Patient Interface

Abstract

To provide novel medical equipment used for screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory diseases.SOLUTION: A patient interface including a pair of connection parts protruding sideways configured to be connected to a gas delivery tube part, a seal formation structure, and a ventilation part is disclosed. The seal formation structure can include a central part configured to seal a lower side periphery part of the nose of a patient when used and a pair of side rear areas. The respective side rear areas can include a connection release part configured to at least partially release connection of the central part from each of the connection parts protruding sideways. The seal formation structure can include a rigid part, a central front part having an upper part of higher rigidity than a lower part, a central side front part having an upper part more rigid than the lower part, and / or an upper lip part having a front part more rigid than a rear part. A chassis part can be formed of a flexible material. The chassis part can include a chassis upper reinforcement part.SELECTED DRAWING: Figure 7A

Description

[Technical field]

[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 reproduction by any person of this patent document or the patent disclosure by facsimile, for purposes of disclosure in the Patent and Trademark Office patent file or records, but reserves all copyright rights thereto for all other purposes.

[0002] 1 CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Australian Patent Application No. 2019902580 (filed July 22, 2019), Australian Patent Application No. 2019904852 (filed December 20, 2019), Singapore Patent Application No. 10202001774V (filed February 27, 2019), Australian Patent Application No. 2020901769 (filed May 29, 2019), and Australian Patent Application No. 2020901770 (filed May 29, 2019), the entire contents of which are incorporated herein by reference.

[0003] 2. Technology Background 2.1 Technology field decomposition part The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof. [Background technology]

[0004] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0005] These airways contain a series of branching tubes that become narrower, shorter and more numerous the deeper they go into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and finally into alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0006] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0007] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD) and chest wall diseases.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes such as closure or obstruction of the upper airway during sleep. It is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the area of ​​the tongue, soft palate and posterior oropharyngeal wall during sleep. Due to this condition, affected patients typically experience breathing cessation for 30-120 seconds, sometimes as many as 200-300 times per night. This results in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. The condition is common, especially in middle-aged overweight men, but patients are asymptomatic. See U.S. Pat. No. 4,944,310: Sullivan.

[0009] Respiratory failure is a general term for respiratory disorders that result in the inability to get enough oxygen or enough CO to meet the patient's needs. 2 It refers to the inability of the lungs to exhale air. Respiratory failure can include some or all of the following conditions: Obesity Hypopnea Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disorders (NMD) and chest wall disease.

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

[0011] A range of treatments are available to treat or ameliorate such conditions, and otherwise healthy individuals may also benefit from preventative treatments for respiratory disease, but these suffer from a number of deficiencies.

[0012] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above respiratory disorders, including continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV) and invasive ventilation (IV).

[0013] Continuous positive airway pressure (CPAP) therapy has been used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy acts as a pneumatic splint, for example by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, which may prevent the upper airway from closing. Because the treatment of OSA with CPAP therapy may be voluntary, patients may choose not to comply with the treatment if they perceive one or more of the following from the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0014] 2.2.3 Treatment system These therapies may be provided by a therapeutic system or device. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

[0015] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0016] Another form of treatment system is a mandibular repositioning device.

[0017] 2.2.3.1 Patient Interface The patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example by providing airflow to an airway inlet. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may form a seal with, for example, an area of ​​the patient's face, thereby providing a pressure at which there is sufficient dispersion with atmospheric pressure for therapy to be performed (e.g., approximately 10 cmH above atmospheric pressure). 2 In other forms of therapy, such as oxygen delivery, the patient interface provides a pressure of approximately 10 cmH 2 They may not contain a sufficient seal to facilitate delivery of the gas supply to the airways at positive O pressures.

[0018] Certain other mask systems may be functionally inadequate in the field, for example masks that are purely decorative may not be able to maintain adequate pressure, mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0019] Certain masks may be clinically unsuitable for use with this technology (eg, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0020] In certain masks, where the patient must insert part of the mask structure into their mouth and create and maintain a seal via the lips, this may be uncomfortable or impractical in the art.

[0021] Certain masks may be impractical for use while sleeping (eg, when sleeping on one's side in bed with head on a pillow).

[0022] There are several challenges in designing a patient interface: The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces; i.e., the chin or mandible may move relative to other bones of the skull. The entire head may move throughout the respiratory treatment period.

[0023] These challenges may result in one or more of the following: some masks may be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if the wear time is long or the patient is unfamiliar with the system. If the wrong size mask is used, this may lead to poor compliance, poor comfort, and poor patient outcomes. While masks designed specifically for aviators, as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for anesthesia administration may be tolerable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., several hours). Such discomfort may result in poor patient compliance with the treatment. This is especially true if the mask must be worn while sleeping.

[0024] CPAP therapy is highly effective in treating certain respiratory diseases if the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect patient compliance.

[0025] Masks for other uses (e.g., for aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0026] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0027] 2.2.3.1.1 Seal formation structure The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0028] The patient interface may be characterized in part according to the design intent of where the seal-forming structure engages the face in use. In one form of the patient interface, the seal-forming structure may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that encloses both nostrils in use. Such a single element may be designed to rest, for example, on the upper lip region and nose bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that encloses the mouth region 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 encloses both nostrils and the mouth region in use. These different types of patient interfaces may be known by various names by their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0029] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swim goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0030] A particular seal-forming structure may be designed for mass production so that one design will fit, be 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 the mass-produced patient interface, one or both may need to be adapted in order to form a seal.

[0031] 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 force is applied to the patient interface with the seal-forming structure engaging against the patient's face. The seal-forming structure may include an air or fluid filled cushion, or may include a molded or formed surface of a resilient sealing element comprised of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will develop between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0032] Another type of seal-forming structure uses a thin flap seal located around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, if the fit between the face and the mask is poor, additional force may be required to achieve a seal or the mask may leak. Additionally, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion may fold or buckle during use, causing leakage.

[0033] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these seal-forming parts uncomfortable.

[0034] Another form of seal-forming structure may use adhesives to achieve a seal. Some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0035] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0036] One form of nasal pillow is found in the Adam line manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Pat. No. 4,782,832 to Trimble et al., assigned to the Puritan-Bennett Corporation.

[0037] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask and MIRAGELIBERTY® Full Face Mask. Embodiments of nasal pillows masks are described in the following patent applications assigned to ResMed Limited: International Patent Application WO 2004 / 073,778 (which describes, among other things, aspects of ResMed Limited's SWIFT® nasal pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® full face mask); and International Patent Application WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX nasal pillows).

[0038] 2.2.3.1.2 Positioning and stabilization Seal-forming structures in patient interfaces used in positive air therapy experience corresponding forces from the air pressure that disrupt a seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0039] In one technique, adhesives are used, see, for example, US Patent Application Publication US2010 / 0000534, but adhesives can be uncomfortable.

[0040] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulkiness, discomfort and awkwardness.

[0041] 2.2.3.1.3 Compressed air conduits In one type of treatment system, a flow of pressurized air is provided to the patient interface through a conduit in the air circuit that is fluidly connected to the patient interface such that when the patient interface is positioned on the patient's face in use, the conduit extends forward from the patient interface and away from the patient's face. This may sometimes be referred to as an "elephant trunk" type interface.

[0042] Some patients find such interfaces unsightly, which can result in poor patient compliance if they stop wearing them. Furthermore, if the conduit is connected to the interface in front of the patient's face, it can easily become entangled with bedding.

[0043] 2.2.3.1.4 Pressurized air conduits used to position / stabilize seal-forming structures Another type of treatment system that attempts to address these problems includes a patient interface in which the tube responsible for delivering pressurized air to the patient's airway also functions as part of the headgear to position and stabilize the seal-forming portion of the patient interface on the appropriate portion of the patient's face. This type of patient interface may also be referred to as using "headgear tubing" or "conduit headgear." Such a patient interface allows a conduit in the air circuit that provides the pressurized air flow from a respiratory pressure treatment device to be provided to the patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. US2007 / 0246043, the contents of which are incorporated herein by reference. In this publication, the conduit connects to a tube in the patient interface through a port positioned on the top of the patient's head in use.

[0044] Using a patient interface with headgear tubing may provide some advantages (e.g., avoiding conduits connecting to the patient interface in front of the patient's face, which can be unsightly and uncomfortable), but it is desirable for a patient interface with headgear tubing to be comfortable while forming an effective seal with the patient's face when worn by the patient for extended periods of time while the patient is asleep.

[0045] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices may be used individually or as part of a system to deliver one or more of the therapies described above, for example by actuating the device to generate an air delivery flow to an interface to the airway. This air flow may be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0046] Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., medical equipment reliability, size, and weight requirements). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0047] One example of a special requirement of a particular RPT device is acoustic noise.

[0048] A device designer may be presented with a myriad of choices. Often, design criteria conflict, making certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular embodiment may be significantly affected by minor changes in one or more parameters.

[0049] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to drying of the airway. When a humidifier is used with the RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[0050] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.

[0051] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when necessary. Bedside medical humidifiers may be small. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, and not the patient's surroundings. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, but these systems also humidify and / or heat the entire room, which may be uncomfortable for the occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0052] Although a number of medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, i.e., some of such medical humidifiers provide inadequate humidification and others are difficult or inconvenient for the patient to use.

[0053] 2.2.3.4 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., the surroundings).

[0054] The vent may include an orifice through which gas may flow when the mask is in use. Many such vents are noisy. Others may become blocked when in use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or airflow concentration.

[0055] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0056] Conventional mask noise table (ISO17510-2:2007, 10cmH at 1m 2 O pressure) [Table 1]

[0057] (*Only one sample was tested at 10cmH in CPAP mode using the test method specified in ISO3744. 2 (Measured at 0

[0058] The sound pressure values ​​of various objects are listed below. [Table 2] [Prior art documents] [Patent documents]

[0059] [Patent Document 1] U.S. Pat. No. 4,944,310 [Patent Document 2] U.S. Pat. No. 4,782,832 Summary of the Invention [Means for solving the problem]

[0060] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0061] A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.

[0062] Another aspect of the present technology relates to methods for use in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0063] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory treatment.

[0064] One form of the present technology involves a patient interface for delivering a supply of pressurized breathable gas to an entrance of a patient airway.

[0065] One aspect of the present technology is a pressure of at least 6 cmH above ambient air pressure. 2 The patient interface includes a plenum chamber pressurizable to a therapeutic pressure of O. The plenum chamber may be at least partially defined by a seal-forming structure of the chassis portion and the patient interface.

[0066] One aspect of the present technology is a cushion module for a patient interface, the cushion module including a chassis portion and a seal-forming structure.

[0067] 3.1 Decoupling sites in the side rear regions of the seal-forming structure

[0068] One aspect of one form of the present technology is a patient interface or cushion module for a patient interface, comprising a chassis portion and a seal-forming structure that together form a plenum chamber. The chassis portion may include laterally projecting connection portions configured for connection to a gas delivery tube portion. The seal-forming structure may include a central portion configured to seal, in use, a lower periphery of the patient's nose surrounding the patient's nares. The seal-forming structure may include decoupling portions each configured to at least partially decouple the central portion from a respective one of the laterally projecting connection portions. The seal-forming structure may further include peripheral portions. The peripheral portions are adjacent to the decoupling portions and are stiffer and / or thicker than the decoupling portions.

[0069] One aspect of one form of the present technology is a patient interface, the patient interface comprising: At least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, said chassis portion including a pair of laterally projecting connectors configured to connect to a gas delivery tube and sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure on said chassis portion partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal forming structure includes: a central portion configured to seal against at least the patient's nasal tip, nasal alar, and upper lip in use; A pair of side rear regions provided on each rear outer side of the seal-forming structure, each side rear region comprising: a decoupling site configured to at least partially decouple a central portion of the seal-forming structure from each one of the laterally projecting connecting portions, the decoupling site being provided within a portion of the lateral rear region configured to be positioned away from and out of contact with the patient's face in use; and a perimeter disposed adjacent the debonding site, at least a portion of the perimeter disposed rearward of the debonding site; The debonding area is stiffer than the surrounding area.

[0070] In examples, (a) a stiffness of each perimeter is greater than a stiffness of a central portion of the seal-forming structure, (b) a stiffness of a decoupling site at each side rear region is greater than a stiffness of a central portion of the seal-forming structure, (c) a wall thickness of the perimeter at each side rear region is greater than a wall thickness of the central portion of the seal-forming structure, (d) a wall thickness of the perimeter at each side rear region is greater than a wall thickness of a decoupling site at each side rear region, (e) a wall thickness of the decoupling site at each side rear region is greater than a wall thickness of the central portion of the seal-forming structure, (f) the decoupling sites at each side rear region are C-shaped when viewed from a side of the seal-forming structure, (g) each of the perimeters partially or fully surrounds each of the decoupling sites, (h) each decoupling site is formed by a recess in an inner surface of the seal-forming structure in each side rear region, and (i) the patient interface further includes a positioning and stabilizing structure that positions the seal-forming structure in a therapeutic position on the patient's head. (j) the patient interface further includes a gas delivery tube portion, the gas delivery tube portion forming part of the positioning and stabilizing structure, each gas delivery tube portion configured to convey air flow from a location on the top of the patient's head to the interior of the chassis portion in use; (k) the central portion of the seal-forming structure is formed from a textile material; (l) the central portion of the seal-forming structure is formed from silicone or another elastomeric material; (m) the lateral posterior regions are formed from silicone or another elastomeric material; (n) the chassis portion is formed from a flexible material; (o) the chassis portion is formed from silicone; (p) the patient interface includes a removable cushion module, the removable cushion module including the chassis portion and the seal-forming structure; and / or (q) the chassis portion is formed from an elastomeric material.

[0071] One aspect of this technology is a pressure of at least 6 cmH above ambient air pressure. 2A patient interface including a chassis portion and a seal-forming structure that together at least partially define a plenum chamber pressurizable to a therapeutic pressure of O. The chassis portion may include a pair of laterally projecting connections configured to connect to a gas delivery tube portion and sized and structured to receive an airflow at a therapeutic pressure for breathing of the patient. The seal-forming structure may be supported by the chassis portion and have at least one hole therein to allow an airflow at said therapeutic pressure to be delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's breathing cycle in use.

[0072] The seal-forming structure may include a central portion configured to, in use, form a seal against the patient's face surrounding the patient's nares (without contacting the bridge of the patient's nose). The seal-forming structure may further include a pair of lateral posterior regions disposed on respective posterior-lateral sides of the seal-forming structure. Each lateral posterior region may include a decoupling site configured to at least partially decouple the central portion of the seal-forming structure from a respective one of the laterally projecting connecting portions. Each lateral posterior region may include a periphery at least partially surrounding a respective decoupling site. At least a portion of the periphery may be disposed posterior to a respective decoupling site. The decoupling sites may be thicker than the periphery.

[0073] 3.2 Stiffening parts in the seal-forming structure One aspect of one form of the present technology is a patient interface or cushion module for a patient interface, including a chassis portion and a seal-forming structure that together form a plenum chamber. The seal-forming structure may include a central portion configured to seal, in use, with a lower periphery of the patient's nose surrounding the patient's nares. The seal-forming structure may further include central lateral portions on either side of the central portion, the central lateral portions configured to be positioned along the patient's ala. The seal-forming structure may further include a stiffening portion disposed at least on a posterior side of the seal-forming structure. The stiffening portion may be stiffer and / or thicker than the central lateral portion. The central lateral portion may be stiffer and / or thicker than the central portion.

[0074] One aspect of one form of the present technology is a patient interface, the patient interface comprising: At least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, the chassis portion being sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient; a seal-forming structure on said chassis portion, said seal-forming structure partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with a patient's facial area surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal forming structure includes: a central portion disposed on a rear side of the seal-forming structure, the central portion being configured to seal against at least the patient's nasal tip, nasal alar, and upper lip in use; a pair of central lateral sections provided on the rear side of the seal-forming structure, each central lateral section being provided on a respective lateral side of the central section and configured to be positioned along a respective ala of the patient's nose in use, each central lateral section being stiffer than the central section; a pair of stiffening portions, each of the stiffening portions extending from a rear side of the seal-forming structure to a front side of the seal-forming structure, the seal-forming structure being configured to be positioned away from the patient's face in use, each stiffening portion being located on each lateral side of the seal-forming structure, each stiffening portion being stiffer than a central lateral portion.

[0075] In an example, (a) each stiffening portion has a negative curvature along a first path from a rear side of the seal-forming structure to a front side of the seal-forming structure, (b) each stiffening portion has zero or a negative curvature along a second path perpendicular to the first path, (c) each stiffening portion includes a front portion disposed on a front side of the seal-forming structure and a rear portion disposed on a rear side of the seal-forming structure, the front portion being stiffer than the rear portion, (d) a thickness of each stiffening portion is greater than a thickness of the rear portion of the stiffening portion, (e) each stiffening portion tapers in thickness between the rear portion of the stiffening portion and the front portion of the stiffening portion, and (f) each stiffening portion has a thickness that is greater than the thickness of the rear portion of the stiffening portion. (g) a stiffening portion has a stiffness greater than a stiffness of an adjacent portion of the anterior seal-forming structure; (h) a stiffening portion has a stiffness greater than a stiffness of an adjacent portion of the posterior seal-forming structure; (i) a stiffening portion has a stiffening thickness greater than a thickness of an adjacent portion of the posterior seal-forming structure; (j) each stiffening portion includes a wall thickness greater than an adjacent region, the greater wall thickness being formed by excess thickness of an inner surface of the seal-forming structure; (k) each stiffening portion is positioned adjacent a respective one of the patient's nasal ala in use; and (l) a shank is provided with a stiffening portion that is adapted to support the stiffening portion. (m) the patient interface includes a pair of laterally projecting connectors configured to connect to the gas delivery tubing sections, each of the gas delivery tubing sections configured to connect to a respective one of the pair of gas delivery tubing sections and receive a gas flow from a respective one of the pair of gas delivery tubing sections; (m) the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including gas delivery tubing sections, each gas delivery tubing section configured to receive an air flow from a connection port on the top of the patient's head and to control the air flow. and delivering the stiffening portion to a respective one of the laterally protruding connection portions of the chassis portion, (n) each stiffening portion is disposed proximate to a respective one of the laterally protruding connection portions, (o) the chassis portion is formed from a flexible material, (p) the chassis portion is formed from silicone or another elastomeric material, (q) the central portion of the seal-forming structure is formed from a textile material, (r) the central portion of the seal-forming structure is formed from silicone or another elastomeric material, and / or (s) the stiffening portion is formed from silicone or another elastomeric material.

[0076] One aspect of this technology is a pressure of at least 6 cmH above ambient air pressure. 2 A patient interface including a chassis portion and a seal-forming structure which together at least partially define a plenum chamber pressurizable to a therapeutic pressure of O. The seal-forming structure may be supported by the chassis portion and have at least one aperture therein to allow an air flow at said therapeutic pressure to be delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use.

[0077] The seal-forming structure may include a central portion on a rear side of the seal-forming structure and configured to, in use, form a seal against the patient's face surrounding the patient's nares (without contacting the patient's bridge of the nose). The seal-forming structure may include a pair of stiffening portions, one stiffening portion disposed on each lateral side of the seal-forming structure. Each stiffening portion may have a front portion on a non-patient-contacting side of the seal-forming structure and a rear portion on the patient-contacting side of the seal-forming structure. The front portions may be thicker than the rear portions.

[0078] 3.3 Center rear support part in seal formation structure One aspect of one form of the present technology is a patient interface or cushion module for a patient interface, including a chassis portion and a seal-forming structure that together form a plenum chamber. The seal-forming structure may include a central portion configured to seal, in use, with a lower periphery of the patient's nose surrounding the patient's nares. The seal-forming structure may further include central lateral portions on either side of the central portion and configured to be positioned along the patient's ala. The seal-forming structure may further include a pair of central posterior supports, each of which is positioned proximate a junction between the central portion and each of the central lateral portions. Each of the central posterior supports may have a stiffness and / or thickness that is greater than the stiffness of the central portion and less than the stiffness of each of the central lateral portions.

[0079] One aspect of one form of the present technology is a patient interface, the patient interface comprising: At least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, the chassis portion being sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient; a seal-forming structure on said chassis portion, said seal-forming structure partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with a patient's facial area surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal forming structure includes: a central portion disposed on a rear side of the seal-forming structure, the central portion configured to seal against at least the patient's nasal tip, the alae of the nose and the upper lip in use; a pair of central side portions provided on the rear side of the seal-forming structure, each central side portion being provided on one side of the central portion, each central side portion being stiffer than the central portion; a pair of central rear supports on the rear side of the seal-forming structure, each of which is adjacent to a junction between the central portion and each of the central lateral portions and is configured to be positioned adjacent a respective lateral rear corner of the base of the patient's nose in use, each of which is stiffer than the central portion and less stiff than each of the central lateral portions;

[0080] In an example, (a) the seal-forming structure includes a pair of posterior corner portions configured to engage, in use, with the patient's face adjacent the patient's nasolabial fold, each central posterior support portion having a lower stiffness than each of the posterior corner portions, (b) the stiffness of each posterior corner portion is greater than the stiffness of each of the central lateral portions, (c) the thickness of each central lateral portion is greater than the thickness of the central portion, (d) the thickness of each central posterior support portion is greater than the thickness of the central portion, (e) the thickness of each central posterior support portion is less than the thickness of each central lateral portion, and (f) each central posterior support portion has a thickness greater than the thickness of each of the central lateral portions. (g) the thickness of each rear corner portion is less than the thickness of each rear corner portion, (h) the thickness of each central rear support portion is tapered and increases approaching each adjacent central side portion, (i) the tapered thickness of each central rear support portion increases approaching the thickness of each adjacent central side portion, (j) the thickness of each central side support portion may be in the range of 0.3 to 0.7 mm, and / or (k) the thickness of each central side support portion may be in the range of 0.4 to 0.6 mm.

[0081] In a further example, (a) the chassis portion includes a pair of laterally protruding connection portions, each of the laterally protruding connection portions configured to connect to and receive a gas flow from a respective one of the pair of gas delivery tube portions; (b) the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including gas delivery tube portions, each gas delivery tube portion configured to receive an air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally protruding connection portions of the chassis portion; (c) a central portion of the seal-forming structure is formed from a textile material; (d) the central portion of the seal-forming structure is formed from silicone or another elastomeric material; (e) the laterally rearward region is formed from silicone or another elastomeric material; (f) the chassis portion is flexible; and / or (g) the chassis portion is formed from silicone or another elastomeric material.

[0082] 3.4 Chassis made of flexible material with stiffener One aspect of one form of the present technology is a patient interface or cushion module for a patient interface, including a chassis portion and a seal-forming structure that together form a plenum chamber. The chassis portion may include a laterally protruding connection portion configured for connection to a gas delivery tube portion. The seal-forming structure may include a central portion configured to seal, in use, with a lower periphery of the patient's nose surrounding the patient's nares. The chassis portion may be formed from a flexible material and may be stiffened by a stiffener. The stiffener may include a vent module.

[0083] One aspect of one form of the present technology is a patient interface, the patient interface comprising: At least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, said chassis portion including a pair of laterally projecting connectors sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure on said chassis portion, said seal-forming structure partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with a patient's facial area surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilizing structure including a pair of gas delivery tube sections, each gas delivery tube section adapted to receive air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally projecting connections of the chassis section; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; the chassis portion and the seal-forming structure are formed from a flexible material; The patient interface further includes a stiffening material disposed on the chassis portion, the stiffening material configured to resist deformation of the chassis portion.

[0084] In an example, (a) the stiffening member is disposed on a front side of the chassis portion, (b) the chassis portion includes a front hole portion configured to receive the stiffening member, (c) the stiffening member includes a vent module including a vent portion, (d) a continuous gas flow caused by the patient's exhalation moves from the interior of the plenum chamber to the atmosphere through a plurality of vent holes included in the vent portion, (e) the plurality of vent holes includes an upper vent hole and a lower vent hole, (f) the plurality of lower vent holes includes one or more upper vent holes and one or more lower vent holes, and (g) the one or more upper vent holes are (h) the one or more lower vent holes are configured to direct exhaled gases in a direction angled upwardly relative to an axis perpendicular to the front surface of the vent module, (i) the upward angle is greater than the downward angle, (j) the sum of the upward angle and the downward angle is within a range of 60 to 100 degrees, and (k) the sum of the upward angle and the downward angle is within a range of 70 to 90 degrees. degrees, (l) a sum of the upward and downward angles is substantially 80 degrees, (m) the plurality of downward airflow holes includes a pair of upper vent holes, (n) the plurality of downward airflow holes includes a pair of lower vent holes, (o) the vent module is configured to support a diffuser through which a continuous flow of gas from the patient's exhalation can move (as it flows to atmosphere), (p) the vent module is configured to allow a continuous flow of gas from the patient's exhalation to move in and out of the diffuser from an interior of the plenum chamber to atmosphere after passing through the upper airflow holes, (q) the vent module is configured to allow a continuous flow of gas from the patient's exhalation to move in and out of the diffuser from an interior of the plenum chamber to atmosphere before passing through the downward airflow holes, and / or (r) the vent module is configured to allow a continuous flow of gas from the patient's exhalation to be moved by the diffuser from an interior of the plenum chamber to atmosphere (without flowing through the diffuser).

[0085] In further examples, (a) the ventilation module includes a peripheral channel configured to receive a portion of the chassis portion of the plenum chamber, (b) the chassis portion includes a lip configured to be received within the peripheral channel of the ventilation module, (c) the lip defines a front aperture of the plenum chamber, (d) the lip is thicker than an adjacent portion of the chassis portion of the plenum chamber, (e) the lip is the thickest portion of the chassis portion, (f) the lip has a thickness within the range of 3-5 mm, and / or (g) the lip has a thickness within the range of 3.5-4.5 mm, and (h) the lip is substantially 4 mm thick.

[0086] In further examples, (a) the chassis portion is formed from an elastomeric material, (b) the chassis portion is formed from silicone, (c) the seal-forming structure is at least partially formed from silicone, (d) the seal-forming structure is at least partially formed from a textile material, and / or (e) the stiffening is at least partially formed from a substantially rigid material.

[0087] In a further example, (a) the seal-forming structure includes a central portion posterior to the seal-forming structure, the central portion configured to seal against at least the patient's nasal tip, nasal alar, and upper lip in use, (b) the seal-forming structure is configured not to enter the patient's nares, and (c) the patient interface is configured to leave the patient's mouth exposed.

[0088] One aspect of this technology is a pressure of at least 6 cmH above ambient air pressure. 2A patient interface including a chassis portion and a seal-forming structure that together at least partially define a plenum chamber pressurizable to a therapeutic pressure of O. The chassis portion may include a pair of laterally projecting connectors configured to connect to a gas delivery tube and sized and structured to receive an airflow at therapeutic pressure for breathing of the patient. The seal-forming structure may be supported by the chassis portion and have at least one aperture therein to allow the airflow at said therapeutic pressure to be delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's breathing cycle in use.

[0089] The patient interface may include a vent that allows a continuous flow of gases exhaled by the patient from inside the plenum chamber to the surroundings, the vent being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use. The vent may include a plurality of vent holes through which gas flow from the patient's exhalation travels from inside the plenum chamber to the atmosphere, the vent holes including one or more upper vent holes and one or more lower vent holes. The one or more upper vent holes may be configured to direct the exhaled gases in a direction angled in an upward direction relative to an axis perpendicular to the front face of the vent module, and the one or more lower vent holes may be configured to direct the exhaled gases in a direction angled in a downward direction relative to an axis perpendicular to the front face of the vent module. The upward angle may be greater than the downward angle.

[0090] 3.5 Upper / Lower Center Front of Seal Forming Structure

[0013] Another aspect of one form of the present technology is a patient interface, comprising: At least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, said chassis portion sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure on said chassis portion partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal forming structure includes: a rear central portion of the seal-forming structure, said central portion configured to seal against at least the patient's nasal tip, nasal alar, and upper lip in use; A central front portion on the front side of the seal-forming structure, which is positioned below and adjacent to the patient's nasal tip when in use, the central front portion includes an upper portion and a lower portion, the lower portion being stiffer than the upper portion.

[0091] In an example, (a) a wall thickness of a lower portion of the central front portion is greater than a wall thickness of the upper portion of the central front portion; (b) the upper portion of the central front portion has substantially the same wall thickness as the central portion of the seal-forming structure; (c) the seal-forming structure includes a pair of central lateral portions aft of the seal-forming structure, one on each lateral side of the central portion, each central lateral portion being stiffer than the central portion; (d) the wall thickness of the central lateral portions is greater than the wall thickness of the upper portion of the central front portion; (e) the seal-forming structure includes a pair of central lateral front portions forward of the seal-forming structure, one on each lateral side of the central front portion, each central lateral front portion having a wall thickness greater than the wall thickness of the central front portion; f) the chassis portion includes a pair of laterally protruding connection portions, each of the laterally protruding connection portions configured to connect to and receive a gas flow from a respective one of the pair of gas delivery tube portions; and / or (g) the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including gas delivery tube portions, each gas delivery tube portion configured to receive an air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally protruding connection portions of the chassis portion.

[0092] In further examples, (a) the chassis portion is formed from an elastomeric material, (b) the chassis portion is formed from silicone, (c) the seal-forming structure is at least partially formed from silicone, and / or (d) the seal-forming structure is at least partially formed from a textile material.

[0093] One aspect of this technology is a pressure of at least 6 cmH above ambient air pressure. 2A patient interface including a chassis portion and a seal-forming structure which together at least partially define a plenum chamber pressurizable to a therapeutic pressure of O. The seal-forming structure may be supported by the chassis portion and have at least one aperture therein to allow an air flow at said therapeutic pressure to be delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use.

[0094] The seal-forming structure may include a central portion on a rear side of the seal-forming structure and configured to form a seal against the patient's face surrounding the patient's nares (without contacting the patient's bridge of the nose) in use. The seal-forming structure may include a central anterior portion on a non-patient contacting side of the seal-forming structure and a pair of central lateral anterior portions on either side of the central anterior portion. The central anterior portion may include an upper portion and a lower portion, the lower portion of the central anterior portion being thicker than the upper portion of the central anterior portion. Each of the central lateral anterior portions may have an upper portion and a lower portion, the lower portion of each central lateral anterior portion being thicker than the upper portion of each central lateral anterior portion.

[0095] 3.6 Upper / Lower of the Center Side Front of the Seal Forming Structure

[0013] Another aspect of one form of the present technology is a patient interface, comprising: At least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, the chassis portion being sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient; a seal-forming structure on said chassis portion partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal forming structure includes: a rear central portion of the seal-forming structure, said central portion configured to seal against at least the patient's nasal tip, nasal alar, and upper lip in use; a central front portion on the front side of the seal-forming structure, the central front portion being positioned adjacent to and below the patient's nasal tip in use; and A pair of central lateral front portions on the front side of the seal-forming structure, each of which is disposed on each lateral side of the central front portion, each of which includes an upper portion and a lower portion, the lower portion being stiffer than the upper portion.

[0096] In the example, (a) the wall thickness of the lower portion of each central lateral front portion is greater than the wall thickness of each upper portion of the central lateral front portion, (b) the wall thickness of the lower portion of each central lateral front portion is greater than the wall thickness of the central front portion of the seal-forming structure, (c) the wall thickness of the lower portion of each central lateral front portion is greater than the wall thickness of the rear central portion of the seal-forming structure, (d) the wall thickness of the upper portion of each central lateral front portion is greater than the wall thickness of the central front portion of the seal-forming structure, (e) the wall thickness of the upper portion of each central lateral front portion is greater than the wall thickness of the rear side of the seal-forming structure, (f) the seal-forming structure includes a pair of central lateral portions rearward of the seal-forming structure, each central lateral portion being disposed on each lateral side of the central portion, the wall thickness of each central lateral portion being greater than the wall thickness of the central portions, and (g) the wall thickness of the lower portion of each central lateral front portion is greater than the wall thickness of the rear central lateral portion of the seal-forming structure. (h) a wall thickness at the top of each central lateral front portion is greater than a wall thickness at the rear central lateral portion of the seal-forming structure; (i) the chassis portion includes a pair of laterally protruding connection portions, each of the laterally protruding connection portions configured to connect to and receive a gas flow from a respective one of the pair of gas delivery tube portions; and / or (j) the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a gas delivery tube portion, each gas delivery tube portion configured to receive an air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally protruding connection portions of the chassis portion.

[0097] In further examples, (a) the chassis portion is formed from an elastomeric material, (b) the chassis portion is formed from silicone, (c) the seal-forming structure is at least partially formed from silicone, and / or (d) the seal-forming structure is at least partially formed from a textile material.

[0098] One aspect of this technology is a pressure of at least 6 cmH above ambient air pressure. 2A patient interface including a chassis portion and a seal-forming structure which together at least partially define a plenum chamber pressurizable to a therapeutic pressure of O. The seal-forming structure may be supported by the chassis portion and have at least one aperture therein to allow an air flow at said therapeutic pressure to be delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use.

[0099] The seal-forming structure may include a central portion on a rear side of the seal-forming structure and configured to, in use, form a seal against the patient's face surrounding the patient's nares (without contacting the patient's bridge of the nose). The seal-forming structure may include a central anterior portion on a non-patient contacting side of the seal-forming structure and a pair of central lateral anterior portions on either side of the central anterior portion. Each of the central lateral anterior portions has an upper portion and a lower portion, the lower portion of each central lateral anterior portion being thicker than the upper portion of each central lateral anterior portion. The seal-forming structure may further include a pair of central lateral portions on a rear side of the seal-forming structure, each of the central lateral portions being on each lateral side of the central portion and having a greater wall thickness than the central portion.

[0100] 3.7 Reinforcement on the chassis

[0013] Another aspect of one form of the present technology is a patient interface, comprising: Made from a flexible material and capable of withstanding at least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, said chassis portion including a pair of laterally projecting connectors sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure on said chassis portion partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilizing structure including a pair of gas delivery tube sections, each gas delivery tube section adapted to receive air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally projecting connections of the chassis section; the seal-forming structure includes a central portion at a rear side of the seal-forming structure, the central portion configured to seal against at least the patient's nasal tip, the alae of the nose, and the upper lip in use; The chassis portion includes a pair of chassis upper reinforcement portions, each disposed on each side and front side of the chassis portion, each chassis upper reinforcement portion being stiffer than one or more adjacent portions of the chassis portion.

[0101] In an example, (a) the chassis reinforcement portion is disposed adjacent to the seal-forming structure, (b) each chassis reinforcement portion is disposed at an upper corner of the front hole of the chassis portion, (c) the seal-forming structure includes a front central front portion of the seal-forming structure that is disposed adjacent to and below the patient's nasal tip in use, and a pair of front central lateral front portions of the seal-forming structure, each central lateral front portion disposed on each lateral side of the central front portion, each chassis reinforcement portion being disposed adjacent a respective one of the central lateral front portions of the seal-forming structure, and (d) each central lateral front portion of the seal-forming structure is disposed at an upper and a lower portion, each of the chassis reinforcement portions being disposed adjacent to a respective lower portion; (e) a wall thickness of the chassis reinforcement portion is the same as a wall thickness of the lower portion of the central lateral front portion; (f) a wall thickness of the chassis reinforcement portion is between 1 mm and 3 mm; (g) a wall thickness of the chassis reinforcement portion is between 1.5 mm and 2 mm; (h) a wall thickness of the chassis reinforcement portion is 1.7 mm; (i) the seal-forming structure is formed from a flexible material; (j) the seal-forming structure does not enter the patient's nares; (k) the patient interface is configured to leave the patient's mouth exposed; and / or (l) a wall thickness of the chassis reinforcement portion is greater than one or more adjacent portions of the chassis portion.

[0102] In further examples, (a) the chassis portion is formed from an elastomeric material, (b) the chassis portion is formed from silicone, (c) the seal-forming structure is at least partially formed from silicone, and / or (d) the seal-forming structure is at least partially formed from a textile material.

[0103] One aspect of this technology is a pressure of at least 6 cmH above ambient air pressure. 2A patient interface including a chassis portion and a seal-forming structure that together at least partially define a plenum chamber pressurizable to a therapeutic pressure of O. The seal-forming structure may be supported by the chassis portion and have at least one aperture therein to allow airflow at said therapeutic pressure to be delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber during use throughout the patient's respiratory cycle. The chassis portion may be formed from a flexible material and may include a pair of chassis reinforcements, one each on each lateral and front side of the chassis portion. Each chassis reinforcement may be stiffer than one or more adjacent portions of the chassis portion.

[0104] 3.8 Front / rear upper lip of seal-forming structure

[0013] Another aspect of one form of the present technology is a patient interface, comprising: Made from a flexible material and capable of withstanding at least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, said chassis portion including a pair of laterally projecting connectors sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure on said chassis portion partially defining said plenum chamber, said seal-forming structure formed from a flexible material, said seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilizing structure including a pair of gas delivery tube sections, each gas delivery tube section adapted to receive air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally projecting connections of the chassis section; the seal-forming structure and at least a majority of the chassis portion are both formed from a single, homogenous piece of flexible material; The seal forming structure includes: a rear central portion of the seal-forming structure, said central portion configured to seal against at least the patient's nasal tip, nasal alar, and upper lip in use; The upper lip portion includes a rear portion configured to seal against the patient's upper lip in use, and a front portion adjacent the chassis portion, the front portion being stiffer than the rear portion of the upper lip.

[0105] In examples, (a) the thickness of the anterior portion of the upper lip is greater than the thickness of the posterior portion of the upper lip, (b) the thickness of the posterior portion of the upper lip is the same as the thickness of a portion of the central portion of the seal-forming structure adjacent to the upper lip, (c) the thickness of the posterior portion of the upper lip is in the range of 0.1 mm to 0.5 mm, (d) the thickness of the posterior portion of the upper lip is in the range of 0.2 mm to 0.3 mm, (e) the thickness of the posterior portion of the upper lip is 0.25 mm, (f) the thickness of the anterior portion of the upper lip is in the range of 1.2 mm to 1.8 mm, (g) the thickness of the anterior portion of the upper lip is in the range of 1.4 mm to 1.6 mm, (h) the thickness of the anterior portion of the upper lip is 1.5 mm, (i) the seal-forming structure includes a pair of lateral posterior regions on each posterior side of the upper lip, the thickness of the posterior portion of the upper lip being less than the thickness of the lateral posterior regions, and / or (j) the thickness of the anterior portion of the upper lip is the same as the thickness of the lateral posterior regions.

[0106] In further examples, (a) the chassis portion is formed from an elastomeric material, (b) the chassis portion is formed from silicone, (c) the seal-forming structure is at least partially formed from silicone, and / or (d) the seal-forming structure is at least partially formed from a textile material.

[0107] One aspect of this technology is a pressure of at least 6 cmH above ambient air pressure. 2 A patient interface including a chassis portion and a seal-forming structure at least partially forming together a plenum chamber pressurizable to a therapeutic pressure of O. The seal-forming structure may be supported by the chassis portion and have at least one hole therein for delivering airflow at said therapeutic pressure to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The seal-forming structure includes a central portion at a rear side of the seal-forming structure configured to seal against the patient's face surrounding the patient's airway, the central portion including an upper lip portion configured to seal against the patient's upper lip, the upper lip portion including a front portion adjacent the chassis portion and a rear portion configured to contact the patient's upper lip, the front portion being thicker than the rear portion. The chassis portion may be formed from a flexible material.

[0108] 3.9 Cushion module connector

[0013] Another aspect of one form of the present technology is a patient interface, comprising: 1. A cushioning module, the cushioning module including: At least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, said chassis portion including a pair of laterally projecting connectors sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure provided on said chassis portion and partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with a patient's facial area surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a pair of gas delivery tube sections, each gas delivery tube section configured to receive an air flow from a connection port on an upper portion of the patient's head and deliver the air flow to a respective one of the laterally projecting connections of the chassis section; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; Each gas delivery tube section of the positioning and stabilizing structure includes a tube end connector proximate a tube end of the gas delivery tube section, each tube end connector having at least one clip protrusion; The cushion module includes a pair of connectors, each connector configured to fluidly connect a respective one of the laterally projecting connectors of the chassis portion to a respective one of the gas delivery tube portions, each connector including: a chassis connection portion connected to each one of the connection portions protruding laterally from the chassis portion; and a protruding connector portion that protrudes away from the chassis connection portion along a length of the connector, the protruding connector portion including: a clip base portion adjacent to the chassis connection portion; and at least one clip arm projecting away from the clip base portion, the at least one clip arm including a recess configured to receive a clip protrusion of a tube end connector of a respective gas delivery tube section to form a snap-fit ​​connection with the tube end connector; The length of the clip base along the length of the connector is equal to or greater than the length of the clip arm between the clip base and the recess along the length of the connector.

[0109] In examples, (a) the length of the clip base portion is longer than the length of the clip arm between the clip base portion and the recess; (b) the ratio between the length of the clip base portion and the length of the clip arm between the clip base portion and the recess is 1.5.1 or greater; (c) the ratio is 1.7.1 or greater; (d) the ratio is 1.9.1 or greater; (e) the ratio is 2.1 or greater; (f) the force required to disconnect each connector of the cushion module from the tube end connector of each gas delivery tube portion exceeds 12 N; (g) the force required exceeds 20 N; and (h) (i) the required force exceeds 25N; (j) the required force is within the range of 12N to 50N; (k) the required force is within the range of 20N to 40N; (l) the connector of the cushion module includes a pair of clip arms protruding away from the clip base portion; (m) each one of the pair of clip arms includes a respective recess configured to receive a respective clip protrusion; and / or (n) the chassis portion of the cushion module is formed from a flexible material.

[0110] 3.10 Middle / side section of centre-side front of seal-forming structure Another aspect of one form of the present technology includes a patient interface, comprising: Made from a flexible material and capable of withstanding at least 6cmH above ambient air pressure 2a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, the chassis portion being sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient; a seal-forming structure on said chassis portion partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal forming structure includes: a rear central portion of the seal-forming structure, said central portion configured to seal against at least the patient's nasal tip, nasal alar, and upper lip in use; a front central portion of the seal-forming structure disposed adjacent to and below the patient's nasal tip in use; A pair of central lateral front portions on the front side of the seal-forming structure are respectively disposed on each lateral side of the central front portion, each central lateral portion including an intermediate portion disposed adjacent to the central front portion and a lateral portion disposed on a lateral side of the intermediate portion, the intermediate portions of each central lateral front portion being stiffer than the lateral portions of the central lateral front portion.

[0111] In the example, (a) the stiffness of each intermediate portion of the central lateral front is greater than the stiffness of the central front, (b) the wall thickness of each intermediate portion of the central lateral front is greater than the wall thickness of the central front, (c) each lateral portion of the central lateral front includes an upper portion and a lower portion, the lower portion being stiffer than the upper portion, (d) the wall thickness of the lower portion of the lateral portion of each central lateral front is greater than the wall thickness of the upper portion, (e) the wall thickness of the intermediate portion of the central lateral front is greater than the wall thickness of the upper portion of the lateral portion of each central lateral front, (f) the wall thickness of the intermediate portion of the central lateral front is less than the wall thickness of the lower portion of each central lateral front, and (g) the chassis portion is a chassis. the chassis reinforcement portion includes a pair of chassis reinforcement portions respectively provided on each lateral and front side of the chassis portion, each of the chassis reinforcement portions being stiffer than one or more adjacent portions of the chassis portion; (h) the chassis reinforcement portions are positioned adjacent to the seal-forming structure; (i) each chassis reinforcement portion is positioned adjacent to a respective one of the central lateral front portions; (j) each chassis reinforcement portion is positioned adjacent to a respective one of the lower portions of the central lateral front portions; (k) a wall thickness of each chassis reinforcement portion is greater than a wall thickness of the central lateral front portions; and / or (l) a wall thickness of each chassis reinforcement portion is greater than a wall thickness of a middle portion of the central lateral front portions.

[0112] In a further example, (a) the chassis portion includes a pair of laterally protruding connection portions, each of the laterally protruding connection portions configured to connect to and receive a gas flow from a respective one of the pair of gas delivery tube portions; (b) the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including the gas delivery tube portions, each gas delivery tube portion configured to receive an air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally protruding connection portions of the chassis portion; (c) the chassis portion is formed from an elastomeric material; (d) the chassis portion is formed from silicone; (e) the seal-forming structure is at least partially formed from silicone; and / or (f) the seal-forming structure is at least partially formed from a textile material.

[0113] 3.11 Upper / lower part of front of side rear area of ​​seal forming structure

[0013] Another aspect of one form of the present technology is a patient interface, comprising: Made from a flexible material and capable of withstanding at least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, the chassis portion being sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient; a seal-forming structure on said chassis portion partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal forming structure includes: a rear central portion of the seal-forming structure, said central portion configured to seal against at least the patient's nasal tip, nasal alar, and upper lip in use; A pair of side rear regions are provided on each rear outer side of the front side of the seal-forming structure, each side rear region includes a front portion and a rear portion, the front portion includes an upper portion and a lower portion, and the upper portion is stiffer than the lower portion.

[0114] In examples, (a) the wall thickness of the upper part of the front of each side rear region is greater than the wall thickness of the rear part, (b) the wall thickness of the upper part of the front of each side rear region is greater than the wall thickness of the lower part of the front of each side rear region, (c) the seal-forming structure includes a pair of central lateral fronts on a front side of the seal-forming structure, each of these central lateral fronts being disposed on each lateral side of the seal-forming structure, the central lateral fronts being stiffer than the central parts, (d) the wall thickness of each of the front parts of the side rear region is greater than the wall thickness of each of the central lateral fronts, (e) the wall thickness of the upper part of the front part of each side rear region is greater than the wall thickness of each central lateral front, (f) each central lateral front includes an upper part and a lower part, the lower part being stiffer than the upper part, (g) the wall thickness of the lower part of each central lateral front is greater than the wall thickness of the upper part of the central lateral front, and / or (h) the boundary between the upper part and the lower part of the front of each side rear region is disposed in a forward / rearward direction at the longest part of the side rear region.

[0115] In a further example, (a) the chassis portion includes a pair of laterally protruding connection portions, each of the laterally protruding connection portions configured to connect to and receive a gas flow from a respective one of the pair of gas delivery tube portions; (b) the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including the gas delivery tube portions, each gas delivery tube portion configured to receive an air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally protruding connection portions of the chassis portion; (c) the chassis portion is formed from an elastomeric material; (d) the chassis portion is formed from silicone; (e) the seal-forming structure is at least partially formed from silicone; and / or (f) the seal-forming structure is at least partially formed from a textile material.

[0116] 3.12 Front / rear of center side lower part of seal forming structure

[0013] Another aspect of one form of the present technology is a patient interface, comprising: Made from a flexible material and capable of withstanding at least 6cmH above ambient air pressure2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, the chassis portion being sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient; a seal-forming structure on said chassis portion partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal forming structure includes: a rear central portion of the seal-forming structure, the central portion configured to seal against at least the patient's nasal tip, the alae of the nose and the upper lip in use, the central portion including an upper lip portion configured to seal against the patient's upper lip in use; A pair of central lateral lower portions disposed on either side of the upper lip portion, each central lateral lower portion having a front portion and a rear portion adjacent the chassis portion, the front portion of the central lateral lower portion being stiffer than the rear portion of the central lateral lower portion.

[0117] In examples, (a) the upper lip portion includes a front portion adjacent the chassis portion and a rear portion configured to seal against the patient's upper lip in use; (b) the front portion of the upper lip is stiffer than the rear portion of the upper lip; (c) the front portion of the central lateral lower portion is stiffer than the front portion of the upper lip; (d) the front portion of the central lateral lower portion is stiffer than the rear portion of the upper lip; (e) the rear portion of the central lateral lower portion is stiffer than the rear portion of the upper lip; (f) a thickness of each of the front portions of the central lateral lower portion is greater than a thickness of the rear portion of the central lateral lower portion; (g) a thickness of the front portion of the upper lip is greater than a thickness of the rear portion of the upper lip; and (h) a thickness of the front portion of the central lateral lower portion is greater than a thickness of the rear portion of the upper lip. is greater than the thickness of the front portion of the upper lip portion; (i) the thickness of the front portion of the central lateral lower portion is greater than the thickness of the rear portion of the upper lip portion; (j) the thickness of the rear portion of the central lateral lower portion is substantially the same as the thickness of the front portion of the upper lip portion; (k) the thickness of the rear portion of the central lateral lower portion is greater than the rear portion of the upper lip portion; (l) the chassis portion includes a pair of under-chassis reinforcement portions, each of which is positioned adjacent a respective one of the central lateral lower portions, each of which is stiffer than an adjacent portion of the chassis portion; and / or (m) the thickness of each under-chassis reinforcement portion is greater than the thickness of an adjacent portion of the chassis portion.

[0118] In a further example, (a) the chassis portion includes a pair of laterally protruding connection portions, each of the laterally protruding connection portions configured to connect to and receive a gas flow from a respective one of the pair of gas delivery tube portions; (b) the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including the gas delivery tube portions, each gas delivery tube portion configured to receive an air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally protruding connection portions of the chassis portion; (c) the chassis portion is formed from an elastomeric material; (d) the chassis portion is formed from silicone; (e) the seal-forming structure is at least partially formed from silicone; and / or (f) the seal-forming structure is at least partially formed from a textile material.

[0119] 3.13 Chassis bottom reinforcement

[0013] Another aspect of one form of the present technology is a patient interface, comprising: Made from a flexible material and capable of withstanding at least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, said chassis portion including a pair of laterally projecting connectors sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure on said chassis portion partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilizing structure including a pair of gas delivery tube sections, each gas delivery tube section adapted to receive air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally projecting connections of the chassis section; the seal-forming structure includes a central portion at a rear side of the seal-forming structure, the central portion configured to seal against at least the patient's nasal tip, the alae of the nose, and the upper lip in use; The chassis portion includes a pair of under-chassis reinforcements, one each disposed on each side and below the chassis portion, each of the under-chassis reinforcements being stiffer than one or more adjacent portions of the chassis portion.

[0120] In examples, (a) the thickness of each of the chassis under reinforcement portions is greater than the thickness of an adjacent portion of the chassis portion; (b) the chassis under reinforcement portions are positioned adjacent to the seal-forming structure; (c) the chassis under reinforcement portions may have spaced apart intermediate boundaries; (d) the chassis under reinforcement portions may each have an intermediate boundary proximate a central region on the underside of the chassis portion; (e) the chassis under reinforcement portions may each have lateral boundaries proximate each rear region of the seal-forming structure; (f) the chassis under reinforcement portions are shaped to follow the boundaries between the chassis portion and the seal-forming structure; and / or (g) the central portion includes an upper lip portion configured to seal against the patient's upper lip in use and a pair of central lateral lower portions, the central lateral lower portions being positioned on either side of the upper lip and being stiffer than the upper lip portion, and each of the chassis under reinforcement portions is positioned adjacent a respective one of the central lateral lower portions.

[0121] In a further example, (a) the chassis portion includes a pair of laterally protruding connection portions, each of the laterally protruding connection portions configured to connect to and receive a gas flow from a respective one of the pair of gas delivery tube portions; (b) the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including the gas delivery tube portions, each gas delivery tube portion configured to receive an air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally protruding connection portions of the chassis portion; (c) the chassis portion is formed from an elastomeric material; (d) the chassis portion is formed from silicone; (e) the seal-forming structure is at least partially formed from silicone; and / or (f) the seal-forming structure is at least partially formed from a textile material.

[0122] 3.14 Chassis disconnection points

[0013] Another aspect of one form of the present technology is a patient interface, comprising: At least 6cmH above ambient air pressure 2 a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O, said chassis portion sized and structured to receive an air flow at the therapeutic pressure for breathing of a patient, said chassis portion including a pair of laterally projecting connectors configured to connect to a gas delivery tube; a seal-forming structure on said chassis portion partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said positioning and stabilizing structure including a pair of gas delivery tube sections, each gas delivery tube section adapted to receive air flow from a connection port on the top of the patient's head and deliver the air flow to a respective one of the laterally projecting connections of the chassis section; the seal-forming structure includes a central portion at a rear side of the seal-forming structure, the central portion configured to seal against at least the patient's nasal tip, the alae of the nose, and the upper lip in use; The chassis portion includes a pair of decoupling sites, each located on each lateral side of the chassis portion and having a lower stiffness than one or more adjacent portions of the chassis portion, and the decoupling sites are configured to at least partially decouple the central portion from forces applied to the chassis portion.

[0123] In examples, (a) each decoupling site is thinner than one or more adjacent sites of the chassis portion, (b) each decoupling site is 0.5 mm thick, (c) the chassis portion is 0.9 mm thick, (d) each decoupling site is located toward a front side of the chassis portion, and / or (e) each decoupling site extends from an upper side of the chassis portion to a lower side of the chassis portion.

[0124] In further examples, (a) each decoupling site is at least partially surrounded by a periphery of the chassis portion, the periphery of the chassis portion being stiffer than both the decoupling site and adjacent portions of the chassis portion relative to the periphery, (b) each periphery is thicker than both the decoupling site and adjacent portions of the chassis portion relative to the periphery, (c) the thickness of each periphery is in the range of 1.5 mm to 2 mm, and / or (d) the thickness of each periphery is 1.75 mm.

[0125] In a further example, (a) the chassis portion includes two decoupling sites on each side of the chassis portion; (b) on each side of the chassis portion, the chassis portion includes an intermediate decoupling site and a lateral decoupling site, the lateral decoupling site being disposed laterally of the intermediate decoupling site; (c) the lateral decoupling site is configured to at least partially decouple the seal-forming structure from a force applied to the laterally protruding connection portion; (d) the intermediate decoupling site is configured to at least partially decouple the seal-forming structure from a force applied to a front central region of the chassis portion; and (e) the cushion module includes a ventilation module including a vent portion, the ventilation module being disposed in the front central region of the chassis portion, and the intermediate decoupling site is configured to at least partially decouple the seal-forming structure from a force applied to the ventilation module.

[0126] In further examples, (a) the lateral decoupling sites are D-shaped; (b) the intermediate decoupling sites are crescent-shaped; (c) each lateral decoupling site has a lateral side proximate a distal end of each laterally-projecting connecting portion and a medial side opposite the lateral side, the medial side having a higher curvature than the lateral side; (d) the lateral side of each lateral decoupling site is shaped to match a shape of a respective distal end of a laterally-projecting connecting portion; (e) each medial decoupling site has a medial side proximate a vent module and a lateral side opposite the medial side, the lateral side having a higher curvature than the medial side; (f) the medial side of each medial decoupling site is curved to follow the curvature of the vent module; and (g) each decoupling site is at least partially surrounded by a periphery of the chassis portion, the chassis portion being configured to be shaped such that the lateral side of each lateral decoupling site is curved to follow the curvature of the vent module. the perimeter is thicker than both the debonding site and the adjacent portion of the chassis portion to the perimeter; (h) on each side of the chassis portion, the chassis portion includes a first perimeter located medially adjacent the lateral debonding site and a second perimeter located laterally adjacent the intermediate debonding site; (i) on each side of the chassis portion, the first perimeter is curved to follow the curvature of the medial side of the lateral debonding site; (j) on each side of the chassis portion, the second perimeter is curved to follow the lateral curvature of the intermediate debonding site; and / or (k) on each side of the chassis portion, the first perimeter and the second perimeter are closest at a midpoint on the front of the chassis portion and farthest apart at the upper and / or lower sides of the chassis portion.

[0127] 3.15 Further Aspects Another aspect of certain forms of the present technology is a system for treating a respiratory disorder, the system including a patient interface according to any one or more of the other aspects of the present technology, an air circuit, and a source of air at positive pressure.

[0128] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.

[0129] Another aspect of certain forms of the present technology is a patient interface that is configured to allow the patient to breathe from the atmosphere through their oral cavity in the absence of pressurized air flow through the plenum chamber inlet port.

[0130] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured to expose the patient's oral cavity in use.

[0131] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured such that, in use, no part of the seal-forming structure enters the oral cavity.

[0132] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured such that the seal-forming structure does not extend into the patient's airway.

[0133] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured such that, in use, the seal-forming structure does not extend under the chin protuberance area.

[0134] Another aspect of certain forms of the present technology is a patient interface constructed and arranged to expose the patient's eye during use.

[0135] Another aspect of certain forms of the present technology is a patient interface constructed and arranged to allow the patient to breathe ambient air in the event of a power outage.

[0136] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured to form a seal on the underside of the patient's nose without contacting the nose bridge region of the patient's nose.

[0137] Another aspect of certain forms of the present technology is a patient interface that includes a vent and a plenum chamber, the patient interface constructed and arranged such that gases from within the plenum chamber can travel through the vent to the surroundings.

[0138] Another aspect of certain forms of the present technology is a patient interface including a vent that allows for a continuous flow of patient exhaled gases from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use.Another aspect of certain forms of the present technology is a patient interface including a vent that allows for a continuous flow of patient exhaled gases from within the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use.

[0139] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a side or lateral sleep position when using the patient interface.

[0140] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a supine sleep position when using the patient interface.

[0141] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a prone sleep position when using the patient interface.

[0142] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or insight, or individuals with limited experience in using medical devices of this type.

[0143] One aspect of one form of the present technology is a patient interface that is washable in the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0144] Of course, some of the above aspects may form sub-aspects of the present technology, and various one of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0145] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0146] 4. Brief Description of the Drawings The present technology is illustrated by way of one non-limiting example in the accompanying drawings, in which like reference symbols include like elements: [Brief description of the drawings]

[0147] [Figure 1A] 4.1 Treatment System: A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C]The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An outline of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] FIG. 1 is a diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. [Figure 2C] FIG. 1 is a front view of a face including several features of the surface anatomy including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The directions of superior, inferior, radially inward, and radially outward are also given. [Figure 2D] FIG. 1 is a lateral view of the head including several features of the surface anatomy including the glabella, serion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior temporal points. The directions of superior and inferior, and anterior and posterior are also given. [Figure 2E] FIG. 1 is a further lateral view of the head, with the approximate locations of the Frankfort horizontal and nasolabial angle noted. The coronal plane is also noted. [Figure 2F] A bottom view of the nose including several features including nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, nostril axis and midsagittal plane. [Figure 2G] FIG. 2 is a side view of the superficial features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla and fibro-adipose tissue. [Figure 2I]The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention to the nasal septal cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull including the frontal, nasal and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] Side view of the skull with the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid and trapezius. [Figure 2L] Shown is the anterolateral aspect of the nose. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively large magnitude compared to the magnitude of curvature shown in 3C. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] 1 is a schematic cross-sectional view of a structure cut at a point, where the outward normal is shown and the curvature value at this point is zero. [Figure 3E] 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of curvature shown in FIG. [Figure 3F] 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of curvature shown in FIG. [Figure 3G]1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is illustrated. The edge of the surface is illustrated. The path on the surface between points A and B is illustrated. The straight line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into it. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] FIGURE 3D is a cross-sectional view through the structure of Figure 3I.The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] 1 shows the right ear including the right ear helix. [Figure 3S] Shown is a right-handed spiral. [Figure 3T] FIG. 13 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A diagram of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [Figure 3V]A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, the midsagittal plane bisects the plenum chamber into a left hand side and a right hand side. [Figure 3W] FIG. 3V is a cross-sectional view through the plenum chamber of FIG. 3V, the cross-section being taken in the midsagittal plane shown in FIG. The "central contact" plane is illustrated. The central contact plane is perpendicular to the midsagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3243. This tendon rests on the midsagittal plane and only contacts the cushion of the plenum chamber at two points on the midsagittal plane (i.e., superior point 3241 and inferior point 3242). Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X] The plenum chamber 3200 of FIG. 3U is shown in a use position on the face. The mid-sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In FIG. 3X, the plenum chamber 3200 is of a nasal mask, with the upper point 3241 resting approximately on the cerion and the lower point 3242 resting on the upper lip. 4.4 RPT Device [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] FIG. 4 is a schematic diagram of an air circuit of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items disposed in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. 4.5 Humidifier [Figure 5A] FIG. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B]5 shows an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Breath Waveforms [Figure 6] A model of a typical human respiratory waveform during sleep is shown. 4.7 Specific Examples of the Technology [Figure 7A] FIG. 13 is a top front-side perspective view of a patient interface 3000 according to an embodiment of the present technology. [Figure 7B] FIG. 7B is a lower front side view of the patient interface 3000 shown in FIG. 7A. [Figure 7C] FIG. 7B is a front view of the patient interface 3000 shown in FIG. 7A. [Figure 7D] FIG. 7B is a rear view of the patient interface 3000 shown in FIG. 7A. [Figure 7E] FIG. 7B is a lateral view of the patient interface 3000 shown in FIG. 7A. [Figure 7F] FIG. 7B is a top view of the patient interface 3000 shown in FIG. 7A. [Figure 7G] FIG. 7B is an underneath view of the patient interface 3000 shown in FIG. 7A. [Figure 7H] FIG. 7B is a perspective view of the patient interface 3000 shown in FIG. 7A when worn by a patient. [Figure 8A] FIG. 7B is a front side view of the cushion module 3150 of the patient interface 3000 shown in FIG. 7A. [Figure 8B] FIG. 8B is a rear side view of the cushion module 3150 shown in FIG. 8A. [Figure 8C] FIG. 8B is a front view of the cushion module 3150 shown in FIG. 8A. [Figure 8D] FIG. 8B is a rear view of the cushion module 3150 shown in FIG. 8A. [Figure 8E] FIG. 8B is a rear bottom view of the cushion module 3150 shown in FIG. 8A. [Figure 8F] FIG. 8B is a top view of the cushion module 3150 shown in FIG. 8A. [Figure 8G]FIG. 8B is a front and bottom view of the cushion module 3150 shown in FIG. 8A. [Figure 8H] FIG. 8B is a lateral view of the cushion module 3150 shown in FIG. 8A. [Figure 9A] FIG. 8B is a rear top view of the cushion module 3150 shown in FIG. 8A, with various portions indicated. [Figure 9B] FIG. 8B is a side view of the cushion module 3150 shown in FIG. 8A with various portions indicated. [Figure 9C] FIG. 8B is a bottom view of the cushion module 3150 shown in FIG. 8A with various portions indicated. [Figure 9D] FIG. 8B is a rear view of the cushion module 3150 shown in FIG. 8A with various portions indicated. [Figure 9E] FIG. 8B is a top view of the cushion module 3150 shown in FIG. 8A with various portions indicated. [Figure 9F] FIG. 8B is a rear lateral view of the cushion module 3150 shown in FIG. 8A with various portions indicated. [Figure 9G] FIG. 8B is an anterior-lateral view of the cushion module 3150 shown in FIG. 8A with various sections indicated. [Figure 9H] FIG. 8B is an inferior anterior lateral view of the cushion module 3150 shown in FIG. 8A with various sections noted. [Figure 10] FIG. 8B is a top view of the cushion module 3150 shown in FIG. 8A. [Figure 11A] 11A is a cross-sectional view of the cushion module 3150 taken along line 11A-11A shown in FIG. [Figure 11B] 11B is a cross-sectional view of the cushion module 3150 taken along line 11B-11B shown in FIG. [Figure 11C] 11C is a cross-sectional view of the cushion module 3150 taken along line 11C-11C shown in FIG. [Figure 12] FIG. 8B is a side view of the cushion module 3150 shown in FIG. 8A. [Figure 13A]13A is a cross-sectional view of the cushion module 3150 taken along line 13A-13A shown in FIG. 12. [Figure 13B] 13B is a cross-sectional view of the cushion module 3150 taken along line 13B-13B shown in FIG. 12. [Figure 14A] FIG. 7B is a front view of the ventilation module 3410 of the patient interface 3000 shown in FIG. 7A. [Figure 14B] FIG. 14B is a front perspective view of the ventilation module 3410 shown in FIG. 14A. [Figure 14C] FIG. 14B is a rear perspective view of the ventilation module 3410 shown in FIG. 14A. [Figure 14D] FIG. 14B is a cross-sectional view of the ventilation module 3410 shown in FIG. 14A. [Figure 15A] FIG. 8B is a top view of the cushion module 3150 shown in FIG. 8A with the ventilation module 3410 removed. [Figure 15B] 15B is a cross-sectional view of the cushion module 3150 through line 15B-15B shown in FIG. 15A. [Figure 15C] 8B is a top view of the cushion module 3150 through line 15B-15B shown in FIG. 8A, which includes a ventilation module 3410. FIG. [Figure 15D] 15D is a cross-sectional view of the cushion module 3150 through line 15D-15D shown in FIG. 15C. [Figure 16A] FIG. 31 is a top view showing a cushion module 3150 according to another embodiment of the present technology. [Figure 16B] FIG. 16B is a rear view of the cushion module 3150 shown in FIG. 16A. [Figure 16C] FIG. 16B is a lateral top view of the cushion module 3150 shown in FIG. 16A. [Figure 16D] FIG. 16B is another lateral top view of the cushion module 3150 shown in FIG. 16A. [Figure 17A] 8B is a perspective view of the connector 3214 of the cushion module 3150 shown in FIG. 8A. [Figure 17B] FIG. 17B is a top view showing the connector 3214 shown in FIG. 17A. [Figure 17C] 17C is a cross-sectional view of the connector 3214 shown in FIG. 17B taken along line 17C-17C. [Figure 17D] FIG. 17B is a side view showing the connector 3214 shown in FIG. 17A. [Figure 17E] 17E is a cross-sectional view of the connector 3214 shown in FIG. 17D taken along line 17E-17E. [Figure 18] FIG. 8B is a top view of the cushion module 3150 shown in FIG. 8A. [Figure 18A] 18A is a cross-sectional view of the cushion module 3150 shown in FIG. 18 taken along line 18A-18A. [Figure 19A] FIG. 31 is a top view of a cushion module 3150 according to another example of the present technology. [Figure 19B] FIG. 19B is a lateral view of the cushion module 3150 shown in FIG. 19A. [Figure 19C] FIG. 19B is a bottom view of the cushion module 3150 shown in FIG. 19A. [Figure 19D] FIG. 19B is a rear bottom view of the cushion module 3150 shown in FIG. 19A. [Figure 19E] FIG. 19B is a front view of the cushion module 3150 shown in FIG. 19A. [Figure 19F] FIG. 19B is a front top view of the cushion module 3150 shown in FIG. 19A. [Figure 20] FIG. 31 is a front view of a cushion module 3150 according to another example of the present technology. [Figure 21] FIG. 19B is a top view of the cushion module 3150 shown in FIG. 19A. [Figure 22A] 22A is a cross-sectional view of the cushion module 3150 shown in FIG. 21 taken along line 22A-22A. [Figure 22B] 22B is a cross-sectional view of the cushion module 3150 shown in FIG. 21 taken along line 22B-22B. [Diagram 23] FIG. 19B is a front view of the cushion module 3150 shown in FIG. 19A. [Figure 24A] 24A is a cross-sectional view of the cushion module 3150 shown in FIG. 23 taken along line 24A-24A. [Figure 24B] FIG. 24 is another front view of the cushion module 3150 shown in FIG. [Figure 24C] FIG. 24 is a top view of the cushion module 3150 shown in FIG. [Figure 25A] FIG. 13 is an anterior-lateral perspective view of a cushion module 3150 according to another example of the present technology, showing various portions. [Figure 25B] FIG. 25B is a lower, rear, and lateral perspective view of the cushion module 3150 shown in FIG. 25A with various portions indicated. [Figure 25C] FIG. 25B is a front view of the cushion module 3150 shown in FIG. 25A with various sections indicated. [Figure 25D] FIG. 25B is a rear view of the cushion module 3150 shown in FIG. 25A with various portions indicated. [Figure 25E] FIG. 25B is a side view of the cushion module 3150 shown in FIG. 25A with various sections indicated. [Figure 25F] FIG. 25B is a bottom view of the cushion module 3150 shown in FIG. 25A with various sections indicated. [Figure 25G] FIG. 25B is a top view of the cushion module 3150 shown in FIG. 25A with various sections indicated. [Fig. 25H] 25H is a cross-sectional view of the cushion module 3150 shown in FIG. 25A taken along line 25H-25H shown in FIG. 25. [Figure 25I] 25I is a cross-sectional view of the cushion module 3150 shown in FIG. 25A taken along line 25I-25I shown in FIG. 25G. [Figure 26A] FIG. 13 is an anterior-lateral perspective view of a cushion module 3150 according to another example of the present technology, showing various portions. [Figure 26B] FIG. 26B is a lower, rear, and lateral perspective view of the cushion module 3150 shown in FIG. 26A with various portions indicated. [Figure 26C] FIG. 26B is a front view of the cushion module 3150 shown in FIG. 26A with various sections indicated. [Figure 26D]FIG. 26B is a rear view of the cushion module 3150 shown in FIG. 26A with various portions indicated. [Figure 26E] FIG. 26B is a side view of the cushion module 3150 shown in FIG. 26A with various sections indicated. [Figure 26F] FIG. 26B is a bottom view of the cushion module 3150 shown in FIG. 26A with various sections indicated. [Figure 26G] FIG. 26B is a top view of the cushion module 3150 shown in FIG. 26A with various sections indicated. [Fig. 26H] 26H is a cross-sectional view of the cushion module 3150 shown in FIG. 26A taken along line 26H-26H shown in FIG. 26G. [Figure 26I] 26I is a cross-sectional view of the cushion module 3150 shown in FIG. 26A taken along line 26I-26I shown in FIG. 26G. [Figure 27A] FIG. 26B is a perspective view of a connector 3214 of the cushion module shown in FIG. 26A. [Figure 27B] 27B is a top view of the connector 3214 shown in FIG. [Figure 27C] 27C is a cross-sectional view of the connector 3214 shown in FIG. 27A taken along line 27C-27C shown in FIG. 27B. [Figure 28A] FIG. 17B is a partial side view of the connector 3214 shown in FIG. 17A with specific dimensions labeled. [Figure 28B] FIG. 27B is a partial side view of the connector 3214 shown in FIG. 27A with specific dimensions labeled. [Figure 29] 7B is a cross-sectional view of the tube end 3314 of the gas delivery tube 3350 of the patient interface 3000 shown in FIG. 7A. [Figure 30A] FIG. 31 is a front perspective view of a cushion module 3150 according to another example of the present technology. [Figure 30B] FIG. 30B is a rear perspective view of the cushion module 3150 of FIG. 30A. [Figure 30C] FIG. 30B is a front-outer perspective view of the cushion module 3150 of FIG. 30A. [Figure 30D]FIG. 30B is a side perspective view of the cushion module 3150 of FIG. 30A. [Figure 30E] FIG. 30B is a bottom perspective view of the cushion module 3150 of FIG. 30A. [Figure 31A] FIG. 31 is a front perspective view of a cushion module 3150 according to another example of the present technology. [Figure 31B] FIG. 31B is a rear perspective view of the cushion module 3150 of FIG. 31A. [Figure 31C] FIG. 31B is a side perspective view of the cushion module 3150 of FIG. 31A. [Figure 31D] FIG. 31B is a bottom view of the cushion module 3150 of FIG. 31A. [Figure 32A] FIG. 31 is a front view of a cushion module 3150 according to another example of the present technology. [Figure 32B] FIG. 32B is a front and bottom view of the cushion module 3150 of FIG. 32A. [Figure 32C] FIG. 32B is a bottom view of the cushion module 3150 of FIG. 32A in an undeformed state. [Fig. 32D] FIG. 32B is a bottom view of the cushion module 3150 of FIG. 32A in a deformed state. [Figure 33A] FIG. 32 is a front view of a connector 3214 according to another example of the present technology. [Figure 33B] FIG. 33B is a rear view of the connector 3214 shown in FIG. 33A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0148] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It should also be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

[0149] The following description is provided in conjunction with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.

[0150] 5.1 Treatment In one form, as shown in Figure IA, the present technology includes a method of treating a respiratory disorder, the method including the step of applying positive pressure to the entrance of the airways of a patient 1000.

[0151] In a particular embodiment of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0152] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0153] 5.2 Treatment system In one form, the technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000. Figures 1A, 1B and 1C show a treatment system that uses a patient interface 3000 with an RPT device 4000 and a humidifier 5000.

[0154] 5.3 Patient Interface 3A, a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functionalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functionalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functionalities. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's airway to facilitate the supply of air at positive pressure to the airway.

[0155] As shown in Figures 7A-7G, a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a form of connection port 3600 for connection to an air circuit (e.g., air circuit 4170 shown in Figures 1A-1C). In this form of the present technology, the functional aspects of the plenum chamber 3200 and the seal-forming structure 3100 are provided by one physical component. In the example shown in Figures 7A-7G, the patient interface 3000 includes a cushion module 3150. In this example, the cushion module 3150 provides both the plenum chamber 3200 and the seal-forming structure 3100 of the functional aspects of the patient interface 3000. The cushion module 3150 of the patient interface 3000 of Figures 7A-7G is shown in Figures 8A-8G with the cushion module 3150 separated. In this example, the seal-forming structure 3100 and other walls of the cushion module 3150 form a plenum chamber 3200. In this form of the technology, a positioning and stabilising structure 3300 is provided and includes several physical components.

[0156] The cushion module 3150 may be modular in that it is interchangeable with another cushion module 3150 within the patient interface 3000. In some examples, a first cushion module 3150 of a patient interface may be interchangeable with a second cushion module 3150, where the second cushion module 3150 is a different type of cushion module than the first cushion module 3150. For example, the second cushion module 3150 may have a different size, shape and / or structure than the first cushion module. In certain examples, a patient interface 3000 having a cushion module 3150 as shown in Figures 8A-8H is disassembled and reassembled to include one of the cushion modules 3150 as shown in Figures 19A-19F, 25A-25I, 26A-26I, 30A-30E, 31A-31D or 32A-32D in the patient interface.

[0157] In other forms of the present technology, the plenum chamber 3200 and the seal-forming structure 3100 may be inseparable from components of the positioning and stabilizing structure 3300. For example, the cushion module 3150 that partially or entirely forms the plenum chamber 3200 may be permanently connected to one or more other components of the patient interface 3000. In such examples of the present technology, the cushion module 3150 may be modular in that it is a subpart of a larger assembly.

[0158] In some examples of the present technology, the component(s) forming the plenum chamber 3200 and / or the seal-forming structure 3100 may be permanently attached to one or more headgear conduits. In some examples, the patient interface 3000 may include a non-removable cushion module 3150 positioned proximate the patient's airway entrance. The non-removable cushion module 3150 forms the plenum chamber 3200 in use and includes the seal-forming structure 3100. The cushion module 3150 may be permanently attached to one or more gas delivery tubing sections that are configured to be positioned against the patient's head in use and to convey airflow from a location over the top of the patient's head to the plenum chamber 3200 for breathing by the patient. The non-removable cushion module 3150 may have a shape or size similar to the removable cushion module 3150 illustrated in Figures 8A-8H (or Figures 19A-19F, 25A-25I, 26A-26I, 30A-30E, 31A-31D or 32A-32D) and described herein, but may be permanently connected to one or more gas delivery tube sections.

[0159] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0160] A patient interface 3000 in accordance with one form of the present technology has a circumferential 2 Constructed and arranged to provide an air supply at positive pressure of O.

[0161] A patient interface 3000 in accordance with one form of the present technology may be configured to provide at least 10 cmH 2 Constructed and arranged to provide an air supply at positive pressure of O.

[0162] A patient interface 3000 in accordance with one form of the present technology may be configured to provide at least 20cmH 2Constructed and arranged to provide an air supply at positive pressure of O.

[0163] 5.3.1 Plenum chamber A patient interface 3000 according to some embodiments of the present technology may provide at least 6 cmH above ambient air pressure. 2 The plenum chamber 3200 includes a plenum chamber 3200 that is pressurizable to a therapeutic pressure of O. The plenum chamber 3200 can receive air flow at the therapeutic pressure for breathing by the patient.

[0164] In some forms of the present technology, the plenum chamber 3200 is provided at least in part by a cushion module 3150 of the patient interface 3000. The cushion module 3150 according to some examples (e.g., those shown in Figs. 7A-7G, 8A-8H, 16A-16D, 25A-25I, 26A-26I, 30A-30E, 31A-31D, 32A-32D) may include a chassis portion 3210 and a seal-forming structure 3100. The plenum chamber 3200 may be at least in part formed by the chassis portion 3210 and the seal-forming structure 3100. The chassis portion 3210 may support the seal-forming structure 3100 in a position facing the patient's face in use. A volume of space may be partially enclosed by both the wall of the chassis portion 3210 and the seal-forming structure 3100. The air in this space is pressurized above ambient pressure in use to form a plenum chamber 3200.

[0165] In particular, the chassis portion 3210 is adapted to withstand at least 6 cmH above ambient air pressure. 2The chassis portion 3210 may at least partially form a plenum chamber 3200 that is pressurizable to a therapeutic pressure of O. The chassis portion 3210 may include one or more laterally projecting connections 3212. These connections 3212 are configured to connect to the gas delivery tube portion 3350 and are sized and configured to receive an air flow at a therapeutic pressure for patient breathing. The laterally projecting connections 3212 may also partially form the plenum chamber 3200 along with other portions of the cushion module 3150. The seal-forming structure 3100 may be provided to the chassis portion 3210 and may at least partially form the plenum chamber 3200. The connection of the seal-forming structure 3100 to the chassis portion 3210 may be permanent or removably. The seal-forming structure 3100 may be supported by the chassis portion 3210.

[0166] In some forms, the plenum chamber 3200 is formed from a single homogenous piece of material. In some forms, the plenum chamber 3200 can be formed from a homogenous piece of material that includes a connector formed from another material.

[0167] In some instances, the cushion module 3150 may be formed from a single homogenous piece of material. In some forms, the cushion module 3150 may be formed from a homogenous piece of material that includes a connector formed from another material.

[0168] In a further example, the chassis portion 3210 may be formed from a single homogenous piece of material. In some forms, the chassis portion 3210 may be formed from a homogenous piece of material that includes a connector formed from another material.

[0169] In some forms of the present technology, such as the patient interface 3000 shown in Figures 7A-7G, the plenum chamber 3200 does not cover the patient's eyes when in use. In other words, when the patient wears the patient interface 3000, the patient's eyes are outside of the pressurized space defined by the plenum chamber. Such forms may improve compliance with treatment, as they are often less intrusive and / or more comfortable for the wearer.

[0170] In some forms of the present technology, the cushion module 3150 is constructed from at least a portion of a transparent material (e.g., silicone, thermoplastic elastomer, clear polycarbonate). For example, in the examples shown in Figures 7A-7G, 19A-19F, 25A-25I, 26A-26I, 30A-30E, 31A-31D, and 32A-32D, the majority of the cushion module 3150 is formed from silicone. Specifically, in these examples, both the chassis portion 3210 and the seal-forming structure 3100 are formed from silicone. In the example shown in Figures 16A-16D, the chassis portion 3210 and the front portion of the seal-forming structure 3100 are formed from silicone. The use of a transparent material may make the patient interface less intrusive compared to an opaque material, thereby increasing the patient's comfort when wearing the patient interface 3000, thereby aiding in improved treatment compliance. The use of transparent materials can aid the clinician in seeing the placement and function of the patient interface.

[0171] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can make the patient interface 3000 less intrusive and can help improve compliance with treatment.

[0172] In some forms of the present technology, the patient interface 3000 does not include a frame formed from a rigid or substantially rigid material (e.g., polycarbonate). In some examples, the patient interface 3000 does not include a rigid frame that is placed in front of the patient's face in use.

[0173] In the exemplary forms of the technology shown in Figures 7A-7G, 8A-8H, 19A-19F, 25A-25I, 26A-26I, 30A-30E, 31A-31D, and 32A-32D, the cushion module 3150 includes a chassis portion 3210 and a seal-forming structure 3100. The chassis portion 3210 may be flexible and may be formed from a flexible material. The seal-forming structure 3100 may be formed from a flexible material. In these examples, the chassis portion 3210 and the seal-forming structure 3100 may be integrally formed and may be formed from a flexible material. The chassis portion 3210 may be formed from an elastomeric material (e.g., silicone). The seal-forming structure 3100 may be formed from an elastomeric material. The chassis portion 3210 and the seal-forming structure 3100 may comprise one piece. In these examples, the chassis portion 3210 and the seal-forming structure 3100 are molded as a single part formed from an elastomeric material (e.g., silicone). The seal-forming structure 3100 and the chassis portion 3210 (or at least a majority of the chassis portion 3210) may be formed (e.g., constructed, molded) from a single homogenous flexible piece of material (e.g., an elastomeric material (e.g., silicone)). The chassis portion 3210 and the seal-forming structure 3100 may be of unitary construction. In some examples, the chassis portion 3210 and the seal-forming structure 3100 are molded together in a single molding step (e.g., a single shot). In other examples, the front side of the chassis portion 3210 and the seal-forming structure 3100 may be molded together as a single first part, and then the rear side of the seal-forming structure 3100 is joined (e.g., overmolded or glued) to the single first part.

[0174] The wall thickness of the chassis portion 3210 may be in the range of 0.7 mm to 5 mm. In some examples, the wall thickness of the majority of the chassis portion may be in the range of 0.7 mm to 1.5 mm (e.g., 0.9 mm to 1.4 mm, 0.7 mm to 1.2 mm, 1.2 mm to 1.5 mm, 0.9 mm, or 1.25 mm, for example). In the examples shown in Figures 9A-9H, 16A-16D, 19A-19F, 25A-25I, and 26A-26I, the wall thickness of the majority of the chassis portion 3210 (including the laterally protruding connection portion 3212 (described below)) may be 1.25 mm. In another example (e.g., the example shown in Figures 31A-31D), the wall thickness of the majority of the chassis portion 3210 is 0.9 mm.

[0175] As will be described further below, chassis portion 3210 may include upper chassis reinforcement portion 3220. Upper chassis reinforcement portion 3220 may have a greater thickness (e.g., 1.7 mm, as described below with reference to FIGS. 19A-19F) than most other portions of chassis portion 3210. Additionally, chassis portion 3210 may include lower chassis reinforcement portion 3221. Lower chassis reinforcement portion 3221 may have a greater thickness (e.g., 3 mm, as described below with reference to FIGS. 30A-30E and 31A-31D). Additionally, chassis portion 3210 may include front hole portion 3215 and lip 3230, as will be described further below. The lip has a greater thickness (e.g., 4 mm, as described below) than most other portions of chassis portion 3210.

[0176] In a further example of a method of manufacturing the cushion module 3150, after production of the rear side of the seal-forming structure 3100, the chassis portion 3210 and the front side of the seal-forming structure 3100 may be overmolded onto the rear side of the seal-forming structure. The rear side of the seal-forming structure 3100 may include a textile material, and in some forms may include a laminate formed from one or more textile and one or more non-textile layers. A cushion module 3150 produced by one such method is shown in Figures 16A-16D.

[0177] In other examples of the present technology, the seal-forming structure 3100 may be removably connected to the chassis portion 3210. The seal-forming structure 3100 may be connected to the chassis portion 3210 by a soft-to-soft connection, a soft-to-hard connection or a hard-to-hard connection.

[0178] The chassis portion 3210 includes a pair of laterally projecting connecting portions 3212, as shown in Figures 7A-7G and shown alone in Figures 8A-8H. Each laterally projecting connecting portion 3212 includes an inlet for receiving air flow into the interior of the cushion module 3150.

[0179] In this example, the cushion module 3150 includes a pair of connectors 3214 configured to connect to the gas delivery tube section 3350 of the positioning and stabilizing structure 3300. In this example, the connectors 3214 are provided on either side of the chassis section 3210. In this example, each connector 3214 is provided to a respective laterally protruding connection section 3212 of the chassis section 3210. In this example, the connectors 3214 are provided at the inlet of the laterally protruding connection section 3212. Figures 7A-7G show the gas delivery tube section 3350 connected to the laterally protruding connection section 3212. The laterally protruding connection sections 3212 are described in further detail below.

[0180] The flexibility of the chassis portion 3210 allows the cushion module 3150 to deform to fit a wider range of patients. A flexible chassis portion 3210 may allow the cushion module 3150 to fit a wider range of patients (than a cushion module 3150 with a rigid chassis portion). For example, the cushion module 3150 may be able to expand to fit a wider range of patients, and may also allow the sides to be wrapped inward to fit a narrower range of patients. Although the flexibility of the chassis portion 3210 of the cushion module 3150 provides these benefits, a certain level of stiffness in the chassis portion 3210 is beneficial for stability and support in the seal-forming structure 3100. Thus, in some instances, stiffeners may be provided in the chassis portion 3210 to make the chassis portion 3210 stiffer (while still remaining flexible). In some examples, the chassis portion 3210 and the seal-forming structure 3100 are formed from a flexible material (e.g., silicone, TPE, etc.) and the chassis portion 3210 includes a stiffening material. In particular, the patient interface 3000 or the cushion module 3150 may include a stiffening material. The stiffening material may be provided to the chassis portion 3210. The stiffening material may be configured to impart rigidity to the chassis portion 3210. The stiffening material may be configured to resist deformation of the chassis portion 3210. The stiffening material may be configured to provide support to the chassis portion 3210.

[0181] In some examples, the stiffener is a member that is stiffer than the chassis portion 3210 of the plenum chamber 3200. The stiffener may be formed from a different material than the chassis portion 3210. The stiffener may be formed from a harder and / or stiffer material than the material forming the chassis portion 3210. The stiffener may be substantially stiff. The stiffener may be sufficiently stiff that it does not deform under finger pressure alone. The stiffener may be formed from, for example, polycarbonate, polypropylene, or nylon. In some examples, the stiffener may be glued to the chassis portion 3210. In certain examples, the stiffener may be overmolded to the chassis portion 3210, or the chassis portion 3210 may be overmolded to the stiffener. The stiffener may be removable from the chassis portion 3210. The stiffener may be provided on one or more sides of the chassis portion 3210. In some examples, the stiffener is provided on the underside of the chassis portion 3210. In other examples, the stiffening is provided on a front side of the chassis portion 3210. In certain examples, the stiffening is provided on an exterior side of the plenum chamber 3200. In other examples, the stiffening is provided on an interior side of the plenum chamber 3200. In some examples, the stiffening defines in part the plenum chamber 3200.

[0182] As shown in FIGS. 7A-7G, 30A-30E, 31A-31D, and 32A-32D, for example, the cushion module 3150 includes a ventilation section 3400. In these examples, the chassis section 3210 includes a stiffener in the form of a ventilation module 3410 (i.e., the ventilation module has a function of providing stiffness to the cushion module 3150). The ventilation module 3410 includes the ventilation section 3400. The ventilation section 3400 may be provided by a plurality of ventilation holes. The rigidizing ventilation module 3410 is provided on the front side of the chassis section 3210. In other examples, the rigidizing ventilation module 3410 may be provided on the lower side of the chassis section 3210. In some examples, the cushion module 3150 may include two ventilation modules 3410. The two ventilation modules 3410 are disposed laterally spaced apart in front of or below the chassis portion 3210 .

[0183] As described below, the chassis portion 3210 and the seal-forming structure 3100 or more generally the cushion module 3150 may include multiple regions, with one or more regions being stiffer than another region. In general, making one portion of the cushion module 3150 stiffer than another portion of the cushion module 3150 may be achieved by one or more of the following: increased material thickness, increased material stiffness (e.g., increased Young's modulus), the presence of stiffeners, and a shape that provides stiffness. Unless otherwise stated in the context, when a first portion of the cushion module 3150 is described as being stiffer than a second portion, each of the above methods for stiffening a portion should be understood as disclosed as an option for making the first portion stiffer than the second portion. Additionally, in embodiments of the present technology, the first portion may be thicker than the second portion by any one or more combinations of the above methods.

[0184] Unless the context indicates otherwise, references to the stiffness of a component or a portion / region thereof should be understood as references to the stiffness of the structure (e.g., the effect of the stiffness of both materials forming the component or a portion thereof and the shape (including thickness) of the component or a portion thereof). However, unless the context indicates otherwise, references to the stiffness of a material, a material having a stiffness, etc. should be understood as references to stiffness as a material property independent of shape / size (e.g., Young's modulus).

[0185] 5.3.1.1 Front hole As shown in Figures 8A-8H, 19A-19F, 25A-25I and 26A-26I, in these examples, the chassis portion 3210 includes a front hole 3215 configured to receive a stiffener (stiffener not shown in Figures 8A-8H). As shown in Figures 7A-7G, 30A-30E, 31A-31D and 32A-32D, a ventilation module 3410, which functions as a stiffener, is received within the front hole 3215 of the chassis portion 3210.

[0186] 8A-8H and 11A, the front hole 3215 is centrally located within the chassis portion 3210. In use, the front hole 3215 is centered in the sagittal plane of the patient. In this example, the front hole 3215 is located in a partially forward and partially downward position in the chassis portion 3210 in use. In use, the front hole 3215 may be aligned with the patient's upper lip in the upper posterior axis. The front hole 3215 may be located anterior to the patient's upper lip. The front hole 3215 may be located above the patient's lower lip and / or upper lip. In this example, the front hole 3215 is located on the opposite side of the chassis portion 3210 to the seal-forming structure. In this example, the upper periphery of the front hole 3215 is located adjacent to a central portion of the anterior portion of the seal-forming structure 3100. 9A-H, 19A-F, 25A-I and 26A-I, an upper perimeter of the front hole 3215 may be adjacent to the central front portion 3115 of the seal-forming structure 3100. A lower perimeter of the front hole 3215 may be adjacent to the upper lip 3116 of the seal-forming structure 3100. The central front portion 3115 and the upper lip 3116 are described in further detail below.

[0187] In some examples, such as those shown in Figures 8A-8H, the front hole 3215 opens partially forward and partially downward in use (but in use, the front hole 3215 includes a ventilation module 3410). The upper periphery of the front hole 3215 may be spaced forward of the lower periphery of the front hole 3215. In use, the front hole 3215 may open forward and downward at an angle of 25 degrees to 65 degrees relative to the horizontal (e.g., the Frankfort Horizontal). In some examples, the angle may be 35 degrees to 55 degrees or 40 degrees to 50 degrees. In some particular examples, the front hole 3215 may open downward and forward at an angle of 45 degrees relative to the horizontal.

[0188] In some examples, such as the example shown in FIGS. 8A-8H, the front hole 3215 is wider than it is tall in the left-right axis. In this example, the top perimeter of the front hole 3215 includes straight sections, the bottom perimeter of the front hole 3215 includes straight sections, and the left and right sides of the front hole 3215 are curved. In other examples, both the top and bottom edges of the front hole 3215 can be curved. The front hole 3215 can be elliptical. In other examples, the front hole 3215 can be oval, circular, rectangular, or square. In some examples, the front hole 3215 can be a generally rectangular or square hole and includes curved corners. In the examples shown in FIGS. 8A-8H, the perimeter of the front hole 3215 is defined by a planar curve (e.g., a curve that extends in a single plane rather than in a space curve).

[0189] In some examples, such as the examples shown in FIGS. 8A-8H and 11A, the cushion module 3150 includes a lip 3230. In this example, the lip 3230 is part of the chassis portion 3210. The ventilation module 3410 is configured to couple with the lip 3230. With reference to FIGS. 14A-14D and 15A-15B, the ventilation module 3410 includes a peripheral channel 3430. In this example, the peripheral channel 3430 is disposed around the periphery of the ventilation module 3410. In this particular example, the peripheral channel is disposed around the entire periphery of the ventilation module. The lip 3230 is configured to be received within the peripheral channel 3430, thereby securing the ventilation module 3410 to the plenum chamber 3200. In this example, the lip 3230 defines the front hole 3215. The size of the ventilation module 3410 and the depth of the peripheral channel 3430 correspond to the size of the front aperture 3215 so that the ventilation module 3410 fits securely within the front aperture 3215 .

[0190] In some examples, such as those shown in Figures 8A-8H, 14A-14D, and 15A-15B, the ventilation module 3410 is inserted into the front hole with a snap-fit ​​connection. When the ventilation module 3410 is pressed into the front hole 3215, the lip 3230 deforms to fit into the peripheral channel 3430 of the ventilation module 3410. When the ventilation module 3410 is pressed into the front hole 3215, the chassis portion 3210 may also deform. In this example, the front hole 3215 is sized such that when the ventilation module 3410 is received within the chassis portion 3210, the chassis portion 3210 is substantially undeformed. The front hole 3215 may have the same size as it had before the ventilation module 3410 was inserted. In other examples, the front hole 3215 may stretch slightly after insertion of the vent module 3410, and the vent module 3410 may be slightly larger than the front hole 3215. This may promote a secure fit.

[0191] To remove the ventilation module 3410, the patient or clinician simply pushes the ventilation module 3410 out of the front hole 3215. The chassis portion 3210 is deformable to allow the ventilation module 3410 to be removed from the front hole 3215. The chassis portion 3210 is deformable to allow a user to peel the lip 3230 away from the ventilation module 3410 to remove the ventilation module 3410. The chassis portion 3210 is compressible to assist in deformation of the ventilation module 3410. In some examples, the patient can squeeze the chassis portion 3210 to at least partially release the lip 3230 from the peripheral channel 3430 of the ventilation module 3410.

[0192] In this example, the cross-sectional profile of the lip 3230 substantially matches the space available within the cross-sectional profile of the peripheral channel 3430, thus promoting a secure fit. The shape of the lip 3230 is complementary to the shape of the peripheral channel 3430.

[0193] In this example of the present technology, the lip 3230 is thicker than adjacent portions of the chassis portion 3210 of the plenum chamber 3200, e.g., the lip 3230 is the thickest portion of the chassis portion 3210. The lip 3230 is the thickest portion of the cushion module 3150. The thickness of the lip 3230 can be in the range of 3-5 mm. In some examples of the present technology, the thickness of the lip 3230 is in the range of 3.5-4.5 mm. In the illustrated example, the thickness of the lip 3230 is substantially 4 mm.

[0194] The lip 3230 may be thick, thus creating a robust connection to the ventilation module 3410. Additionally, the lip 3230 may be thick, thus providing rigidity to the chassis portion 3210. A thick lip 3230 may advantageously increase the resistance of the cushion module 3150 to twisting. The cushion module 3150 may be subjected to twisting forces, particularly when sleeping on its side or when the patient moves (e.g., tosses and turns) while sleeping. The increased rigidity provided by the thickness of the lip 3230 provides resistance to excessive deformation due to twisting or other forces that may disrupt the seal between the seal-forming structure 3100 and the patient's face. Thus, in this example, the cushion module 3150 includes a reinforced area on its front side, which resists twisting.

[0195] In the illustrated example of the present technology, the lip 3230 is a thickened portion of the cushion module 3150. The lip 3230 and the remainder of the chassis portion 3210 of the cushion module 3150 are integrally formed in this example. They are formed from the same piece of material. The chassis portion 3210 and its lip 3230 may be molded together. The lip 3230 may be formed from an elastomeric material (e.g., silicone, TPE) with the rest of the chassis portion 3210 in the same molding process.

[0196] In other examples, the lip 3230 may be formed separately from one or more other portions of the chassis portion 3210. In some examples, the lip 3230 is formed from a different material than the remainder of the chassis portion 3210 (i.e., the lip 3230 may be formed from a first material and the remainder of the chassis portion 3210 may be formed from a second material). In some examples, the lip 3230 is overmolded onto the remainder of the chassis portion 3210. In other examples, the chassis portion 3210 is overmolded onto the lip 3230.

[0197] In some examples, the chassis portion 3210 except for the lip 3230 is formed from a first silicone material, and the lip 3230 is formed from a second silicone material. The second silicone material may have one or more properties different from the first silicone material. The second silicone material may be stiffer than the first silicone material. The second silicone material may have a higher durometer hardness than the first silicone material.

[0198] In some examples, the chassis portion 3210, except for the lip 3230, is formed from an elastomeric material (eg, silicone, TPE), and the lip 3230 is formed from a stiffer material (eg, polycarbonate, polypropylene, nylon).

[0199] In some examples, the chassis portion 3210 includes a female feature (e.g., groove, peripheral channel) around the front hole 3215 that is configured to receive a complementary male feature (e.g., lip, flange) of the ventilation module 3410. In some examples, the ventilation module 3410 includes a flange around its periphery that is configured to be received within a complementary channel around the periphery of the front hole 3215 of the cushion module 3150.

[0200] In another form of the present technology, the chassis portion 3210 of the cushion module 3150 may include a stiffening portion (in addition to the rigidizing ventilation module 3410). The stiffening portion may take the form of a thickened portion spaced from the front hole 3215. In one example, the chassis portion 3210 may include a stiffening portion that covers the front side of the cushion module 3150. In another example, the chassis portion 3210 may include a stiffening member. The stiffening member may be formed from a material that is stiffer than the material (e.g., silicone) that forms the chassis portion 3210. The chassis portion 3210 may be overmolded onto the stiffening member (or vice versa). Alternatively, the stiffening member may be inserted into the chassis portion 3210 and snap-fitted or otherwise secured to the front side of the chassis portion 3210.

[0201] It is advantageous to have sufficient resistance to excessive deformation, especially due to twisting. However, it is advantageous to have some independence between the sides of the cushion module 3150, since this provides a decoupling effect, allowing the cushion module 3150 to withstand forces received at one side without transmitting the forces to the other side. As mentioned above, the chassis portion 3210 may be made of a flexible material, which allows one side of the cushion module 3150 to be partially decoupled from the other side. For example, the chassis portion 3210 may move one of the laterally protruding connecting portions 3212 at least partially decoupled from the other of the laterally protruding connecting portions 3212.

[0202] 5.3.1.2 Ventilated Module Locating Features The cushion module 3150 may include one or more features configured to allow for easy positioning of the ventilation module 3410 and to avoid misalignment of the ventilation module 3410. In particular, the cushion module 3150 may include one or more positioning features 3216 that are structured and / or arranged to make correct orientation of the ventilation module 3410 apparent to a user. The chassis portion 3210 may include positioning features 3216. The chassis portion 3210 may include one or more positioning features 3216 that engage or fit with corresponding features of the ventilation module 3410.

[0203] In some examples, such as the examples shown in FIGS. 8A-8H, the chassis portion 3210 includes two positioning features 3216. One positioning feature 3216 is provided to the side of the front hole 3215 and another positioning feature 3216 is provided below the front hole 3215. In this example, the positioning feature 3216 is a protrusion and is shaped to fit within a correspondingly shaped recess in the ventilation module 3410. In other examples, the cushion module 3150 may include a positioning feature 3216 above the front hole 3215. In other examples, the cushion module 3150 may include only one positioning feature 3216 or may include three or more positioning features 3216.

[0204] The one or more positioning features 3216 may prevent the ventilation module 3410 from being inserted incorrectly into the front hole 3215. The one or more positioning features 3216 may prevent the ventilation module 3410 from being inserted in an incorrect orientation (e.g., upside down or back-to-front). For example, the positioning features 3216 may be positioned asymmetrically with respect to the front hole 3215.

[0205] In the examples shown in FIGS. 8A-8H, the shape of the front hole 3215 and the ventilation module 3410 are at least partially asymmetrical, reducing the likelihood that a user will misalign the ventilation module 3410. The shape of the front hole 3215 and the ventilation module 3410 are taller than they are wide, so that the ventilation module 3410 can only be inserted into the front hole 3215 in a horizontal direction. In some examples, the front hole 3215 can be asymmetrical in at least one axis, and in some examples, the front hole 3215 is asymmetrical in multiple axes. In some examples, the front hole 3215 is asymmetrical, so that the ventilation module 3410 can only fit into the front hole 3215 in one direction.

[0206] In some examples, the cushion module 3150 and / or the ventilation module 3410 include guides that indicate correct orientation of the ventilation module 3410 (e.g., alignment markings, indentations, or other visual or tactile features that indicate correct orientation of the ventilation module 3410).

[0207] 5.3.1.3 Reinforcement on the chassis In some examples of the present technology, the chassis portion 3210 of the cushion module 3150 includes a pair of on-chassis reinforcing portions 3220. The cushion module 3150 shown in FIGS. 19A to 19F, 22B, 30A to 30E, 31A to 31D, and 32A to 32D includes the on-chassis reinforcing portion 3220. The on-chassis reinforcing portion 3220 is provided on the front side of the chassis portion 3210. The on-chassis reinforcing portion 3220 is configured to reinforce the chassis portion 3210. The chassis reinforcement portion 3220 and its features described with reference to Figures 19A-19F, 22B, 30A-30E, 31A-31D and 32A-32D may be applied to the chassis portion 3210 shown and described with reference to Figures 8A-8H, 16A-16D, 25A-25I and 26A-26I or the chassis portion 3210 of other examples of the present technology.

[0208] Each chassis top reinforcement portion 3220 is provided on each lateral and front side of the chassis portion 3210. Each chassis top reinforcement portion 3220 is spaced medially from a distal end of a respective laterally projecting connecting portion 3212. For example, each chassis top reinforcement portion 3220 may be spaced medially from a respective one of the laterally projecting connecting portions 3212. Each chassis top reinforcement portion 3220 may have a lateral boundary spaced from a distal end of a respective one of the laterally projecting connecting portions 3212.

[0209] As noted above, the chassis portion 3210 may be formed from a flexible material, which may be an elastomeric material. The chassis reinforcement portion 3220 may be formed from the flexible material forming the chassis portion 3210. The seal-forming structure 3100 may be formed from a flexible material. The chassis reinforcement portion 3220 may be integrally formed with the chassis portion 3210. For example, the chassis reinforcement portion 3220 may be molded with adjacent portions of the chassis portion 3210 in a single molding step. The chassis reinforcement portion 3220 may partially define the plenum chamber 3200 with other portions of the chassis portion 3210.

[0210] In the illustrated example, each of the chassis reinforcement parts 3220 is disposed at an upper position of the chassis part 3210 (e.g., generally above the front hole 3215). Each chassis reinforcement part 3220 may be stiffer than one or more adjacent parts of the chassis part 3210. This stiffer stiffness may be obtained because the wall thickness of the chassis reinforcement part 3220 is greater than the wall thickness of one or more adjacent parts of the chassis part 3210. In some examples, the wall thickness of the chassis reinforcement part 3220 is 1 mm to 3 mm. In some examples, the wall thickness is 1.2 mm to 2.5 mm or 1.5 mm to 2.3 mm. In the examples shown in Figures 19A to 19F, 22B, and 31A to 31D, the wall thickness of the chassis reinforcement part 3220 is 1.7 mm. In the examples shown in Figures 30A to 30E, the wall thickness of the chassis reinforcement part 3220 is 2.1 mm.

[0211] The chassis reinforcement 3220 may help increase the stability of the cushion module 3150 (e.g., when the patient is sleeping or in bed) and the seal it creates against the patient's face during dynamic facial movements. The chassis reinforcement 3220 may also provide greater resistance to excessive flare from the seal-forming structure 3100 when it comes into contact with the patient's face, which may have a slightly different contour than the seal-forming surface of the seal-forming structure 3100. Such flare may cause a leak path to form, where the seal-forming structure 3100 loses contact with the patient's face due to the normally flexible chassis portion 3210 (in the example of the present technology, the chassis portion 3210 is flexible). The chassis reinforcement 3220 may also provide increased torsional resistance. The chassis reinforcement 3220 may prevent one side of the cushion module 3150 from twisting away from or against the other side of the cushion module 3150, which may result in loss of contact with the patient's nose and leak paths.

[0212] 19A to 19F, 30A to 30E, 31A to 31D, and 32A to 32D, chassis upper reinforcement parts 3220 are provided at upper positions on the sides of front hole 3215. Each chassis upper reinforcement part 3220 is disposed adjacent to each upper corner of front hole 3215. A part of each chassis upper reinforcement part 3220 may be disposed on the front surface of connecting part 3212 protruding to each side.

[0213] Each chassis reinforcement 3220 may be disposed on the chassis portion 3210 adjacent to and in front of the seal-forming structure 3100. The chassis reinforcement 3220 may share a border with the seal-forming structure 3100. Each chassis reinforcement 3220 may include an upper border that meets a portion of the lower border of the front of the seal-forming structure 3100. As shown in Figures 19E, 19F, 30A and 31A, each chassis reinforcement 3220 may have a curved upper surface that matches the curvature of the lower border of the seal-forming structure 3100. Each chassis reinforcement 3220 may have a curved lower surface that matches the curvature of the front hole 3215. As shown in Figures 19E and 19F, in one example, the laterally outward side of each chassis reinforcement 3220 may have a pointed shape in the outward lateral direction.

[0214] In some examples, each chassis upper reinforcement portion 3220 may extend laterally outward relative to a lateral portion of each connecting portion 3212 of the chassis portion 3210. This is exemplarily shown in Figs. 30A-30E. In this example, each chassis upper reinforcement portion 3220 extends from a front hole 3215 in the chassis portion 3210 along each laterally protruding connecting portion 3212 to an upper ridge 3213. These upper ridges 3213 will be described in more detail below. In use, each chassis upper reinforcement portion 3220 may be provided on a portion of the chassis portion 3210 that faces partially forward. In the example shown in Figs. 30A-30E, each chassis upper reinforcement portion 3220 is provided on the chassis portion 3210 along the boundary between the chassis portion 3210 and the seal-forming structure 3100. Each chassis reinforcement 3220 may be wider near the middle of the chassis portion 3210 (eg, at the front hole 3215 or the ventilation module 3410 ) than at the sides of the chassis portion 3210 .

[0215] As will be described in more detail below, the seal-forming structure 3100 may include central lateral fronts 3125. Each of these central lateral fronts 3125 is disposed on a respective lateral side of the central front 3115. This is shown in Figures 19A-19F, 22B, 30A-30E, and 31A-31D. Each of the chassis top reinforcements 3220 may be disposed adjacent to a respective one of the central lateral fronts 3125 of the seal-forming structure 3100. In particular, each of the chassis top reinforcements 3220 may be disposed below each of the central lateral fronts 3125. Each of the chassis top reinforcements 3220 may be disposed adjacent to and / or below a respective lower portion 3127 of each of the central lateral fronts 3125.

[0216] In some examples of the present technology, the wall thickness of each chassis top reinforcement 3220 is the same as the wall thickness of the lower portion 3127 of the central lateral front portion 3125 of the seal-forming structure 3100.

[0217] In another example of the present technology, the chassis reinforcement portion 3220 may be formed by a stiffener formed of a material that is stiffer than the material forming the remainder of the chassis portion 3210.

[0218] 5.3.1.4 Reinforcement under the chassis In some examples of the present technology, the cushion module 3150 may include an under-chassis reinforcement portion 3221. The cushion module 3150 may include an under-chassis reinforcement portion 3221 in addition to or as an alternative to the over-chassis reinforcement portion 3220. In other examples of the present technology, the cushion module 3150 may not include the over-chassis reinforcement portion 3220 or the under-chassis reinforcement portion 3221.

[0219] As shown in detail in Figures 30E and 31D, the chassis portion 3210 of each cushion module 3150 in the examples shown in Figures 30A-30E and 31A-31D includes a pair of under-chassis reinforcement portions 3221. Each of the under-chassis reinforcement portions 3221 may be provided on the lower portion of the chassis portion 3210. In these examples, each of the under-chassis reinforcement portions 3221 is disposed adjacent a respective one of the central lateral lower portions 3122 of the seal-forming structure 3100 (described below). The under-chassis reinforcement portions 3221 are provided on each lateral side of a central region of the underside of the chassis portion 3210.

[0220] Each chassis under reinforcement portion 3221 may be spaced medially from a distal end of a respective laterally projecting connecting portion 3212. For example, each chassis under reinforcement portion 3221 may be spaced medially from a respective one of the laterally projecting connecting portions 3212. Each chassis under reinforcement portion 3221 may have a lateral boundary spaced from a distal end of a respective one of the laterally projecting connecting portions 3212.

[0221] As discussed above, the chassis portion 3210 may be formed from a flexible material, which may be an elastomeric material. The under-chassis reinforcement portion 3221 may be formed from the flexible material that forms the chassis portion 3210. The under-chassis reinforcement portion 3221 may be integrally formed with the chassis portion 3210. For example, the under-chassis reinforcement portion 3221 may be molded with adjacent portions of the chassis portion 3210 in a single molding step. The under-chassis reinforcement portion 3221 may partially define the plenum chamber 3200 with other portions of the chassis portion 3210.

[0222] The under chassis reinforcement portions 3221 may be elongated. As shown in Figures 30E and 31D, the under chassis reinforcement portions 3221 each extend laterally along the chassis portion 3210 from an intermediate location adjacent the upper lip portion 3116 of the seal-forming structure 3100 (described in further detail below) to a lateral location adjacent a lateral rear region 3141 of the seal-forming structure 3100. As shown, the under chassis reinforcement portions 3221 have spaced apart intermediate boundaries. The under chassis reinforcement portions 3221 may be shaped to follow the boundary between the chassis portion 3210 and the seal-forming structure.

[0223] Each under-chassis reinforcement portion 3221 may be stiffer than adjacent portions of chassis portion 3210. In the example shown in Figs. 30A-30E, the thickness of each under-chassis reinforcement portion 3221 is greater than the thickness of adjacent portions of chassis portion 3210. In this example, such greater thickness provides greater stiffness. Under-chassis reinforcement portion 3221 may provide similar benefits to over-chassis reinforcement portion 3220. The stiffening provided by under-chassis reinforcement portion 3221 to chassis portion 3210 aids in the conversion of headgear forces to sealing forces.

[0224] In the example shown in Figs. 30A to 30E, each chassis under reinforcement portion 3221 has a thickness of 3 mm, and in other examples, the thickness may be 1.5 mm to 4.5 mm. In the example shown in Figs. 31A to 31D, the thickness of chassis under reinforcement portion 3221 is also 3 mm. The thickness of chassis portion 3210 may gradually change between chassis under reinforcement portion 3221 and an adjacent portion. That is, chassis portion 3210 of cushion module 3150 may include a portion where the thickness between each chassis under reinforcement portion 3221 and one or more adjacent portions changes in a tapered shape. In other examples, chassis portion 3210 may include a portion where the thickness changes stepwise at the boundary of chassis under reinforcement portion 3221.

[0225] 5.3.1.5 Lateral protruding connections As mentioned above, the chassis portion 3210 may include a pair of laterally projecting connections 3212. Each of the laterally projecting connections 3212 may be configured to connect to and receive gas flow from a respective gas delivery tube portion 3350. Each laterally projecting connection 3212 may include an inlet into the interior of the chassis portion 3210.

[0226] In some examples of the present technology, each laterally projecting connector 3212 may define a plenum chamber inlet port.

[0227] The angle at which the laterally protruding connecting portion 3212 protrudes advantageously orients the seal-forming structure 3100 at an angle that enables the seal-forming structure 3100 to form a stable seal with the patient's face (without occlusion of the patient's nose).

[0228] 23 and 24A-24C show the angles of the laterally projecting connectors 3212 in some forms of the present technology. The angles and other features of the laterally projecting connectors 3212 described with reference to 23 and 24A-24C may also be applied to the laterally projecting connectors 3212 of the cushion modules 3150 of examples of the present technology (e.g., those shown in FIGS. 16A-16D, 19A-19F, 25A-25I, 26A-26I, 30A-30E, 31A-31D, and 32A-32D).

[0229] FIG. 24A is a cross-sectional view of the cushion module 3150 through the center of the cushion module 3150 as shown in FIG. 23. Line L is shown in FIG. 24A. Line L is a straight line that is tangent to two points on the face of the seal-forming structure 3100 and does not pass through the seal-forming structure 3100. That is, if one line is moved to the center of the patient-contacting side of the seal-forming structure 3100 (until it contacts a point on the patient-contacting side of the seal-forming structure 3100) and then rotated around that point until it contacts a second point on the patient-contacting side, line L is obtained. In an example of the present technology, if the line cannot be drawn in this way or there are multiple possible orientations for such a line, line L can be a centerline drawn across the patient-contacting side of the seal-forming structure 3100 generally from the portion of the seal-forming structure 3100 that contacts the patient's upper lip to the portion of the seal-forming structure 3100 that contacts the patient's nasal tip.

[0230] FIG. 24B shows line L1, which is a horizontal line perpendicular to line L. Also shown in FIG. 24B is angle A between line L1 and line LA. Line LA indicates the direction in which connection portion 3212 projects in the plane of the drawing. Thus, angle A is an angle in the plane of the drawing, and does not indicate an angle in three-dimensional space. Angle A may be considered an "elevation" angle. Angle A may be considered an upward angle of connection portion 3212 or connector 3214.

[0231] In some examples of the present technology, angle A can be between 10 degrees and 30 degrees (e.g., between 15 degrees and 25 degrees or between 18 degrees and 23 degrees). In one example, angle A is 21 degrees. In another example, angle A is 21.5 degrees.

[0232] In other examples of the present technology, angle A can be between 15 degrees and 35 degrees (e.g., between 20 degrees and 30 degrees or between 23 degrees and 29 degrees). In one example, angle A is 25 degrees. In another example, angle A is 27 degrees.

[0233] Line L2 shown in FIG. 24C is another horizontal line perpendicular to line L. Also shown in FIG. 24C is angle B between line L2 and line LB. Line LB indicates the direction in which the connection protrudes in the plane of the drawing. Thus, angle B is an angle in the plane of the drawing, and does not indicate an angle in three-dimensional space. Angle B may be considered a "depth" angle. Angle B may be considered an angle toward the rear of connection 3212 or connector 3214.

[0234] In some examples of the present technology, angle B can be between 25 degrees and 45 degrees (e.g., between 30 degrees and 40 degrees or between 32 degrees and 37 degrees). In one example, angle B is 34.5 degrees. In another example, angle B is 33 degrees.

[0235] In some examples of the present technology, angle B can be between 20 degrees and 40 degrees (e.g., between 25 degrees and 35 degrees or between 26 degrees and 30 degrees). In one example, angle B is 28 degrees.

[0236] These particular angles allow the seal-forming structure 3100 to be held in a sufficiently expanded state when the connection portion 3212 is connected to the gas delivery tube portion 3350 of the positioning and stabilizing structure 3300 so that it does not compress the patient's nose to an excessive extent (which could cause obstruction of the patient's nasal airway). In examples of the present technology where the chassis portion 3210 is flexible, the seal-forming structure 3100 may be more likely to collapse medially than if the chassis portion 3210 were rigid. Thus, angles of the connection portion 3212 that hold the seal-forming structure 3100 in a sufficiently open state are useful in avoiding excessive medial forces on the sides of the patient's nose.

[0237] The line L shown in Fig. 24A may be oriented relative to the Frankfort Horizontal of the patient's head such that, in use of the patient interface 3000, the presentation angle of the seal-forming structure 3100 is between the line L and the Frankfort Horizontal. More specifically, the presentation angle may be the angle between the line L in use and a line that extends both in the Frankfort Horizontal and in the sagittal plane of the patient's head. The presentation angle may be formed, in use, between the line L of the patient interface 3000 and a line at the intersection of the Frankfort Horizontal and the sagittal plane.

[0238] In some specific examples of the present technology, the presentation angle may be between 20 degrees and 40 degrees (e.g., between 24 degrees and 36 degrees, between 25 degrees and 32 degrees, or between 32 degrees and 38 degrees). In some examples, the seal-forming structure 3100 of the patient interface 3000 may have a presentation angle as defined above in the range of 22 degrees to 30 degrees. In other examples, the seal-forming structure 3100 may have a presentation angle as defined above in the range of 31 degrees to 39 degrees. The cushion module 3150 shown in Figures 24A-24C may have a presentation angle as defined above in the range of 24 degrees to 29 degrees in use. The cushion module 3150 shown in Figures 30A-30E may have a presentation angle as defined above in the range of 33 degrees to 38 degrees. The cushion module 3150 shown in Figures 31A-31D may have a presentation angle as defined above in the range of 31 degrees to 35 degrees.

[0239] The presentation angle of the cushion module 3150 shown in Figures 30A-30E may be 9 degrees greater than the presentation angle of the cushion module 3150 shown in Figures 24A-24C. The presentation angle of the cushion module 3150 shown in Figures 31A-31D may be 6.5 degrees greater than the presentation angle of the cushion module 3150 shown in Figures 24A-24C.

[0240] 5.3.1.6 Connectors 17A-17E show a connector 3214 according to one example of the present technology, 27A-27C show a connector 3214 according to another example of the present technology, and 33A-33B show a connector 3214 according to yet another example of the present technology. The connectors 3214 described with reference to 17A-17E, 27A-27C, and 33A-33B may each be provided in any of the cushion modules 3150 described herein (e.g., any of the cushion modules 3150 described with reference to 8A-8H, 9A-9H, 16A-16D, 19A-19F, 20, 23, 24A-24C, 25A-25I, 26A-26I, 30A-30E, 31A-31D, and 32A-32D, etc.). As noted above, a connector 3214 may be provided on each laterally-projecting connection portion 3212 of the chassis portion 3210. In this example, the connector 3214 is provided at the inlet of the laterally-projecting connection portion 3212. Each of the connectors 3214 may be configured to connect to a corresponding connector on a respective one of the gas delivery tube portions 3350. In particular, each of the connectors 3214 is configured to connect a respective one of the laterally-projecting connection portions 3212 of the chassis portion 3210 to a respective one of the gas delivery tube portions 3350.

[0241] In the illustrated example, the connector 3214 is rigid. Although the chassis portion 3210 may be advantageously formed from a flexible material, the connector 3214 may be formed from a rigid material. The rigid connector 3214 may allow for a snap-fit ​​connection between the cushion module 3150 and the gas delivery tube portion 3350. In some examples, the connector 3214 may be formed from polypropylene, nylon, polycarbonate, or similar materials.

[0242] 17A to 17E and 27A to 27C, each connector 3214 includes a chassis connection portion 3181. The chassis connection portion 3181 may be the widest portion of the connector 3214. The chassis connection portion 3181 of each connector 3214 may be connected to connection portions 3212 protruding on each side of the chassis portion 3210.

[0243] Each connector 3214 may be joined to the chassis portion 3210 by an overmolding process. In an overmolding process, it may be necessary to mold the chassis portion 3210 to the connector 3214 after forming the connector 3214. An outwardly facing surface 3181a of the chassis connection portion 3181 of each connector 3214 may be joined to the material forming the chassis portion 3210. In some examples, the outwardly facing surface 3181a may be known as a joining surface. In this example, the chassis connection portion 3181 of each connector 3214 is provided at a downstream end of the connector 3214. In other examples, the chassis connection portion 3181 may be glued to the chassis portion 3210 or may be mechanically connected (e.g., by a press fit, snap fit, etc.). FIG. 18A is a cross-sectional view showing the connector 3214 connected to a laterally protruding connection portion 3212.

[0244] In the cross-sectional views shown in Figures 17C, 17E and 27C, for example, the outwardly facing surface 3181a of the chassis connection portion 3181 may be substantially straight. In these three dimensions shown in Figures 17A and 27A, for example, the chassis connection portion 3181 may be curved around the outer perimeter of the connector 3214. The shape of the outwardly facing surface 3181a of the chassis connection portion 3181 may correspond to the inwardly facing mating surfaces of the connecting portions 3212 that protrude on each side of the chassis portion 3210.

[0245] As shown in FIGS. 17C, 17E, and 27C, the chassis connection portion 3181 includes an inwardly facing surface 3181b (shown in FIG. 27C) opposite the outwardly facing surface 3181a. The length of the inwardly facing surface 3181b may be shorter than the outwardly facing surface 3181a. The cross section of the inwardly facing surface 3181b may be substantially straight and parallel to the length of the connector 3214. The cross section of the inwardly facing surface of the chassis connection portion 3181 may be parallel to the outwardly facing surface 3181a of the chassis connection portion 3181. The inwardly facing surface of the chassis connection portion 3181 may extend around an inner periphery of the chassis connection portion 3181.

[0246] Between the outwardly facing surface 3181a and the inwardly facing surface 3181b of the chassis connecting portion 3181 of each connector 3214 on the downstream side of the connector 3214 (for example, a side portion of the connector 3214 inside the chassis portion 3210) is a substantially flat downstream end surface. This downstream end surface connects the downstream side of the outwardly facing surface 3181a and the inwardly facing surface 3181b of the chassis connecting portion 3181n.

[0247] Each of the connectors 3214 includes a protruding connector portion 3182. In this embodiment of the present technology, the protruding connector portion 3182 extends in a direction away from the chassis portion 3210. Each of the protruding connector portions 3182 extends in an upstream direction. Each of the protruding connector portions 3182 extends from the chassis connection portion 3181 from the inner side relative to the chassis connection portion 3181. In detail, the protruding connector portion 3182 may protrude in a direction away from the chassis connection portion 3181 along the length of the connector 3214. As shown in FIG. 17E and FIG. 27C, each of the protruding connector portions 3182 is disposed adjacent to a surface 3181b facing inward of a respective one of the chassis connection portions 3181 of the connector 3214.

[0248] Each protruding connector portion 3182 is configured to mate with a corresponding connector provided on the gas delivery tubing portion 3350. In this example of the present technology, the protruding connector portion 3182 mates with a corresponding female connector provided on each gas delivery tubing portion 3350 of the patient interface 3000. In the illustrated example, and with reference to Figs. 17A, 17E and 27C, in particular, the protruding connector portion 3182 of each connector 3214 includes a pair of recesses 3185. These recesses 3185 are configured to receive and retain corresponding portions of the connector on the gas delivery tubing portion 3350, thereby facilitating a snap-fit ​​connection. The connector on the gas delivery tubing portion 3350 may be as described in International Application No. PCT / AU2019 / 050873, which is incorporated herein by reference in its entirety. The gas delivery tubing portion 3350 may be as described in International Application No. PCT / AU2019 / 050874. The entirety of which is incorporated herein by reference. In some examples of the present technology, each protruding connector portion 3182 may include only one recess. In other examples, each protruding connector portion 3182 may include more than two recesses 3185.

[0249] In the example of the present technology shown in FIGS. 17A-17E and 27A-27C, a cross section is bent between the chassis connection portion 3181 and the protruding connector portion 3182 of each connector 3214. Specifically, as shown in the cross-sectional views of FIGS. 17C, 17E, and 27C, the connector 3214 has a bent cross section at the transition between the chassis connection portion 3181 and the protruding connector portion 3182. This bend causes a change in width of the connector 3214. Specifically, the protruding connector portion 3182 is narrower than the chassis connection portion 3181.

[0250] On either side of the chassis connection portion 3181 and the protruding connector portion 3182 are an outer shoulder 3183 and an inner shoulder 3184. The outer shoulder 3183 is provided on the side of the connector 3214 that faces outward. The inner shoulder 3184 is provided on the side of the connector 3214 that faces inward.

[0251] As shown in FIG. 17E and FIG. 27C, the outer shoulder 3183 includes a wall 3183a that is substantially flat relative to the length of the connector 3214. The flat wall 3183a of the outer shoulder 3183 may be perpendicular to the outwardly facing surface 3181a of the chassis connection portion 3181 and / or the inwardly facing surface of the chassis connection portion 3181. The flat wall 3183a of the outer shoulder 3183 may be parallel to a downstream end wall of the chassis connection portion 3181 that connects the outwardly facing surface 3181a and the inwardly facing surface of the chassis connection portion 3181. As shown in FIG. 17E and FIG. 27C, the protruding connector portion 3182 may include an outwardly facing wall that is substantially flat and substantially parallel to the outwardly facing surface 3181 of the chassis connection portion 3181. The flat wall 3183a of the outer shoulder 3183 may be substantially perpendicular to this outwardly facing wall of the protruding connector portion 3182. Between the flat wall 3183a of the outer shoulder 3183 and the outwardly facing wall 3183a of the protruding connector portion 3182, a curved cross-section of the outer shoulder 3183 is provided. In other examples, the transition between the flat wall 3183a and the protruding connector portion 3182 may be a sharp corner.

[0252] The outer shoulder 3183 may be configured to form a seal with an end of the gas delivery tubing section 3350 in use. Each gas delivery tubing section 3350 may include a substantially flat surface at its downstream end. The substantially flat surface is configured to engage and form a seal with the outer shoulder 3183 of the respective connector 3214. The outer shoulder 3183 may extend around the periphery of the connector 3214 and be configured to engage a sealing surface around the periphery of the corresponding connector of each gas delivery tubing section 3350. The flat wall 3183a may be configured to mate with the flat surface of each gas delivery tubing section 3350. The recess 3185 can be spaced apart relative to the outer shoulder 3183 so that when a snap fit is formed between the recess 3185 and a corresponding portion of the connector on the gas delivery tube portion 3350, the compliant portion of the gas delivery tube portion 3350 is held tightly against the outer shoulder 3183.

[0253] In some examples, a portion of the protruding connector portion 3182 adjacent the outer shoulder 3183 may also form a seal with the end of the gas delivery tube portion 3350 in use. In some examples, the gas delivery tube portion 3350 includes a radially inwardly protruding lip at its end which may form a seal with one or more of the protruding connector portion 3182, the chassis connection portion 3181 (e.g., the flat wall portion 3183a) and the outer shoulder 3183.

[0254] The gas delivery tube section 3350 may also seal a portion of the chassis section 3210 (e.g., the end of the connection section 3212 that protrudes laterally). Advantageously, the chassis section 3210 may be formed from a soft material (e.g., silicone, TPE). The gas delivery tube section 3350 may also be formed from a soft material (e.g., silicone, TPE), such that a soft-to-soft connection is obtained between the gas delivery tube section 3350 and the chassis section 3210. In other examples, the connection may be a soft-to-hard connection (e.g., when the end of the gas delivery tube section 3350 is formed by a hard component or when the end of the gas delivery tube section 3350 is soft but engages with a hard portion of the chassis section 3210 (e.g., hard connector 3214)). In a further example, the connection may be a hard-to-hard connection (eg, where the end of the gas delivery tube portion 3350 is formed by a hard component and connects to a hard portion of the chassis portion 3210 (eg, hard connector 3214)).

[0255] The inner shoulder 3184 includes a gradually curvilinear cross-section. The inner shoulder 3184 includes a gradually curvilinear transition between the inwardly facing wall of the chassis connection portion 3181 and the inwardly facing wall of the protruding connector portion 3182. The inwardly facing wall of the protruding connector portion 3182 may be substantially parallel to the inwardly facing wall of the chassis connection portion 3181. The inwardly facing wall of the protruding connector portion 3182 may also be parallel to the outwardly facing wall of the protruding connector portion 3182. The inwardly facing wall of the protruding connector portion 3182 may be perpendicular to the downstream end face of the chassis connection portion 3181 and / or the flat wall 3183a of the outer shoulder 3183. Each recess 3185 of the protruding connector portion 3182 may be concave relative to the outwardly facing wall of the protruding connector portion 3182.

[0256] 17A-17E and 27A-27C, in these examples, the connectors 3214 each include a clip base portion 3186 and a pair of clip arms 3187. In these examples, the protruding connector portion 3182 includes a clip base portion 3186 and clip arms 3187.

[0257] The clip base portion 3186 is adjacent to the chassis connection portion 3181 of the connector 3214. As shown in FIG. 27C, the clip base portion 3186 may extend from an inner periphery of the chassis connection portion 3181. The cross-sectional shape of the clip base portion 3186 is similar to but smaller than the chassis connection portion 3181, resulting in a step at the outer surface of the connector 3214 and at the interface between the clip base portion 3186 and the chassis connection portion 3181. The chassis connection portion 3181 and the clip base portion 3186 may surround a hole through the connector 3214 through which breathable gas travels during use. For example, the chassis connection portion 3181 and the clip base portion 3186 may each be formed roughly D-shaped when viewed from a cross-section along a central axis through the interior of the connector 3214.

[0258] The protruding connector portion 3182 may include a pair of clip arms 3187 protruding away from the clip base portion 3186. In contrast to the clip base portion 3186, the clip arms 3187 may each surround only a portion of a hole through the connector 3214 through which breathable gas travels during use. In the example shown in FIGS. 17A-17E and 27A-27C, each clip arm 3187 includes a recess 3185. The recess 3185 is configured to receive a clip protrusion 3304 (described below) of the tube end connector 3302 of the gas delivery tube portion 3350 to form a snap-fit ​​connection with the tube end connector 3302. In other examples, the connector 3214 may have only one clip arm 3187 or may have three or more clip arms. Each clip arm 3187 may include a respective recess 3185 configured to receive a respective clip protrusion 3304.

[0259] FIG. 29 illustrates the tube end 3314 of the gas delivery tubing 3350 of the patient interface 3000 illustrated in FIGS. 7A-7G. The connector 3214 illustrated in FIGS. 17A-17E and 27A-27C is configured to connect to this tube end 3314. In particular, the protruding connector portion 3182 of the connector 3214 is configured to be received within the tube end 3314 and connect to a tube end connector 3302 within the tube end 3314. In the example illustrated in FIG. 29, the tube end connector 3302 is overmolded onto a clip overmolded 3318, which is itself overmolded into the tube end 3314. In other examples, the clip is overmolded directly onto the flexible material forming the gas delivery tubing 3350 at the tube end 3314.

[0260] When a snap-fit ​​connection is made between the connector 3214 and a corresponding tube end connector 3302 on the tube end 3314 of the gas delivery tube section 3350, in these examples the clip arms 3187 deform to allow the clip protrusions 3304 of the tube end connector 3302 to slide over the outwardly facing surface of the clip arms 3187 and then engage within the recesses 3185 to form the snap-fit ​​connection. To facilitate the snap-fit ​​connection, the clip arms 3187 may each bend inwardly toward the central axis of the connector 3214. In some examples of the present technology, the tube end connector 3302 may also deform upon snap-fit ​​connection to the connector 3214. The tube end 3314 also includes a lip 3324 that forms a seal with the connector 3214. The lip 3324 may seal one or more of the protruding connector portion 3182 , the outer shoulder 3183 , the flat wall portion 3183 a of the outer shoulder 3183 and the connection portion 3212 of the chassis portion 3210 .

[0261] Figure 28A is a partial side view of the connector 3214 shown in Figures 17A-17E with some dimensions shown, and Figure 28B is a partial side view of the connector 3214 shown in Figures 27A-27C with some dimensions shown.

[0262] The location of the recess 3185 in the connector 3214 corresponds to the location of the clip protrusion 3304 of the tube end connector 3302, since the recess 3185 receives the clip protrusion 3304 when the tube end 3314 is connected to the connector 3214. The distance C1 shown in FIG. 28A is the distance from the chassis connection 3181 to the recess 3185 in the connector 3214 shown in FIGS. 17A-17E. The distance C2 shown in FIG. 28B is the distance from the chassis connection 3181 to the recess 3185 in the connector 3214 shown in FIGS. 27A-27C. The distances C1 and C2 may be substantially equal to each other and may be substantially equal to the distance from the end wall of the tube end 3314 to the clip protrusion 3304. Thus, when the clip projection 3304 is fitted into the recess 3185 of the connector 3214 shown in FIG. 28A or 28B, the distal most end of the tube wall portion 3314 is adjacent to the chassis connection portion 3181 of the connector 3214 or the connection portion 3212 of the chassis portion 3210.

[0263] 28A, the distance C1 from the chassis connection portion 3181 to the recess 3185 is divided into two illustrated distances CB1 and CA1. Distance CB1 is the length of the clip base portion 3186 along the length of the connector 3214, and distance CA1 is the length of the clip arm 3187 between the clip base portion 3186 and the recess 3185.

[0264] 28B, the distance C2 from the chassis connection portion 3181 to the recess 3185 is divided into two illustrated distances CB2 and CA2. Distance CB2 is the length of the clip base portion 3186 along the length of the connector 3214, and distance CA2 is the length of the clip arm 3187 between the clip base portion 3186 and the recess 3185.

[0265] Applicant has discovered that an advantageous retention force of the connector 3214 when connected to the gas delivery tubing 3350 is achieved by independently adjusting the length of the clip base portion 3186 and the clip arm 3187 without changing the spacing (e.g., distances C1 and C2) between the recess 3185 and the chassis connection portion 3181. When the patient interface 3000 is in use, the gas delivery tubing 3350 holds the cushion module 3150 in a sealing position. It is advantageous to have a sufficiently high force required to disconnect the gas delivery tubing 3350 so that it does not become unintentionally disconnected (e.g., when the patient pulls on the gas delivery tubing 3350 to don or adjust the patient interface 3000 during set-up, or when the patient moves during sleep during use). Additionally, it would be advantageous if the force required to connect and disconnect the gas delivery tube portion 3350 was not so high that it became difficult for the patient to disassemble and reassemble the patient interface 3000 (e.g., when cleaning or replacing the cushion module 3150).

[0266] The length of the clip arms 3187 is a factor in the force required to fully deflect the clip arms 3187 during a snap-fit ​​connection to the tube end connector 3302. If the clip arms 3187 are longer, less force needs to be applied to the free ends of the clip arms 3187 to deflect them a particular amount. When connecting and disconnecting the gas delivery tubing section 3350 to the connector 3214, a force from the tube end connector 3302 is applied to each clip arm 3187 inwardly relative to the connector 3214. A particular amount of deflection of each clip arm 3187 is required to allow the gas delivery tubing section 3350 to connect and disconnect to the connector 3214. Thus, if the clip arms 3187 are longer, less force is required to connect or disconnect the gas delivery tubing section 3350 to the connector 3214. Similarly, if the clip arms 3187 are shorter, more force is required to connect or disconnect the gas delivery tubing section 3350 to the connector 3214.

[0267] Thus, for a given spacing between the recess 3185 and the chassis connection portion 3181 (e.g., C1 in FIG. 28A and C2 in FIG. 28B), individual adjustment of the length of the clip base portion 3186 (e.g., CB1 in FIG. 28A and CB2 in FIG. 28B) and the length of the clip arm 3187 between the clip base portion 3186 and the recess 3185 (e.g., CA1 in FIG. 28A and CA2 in FIG. 28B) can be made to achieve a retention force of the connector 3214 that balances the requirement of keeping the connector 3214 connected to the gas delivery tube portion 3350 in use and allowing the patient to disconnect the connector 3214 from the gas delivery tube portion 3350 as appropriate.

[0268] 17A-17E and 28A, the length CB1 of the clip base portion 3186 is less than the length CA1 of the clip arm 3187 along the length of the connector 3214 between the clip base portion 3186 and the recess 3185. Applicant has discovered that a cushion module 3150 including this connector 3214 can be connected to a gas delivery tube portion 3350 and the connection can be maintained with a sufficiently high retention force to allow a sufficiently stable connection in use.

[0269] In another form of the present technology, for example as shown in FIGS. 27A-27C and 28B connector 3214, length CB2 of clip base portion 3186 is longer than length CA2 of clip arm 3187 along the length of connector 3214 between clip base portion 3186 and recess 3185.

[0270] Applicant has discovered that a particularly advantageous retention force is achieved when the length of the clip base portion 3186 along the length of the connector 3214 is equal to or greater than the length of the clip arms 3187 along the length of the connector 3214 between the clip base portion 3186 and the recess 3185. The retention force (e.g., the separation force that the connection can withstand before separation) is high enough that unintentional disconnection during set-up or use is unlikely, yet not excessively high so that it is difficult for the patient to intentionally disconnect the cushion module 3150 from the gas delivery tube portion 3350.

[0271] Thus, in some examples of the present technology, the length of the clip base portion 3186 is longer than the length of the clip arm 3187 between the clip base portion 3186 and the recess 3185. The relationship of the length of the clip base portion 3186 to the length of the clip arm 3187 between the clip base portion 3186 and the recess 3185 may also be expressed as a ratio. In some examples, the ratio of the length of the clip base portion 3186 to the length of the clip arm 3187 between the clip base portion 3186 and the recess 3185 is greater than or equal to 1.2, 1 or 1.3, 1. In further examples, the ratio is greater than about 1.5, 1, 1.7, 1 or 1.9, 1. In the example shown in FIG. 28B, the ratio is about 2, 1.

[0272] In some examples of the present technology, the force required to disconnect each connector 3214 of the cushion module 3150 from the tube end connector 3302 of each gas delivery tube section 3350 may exceed 12N. In further examples, the required force may exceed 20N, 25N, or exceed 30N. In some examples, the required force may be in a range of 12N-50N. In further examples, the required force is in a range of 20N-40N (e.g., in a range of 20N-30N or in a range of 30N-40N). In some examples, the required force is in a range of 25N-35N. In some examples of patient interfaces 3000 according to the present technology, the cushion module 3150 may be detachable from the gas delivery tube portion 3350 of the patient interface 3000 (upon application of forces above or within the ranges noted above), but may also include one or more connectors 3214 of a design other than those shown in Figures 17A-17E, 27A-27C, or 28A-28B.

[0273] 33A-33B, the clip arms 3187 of the connector 3214 include clip arm corners 3188. Each clip arm 3187 may include a pair of clip arm corners 3188 at a distal end of the clip arm 3187 opposite the chassis connection portion 3181 of the connector 3214. In this example, the clip arm corners 3188 are curved. Curving the clip arm corners 3188 may reduce stress at the clip arm corners 3188 upon connection of the connector 3214 to the gas delivery tube 3350. If excessive stress is present at the clip arm corners 3188, this may reduce the life or reliability of the cushion module 3150. Shaping the clip arm corners 3188 as described below may advantageously result in a connector 3214 that is less likely to chip, crack or otherwise break or fail during use.

[0274] 33A is a view of the connector 3214 from a first side with the front clip arm 3187 and its clip arm corner 3188 shown and described. The first side may be the front side of the connector 3214 in use. In another example, the first side may be the rear side of the connector 3214 in use and the illustrated clip arm 3187 may be the rear clip arm 3187. Each clip arm corner 3188 may be arc shaped. The arc may have a transverse dimension CR1 perpendicular to the longitudinal axis of the connector 3214 (which longitudinal axis is substantially parallel to the direction of gas flow through the connector 3214 in use) and a longitudinal dimension CR2 parallel to the longitudinal axis of the connector 3214.

[0275] The transverse dimension CR1 of the arc of the clip arm corner 3188 of the front clip arm 3187 is in the range of 2 to 5 mm (e.g., in the range of 2.5 to 4 mm). In the example shown in FIG. 33A, the dimension CR1 is 3 mm. The longitudinal dimension CR2 of the arc of the clip arm corner 3188 of the front clip arm 3187 can be the same as the transverse dimension CR1. In other examples, the longitudinal dimension CR2 can be different from the transverse dimension CR1. The longitudinal dimension CR2 of the arc of the clip arm corner 3188 of the front clip arm 3187 can be in the range of 2 to 5 mm (e.g., in the range of 2.5 to 4 mm). In the example shown in FIG. 33A, the dimension CR2 is 3 mm.

[0276] 33B is a view of the connector 3214 from a second side where the rear clip arm 3187 and its clip arm corner 3188 are shown and described. The second side may be the rear side of the connector 3214 in use. In another example, the second side may be the front side of the connector 3214 in use and the illustrated clip arm 3187 may be the front clip arm 3187. Each clip arm corner 3188 may be arc shaped. The arc may have a transverse dimension CR3 perpendicular to the longitudinal axis of the connector 3214 and a longitudinal dimension CR4 parallel to the longitudinal axis of the connector 3214.

[0277] The transverse dimension CR3 of the arc of the clip arm corner 3188 of the rear clip arm 3187 can be in the range of 1 to 4 mm (e.g., in the range of 1.5 to 3 mm). In the example shown in FIG. 33B, the dimension CR3 is 2 mm. The longitudinal dimension CR4 of the arc of the clip arm corner 3188 of the rear clip arm 3187 can be different from the transverse dimension CR3. In other examples, the longitudinal dimension CR4 can be the same as the transverse dimension CR3. The longitudinal dimension CR4 of the arc of the clip arm corner 3188 of the rear clip arm 3187 can be in the range of 2 to 5 mm (e.g., in the range of 2.5 to 4 mm). In the example shown in FIG. 33B, the dimension CR4 is 3 mm.

[0278] 5.3.1.7 Connections between connectors and laterally protruding connections 18A is a cross-sectional view through chassis portion 3210, showing the connection between connector 3214 and laterally protruding connection portion 3212. As shown, an end of laterally protruding connection portion 3212 is joined to chassis connection portion 3181 of connector 3214. Protruding connector portion 3182 protrudes outwardly away from laterally protruding connection portion 3212.

[0279] As shown in Figure 18A, each laterally projecting connecting portion 3212 may include an upper portion that is convex when viewed from above and a lower portion that is concave when viewed from below. Each laterally projecting connecting portion 3212 may be curved downwardly in a direction away from the seal-forming structure 3100. This is also evident in Figures 8D and 8H.

[0280] As shown in FIG. 21, each laterally projecting connecting portion 3212 includes an upper ridge 3213. Each upper ridge 3213 may extend laterally across the length of each laterally projecting connecting portion 3212. Each upper ridge 3213 may extend longitudinally along the length of each laterally projecting connecting portion 3212. In this example of the present technology, each upper ridge 3213 extends laterally across each one of the laterally projecting connecting portions 3212 and longitudinally along each one of the laterally projecting connecting portions 3212. One end of each upper ridge 3213 may be disposed at an upper and forward position relative to the laterally projecting connecting portion 3212. The other end of each upper ridge 3213 may be disposed adjacent to the seal-forming structure 3100 on the upper and rear side of the laterally projecting connecting portion 3212, as shown in FIG. 21.

[0281] 5.3.2 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position in use by the positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 comprises and functions as a "headgear" as it engages the patient's head to hold the patient interface 3000 in a sealed position. In some examples of the present technology, the positioning and stabilizing structure 3300 may include any one or more of the features described in International Application No. PCT / AU2019 / 050874, the entirety of which is incorporated herein by reference.

[0282] In one form, the positioning and stabilizing structure 3300 provides at least enough retention force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0283] In one form, the positioning and stabilising structure 3300 provides a retaining force sufficient to overcome the attractive force on the patient interface 3000.

[0284] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0285] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be worn by a patient while sleeping. In one embodiment, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0286] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be excessively large or bulky in size that would interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0287] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleep position with the side region of the patient's head resting on a pillow.

[0288] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling site located between an anterior portion of the positioning and stabilizing structure 3300 and a posterior portion of the positioning and stabilizing structure 3300. The decoupling site does not resist compression and can be, for example, a flexible or flimsy strap. The decoupling site is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling site avoids a posterior force being transferred along the positioning and stabilizing structure 3300 that would disrupt the seal.

[0289] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0290] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a stretchable (e.g., stretchable with elasticity) strap. For example, the strap may be configured, and in some embodiments may be configured in combination with other straps or other structures, such that in use it is held taut to direct a force that seals the seal-forming structure against a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0291] A tie may be understood as a structure designed to resist tension. In use, the tie is the portion of the positioning and stabilizing structure 3300 that is under tension. Some ties add elasticity resulting from this tension, as described above. The tie may function to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient's head.

[0292] In one form of the present technology, the positioning and stabilizing structure 3300 includes a first tie constructed and arranged such that in use at least a portion of its lower edge passes over and moves to the superior ear-base point of the patient's head and covers a portion of the parietal and / or frontal bone. The first tie may be provided as part of a patient interface including, for example, a cradle cushion, a nasal pillow, a nasal cushion or a full face cushion (such as an under-nose full face cushion or a full face cushion that seals the patient's nose against the superior nose point), a full face cushion or an oral-nasal cushion.

[0293] In some examples of the present technology, the first tie of the positioning and stabilizing structure 3300 includes an upper first tie portion and a lower first tie portion. The upper first tie portion can rest on a portion of the parietal bone and / or frontal bone. The lower first tie portion rests on or covers the rear of the occipital bone of the patient's head. The first tie can be bifurcated. The first tie can be bifurcated into an upper first tie portion and a lower first tie portion. The first tie can include a front portion configured to rest on the side of the patient's head / face and a bifurcation portion configured to rest on the side, top, and / or back of the patient's head. The front portion can be integrally formed with the upper first tie portion. The lower first tie portion can connect to a junction between the front portion and the upper first tie portion.

[0294] For example, as shown in Figures 7A-7G, the positioning and stabilizing structure 3300 includes a first tie that connects to the cushion module 3150 and is positioned along the patient's head across the top of the patient's head and the back of the patient's head in use. The first tie bifurcates into an upper first tie section and a lower first tie section. The upper first tie section is provided by the top of each gas delivery tube section 3350 and the lower first tie section is provided by the strap 3310 shown in Figure 7A.

[0295] In one form of the present technology, the positioning and stabilizing structure 3300 includes a second tie. The second tie is constructed and arranged such that in use at least a portion of its upper edge passes under the lower ear base point of the patient's head and covers or rests under the occipital bone of the patient's head. The second tie may pass under the patient's ear. The second tie may include, for example, a full face cushion (which may or may not leave the patient's nasal tip exposed) or a nasal cushion. It may be provided as part of the patient interface. In other examples, the second tie may be provided as part of the patient interface including a cradle cushion or a nasal pillow cushion. The second tie may rest on the side and / or behind the patient's neck in use and may connect to a lower part of the frame of the positioning and stabilizing structure 3300, a lower part of the cushion module 3150, or a lower part of the plenum chamber 3200.

[0296] In one form of the present technology, the positioning and stabilizing structure 3300 includes a third tie constructed and arranged to interconnect the first and second ties to reduce the tendency of the first and second ties to move apart relative to one another. The third tie may be provided as part of a patient interface including a full face cushion (which may or may not leave the patient's nasal tip exposed) or a nasal cushion. In other examples, the third tie may be provided as part of a patient interface including a cradle cushion or a nasal pillows cushion.

[0297] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes a strap that is bendable, e.g., non-rigid. An advantage of this embodiment is that the strap is more comfortable when the patient lies down to sleep. As shown in Figures 7A-7G, the positioning and stabilizing structure 3300 includes a pair of gas delivery tubes 3350 that are non-rigid. Additionally, the positioning and stabilizing structure 3300 includes a strap 3310 that is non-rigid.

[0298] 7A-7G, the positioning and stabilizing structure 3300 includes a pair of tabs 3320. In use, a strap 3310 (shown in FIG. 7A) may be connected between the tabs 3320. The strap 3310 is sufficiently flexible so that it may be passed around the rear of the patient's head and positioned comfortably against the patient's head (even when under tension in use).

[0299] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow water vapor to pass therethrough. The straps 3310 of the positioning and stabilizing structure 3300 of the exemplary patient interface 3000 shown in Figures 7A-7G are constructed from a foam material coated in a textile material. In other examples, the straps 3310 may be formed solely from a foam material, a textile material, or another material (e.g., a soft plastic material).

[0300] 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 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, a system may include one form of positioning and stabilizing structure 3300 that is suitable for a large sized head but not a small sized head and another that is suitable for a small sized head but not a large sized head.

[0301] 5.3.2.1 Headgear tubing In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more tubes 3350 that deliver pressurized air received from the air circuit 4170, for example through the cushion module 3150 and the seal-forming structure 3100, to the plenum chamber 3200 and to the patient's airway. The tube 3350 may receive a pressurized gas flow from a conduit that forms part of the air circuit 4170. This conduit may be connected to the RPT device 4000.

[0302] In the form of the technology shown in Figures 7A-7G, the positioning and stabilizing structure 3300 includes two gas delivery tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. In this example, the tubes 3350 are removably connected to the cushion module 3150. In other examples, the tubes 3350 may be permanently connected to the cushion module 3150 of the patient interface 3000 that at least partially forms the plenum chamber 3200. These tubes 3350 are an integral part of the positioning and stabilizing structure 3300 of the patient interface 3000 that forms part of the headgear for positioning and stabilizing the seal-forming structure 3100 of the patient interface to an appropriate portion of the patient's face (e.g., nose and / or mouth). As a result, it is possible to connect the conduit of the air circuit 4170 that provides the pressurized air flow to the connection port 3600 of the patient interface 3000 at a location other than in front of the patient's face, which may be obtrusive to some people.

[0303] The positioning and stabilizing structure 3300 may be described as inflatable because air may be contained and moved through the headgear tubing 3350 to deliver pressurized air from the air circuit 4170 to the patient's airway. It is understood that an inflatable positioning and stabilizing structure 3300 does not require all components of the positioning and stabilizing structure 3300 to be inflatable. For example, in the example shown in Figures 7A-7G, the positioning and stabilizing structure 3300 includes headgear tubes 3350 that are inflatable and straps 3310 that are non-inflatable.

[0304] In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or back of the patient's head. For example, in the form of the present technology shown in Figures 7A-7G, the connection port 3600 is located on the patient's head. In this example, the patient interface 3000 includes an elbow 3610 with the connection port 3600 provided. The elbow 3610 may be rotatable relative to the positioning and stabilizing structure 3300 to allow movement of a conduit connected to the connection port 3600 to decouple it from the positioning and stabilizing structure 3300. The elbow 3610 is configured to be fluidly connected to a conduit of the air circuit 4170.

[0305] Patient interfaces where the connection port is not located in front of the patient's face may be advantageous because some patients find it unsightly and uncomfortable when the conduit is connected to a front-of-the-face patient interface. For example, conduits that connect to a front-of-the-face patient interface may be prone to entanglement with bedding or bed linens, especially if the conduit extends downward from the patient interface in use. Forms of the present technology using patient interfaces where the connection port is located near and above the patient's head in use may be easier or more comfortable than other types of patient interfaces when the patient lies or sleeps in one or more of the following positions: lateral or sideways position, supine position (i.e., face up on the back), and prone position (i.e., face down on the stomach). Furthermore, connecting the conduit to the front of the patient interface may exacerbate a problem known as tube drag. In tube drag, an undesirable pulling force may be generated from the conduit to the patient interface, causing it to be dragged down from the face.

[0306] In some examples, at least one tube portion 3350 extends between the plenum chamber 3200 and the connection port 3600 over the patient's cheek area and above the patient's ear. A portion of the tube 3350 that connects to the cushion module 3150 covers the maxillary area of ​​the patient's head in use, and a portion of the tube 3350 covers the area of ​​the patient's head above the supra-ear point on the patient's head. Each of the one or more tubes 3350 may also rest on the patient's sphenoid and / or temporal bones and one or both of the patient's frontal and parietal bones. The elbow 3610 may be positioned over the patient's parietal bone, frontal bone, or the junction therebetween in use.

[0307] In the form of the technology shown in Figures 7A-7G, the positioning and stabilizing structure 3300 includes two tubes 3350. Each tube 3350 is positioned on a different side of the patient's head in use and extends from the plenum chamber 3200 across each cheek area, above each ear (above the upper ear base point on the patient's head), to a connection port 3600 on the top of the patient's 1000 head. This form of technology may be advantageous because if the patient is lying on their side and one of the tubes is compressed causing gas flow along that tube to be blocked or partially blocked, the other tube remains open and can provide pressurized gas to the patient. In other embodiments of the technology, the patient interface 3000 may include a different number of tubes (e.g., one tube or three or more tubes). In one example where the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head during use (e.g., on one cheek area) and the strap forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head during use (e.g., on the other area) to assist in securing the patient interface 3000 on the patient's head.

[0308] In the form of the technology shown in Figures 7A-7G, the two tubes 3350 are fluidly connected to each other at their upper ends and to a connection port 3600. In one form, the two tubes are integrally formed, in other forms the tubes are separate components that may be interconnected during use and disconnected, for example for cleaning, storage or replacement. If separate tubes are used, the tubes may be indirectly connected to each other, for example each may be connected to an intermediate tube, for example a T-shaped conduit having two conduit arms each fluidly connectable to tube 3350, and a third conduit arm or opening that functions as the connection port 3600 and is connectable to the air circuit 4170 during use.

[0309] The tubes 3350 may be formed of a semi-rigid material, such as an elastomeric material (e.g., silicone). The tubes 3350 may have a natural preformed shape, or may bend or move to assume another shape when a force is applied to the tube. For example, the tubes may generally assume an arc or curved shape that resembles the contour of the patient's head between the top of the head and the nose or mouth area.

[0310] As described in U.S. Patent No. 6,044,844, the entire contents of which are incorporated herein, the tube 3350 may also be crush resistant to prevent the flow of breathable gas through the tube if it is crushed during use (e.g., when crushed between the patient's face and a pillow). A crush resistant tube is not necessary in all cases, as the pressurized gas in the tube may act as a splint to prevent or at least limit the collapse of the tube 3350 during use. Using a crush resistant tube may be advantageous when there is only a single tube 3350, since if the single tube is blocked during use, gas flow will be restricted and treatment will cease or be less effective.

[0311] Further features of the positioning and stabilizing structure 3300, according to some examples of the present technology, are described in U.S. Provisional Patent Application No. 62 / 764,995, the entirety of which is incorporated herein by reference.

[0312] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned at a range of locations across the top of the patient's head, allowing the patient interface 3000 to be positioned to suit the comfort or fit of an individual patient. Movement of the upper portion of the patient interface 3000 can decouple from the lower portion of the patient interface 3000. This allows the cushion module 3150 to form an effective seal with the patient's face (regardless of the location of the connection port 3600 on the patient's head). Such decoupling can be achieved, for example, using mechanisms that allow parts of the headgear tubes 3350 to easily move or flex relative to other parts of the patient interface 3000. Examples of such mechanisms are described below.

[0313] In certain forms of the present technology, the patient interface 3000 is configured such that, in use, the connection port 3600 is generally located at the top point of the patient's head. The connection port 3600 may be located in the sagittal plane and aligned with the superior basal point in a plane parallel to the coronal plane.

[0314] As noted above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion. The seal-forming structure 3100 is positioned generally under the nose to seal around the lower nose. The positioning and stabilizing structure 3300 may be constructed and arranged to pull the seal-forming structure 3100 into the patient's face under the nose (with a sealing force vector having a posterior and superior direction (e.g., a posterior-superior direction)). A sealing force vector in the posterior-superior direction may encourage the seal-forming structure 3100 to form a good seal on either side of the patient's nose and upper lip against both the lower nose circumference and the anterior surface of the patient's face.

[0315] 5.3.2.1.1 Headgear tubing fluid connections The two tubes 3350 are fluidly connected at their lower ends to the plenum chamber 3200 .

[0316] Examples of laterally projecting connections of the cushion module 3150 to which the gas delivery tube 3350 connects in some forms of the present technology are provided above. In these forms, the gas delivery tube 3350 is configured to engage with such connections of the cushion module 3150.

[0317] In certain forms of the present technology, the connection between the tube 3350 and the cushion module 3150 is accomplished by connecting two rigid components such that the patient can easily connect the two rigid components in a reliable manner. A "noticeable click" or similar audible tactile feedback may be used by the patient and may also let the patient know that the tube is properly connected to the cushion module 3150. In one form, the tube 3350 is formed from silicone and the bottom end of each of the silicone tubes 3350 is overmolded into a rigid connector formed from, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector may include a female mating feature configured to connect to a male mating feature on the cushion module 3150. Alternatively, the rigid connector may include a male mating feature configured to connect to a female mating feature on the cushion module 3150.

[0318] In another embodiment, a compression seal is used to connect each tube 3350 to the cushion module 3150. For example, if a resilient flexible (e.g., silicone) tube 3350 is used without a rigid connector, the tube 3350 may need to be compressed slightly to reduce its diameter so that it can be forced into the port in the cushion module 3150, and the inherent elasticity of the silicone will push the tube 3350 outward to hermetically seal the tube 3350 into the port. If the engagement between the tube 3350 and the port is a rigid-to-rigid type engagement, a pressure activated seal such as a peripheral sealing flange may be used. When pressurized gas is supplied through the tube 3350, the sealing flange is urged against the joint between the tube and the inner periphery of the port of the cushion module 3150 to promote a seal between the two. If the port is flexible and a rigid connector is provided to the tube 3350, a pressure activated seal as described above may also be used to ensure that the connection is airtight. In another example, each tube 3350 is formed from an elastically flexible (e.g., silicone) material and overmolded onto a rigid connector so that the elastically flexible material fits over the rigid connector and the elastically flexible material itself acts as a gasket to seal the connection between the tube 3350 and the cushion module 3150 around the airflow passage from the tube 3350 into the cushion module 3150.

[0319] 5.3.2.1.2 Extendible bellows structure The patient interface 3000 may include one or more extendable tubes. In some examples, the extendable tubes include an extendable bellows structure. The patient interface 3000 may include a positioning and stabilizing structure 3300 including at least one gas delivery tube including a tube wall having an extendable bellows structure. For example, the patient interface 3000 shown in Figures 7A-7G includes a tube 3350 with extendable tubes each in the form of an extendable bellows structure 3362 provided on the top of the tube 3350. In other examples of the present technology, the patient interface 3000 includes a single tube 3350 with an extendable bellows structure 3362. In general, any feature of the tube 3350 described herein may apply to a patient interface 3000 having a single tube 3350 or may apply to each tube 3350 of a patient interface having multiple tubes 3350.

[0320] Each extendable bellows structure 3362 may include a portion of the tube 3350 having one or more folds, pleats, corrugations, or bellows to form an extendable portion of the tube 3350. In the example shown in FIGS. 7A-7G, each of the extendable bellows structures 3362 takes the form of an extendable bellows structure. The extendable bellows structures 3362 are separated by elbows 3610 and connection ports 3600. The extendable bellows structures 3362 are variable in length. In particular, each extendable bellows structure 3362 is capable of expanding or contracting to change the length of each tube 3350.

[0321] 5.3.2.1.3 Non-extendable headgear tubing The patient interface 3000 may include one or more non-extensible tubes 3363. For example, the patient interface 3000 shown in Figures 7A-7G includes a tube 3350. A non-extensible tube 3363 is provided at a lower portion of the tube 3350. The non-extensible tube 3363 may be configured to rest on the patient's cheek and to contact the patient's face below the patient's cheekbone. Each non-extensible tube 3363 may extend downward from a connection between each headgear tube 3350 in a curve and then extend partially forward and partially medially into the plenum chamber 3200 to avoid the patient's cheekbone.

[0322] The cross-sectional shape of the non-extendable tube section 3363 of the tube 3350 may be circular, elliptical, oval, D-shaped, or rectangular with rounded corners, for example as described in U.S. Patent No. 6,044,844. Cross-sectional shapes that present a flat surface of the tube on the side that faces and contacts other parts of the patient's face or head may be more comfortable to wear than, for example, a tube with a circular cross section.

[0323] In some examples of the present technology, the non-extendable tube section 3363 connects to the plenum chamber 3200 at a low angle. The headgear tube 3350 may extend downward on the side of the patient's head, then curve forward and medially to connect to the plenum chamber 3200 in front of the patient's face. Before connecting to the plenum chamber 3200, the tube 3350 may extend to the same vertical position as the connection to the plenum chamber 3200 or in some examples below the connection to the cushion module 9150. That is, the tube 3350 may protrude at least partially upward before connecting to the plenum chamber 3200. A portion of the tube 3350 may be positioned below the plenum chamber 3200 and / or the seal-forming structure 3100. The tube 3350 is positioned downward and in front of the patient's face to promote contact with the patient's face below the patient's cheekbones.

[0324] Each non-telescopic tube section 3363 may be permanently or removably connected to a cushion module 3150 of the patient interface that at least partially forms the plenum chamber 3200.

[0325] 5.3.2.2 Headgear Straps In certain forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap. These headgear straps function to position and stabilize the seal-forming structure 3100 relative to the entrance to the patient's airway in addition to the tube 3350. As shown in FIG. 7A, the patient interface 3000 includes a strap 3310 forming part of the positioning and stabilizing structure 3300. The strap 3310 may be known, for example, as a rear strap or a rear headgear strap. In other examples of the present technology, one or more additional straps may be provided. For example, a patient interface 3000 according to an embodiment of the present technology having a full face or oral-nasal cushion module may have a second lower strap configured to rest on the rear of the patient's neck.

[0326] In the example shown in FIG. 7A, the straps 3310 of the positioning and stabilizing structure 3300 are connected between two tubes 3350 that are positioned on each side of the patient's head and pass behind the patient's head (e.g., over or cover the back of the occipital bone of the patient's head in use). The straps 3310 connect to each tube above the patient's ear. In other embodiments, for example as part of an oronasal patient interface, the positioning and stabilizing structure 3300 includes upper straps similar to the straps 3310 and at least one additional lower headgear strap. These lower headgear straps connect between the tubes and / or between the cushion modules and pass below the patient's ears and pass behind the patient's head. Such lower headgear straps may also be connected to upper straps (e.g., similar to the straps 3310).

[0327] 5.3.3 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session from day to day depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0328] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0329] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber, a woven material, or a combination of such materials).

[0330] A seal-forming structure 3100 according to some embodiments of the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0331] The seal-forming structure 3100 according to some examples of the present technology may include non-patient-contacting portions and patient-contacting portions. In some examples, the seal-forming structure 3100 may include forward-facing portions, side-facing portions, upward-facing portions, and / or downward-facing portions. These portions may not contact the patient's face.

[0332] A seal-forming structure 3100 according to further embodiments of the present technology may be constructed from a woven material. In some examples, the front side of the seal-forming structure 3100 may be formed from an elastomeric material such as silicone or TPE, while the back side may be formed from a textile material.

[0333] Where the seal-forming structure 3100 comprises a woven fabric or woven portion, the woven fabric may comprise a material formed by a fiber network and adapted to be impermeable to air, for example, the woven fabric may have an air impermeable film on at least one surface thereof.

[0334] In some forms, the seal-forming structure 3100 may be constructed to elastically stretch in at least one dimension. For example, if the seal-forming structure is constructed from a fiber web, the seal-forming structure may be able to stretch in either the longitudinal warp direction or the transverse weft direction across the fabric, or both. In some forms, the woven seal-forming structure 3100 is constructed to elastically stretch to a range beyond that achievable by conventional silicone seal-forming structures.

[0335] In some forms, the seal-forming structure 3100 is constructed to be substantially inelastic in at least one dimension. For example, if the fabric seal-forming structure is constructed from a woven fabric, the seal-forming structure may be capable of substantially withstanding stretch in either or both the longitudinal warp direction or the transverse weft direction across the fabric.

[0336] The seal-forming structure 3100 may be constructed from a single layer or multiple layers. In configurations where multiple layers are used, the individual layers may be formed using the same material or a variety of different materials, each with unique material properties.

[0337] In some forms, the textile seal-forming structure 3100 may include at least one layer that exhibits substantially air impermeable properties while maintaining the necessary material properties for comfort and minimal pressure points. In some forms, the textile seal-forming structure 3100 may include an air impermeable material formed on the inner surface of the textile material. The air impermeable material may be laminated onto the textile material in some forms. In some forms, the air impermeable material and the textile material may be selected such that the resulting textile material may exhibit a predetermined overall elasticity or elastic resistance as desired.

[0338] In some configurations, the seal-forming structure 3100 may exhibit a low spring constant (i.e., high compliance) in both warp and weft directions. In such configurations, in contrast to conventional designs that may cause distortion of the patient's face due to a fixed cushion (to form an effective seal), the textile membrane of the seal-forming structure 3100 may have a material spring constant and spring length that makes the textile seal-forming structure 3100 more compliant than the patient's skin that engages the textile seal-forming structure 3100. This may advantageously improve mask comfort and reduce the formation of localized pressure "hot spots."

[0339] In some forms, the surface of the woven material of the seal-forming structure 3100 that contacts the patient's face may have low friction characteristics. This may advantageously increase the surface texture comfort of the woven seal-forming structure 3100 and reduce friction against the patient's face. In some forms, a higher friction woven material may cause the seal-forming structure 3100 to snag or rub in the contact area with the patient's face 1300 during use. Such rubbing or snagging may cause the seal-forming structure to distort or deform, which may lead to reduced seal effectiveness and potential undesirable air leakage from the device.

[0340] In some forms, the overall thickness of the woven material of the seal-forming structure 3100 is 0.275 mm or less.

[0341] The cushion module 3150 shown in Figures 16A-16D includes a seal-forming structure 3100 that includes a textile material. In this particular example, the seal-forming structure 3100 includes a textile material in a central portion 3111 of the patient-facing portion (i.e., rear side) of the seal-forming structure. Other portions of the seal-forming structure 3100 (e.g., the forward facing and upward facing surfaces) may also be formed from silicone. In other examples, the entire seal-forming structure 3100 may be formed from a textile material. Advantageously, a seal-forming structure 3100 having a textile surface that contacts and seals against the patient's face may have the advantage of improved tactile comfort and is more stretchy than silicone (e.g., due to the use of a weave pattern selected for stretchiness). Additionally, a textile seal-forming structure 3100 or its seal-forming surface may have lower friction than silicone, leading to improved comfort and allowing the seal to slidably and sealingly conform to the complex surface of the patient's face. In a seal-forming structure 3100 that includes both a silicone portion and a textile portion, the silicone portion can advantageously act as an easily molded support for the textile portion that forms a sealing interface with the patient's face.

[0342] The textile seal-forming structure 3100 shown in Figures 16A-16D is described in further detail below.

[0343] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 suitable for large head sizes but not small head sizes, and another suitable for small head sizes but not large head sizes.

[0344] 5.3.3.1 Sealing mechanism In one form, the seal-forming structure 3100 includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 to act on its underside to form a tight sealing engagement with a surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0345] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the edge length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the edge length. The support flange is or includes a spring-like element and functions to support the sealing flange against buckling in use.

[0346] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged such that, in use, it is in a compressed state due to, for example, elastic tension in the positioning and stabilizing structure.

[0347] In one form the seal-forming structure includes a tension part which, in use, is held taut, for example by an adjacent region of a sealing flange.

[0348] In one form, the seal-forming structure includes an area having a sticky or adhesive surface and / or a high coefficient of friction relative to other surfaces.

[0349] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0350] In some forms of the present technology, the seal-forming structure 3100 may include a low friction surface in one or more regions that may allow the seal-forming structure 3100 to slide over the patient's skin and conform to surfaces of the patient's face that include complex geometries (e.g., near the nasolabial folds and recesses that often exist where the patient's ala meets the patient's face).

[0351] 5.3.3.2 Nasal bridge or nasal ridge area In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal on the nasal bridge or nasal ridge region of the patient's face.

[0352] In one form, the seal-forming structure includes a saddle-like region constructed to form a seal over the nasal bridge or nasal ridge region of the patient's face in use.

[0353] 5.3.3.3 Upper lip area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the upper lip area (ie, upper lip) of the patient's face.

[0354] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face in use.

[0355] 5.3.3.4 Jaw area In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal over the chin area of ​​the patient's face.

[0356] In one form, the seal-forming structure includes a saddle-like region constructed to form a seal over the chin region of the patient's face in use.

[0357] 5.3.3.5 Nasal pillow In one form, the seal-forming structure 3100 of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0358] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum forms a seal over the underside of the patient's nose, the stalk, and a flexible region on the underside of the frustum, connecting the frustum to the stalk. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent the base of the stalk. The flexible region may function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the frustum of the cone and the relative movement of the structure to which the nasal pillows are connected. For example, the frustum of the cone may be displaced axially towards the structure to which the stalk is connected.

[0359] 5.3.3.6 Nasal mask cushion In one form, the non-invasive patient interface 3000 includes a seal-forming portion that, in use, forms a seal over the upper lip area (i.e., upper lip), nose bridge area, and cheek area of ​​the patient's face, such as the patient interface 3000 shown in FIG. IB. The seal-forming portion delivers an air supply or breathable gas to both nares of the patient 1000 through a single orifice. This type of seal-forming structure may also be referred to as a "nasal cushion" or "nasal mask." In some embodiments of the present technology, a positioning and stabilizing structure 3300 shown in FIGS. 7A-7G may be utilized to hold the nasal cushion in a sealing position on the patient's face.

[0360] 5.3.3.7 Full face mask cushion In one form, the patient interface 3000 includes a seal-forming portion that forms a seal over the chin region, cheek region, and either the nose bridge region or the under-nose region of the patient's face, such as the patient interface 3000 shown in FIG. 1C. The seal-forming portion delivers an air supply or breathable gas to both nares and the oral cavity of the patient 1000 through a single orifice or through separate orifices. This type of seal-forming structure may also be referred to as a "full face mask" or a "mini full face mask." In some embodiments of the present technology, the positioning and stabilizing structure 3300 shown in FIG. 7A-7G may be utilized to hold the full face cushion in a sealing position on the patient's face. The portions of the seal-forming structure 3100 described below may be provided in the chassis that supports the full face mask cushion or the full face mask.

[0361] 5.3.3.8 Nasal Cradle In one form of the present technology, as shown, for example, in Figs. 7A-7G, the seal-forming structure 3000 of the patient interface 3100 is configured to form a seal with the underside of the nose around the nares in use. In this example, the seal-forming structure 3100 is also configured to form a seal with the upper lip of the patient 1000 in use. This type of seal-forming structure may also be referred to as a "cradle", "nasal cradle cushion", "undernose cradle cushion" or "undernose nasal cushion". The shape of the seal-forming structure 3100 may be configured to conform to or closely follow the underside of the patient's nose. In one form of the nasal cradle cushion, the seal-forming structure 3100 includes a bridge region that defines two orifices. Each of the two orifices delivers air or breathable gas to a different one of the patient's nares in use. The bridge region may be configured to contact or seal against the bridge of the patient's nose in use. In some forms of the present technology, the seal-forming structure 3100 is configured to form a seal with the underside of the patient's nose without contacting the nose bridge region of the patient's nose.

[0362] In certain forms of the present technology, the seal-forming structure 3100 includes a central portion configured to form a seal against the underside of the patient's nose. The central portion may seal against the lower periphery of the patient's nose (e.g., around the patient's nostrils and the patient's upper lip). In examples, the seal-forming structure 3100 may be configured to contact the patient's face under the bridge of the nose or under the tip of the nose.

[0363] The seal-forming structure 3100 may be configured to enter the patient's nares in use. For example, the seal-forming structure 3100 may seal against the patient's face without entering the patient's nares. The seal-forming structure 3100 may be configured to form a seal (without entering the patient's nares) with areas of the patient's face surrounding the patient's nares. In some examples, the seal-forming structure 3100 is configured to form a seal surrounding the patient's nares and bridge of the nose. The seal-forming structure 3100 may form a single contiguous seal surrounding both nares.

[0364] The seal-forming structure 3100 may be configured to seal against the anterior and / or inferior surface of the patient's nasal tip in use. The seal-forming structure 3100 may seal against the lateral and / or inferior surface of the patient's ala in use. The seal-forming structure 3100 may be configured to seal against any one or more of the patient's subnasal point, the inferior surface of the patient's nose between the patient's nostrils and the upper lip and / or between the patient's upper lip.

[0365] In some embodiments, the seal-forming structure 3100 is configured to leave the patient's nose tip exposed in use. The seal-forming structure 3100 may be configured to leave the patient's nose bridge exposed in use. In some forms, the seal-forming structure 3100 may not seal against any surface of the patient's face above the lateral cartilage of the patient's nose (as shown in FIG. 2H). In further forms, the seal-forming structure 3100 may not seal against any surface of the patient's face above the greater alar cartilage of the patient's nose (also shown in FIG. 2H). The seal-forming structure 3100 may be configured not to engage the patient's nose bridge in use. In some embodiments, the seal-forming structure 3100 may be configured not to engage the patient's nose above the nasal tip in use. The patient interface 3000 may be configured to leave the patient's mouth exposed in use.

[0366] 8A-8H show the cushion module 3150 in a separated state, and 9A-9H show the cushion module 3150 with specific parts. 19A-19F, 25A-25I, 26A-26I, 30A-30E, 31A-31D, and 32A-32D show the cushion module 3150 according to further examples of the present technology. The connector 3214 is not shown in 9A-9H or 19A-19F. Features of the cushion module 3150 according to these and other examples of the present technology are described below.

[0367] 5.3.3.8.1 Central part The seal-forming structure 3100 includes a central portion 3111 configured to seal against the patient's face at the bottom of the patient's nose in use. In some examples of the present technology, the central portion 3111 is configured to seal against at least the patient's nasal tip, nasal ala, and upper lip in use. The central portion 3111 may seal against the patient's nostrils and the lower periphery of the patient's nose around the patient's upper lip in use. The central portion 3111 is provided on the rear side of the seal-forming structure 3100. The central portion 3111 may be bisected by a plane parallel to the sagittal plane of the patient in use. Figures 9A-9H, 11A, 11B, 19A-19F, 25A-25I, 26A-26I, 30A-30E, 31A-31D, and 32A-32D show examples of a seal-forming structure 3100 having a central portion 3111 among other portions.

[0368] Most of the contact with the patient's nose may be made by the central portion 3111. Some of the contact may be made by the central lateral portions 3121, which are described below. In some instances, the majority of the seal formed from the seal-forming surface 3100 to the lower periphery of the patient's nose may be made by the central portion 3111.

[0369] It will be understood that the actual amount that the seal-forming structure 3100 contacts the patient's face will depend on the particular implementation of the technique and the particular patient's anatomy, particularly the way the patient has the patient interface set up, etc.

[0370] The cushion module 3150 includes two holes 3272 configured to deliver airflow at therapeutic pressure to the patient's nares. These holes 3272 are shown in Figures 8D-8F. Each hole 3272 is aligned with a respective nostril of the patient in use. In some examples, the cushion module 3150 may include a single hole 3272 configured to deliver airflow to both nostrils of the patient. These holes 3272 are formed in the seal-forming structure 3100 of the cushion module 3150. In some examples, the hole 3272 is formed in the central portion 3111 of the seal-forming structure 3100.

[0371] In some examples, the wall thickness of the central portion 3111 may be between 0.15 mm and 0.4 mm. In some examples, the wall thickness of the central portion 3111 may be between 0.2 mm and 0.35 mm. In some examples, the wall thickness of the central portion 3111 may be substantially 0.25 mm.

[0372] 5.3.3.8.1.1 Upper lip In one form, the patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal over the upper lip region (i.e., upper lip) of the patient's face. In one form, the seal-forming structure 3100 includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face in use.

[0373] 9A-9H, 19A-19F, 25A-25I, 26A-26I, 30A-30E, 31A-31D, and 32A-32D, the seal-forming structure 3100 also includes an upper lip 3116. The upper lip 3116 may be disposed within the central portion 3111 and may contact the underside of the patient's nose as well as the patient's upper lip.

[0374] In some instances, the upper lip 3116 has the same stiffness as the remainder of the central portion 3111. In the seal-forming structure 3100 included in the cushion module 3150 shown in Figures 9A-9H, the upper lip 3116 and the remainder of the central portion 3111 have substantially the same stiffness.

[0375] The central portion 3111 and its upper lip 3116 may be less stiff than most or all of the other portions of the seal-forming structure 3100. In some examples of the present technology, such less stiffness is provided by a thinner wall thickness than other portions of the seal-forming structure 3100. The nasal tip, which is the underside of the patient's nose and upper lip, may have a complex geometry and may also be sensitive to pressure. Therefore, it is advantageous to make the areas of the plenum chamber 3200 that contact or are sealed against these locations flexible and compliant to avoid excessive pressure on the face in these areas.

[0376] The low stiffness in certain areas of the seal-forming structure 3100, which may be provided by the thin wall thickness, allows the seal-forming structure 3100 to easily deform to seal against the lower surface of the patient's nose (e.g., the anterior tip, the lateral sides and either ala of the upper lip).

[0377] In some examples of the present technology, the central portion 3111 may have a higher stiffness in the upper lip 3116 than in other areas of the central portion 3111. For example, the upper lip 3116 may be stiffer than the portion of the central portion 3111 surrounding the hole 3272. The cushion module 3150 shown in Figures 25A-25I has a stiffer upper lip 3116 than other portions of the central portion 3111. Such higher stiffness may be provided by a greater wall thickness.

[0378] The cushion module 3150 shown in Figures 25A-25I is wider than the cushion module 3150 shown in Figures 9A-9H. The wall thickness of the upper lip 3116 of the cushion module 3150 shown in Figures 9A-9H is the same as the wall thickness of the adjacent portion of the central portion 3111. The wall thickness of the upper lip 3116 of the cushion module 3150 shown in Figures 25A-25I is greater than the wall thickness of the adjacent portion of the central portion 3111. Although the cushion module 3150 and its upper lip 3116 shown in Figures 25A-25I are wider than the other cushion modules 3150, the upper lip 3116 may be more prone to buckling or wrinkling due to its greater width. The extra thickness in the upper lip 3116 of the cushion module 3150 may reduce the tendency to buckle, which may result in better stability during use.

[0379] 5.3.3.8.1.2 Anterior and posterior upper lip In some examples of the present technology, e.g., as shown in Figures 19A-19F and 22A, and examples shown in Figures 25A-25I, 26A-26I, 30A-30E and 31A-31D, the upper lip portion 3116 includes a front portion 3133 and a rear portion 3134. The chassis portion 3210 is curved rearwardly on either side of the chassis portion 3210, such that the front portion 3133 is disposed adjacent the chassis portion 3210 and may be located rearward of the chassis portion 3210 or at least rearward of a central portion of the chassis portion 3210. The rear portion 3134 is configured to seal against the patient's upper lip in use.

[0380] The front 3133 of the upper lip 3116 may be stiffer than the rear 3134 of the upper lip 3116. In the examples shown in Figures 19A-19F, 22A, 25A-26I, 26A-26I, 30A-30E and 31A-31D, such stiffness is provided by a greater wall thickness of the seal-forming structure 3100. In these examples, the thickness of the front 3133 of the upper lip 3116 is greater than the thickness of the rear 3134 of the upper lip 3116. In other examples of the present technology, the cushion module 3150 may include a stiffener disposed at the front 3133 of the upper lip 3116 to provide the stiffener. The stiffener may be formed from a stiffer material than other portions of the seal-forming structure 3100 and may be overmolded onto the front 3133.

[0381] The thickness of the rear portion 3134 of the upper lip 3116 can be the same as the thickness of one or more portions of the central portion 3111 adjacent the upper lip 3116. In the examples shown in Figures 19A-19F and 26A-26I, the thickness of the rear portion 3134 is the same as the thickness of the remainder of the central portion 3111.

[0382] In other examples, the thickness of the rear portion 3134 of the upper lip 3116 can be greater than the thickness of one or more areas of the central portion 3111 adjacent the upper lip 3116. In the examples shown in 25A-25I, the thickness of the rear portion 3134 is greater than other areas of the central portion 3111.

[0383] The thickness of the rear portion 3134 of the upper lip 3116 may be in the range of 0.1 mm to 1 mm (e.g., 0.2 mm to 0.8 mm, 0.3 mm to 0.7 mm, 0.4 mm to 0.6 mm, 0.15 mm to 0.35 mm, or 0.2 mm to 0.3 mm). In certain examples, the thickness of the rear portion 3134 may be 0.25 mm or 0.5 mm. In the examples shown in Figures 19A-19F, 26A-26I, 30A-30E, and 31A-31D, the thickness of the rear portion 3134 is 0.25 mm. In the examples shown in Figures 25A-25I, the thickness of the rear portion 3134 is 0.5 mm.

[0384] The thickness of the front portion 3133 of the upper lip 3116 may be in the range of 0.4 mm to 2 mm (e.g., 0.5 mm to 1.6 mm, 0.9 mm to 1.3 mm, or 1.4 mm to 1.6 mm). In certain examples, the thickness of the front portion 3133 may be 1.5 mm, 1.2 mm, 1.15 mm, or 0.5 mm. In the example shown in Figures 19A to 19F, the thickness of the front portion 3133 of the upper lip 3116 is 1.5 mm. In the example shown in Figures 31A to 31D, the thickness of the front portion 3133 is 1.2 mm, and in the examples shown in Figures 25A to 25I and 26A to 26I, the thickness of the front portion 3133 is 1.15 mm. In the example shown in Figures 30A to 30E, the thickness of the front portion 3133 of the upper lip 3116 is 0.5 mm.

[0385] As will be described in more detail below, the seal-forming structure 3100 may include a pair of side rear regions 3141 on each rear outer side of the upper lip 3116. In the example shown in Figures 19A-19F and 22A, the thickness of the rear portion 3134 of the upper lip 3116 is less than the thickness of the side rear regions 3141. In particular, the thickness of the rear portion 3134 of the upper lip 3116 is less than the thickness of both the debonding region 3142 and the perimeter portion 3143 of each side rear region 3141. The debonding region 3142 and the perimeter portions 3143 are described in more detail below.

[0386] 19A-19F, the thickness of the front portion 3133 of the upper lip 3116 is substantially the same as the thickness of the side rear region 3141. In particular, the thickness of the front portion 3133 of the upper lip 3116 is substantially the same as the thickness of the peripheral portion 3143 of the side rear region 3141. The thickness of the front portion 3133 of the upper lip 3116 is greater than the thickness of the debonding portion 3142 in this example. The front portion 3133 of the upper lip 3116 may be adjacent to the side rear region 3141.

[0387] 25A-25I and 26A-26I, the thickness of the front portion 3133 of the upper lip 3116 is substantially the same as the thickness of the side rear regions 3141. In particular, the thickness of the front portion 3133 is substantially the same as the rear portions of each side rear region 3141. The front portions of each side rear region 3141 may have a greater thickness than the front portion 3133 of the upper lip 3116.

[0388] As shown in Figures 19A-19F, 22A, 25A-25I, 26A-26I, 30A-30E and 31A-31D, the interface between the anterior portion 3133 and the posterior portion 3134 of the upper lip portion 3116 is curved, with the center of the curve being located further forward than the ends of the lateral portions of the curve. Such interface may be curved to generally correspond to the curved shape of the patient's upper lip. The cushion module 3150 may include an interface between the anterior portion 3133 of the upper lip portion 3116 and the chassis portion 3210. This interface may be curved. The curvature of this interface may have a larger radius of curvature than the interface between the anterior portion 3133 and the posterior portion 3134 of the upper lip portion 3116. This interface may be part of a longer interface between the chassis portion 3210 and the seal-forming structure 3100. In other instances, the boundary between the front portion 3133 and the rear portion 3134 of the upper lip 3116 may include a more gradual curve, or may be straight.

[0389] The difference in thickness between the front portion 3133 and the rear portion 3134 of the upper lip 3116 may be obtained by an abrupt or gradual change in thickness. The change in thickness may be produced by a step formed in the material forming the seal-forming structure 3100, the step being formed in the inner surface of the seal-forming structure 3100.

[0390] Making the front portion 3133 thicker relative to the rear portion 3134 of the upper lip portion 3116 is advantageous because it may provide additional wrinkle resistance to the seal-forming structure 3100 (as compared to these portions having the same thickness as each other and / or the same thickness as the remainder of the central portion 3111). The front portion 3133 may avoid or at least prevent wrinkles in the seal-forming structure 3100 adjacent the junction between the seal-forming structure 3100 and the chassis portion 3210. The increased thickness of the front portion 3133 may also stiffen the chassis portion 3210 adjacent the upper lip portion 3116, which may improve the dynamic seal at the upper lip (e.g., improving the stability of the seal formed with the patient's upper lip during movement of the patient's head).

[0391] 5.3.3.8.1.3 Central saddle area In this example, the central portion 3111 is adjacent to the central front portion 3115. The central front portion 3115 is the forward facing portion of the seal-forming structure 3100. In use, the central front portion 3115 may be positioned adjacent to and below the tip of the patient's nose.

[0392] In the examples shown in Figures 9A-9H and 19A-19F, the seal-forming structure 3100 has a central saddle portion 3112 that may seal an area in front or below the patient's nose tip in addition to the central portion 3111. In this example, the central saddle portion 3112 or a portion thereof includes the same or similar stiffness as the central portion 3111 and the central front portion 3115. The central saddle portion 3112 connects the central portion 3111 and the central front portion 3115. In the examples shown in Figures 25A-25I and 26A-26I, the seal-forming structure 3100 may also have a central saddle portion 3112 (shown in Figures 25A and 26A). In these examples, the curvature of the central saddle portion 3112 is less than the central saddle portion 3112 of the seal-forming structure 3100 shown in Figures 9A-9H and 19A-19F. In these examples, the central portion 3111 or the central saddle portion 3112 may seal against the underside and / or anterior surface of the patient's nasal tip.

[0393] The central portion 3111 of the seal-forming structure 3100 may be configured to expand to conform to the underside and around the patient's nose. Thinner walls of the seal-forming structure 3100 in the upwardly facing central portion 3111 are advantageous in creating a good seal against the complex geometry under and around the nose. The thinner walls can deform and expand under the pressure of the breathable gas in the plenum chamber 3200 to conform to the surface of the patient's face and create an effective and comfortable seal.

[0394] While keeping the wall thickness thin in areas configured to contact the sensitive nasal tip and upper lip areas is advantageous for comfort, in examples of the present technology, the wall thickness in these areas is not reduced to an extent that the seal-forming structure 3100 cannot maintain a stable seal against the patient's face. If the wall thickness is too thin in these areas, the seal-forming structure 3100 will be prone to puckers, which can lead to seal breakdown and leak paths allowing air to flow between the patient's face and the cushion to the surroundings.

[0395] 5.3.3.8.1.4 Central anterior region In some examples of the present technology, as shown in Figures 19A-19F and 21A-21B, the central front portion 3115 includes an upper portion 3114 and a lower portion 3113.

[0396] The central front portion 3115 is provided on a front side of the seal-forming structure 3100 (which may be a non-patient-contacting side). The central front portion 3115 is disposed adjacent to and below the patient's nasal tip in use. The central front portion 3115 may face at least partially forward. For example, the central front portion 3115 may include an at least partially forward-facing surface. At least a majority of the central front portion 3115 may be provided on the front side of the seal-forming structure 3100. A portion of the central front portion 3115 may be configured not to contact the patient's face in use. A lower portion 3113 of the central front portion 3115 may be configured not to contact the patient's face in use. In some examples, an upper portion 3114 may be configured not to contact the patient's face in use.

[0397] In the example of the present technology shown in Figs. 19A-19F and 21A-21B, the stiffness of the lower portion 3113 of the central front portion 3115 is greater than the stiffness of the upper portion 3114 of the central front portion 3115. In this example, the wall thickness of the lower portion 3113 of the central front portion 3115 is greater than the wall thickness of the upper portion 3114 of the central front portion 3115. The lower portion 3113 may also be known as a stiffening portion or rigidizing band. The lower portion 3113 may cover the front side of the seal-forming structure 3100. The lower portion 3113 may be provided adjacent to the junction between the seal-forming structure 3100 and the chassis portion 3210.

[0398] The central front portion 3115 is typically a thin and relatively flexible portion of the seal-forming structure 3100 (compared to other portions of the seal-forming structure). For example, in the examples shown in Figures 9A-9H and 19A-19F, the central front portion 3115 is one of the thinnest and most flexible portions of the seal-forming structure. The flexibility of the central front portion 3115 allows the seal-forming structure 3100 to conform around the lower nose of the patient. However, because the central front portion 3115 is highly flexible, it may be prone to wrinkling. The lower portion 3113 of the central front portion 3115 is stiffer than the upper portion 3114 and therefore provides support to the central front portion 3115. The lower portion 3113 of the central front portion 3115 may provide wrinkle resistance to the central front portion 3115.

[0399] In the example shown in FIGS. 19A-19F and 22A-22B, the upper portion 3114 of the central front portion 3115 has substantially the same stiffness and wall thickness as the rear central portion 3111 of the seal-forming structure 3100.

[0400] In the examples shown in Figures 19A-19F and 22A-22B, the wall thickness of the portion of the seal-forming structure 3100 at the lower portion 3113 of the central front portion 3115 is generally greater than one or more adjacent portions of the seal-forming structure 3100. The wall thickness of the lower portion 3113 of the central front portion 3115 may be between 0.3 mm and 1 mm. In some examples, the wall thickness of the lower portion 3113 is between 0.4 and 0.7 mm. In the examples shown in Figures 19A-19F, the wall thickness of the lower portion 3113 is substantially 0.5 mm. In the examples shown in Figures 19A-19F, the wall thickness of the upper portion 3114 may be between 0.1 mm and 0.5 mm (e.g., between 0.2 mm and 0.3 mm, or 0.25 mm).

[0401] In other examples of the present technology, the lower portion 3113 of the central front portion 3115 may include a stiffening member, a portion of the seal-forming structure formed from a stiffer material, or another suitable stiffening means.

[0402] 22A, the central front portion 3115 has a graduated thickness between the lower portion 3113 and the upper portion 3114. In other examples, the central front portion 3115 can be tapered in thickness between the lower portion 3113 and the upper portion 3114.

[0403] More generally, any change in thickness between two portions of the seal-forming structure 3100 or chassis portion 3210 exemplified herein as a graduated thickness change may include a tapered thickness in other examples. Similarly, any thickness change exemplified by a tapered thickness may include a graduated change in thickness in other examples.

[0404] In some examples of the present technology, a lower portion 3113 having greater stiffness and / or thickness than the upper portion 3114 may be provided at the central front portion 3115 of the cushion module 3150 shown in Figures 25A-25I and 26A-26I. In these configurations of the cushion module 3150 shown in Figures 25A-25I and 26A-26I, the thickness of the central front portion 3115 is substantially uniform.

[0405] 5.3.3.8.2 Medial lateral section As shown in Figures 9A-H, 19A-F, 25A-I, 26A-I, 30A-E and 31A-D, the seal-forming structure 3100 may also include a pair of central lateral portions 3121. The central lateral portions 3121 may be configured to be positioned against or adjacent the patient's ala in use. The central lateral portions 3121 may be provided on a rear side of the seal-forming structure 3100. Each central lateral portion 3121 may be provided on a respective lateral side of the central portion 3111 and may be configured to be positioned along a respective ala of the patient's nose in use. As shown in Figures 9A-9H, 19A-19F, 25A-25G, 26A-26G, 30A-30E and 31A-31D, the central lateral portions 3121 can each be positioned between the central portion 3111 and a lateral peripheral portion of the seal-forming structure 3100.

[0406] As shown in particular in Figures 9A, 9F and 19A, each central lateral portion 3121 may have a crescent shape. Each central lateral portion 3121 includes a medial boundary and a lateral boundary. Each medial boundary may include a three-dimensional curve (e.g., a space curve) that is curved downward and medially in front of the cushion module 3150 adjacent the central saddle portion 3112 in terms of moving generally forward along the curve. Each lateral boundary may also include a three-dimensional curve. The three-dimensional curve is curved medially in front of the cushion module 3150 in terms of moving generally forward along the curve. The central lateral portion 3121 may include a surface curvature that follows the curvature of the lower circumference of the patient's nose.

[0407] Due to the curvature of the boundaries of the central lateral portions 3121, each central lateral portion 3121 as a whole may include a curved shape, such that it is curved in the medial direction adjacent the front side of the seal-forming structure 3100 from the perspective of moving generally forward.

[0408] The curvature of the central lateral portions 3121 and the curvature of their boundaries may result in central lateral portions 3121 that follow the shape of the lower circumference of the patient's nose. The central lateral portions 3121 may be concave relative to the patient's nose near the widest portion of the patient's nose (e.g., near the ala). Each central lateral portion 3121 may be curved in a downward and / or medial direction near the posterior corner portion 3131 (described below) and / or the upper lip portion 3116 in terms of moving along the central lateral portion curve in a generally posterior direction.

[0409] Each of the central lateral portions 3121 may extend such that one end is adjacent the upper lip portion 3116 and the other end is adjacent the forward-most portion of the central portion 3111. In the example shown in Figures 9A-9H and 19A-19F, one end of each of the central lateral portions 3121 extends to the central saddle portion 3112. The central saddle portion 3112 may be disposed between the forward-most portions of the central lateral portions. In this example, the forward-most portion of each of the central lateral portions 3121 is pointed. The anterior junction between the middle boundary and the lateral boundary of each of the central lateral portions 3121 includes a pointed shape. The middle boundary and the lateral boundaries meet to form a pointed corner. In this example, the anterior junction of the middle boundary and the lateral boundary of each of the central lateral portions 3121 are tapered to a point.

[0410] In this example, a lateral boundary of each central lateral portion is disposed between a medial facing portion of the seal-forming structure 3100 and a lateral facing portion of the seal-forming structure 3100. The seal-forming structure 3100 may include an upper ridge 3117 (shown in FIGS. 8A-8H ). The upper ridge 3117 separates the medial and rearward facing portions of the seal-forming structure 3100 from the lateral and forward facing portions. The upper ridge 3117 may include a central saddle portion 3112. A lateral boundary of each central lateral portion 3121 may be disposed proximate the upper ridge 3117. A lateral boundary of each central lateral portion 3121 may be disposed proximate and medially from the upper ridge 3117.

[0411] In the examples shown in Figures 25A-I and 26A-26I, the central lateral portion 3121 is roughly C-shaped, as shown in detail in Figures 25G and 26G. In these examples, the central front portion 3115 and the central saddle portion 3112 are wider than in the examples shown in Figures 9A-9H and 19A-19F. As shown in Figures 25G and 26G, the central saddle portion 3112 may include a portion on an upwardly facing (e.g., patient-contacting) portion of the seal-forming structure 3100 such that a joint is provided within the seal-forming structure 3100 between the central saddle portion 3112, the central portion 3111, and each one of the central lateral portions 3121.

[0412] The intermediate lateral portions 3121 may be positioned around some or all of the lower periphery of the patient's nose in use. For example, the intermediate lateral portions 3121 may be configured to be positioned just outside the patient's nose at the base of the nose (e.g., adjacent to or against the ala of the nose).

[0413] The medial lateral portion 3121 of the seal-forming structure 3100 may include a pair of outer walls that face partially in a medial direction and partially in an upward direction (e.g., have outer and outer faces that face in a medial and upward direction) and in some instances face partially toward the rear.

[0414] Each central lateral portion 3121 may be stiffer than the central portion 3111. The seal-forming structure 3100 may have a greater wall thickness at the intermediate lateral portions 3121 than at the central portion 3111. By having a greater wall thickness at the central lateral portions 3121 than at the central portion 3111, the central lateral portions 3121 may be made stiffer.

[0415] In some examples, the intermediate lateral portions 3121 of the seal-forming structure 3100 reinforce the central portion 3111 of the seal-forming structure 3100. In further examples, the central lateral portions 3121 are configured to prevent wrinkling in the seal-forming structure. In the illustrated example, this wrinkling resistance is achieved by an increased thickness of the seal-forming structure 3100 at the central lateral portions. In some configurations, the central lateral portions provide a barrier against wrinkling and prevent leak paths from forming in the seal-forming structure 3100. The central lateral portions 3121 may be configured to prevent leak paths from forming due to wrinkling in the central portion 3111 of the seal-forming structure 3100. Such leak paths may allow gas leakage through the wrinkles from the interior of the plenum chamber 3200 to the atmosphere.

[0416] As such, the positive lateral portion 3121 is positioned at or near the edge of the patient's alar around the base of the nose, thereby acting as a barrier against the folds that closely follow the shape of the patient's nose.

[0417] Additionally, the intermediate side portions 3121 may provide flexible support for side loading onto the plenum chamber 3200 and help avoid seal failure under lateral forces. The central side portions 3121 may be flexible and thus may be thicker than the central portion 3111 yet deform under lateral forces to support the central portion 3111 (in sealing contact against the underside of the patient's nose).

[0418] 5.3.3.8.2.1 Center lateral front In some examples of the present technology, on either side of the central anterior portion 3115 (as described above), central lateral anterior portions 3125 are provided (e.g., in the cushion module 3150 shown in Figs. 9A-H, 19A-F, 25A-H, 26A-H, 30A-E, and 31A-D). The central lateral anterior portion 3125 may be located on the anterior side of the seal-forming structure 3100. A constant contact with the patient's nose may be provided by the central anterior portion 3115 and the central lateral anterior portion 3125 depending on the anatomy and setup. The wall thickness of these central lateral anterior portions 3125 is greater than the wall thickness of the central lateral portion 3121 behind the central portion 3111. Also, the wall thickness of these central lateral anterior portions 3125 is greater than the central anterior portion 3115. The central lateral anterior portion 3125 may have a greater stiffness and / or wall thickness than the upper portion 3114 of the central anterior portion 3115. The central lateral anterior portion 3125 may have a greater stiffness and / or wall thickness than the lower portion 3113 of the central anterior portion 3115.

[0419] In another example, the central lateral front portion 3125 has substantially the same wall thickness as the central lateral portion 3121 on the patient-contacting side of the seal-forming structure 3100.

[0420] Each central lateral front portion 3125 may have an upper portion 3126 and a lower portion 3127. The central lateral front portions 3125 may face at least partially forward and at least partially sideways. For example, each central lateral front portion 3125 may include a surface that faces at least partially forward and at least partially sideways. At least a majority of the central lateral front portions 3125 may be provided on the front side of the seal-forming structure 3100. A portion of each central lateral front portion 3125 may be configured to contact the patient's face in use. The lower portion 3127 of each central lateral front portion 3125 may be configured to contact the patient's face in use. In some examples, the upper portion 3126 may be configured not to contact the patient's face in use.

[0421] The lower portion 3127 of each central lateral front portion 3125 may be stiffer than the upper portion 3126 of the central lateral front portion 3125. As shown in FIGS. 19A-19F and 22B, each of the central lateral front portions 3125 included in the cushion module 3150 according to some examples has a lower portion 3127. The wall thickness of the lower portion 3127 is greater than the wall thickness of each upper portion 3126. The cushion module shown in FIGS. 30A-30E and 31A-31D also includes a central lateral front portion 3125 having an upper portion 3126 and a lower portion 3127. The central lateral front portion 3125 of the cushion module 3150 shown in Figures 30A-30E and 31A-31D is described separately below, however, unless the context indicates otherwise, the features of the central lateral front portion 3125 described with reference to Figures 19A-19F and 22B may apply to the cushion module 3150 shown in Figures 30A-30E and 31A-31D and vice versa. In some examples, the cushion module 3150 shown in Figures 32A-32D may also include a central lateral front portion 3125.

[0422] The stiffness of the lower portion 3127 of the central lateral anterior portion 3125 may aid in increasing the stability of the cushion module 3150 and the seal it forms against the patient's face during dynamic movement (e.g., when the patient moves while sleeping or in bed). The stiffness and thickness of the lower portion 3127 may also better prevent excessive flare from the seal-forming structure 3100, which would otherwise cause a leak path through loss of contact with the patient's nose, as the seal-forming structure 3100 is typically flexible. Finally, the stiffness of the lower portion 3127 of the central lateral anterior portion 3125 may provide increased resistance to twisting. The lower portion 3127 may prevent one side of the cushion module 3150 from twisting away from or against the other side of the cushion module 3150, which could result in loss of contact with the patient's nose and a leak path. The lower portion 3127 of the central lateral front portion 3125 and the chassis reinforcement portion 3220 together may provide the above-mentioned advantages in a cushion module 3150 provided with both a stiffer lower portion 3127 and chassis reinforcement portion 3220.

[0423] In the example shown in Figures 19A-19F, each lower portion 3127 of the central lateral front portion 3125 is stiffer than the central portion 3111 of the seal-forming structure 3100. Each lower portion 3127 is also stiffer than the central front portion 3115 of the seal-forming structure 3100. Furthermore, the stiffness of each lower portion 3127 is greater than the stiffness of both the upper portion 3114 and the lower portion 3113 of the central front portion 3115 of the seal-forming structure 3100. The stiffness of each lower portion 3127 is also greater than the stiffness of the rear central lateral portion 3121 of the seal-forming structure 3100. This relatively greater stiffness and thickness of the upper portion 3126 and the lower portion 3127 of the central lateral front portion 3125 may provide the advantages discussed above.

[0424] 19A-19F, the stiffness of each upper portion 3126 of the central lateral front portion 3125 is greater than the stiffness of the central portion 3111. The stiffness of each upper portion 3126 is also greater than the stiffness of the central front portion 3115. In this example, the stiffness of each upper portion 3126 is greater than the stiffness of each of the upper portions 3114 and lower portions 3113 of the central front portion 3115. In addition, the stiffness of each upper portion 3126 is greater than the stiffness of each of the central lateral portions 3121 rearward of the seal-forming structure.

[0425] In the examples shown in Figures 19A-19F, such higher stiffness is obtained by increasing wall thickness, while in other examples, higher stiffness is obtained by the addition of stiffer material and / or additional stiffening components.

[0426] In the example shown in Figures 19A-19F, the lower portion 3127 of each central lateral front portion 3125 is disposed adjacent to the chassis portion 3210. That is, the central lateral front portion 3125 is provided directly above the junction between the chassis portion 3210 and the front side of the seal-forming structure 3100. The lower boundary of each central lateral front portion 3125 is also part of the upper boundary of the chassis portion at the front side of the cushion module 3150. As described above, the chassis portion 3210 may include a chassis upper reinforcement portion 3220. The wall thickness of the lower portion 3127 may be the same as the wall thickness of the chassis upper reinforcement portion 3220.

[0427] In some examples, the wall thickness of the lower portion 3127 is between 1 mm and 3 mm. In some examples, the wall thickness is between 1.2 mm and 2.5 mm or between 1.5 mm and 2 mm. In the examples shown in Figures 19A-19F and 22B, the wall thickness of the lower portion 3127 is 1.7 mm.

[0428] 19A-19F, the wall thickness of the lower portion 3127 of the central lateral anterior portion 3125 is substantially the same as the wall thickness of the anterior portion 3162 of the stiffening portion 3161 (described below). In such an example, the lower portion 3127 of the central lateral anterior portion 3125 may be considered to be adjacent the stiffening portion 3161.

[0429] In some examples of the present technology, the central lateral front portions 3125 that may be included in the seal-forming structure are tapered in thickness, being thicker at the bottom and less thick at the top of each central lateral front portion 3125. More specifically, in examples of the present technology, the thickness of any non-patient contacting portion of the seal-forming structure 3100 is tapered, being thicker in the area adjacent the chassis portion 3210 and less thick adjacent the central portion 3111.

[0430] 5.3.3.8.2.2 Medial / lateral anterior section In some examples of the present technology, the seal-forming structure 3100 of the cushion module 3150 may include a central lateral front portion 3125 including a middle portion 3128 and a lateral portion 3129. In the cushion module 3150 shown in Figs. 30A-30E and 31A-31D, the seal-forming structure 3100 include...

Claims

1. A patient interface comprising: At least 6 cmH above ambient air pressure ２ a chassis portion partially defining a plenum chamber pressurizable to a therapeutic pressure of O, said chassis portion sized and configured to receive a flow of air at said therapeutic pressure for breathing by a patient; a seal-forming structure on said chassis portion, said seal-forming structure partially defining said plenum chamber, said seal-forming structure constructed and arranged to form a seal with a patient's facial area surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture therein to allow airflow at said therapeutic pressure to be delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a vent that allows gases exhaled by a patient to flow from within the plenum chamber to the surroundings, the vent being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; Including, The seal forming structure includes: a central portion disposed on a rear side of the seal-forming structure, the central portion being configured to contact and seal against at least the patient's nasal tip, nasal alar and upper lip in use; a pair of central side portions provided on the rear side of the seal-forming structure, each central side portion being provided on one side of the central portion, each central side portion being more rigid than the central portion; a pair of stiffening portions, each of the stiffening portions extending from the rear side of the seal-forming structure to a front side of the seal-forming structure, the seal-forming structure being configured to be positioned away from a patient's face in use, one stiffening portion located on each lateral side of the seal-forming structure, each stiffening portion being stiffer than the central lateral portion; Including, The patient interface, wherein the seal-forming structure is configured not to engage the bridge of the patient's nose in use, and wherein the patient interface is configured to leave the patient's mouth exposed in use.

2. The patient interface of claim 1 , wherein each of the stiffening portions has a negative curvature along a first path from the posterior side of the seal-forming structure to the anterior side of the seal-forming structure.

3. The patient interface of claim 2 , wherein each of the stiffening portions has zero or negative curvature along a second path perpendicular to the first path.

4. 4. A patient interface according to any one of claims 1 to 3, wherein each of the stiffening portions includes a front portion provided on the front side of the seal-forming structure and a rear portion provided on the rear side of the seal-forming structure, the front portions being stiffer than the rear portions.

5. The patient interface of claim 4 , wherein a thickness of the anterior portion of each of the stiffening portions is greater than a thickness of the posterior portion of the stiffening portion.

6. 6. The patient interface of claim 5, wherein each of the stiffening portions has a gradually increasing thickness between the rear portion of the stiffening portion and the front portion of the stiffening portion.

7. A patient interface according to any preceding claim, wherein a front portion of the stiffening portion has a greater stiffness in front of the seal-forming structure than an adjacent portion of the seal-forming structure.

8. A patient interface according to claim 7, wherein a thickness of a front portion of the stiffening portion is greater in front of the seal-forming structure than a thickness of the adjacent portion of the seal-forming structure.

9. A patient interface according to any preceding claim, wherein a rear portion of the stiffening portion has a greater stiffness than an adjacent rear portion of the seal-forming structure.

10. 10. A patient interface according to claim 9, wherein a thickness of the rear portion of the stiffening portion is greater than a thickness of a rear adjacent portion of the seal-forming structure.

11. 11. A patient interface according to any one of the preceding claims, wherein each of the stiffening portions includes a greater wall thickness than adjacent areas, the greater wall thickness being formed by extra thickness of an inner surface of the seal-forming structure.

12. A patient interface according to any preceding claim, wherein each of the stiffening portions is positioned adjacent a respective one of the patient's nasal alae in use.

13. A patient interface according to any one of claims 1 to 12, wherein the chassis portion includes a pair of laterally protruding connection portions, each of the connection portions configured to connect to a respective one of a pair of gas delivery tube portions and to receive gas flow from a respective one of the pair of gas delivery tube portions.

14. the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head; the positioning and stabilizing structure includes the gas delivery tube; 14. A patient interface as described in claim 13, wherein each of the gas delivery tube portions is configured to receive air flow from a connection port on the top of the patient's head and to deliver air flow to a respective one of the laterally protruding connections of the chassis portion.

15. A patient interface according to claim 13 or claim 14, wherein each of the stiffening portions is located adjacent a respective one of the laterally projecting connection portions.

16. A patient interface according to any preceding claim, wherein the chassis portion is formed from a flexible material.

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