufficiently large (e.g., curved in a sufficient amount in the anterior direction) so that only the sealing portion 6130 (e.g., only the fabric membrane) can contact and sealingly engage the patient's face. Optionally, the support structure 6120 may also be constructed of a fabric material.

[0693] In one example, the seal-forming structure 6100 may include a support structure 6120 having at least two regions (e.g., two, three, or four regions) of varying thickness (e.g., the seal-forming structure 6100 includes a support structure 6120 having a lateral support region with an increased thickness relative to other portions of the wall structure (e.g., see FIG. Figure 58 and 59 3122) in the wall structure). For example, Figure 58 and 59 As shown, some portions 3123 of the support structure 3120 can be thicker than other portions 3124, 3126 of the support structure 3120. For example, the thicker portion 3123 can be adjacent to or connected to the plenum chamber, and the portions 3124, 3126 can be adjacent to or connected to the fabric membrane 3130 to provide structural stability at the connection with the plenum chamber 3200 and flexibility at the interface with the patient. Optionally, the thicker portions of the lateral support region 3122 can be located, for example, at the corners of the nasal region of the seal-forming structure (and, for example, can be directly connected to the fabric membrane) to ensure that an adequate seal is formed in the upper rear side panel region of the patient's face.

[0694] As described above, the seal-forming structure 6100 can be sealingly connected to the inflatable chamber 6200. The support structure 6120 can be less rigid than the inflatable chamber 6200 and can be composed of silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable materials as described below. In addition, the sealing portion 6130 can be less rigid than the support structure 6120 and can be composed of a fabric material 6130 such as nylon, polyester, a nylon and polyester blend, microfiber, or polyurethane, as will be described in more detail later.

[0695] exist Figure 32 In the example of , the support structure 6120 can extend into the cavity 6001 to form a bottom liner 6121 to provide support for the sealing portion 6130. The bottom liner 6121 and the sealing portion 6130 can form a double-walled structure around the perimeter of the sealing portion. In optional examples, a second or third bottom liner layer can be provided to form a three-layer or four-layer wall structure. Figure 32 In an example, the bottom liner is made of a foam material (e.g., polyurethane foam). In an optional example, the bottom liner 6122 can be made of silicone, such as Figure 33 However, it will be appreciated that the base pad may be constructed of other suitable materials (eg, fabric).

[0696] The sealing portion 6130 can be constructed from two different fabric membranes (or alternatively, simply an elastic membrane). For example, one membrane 6131 can be used to seal around the patient's nose, while the other membrane 6132 can be used to seal around the patient's mouth. The sealing portions 6131 and 6132 can be used to independently seal each orifice. In other words, the first or upper sealing portion 6131 may not contact the area around the patient's mouth, while the second or lower sealing portion 6132 may not contact the area around the patient's nose.

[0697] like Figures 26 to 33 As shown, the first sealing portion 6131 is disposed at an upper portion (ie, when in use) of the patient interface 6000 compared to the second sealing portion 6132. The first sealing portion 6131 forms a circular (eg, generally tri-oval) perimeter that surrounds the patient's nostrils when in use.

[0698] In some forms, the first sealing portion 6131 can contact the area between the nose wing and the upper lip while leaving the nasal protuberance exposed (e.g., see Figures 23 to 25, showing a similar first sealing portion 9131). The fabric membrane of the first sealing portion 6131 can be the only material of the seal-forming structure 6100 that contacts the patient in this area. In other words, the second sealing portion 6132 and the support structure 6120 do not contact the patient in this area. This can help improve patient compliance because the patient only contacts the fabric layer in the area of ​​their face, where they may be more closely bonded to the bed sheet than to the medical device.

[0699] The second sealing portion 6132 is disposed at a lower portion of the patient interface 6000 (i.e., when in use and compared to the first sealing portion 6131). In the example shown, the second sealing portion 6132 forms a generally U-shape and seals around a portion of the patient's mouth. The fabric membrane forming the second sealing portion 6132 does not extend completely around the patient's mouth. In other words, other materials besides the fabric membrane may come into contact with the patient to form a seal around the patient's mouth. In this example, a support structure 6120 (e.g., a silicone material) is molded between the free ends of the second sealing portion 6132 to complete the oral portion aperture 6104. The fabric membrane of the second sealing portion 6132 may contact the patient's lower lip, areas outside the patient's corners of the mouth, and a portion of the patient's upper lip, and may not contact a central portion of the patient's upper lip (e.g., near the patient's philtrum). The support structure 6120 extends across the patient's philtrum between the ends of the second sealing portion 6132. The combination of the fabric membrane of the sealing portion 6130 and the silicone material of the support structure 6120 can be responsible for forming a seal around the patient's mouth.

[0700] The support structure 6120 extends from the lower surface of the first sealing portion 6131 to the opening of the cavity 6001. In other words, the first sealing portion 6131 is separated from the second sealing portion 6132 by the support structure 6120. The material of the support structure 6120 (e.g., silicone) also helps to bond the first sealing portion 6131 and the second sealing portion 6132 to each other during the manufacturing process.

[0701] like Figure 33-1As shown, the second sealing portion 21130b extends completely around the patient's mouth. In other words, the fabric membrane and support structure 21120 contact the philtrum opposite each other. Support structure 21120 (e.g., silicone material) is disposed in the vertical direction between first sealing portion 21130a and second sealing portion 21130b (e.g., first segment and second segment). Although the seal is primarily or solely achieved by the fabric membrane in first sealing portion 21130a and second sealing portion 21130b, support structure 21120 may slightly contact the upper portion of the patient's lip. In other words, during treatment, the location where support structure 21120 contacts the patient's skin may not be subject to pressure and / or exposure to the surrounding environment. Compared to a U-shaped second sealing structure 21130b, extending the second support structure 21130b completely around the patient's mouth may provide greater patient comfort (e.g., because the patient may find the fabric membrane more comfortable than silicone), which may increase patient compliance with treatment. However, only elastic films can substantially replicate the comfort of a fabric membrane, such that patient compliance with therapy is substantially unchanged when a substantially thin film is used.

[0702] In another example of a patient interface 23000, as Figure 33-2 As shown, the second sealing portion 23132 is U-shaped. However, the upper end and central portion of the upper lip portion are contacted by the fabric membrane. In this example, the first sealing portion 23131 extends downward to the edge of the oral portion hole 23104. In other words, the first sealing portion 23131 is responsible for forming a seal around the patient's nose and is also partially responsible for forming a seal around the patient's mouth. The U-shaped second sealing portion 23132 extends roughly around the rest of the patient's mouth (although a small portion of the support structure 23120 is laterally disposed in the left-right direction between the first sealing portion 23131 and the second sealing portion 23132). This example can provide similarities to the above description of Figure 33-1 Similar comfort benefits are described (e.g., because substantially all contact with the patient's nose and mouth through the patient interface 23000 is made by the fabric membrane). However, Figure 33-2 The example can be easier to manufacture because the support material 23120 between the first sealing portion 23131 and the second sealing portion 23132 is removed in the upper and lower directions. A small portion of the support structure 23120 between the sealing portions 23131, 23132 can help form a pressurized volume around the patient's mouth.

[0703] In another example of a patient interface 25000, as Figure 33-3As shown, the sealing portions 25131, 25132 are formed from a single piece of fabric material. In other words, the first sealing portion 25131 and the second sealing portion 25132 are not formed from separate materials. The single piece of material forming the sealing portions 25131, 25132 is responsible for forming a seal around the patient's nose and the patient's mouth. The sealing portions 25131, 25132 may have a periphery similar to that described above (for example, in the example of a patient interface 25132 having first and second sealing portions 25131). In some examples, the sealing portions 25131, 25132 may only seal around their periphery, as not sealing the upper portion of the patient's lips may not allow air to leak out of the seal-forming structure 25100. However, the sealing portions 25131, 25132 can still seal the upper portion of the patient's lips so that pressurized air can be delivered more directly to the patient's airway. By using a single piece of fabric membrane to form the sealing portions 25131, 25132, the support structure 25120 may not contact the upper portion of the patient's lips. Additionally, manufacturing the patient interface may be easier because a thin strip of support structure 25120 is no longer required between two sheets of fabric membrane to connect them together. Thus, the molding process can be simplified so that a small amount of material (e.g., silicone) does not need to flow between them, rather than covering the fabric layer 10133.

[0704] like Figures 22 to 25 As shown in FIG31-1 to FIG39, each seal forming structure may have a three-dimensional shape. Specifically, each first seal portion may have a Figures 26 to 33 The flat surface (e.g., in the left-right direction) shown is opposed by a curved surface (e.g., in the left-right direction). The three-dimensional shape can be formed at least in part by selectively applying tension to the bridge portion of the corresponding first sealing portion. No tension can be applied to the material of the first sealing portion surrounding the bridge portion on each seal-forming structure, so that the first sealing portion can include a curved shape.

[0705] In any of these embodiments (e.g., Figures 22 to 39 ), the strength of the seal against the patient's face is approximately the same. For example, having only a fabric material, or having a combination of a fabric material and a silicone material, does not generally affect the quality of the seal (i.e., increase or decrease the leakage area). Different patients (e.g., different facial geometries) may be more suitable for one of the specific examples than for the other (e.g., due to comfort, fit, etc.). In addition, although the examples with more fabric coverings may provide additional comfort to the patient, the increased comfort may be minimal (e.g., because the support structure 6120 in the examples provides minimal contact with both the first sealing portion 6131 and the second sealing portion 6132).

[0706] 5.3.3.3 Positioning and stabilizing the structure

[0707] The seal-forming structure 9000 of the patient interface 9100 of the present technology can be maintained in a sealed position when in use by a positioning and stabilizing structure 9300. Although the positioning and stabilizing structure 9300 is specifically shown with the patient interface 9000, it can be used with any full face cushion (e.g., Figures 22 to 39 The positioning and stabilizing structure 9300 may also be similar to the positioning and stabilizing structure 3300.

[0708] In one form, the positioning and stabilising structure 9300 provides a retaining force at least sufficient to overcome the positive pressure in the cavity 9001 to lift off the face.

[0709] In one form, the positioning and stabilising structure 9300 provides a retaining force to overcome the effects of gravity on the patient interface 9000 .

[0710] In one form, the positioning and stabilising structure 9300 provides a retaining force as a safety margin to overcome the potential impact of damaging forces on the patient interface 9000, such as those caused by resistance from tubing or accidental interference with the patient interface.

[0711] In one form of the present technology, a positioning and stabilizing structure 9300 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 9300 has a small side or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 9300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 9300 includes at least one flat strap.

[0712] In one form of the present technology, a positioning and stabilizing structure 9300 is provided that is configured not to be too large and bulky to prevent a patient from lying in a supine sleeping position and resting the back region of the patient's head on a pillow.

[0713] In one form of the present technology, a positioning and stabilizing structure 9300 is provided that is configured not to be too large and bulky to prevent a patient from lying in a side sleeping position and resting the side region of the patient's head on a pillow.

[0714] In one form of the present technology, the positioning and stabilizing structure 9300 is configured with a decoupling portion between the front of the positioning and stabilizing structure 9300 and the back of the positioning and stabilizing structure 9300. The decoupling portion does not resist compression and can be, for example, a flexible strap or soft band. The decoupling portion is constructed and arranged such that when a patient rests their head on the pillow, the presence of the decoupling portion prevents forces at the back from being transmitted along the positioning and stabilizing structure 9300 and disrupting the seal.

[0715] In one form of the present technology, the positioning and stabilizing structure 9300 comprises a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer comprises a loop material to partially engage with the hook material. In one form, the conduit 9900 for delivering air to the cushion assembly 9105 may also constitute the positioning and stabilizing structure 9100.

[0716] In some forms of the present technology, the positioning and stabilizing structure 9300 comprises a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state during use and to direct a force to seal the seal-forming structure against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0717] In one form of the present technology, the positioning and stabilizing structure may include a first strap (e.g., upper strap 9302 ( Figure 24 )), the first strap is constructed and arranged so that when in use, at least a portion of its lower edge passes above the base point above the ear of the patient's head.

[0718] In one form of the present technology adapted for a full face mask, the positioning and stabilizing structure includes a second strap (e.g., lower strap 9303 ( Figure 42 )), the second strap is constructed and arranged so that when in use, at least a portion of its upper edge passes below the sub-auricular base point of the patient's head and covers or is located below the occipital bone of the patient's head.

[0719] In one form of the present technology applicable to a nasal mask only or a full face mask, the positioning and stabilizing structure includes a third strap (e.g., strap connector 9304 ( Figure 22 )), the third tether is constructed and arranged to interconnect the first tether and the second tether to reduce the tendency of the first tether and the second tether to move apart from each other.

[0720] In some forms of the present technology, the positioning and stabilizing knot 9300 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.

[0721] In some forms of the present technology, the positioning and stabilising structure 9300 comprises a strap that is configured to be breathable to allow moisture vapor to be transferred through the strap.

[0722] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 9300, each positioning and stabilizing structure configured to provide a retaining force corresponding to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 9300 that is suitable for large heads but not for small heads, while another form of seal-forming structure is suitable for small heads but not for large heads.

[0723] The positioning and stabilizing structure 9300 may include a clip 9301 to secure a corresponding tether to a catheter connector 9800, for example. Figure 22 The clip 9301 and the catheter connector 9800 can each include magnets that are arranged with opposite polarity to facilitate connection therebetween.

[0724] 5.3.3.4 Ventilation

[0725] In one form, the patient interface 6000 includes a vent 6400 constructed and arranged to allow exhaled gases, such as carbon dioxide, to be flushed out. Figure 30 shown.

[0726] In some forms, the vent 6400 is configured to allow continuous vent flow from the plenum chamber 6200 to the environment while the pressure in the plenum chamber is positive relative to the environment. The vent 6400 is configured to allow a vent flow rate sufficient to reduce rebreathing of CO2 exhaled by the patient while maintaining a therapeutic pressure in the plenum chamber during use.

[0727] One form of a vent 6400 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.

[0728] The vent 6400 can be located in the plenum 6200. Optionally, the vent 9404 is located in a decoupling structure, such as a swivel (e.g., Figure 22 ).

[0729] The catheter connector 6800, described in more detail below, may also include a vent feature.

[0730] 5.3.3.5 Decoupling Structure

[0731] In one form, the patient interface 9000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0732] 5.3.3.6 Connection Port

[0733] The connection port 6600 allows connection to the tube 6348 of the air circuit 4170 (see, for example, Figure 7). A connection port 9600 according to an example of the present technology may be connected to a connection port housing 9903 (e.g., see Figure 22 ). The connection port 9600 can be rotated relative to the connection port housing 9903, and the connection with the air circuit 4170 can also be rotated.

[0734] When in use, the connection port 9600 and the connection port housing 9903 can be positioned above the patient's head.

[0735] 5.3.3.7 Forehead support

[0736] Figures 22 to 39 The example of a patient interface of the present technology shown in does not include a forehead support. Variations of patient interfaces of the present technology may include a forehead support.

[0737] 5.3.3.8 Loop

[0738] A patient interface 9000 according to an example of the present technology may include a conduit 9900 to provide a flow of pressurized air from a connection port 9600 to a cavity 9001 in a plenum chamber 9200. The conduit 9900 may be similar to Figure 6 The lateral portion 3302 and the upper portion 3304 and Figure 7 The conduit 9900 can be connected to the top of the patient's head at the connection port housing 9903 and can be passed along the side of the patient's head between the patient's eyes and ears. The conduit 9900 can be connected to the cushion assembly 9105 (e.g., the plenum 9200) via a conduit connector 9800, as described below, to provide a pressurized air flow to the cavity 9001.

[0739] The catheter 9900 may also stabilize and position the seal-forming structure 9100 on the patient's face. Thus, the catheter 9900 may function similarly to a tie that positions and stabilizes the structure 9300. Thus, the mechanical connection between the catheter 9900 and the catheter connector 9800 may be sufficient to allow tension in the catheter 9900 to be transmitted through the catheter connector 9800 to the seal-forming structure 9100.

[0740] The catheter 9900 may include features similar to the catheter disclosed in International Application Publication No. WO 2017 / 124155 A1, the entire contents of which are incorporated herein by reference. For example, the catheter 9900 of the present technology may include features similar to the catheter disclosed in International Application Publication No. WO 2017 / 124155 A1, the entire contents of which are incorporated herein by reference. Figures 3A to 3L Features of the headband tube 3350 as described in and in the associated written description.

[0741] The catheter 9900 may also be provided with a sleeve 9901 to cushion the patient's face against the catheter 9900. The sleeve 9901 is removable. The sleeve 9901 may be made of a breathable material.

[0742] The catheter 9900 may also include a tether connector 9902 to facilitate connection to the tether of the positioning and stabilizing structure 9300.

[0743] 5.3.3.9 Catheter connector

[0744] like Figures 26 to 33 As shown, according to an example of the present technology, the patient interface 6000 can include a conduit connector 6800 of the patient interface 6000. The conduit connector can connect the conduit to the cushion assembly 6105 to provide a flow of pressurized air to the cavity 6001. These conduit connectors 6800 can be similar to the conduit connector 9800 (e.g., see Figures 22 to 25 ), the following description is equally applicable to catheter connector 9800.

[0745] The catheter connectors 6800 can each be formed with a catheter connector housing 6801. The catheter connectors 6800 can provide other functions, as described below, such as venting of the plenum chamber 6200, connection to a positioning and stabilizing structure, and prevention of asphyxiation by including an anti-asphyxiation valve 6850.

[0746] exist Figures 26 to 33 In FIG, a catheter connector 6800 is shown attached to the plenum 6200 at a plenum hole (e.g., see similar plenum hole 9210). As can be seen, there is a catheter connector 6800 on each side of the cushion assembly 6105, and each catheter connector 6800 is connected to the plenum hole on each corresponding side of the cushion assembly 6105. The catheter connectors 6800 can each include a catheter connector attachment structure to connect each catheter connector 6800 to the corresponding plenum hole at a connection edge (not shown). The connection can be mechanical, such as a snap fit or a friction fit. The connection can also be removable. The material of the catheter connector 6800 and the material of the plenum 6200 can each be selected to promote desired connection characteristics. For example, the material of the catheter connector 6800 and the material of the plenum 6200 can each be relatively rigid to allow for audible and / or tactile feedback associated with the snap fit. In at least one aspect, the material of the catheter connector 6800 and the material of the plenum 6200 can be different, or the materials can be the same. The catheter connector 6800 may also be permanently connected to the plenum chamber at the plenum chamber hole. For example, the catheter connector 6800 may be ultrasonically welded to the plenum chamber 6200. The connection between the catheter connector 6800 and the plenum chamber 6200 (whether removable or permanent) may also be determined to be sufficiently secure so that tension from the catheter can be transferred to the plenum chamber 6200 without disrupting the connection, because, as explained above, the catheter connector 6800 may facilitate positioning and stabilization of the seal-forming structure 6100 on the patient's head.

[0747] The conduit connector 6800 can also be attached to the side of the plenum 6200 to improve the aesthetics of the patient interface 6000. As explained above, the plenum 6200 can be constructed of a transparent or translucent material, which can allow the patient's facial features to be visible. By positioning the conduit connector 6800 laterally on the plenum, for example, as shown in the depicted example, more of the patient's face is visible, and this arrangement can improve the aesthetics of the patient interface 6000. This is in contrast to an alternative design in which the elbow and air circuit can be connected to the center of the plenum 6200, thereby obscuring the view of the patient's face.

[0748] The catheter connectors 6800 may also each include a connector that connects to a corresponding catheter (e.g., similar to Figure 22 The catheter 9900 in FIG. 6 is a diagram illustrating a catheter connection end 6802 of the patient's face. The connection between the catheter and the catheter connector 6800 at the catheter connection end 6802 can be removable or permanent. A catheter connector inlet port 6803 can be formed in the catheter connector housing 6801 at the catheter connection end 6802 to receive the pressurized air flow. The catheter connector 6800 can include, for example, undercut features to facilitate a removable, snap-fit ​​connection with the corresponding catheter, and each catheter can include a relatively rigid feature at the end connected to the catheter connector 6800 to facilitate such connection. The catheter connector 6800 can also be connected to the catheter via a friction fit, a snap fit, or any similar fit. Again, as explained above, the catheter can provide positioning and stabilization functions to position the seal-forming structure in a therapeutically effective sealing position on the patient's face. Therefore, the connection between the catheter at the catheter connection end 6802 and the catheter connector 6800 can be sufficiently secure to allow tension from the catheter to be transmitted to the catheter connector 6800 without damaging the connection between the catheter at the catheter connection end 6802 and the catheter connector 6800.

[0749] like Figure 29 As shown, the catheter connector 6800 can also provide ventilation functionality for the patient interface 6000. The catheter connector housing 6801 can include a vent inlet that is in pneumatic communication with the cavity 6001 when the patient interface 6000 is assembled. The catheter connector housing 6801 can also include at least one catheter connector vent hole 6831. As can be seen from the depicted example, each catheter connector housing 6801 includes a plurality of catheter connector vent holes 6831. This ensures that the newly introduced air is fully mixed with the air already present in the plenum 6200, which can enhance carbon dioxide washout and increase the amount of fresh air provided to the patient for breathing.

[0750] like Figures 22 to 24As shown, a similar catheter connector 9800 can also provide a connection to the tether of the positioning and stabilizing structure 9300. The lower tether can be connected to the catheter connector 9800 by a clip 9301. The clip 9301 and the catheter connector 9800 can include magnets with opposite polarities to facilitate the connection. The connection between the tether of the positioning and stabilizing structure 9300 and the catheter connector 9800 can be releasable. The tension from the lower tether of the positioning and stabilizing structure 9300 can cause the lower portion of the seal-forming structure 9100 to seal with the patient's face, for example, around the mouth. Alternatively, a structure for connecting to the clip 9301 can be formed directly on the catheter connector housing.

[0751] 5.3.3.10 Anti-suffocation valve

[0752] In one form, the patient interface 6000 includes an anti-asphyxia valve. Figure 30 and 31 As best shown, each catheter connector 6800 can include an anti-asphyxia valve assembly 6850. Thus, the patient interface 6000 can include two anti-asphyxia valve assemblies 6850. Each anti-asphyxia valve assembly 6850 can operate independently of the other (i.e., in response to the air flow ceasing pressurization). For example, if the patient is sleeping on their side when the air flow ceasing pressurization, and one of the anti-asphyxia valve assemblies 6850 is blocked, for example, by a pillow, the other anti-asphyxia valve assembly 6850 can be used to prevent the patient from suffocating. Although not explicitly shown, Figures 22 to 25 The patient interfaces 33-1 to 39 may also include at least one anti-asphyxia valve.

[0753] 5.3.3.11 Port

[0754] In one form of the present technology, the patient interface 6000 includes one or more ports that allow access to the volume within the plenum chamber 6200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows for direct measurement of properties of the gas within the plenum chamber 6200, such as pressure. Although not explicitly shown, Figures 22 to 25 The patient interfaces 33-1 to 39 may also include at least one port.

[0755] 5.3.4 Arrangement of supporting structure and sealing parts

[0756] The support structure and sealing portion of the examples described above can have many different configurations and arrangements.

[0757] In use, the sealing portion 3130 (e.g., a fabric membrane) can be maintained in sealing contact with the patient's face by: 1) the reactive stress of the support structure 3120; 2) the preformed state of the fabric membrane 3130, which is formed as an untensioned but substantially constant surface without leak-causing discontinuities such as wrinkles, creases, bends, or folds in the fabric membrane 3130; and / or 3) the air pressure within the cavity against the inner surface of the sealing portion 3130. Each of these factors can cause the sealing portion 3130 to conform to the anthropometric contours of the patient's face, thereby minimizing wrinkles or blowout and maximizing the contact area of ​​the sealing portion 3130. Due to any of these factors, tension in the sealing portion 3130 may increase, but the sealing portion 3130 may return to a relaxed state if the offending factor is eliminated.

[0758] In some examples, the sealing portion 3130 may include a relatively thin, compliant, stretchable elastic material, such as a fabric membrane comprising a suitable fabric material (e.g., nylon, polyester, a nylon and polyester blend, microfiber, or polyurethane). The sealing portion 3130 may be molded or otherwise attached (e.g., adhered, glued) to the support structure 3120 so that there are no wrinkles in the material of the sealing portion 3130. This may be advantageous in ensuring that the sealing portion forms a smooth and continuous seal on the patient's face without any folded portions that may leak air. In addition, the sealing portion 3130 may be shaped or imparted with a curvature. The support structure 3120 may also impart a curvature to the sealing portion 3130. In the example shown, the sealing portion 3130 may include curvatures about multiple axes. This can help the sealing portion 3130 contour to the complex facial structures of different patients.

[0759] For example, Figures 12 to 21 As shown, the sealing portion 3130 can have a concavely curved profile from one side (right) to the opposite side (left) (e.g., a positive arch curvature in the left-right direction) to cradle the patient's nose when the patient interface 3000 is worn. In other words, the curvature of the sealing portion 3130 is positive relative to the location where the patient's columella and / or subnasal point contacts the sealing portion 3130.

[0760] In some forms, such as Figures 11 to 39 As shown in FIG, the patient's nose is not intended to be accommodated in the cavity 3101 formed by the plenum chamber 3200 and the seal-forming structure 3100. Instead, unlike conventional masks, the patient's nose is intended to be pressed against the fabric membrane 3130, which in turn adapts to the contours of the patient's face to comfortably form a reliable seal with the patient's airway. The fabric membrane 3130 can be stretched to fit the patient's face. Specifically, before contact with the patient, Figures 11 to 21 Fabric membrane 3130 and Figure 31-1 to 39 can be maintained in a relatively relaxed (i.e., untensioned) state. When the patient contacts the fabric membrane 3130 (e.g., through their nose), the seal-forming structure 3100 forms to the patient's face (e.g., their nose) due to its compliant, stretchable nature. In other words, the contact with the patient's face applies tension to the fabric membrane 3130 and forms it into a shape that complements the patient's nose. The relaxation in the initial formation of the seal-forming structure 3100 can allow for better contouring of the patient's face than if the seal-forming structure 3100 were initially in a tensioned state because there are fewer locations where the shape can be changed. Some examples include a bridging portion 3104 that can be used to help provide a sealing portion that presses against the patient's nose rather than accommodating the patient's nose within the cavity 3101 by eliminating a central opening on the fabric membrane 3130. The bridging portion 3104 can create a position where the patient can apply tension to the fabric membrane 3130, causing the seal-forming structure 3100 to fit snugly and / or against the patient's facial features (e.g., to limit and / or prevent leakage). This also creates a different sealing experience compared to conventional masks. This sealing experience can provide enhanced comfort due to contact with the compliant fabric membrane 3130, rather than with the harder materials of conventional masks or conventional sealing arrangements, in which the sealing portion 3130 has a smaller contact area around the nose and / or mouth. The bridging portion 3104 (or any area that is selectively tensioned) can create a position where the patient can apply tension to the fabric membrane 3130, regardless of whether the bridging portion 3104 is located near the at least one aperture.

[0761] Prior to contact with the patient, the fabric membrane 6130 (e.g., the first sealing portion 6131) can be maintained in a relatively taut state (e.g., the first sealing portion 6131 can be under continuous tension). When the patient contacts the fabric membrane 6130 (e.g., through their nose), the seal-forming structure 6100 forms to the patient's face (e.g., their nose) due to its compliant, stretchable nature. In other words, contact with the patient's face applies additional tension to the fabric membrane 6130 and causes it to form a shape that complements the patient's nose. The entire first sealing portion 6131 can function in a similar manner to the bridge portion 3104 described above in that it can create a position where the patient can apply tension to the fabric membrane 6130, thereby causing the seal-forming structure 6100 to fit snugly and / or against the patient's facial features (e.g., to limit and / or prevent leakage). When the fabric membrane 6130 is stretched taut, the material can be soft or elastic so that the material can adapt to the patient's facial features by applying additional tension. The pretension in the first sealing portion 6131 combined with the pressurized seal created by the pressurized air flow can create a stronger seal (e.g., in patient interfaces 3000, 9000, 21000, 23000, 25000) than having only a pressurized seal created by the pressurized air flow.

[0762] Compared to conventional silicone membranes and compressed foam seals, the sealing portion 3130 in some of the present examples has a more flexible structural rigidity and thus a dynamic rebound property that enables the sealing portion 3130 to recover more quickly when disturbed by external forces. In addition, due to the lower structural rigidity, less sealing force is required, allowing the sealing portion 3130 to be more comfortable and form fewer facial marks during use.

[0763] The fabric membrane 3130 may exhibit variable tension throughout the material (e.g., having less tension near the nostril openings 3102 or in wider stretches of the material). The fabric membrane 6130 may also exhibit less tension near the nostrils 6103 because the central portion of the fabric membrane 6130 may be less supported and slightly looser than the perimeter of the fabric membrane 6130. In some forms, the surface of the material of the sealing portion (e.g., 3130) that contacts the patient's face may have low-friction properties (e.g., a low-friction finish), which may advantageously improve the conformability of the material to the patient's face while also improving patient comfort.

[0764] The fabric membrane 3130 can exhibit variable tension on the material (e.g., greater tension near the bridge portion 3104). The fabric membranes 9130, 21130, 23131, 23132, 25131, 25132 can exhibit similar variable tension. In some forms, the surface of the material of the fabric membrane 3130 that contacts the patient's face can have low-friction properties (e.g., a low-friction finish), which can advantageously improve the conformability of the material to the patient's face while also improving patient comfort.

[0765] In some examples, the underlying cushioning layer (e.g., portion or second wall 3126) can help optimize the surface area of ​​contact between the sealing portion 3130 and the patient's face. Additionally, in examples where the sealing portion 3130 is comprised of a breathable material (e.g., a breathable fabric), the underlying cushioning layer can provide sufficient contact area behind the sealing portion to adequately seal the sealing portion against the patient's face and prevent leakage.

[0766] The bottom cushion layer can provide additional flexibility and allow the cushion to fit most patients' faces (e.g., one-size-fits-all). For example, the sealing portion can be configured as a dual air-assisted sealing portion (e.g., a dual fabric membrane), a sealing portion with a compression support (e.g., open-cell foam, polyurethane foam, gel), a sealing portion with a TPU, TPE, or silicone support, or a dual air-assisted sealing portion with an additional support (e.g., a dual fabric membrane with an inner membrane having a foam laminate layer (e.g., open-cell, polyurethane) or a TPU, TPE, polyurethane, or silicone molded layer thereon).

[0767] In use, the engagement of the patient's face 1000 with the sealing portion 10130 will create temporary strain forces that attempt to pull the walls of the support structure 10120 toward each other, as shown in FIG. Figure 43 As shown, the support structure 10120 will respond to the strain force with a reaction force that pulls outward. The reaction force transfers more tension to the sealing portion 10130 by preferentially stretching the more compliant sealing portion, which creates a resultant spring force in the sealing portion that is applied to the patient's face.

[0768] The sealing portion 10130 can be integral with the support structure 10120 by molding or otherwise attaching the sealing portion 10130 to the inner edge of the support structure 10120. Thus, for example, the outer periphery of the sealing portion 10130 can be attached to the inner edge of the support structure 10120 such that the sealing portion 10130 extends beyond or radially further than the support structure 10120 radially inward of the seal-forming structure. The inner edge of the support structure 10120 can be curved such that the sealing portion 10130 can be angled slightly inward toward the interior of the mask. By attaching the sealing portion 10130 along the inner edge of the support structure 10120, the sealing portion 10130 does not need to be folded or cut to fit around the corners of the support structure 10120. This can help reduce the occurrence of prominent creases or wrinkles in the sealing portion 10130, which can cause leaks, thereby improving the performance of the seal.

[0769] 5.3.4.1 Fabric membrane

[0770] According to an example of the disclosed technology, the seal-forming structure 3100 may include a fabric membrane 3130 comprising a fabric material (e.g., see 10133). The fabric material may have an airtight diaphragm / membrane or layer coated or otherwise applied thereto to produce an airtight fabric composite material. The fabric composite material may be cut (e.g., die-cut, ultrasonic, laser, or RF-cut) into a desired shape and then attached to the support structure 3120. The resulting fabric sealing portion 3130 (or fabric membrane) may be attached to the support structure 3120 (e.g., silicone, TPE), for example, by overmolding or injection molding. In another example, the fabric sealing portion 3130 may be heat welded at its edge (outer periphery) to the material (e.g., silicone, TPE) of the support structure 3120. In another example, the fabric sealing portion 3130 may not be coupled to the support structure 3120, and the gasket interface 3105 may be substantially constructed of a fabric material.

[0771] In some examples, ultrasonic cutting can be used to produce a fabric membrane 3130 with minimal wear. For example, using an ultrasonic cutting process can melt the edges of the cut material and limit wear (e.g., compared to other cutting processes). This can increase the durability of the fabric membrane 3130 and limit leaks or other defects.

[0772] In certain versions, a sheet of fabric membrane 10135 may be cut into fabric membrane 3130 by ultrasonic processing using a stationary sonotrode and a rotating knife. This may produce a fabric membrane 3130 with limited wear.

[0773] The material can be cut into various patterns to produce the maximum number of fabric membranes 3130 on a given piece of material. For example, the cushion components 3105 (and therefore the fabric membranes 3130) can have different sizes (e.g., to fit patients of different sizes). The material can be cut in different orientations (e.g., horizontal or vertical) and with one or more sizes of fabric membranes 3130 to minimize material waste.

[0774] In one example, the fabric material 10133 is a stretch fabric. This can include knitted materials, woven materials or any other suitable material. In particular, compared to woven materials, knitted materials may be preferred because they provide elasticity (e.g., stretchability) to the fabric. As described below, this may be advantageous in providing comfort to the patient. The elasticity can be in all directions (e.g., four-wa...

Claims

1. A patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the patient's airway including at least the entrance to the patient's nares, wherein: The patient interface is configured to maintain a therapeutic pressure within a range of 4 cmH2O to 30 cmH2O above ambient air pressure during the patient's breathing cycle while the patient is sleeping, so as to improve sleep-disordered breathing; the patient interface comprises: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive the flow of air at the therapeutic pressure for breathing by a patient; and The seal forms a structure comprising: a membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face below a nasal bridge region of the patient's face surrounding the entrance to the patient's airway, the membrane being a fabric or elastomeric membrane and having two apertures such that the flow of air at the therapeutic pressure is delivered to at least at least one entrance to the patient's nostril, the seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure in the cavity throughout the patient's breathing cycle; wherein the membrane comprises a three-dimensional shape having a plurality of curvatures; wherein the two apertures comprise a first aperture and a second aperture, the first aperture and the second aperture each being configured to be positioned adjacent one of the patient's nostrils in use; wherein the bridging portion is arranged between the first hole and the second hole; wherein the membrane comprises a first arch on a side of the first hole and a second arch on a side of the second hole; wherein the first arch forms a first saddle-shaped area arranged on a side of the first hole and the second arch forms a second saddle-shaped area arranged on a side of the second hole, the first saddle-shaped area and the second saddle-shaped area being in a relaxed state before use; and wherein the first arch and the second arch are configured to be inverted into a cavity after contact with the patient's nostril and to move to a generally taut state during use.

2. A patient interface according to claim 1, wherein The film includes a first layer and a second layer coupled to the first layer.

3. A patient interface according to claim 2, wherein: The film is the elastic film, and the first layer is coupled to the second layer by an adhesive.

4. A patient interface according to claim 3, wherein: The first layer is generally homogeneous, and the second layer is formed from a non-homogeneous matrix structure configured such that the elastic membrane is anisotropic.

5. A patient interface according to claim 4, wherein: The second layer is formed of a plurality of spaced-apart spherical or cylindrical structures.

6. A patient interface according to claim 5, wherein: The membrane is configured to seal against at least the underside of the patient's nose in use.

7. A patient interface according to claim 6, wherein: The bridge portion is maintained in tension prior to contact with the patient's face.

8. A patient interface according to claim 7, wherein: The bridge portion is curled to maintain a greater tension than the remainder of the membrane.

9. A patient interface according to claim 8, wherein: The membrane includes a fabric layer coupled to a silicone layer.

10. A patient interface according to claim 9, wherein: The fabric layer is configured to be cut from the sheet of material using ultrasonic cutting.

11. The patient interface of claim 9, wherein: The fabric layer is a breathable material and is configured to allow air flow through and contact the patient's skin to provide cooling and / or moisture wicking.

12. The patient interface of claim 8, wherein: The membrane is connected in the three-dimensional shape to a flexible support structure of the seal-forming structure.

13. A patient interface according to claim 12, wherein: The seal-forming structure comprises a single wall, and wherein one end of the flexible support structure contacts the membrane.

14. A patient interface according to claim 12, wherein: The seal-forming structure includes a pair of walls, wherein the flexible support structure includes a free end and the membrane is coupled to the flexible support structure distal to the free end, and wherein the free end is spaced apart from the membrane such that the membrane is disposed radially outward of the free end.

15. The patient interface of claim 8, wherein: The membrane includes a primary curvature about a first axis intersecting the first aperture and the second aperture, wherein the primary curvature is a negative dome curvature.

16. A patient interface according to claim 15, wherein A second axis is inclined relative to the first axis, and the membrane includes a second curvature about the second axis, wherein the second curvature forms a third saddle-shaped region.

17. A patient interface according to claim 16, wherein: The second curvature is configured to contact the patient's upper lip in use.

18. A patient interface according to claim 16, wherein: A third axis extends transverse to the second axis and parallel to the first axis, the membrane including a third curvature about the third axis, wherein the third curvature forms a fourth saddle-shaped region.

19. A patient interface according to claim 18, wherein The third curvature includes a variable radius of curvature.

20. The patient interface of claim 18, wherein The third curvature extends to the primary curvature near an edge of the membrane.

21. The patient interface of claim 8, wherein: The first arch of the first aperture is movable between a first position in the relaxed state prior to use and a second position in which the first arch has been inverted into the cavity.

22. A patient interface according to claim 21, wherein The first aperture comprises a generally teardrop shape in the second position.

23. A patient interface according to claim 22, wherein The first arch of the first hole may be further moved to a third position due to an additional external force, and the first arch is configured to be tensioned in the third position.

24. A patient interface according to claim 23, wherein The generally teardrop-shaped corners extend to a generally circular perimeter at the third location.

25. A patient interface according to claim 21, wherein In the second position, the first aperture is configured to contact a perimeter of the entrance of one of the patient's nostrils proximate the alar rim.

26. A patient interface according to claim 21, wherein The arcuate shape of the second aperture is movable between the first position and the second position.

27. A patient interface according to claim 21, wherein The first aperture comprises a generally tear drop shape at the first location prior to contact with the patient's face.

28. A patient interface according to claim 27, wherein In use, the generally teardrop-shaped corners extend to a generally circular perimeter in the second position.

29. A patient interface according to any one of claims 1 to 28, wherein The membrane comprises a silicone layer having impermeable properties.

30. A patient interface according to claim 1, wherein The membrane comprises a silicone layer having impermeable properties, and wherein the membrane comprises a fabric layer coupled to the silicone layer.

31. A patient interface according to claim 30, wherein The fabric layer is configured to be cut from the sheet of material using ultrasonic cutting.

32. A patient interface according to claim 30, wherein The fabric layer is configured to allow air flow therethrough to provide cooling and / or moisture wicking to the patient.

33. A patient interface according to claim 30, wherein The film is an elastic film, and the silicone layer includes a first sub-layer and a second sub-layer.

34. A patient interface according to claim 33, wherein The first sub-layer is substantially uniform, while the second sub-layer is non-uniform.

35. A patient interface according to claim 34, wherein The second sub-layer is formed of a plurality of spaced-apart structures configured to provide anisotropic properties to the elastic membrane.

36. A patient interface according to claim 30, wherein The film includes a curled portion to selectively apply local tension.

37. A patient interface according to claim 33, wherein The silicone layer is 20 microns to 100 microns thick.

38. A patient interface according to claim 33, wherein The silicone layer has low hardness characteristics.

39. A patient interface according to any one of claims 1 to 28, wherein The patient interface is a nose pad, a nose support, a mouth-nose pad, an ultra-compact full-face mask or a full-face mask.

40. A patient interface according to claim 1, wherein The arch is configured to initially maintain the relaxed state after being inverted into the cavity.

41. A patient interface according to any one of claims 1 to 28, wherein The arch is configured to have a teardrop shape after being inverted into the cavity.

42. A patient interface according to claim 41, wherein The teardrop-shaped corners are configured to expand into a rounded shape during use.

43. A patient interface according to any one of claims 1 to 28, wherein The portion of the membrane immediately adjacent the periphery of each of the two apertures forms a dome region and / or a fifth saddle region in the non-use state of the patient interface.

44. A patient interface according to claim 43, wherein The portion of the membrane immediately adjacent the periphery of each aperture forms the fifth saddle region in the non-use state.

45. A patient interface according to claim 43, wherein The portion of the membrane immediately adjacent the periphery of each of the two apertures forms the dome region and / or the fifth saddle region in the operational state of the patient interface.

46. ​​A patient interface according to claim 1, wherein The membrane is the fabric membrane and comprises a fabric material and a silicone air-impermeable layer.

47. A patient interface according to claim 46, wherein The fabric membrane is attached to a flexible support structure of the seal-forming structure.

48. A method of constructing a patient interface, the method comprising: providing a mold having a shape corresponding to the film of any one of claims 1 to 28; introducing a liquid material into the mold to form the three-dimensional shape of the film; as well as The mold is separated.

49. The method of claim 48, further comprising applying a fabric layer to at least a portion of the membrane after separating the mold.

50. The method of claim 49, further comprising providing a sheet of fabric material and cutting the sheet of fabric material into the shape corresponding to the membrane using ultrasonic cutting to form the fabric layer.

51. The method of claim 49, further comprising forming the fabric layer by curling the membrane into a three-dimensional shape corresponding to the shape of the membrane after applying the fabric layer.

52. A patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airway, the patient's airway including at least the entrance to the patient's nares, wherein The patient interface is configured to maintain a therapeutic pressure within a range of 4 cmH2O to 30 cmH2O above ambient air pressure during the patient's breathing cycle while the patient is sleeping, so as to improve sleep-disordered breathing; the patient interface comprises: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum inlet port sized and configured to receive the flow of air at the therapeutic pressure for breathing by a patient; and The seal forms a structure having: a silicone support structure; and a fabric membrane attached to the support structure along an outer periphery of the fabric membrane such that the fabric membrane extends radially inward beyond the support structure; the fabric membrane being configured to be pressed against the patient's face in use such that the patient's nose is not received in the cavity; The fabric membrane is constructed and arranged to form a seal, in use, with an area of ​​the patient's face below the nasal bridge area of ​​the patient's face surrounding the entrance to the patient's airway, the fabric membrane having at least one aperture such that the 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 maintain the treatment pressure in the cavity throughout the patient's breathing cycle, the fabric membrane comprising: a first layer constructed of a fabric material and configured to contact the patient's face; and a second layer coated directly on the first layer, the second layer being constructed of an elastomeric material and forming a portion of an inner wall of the cavity; wherein the fabric membrane has a three-dimensional shape having a plurality of curvatures; wherein the elastic material of the second layer is air-impermeable; and Wherein, the fabric material is breathable such that, in use, the fabric material is configured to allow the air flow to pass through the fabric material, thereby providing a cooling effect to the patient's skin.

53. A patient interface according to claim 52, wherein At least the fabric material of the fabric membrane is cut from a sheet of material using ultrasonic cutting.

54. A patient interface according to claim 53, wherein The entirety of the fabric membrane is cut from the sheet of material using ultrasonic cutting.

55. A patient interface according to claim 53, wherein The perimeter of the first layer is configured to be substantially free of wear due to the ultrasonic cutting.

56. A patient interface according to claim 52, wherein The second layer is an airtight layer.

57. A patient interface according to claim 52, wherein The first layer is a breathable layer.

58. A patient interface according to claim 52, wherein The first layer is exposed around at least a portion of a perimeter of the at least one aperture of the fabric membrane.

59. A patient interface according to any one of claims 52 to 58, wherein The first layer is configured to receive a portion of the air flow exiting the plenum through the at least one aperture of the fabric membrane.

60. A patient interface according to claim 59, wherein The first layer is configured to be positioned between the patient's skin and the second layer and is configured to bounce the air flow between the patient's skin and the second layer.

61. A patient interface according to claim 60, wherein The first layer is configured to allow moisture from the patient's skin to be drawn away by the air flow through the first layer.

62. A patient interface according to any one of claims 52 to 58, wherein The thickness of the second layer is 20 micrometers to 100 micrometers.

63. A patient interface according to any one of claims 52 to 58, wherein The thickness of the first layer is 0.6 mm to 0.8 mm.

64. A patient interface according to claim 52, wherein A bridge portion is formed between the first hole and the second hole of the at least one hole of the elastic material.

65. A patient interface according to any one of claims 52 to 58, wherein In use, the fabric membrane is configured to allow the air flow to enter the fabric material in a first direction at an angle that is non-perpendicular to a thickness direction of the fabric material.

66. A patient interface according to any one of claims 52 to 58, wherein The resilient material comprises an arch on a side of the at least one aperture, the arch being in a relaxed state prior to use and the arch being configured to move to a substantially taut state in use.

67. A patient interface according to any one of claims 52 to 58, wherein The patient interface is a nose pad, a nose support, a mouth-nose pad, an ultra-compact full-face mask or a full-face mask.

68. A patient interface according to any one of claims 52 to 58, wherein The second layer includes a first sub-layer and a second sub-layer coupled to the first sub-layer.

69. A patient interface according to claim 65, wherein In use, the fabric membrane is configured to allow the air flow entering the fabric material to be redirected from the patient's nose in a second direction back into the fabric material to flow through the fabric material between the patient's nose and the second layer until the air flow reaches ambient air.

70. A patient interface according to claim 69, wherein The first direction is different from the second direction.

71. A patient interface according to claim 68, wherein The first sub-layer is substantially uniform and the second sub-layer is formed from a non-uniform matrix structure configured to render the elastic material anisotropic, wherein the second sub-layer is formed from a plurality of spaced-apart spherical or cylindrical structures.

72. A patient interface according to claim 68, wherein The first sub-layer has a thickness of 0.01 mm to 0.05 mm.

73. A patient interface according to claim 72, wherein The thickness of the second sub-layer is equal to the thickness of the first sub-layer.

74. A patient interface according to claim 72, wherein The thickness of the second sub-layer is smaller than the thickness of the first sub-layer.

75. A patient interface according to claim 68, wherein The first sub-layer has a porosity of 30 gsm to 50 gsm.

76. A patient interface according to claim 75, wherein The second sub-layer has a lower porosity than the first sub-layer.

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