Patient interface

Abstract

A patient interface is disclosed, including a chassis portion having a pair of laterally projecting connection portions configured to be connected to a gas delivery tube, a seal-forming structure, and a vent. The seal-forming structure may include a central portion and a pair of lateral rear regions, the central portion being configured to seal against the lower peripheral side of a patient's nose in use. Each lateral rear region may include a decoupling portion configured to at least partially decouple the central portion from a corresponding one of the laterally projecting connection portions. The seal-forming structure may include a stiffening portion, a central front portion that is stiffer on the upper side than on the lower side, an intermediate lateral front portion that is stiffer on the upper side than on the lower side, and / or an upper lip portion that is stiffer on the front side than on the rear side. The chassis portion may be formed of a flexible material and may include an upper chassis reinforcement portion.

Description

[0001] A part of the disclosure of this patent document contains copyrighted material. The copyright owner does not oppose the reproduction of this patent document or patent disclosure by anyone in the form in which it appears in the patent office file or records, but reserves all copyright rights otherwise. 1 Cross - reference to related applications

[0002] This application claims the benefit of Australian Patent Application No. 2019902580, filed on July 22, 2019, Australian Patent Application No. 2019904852, filed on December 20, 2019, Singapore Patent Application No. 10202001774V, filed on February 27, 2020, Australian Patent Application No. 2020901769, filed on May 29, 2020, and Australian Patent Application No. 2020901770, filed on May 29, 2020, the entire contents of each of which are incorporated herein by reference in their entirety. 2 Background art 2.1 Technical field

[0004] This technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory - related disorders. This technology also relates to medical devices or equipment, and their uses.

[0005] 2.2 Description of related technologies

[0006] 2.2.1 The human respiratory system and its disorders

[0007] The respiratory system of the human body facilitates gas exchange. The nose and mouth form the airway entrance of the patient.

[0008] The airway includes a series of branched tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter venous blood from the inhaled air and expelling carbon dioxide in the opposite direction. The trachea divides into the right main bronchus and the left main bronchus, which ultimately divide further into terminal bronchioles. The bronchi constitute the conducting airways but do not participate in gas exchange. Further branching of the airway leads to respiratory bronchioles and ultimately to alveoli. The alveolar region of the lungs is the region where gas exchange occurs and is called the respiratory zone. See "Respiratory Physiology", 9th Edition, by John B. West, published by Lippincott Williams & Wilkins in 2012.

[0009] There is a series of respiratory disorders. Some disorders can be characterized by specific events, such as apnea, hypopnea, and hyperpnea.

[0010] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0011] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events that include the occlusion or obstruction of the upper airway during sleep. It is caused by a combination of an abnormally narrow upper airway during sleep and a normal decrease in muscle tone in the regions of the tongue, soft palate, and posterior oropharyngeal wall. This condition causes affected patients to stop breathing, typically for a period of 30 seconds to 120 seconds, sometimes 200 to 300 times per night. This often results in excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. This complication is a common disorder, particularly in middle-aged overweight men, although affected individuals may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0012] Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inhale sufficient oxygen or exhale sufficient CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders: obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0013] Patients with respiratory insufficiency, a form of respiratory failure, may experience abnormal shortness of breath during exercise.

[0014] A range of treatments have been used to treat or improve such conditions. In addition, these treatments can be utilized by other healthy individuals to prevent the occurrence of respiratory disorders. However, these treatments have many drawbacks.

[0015] 2.2.2 Treatments

[0016] A variety of treatments have been used to treat one or more of the above respiratory disorders, such as continuous positive airway pressure (CPAP) treatment, non-invasive ventilation (NIV), and invasive ventilation (IV).

[0017] Continuous positive airway pressure (CPAP) treatment has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP can be voluntary, so patients can choose not to comply with the treatment if they find the device used to provide such treatment to be any one or more of uncomfortable, difficult to use, expensive, and unaesthetic.

[0018] 2.2.3 Treatment system

[0019] These treatments can be provided by a treatment system or device. Such systems and devices can also be used to screen, diagnose, or monitor a condition without treatment.

[0020] A treatment system can include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0021] Another form of treatment system is a mandibular repositioning device.

[0022] 2.2.3.1 Patient interface

[0023] A patient interface can be used to couple a breathing device to its wearer, for example by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area of the patient's face, for example, to cause gas to be delivered at a pressure that is sufficiently different from ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to ambient pressure) to effect treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to cause the delivery of a gas supply at a positive pressure of about 10 cmH2O to the airway.

[0024] Some other mask systems may not be functionally suitable for the present field. For example, a mere decorative mask may not be able to maintain a suitable pressure. A mask system for underwater swimming or diving can be configured to prevent water from flowing in from the external high pressure, rather than maintaining air at a pressure higher than ambient inside.

[0025] Some masks may be clinically disadvantageous to this technology, for example, in cases where they block the air flow through the nose and only allow it through the mouth.

[0026] If some masks require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal through their lips, they may be uncomfortable or infeasible for this technology.

[0027] Some masks may be infeasible for use during sleep (e.g., when sleeping on the side in bed with the head on a pillow).

[0028] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly from person to person. Since the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The mandible or jawbone can move relative to other bones of the skull. The entire head can move during the course of a respiratory treatment session.

[0029] Due to these challenges, some masks face one or more of the following problems: obtrusiveness, unsightliness, expense, disproportion, difficulty of use, and discomfort, especially when worn for long periods or when the patient is unfamiliar with the system. A mask of incorrect size can cause reduced compliance, reduced comfort, and a worse patient prognosis. Masks designed only for pilots, masks designed as part of personal protective equipment (such as filtering masks), SCUBA masks, or masks designed for the administration of anesthetics are acceptable for their original applications, but are not as comfortable as desired for long-term (e.g., several hours) wear. This discomfort can lead to reduced patient compliance with treatment. This is especially true if the mask is worn during sleep.

[0030] Assuming patient compliance with treatment, CPAP treatment is very effective in treating certain respiratory disorders. If the mask is uncomfortable or difficult to use, the patient may not comply with treatment. Since patients are typically advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which can affect patient compliance.

[0031] While masks for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea can be suitable for other applications.

[0032] For these reasons, patient interfaces for delivering CPAP during sleep form a distinct field.

[0033] 2.2.3.1.1 Seal-forming structure

[0034] The patient interface can include a seal-forming structure. Due to its direct contact with the patient's face, the shape and construction of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0035] The patient interface can be characterized in part according to the design intent of the seal-forming structure to engage with the face in use. In one form of patient interface, the seal-forming structure can include a first sub-part and a second sub-part, the first sub-part forming a seal around the left nostril and the second sub-part forming a seal around the right nostril. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils in use. Such a single element can be designed to cover, for example, the upper lip area and the nasal bridge area of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the mouth area in use, for example, by forming a seal over the lower lip area of the face. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the mouth area in use. These different types of patient interfaces can be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0036] A seal-forming structure that is effective in one area of the patient's face may not be suitable in another area, for example, because of differences in the shape, structure, variations, and sensitive areas of the patient's face. For example, a seal on swimming goggles that cover the patient's forehead may not be suitable for use on the patient's nose.

[0037] Certain seal-forming structures can be designed for mass production such that one design is suitable, comfortable, and effective for a wide range of different face shapes and sizes. To the extent that 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 must adapt to form a seal.

[0038] One type of seal-forming structure extends around the perimeter of the patient interface and is used to seal against the patient's face when a force is applied to the patient interface while the seal-forming structure is in face-to-face engagement with the patient's face. The seal-forming structure can include an air or fluid-filled pad, or a molded or formed surface of an elastomeric seal element (such as rubber). For this type of seal-forming structure, if the fit is inadequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0039] Another type of seal-forming structure includes a sheet-like seal of thin material positioned around the perimeter of the face mask to provide a self-sealing action against the patient's face when positive pressure is applied inside the face mask. Similar to the previous form of seal-forming part, if the match between the face and the face mask is poor, additional force may be required to achieve a seal, or the face mask may leak. Additionally, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or bend during use, resulting in leakage.

[0040] Another type of seal-forming structure may include friction fit elements, such as for insertion into the nostrils, however some patients find these uncomfortable.

[0041] Another form of seal-forming structure may use an adhesive to effect the seal. Some patients may find it inconvenient to constantly apply and remove the adhesive to their face.

[0042] A series of patient interface seal-forming structure techniques are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0043] One form of nasal pillows is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.) assigned to the Puritan-Bennett Corporation.

[0044] ResMed Limited has manufactured the following products including nasal pillows: SWIFT TM nasal pillow masks, SWIFT TM II nasal pillow masks, SWIFT TM LT nasal pillow masks, SWIFT TM FX nasal pillow masks and MIRAGE LIBERTY TM full face masks. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO2004 / 073,778 (which describes other aspects of the ResMed Limited SWIFT TM nasal pillows); U.S. Patent Application 2009 / 0044808 (which describes other aspects of the ResMed Limited SWIFT TM LT nasal pillows); International Patent Applications WO2005 / 063,328 and WO 2006 / 130,903 (which describe other aspects of the ResMed Limited MIRAGE LIBERTY TM full face masks); International Patent Application WO 2009 / 052,560 (which describes other aspects of the ResMed Limited SWIFT TM FX nasal pillows).

[0045] 2.2.3.1.2 Positioning and stabilization

[0046] The seal-forming structure of a patient interface for positive pressure therapy is subject to corresponding forces from the air pressure that would break the seal. Accordingly, various techniques have been used to position the seal-forming structure and maintain its sealing relationship with the appropriate portion of the face.

[0047] One technique is to use an adhesive. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0048] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the problems of ill-fitting, bulky, uncomfortable, and difficult to use.

[0049] 2.2.3.1.3 Pressurized air conduit

[0050] In one type of treatment system, a pressurized air stream is provided to the patient interface through a conduit in an air circuit that is in fluid communication with the patient interface such that when the patient interface is positioned on the patient's face during use, the conduit extends forwardly away from the patient's face outside of the patient interface. This is sometimes referred to as a "trunk" type of interface.

[0051] Some patients find such interfaces to be unsightly and thus do not want to wear them, reducing patient compliance. Additionally, the conduit connected to the interface located in front of the patient's face can sometimes be prone to tangling in bedding.

[0052] 2.2.3.1.4 Pressurized air conduit for positioning / stabilizing the seal-forming structure

[0053] Alternative types of treatment systems that attempt to address these problems include patient interfaces where the tube that delivers pressurized air to the patient airway also serves as part of a headband to position and stabilize the seal-forming portion of the patient interface to the appropriate portion of the patient's face. This type of patient interface can be referred to as an integrated "headband tube" or "tube headband". Such patient interfaces allow the conduit in the air circuit that provides the pressurized air stream from the respiratory pressure treatment device to be connected 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. US 2007 / 0246043, the content of which is incorporated herein by reference, where the conduit is connected to a tube in the patient interface through a port that is positioned on top of the patient's head during use.

[0054] Patient interfaces that incorporate a headband tube can offer several advantages, such as avoiding the connection of the conduit to the patient interface in front of the patient's face, which can be unsightly and prominent. However, it is desirable for patient interfaces that incorporate a headband tube to be comfortable for the patient to wear over long durations while the patient is asleep and to form an effective seal with the patient's face.

[0055] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0056] A Respiratory Pressure Therapy (RPT) device can be used alone or as part of a system to achieve one or more of the above-mentioned various therapies, for example, by operating the device to generate an air flow to be delivered to an interface leading to the airway. The air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0057] Air pressure generators are known in a series of applications, such as industrial-scale ventilation systems. However, medical air pressure generators have specific requirements that are not met by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. In addition, even devices designed for medical use may have drawbacks regarding one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

[0058] An example of a special requirement for some RPT devices is noise.

[0059] The designer of the device may have to make an infinite number of choices. Design criteria often conflict, which means that some design choices deviate from the norm or are inevitable. Additionally, comfort and efficacy in some aspects may be highly sensitive to small and subtle changes in one or more parameters.

[0060] 2.2.3.3 Humidifier

[0061] Delivering an air flow without humidification may cause airway dryness. Using a humidifier with an RPT device and a patient interface generates humidified gas, minimizing dryness of the nasal mucosa and improving patient airway comfort. In addition, in colder climates, warm air typically applied to the patient interface and the facial area around the patient interface is more comfortable than cold air.

[0062] A series of artificial humidification devices and systems are known, but they may not meet the special requirements of medical humidifiers.

[0063] When needed, typically at a place where the patient may be asleep or resting (such as in a hospital), a medical humidifier is used to increase the humidity and / or temperature of the air flow relative to the ambient air. A medical humidifier for bedside placement can be very small. A medical humidifier can be configured to humidify and / or heat only the air flow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (such as saunas, air conditioners, or evaporative coolers), for example, can also humidify the air the patient breathes, however, these systems also humidify and / or heat the entire room, which may cause discomfort to the occupants. In addition, medical humidifiers may have more stringent safety limitations than industrial humidifiers.

[0064] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient for patients to use.

[0065] 2.2.3.4 Vent Port Technology

[0066] Some forms of treatment systems may include a vent port to allow flushing of exhaled carbon dioxide. The vent port may allow gas to flow from the internal space (e.g., the inflation chamber) of the patient interface to the external space of the patient interface, such as to the environment.

[0067] The vent port may include an aperture, and gas may flow through the aperture when using a face mask. Many such vent ports are noisy. Others may become blocked during use, thus providing inadequate flushing. Some vent ports may disrupt the sleep of the patient's bed partner 1100 of patient 1000, for example, through noise or a concentrated airflow.

[0068] ResMed Limited has developed a number of improved face mask vent port technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0069] Noise table of existing face masks (ISO 17510-2:2007, pressure of 10 cmH2O at 1 m)

[0070]

[0071]

[0072] (*Only one sample, measured at 10 cmH2O using the test method specified in ISO 3744 in CPAP mode)

[0073] The sound pressure values of various objects are listed below

[0074] 3 Summary of the Invention

[0075] The present technology aims to provide a medical device for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, having one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.

[0076] The first aspect of the present technology relates to a device for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0077] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0078] One aspect of certain forms of the present technology is to provide methods and / or devices for improving a patient's compliance with respiratory therapy.

[0079] One form of the present technology includes a patient interface for delivering a supply of pressurized breathable gas to the patient airway inlet.

[0080] One aspect of the present technology includes a patient interface having an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than ambient air pressure. The inflatable chamber can be formed at least in part by a chassis portion of the patient interface and a seal-forming structure.

[0081] One aspect of the present technology is a gasket module for a patient interface, the gasket module including a chassis portion and a seal-forming structure.

[0082] 3.1 Decoupling portions in the lateral rearward region of the seal-forming structure

[0083] One aspect of one form of the present technology is a patient interface, or a gasket module for a patient interface, that includes a chassis portion and a seal-forming structure that together form an inflatable chamber. The chassis portion can include a laterally projecting connection portion configured to connect to a gas delivery tube. The seal-forming structure can include a central portion configured to seal against the lower lateral perimeter of the patient's nose around the patient's nostrils in use. The seal-forming structure can include decoupling portions, each decoupling portion configured to at least partially decouple the central portion from a corresponding one of the laterally projecting connection portions. The seal-forming structure can also include a peripheral portion adjacent to the decoupling portions and that is stiffer and / or thicker than the decoupling portions.

[0084] One aspect of one form of the present technology is a patient interface, including:

[0085] A chassis portion that partially forms an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than ambient air pressure, the chassis portion including a pair of laterally projecting connection portions configured to connect to a gas delivery tube and sized and structured to receive an air flow at the therapeutic pressure for the patient to breathe;

[0086] A seal-forming structure is provided on the chassis portion and partially forms an inflation chamber. The seal-forming structure is configured and arranged to form a seal with the area of the patient's face surrounding the patient's airway inlet. The seal-forming structure has at least one aperture therein such that air flow at a treatment pressure is delivered at least to the inlets of the patient's nostrils. The seal-forming structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's respiratory cycle during use;

[0087] A vent that allows gas exhaled by the patient to flow from the interior of the inflation chamber to the surrounding environment. The vent is sized and shaped to maintain the treatment pressure in the inflation chamber during use;

[0088] Wherein, the seal-forming structure includes:

[0089] A central portion configured to seal against at least the patient's nasal spine, alae nasi, and upper lip during use;

[0090] A pair of latero-posterior regions provided on respective latero-posteriors of the seal-forming structure. Each latero-posterior region includes:

[0091] A decoupling portion configured to at least partially decouple the central portion of the seal-forming structure from a respective one of the laterally projecting connection portions. The decoupling portion is located in a part of the latero-posterior region configured to face away from and not contact the patient's face during use; and

[0092] An outer peripheral portion provided adjacent to the decoupling portion, with at least a part of the outer peripheral portion located behind the decoupling portion,

[0093] Wherein, the stiffness of the decoupling portion is less than the stiffness of the outer peripheral portion.

[0094] In an example: (a) the stiffness of each peripheral portion is greater than the stiffness of the central portion of the seal-forming structure; (b) the stiffness of the decoupled portion of each lateral rear region is greater than the stiffness of the central portion of the seal-forming structure; (c) the wall thickness of the peripheral portion of each lateral rear region is greater than the wall thickness of the central portion of the seal-forming structure; (d) the wall thickness of the peripheral portion of each lateral rear region is greater than the wall thickness of the decoupled portion of each lateral rear region; (e) the wall thickness of the decoupled portion of each lateral rear region is greater than the wall thickness of the central portion of the seal-forming structure; (f) when viewed from the lateral side of the seal-forming structure, the decoupled portion of each lateral rear region is C-shaped; (g) each peripheral portion partially or completely surrounds the corresponding decoupled portion; (h) each decoupled portion is formed by a recess in the inner surface of the seal-forming structure within the corresponding lateral rear region; (i) the patient interface further 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; (j) the patient interface further includes a gas delivery tube, and the gas delivery tube forms part of the positioning and stabilizing structure, and each gas delivery tube is configured to deliver an air flow from a position above the patient's head to the interior of the chassis portion during use; (k) the central portion of the seal-forming structure is formed of a textile material; (l) the central portion of the seal-forming structure is formed of silicone or another elastomeric material; (m) the lateral rear regions are formed of silicone or another elastomeric material; (n) the chassis portion is formed of a flexible material; (o) the chassis portion is formed of silicone; (p) the patient interface includes a removable cushion module that includes the chassis portion and the seal-forming structure; and / or (q) the chassis portion is formed of an elastomeric material.

[0095] One aspect of one form of the present technology is a patient interface including a chassis portion and a seal-forming structure, the chassis portion and the seal-forming structure together at least partially form an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure. The chassis portion may include a pair of laterally projecting connection portions configured to be connected to a gas delivery tube and sized and structured to receive an air flow at the therapeutic pressure for the patient to breathe. The seal-forming structure may be supported by the chassis portion and may have at least one aperture therein such that the air flow at the therapeutic pressure is delivered at least to the entrance of the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient breathing cycle.

[0096] The seal-forming structure may include a central portion configured to form a seal against a patient's face around the patient's nostrils but not contacting the patient's nasal bridge during use. The seal-forming structure may also include a pair of latero-posterior regions disposed on respective latero-posterior sides of the seal-forming structure. Each latero-posterior region may include a decoupling portion configured to at least partially decouple the central portion of the seal-forming structure from a corresponding one of the laterally projecting connecting portions. Each latero-posterior region may include a peripheral portion at least partially surrounding the respective decoupling portion. At least a portion of the peripheral portion may be located behind the respective decoupling portion. The decoupling portion may be thicker than the peripheral portion.

[0097] 3.2 Rigidifying portion in the seal-forming structure

[0098] One aspect of one form of the present technology is a patient interface, or a cushion module for a patient interface, comprising a chassis portion and a seal-forming structure that together form an inflatable chamber. The seal-forming structure may include a central portion configured to seal against the lower lateral perimeter of a patient's nose around the patient's nostrils during use. The seal-forming structure may also include intermediate lateral portions on either side of the central portion and configured to be located beside the patient's nasal wings. The seal-forming structure may also include a rigidifying portion located at least on the posterior side of the seal-forming structure. The rigidifying portion may be harder and / or thicker than the intermediate lateral portions. The intermediate lateral portions may be harder and / or thicker than the central portion.

[0099] One aspect of one form of the present technology is a patient interface, comprising:

[0100] A chassis portion that partially forms an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than ambient air pressure, the size and structure of the chassis portion being set to receive an air flow at the therapeutic pressure for a patient to breathe; and

[0101] A seal-forming structure disposed on the chassis portion, the seal-forming structure partially forming the inflatable chamber and being constructed and arranged to form a seal with a region of the patient's face around the patient's airway inlet, the seal-forming structure having at least one aperture therein such that an air flow at the therapeutic pressure is at least delivered to the inlet of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle;

[0102] A vent that allows gas exhaled by the patient to flow from the interior of the inflatable chamber to the surrounding environment, the size and shape of the vent being set to maintain the therapeutic pressure in the inflatable chamber during use;

[0103] Wherein, the seal-forming structure includes:

[0104] A central portion, the central portion being disposed at the rear side of the seal-forming structure and configured to seal against at least the nasal spine, alae nasi, and upper lip of the patient in use;

[0105] A pair of intermediate lateral portions, the intermediate lateral portions being on the rear side of the seal-forming structure, each intermediate lateral portion being disposed on a respective lateral side of the central portion and configured to be located beside the respective alae nasi of the patient's nose in use, and the stiffness of each intermediate lateral portion being greater than the stiffness of the central portion; and

[0106] A pair of stiffening portions, each stiffening portion extending from the rear side of the seal-forming structure to the front side of the seal-forming structure configured to face away from the patient's face during use, each stiffening portion being positioned on a respective lateral side of the seal-forming structure, and the stiffness of each stiffening portion being greater than the stiffness of the intermediate lateral portion.

[0107] 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 a zero or negative curvature along a second path perpendicular to the first path; (c) each stiffening portion includes a front-side portion disposed on the front side of the seal-forming structure and a rear-side portion disposed on the rear side of the seal-forming structure, wherein the stiffness of the front-side portion is greater than the stiffness of the rear-side portion; (d) the thickness of the front-side portion of each stiffening portion is greater than the thickness of the rear-side portion of the stiffening portion; (e) each stiffening portion has a tapered thickness increase between the rear-side portion of the stiffening portion and the front-side portion of the stiffening portion; (f) the stiffness of the front-side portion of the stiffening portion is greater than the stiffness of an adjacent portion on its front side of the seal-forming structure; (g) the thickness of the front-side portion of the stiffening portion is greater than the thickness of an adjacent portion on its front side of the seal-forming structure; (h) the stiffness of the rear-side portion of the stiffening portion is greater than the stiffness of an adjacent portion on the rear side of the seal-forming structure; (i) the thickness of the rear-side portion of the stiffening portion is greater than the thickness of an adjacent portion on the rear side of the seal-forming structure; (j) each stiffening portion has a greater wall thickness than an adjacent region, the greater wall thickness being formed by an additional thickness of an inner surface of the seal-forming structure; (k) each stiffening portion is positioned in use adjacent to a respective one of the patient's nasal wings; (l) the chassis portion includes a pair of laterally projecting connection portions configured to connect to a gas delivery tube, each laterally projecting connection portion being configured to connect to a respective one of a pair of gas delivery tubes and receive a gas flow from the respective one of the pair of gas delivery tubes; (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 a gas delivery tube, each gas delivery tube being configured to receive an air flow from a connection port located on the top of the patient's head and deliver the air flow to a respective one of the laterally projecting connection portions of the chassis portion; (n) each stiffening portion is positioned adjacent to a respective one of the laterally projecting connection portions; (o) the chassis portion is formed of a flexible material; (p) the chassis portion is formed of silicone or another elastomeric material; (q) a central portion of the seal-forming structure is formed of a textile material; (r) a central portion of the seal-forming structure is formed of silicone or another elastomeric material; and / or (s) the stiffening portion is formed of silicone or another elastomeric material.

[0108] One aspect of one form of the present technology is a patient interface including a chassis portion and a seal-forming structure, the chassis portion and the seal-forming structure together at least partially forming an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than ambient air pressure. The seal-forming structure can be supported by the chassis portion and can have at least one aperture therein such that air flow at the therapeutic pressure is delivered at least to the entrance of the patient's nostrils, and the seal-forming structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0109] The seal-forming structure can include a central portion that is on the rear side of the seal-forming structure and is configured to form a seal against the patient's face around the patient's nostrils but not contacting the patient's nasal bridge during use. The seal-forming structure can include a pair of stiffening portions, each stiffening portion being located on a respective lateral side of the seal-forming structure. Each stiffening portion can have a front side portion on the non-patient-contact side of the seal-forming structure and a rear side portion on the patient-contact side of the seal-forming structure. The front side portion can be thicker than the rear side portion.

[0110] 3.3 Intermediate-side to rear-side support portion in the seal-forming structure

[0111] One aspect of one form of the present technology is a patient interface, or a gasket module for a patient interface, including a chassis portion and a seal-forming structure that together form an inflatable chamber. The seal-forming structure can include a central portion that is configured to seal against the lower-side perimeter of the patient's nose around the patient's nostrils during use. The seal-forming structure can further include intermediate lateral portions that are on either side of the central portion and are configured to be located beside the patient's nasal wings. The seal-forming structure can further include a pair of intermediate-side to rear-side support portions, each intermediate-side to rear-side support portion being positioned near the junction between the central portion and the respective intermediate lateral portion. The stiffness and / or thickness of each intermediate-side to rear-side support portion can be greater than the stiffness of the central portion and less than the stiffness of each intermediate lateral portion.

[0112] One aspect of one form of the present technology is a patient interface including:

[0113] A chassis portion that partially forms an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than ambient air pressure, the chassis portion being sized and structured to receive an air flow at the therapeutic pressure for the patient to breathe;

[0114] A seal-forming structure is provided on a chassis portion. The seal-forming structure partially forms an inflation chamber and is constructed and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The seal-forming structure has at least one aperture therein such that air flow at a treatment pressure is delivered at least to the inlets of the patient's nostrils. The seal-forming structure is constructed and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's breathing cycle during use;

[0115] A vent that allows gas exhaled by the patient to flow from the interior of the inflation chamber to the surrounding environment. The vent is sized and shaped to maintain the treatment pressure in the inflation chamber during use;

[0116] Wherein, the seal-forming structure comprises:

[0117] A central portion provided on the rear side of the seal-forming structure. The central portion is configured to seal against at least the patient's nasal spine, alae nasi, and upper lip during use;

[0118] A pair of intermediate lateral portions provided on the rear side of the seal-forming structure. Each intermediate lateral portion is provided on a respective lateral side of the central portion. The stiffness of each intermediate lateral portion is greater than the stiffness of the central portion;

[0119] A pair of intermediate lateral rear support portions provided on the rear side of the seal-forming structure. Each intermediate lateral rear support portion is provided near the junction between the central portion and the respective intermediate lateral portion and is configured to be located near the respective lateral rear corner of the base of the patient's nose during use. The stiffness of each intermediate lateral rear support portion is greater than the stiffness of the central portion and less than the stiffness of each intermediate lateral portion.

[0120] In an example: (a) The seal-forming structure includes a pair of rear-side corner portions configured to engage with a patient's face near the nasolabial groove of the patient in use, and the stiffness of each intermediate side-rear support portion is less than the stiffness of each rear-side corner portion; (b) The stiffness of each rear-side corner portion is greater than the stiffness of each intermediate side portion; (c) The thickness of each intermediate side portion is greater than the thickness of the central portion; (d) The thickness of each intermediate side-rear support portion is greater than the thickness of the central portion; (e) The thickness of each intermediate side-rear support portion is less than the thickness of each intermediate side portion; (f) The thickness of each intermediate side-rear support portion is less than the thickness of each rear-side corner portion; (g) The thickness of each rear-side corner portion is greater than the thickness of the intermediate side portion; (h) The thickness of each intermediate side-rear support portion is tapered and increases towards the corresponding adjacent intermediate side portion; (i) The tapered thickness of each intermediate side-rear support portion increases to the thickness of the corresponding adjacent intermediate side portion; (j) The thickness of each intermediate side support portion can be in the range of 0.3 to 0.7 mm; and / or (k) The thickness of each intermediate side support portion can be in the range of 0.4 to 0.6 mm.

[0121] In a further example: (a) The chassis portion includes a pair of laterally protruding connection portions, each laterally protruding connection portion being configured to connect to a corresponding one of a pair of gas delivery tubes and receive a gas flow from the corresponding one of the pair of gas delivery tubes; (b) wherein 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 tubes, each gas delivery tube being configured to receive an air flow from a connection port located on the top of the patient's head and deliver the air flow to a corresponding one of the laterally protruding connection portions of the chassis portion; (c) The central portion of the seal-forming structure is formed of a textile material; (d) The central portion of the seal-forming structure is formed of silicone or another elastomeric material; (e) The side-rear region is formed of silicone or another elastomeric material; (f) The chassis portion is flexible; and / or (g) The chassis portion is formed of silicone or another elastomeric material.

[0122] 3.4 A chassis portion formed of a flexible material with rigid members

[0123] One aspect of one form of the present technology is a patient interface, or a cushion module for a patient interface, which includes a chassis portion and a seal-forming structure that together form an inflatable chamber. The chassis portion may include laterally projecting connection portions configured to connect to a gas delivery tube. The seal-forming structure may include a central portion configured to seal against the lower peripheral side of the patient's nose surrounding the patient's nostrils during use. The chassis portion may be formed of a flexible material and may be reinforced by a rigid member. The rigid member may include a vent module.

[0124] One aspect of one form of the present technology is a patient interface, comprising:

[0125] A chassis portion that partially forms an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure, the chassis portion including a pair of laterally projecting connection portions sized and configured to receive an air flow at the therapeutic pressure for the patient to breathe;

[0126] A seal-forming structure disposed on the chassis portion, the seal-forming structure partially forming the inflatable chamber and being constructed and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet, the seal-forming structure having at least one aperture therein such that an air flow at the therapeutic pressure is at least delivered to the inlet of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle;

[0127] 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 pair of gas delivery tubes, each gas delivery tube being configured to receive an air flow from a connection port located on the top of the patient's head and deliver the air flow to a respective one of the laterally projecting connection portions of the chassis portion;

[0128] A vent that allows the gas exhaled by the patient to flow from the interior of the inflatable chamber to the surrounding environment, the vent being sized and shaped to maintain the therapeutic pressure in the inflatable chamber during use;

[0129] wherein the chassis portion and the seal-forming structure are formed of a flexible material, and

[0130] wherein the patient interface further includes a rigid member disposed on the chassis portion, the rigid member being configured to resist deformation of the chassis portion.

[0131] In an example: (a) A rigid member is disposed on the front side of the chassis portion; (b) The chassis portion includes a front hole configured to receive the rigid member; (c) The rigid member includes a vent module, and the vent module includes a vent; (d) The vent includes a plurality of vent holes, and the gas exhaled by the patient passes through the vent holes and continuously flows from the inside of the inflation chamber to the surrounding environment; (e) The plurality of vent holes include upstream vent holes and downstream vent holes; (f) The plurality of downstream vent holes include one or more upper side vent holes and one or more lower side vent holes; (g) One or more of the upper side vent holes are configured to direct the exhaust gas in a direction angled upward with respect to an axis orthogonal to the front surface of the vent module; (h) One or more of the lower side vent holes are configured to direct the exhaust gas in a direction angled downward with respect to an axis orthogonal to the front surface of the vent module; (i) The angle upward is greater than the angle downward; (j) The sum of the angle upward and the angle downward is in the range of 60 to 100 degrees; (k) The sum of the angle upward and the angle downward is in the range of 70 to 90 degrees; (l) The sum of the angle upward and the angle downward is substantially 80 degrees; (m) The plurality of downstream vent holes include a pair of upper side vent holes; (n) The plurality of downstream vent holes include a pair of lower side vent holes; (o) The vent module is configured to support a diffuser, and the continuous gas flow exhaled by the patient can pass through the diffuser when flowing to the surrounding environment; (p) The vent module is configured to allow the gas continuously flowing from the inside of the inflation chamber to the surrounding environment exhaled by the patient to enter and leave the diffuser after passing through the upstream vent holes; (q) The vent module is configured to allow the gas continuously flowing from the inside of the inflation chamber to the surrounding environment exhaled by the patient to enter and leave the diffuser before passing through the downstream vent holes; and / or (r) The vent module is configured to allow the gas continuously flowing from the inside of the inflation chamber to the surrounding environment exhaled by the patient to pass by the diffuser without flowing through the diffuser.

[0132] In a further example: (a) The vent module includes a peripheral channel configured to receive a part of the chassis portion of the inflation chamber; (b) The chassis portion includes a lip configured to be received in the peripheral channel of the vent module; (c) The lip defines the front hole of the inflation chamber; (d) The lip is thicker than an adjacent part of the chassis portion of the inflation chamber; (e) The lip is the thickest part of the chassis portion; (f) The thickness of the lip is in the range of 3 to 5 mm; and / or (g) The thickness of the lip is in the range of 3.5 to 4.5 mm; (H) The thickness of the lip is substantially 4 mm.

[0133] In a further example: (c) The chassis portion is formed of an elastomeric material; (b) The chassis portion is formed of silicone; (c) The seal-forming structure is at least partially formed of silicone; (d) The seal-forming structure is at least partially formed of a textile material; and / or (e) The rigid member is at least partially formed of a substantially rigid material.

[0134] In a further example: (a) the seal-forming structure includes a central portion on the rear side of the seal-forming structure, the central portion being configured to seal against at least the nasal spine point, alae nasi, and upper lip of the patient in use; (b) the seal-forming structure does not enter the patient's nostrils; (c) the patient interface is configured to leave the patient's mouth uncovered.

[0135] One aspect of a form of the present technology is a patient interface including a chassis portion and a seal-forming structure, the chassis portion and the seal-forming structure together at least partially forming an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure. The chassis portion may include a pair of laterally projecting connection portions configured to be connected to a gas delivery tube and sized and structured to receive an air flow at the therapeutic pressure for the patient to breathe. The seal-forming structure may be supported by the chassis portion and may have at least one aperture therein such that the air flow at the therapeutic pressure is delivered at least to the entrance of the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle.

[0136] The patient interface may include a vent that allows the gas exhaled by the patient to flow from the interior of the inflatable chamber to the surrounding environment, the vent being sized and shaped to maintain the therapeutic pressure in the inflatable chamber in use. The vent may include a plurality of vent holes through which the gas exhaled by the patient flows from the interior of the inflatable chamber to the surrounding environment, the vent holes including one or more upper side vent holes and one or more lower side vent holes. The one or more upper side vent holes are configured to direct the exhaust gas in a direction angled upward relative to an axis orthogonal to the front surface of the vent module, and the one or more lower side vent holes are configured to direct the exhaust gas in a direction angled downward relative to an axis orthogonal to the front surface of the vent module. The angle upward may be greater than the angle downward.

[0137] 3.5 Upper / lower portions of the central front side portion of the seal-forming structure

[0138] Another aspect of a form of the present technology is a patient interface including:

[0139] A chassis portion that partially forms an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure, the chassis portion being sized and structured to receive an air flow at the therapeutic pressure for the patient to breathe;

[0140] A seal-forming structure is provided on a chassis portion and partially forms an inflation chamber. The seal-forming structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The seal-forming structure has at least one aperture therein such that air flow at a treatment pressure is delivered at least to the inlet of the patient's nostrils. The seal-forming structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's respiratory cycle during use;

[0141] A vent allows gas exhaled by the patient to flow from the interior of the inflation chamber to the surrounding environment. The vent is sized and shaped to maintain the treatment pressure in the inflation chamber during use;

[0142] Wherein, the seal-forming structure includes:

[0143] A central portion on the rear side of the seal-forming structure, the central portion being configured to seal against at least the patient's nasal bridge, alae nasi, and upper lip during use; and

[0144] A central front portion on the front side of the seal-forming structure and positioned adjacent to and below the patient's nasal bridge during use. The central front portion includes an upper side portion and a lower side portion, and the lower side portion has a greater stiffness than the upper side portion.

[0145] In an example: (a) the wall thickness of the lower side portion of the central front portion is greater than the wall thickness of the upper side portion of the central front portion; (b) the wall thickness of the upper side portion of the central front portion is substantially the same as the wall thickness of the central portion of the seal-forming structure; (c) the seal-forming structure includes a pair of intermediate lateral portions on the rear side of the seal-forming structure, each intermediate lateral portion being disposed on a respective lateral side of the central portion, and each intermediate lateral portion having a greater stiffness than the central portion; (d) the wall thickness of the intermediate lateral portion is greater than the wall thickness of the upper side portion of the central front portion; (e) the seal-forming structure includes a pair of intermediate front-lateral portions on the front side of the seal-forming structure and located on respective lateral sides of the central front portion, and the wall thickness of each of the pair of intermediate front-lateral portions is greater than the wall thickness of the central front portion. (f) The chassis portion includes a pair of laterally projecting connection portions, each laterally projecting connection portion being configured to connect to a respective one of a pair of gas delivery tubes and receive a gas flow from the respective one of the gas delivery tubes; 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, and the positioning and stabilizing structure includes gas delivery tubes, each gas delivery tube being configured to receive an air flow from a connection port located on the top of the patient's head and deliver the air flow to a respective one of the laterally projecting connection portions of the chassis portion.

[0146] In a further example: (a) the chassis portion is formed of an elastomeric material; (b) the chassis portion is formed of silicone; (c) the seal-forming structure is at least partially formed of silicone; and / or (d) the seal-forming structure is at least partially formed of a textile material.

[0147] One aspect of one form of the present technology is a patient interface including a chassis portion and a seal-forming structure, the chassis portion and the seal-forming structure together at least partially forming an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than ambient air pressure. The seal-forming structure can be supported by the chassis portion and can have at least one aperture therein such that air flow at the therapeutic pressure is delivered at least to the entrance of the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use.

[0148] The seal-forming structure can include a central portion that is on the rear side of the seal-forming structure and is configured to form a seal against the patient's face around the patient's nostrils but not contacting the patient's nasal bridge during use. The seal-forming structure can include a central front-side portion on the non-patient-contact side of the seal-forming structure and a pair of intermediate side-front-side portions disposed on either side of the central front-side portion. The central front-side portion can include an upper side portion and a lower side portion, and the lower side portion of the central front-side portion is thicker than the upper side portion of the central front-side portion. Each intermediate side-front-side portion can have an upper side portion and a lower side portion, and the lower side portion of each intermediate side-front-side portion is thicker than the upper side portion of each intermediate side-front-side portion.

[0149] 3.6 Upper / lower side portions of the intermediate side-front-side portion of the seal-forming structure

[0150] Another aspect of one form of the present technology is a patient interface including:

[0151] A chassis portion that partially forms an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than ambient air pressure, the chassis portion being sized and configured to receive an air flow at the therapeutic pressure for the patient to breathe;

[0152] A seal-forming structure disposed on the chassis portion and partially forming the inflatable chamber, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face surrounding the patient's airway entrance, the seal-forming structure having at least one aperture therein such that an air flow at the therapeutic pressure is delivered at least to the entrance of the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use;

[0153] A vent that allows the gas exhaled by the patient to flow from the interior of the inflatable chamber to the surrounding environment, the size and shape of the vent being configured to maintain the treatment pressure in the inflatable chamber during use;

[0154] Wherein, the seal-forming structure includes:

[0155] A central portion on the rear side of the seal-forming structure, the central portion being configured to seal against at least the patient's nasal bridge point, nasal wings, and upper lip during use;

[0156] A central front portion on the front side of the seal-forming structure and positioned adjacent to and below the patient's nasal bridge point during use; and

[0157] A pair of intermediate side-to-front portions on the front side of the seal-forming structure, each intermediate side-to-front portion being located on the respective lateral side of the central front portion, each intermediate side-to-front portion including an upper portion and a lower portion, the lower portion having a greater stiffness than the upper portion.

[0158] In an example: (a) the wall thickness of the lower portion of each intermediate side-to-front portion is greater than the wall thickness of the respective upper portion of the intermediate side-to-front portion; (b) the wall thickness of the lower portion of each intermediate side-to-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 intermediate side-to-front portion is greater than the wall thickness of the central portion of the rear side of the seal-forming structure; (d) the wall thickness of the upper portion of each intermediate side-to-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 intermediate side-to-front portion is greater than the wall thickness of the central portion of the rear side of the seal-forming structure; (f) the seal-forming structure includes a pair of intermediate lateral portions on the rear side of the seal-forming structure, each intermediate lateral portion being disposed on the respective lateral side of the central portion, and the wall thickness of each intermediate lateral portion is greater than the wall thickness of the central portion; (g) the wall thickness of the lower portion of each intermediate side-to-front portion is greater than the wall thickness of the intermediate lateral portion of the rear side of the seal-forming structure; (h) the wall thickness of the upper portion of each intermediate side-to-front portion is greater than the wall thickness of the intermediate lateral portion of the rear side of the seal-forming structure; (i) the chassis portion includes a pair of laterally protruding connection portions, each laterally protruding connection portion being configured to connect to a respective one of a pair of gas delivery tubes and receive a gas flow from the respective one of the pair of gas delivery tubes; 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 gas delivery tubes, each gas delivery tube being configured to receive an air flow from a connection port located 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.

[0159] In a further example: (a) the chassis portion is formed of an elastomeric material; (b) the chassis portion is formed of silicone; (c) the seal-forming structure is at least partially formed of silicone; and / or (d) the seal-forming structure is at least partially formed of a textile material.

[0160] One aspect of a form of the present technology is a patient interface including a chassis portion and a seal-forming structure, the chassis portion and the seal-forming structure together at least partially forming an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure. The seal-forming structure can be supported by the chassis portion and can have at least one aperture therein such that air flow at the therapeutic pressure is delivered at least to the entrance of the patient's nostrils, and the seal-forming structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use.

[0161] The seal-forming structure can include a central portion that is on the rear side of the seal-forming structure and is configured to form a seal against the patient's face around the patient's nostrils but not contact the patient's nasal bridge during use. The seal-forming structure can include a central front-side portion on the non-patient-contact side of the seal-forming structure and a pair of intermediate side-front-side portions disposed on either side of the central front-side portion. Each intermediate side-front-side portion has an upper side portion and a lower side portion, and the lower side portion of each intermediate side-front-side portion is thicker than the upper side portion of each intermediate side-front-side portion. The seal-forming structure can also include a pair of intermediate side portions that are on the rear side of the seal-forming structure, each intermediate side portion being disposed on a respective lateral side of the central portion and having a wall thickness greater than the wall thickness of the central portion.

[0162] 3.7 Upper-side reinforcement portion of the chassis

[0163] Another aspect of a form of the present technology is a patient interface including:

[0164] a chassis portion formed of a flexible material and partially forming an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure, the chassis portion including a pair of laterally projecting connection portions sized and configured to receive air flow at the therapeutic pressure for the patient's respiration;

[0165] A seal-forming structure is provided on a chassis portion and partially forms an inflation chamber. The seal-forming structure is configured and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet. The seal-forming structure has at least one aperture therein such that an air flow at a treatment pressure is delivered at least to the inlets of the patient's nostrils. The seal-forming structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's respiratory cycle during use;

[0166] A vent that allows gas exhaled by the patient to flow from the interior of the inflation chamber to the surrounding environment. The vent is sized and shaped to maintain the treatment pressure in the inflation chamber during use;

[0167] 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 a pair of gas delivery tubes, each configured to receive an air flow from a connection port located on the top of the patient's head and deliver the air flow to a respective one of laterally protruding connection portions of the chassis portion;

[0168] Wherein, the seal-forming structure includes a central portion on the rear side of the seal-forming structure. The central portion is configured to seal against at least the patient's nasal spine, alae nasi, and upper lip during use;

[0169] Wherein, the chassis portion includes a pair of upper chassis reinforcement portions, each provided on a respective lateral front side of the chassis portion. The stiffness of each upper chassis reinforcement portion is greater than the stiffness of one or more adjacent portions of the chassis portion.

[0170] In an example: (a) The upper side reinforcement portion of the chassis is positioned adjacent to the seal-forming structure; (b) Each upper side reinforcement portion of the chassis is positioned at the corresponding upper side corner of the front hole of the chassis portion; (c) The seal-forming structure includes: a central front side portion, the central front side portion being on the front side of the seal-forming structure and being positioned adjacent to and below the patient's nasal prominence point in use; and a pair of intermediate side-to-front side portions, the intermediate side-to-front side portions being on the front side of the seal-forming structure, each intermediate side-to-front side portion being positioned on the corresponding lateral side of the central front side portion, wherein each upper side reinforcement portion of the chassis is positioned adjacent to a corresponding one of the intermediate side-to-front side portions of the seal-forming structure; (d) Each of the intermediate side-to-front side portions of the seal-forming structure includes an upper side portion and a lower side portion, and each upper side reinforcement portion of the chassis is positioned adjacent to a corresponding one of the lower side portions; (e) The wall thickness of the upper side reinforcement portion of the chassis is the same as the wall thickness of the lower side portion of the intermediate side-to-front side portion; (f) The upper side reinforcement portion of the chassis has a wall thickness between 1 mm and 3 mm; (g) The upper side reinforcement portion of the chassis has a wall thickness between 1.5 mm and 2 mm; (h) The upper side reinforcement portion of the chassis has a wall thickness of 1.7 mm; (i) The seal-forming structure is formed of a flexible material; (j) The seal-forming structure does not enter the patient's nostrils; (k) The patient interface is configured to leave the patient's mouth uncovered; and / or (l) The wall thickness of the upper side reinforcement portion of the chassis is greater than the wall thickness of one or more adjacent portions of the chassis portion.

[0171] In a further example: (a) The chassis portion is formed of an elastomeric material; (b) The chassis portion is formed of silicone; (c) The seal-forming structure is at least partially formed of silicone; and / or (d) The seal-forming structure is at least partially formed of a textile material.

[0172] One aspect of a form of the present technology is a patient interface including a chassis portion and a seal-forming structure, the chassis portion and the seal-forming structure together at least partially forming an inflatable chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure. The seal-forming structure can be supported by the chassis portion and can have at least one hole therein such that air flow at the treatment pressure is at least delivered to the entrance of the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's breathing cycle. The chassis portion can be formed of a flexible material and can include a pair of upper side reinforcement portions of the chassis, each upper side reinforcement portion of the chassis being disposed at the corresponding side-to-front side of the chassis portion. The stiffness of each upper side reinforcement portion of the chassis can be greater than the stiffness of one or more adjacent portions of the chassis portion.

[0173] 3.8 The front / rear side portion of the upper lip portion of the seal-forming structure

[0174] Another aspect of one form of the present technology is a patient interface comprising:

[0175] A chassis portion formed of a flexible material and partially forming an inflatable chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure. The chassis portion includes a pair of laterally projecting connection portions sized and configured to receive an air flow at the treatment pressure for the patient to breathe;

[0176] A seal-forming structure disposed on the chassis portion and partially forming the inflatable chamber. The seal-forming structure is formed of a flexible material and is constructed and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet. The seal-forming structure has at least one aperture therein such that the air flow at the treatment pressure is delivered at least to the inlet of the patient's nostrils. The seal-forming structure is constructed and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's breathing cycle;

[0177] A vent that allows the gas exhaled by the patient to flow from the interior of the inflatable chamber to the surrounding environment. The vent is sized and shaped to maintain the treatment pressure in the inflatable chamber during use;

[0178] 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 a pair of gas delivery tubes, each configured to receive an air flow from a connection port located on the top of the patient's head and deliver the air flow to a respective one of the laterally projecting connection portions of the chassis portion;

[0179] wherein the seal-forming structure and at least most of the chassis portion are formed together from a single-piece homogeneous flexible material;

[0180] wherein the seal-forming structure includes:

[0181] A central portion on the rear side of the seal-forming structure, the central portion being configured to seal against at least the patient's nasal spine, alae nasi, and upper lip during use;

[0182] An upper lip portion including a rear side portion configured to seal against the patient's upper lip during use and a front side portion adjacent to the chassis portion. The front side portion of the upper lip portion has a greater stiffness than the rear side portion of the upper lip portion.

[0183] In an example: (a) the thickness of the front portion of the upper lip portion is greater than the thickness of the rear portion of the upper lip portion; (b) the thickness of the rear portion of the upper lip portion is the same as the thickness of the portion of the central portion of the seal-forming structure adjacent to the upper lip portion; (c) the thickness of the rear portion of the upper lip portion is in the range of 0.1 mm to 0.5 mm; (d) the thickness of the rear portion of the upper lip portion is in the range of 0.2 mm to 0.3 mm; (e) the thickness of the rear portion of the upper lip portion is 0.25 mm; (f) the thickness of the front portion of the upper lip portion is in the range of 1.2 mm to 1.8 mm; (g) the thickness of the front portion of the upper lip portion is in the range of 1.4 to 1.6 mm; (h) the thickness of the front portion of the upper lip portion is 1.5 mm; (i) the seal-forming structure includes a pair of latero-rear regions on the respective latero-rears of the upper lip portion, and the thickness of the rear portion of the upper lip portion is less than the thickness of the latero-rear regions; and / or (j) the thickness of the front portion of the upper lip portion is the same as the thickness of the latero-rear regions.

[0184] In a further example: (a) the chassis portion is formed of an elastomeric material; (b) the chassis portion is formed of silicone; (c) the seal-forming structure is at least partially formed of silicone; and / or (d) the seal-forming structure is at least partially formed of a textile material.

[0185] One aspect of one form of the present technology is a patient interface including a chassis portion and a seal-forming structure, the chassis portion and the seal-forming structure together at least partially forming an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure. The seal-forming structure can be supported by the chassis portion and can have at least one aperture therein such that air flow at the therapeutic pressure is delivered at least to the entrance of the patient's nostrils, and the seal-forming structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle. The seal-forming structure can include a central portion on the rear side of the seal-forming structure, the central portion being 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 to 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 can be formed of a flexible material.

[0186] 3.9 Pad Module Connector

[0187] Another aspect of one form of the present technology is a patient interface including:

[0188] A pad module including:

[0189] The chassis part, which partly forms an inflatable chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than the ambient air pressure. The chassis part includes a pair of laterally protruding connection parts, and the size and structure of the laterally protruding connection parts are set to receive an air flow under the treatment pressure for the patient to breathe; and

[0190] A sealing formation structure, which is arranged on the chassis part and partly forms the inflatable chamber. The sealing formation structure is constructed and arranged to form a seal with the area of the patient's face surrounding the patient's airway entrance. The sealing formation structure has at least one hole therein, such that the air flow under the treatment pressure is at least delivered to the entrance of the patient's nostrils. The sealing formation structure is constructed and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's breathing cycle,

[0191] A positioning and stabilizing structure, which provides a force to hold the sealing formation structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes a pair of gas delivery tubes, each gas delivery tube being configured to receive an air flow from a connection port located on the top of the patient's head and deliver the air flow to a corresponding one of the laterally protruding connection parts of the chassis part; and

[0192] A vent, which allows the gas exhaled by the patient to flow from the inside of the inflatable chamber to the surrounding environment. The size and shape of the vent are set to maintain the treatment pressure in the inflatable chamber during use,

[0193] wherein each gas delivery tube of the positioning and stabilizing structure includes a tube end connector near the tube end of the gas delivery tube, and each tube end connector has at least one clip protrusion; and

[0194] wherein the gasket module includes a pair of connectors, each connector being configured to fluidly connect a corresponding one of the laterally protruding connection parts of the chassis part to a corresponding one of the gas delivery tubes. Each connector includes:

[0195] A chassis connection part, which is connected to a corresponding one of the laterally protruding connection parts of the chassis part; and

[0196] A protruding connector part, which protrudes away from the chassis connection part along the length of the connector. The protruding connector part includes:

[0197] A clip seat part, which is adjacent to the chassis connection part; and

[0198] At least one clip arm, which protrudes away from the clip seat part. The at least one clip arm includes a recess, which is configured to receive the clip protrusion of the tube end connector of the corresponding gas delivery tube to form a snap-fit connection with the tube end connector,

[0199] Wherein, the length of the clamp portion along the length of the connector is equal to or greater than the length of the clamp arm between the clamp portion and the recess along the length of the connector.

[0200] In an example: (a) the length of the clamp portion is greater than the length of the clamp arm between the clamp portion and the recess; (b) the ratio of the length of the clamp portion to the length of the clamp arm between the clamp portion and the recess is equal to or greater than 1.5:1; (c) the ratio is equal to or greater than 1.7:1; (d) the ratio is equal to or greater than 1.9:1 (e) the ratio is equal to or greater than 2:1; (f) the force required to disconnect each connector of the gasket module from the pipe end connector of the corresponding gas delivery pipe is greater than 12 N; (g) the required force is greater than 20 N; (h) the required force is greater than 25 N; (i) the required force is greater than 30 N; (j) the required force is in the range of 12 N to 50 N; the required force is in the range of 20 N to 40 N; (k) the required force is in the range of 25 N to 35 N; (l) the connector of the gasket module includes a pair of clamp arms protruding away from the clamp portion; (m) each of the pair of clamp arms includes a corresponding recess configured to receive a corresponding clamp protrusion; and / or (n) the chassis portion of the gasket module is formed of a flexible material.

[0201] 3.10 Inner / outer portion of the middle side to front side portion of the seal forming structure

[0202] Another aspect of one form of the present technology includes a patient interface, comprising:

[0203] A chassis portion formed of a flexible material and partially forming an inflatable chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure. The size and structure of the chassis portion are set to receive an air flow at the treatment pressure for the patient to breathe;

[0204] A seal forming structure disposed on the chassis portion and partially forming the inflatable chamber. The seal forming structure is configured and arranged to form a seal with the area of the patient's face surrounding the patient's airway inlet. The seal forming structure has at least one hole therein such that an air flow at the treatment pressure is at least delivered to the inlet of the patient's nostrils. The seal forming structure is configured and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's breathing cycle;

[0205] A vent that allows the gas exhaled by the patient to flow from the inside of the inflatable chamber to the surrounding environment. The size and shape of the vent are set to maintain the treatment pressure in the inflatable chamber during use;

[0206] Wherein, the seal forming structure includes:

[0207] A central portion, the central portion being on the rear side of the seal-forming structure and configured to seal against at least the patient's nasion, alae nasi, and upper lip in use;

[0208] A central front portion, the central front portion being on the front side of the seal-forming structure and positioned adjacent to and below the patient's nasion in use;

[0209] A pair of intermediate side-to-front portions, the intermediate side-to-front portions being on the front side of the seal-forming structure, each intermediate side-to-front portion being positioned on a respective lateral side of the central front portion, each intermediate side portion including an inner portion positioned adjacent to the central front portion and a lateral portion located laterally of the inner portion, the stiffness of the inner portion of each intermediate side-to-front portion being greater than the stiffness of the lateral portion of the intermediate side-to-front portion.

[0210] In an example: (a) the stiffness of each inner portion of the intermediate side-to-front portions is greater than the stiffness of the central front portion; (b) the wall thickness of each inner portion of the intermediate side-to-front portions is greater than the wall thickness of the central front portion; (c) each lateral portion of the intermediate side-to-front portions includes an upper side portion and a lower side portion, the stiffness of the lower side portion being greater than the stiffness of the upper side portion; (d) the wall thickness of the lower side portion of the lateral portion of each intermediate side-to-front portion is greater than the wall thickness of the upper side portion; (e) the wall thickness of the inner portion of the intermediate side-to-front portion is greater than the wall thickness of the upper side portion of the lateral portion of each intermediate side-to-front portion; (f) the wall thickness of the inner portion of the intermediate side-to-front portion is less than the wall thickness of the lower side portion of each intermediate side-to-front portion; (g) the chassis portion includes a pair of upper chassis reinforcement portions, each upper chassis reinforcement portion being provided on a respective side-to-front of the chassis portion, the stiffness of each upper chassis reinforcement portion being greater than the stiffness of one or more adjacent portions of the chassis portion; (h) the upper chassis reinforcement portions are positioned adjacent to the seal-forming structure; (i) each upper chassis reinforcement portion is positioned adjacent to a corresponding one of the intermediate side-to-front portions; (j) each upper chassis reinforcement portion is positioned adjacent to a respective one of the lower side portions of the intermediate side-to-front portions; (k) the wall thickness of each upper chassis reinforcement portion is greater than the wall thickness of the intermediate side-to-front portion; and / or (l) the wall thickness of each upper chassis reinforcement portion is greater than the wall thickness of the inner portion of the intermediate side-to-front portion.

[0211] In a further example: (a) the chassis portion includes a pair of laterally projecting connection portions, each laterally projecting connection portion being configured to connect to a respective one of a pair of gas delivery tubes and receive a gas flow from the respective one of the pair of gas delivery tubes; (b) the patient interface includes positioning and stabilizing structures that provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structures including gas delivery tubes, each gas delivery tube being configured to receive an air flow from a connection port located on the top of the patient's head and deliver the air flow to a respective one of the laterally projecting connection portions of the chassis portion; (c) the chassis portion is formed of an elastomeric material; (d) the chassis portion is formed of silicone; (e) the seal-forming structure is at least partially formed of silicone; and / or (f) the seal-forming structure is at least partially formed of a textile material.

[0212] 3.11 Upper / Lower portion of the front side portion of the latero-posterior region of the seal-forming structure

[0213] Another aspect of one form of the present technology is a patient interface including:

[0214] A chassis portion formed of a flexible material and partially forming an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure, the size and structure of the chassis portion being set to receive an air flow at the therapeutic pressure for the patient to breathe;

[0215] A seal-forming structure disposed on the chassis portion and partially forming the inflatable chamber, the seal-forming structure being constructed and arranged to form a seal with the region of the patient's face surrounding the patient's airway inlet, the seal-forming structure having at least one hole therein such that an air flow at the therapeutic pressure is at least delivered to the inlet of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle;

[0216] A vent that allows gas exhaled by the patient to flow from the interior of the inflatable chamber to the surrounding environment, the size and shape of the vent being set to maintain the therapeutic pressure in the inflatable chamber during use;

[0217] Wherein the seal-forming structure includes:

[0218] A central portion on the rear side of the seal-forming structure, the central portion being configured to seal against at least the patient's nasal bridge point, nasal wings, and upper lip during use;

[0219] A pair of latero-posterior regions disposed on the respective latero-posteriors of the front side of the seal-forming structure, each latero-posterior region including a front side portion and a rear side portion, the front side portion including an upper side portion and a lower side portion, the stiffness of the upper side portion being greater than the stiffness of the lower side portion.

[0220] In an example: (a) the wall thickness of the upper part of the front part of each lateral rear part is greater than the wall thickness of the rear part; (b) the wall thickness of the upper part of the front part of each lateral rear part is greater than the wall thickness of the lower part of the front part of each lateral rear part; (c) the seal-forming structure includes a pair of intermediate lateral front parts on the front side of the seal-forming structure, each intermediate lateral front part is positioned on the corresponding lateral side of the seal-forming structure, and the stiffness of the intermediate lateral front part is greater than the stiffness of the central part; (d) the wall thickness of each of the front parts of the lateral rear parts is greater than the wall thickness of each intermediate lateral front part; (e) the wall thickness of the upper part of the front part of each lateral rear part is greater than the wall thickness of each intermediate lateral front part; (f) each intermediate lateral front part includes an upper part and a lower part, and the lower part is harder than the upper part; (g) the wall thickness of the lower part of each intermediate lateral front part is greater than the wall thickness of the upper part of the intermediate lateral front part; and / or (h) the boundary between the upper part and the lower part of the front part of each lateral rear part is located at the longest part of the lateral rear part in the front-rear direction.

[0221] In a further example: (a) the chassis part includes a pair of laterally protruding connection parts, each laterally protruding connection part is configured to be connected to a corresponding one of a pair of gas delivery tubes and receive a gas flow from the corresponding one of the gas delivery tubes; (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, and the positioning and stabilizing structure includes gas delivery tubes, each gas delivery tube is configured to receive an air flow from a connection port located on the top of the patient's head and deliver the air flow to a corresponding one of the laterally protruding connection parts of the chassis part; (c) the chassis part is formed of an elastomeric material; (d) the chassis part is formed of silicone; (e) the seal-forming structure is at least partially formed of silicone; and / or (f) the seal-forming structure is at least partially formed of a textile material.

[0222] 3.12 The front / rear part of the intermediate side to lower side part of the seal-forming structure

[0223] Another aspect of one form of the present technology is a patient interface, including:

[0224] A chassis part formed of a flexible material and partially forming an inflatable chamber that can be pressurized to a therapeutic pressure at least 6 cmH2O higher than the ambient air pressure, and the size and structure of the chassis part are set to receive an air flow at the therapeutic pressure for the patient to breathe;

[0225] A sealing formation structure is provided on a chassis portion and partially forms an inflation chamber. The sealing formation structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The sealing formation structure has at least one aperture therein such that a flow of air at a treatment pressure is delivered at least to the inlets of the patient's nostrils. The sealing formation structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's respiratory cycle during use;

[0226] A vent that allows gas exhaled by the patient to flow from the interior of the inflation chamber to the surrounding environment. The vent is sized and shaped to maintain the treatment pressure in the inflation chamber during use;

[0227] Wherein, the sealing formation structure includes:

[0228] A central portion on the rear side of the sealing formation structure. The central portion is configured to seal against at least the patient's nasal tubercle, alae nasi, and upper lip during use. The central portion includes an upper lip portion configured to seal against the patient's upper lip;

[0229] A pair of intermediate side-to-lower side portions located on either side of the upper lip portion. Each intermediate side-to-lower side portion has a front portion and a rear portion adjacent to the chassis portion. The front portion of the intermediate side-to-lower side portion is stiffer than the rear portion of the intermediate side-to-lower side portion.

[0230] In an example: (a) the upper lip portion includes a front portion adjacent to 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 portion is harder than the rear portion of the upper lip portion; (c) the front portion of the intermediate side to lower side portion is harder than the front portion of the upper lip portion; (d) the front portion of the intermediate side to lower side portion is harder than the rear portion of the upper lip portion; (e) the rear portion of the intermediate side to lower side portion is harder than the rear portion of the upper lip portion; (f) the thickness of each of the front portions of the intermediate side to lower side portion is greater than the thickness of the rear portion of the intermediate side to lower side portion; (g) the thickness of the front portion of the upper lip portion is greater than the thickness of the rear portion of the upper lip portion; (h) the thickness of the front portion of the intermediate side to lower side portion is greater than the thickness of the front portion of the upper lip portion; (i) the thickness of the front portion of the intermediate side to lower side portion is greater than the thickness of the rear portion of the upper lip portion; (j) the thickness of the rear portion of the intermediate side to lower side 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 intermediate side to lower side portion is greater than the thickness of the rear portion of the upper lip portion; (l) the chassis portion includes a pair of lower chassis reinforcement portions, each lower chassis reinforcement portion being positioned adjacent to a respective one of the intermediate side to lower side portions, and the stiffness of each lower chassis reinforcement portion is greater than the stiffness of the adjacent portion of the chassis portion; and / or (m) the thickness of each lower chassis reinforcement portion is greater than the thickness of the adjacent portion of the chassis portion.

[0231] In a further example: (a) the chassis portion includes a pair of laterally protruding connection portions, each laterally protruding connection portion being configured to connect to a respective one of a pair of gas delivery tubes and receive a gas flow from the respective one of the gas delivery tubes; (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 tubes, each gas delivery tube being configured to receive an air flow from a connection port located 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 of an elastomeric material; (d) the chassis portion is formed of silicone; (e) the seal-forming structure is at least partially formed of silicone; and / or (f) the seal-forming structure is at least partially formed of a textile material.

[0232] 3.13 Lower Chassis Reinforcement Portion

[0233] Another aspect of one form of the present technology is a patient interface, comprising:

[0234] The chassis part, which is formed of a flexible material and partially forms an inflatable chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than the ambient air pressure. The chassis part includes a pair of laterally protruding connection parts, and the size and structure of the laterally protruding connection parts are set to receive an air flow at the treatment pressure for the patient to breathe;

[0235] The seal-forming structure, which is provided on the chassis part and partially forms the inflatable chamber. The seal-forming structure is constructed and arranged to form a seal with the area around the patient's airway entrance on the patient's face. The seal-forming structure has at least one hole therein such that the air flow at the treatment pressure is at least delivered to the entrance of the patient's nostrils. The seal-forming structure is constructed and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's breathing cycle;

[0236] The vent, which allows the gas exhaled by the patient to flow from the inside of the inflatable chamber to the surrounding environment. The size and shape of the vent are set to maintain the treatment pressure in the inflatable chamber during use;

[0237] The positioning and stabilization structure, which provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure includes a pair of gas delivery tubes, each gas delivery tube being configured to receive an air flow from a connection port located on the top of the patient's head and deliver the air flow to a corresponding one of the laterally protruding connection parts of the chassis part;

[0238] Wherein, the seal-forming structure includes a central part, which is on the rear side of the seal-forming structure. The central part is configured to seal at least against the patient's nasal prominence, alae nasi, and upper lip during use;

[0239] Wherein, the chassis part includes a pair of lower chassis reinforcement parts, each lower chassis reinforcement part being provided on the corresponding lateral lower side of the chassis part, and the stiffness of each lower chassis reinforcement part is greater than the stiffness of one or more adjacent parts of the chassis part.

[0240] In an example: (a) the thickness of each lower-side reinforcement portion of the chassis is greater than the thickness of an adjacent portion of the chassis portion; (b) the lower-side reinforcement portion of the chassis is arranged to be adjacent to the seal-forming structure; (c) the lower-side reinforcement portion of the chassis may have spaced-apart inner boundaries; (d) each lower-side reinforcement portion of the chassis may have an inner boundary close to a central region on the lower side of the chassis portion; (e) each lower-side reinforcement portion of the chassis may have a lateral boundary close to a respective latero-rearward region of the seal-forming structure; (f) the lower-side reinforcement portion of the chassis is shaped to follow the boundary 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 intermediate latero-lower portions located on either side of the upper-lip portion and having a greater stiffness than the upper-lip portion, and each lower-side reinforcement portion of the chassis is positioned adjacent to a respective one of the intermediate latero-lower portions.

[0241] In a further example: (a) the chassis portion includes a pair of laterally projecting connection portions, each laterally projecting connection portion being configured to be connected to a respective one of a pair of gas delivery tubes and to receive a gas flow from the respective one of the pair of gas delivery tubes; (b) the patient interface includes a positioning and stabilization structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including gas delivery tubes, each gas delivery tube being configured to receive an air flow from a connection port located on the top of the patient's head and to deliver the air flow to a respective one of the laterally projecting connection portions of the chassis portion; (c) the chassis portion is formed of an elastomeric material; (d) the chassis portion is formed of silicone; (e) the seal-forming structure is at least partially formed of silicone; and / or (f) the seal-forming structure is at least partially formed of a textile material.

[0242] 3.14 Decoupled portion of the chassis portion

[0243] Another aspect of one form of the present technology is a patient interface, comprising:

[0244] A chassis portion that partially forms an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure, the size and structure of the chassis portion being set to receive an air flow at the therapeutic pressure for the patient to breathe, and the chassis portion including a pair of laterally projecting connection portions configured to be connected to gas delivery tubes;

[0245] A sealing formation structure is disposed on a chassis portion and partially forms an inflation chamber. The sealing formation structure is configured and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet. The sealing formation structure has at least one aperture therein such that an air flow under a treatment pressure is delivered at least to the inlets of the patient's nostrils. The sealing formation structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's respiratory cycle during use;

[0246] A vent that allows the gas exhaled by the patient to flow from the interior of the inflation chamber to the surrounding environment. The size and shape of the vent are set to maintain the treatment pressure in the inflation chamber during use;

[0247] A positioning and stabilizing structure that provides a force to hold the sealing formation structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes a pair of gas delivery tubes, each gas delivery tube being configured to receive an air flow from a connection port located 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;

[0248] Wherein, the sealing formation structure includes a central portion on the rear side of the sealing formation structure. The central portion is configured to seal at least against the patient's nasal spine, nasal wings, and upper lip during use;

[0249] Wherein, the chassis portion includes a pair of decoupling portions, each decoupling portion being disposed on a respective lateral side of the chassis portion and having a lower stiffness than one or more adjacent portions of the chassis portion. The decoupling portions are configured to at least partially decouple the central portion from the forces applied to the chassis portion.

[0250] In an example: (a) the thickness of each decoupling portion is less than the thickness of one or more adjacent portions of the chassis portion; (b) the thickness of each decoupling portion is 0.5 mm; (c) the thickness of the chassis portion is 0.9 mm; (d) each decoupling portion is disposed on the front side of the chassis portion; and / or (e) each decoupling portion extends from the upper side of the chassis portion to the lower side of the chassis portion.

[0251] In a further example: (a) each decoupling portion is at least partially surrounded by an outer peripheral portion of the chassis portion, and the outer peripheral portion of the chassis portion has a greater stiffness than both the decoupling portion and the portion of the chassis portion adjacent to the outer peripheral portion; (b) each outer peripheral portion has a greater thickness than both the decoupling portion and the portion of the chassis portion adjacent to the outer peripheral portion; (c) each outer peripheral portion has a thickness in the range of 1.5 mm to 2 mm; and / or (d) each outer peripheral portion has a thickness of 1.75 mm.

[0252] In a further example: (a) The chassis part includes two decoupling parts on each lateral side of the chassis part; (b) On each lateral side of the chassis part, the chassis part includes an inner decoupling part and a lateral decoupling part, and the lateral decoupling part is located laterally of the inner decoupling part; (c) The lateral decoupling part is configured to at least partially decouple the seal-forming structure from the force applied to the laterally protruding connecting part; (d) The inner decoupling part is configured to at least partially decouple the seal-forming structure from the force applied to the central area of the front side of the chassis part; (e) The gasket module includes a vent module, the vent module includes a vent, the vent module is located in the central area of the front side of the chassis part, and the decoupling part is configured to at least partially decouple the seal-forming structure from the force applied to the vent module.

[0253] In a further example: (a) The lateral decoupling part is D-shaped; (b) The inner decoupling part is crescent-shaped; (c) Each lateral decoupling part has a lateral side near the distal end of the corresponding laterally protruding connecting part and an inner side opposite the lateral side, and the curvature of the inner side is greater than the curvature of the lateral side; (d) The lateral side of each lateral decoupling part is shaped to match the shape of the corresponding distal end of the laterally protruding connecting part; (e) Each inner decoupling part has an inner side near the vent module and a lateral side opposite the inner side, and the curvature of the lateral side is greater than the curvature of the inner side; (f) The inner side of each inner decoupling part is shaped to completely follow the curvature of the vent module; (g) Each decoupling part is at least partially surrounded by the outer peripheral part of the chassis part, and the outer peripheral part of the chassis part has a greater thickness than both the decoupling part and the part of the chassis part adjacent to the outer peripheral part; (h) On each lateral side of the chassis part, the chassis part includes a first outer peripheral part positioned adjacent to the lateral decoupling part on the inner side and a second outer peripheral part positioned adjacent to the inner decoupling part laterally; (i) On each lateral side of the chassis part, the first outer peripheral part is bent to follow the curvature of the inner side of the lateral decoupling part; (j) On each lateral side of the chassis part, the second outer peripheral part is bent to follow the curvature of the lateral side of the inner decoupling part; and / or (k) On each lateral side of the chassis part, the first outer peripheral part and the second outer peripheral part are closest at the midpoint of the front side of the chassis part and are spaced farther apart at the upper side and / or lower side of the chassis part.

[0254] 3.15 Further aspects

[0255] Another aspect of certain forms of the present technology is a system for treating a respiratory disorder, the system including a patient interface, an air circuit, and a positive pressure air source according to any one or more aspects of other aspects of the present technology.

[0256] Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured to have a peripheral shape complementary to the peripheral shape of the intended wearer.

[0257] Another aspect of certain forms of the present technology is a patient interface configured to allow a patient to breathe ambient air through their mouth without pressurized air flowing through the inflation chamber inlet port.

[0258] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured to leave the patient's mouth uncovered in use.

[0259] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured such that no part of the seal-forming structure enters the mouth in use.

[0260] 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 interior of the patient's airway.

[0261] 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 below the mentum region in use.

[0262] Another aspect of certain forms of the present technology is a patient interface constructed and arranged to leave the patient's eyes uncovered in use.

[0263] Another aspect of certain forms of the present technology is a patient interface constructed and arranged to allow a patient to breathe ambient air in the event of a power failure.

[0264] 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 nasal bridge region of the patient's nose.

[0265] Another aspect of certain forms of the present technology is a patient interface that includes a vent and an inflation chamber, wherein the patient interface is constructed and arranged such that gas from the interior of the inflation chamber can be transmitted to the surrounding environment via the vent.

[0266] Another aspect of certain forms of the present technology is a patient interface that includes a vent that allows gas exhaled by a patient to flow from the interior of the inflation chamber to the surrounding environment, the vent being sized and shaped to maintain a therapeutic pressure in the inflation chamber during use. Another aspect of certain forms of the present technology is a patient interface that includes a vent that allows gas exhaled by a patient to flow continuously from the interior of the inflation chamber to the surrounding environment, the vent being sized and shaped to maintain a therapeutic pressure in the inflation chamber during use.

[0267] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged such that, during use of the patient interface, a patient can lie down comfortably in a side or lateral sleeping position.

[0268] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged such that, during use of the patient interface, a patient can lie down comfortably in a supine sleeping position.

[0269] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged such that, during use of the patient interface, a patient can lie down comfortably in a prone sleeping position.

[0270] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, a person with limited dexterity, a person with limited vision, or a person with limited experience using such medical devices.

[0271] One aspect of one form of the present technology is a patient interface that can be washed in a patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0272] Of course, portions of these aspects can form sub - aspects of the present technology. Additionally, the various sub - aspects and / or aspects can be combined in various ways and also form additional aspects or sub - aspects of the present technology.

[0273] Other features of the present technology will be apparent from consideration of the following detailed description, the information contained in the abstract, the drawings, and the claims. 4 BRIEF DESCRIPTION OF THE DRAWINGS

[0274] The present technology is illustrated, by way of example and not limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements and include:

[0275] 4.1 Treatment System

[0276] Figure 1AA system is shown, which includes a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow receiving a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and conveyed along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient sleeps in a supine position.

[0277] Figure 1B A system is shown, which includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receiving a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and conveyed along an air circuit 4170 to the patient 1000.

[0278] Figure 1C A system is shown, which includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and conveyed along an air circuit 4170 to the patient 1000. The patient sleeps in a lateral position.

[0279] 4.2 Respiratory System and Facial Anatomy

[0280] Figure 2A A schematic diagram of the human respiratory system including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm is shown.

[0281] Figure 2B A view of the human upper airway including the nasal cavity, nasal bone, lateral nasal cartilage, major alar cartilage, nostril, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0282] Figure 2C Is a front view of the face with several identified surface anatomical features, including the upper lip, vermilion border of the upper lip, vermilion border of the lower lip, lower lip, mouth width, inner canthus, alae nasi, nasolabial groove, and oral commissure. The upper, lower, radially inward, and radially outward directions are also marked.

[0283] Figure 2D Is a side view of the head with several identified surface anatomical features, including the glabella, nasion, nasal prominence, subnasale, upper lip, lower lip, submental point, nasal ridge, alar apex, superior auricular point, and inferior auricular point. The up-down and front-back directions are also marked.

[0284] Figure 2E Is a side view of the other side of the head. The approximate positions of the Frankfurt horizontal plane and the nasolabial angle are marked. The coronal plane is also marked.

[0285] Figure 2FA bottom view of the nose showing several identified features, including the nasolabial fold, lower lip, vermilion of the upper lip, nostril, subnasale, columella, nasion, the long axis of the nostril, and the median sagittal plane.

[0286] Figure 2G A side view showing the surface features of the nose.

[0287] Figure 2H A view showing the subcutaneous structures of the nose, including the lateral cartilage, septal cartilage, major alar cartilage, minor alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0288] Figure 2I A medial anatomical view of the nose at approximately several millimeters from the median sagittal plane, also showing the medial crura of the septal cartilage and the major alar cartilage.

[0289] Figure 2J A front view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal concha, as well as the maxilla and mandible, are also labeled.

[0290] Figure 2K A side view of the skull showing the head surface contour and several muscles. The following bony parts are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also labeled. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0291] Figure 2L A anterolateral view of the nose.

[0292] 4.3 Patient Interface

[0293] Figure 3A A view showing a patient interface in the form of a nasal mask according to one form of the present technology.

[0294] Figure 3B A schematic view of a cross-section through the structure at a point. The outward normal at that point is labeled. The curvature at that point has a positive sign and has a relatively large magnitude when compared with Figure 3C the magnitude of the curvature shown.

[0295] Figure 3C A schematic view of a cross-section through the structure at a point. The outward normal at that point is labeled. The curvature at that point has a positive sign and has a relatively small magnitude when compared with Figure 3B the magnitude of the curvature shown.

[0296] Figure 3D A schematic view of a cross-section through the structure at a point. The outward normal at that point is labeled. The curvature at that point has a zero value.

[0297] Figure 3E A schematic view of a cross-section through a structure at a point is shown. The outward normal at that point is labeled. The curvature at that point has a negative sign and has a relatively small magnitude when compared to the Figure 3F magnitude of the curvature shown.

[0298] Figure 3F A schematic view of a cross-section through a structure at a point is shown. The outward normal at that point is labeled. The curvature at that point has a negative sign and has a relatively large magnitude when compared to the Figure 3E magnitude of the curvature shown.

[0299] Figure 3G A cushion for a face mask including two pillows is shown. The outer surface of the cushion is labeled. The edges of the surface are labeled. The dome region and the saddle region are labeled.

[0300] Figure 3H A cushion for a face mask is shown. The outer surface of the cushion is labeled. The edges of the surface are labeled. A path on the surface between point A and point B is labeled. The straight-line distance between point A and point B is labeled. Two saddle regions and a dome region are labeled.

[0301] Figure 3I A surface of a structure is shown, in which there is a one-dimensional hole in the surface. The illustrated planar curve forms the boundary of the one-dimensional hole.

[0302] Figure 3J A cross-section through the Figure 3I structure is shown. The illustrated surface defines a two-dimensional hole in the Figure 3I structure.

[0303] Figure 3K A perspective view of the Figure 3I structure including a two-dimensional hole and a one-dimensional hole is shown. Also shown is the surface that defines the two-dimensional hole in the Figure 3I structure.

[0304] Figure 3L A face mask having an inflatable bladder as a cushion is shown.

[0305] Figure 3M A cross-section through the Figure 3L face mask is shown, and the inner surface of the bladder is shown. The inner surface defines a two-dimensional hole in the face mask.

[0306] Figure 3N A cross-section through the Figure 3L face mask is shown. The inner surface is also labeled.

[0307] Figure 3O The left-hand rule is shown.

[0308] Figure 3P Shows the right - hand rule.

[0309] Figure 3Q Shows the left ear, including the left ear helix.

[0310] Figure 3R Shows the right ear, including the right ear helix.

[0311] Figure 3S Shows the right - hand helix.

[0312] Figure 3T Shows a view of the face mask, which includes the sign of the twist of a space curve defined by the edges of the sealing membranes in different regions of the face mask.

[0313] Figure 3U Shows a view of the inflatable chamber 3200, showing the sagittal plane and the intermediate contact plane.

[0314] Figure 3V Shows Figure 3U a view of the rear part of the inflatable chamber. The direction of this view is perpendicular to the intermediate contact plane. Figure 3V The sagittal plane in bisects the inflatable chamber into a left - hand side and a right - hand side.

[0315] Figure 3W Shows a cross - section through Figure 3V the inflatable chamber, which is taken at the sagittal plane shown in Figure 3V The 'intermediate contact' plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of the chord line 3243, which lies on the sagittal plane and touches the cushion of the inflatable chamber at just two points on the sagittal plane: the upper point 3241 and the lower point 3242. Depending on the geometry of the cushion in this region, the intermediate contact plane can be the tangent plane at both the upper and lower points.

[0316] Figure 3X Shows Figure 3U the position of the inflatable chamber 3200 of when used on the face. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 approximately coincides with the median sagittal plane of the face. When the inflatable chamber is in the use position, the intermediate contact plane approximately corresponds to the 'plane of the face'. In Figure 3X the inflatable chamber 3200 is the inflatable chamber of a nasal mask, and the upper point 3241 is approximately located on the nasal bridge point, while the lower point 3242 is located on the upper lip.

[0317] 4.4 RPT device

[0318] Figure 4A Shows an RPT device according to one form of the present technology.

[0319] Figure 4B It is a schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. The upstream and downstream directions are indicated with reference to the blower and the patient interface. The blower is defined as upstream of the patient interface, and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any given moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0320] 4.5 Humidifier

[0321] Figure 5A Shows an isometric view of a humidifier according to one form of the present technology.

[0322] Figure 5B Shows an isometric view of a humidifier according to one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0323] 4.6 Respiratory waveform

[0324] Figure 6 Shows a typical respiratory waveform model of a person during sleep.

[0325] 4.7 Specific examples of the present technology

[0326] Figure 7A Is a front upper lateral perspective view illustration of the patient interface 3000 according to an example of the present technology.

[0327] Figure 7B Is Figure 7A A lower front lateral view illustration of the patient interface 3000 shown in

[0328] Figure 7C Is Figure 7A A front view illustration of the patient interface 3000 shown in

[0329] Figure 7D Is Figure 7A A rear view illustration of the patient interface 3000 shown in

[0330] Figure 7E Is Figure 7A A lateral view illustration of the patient interface 3000 shown in

[0331] Figure 7F Is Figure 7A An upper view illustration of the patient interface 3000 shown in

[0332] Figure 7G Is Figure 7A A lower view illustration of the patient interface 3000 shown in

[0333] Figure 7H is Figure 7A A perspective view illustration when the patient interface 3000 shown is worn by a patient.

[0334] Figure 8A is Figure 7A An anterior lateral view illustration of the cushion module 3150 of the patient interface 3000 shown in

[0335] Figure 8B is Figure 8A A posterior lateral view illustration of the cushion module 3150 shown in

[0336] Figure 8C is Figure 8A An anterior view illustration of the cushion module 3150 shown in

[0337] Figure 8D is Figure 8A A posterior view illustration of the cushion module 3150 shown in

[0338] Figure 8E is Figure 8A A posterior inferior view illustration of the cushion module 3150 shown in

[0339] Figure 8F is Figure 8A An upper view illustration of the cushion module 3150 shown in

[0340] Figure 8G is Figure 8A An anterior inferior view illustration of the cushion module 3150 shown in

[0341] Figure 8H is Figure 8A A lateral view illustration of the cushion module 3150 shown in

[0342] Figure 9A is Figure 8A A posterior upper view illustration of the cushion module 3150 shown in, where various parts are identified.

[0343] Figure 9B is Figure 8A A lateral view illustration of the cushion module 3150 shown in, where various parts are identified.

[0344] Figure 9C is Figure 8A A lower view illustration of the cushion module 3150 shown in, where various parts are identified.

[0345] Figure 9D is Figure 8ARear side view illustration of the gasket module 3150 shown, with each part identified.

[0346] Figure 9E is Figure 8A Upper side view illustration of the gasket module 3150 shown, with each part identified.

[0347] Figure 9F is Figure 8A Rear outer side view illustration of the gasket module 3150 shown, with each part identified.

[0348] Figure 9G is Figure 8A Front outer side view illustration of the gasket module 3150 shown, with each part identified.

[0349] Figure 9H is Figure 8A Lower front outer side view illustration of the gasket module 3150 shown, with each part identified.

[0350] Figure 10 is Figure 8A Upper side view illustration of the gasket module 3150 shown.

[0351] Figure 11A is a cross-sectional view illustration of the gasket module 3150 taken along Figure 10 the line 11A - 11A indicated in.

[0352] Figure 11B is a cross-sectional view illustration of the gasket module 3150 taken along Figure 10 the line 11B - 11B indicated in.

[0353] Figure 11C is a cross-sectional view illustration of the gasket module 3150 taken along Figure 10 the line 11C - 11C indicated in.

[0354] Figure 12 is Figure 8A Lateral view illustration of the gasket module 3150 shown.

[0355] Figure 13A is a cross-sectional view illustration of the gasket module 3150 taken along Figure 12 the line 13A - 13A indicated in.

[0356] Figure 13B is a cross-sectional view illustration of the gasket module 3150 taken along Figure 12 the line 13B - 13B indicated in.

[0357] Figure 14A is Figure 7AFront view illustration of the vent module 3410 of the patient interface 3000 shown in

[0358] Figure 14B is Figure 14A Front perspective view illustration of the vent module 3410 shown in

[0359] Figure 14C is Figure 14A Rear perspective view illustration of the vent module 3410 shown in

[0360] Figure 14D is Figure 14A Cross-sectional view illustration of the vent module 3410 shown in

[0361] Figure 15A is Figure 8A Upper side view illustration of the gasket module 3150 shown in, with the vent module 3410 removed.

[0362] Figure 15B is the gasket module 3150 along Figure 15A Cross-sectional view illustration taken along the line 15B-15B indicated in

[0363] Figure 15C is Figure 8A Upper side view illustration of the gasket module 3150 shown in, including the vent module 3410.

[0364] Figure 15D is the gasket module 3150 along Figure 15C Cross-sectional view illustration taken along the line 15D-15D indicated in

[0365] Figure 16A Upper side view illustration of the gasket module 3150 according to another example of the present technology.

[0366] Figure 16B is Figure 16A Rear side view illustration of the gasket module 3150 shown in

[0367] Figure 16C is Figure 16A Lateral upper side view illustration of the gasket module 3150 shown in

[0368] Figure 16D is Figure 16A Another lateral upper side view illustration of the gasket module 3150 shown in

[0369] Figure 17A is Figure 8A Perspective view illustration of the connector 3214 of the gasket module 3150 shown in

[0370] Figure 17B is Figure 17A a top view illustration of the connector 3214 shown in

[0371] Figure 17C is Figure 17B a cross-sectional view illustration of the connector 3214 taken along line 17C-17C shown in

[0372] Figure 17D is Figure 17A a side view illustration of the connector 3214 shown in

[0373] Figure 17E is Figure 17D a cross-sectional view illustration of the connector 3214 taken along line 17E-17E shown in

[0374] Figure 18 is Figure 8A a top side view illustration of the gasket module 3150 shown in

[0375] Figure 18A is Figure 18 a cross-sectional view illustration of the gasket module 3150 taken along line 18A-18A shown in

[0376] Figure 19A is a top side view illustration of the gasket module 3150 according to another example of the present technology.

[0377] Figure 19B is Figure 19A a side view illustration of the gasket module 3150 shown in

[0378] Figure 19C is Figure 19A a front bottom side view illustration of the gasket module 3150 shown in

[0379] Figure 19D is Figure 19A a rear bottom side view illustration of the gasket module 3150 shown in

[0380] Figure 19E is Figure 19A a front side view illustration of the gasket module 3150 shown in

[0381] Figure 19F is Figure 19A a front top side view illustration of the gasket module 3150 shown in

[0382] Figure 20 is a front side view illustration of the gasket module 3150 according to another example of the present technology.

[0383] Figure 21 is Figure 19AUpper side view illustration of the gasket module 3150 shown in

[0384] Figure 22A is Figure 21 Cross-sectional view illustration of the gasket module 3150 taken along line 22A-22A shown in

[0385] Figure 22B is Figure 21 Cross-sectional view illustration of the gasket module 3150 taken along line 22B-22B shown in

[0386] Figure 23 is Figure 19A Front side view illustration of the gasket module 3150 shown in

[0387] Figure 24A is Figure 23 Cross-sectional view illustration of the gasket module 3150 taken along line 24A-24A shown in

[0388] Figure 24B is Figure 23 Another front side view illustration of the gasket module 3150 shown in

[0389] Figure 24C is Figure 23 Upper side view illustration of the gasket module 3150 shown in

[0390] Figure 25A Front outer perspective view illustration of the gasket module 3150 according to another example of the present technology, where each part is identified.

[0391] Figure 25B is Figure 25A Lower rear outer perspective view illustration of the gasket module 3150 shown in, where each part is identified.

[0392] Figure 25C is Figure 25A Front side view illustration of the gasket module 3150 shown in, where each part is identified.

[0393] Figure 25D is Figure 25A Rear side view illustration of the gasket module 3150 shown in, where each part is identified.

[0394] Figure 25E is Figure 25A Lateral view illustration of the gasket module 3150 shown in, where each part is identified.

[0395] Figure 25F is Figure 25A Lower side view illustration of the gasket module 3150 shown in, where each part is identified.

[0396] Figure 25G is Figure 25A An upper side view of the gasket module 3150 shown in

[0397] Figure 25H is Figure 25A A cross-sectional view of the gasket module 3150 shown in Figure 25G taken along the line 25H-25H indicated in

[0398] Figure 25I is Figure 25A A cross-sectional view of the gasket module 3150 shown in Figure 25G taken along the line 25I-25I indicated in

[0399] Figure 26A A front outer perspective view of the gasket module 3150 according to another example of the present technology, in which various parts are identified.

[0400] Figure 26B is Figure 26A A lower rear outer perspective view of the gasket module 3150 shown in

[0401] Figure 26C is Figure 26A A front side view of the gasket module 3150 shown in

[0402] Figure 26D is Figure 26A A rear side view of the gasket module 3150 shown in

[0403] Figure 26E is Figure 26A A side view of the gasket module 3150 shown in

[0404] Figure 26F is Figure 26A A lower side view of the gasket module 3150 shown in

[0405] Figure 26G is Figure 26A An upper side view of the gasket module 3150 shown in

[0406] Figure 26H is Figure 26A A cross-sectional view of the gasket module 3150 shown in Figure 26G taken along the line 26H-26H indicated in

[0407] Figure 26I is Figure 26A a cross-sectional view taken along line 26I-26I as indicated in Figure 26G of the gasket module 3150 shown in

[0408] Figure 27A is Figure 26A a perspective view of the connector 3214 of the gasket module shown in

[0409] Figure 27B is Figure 27A an upper side view of the connector 3214 shown in

[0410] Figure 27C is Figure 27A a cross-sectional view taken along line 27C-27C as indicated in Figure 27B of the connector 3214 shown in

[0411] Figure 28A is Figure 17A a partial side view of the connector 3214 shown in , where certain dimensions are marked.

[0412] Figure 28B is Figure 27A a partial side view of the connector 3214 shown in , where certain dimensions are marked.

[0413] Figure 29 is Figure 7A a cross-sectional view of the tube end 3314 of the gas delivery tube 3350 of the patient interface 3000 shown in

[0414] Figure 30A is a front perspective view of the gasket module 3150 according to another example of the present technology.

[0415] Figure 30B is Figure 30A a rear perspective view of the gasket module 3150 of

[0416] Figure 30C is Figure 30A a front outer perspective view of the gasket module 3150 of

[0417] Figure 30D is Figure 30A a side perspective view of the gasket module 3150 of

[0418] Figure 30E is Figure 30A a bottom perspective view of the gasket module 3150 of

[0419] Figure 31AFront side perspective view illustration of the gasket module 3150 according to another example of the present technology.

[0420] Figure 31B is Figure 31A Rear side perspective view illustration of the gasket module 3150.

[0421] Figure 31C is Figure 31A Lateral side perspective view illustration of the gasket module 3150.

[0422] Figure 31D is Figure 31A Bottom side view illustration of the gasket module 3150.

[0423] Figure 32A Front side view illustration of the gasket module 3150 according to another example of the present technology.

[0424] Figure 32B is Figure 32A Front bottom side view illustration of the gasket module 3150.

[0425] Figure 32C is Figure 32A Bottom side view illustration of the gasket module 3150 in an undeformed state.

[0426] Figure 32D is Figure 32A Bottom side view illustration of the gasket module 3150 in a deformed state.

[0427] Figure 33A Front side view illustration of the connector 3214 according to another example of the present technology.

[0428] Figure 33B is Figure 33A Rear side view illustration of the connector 3214 shown in. 5 Specific embodiments

[0429] Before describing the technology of the present invention in further detail, it should be understood that the technology of the present invention is not limited to the specific examples described herein, and the specific examples described herein can be changed. It should also be understood that the terms used in this disclosure are only for the purpose of describing the specific examples described herein and are not intended to be limiting.

[0430] The following description is provided in relation to various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. Additionally, in any one example, any single feature or combination of features can constitute a further example.

[0431] 5.1 Treatment

[0432] In one form, as Figure 1A shown, the technology includes a method for treating a respiratory disorder, the method including the step of applying positive pressure to the entrance of the airway of a patient 1000.

[0433] In certain instances of the technology, a supply of pressurized air is provided to the nasal passages of the patient via one or both nostrils.

[0434] In certain instances of the technology, mouth breathing is limited, restricted or prevented.

[0435] 5.2 Treatment System

[0436] In one form, the technology includes a device or apparatus for treating a respiratory disorder. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000. Figure 1A , 1B and 1C illustrate a treatment system in which the patient interface 3000 is used with an RPT device 4000 and a humidifier 5000.

[0437] 5.3 Patient Interface

[0438] Referring to Figure 3A , a non-invasive patient interface 3000 according to one aspect of the technology includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilization structure 3300, a vent 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3700. In some forms, one functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0439] As Figure 7A - 7G shown, a non-invasive patient interface 3000 according to one aspect of the technology includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilization structure 3300, a vent 3400, a connection port 3600 in one form for connection to an air circuit (e.g., Figure 1A - 1C the air circuit 4170 shown in Figure 7A - 7G ). In this form of the technology, the functional aspects of the inflation chamber 3200 and the seal-forming structure 3100 are provided by one physical component. In the Figure 8A - 8Gis shown separately in Figure 7A - 7G the gasket module 3150 of the patient interface 3000. In this example, the seal-forming structure 3100 and other walls of the gasket module 3150 form an inflation chamber 3200. In this form of the technology, the positioning and stabilization structure 3300 is provided by and includes a plurality of physical components.

[0440] The gasket module 3150 can be modular in the sense that it can be replaced in the patient interface 3000 by another gasket module 3150. In some examples, a first gasket module 3150 of the patient interface can be capable of being replaced by a second gasket module 3150, the second gasket module 3150 being a different type of gasket module from the first gasket module 3150. For example, the second gasket module 3150 can have a different size, shape, and / or structure from the first gasket module. In a particular example, the patient interface 3000 having the Figure 8A - 8H gasket module 3150 shown in can be disassembled and reassembled such that the patient interface includes, for example, [[ID= one of the gasket modules 3150 shown in, 25A-25I, 26A-26I, 30A-30E, 31A-31D, or 32A-32D.

[0441] In other forms of the technology, the inflation chamber 3200 and the seal-forming structure 3100 can be inseparable from the components of the positioning and stabilization structure 3300. For example, the gasket module 3150 that fully or partially forms the inflation chamber 3200 can be permanently attached to one or more other components of the patient interface 3000. The gasket module 3150 in this example of the technology can be modular in the sense of being a sub-part of a larger assembly.

[0442] In some examples of the technology, the components that form the inflation chamber 3200 and / or the seal-forming structure 3100 can be permanently attached to one or more headband conduits. In some examples, the patient interface 3000 can include a non-removable gasket module 3150 that is located near the entrance of the patient's airway in use, that forms the inflation chamber 3200 and includes the seal-forming structure 3100. The gasket module 3150 can be permanently attached to one or more gas delivery tubes configured to be placed against the patient's head in use and to deliver an air stream from a location on top of the patient's head to the inflation chamber 3200 for the patient to breathe. The non-removable gasket module 3150 can have a shape and size similar to that of the ​ (or ​ 、 25A-25I, 26A-26I, 30A-30E, 31A-31D, or 32A-32D) shown and described herein removable gasket module 3150, but can be permanently connected to one or more gas delivery tubes.

[0443] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may not be suitable for use in respiratory pressure therapy.

[0444] A patient interface 3000 according to one form of the present technology is configured and arranged to be able to supply air at a positive pressure of at least 6 cmH2O relative to the environment.

[0445] A patient interface 3000 according to one form of the present technology is configured and arranged to be able to supply air at a positive pressure of at least 10 cmH2O relative to the environment.

[0446] A patient interface 3000 according to one form of the present technology is configured and arranged to be able to supply air at a positive pressure of at least 20 cmH2O relative to the environment.

[0447] 5.3.1 Inflatable chamber

[0448] A patient interface 3000 according to some examples of the present technology includes an inflatable chamber 3200 that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure. The inflatable chamber 3200 can receive an air stream at that treatment pressure for the patient to breathe.

[0449] In some forms of the present technology, the inflatable chamber 3200 is at least partially provided by a gasket module 3150 of the patient interface 3000. The gasket module 3150 according to some examples (such as ​ those shown in 8A-8H, 16A-16D, 25A-25I, 26A-26I, 30A-30E, 31A-31D, 32A-32D) can include a chassis portion 3210 and a seal-forming structure 3100. The inflatable chamber 3200 can be at least partially formed by both the chassis portion 3210 and the seal-forming structure 3100. The chassis portion 3210 can support the seal-forming structure 3100 in a proper position against the patient's face during use. The walls of the chassis portion 3210 and the seal-forming structure 3100 can together partially enclose a space volume in which air is pressurized to be higher than atmospheric pressure during use, thereby forming the inflatable chamber 3200.

[0450] In particular, the chassis portion 3210 can at least partially form an inflatable chamber 3200, which can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure. The chassis portion 3210 can include one or more laterally protruding connection portions 3212 that are configured to connect to a gas delivery tube 3350 and are sized and structured to receive an air flow at the therapeutic pressure for a patient to breathe. These laterally protruding connection portions 3212 can also partially form the inflatable chamber 3200 together with other parts of the cushion module 3150. A seal-forming structure 3100 can be provided on the chassis portion 3210 and can at least partially form the inflatable chamber 3200. The seal-forming structure 3100 can be permanently or removably connected to the chassis portion 3210. The seal-forming structure 3100 can be supported by the chassis portion 3210.

[0451] In some forms, the inflatable chamber 3200 is formed from a single-piece homogeneous material. In some forms, the inflatable chamber 3200 can be formed from a homogeneous material that mates with a connector formed from another material.

[0452] In some instances, the cushion module 3150 can be formed from a single-piece homogeneous material. In some forms, the cushion module 3150 can be formed from a homogeneous material that mates with a connector formed from another material.

[0453] In additional instances, the chassis portion 3210 can be formed from a single-piece homogeneous material. In some forms, the chassis portion 3210 can be formed from a homogeneous material that mates with a connector formed from another material.

[0454] In certain forms of the present technology, such as in ​ the patient interface 3000, the inflatable chamber 3200 does not cover the patient's eyes in use. In other words, when the patient wears the patient interface 3000, their eyes are outside the pressurized volume defined by the inflatable chamber. Such forms are less obtrusive and / or more comfortable for the wearer, which can improve compliance with the treatment.

[0455] In certain forms of the present technology, the cushion module 3150 is made of at least partially transparent materials, such as silicone, thermoplastic elastomer, transparent polycarbonate, etc. For example, in ​ instances 19A - 19F, 25A - 25I, 26A - 26I, 30A - 30E, 31A - 31D, and 32A - 32D, most of the cushion module 3150 is formed of silicone. In particular, in these instances, both the chassis portion 3210 and the seal-forming structure 3100 are formed of silicone. In Figures 16A - 16DIn the illustrated example, the chassis portion 3210 and the front side portion of the seal forming structure 3100 are formed of silicone. Compared with opaque materials, using transparent materials can reduce the obtrusiveness of the patient interface, making the patient feel more comfortable when wearing the patient interface 3000, thus helping to improve compliance with the treatment. Using transparent materials can also help clinicians observe how the patient interface is positioned and functions.

[0456] In certain forms of the present technology, the inflation chamber 3200 is made of a translucent material. Using a translucent material can reduce the obtrusiveness of the patient interface 3000 and help improve compliance with the treatment.

[0457] In some forms of the present technology, the patient interface 3000 does not include a frame formed of a rigid or substantially rigid material (such as polycarbonate, etc.). In some instances, the patient interface 3000 does not include a rigid frame that is positioned in front of the patient's face during use.

[0458] In Figures 7A - 7G In the exemplary forms of the present technology shown in FIGS. 8A-8H, 19A-19F, 25A-25I, 26A-26I, 30A-30E, 31A-31D, and 32A-32D, the gasket module 3150 includes a chassis portion 3210 and a seal forming structure 3100. The chassis portion 3210 can be flexible and can be formed of a flexible material. The seal forming structure 3100 can be formed of a flexible material. In these instances, the chassis portion 3210 and the seal forming structure 3100 are integrally formed and can be formed of a flexible material. The chassis portion 3210 can be formed of an elastomeric material such as silicone. The seal forming structure 3100 can be formed of the elastomeric material. The chassis portion 3210 and the seal forming structure 3100 can include a single piece. In these instances, the chassis portion 3210 and the seal forming structure 3100 are molded together as a single component formed of an elastomeric material such as silicone. The seal forming structure 3100 and the chassis portion 3210 (or at least most of the chassis portion 3210) can be formed together (e.g., constructed, molded, etc.) of a single sheet of homogeneous flexible material such as an elastomeric material (e.g., silicone). The chassis portion 3210 and the seal forming structure 3100 can be a monolithic structure. In some instances, the chassis portion 3210 and the seal forming structure 3100 are molded together in a single molding step (e.g., single shot molding). In other instances, the front side portion of the chassis portion 3210 and the seal forming structure 3100 can be molded together as a single first portion, and then the rear side portion of the seal forming structure 3100 is connected (e.g., overmolded or glued) to the single first portion.

[0459] The wall thickness of the chassis part 3210 can be in the range of 0.7 mm to 5 mm. In some examples, the wall thickness of most of the chassis part can be, for example, in the range of 0.7 mm to 1.5 mm, such as 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. In Figures 9A - 9H In the examples shown in 16A - 16D, 19A - 19F, 25A - 25I, 26A - 26I, most of the chassis part 3210, including the laterally protruding connecting part 3212 (described later), can have a wall thickness of 1.25 mm. In another example, such as the example shown in FIGS. 31A - 31D, most of the chassis part 3210 has a wall thickness of 0.9 mm.

[0460] It is also described below that the chassis part 3210 can include an upper chassis reinforcement part 3220, which can have a greater thickness than most of the other parts of the chassis part 3210 (for example, 1.7 mm as described below with reference to Figures 19A - 19F In addition, the chassis part 3210 can include a lower chassis reinforcement part 3221, which can have a greater thickness than the other parts of the chassis part 3210 (for example, 3 mm as described below with reference to Figures 30A - 30E and FIGS. 31A - 31D). In addition, as described in more detail below, the chassis part 3210 can include a front hole 3215 and a lip 3230, and the lip has a greater thickness than most of the other parts of the chassis part 3210 (for example, 4 mm as described below).

[0461] In another example of a method for manufacturing the gasket module 3150, the rear side part of the seal - forming structure 3100 can be manufactured, and then the chassis part 3210 and the front side part of the seal - forming structure 3100 can be overmolded onto the rear side part of the seal - forming structure. The rear side of the seal - forming structure 3100 can include a textile material and, in some forms, can include a laminated material formed by one or more textile layers and one or more non - woven layers. Figures 16A - 16D A gasket module 3150 manufactured by such a method is shown.

[0462] In other examples of this technology, the seal - forming structure 3100 can be removably connected to the chassis part 3210. The seal - forming structure 3100 can be connected to the chassis part 3210 by a soft - to - soft, soft - to - hard or hard - to - hard connection.

[0463] The chassis part 3210, as in Figures 7A - 7G and in Figures 8A - 8HShown separately, including a pair of laterally projecting connection portions 3212. Each laterally projecting connection portion 3212 includes an inlet configured to receive an air flow into the interior of the cushion module 3150.

[0464] In this example, the cushion module 3150 includes a pair of connectors 3214 configured to connect to a gas delivery tube 3350 of the positioning and stabilizing structure 3300. In this example, the connectors 3214 are disposed on either lateral side of the chassis portion 3210. In this example, each connector 3214 is disposed on a corresponding laterally projecting connection portion 3212 of the chassis portion 3210. In this example, the connectors 3214 are disposed at the inlets of the laterally projecting connection portions 3212. Figures 7A - 7G Shown is the gas delivery tube 3350 connected to the laterally projecting connection portion 3212. The laterally projecting connection portion 3212 will be described in more detail below.

[0465] The flexible nature of the chassis portion 3210 allows the cushion module 3150 to deform to fit a wide range of patients. Compared to a cushion module 3150 with a rigid chassis portion, this flexible chassis portion 3210 can enable the cushion module 3150 to fit a wider range of patients. For example, the cushion module 3150 can be able to expand outward to a degree suitable for a patient with a relatively wide nose, while allowing the sides to wrap inward to a degree suitable for a patient with a relatively narrow nose. Although the chassis portion 3210 of the cushion module 3150 is flexible to provide these advantageous effects, having a certain level of rigidity in the chassis portion 3210 is advantageous for providing stability and support to the seal-forming structure 3100. Thus, in some examples, a rigid member is provided in the chassis portion 3210 to make it more rigid (while still being flexible). In some examples, the chassis portion 3210 and the seal-forming structure 3100 are formed of a flexible material (e.g., silicone, TPE, etc.) and the chassis portion 3210 includes a rigid member. In particular, the patient interface 3000 or the cushion module 3150 may include a rigid member. The rigid member may be disposed in the chassis portion 3210. The rigid member may be configured to rigidify the chassis portion 3210. The rigid member may be configured to resist deformation of the chassis portion 3210. The rigid member may be configured to provide support to the chassis portion 3210.

[0466] In some instances, the rigid member is a member having a stiffness greater than the stiffness of the chassis portion 3210 of the inflatable chamber 3200. The rigid member may be formed of a material different from that of the chassis portion 3210. The rigid member may be formed of a material that is harder and / or more rigid than the material forming the chassis portion 3210. The rigid member may be substantially rigid. The rigid member may be rigid enough such that it cannot be deformed by finger pressure alone. For example, the rigid member may be formed of polycarbonate, polypropylene, or nylon. In some instances, the rigid member may be adhered to the chassis portion 3210. In certain instances, the rigid member may be overmolded onto the chassis portion 3210 or the chassis portion 3210 may be overmolded onto the rigid member. The rigid member may be removable from the chassis portion 3210. The rigid member may be disposed on one or more sides of the chassis portion 3210. In some instances, the rigid member is disposed on the underside of the chassis portion 3210. In other instances, the rigid member is disposed on the front side of the chassis portion 3210. In certain instances, the rigid member is disposed outside the inflatable chamber 3200. In other instances, the rigid member is disposed inside the inflatable chamber 3200. In some instances, the rigid member partially defines the inflatable chamber 3200.

[0467] For example, as Figures 7A - 7G shown in FIGS. 30A - 30E, 31A - 31D, and 32A - 32D, the gasket module 3150 includes a vent 3400. In these instances, the chassis portion 3210 includes a rigid member in the form of a vent module 3410, i.e., the vent module serves to add rigidity to the gasket module 3150. The vent module 3410 includes the vent 3400. The vent 3400 may be provided by a plurality of vent holes. The rigidified vent module 3410 is disposed on the front side of the chassis portion 3210. In other instances, it may be disposed on the underside of the chassis portion 3210. In some instances, the gasket module 3150 may include two vent modules 3410 that are laterally spaced apart on the front side of the chassis portion 3210 or on the underside of the chassis portion 3210.

[0468] As will be described, the chassis portion 3210 and the seal-forming structure 3100, or more generally the gasket module 3150, may include multiple regions, with one or more regions having a greater stiffness than another region. Generally, a portion of the gasket module 3150 having a greater stiffness relative to another portion of the gasket module 3150 can be provided by one or more of a greater material thickness, a harder material (e.g., a greater Young's modulus), the presence of a rigid member, and providing greater stiffness. Unless the context otherwise requires, in the case where a first portion of the gasket module 3150 is described as having a greater stiffness than a second portion, each of the ways of hardening a portion as described above should be understood to be disclosed as an option for how to strengthen the first portion relative to the second portion. Additionally, the forms of the technology can combine any one or more of the above ways to make the first portion thicker than the second portion.

[0469] Unless the context otherwise clearly requires, a reference to the stiffness of a component or a part / region thereof should be understood to be a reference to the stiffness of the structure, including the influence of the stiffness of both the material forming the component or its part and the shape (including thickness) of the component or its part. However, unless the context otherwise clearly requires, a reference to the stiffness of a material, a material having stiffness, etc. should be understood to be a reference to stiffness as a material property independent of shape / size (e.g., Young's modulus, etc.).

[0470] 5.3.1.1 Front Hole

[0471] As Figures 8A - 8H shown in, for example, FIGS. 19A - 19F, 25A - 25I, and 26A - 26I, in these examples, the chassis portion 3210 includes a front hole 3215 configured to receive a rigid member (the rigid member is not shown in Figures 8A - 8H ). As Figures 7A - 7G shown in, for example, FIGS. 30A - 30E, 31A - 31D, and 32A - 32D, the vent module 3410, which serves as the rigid member, is received in the front hole 3215 of the chassis portion 3210.

[0472] See Figures 8A - 8H and Figure 1A, the front hole 3215 is centered in the chassis portion 3210. In use, the front hole 3215 is centered on the sagittal plane of the patient. In this example, the front hole 3215 is in a partially forward and partially downward position within the chassis portion 3210 during use. In use, the front hole 3215 can be aligned with the upper lip of the patient in the superior-posterior axis. The front hole 3215 can be located in front of the upper lip of the patient. The front hole 3215 can be located above the vermilion of the lower lip and / or the vermilion of the upper lip. In this example, the front hole 3215 is located on the side of the chassis portion 3210 opposite to the seal-forming structure. In this example, the upper peripheral side of the front hole 3215 is near the central portion of the front side portion of the seal-forming structure 3100. See Figures 9A - 9H , 19A - 19F, 25A - 25I, and 26A - 26I, the upper peripheral side of the front hole 3215 can be adjacent to the central front side portion 3115 of the seal-forming structure 3100. The lower peripheral side of the front hole 3215 can be adjacent to the upper lip portion 3116 of the seal-forming structure 3100. The central front side portion 3115 and the upper lip portion 3116 will be described in more detail below.

[0473] In some examples, such as Figures 8A - 8H the example shown in, the front hole 3215 opens in a partially forward and partially downward direction during use (although the front hole 3215 includes a vent module 3410 during use). The upper peripheral side of the front hole 3215 can be spaced forward from the lower peripheral side of the front hole 3215. In use, the front hole 3215 can open forward and downward at an angle between 25 degrees and 65 degrees relative to a horizontal plane (such as the Frankfurt horizontal plane). In some examples, this angle can be between 35 degrees and 55 degrees, or between 40 degrees and 50 degrees. In some specific examples, the front hole 3215 can open downward and forward at an angle of 45 degrees relative to the horizontal plane.

[0474] In some examples, such as Figures 8A - 8H the example shown in, the front hole 3215 is wider in the left-right axis than its height. In this example, the upper peripheral side of the front hole 3215 includes a straight portion, the lower peripheral side of the front hole 3215 includes a straight portion, and the left and right sides of the front hole 3215 are curved. In other examples, one or both of the upper and lower edges of the front hole 3215 can be curved. The front hole 3215 can be oval. In other examples, the front hole 3215 can be oval, circular, rectangular, or square. In some examples, the front hole 3215 can be a substantially rectangular or square hole with rounded corners. In Figures 8A - 8H the example shown in, the perimeter of the front hole 3215 is defined by a planar curve (e.g., a curve lying in a single plane rather than a space curve).

[0475] In some examples, such as Figures 8A - 8H andFigure 11A In the example shown, gasket module 3150 includes a lip 3230. In this example, lip 3230 is part of chassis portion 3210. Vent module 3410 is configured to be coupled to lip 3230. Referring Figures 14A - 14D to FIGS. 14A-14D and 15A-15B, vent module 3410 includes a peripheral channel 3430. In this example, peripheral channel 3430 is disposed around the perimeter of vent module 3410. In this particular example, peripheral channel surrounds the entire perimeter of the vent module. Lip 3230 is configured to be received within peripheral channel 3430 to secure vent module 3410 to inflation chamber 3200. In this example, lip 3230 defines a front aperture 3215. The size of vent module 3410 and the depth of peripheral channel 3430 correspond to the size of front aperture 3215 such that vent module 3410 can fit securely within front aperture 3215.

[0476] In some examples, such as Figures 8A - 8H the examples shown in FIGS. 14A-14D and 15A-15B, vent module 3410 is inserted into the front aperture by a snap-fit connection. When vent module 3410 is pressed into front aperture 3215, lip 3230 deforms until it fits within peripheral channel 3430 of vent module 3410. When vent module 3410 is pressed into front aperture 3215, chassis portion 3210 may also deform. In this example, the size of front aperture 3215 is set such that when vent module 3410 is received within chassis portion 3210, chassis portion 3210 is substantially undeformed. Front aperture 3215 may have the same size as before vent module 3410 is inserted. In other examples, front aperture 3215 may stretch slightly after vent module 3410 is inserted and vent module 3410 may be slightly larger than front aperture 3215. This can facilitate a secure fit.

[0477] To remove vent module 3410, a patient or clinician can push or pull vent module 3410 out of front aperture 3215. Chassis portion 3210 can deform to allow removal of vent module 3410 from front aperture 3215. Chassis portion 3210 can be configured to allow a user to peel lip 3230 away from vent module 3410 to allow removal of vent module 3410. Chassis portion 3210 can be capable of being squeezed to assist in removing vent module 3410. In some examples, a patient may be able to squeeze chassis portion 3210 to at least partially release lip 3230 from peripheral channel 3430 of vent module 3410.

[0478] In this example, the cross-sectional profile of the lip 3230 substantially matches the available space within the cross-sectional profile of the outer peripheral channel 3430 to facilitate a secure fit. The shape of the lip 3230 is complementary to the shape of the outer peripheral channel 3430.

[0479] In this example of the present technology, the lip 3230 is thicker than the adjacent part of the chassis portion 3210 of the inflatable chamber 3200. For example, the lip 3230 can be the thickest part of the chassis portion 3210. The lip 3230 can also be the thickest part 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 within 3.5 - 4.5 mm. In the illustrated example, the thickness of the lip 3230 is substantially 4 mm.

[0480] The lip 3230 can be thick to form a secure connection with the vent module 3410. Additionally, the lip 3230 can be thick to provide stiffness to the chassis portion 3210. The thick lip 3230 can advantageously increase the resistance of the cushion module 3150 to torsion. The cushion module 3150 can receive torsional forces, especially during side sleeping or when the patient moves while sleeping, for example if they roll over. The increased stiffness provided by the thickness of the lip 3230 provides resistance to excessive deformation due to torsional forces or other forces that may interfere with the seal formation between the sealing structure 3100 and the patient's face. Thus, in this example, the cushion module 3150 includes a reinforcing portion on its front side. This reinforcing portion resists torsion.

[0481] In the illustrated example of the present technology, the lip 3230 is a thick part of the cushion module 3150. In this example, the lip 3230 is integrally formed with the remaining part of the chassis portion 3210 of the cushion module 3150. They are formed of a homogeneous material. The chassis portion 3210 and its lip 3230 can be molded together. The lip 3230 can be formed of an elastomeric material (such as silicone, TPE, etc.) together with the other parts of the chassis portion 3210 in the same molding process.

[0482] In other examples, the lip 3230 can be formed separately from one or more other parts of the chassis portion 3210. In some examples, the lip 3230 is formed of a material different from the remaining part of the chassis portion 3210, that is, the lip 3230 is formed of a first material while the remaining part of the chassis portion 3210 can be formed of a second material. In some examples, the lip 3230 is overmolded onto the remaining part of the chassis portion 3210. In other examples, the chassis portion 3210 is overmolded onto the lip 3230.

[0483] In some examples, portions of the chassis portion 3210 other than the lip 3230 are formed of a first silicone material, while the lip 3230 is formed of a second silicone material. The second silicone material may have one or more properties different from those of the first silicone material. The stiffness of the second silicone material may be greater than the stiffness of the first silicone material. The gauge hardness of the second silicone material may be greater than the gauge hardness of the first silicone material.

[0484] In some examples, the chassis portion 3210 other than the lip 3230 is formed of an elastomeric material (such as silicone, TPE, etc.), and the lip 3230 is formed of a more rigid material (such as polycarbonate, polypropylene, nylon, etc.).

[0485] In some examples, the chassis portion 3210 includes concave features around the front hole 3215, such as grooves, peripheral channels, etc., which are configured to receive complementary convex features of the vent module 3410, such as lips, flanges, etc. In some examples, the vent module 3410 includes a flange around its perimeter, which is configured to be received within a complementary channel around the perimeter of the front hole 3215 of the gasket module 3150.

[0486] In other forms of the present technology, the chassis portion 3210 of the gasket module 3150 may include a stiffening portion (in addition to stiffening the vent module 3410) in the form of a thickened portion spaced apart from the front hole 3215. In one example, the chassis portion 3210 may include a stiffening portion spanning the front side portion of the gasket module 3150. In other examples, the chassis portion 3210 may include a stiffening member. The stiffening member may be formed of a material having a greater stiffness than the material forming the chassis portion 3210 (such as silicone). 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, snap-fitted onto the chassis portion 3210, or otherwise secured to the front side portion of the chassis portion 3210.

[0487] It is advantageous to have sufficient resistance to excessive deformation (especially caused by torsion). However, some independence between the sides of the gasket module 3150 is advantageous for providing a decoupling effect in which the gasket module 3150 can withstand a force received on one lateral side without transferring the force to the other lateral side. As described above, the chassis portion 3210 may be formed of a flexible material to partially decouple one lateral side portion of the gasket module 3150 from the other lateral side. For example, the chassis portion 3210 may at least partially decouple the movement of one of the laterally protruding connection portions 3212 from the other of the laterally protruding connection portions 3212.

[0488] 5.3.1.2 Vent Module Positioning Features

[0489] The gasket module 3150 may include one or more features configured to facilitate the positioning of the vent module 3410 and prevent misalignment thereof. In particular, the gasket module 3150 may include one or more positioning features 3216 that are constructed and / or arranged such that the correct orientation of the vent module 3410 is apparent to the user. The chassis portion 3210 may include the positioning features 3216. The chassis portion 3210 may include one or more positioning features 3216 that engage or mate with corresponding features of the vent module 3410.

[0490] In some instances, such as Figures 8A - 8H the instance shown in, the chassis portion 3210 includes two positioning features 3216. One positioning feature 3216 is disposed on the lateral side of the front hole 3215, and the other positioning feature 3216 is disposed on the lower side of the front hole 3215. In this instance, the positioning features 3216 are protrusions that are shaped to fit within corresponding shaped recesses of the vent module 3410. In other instances, the gasket module 3150 may include a positioning feature 3216 located on the upper side of the front hole 3215. In other instances, the gasket module 3150 may include only one positioning feature 3216, or may include three or more positioning features 3216.

[0491] One or more positioning features 3216 may prevent the vent module 3410 from being incorrectly inserted into the front hole 3215. One or more positioning features 3216 may prevent the vent module 3410 from being inserted in an incorrect orientation (e.g., upside down or backwards). For example, the positioning features 3216 may be positioned asymmetrically with respect to the front hole 3215.

[0492] In Figures 8A - 8H the instance shown in, the shapes of the front hole 3215 and the vent module 3410 are at least partially asymmetric to discourage the user's ability to misalign the vent module 3410. Since the height of the shapes of the front hole 3215 and the vent module 3410 is greater than the width, the vent module 3410 can only be inserted horizontally into the front hole 3215. In some instances, the front hole 3215 may be asymmetric about at least one axis, and in some instances, the front hole 3215 is asymmetric about multiple axes. In some instances, the front hole 3215 is asymmetric such that the vent module 3410 can only be mated to the front hole 3215 in one direction.

[0493] In some instances, the gasket module 3150 and / or the vent module 3410 includes a guide for indicating the correct orientation of the vent module 3410, such as mating marks, indentations, or other visual or tactile features for indicating the correct orientation of the vent module 3410.

[0494] 5.3.1.3 Upper Chassis Reinforcement Portion

[0495] In some instances of the present technology, the chassis portion 3210 of the gasket module 3150 includes a pair of upper chassis reinforcement portions 3220. Figures 19A - 19F The gasket module 3150 shown in FIGS. 19A - 19F, 22B, 30A - 30E, 31A - 31D, and 32A - 32D includes the upper chassis reinforcement portion 3220. The upper chassis reinforcement portion 3220 is disposed on the front side of the chassis portion 3210. The upper chassis reinforcement portion 3220 is configured to reinforce the chassis portion 3210. The upper chassis reinforcement portion 3220 and its features described with reference to FIGS. 19A - 19F, 22B, 30A - 30E, 31A - 31D, and 32A - 32D can be applied to the chassis portion 3210 shown and described with reference to FIGS. 8A - 8H, 16A - 16D, 25A - 25I, and 26A - 26I, or to the chassis portion 3210 of other instances of the present technology.

[0496] Each upper chassis reinforcement portion 3220 is disposed on the corresponding lateral front side of the chassis portion 3210. Each upper chassis reinforcement portion 3220 can be spaced inwardly from the distal end of the corresponding laterally protruding connecting portion 3212. For example, each upper chassis reinforcement portion 3220 can be spaced inwardly from a corresponding one of the laterally protruding connecting portions 3212. Each upper chassis reinforcement portion 3220 can have a lateral boundary spaced from the distal end of a corresponding one of the laterally protruding connecting portions 3212.

[0497] As described above, the chassis portion 3210 can be formed of a flexible material, which can be an elastomeric material. The upper chassis reinforcement portion 3220 can be formed of the flexible material forming the chassis portion 3210. The seal forming structure 3100 can also be formed of a flexible material. The upper chassis reinforcement portion 3220 can be integrally formed with the chassis portion 3210. For example, the upper chassis reinforcement portion 3220 can be molded together with an adjacent portion of the chassis portion 3210 in a single molding step. The upper chassis reinforcement portion 3220 can partially define the inflation chamber 3200 together with other portions of the chassis portion 3210.

[0498] In the illustrated example, the upper chassis reinforcement portions 3220 are each disposed at an upper position on the chassis portion 3210, for example generally above the front holes 3215. Each upper chassis reinforcement portion 3220 may be stiffer than one or more adjacent portions of the chassis portion 3210. The upper chassis reinforcement portions 3220 may provide greater stiffness, with a wall thickness greater than that of one or more adjacent portions of the chassis portion 3210. In some examples, the wall thickness of the upper chassis reinforcement portions 3220 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 2.3 mm. In the examples shown in Figures 19A - 19F 、22B and 31A - 31D, the upper chassis reinforcement portions 3220 have a wall thickness of 1.7 mm. In Figures 30A - 30E the example shown in, the upper chassis reinforcement portions 3220 have a wall thickness of 2.1 mm.

[0499] The upper chassis reinforcement portions 3220 can help increase the stability of the cushion module 3150 and the seal it makes with the patient's face during dynamic movement (e.g., when the patient is asleep or moving in bed). When the seal - forming structure 3100 contacts a patient's face having a contour slightly different from the seal - forming surface of the seal - forming structure 3100, the upper chassis reinforcement portions 3220 can also provide greater resistance to excessive opening of the seal - forming structure 3100. In examples of the present technology where the chassis portion 3210 is flexible, due to the additional flexible characteristics of the chassis portion 3210, such opening can result in the formation of a leakage path at the location where the seal - forming structure 3100 loses contact with the patient's face. The upper chassis reinforcement portions 3220 can also provide additional torsional resistance. The upper chassis reinforcement portions 3220 can prevent one side of the cushion module 3150 from twisting away from or relative to the other side of the cushion module 3150, which may result in loss of contact with the patient's nose and the formation of a leakage path.

[0500] As Figures 19A - 19F 、30A - 30E, 31A - 31D and 32A - 32D shown, the upper chassis reinforcement portions 3220 are each disposed at an upper position on the lateral side of the front holes 3215. Each upper chassis reinforcement portion 3220 is located adjacent to the corresponding upper - side corner of the front holes 3215. A portion of each upper chassis reinforcement portion 3220 may be located on the front - side surface of the corresponding laterally - protruding connecting portion 3212.

[0501] Each upper chassis reinforcement portion 3220 may be located on the chassis portion 3210, adjacent to the seal forming structure 3100 and in front of the seal forming structure 3100. The upper chassis reinforcement portion 3220 may share a boundary with the seal forming structure 3100. Each upper chassis reinforcement portion 3220 may include an upper boundary that abuts a portion of the lower boundary of the front side portion of the seal forming structure 3100. As Figure 19E 、 19F 、as shown in 30A and 31A, each upper chassis reinforcement portion 3220 may have a curved upper surface that matches the curvature of the lower boundary of the seal forming structure 3100. Each upper chassis reinforcement portion 3220 may have a curved lower surface that matches the curvature of the front hole 3215. As Figure 19E and 19F shown, in one example, the laterally outward side of each upper chassis reinforcement portion 3220 may include a sharp shape toward the laterally outward direction.

[0502] In some examples, each upper chassis reinforcement portion 3220 may extend laterally outward to the lateral portions of each connecting portion 3212 of the chassis portion 3210, as illustrated by example in Figures 30A - 30E . In this example, each upper chassis reinforcement portion 3220 extends from the front hole 3215 in the chassis portion 3210 along the corresponding laterally projecting connecting portion 3212 to the upper ridge 3213. The upper ridge 3213 is described in more detail below. Each upper chassis reinforcement portion 3220 may be disposed in use on the portion of the chassis portion 3210 facing the front side. In the example shown in Figures 30A - 30E , each upper chassis reinforcement portion 3220 is disposed along the boundary between the chassis portion 3210 and the seal forming structure 3100 on the chassis portion 3210. Each upper chassis reinforcement portion 3220 may be wider at an inner portion of the chassis portion 3210 (e.g., at the front hole 3215 or the vent module 3410) than at the lateral portions of the chassis portion 3210.

[0503] As discussed in more detail below, the seal forming structure 3100 may include intermediate side-to-front side portions 3125, each intermediate side-to-front side portion 3125 being located on a respective lateral side of the central front side portion 3115, as shown in Figures 19A - 19F , 22B, 30A - 30E, and 31A - 31D. The upper chassis reinforcement portions 3220 may each be positioned adjacent to a corresponding one of the intermediate side-to-front side portions 3125 of the seal forming structure 3100. In particular, each upper chassis reinforcement portion 3220 may be located below the corresponding intermediate side-to-front side portion 3125. The upper chassis reinforcement portions 3220 may each be positioned adjacent to and / or below the corresponding lower side portion 3127 of each intermediate side-to-front side portion 3125.

[0504] In some examples of the present technology, each upper chassis reinforcement portion 3220 has the same wall thickness as the lower portion 3127 of the middle side to front side portion 3125 of the seal forming structure 3100.

[0505] In other examples of the present technology, the upper chassis reinforcement portion 3220 may be formed of a rigid member formed of a material harder than the material forming the remainder of the chassis portion 3210.

[0506] 5.3.1.4 Lower Chassis Reinforcement Portion

[0507] In some examples of the present technology, the gasket module 3150 may include a lower chassis reinforcement portion 3221. In addition to or as an alternative to the upper chassis reinforcement portion 3220, the gasket module 3150 may include a lower chassis reinforcement portion 3221. In other examples of the present technology, the gasket module 3150 may include neither the upper chassis reinforcement portion 3220 nor the lower chassis reinforcement portion 3221.

[0508] Specifically as Figure 30E and 31D shown, in Figures 30A - 30E and Figures 31A - 31D each chassis portion 3210 of the gasket module 3150 in the examples shown includes a pair of lower chassis reinforcement portions 3221. The lower chassis reinforcement portions 3221 may each be disposed on the lower portion of the chassis portion 3210. In these examples, the lower chassis reinforcement portions 3221 are each positioned adjacent to a corresponding one of the middle side to lower side portions 3122 of the seal forming structure 3100 (described below). The lower chassis reinforcement portions 3221 are disposed on the corresponding lateral sides of the central region on the lower side of the chassis portion 3210.

[0509] Each lower chassis reinforcement portion 3221 may be spaced inwardly from the distal end of the corresponding laterally protruding connection portion 3212. For example, each lower chassis reinforcement portion 3221 may be spaced inwardly from a corresponding one of the laterally protruding connection portions 3212. Each lower chassis reinforcement portion 3221 may have a lateral boundary spaced from the distal end of a corresponding one of the laterally protruding connection portions 3212.

[0510] As described above, the chassis portion 3210 can be formed of a flexible material, which can be an elastomeric material. The lower chassis reinforcement portion 3221 can be formed of the flexible material forming the chassis portion 3210. The lower chassis reinforcement portion 3221 can be integrally formed with the chassis portion 3210. For example, the lower chassis reinforcement portion 3221 can be molded together with an adjacent portion of the chassis portion 3210 in a single molding step. The lower chassis reinforcement portion 3221 can partially define the inflation chamber 3200 together with other portions of the chassis portion 3210.

[0511] The lower chassis reinforcement portion 3221 can be elongated. As Figure 30E and 31D shown, the lower chassis reinforcement portions 3221 each extend laterally along the chassis portion 3210 from an inner position (described in more detail below) near the upper lip portion 3116 of the seal forming structure 3100 to a lateral position near the latero-rearward region 3141 of the seal forming structure 3100. As shown, the lower chassis reinforcement portions 3221 have spaced-apart inner boundaries. The lower chassis reinforcement portion 3221 can be shaped to follow the boundary between the chassis portion 3210 and the seal forming structure.

[0512] The lower chassis reinforcement portions 3221 can each have a greater stiffness than an adjacent portion of the chassis portion 3210. In Figures 30A - 30E the example shown, the lower chassis reinforcement portions 3221 each have a greater thickness than an adjacent portion of the chassis portion 3210. In this example, the greater the thickness, the greater the stiffness. The lower chassis reinforcement portion 3221 can provide advantages similar to those of the upper chassis reinforcement portion 3220. The lower chassis reinforcement portion 3221 can provide stiffness to the chassis portion 3210, thereby helping to convert the headband force into a sealing force.

[0513] In Figures 30A - 30E the example shown, the thickness of each lower chassis reinforcement portion 3221 is 3 mm. In other examples, the thickness can be between 1.5 mm and 4.5 mm. In Figures 31A - 31D the example shown, the thickness of the lower chassis reinforcement portion 3221 is also 3 mm. The thickness of the chassis portion 3210 can vary gradually between the lower chassis reinforcement portion 3221 and an adjacent portion. That is, the chassis portion 3210 of the gasket module 3150 can have a tapered thickness change between each lower chassis reinforcement portion 3221 and one or more adjacent portions. In other examples, the chassis portion 3210 can have a stepped thickness change at the boundary of the lower chassis reinforcement portion 3221.

[0514] 5.3.1.5 Laterally protruding connecting portion

[0515] As described above, the chassis portion 3210 may include a pair of laterally projecting connection portions 3212. Each of the laterally projecting connection portions 3212 may be configured to connect to and receive a gas flow from a respective gas delivery tube 3350. Each laterally projecting connection portion 3212 may include an inlet leading into the interior of the chassis portion 3210.

[0516] In some examples of the present technology, each laterally projecting connection portion 3212 may define an inflation chamber inlet port.

[0517] The angle at which the laterally projecting connection portion 3212 projects advantageously positions the seal forming structure 3100 at an angle that allows the seal forming structure 3100 to form a stable seal with the patient's face without occluding the patient's nose.

[0518] Figure 23 and 24A -24C illustrate the angle of the laterally projecting connection portion 3212 in certain forms of the present technology. The angles and other features of the laterally projecting connection portion 3212 described with reference to Figure 23 and FIGS. 24A - 24C may also apply to the laterally projecting connection portions 3212 of the gasket module 3150 in other examples of the present technology, such as those shown in Figures 16A - 16D 、19A - 19F、25A - 25I、26A - 26I、30A - 30E、31A - 31D and 32A - 32D.

[0519] Figure 24A is a cross - sectional view of the gasket module 3150 taken along the center of the gasket module 3150 as indicated in Figure 23 . Line L is shown in Figure 24A . Line L is a straight line that is tangent to two points on the surface of the seal forming structure 3100 and does not pass through the seal forming structure 3100. That is, if a line is moved towards the center of the patient - contact side of the seal forming structure 3100 until it contacts a point on the patient - contact side of the seal forming structure 3100, and then rotated around that point until it contacts a second point on the patient - contact side, line L will be obtained. In instances of the technology where such a line cannot be drawn in this manner, or where there are multiple possible orientations for such a line, then line L may be a center line drawn generally on the patient - contact side of the seal forming structure 3100 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 protuberance point.

[0520] Figure 24B illustrates line L1, which is a horizontal line perpendicular to line L. In Figure 24BAlso shown is the angle A between line L1 and line LA. Line LA indicates the direction in which the connecting portion 3212 protrudes in the plane of the figure. Thus, angle A is an angle in the plane of the figure, rather than an angle representation in three-dimensional space. Angle A can be considered a "height" angle. Angle A can be considered the angle of the connecting portion 3212 or the connector 3214 towards the upward direction.

[0521] In some examples of the present technology, angle A can be between 10 degrees and 30 degrees, such as 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.

[0522] In other examples of the present technology, angle A can be between 15 degrees and 35 degrees, such as 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.

[0523] Figure 24C Line L2 is shown, which is another horizontal line perpendicular to line L. In Figure 24C Also shown is the angle B between line L2 and line LB. Line LB indicates the direction in which the connecting portion protrudes in the plane of the figure. Thus, angle B is an angle in the plane of the figure, rather than an angle representation in three-dimensional space. Angle B can be considered a "depth" angle. Angle B can be considered the angle of the connecting portion 3212 or the connector 3214 towards the backward direction.

[0524] In some examples of the present technology, angle B can be between 25 degrees and 45 degrees, such as 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.

[0525] In some examples of the present technology, angle B can be between 20 degrees and 40 degrees, such as between 25 degrees and 35 degrees or between 26 degrees and 30 degrees. In one example, angle B is 28 degrees.

[0526] These specific angles can enable the connecting portion 3212 to hold the seal-forming structure 3100 in a fully deployed state when connected to the gas delivery tube 3350 of the positioning and stabilizing structure 3300, such that it does not overly squeeze the patient's nose and cause occlusion of the patient's nasal airway. In examples of the present technology where the chassis portion 3210 is flexible, compared to the case where the chassis portion 3210 is rigid, the seal-forming structure 3100 is more likely to fold inwardly. Thus, the angle of the connecting portion 3212 that holds the seal-forming structure 3100 fully deployed is beneficial for avoiding excessive inward force on the side of the patient's nose.

[0527] Figure 24A The line L shown in can be oriented relative to the Frankfurt horizontal plane of the patient's head during the use of the patient interface 3000 such that a presentation angle of the seal-forming structure 3100 is formed between the line L and the Frankfurt horizontal plane. More specifically, the presentation angle can be the angle between the line L during use and a line located in the sagittal plane of the patient's head while being in the Frankfurt horizontal plane. The presentation angle can be formed between the line L during the use of the patient interface 3000 and a line at the intersection of the Frankfurt horizontal plane and the sagittal plane.

[0528] In some specific instances of the present technology, the presentation angle can be between 20 degrees and 40 degrees, such as between 24 degrees and 36 degrees, within the range of 25 - 32 degrees or within the range of 32 - 38 degrees. In some instances, the seal-forming structure 3100 of the patient interface 3000 can have the presentation angle as defined above within the range of 22 - 30 degrees. In other instances, the seal-forming structure 3100 can have the presentation angle as defined above within the range of 31 - 39 degrees. Figures 24A - 24C The gasket module 3150 shown in can have the presentation angle as defined above within the range of 24 - 29 degrees during use. Figures 30A - 30E The gasket module 3150 shown in can have the presentation angle as defined above within the range of 33 - 38 degrees. Figures 31A - 31D The gasket module 3150 shown in can have a presentation angle within the range of 31 - 35 degrees.

[0529] Figures 30A - 30E The presentation angle of the gasket module 3150 shown in can be larger than Figures 24A - 24C the presentation angle of the gasket module 3150 shown in by 9 degrees. Figures 31A - 31D The presentation angle of the gasket module 3150 shown in can be larger than Figures 24A - 24C the presentation angle of the gasket module 3150 shown in by 6.5 degrees.

[0530] 5.3.1.6 Connector

[0531] Figures 17A - 17E FIG. shows a diagram of a connector 3214 according to an example of the present technology, while Figures 27A - 27C FIG. shows a diagram of a connector 3214 according to another example of the present technology, and Figures 33A - 33B FIG. shows a diagram of a connector 3214 according to yet another example of the present technology. Each connector 3214 described with reference to Figures 17A - 17E FIGS. 27A - 27C and 33A - 33B can be disposed in any of the gasket modules 3150 described herein, such as where reference is made to Figures 8A - 8H, any gasket module 3150 described by 9A-9H, 16A-16D, 19A-19F, 20, 23, 24A-24C, 25A-25I, 26A-26I, 30A-30E, 31A-31D, and 32A-32D. As described above, the connector 3214 can be disposed on the corresponding laterally protruding connection portion 3212 of the chassis portion 3210. In this example, the connector 3214 is disposed at the entrance of the laterally protruding connection portion 3212. The connectors 3214 can each be configured to connect to a corresponding connector on a respective one of the gas delivery tubes 3350. In particular, the connectors 3214 are each configured to connect a respective one of the laterally protruding connection portions 3212 of the chassis portion 3210 to a respective one of the gas delivery tubes 3350.

[0532] In the illustrated example, the connector 3214 is rigid. Although the chassis portion 3210 can advantageously be formed of a flexible material, the connector 3214 can be formed of a rigid material. The rigid connector 3214 can enable a snap-fit connection between the gasket module 3150 and the gas delivery tube 3350. In some examples, the connector 3214 is formed of polypropylene, nylon, polycarbonate, or a similar material.

[0533] As Figures 17A - 17E shown in and 27A-27C, each connector 3214 includes a chassis connection portion 3181. The chassis connection portion 3181 can be the widest portion of the connector 3214. The chassis connection portion 3181 of each connector 3214 can be connected to the corresponding laterally protruding connection portion 3212 of the chassis portion 3210.

[0534] Each connector 3214 can be connected to the chassis portion 3210 by an overmolding process. The overmolding process can involve forming the connector 3214 and then molding the chassis portion 3210 onto the connector 3214. The outward-facing surface 3181a of the chassis connection portion 3181 of each connector 3214 can be bonded to the material forming the chassis portion 3210. In some examples, the outward-facing surface 3181a can be referred to as a bonding surface. In this example, the chassis connection portion 3181 of each connector 3214 is located at the downstream end of the connector 3214. In other examples, the chassis connection portion 3181 can be glued to the chassis portion 3210, or can be mechanically connected, for example, by a press fit, snap fit, etc. Figure 18A A cross-sectional view of the connector 3214 connected to the laterally protruding connection portion 3212 is shown.

[0535] In cross-section, as Figure 17C , 17EAs shown in FIGS. 27B and 27C, the outward-facing surface 3181a of the chassis connection portion 3181 can be substantially straight. In three dimensions such as those shown in Figure 17A and 27A , the chassis connection portion 3181 can be curved around the outer periphery of the connector 3214. The shape of the outward-facing surface 3181a of the chassis connection portion 3181 can correspond to the inward-facing bonding surface of each laterally projecting connection portion 3212 of the chassis portion 3210.

[0536] As Figure 17C , 17E and FIGS. 27B and 27C show, the chassis connection portion 3181 includes an inward-facing surface 3181b (marked in Figure 27C ) that is opposite the outward-facing surface 3181a. The length of the inward-facing surface 3181b can be shorter than that of the outward-facing surface 3181a. The inward-facing surface 3181b can be substantially straight in cross-section and parallel to the length of the connector 3214. The inward-facing surface of the chassis connection portion 3181 can be parallel in cross-section to the outward-facing surface 3181a of the chassis connection portion 3181. The inward-facing surface of the chassis connection portion 3181 can extend around the inner periphery of the chassis connection portion 3181.

[0537] Between the outward-facing surface 3181a and the inward-facing surface 3181b of the chassis connection portion 3181 of each connector 3214 on the downstream side of the connector 3214 (e.g., the side of the connector 3214 that is inside the chassis portion 3210) is a substantially flat downstream end surface. The downstream end surface connects the downstream sides of the outward-facing surface 3181a and the inward-facing surface 3181b of the chassis connection portion 3181.

[0538] Each connector 3214 includes a projecting connector portion 3182. In this form of the technology, the projecting connector portions 3182 extend away from the chassis portion 3210. The projecting connector portions 3182 each extend in the upstream direction. The projecting connector portions 3182 each extend from the chassis connection portion 3181 inwardly relative to the chassis connection portion 3181. In particular, the projecting connector portions 3182 can project away from the chassis connection portion 3181 along the length of the connector 3214. As Figure 17E and 27C show, each projecting connector portion 3182 is positioned adjacent to the inward-facing surface 3181b of the chassis connection portion 3181 of the corresponding one of the connectors 3214.

[0539] Each protruding connector portion 3182 is configured to engage with a corresponding connector provided on the gas delivery tube 3350. In this example of the present technology, the protruding connector portion 3182 engages with a corresponding female connector of the respective gas delivery tube 3350 provided on the patient interface 3000. In the example shown, with particular reference to Figure 17A 、 17E and 27C, the protruding connector portion 3182 of each connector 3214 includes a pair of recesses 3185. The recesses 3185 are configured to receive and hold a corresponding portion of the connector on the gas delivery tube 3350 for snap-fit connection. The connectors on the gas delivery tube 3350 may be those described in International Application No. PCT / AU2019 / 050873, the entire content of which is incorporated herein by reference. The gas delivery tube 3350 may be those described in International Application No. PCT / AU2019 / 050874, the entire content 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.

[0540] The cross-section between the chassis connection portion 3181 and the protruding connector portion 3182 of each connector 3214 is curved, in the examples of the present technology shown in FIGS. 17A - 17E and 27A - 27C. In particular, as Figure 17C 、 17E and the cross-sectional views shown in 27C, the cross-section of the connector 3214 is curved to transition between the chassis connection portion 3181 and the protruding connector portion 3182. This curvature results in a change in the width of the connector 3214. Specifically, the protruding connector portion 3182 is narrower than the chassis connection portion 3181.

[0541] On either side of the chassis connection portion 3181 and the protruding connector portion 3182, there are an outer shoulder 3183 and an inner shoulder 3184. The outer shoulder 3183 is provided on the outward-facing side of the connector 3214. The inner shoulder 3184 is provided on the inward-facing side of the connector 3214.

[0542] The outer shoulder 3183 includes a substantially flat wall 3183a perpendicular to the length of the connector 3214, as Figure 17E and 27CAs shown. The flat wall 3183a of the outer shoulder 3183 can be perpendicular to the outward-facing surface 3181a of the chassis connection portion 3181 and / or the inward-facing surface of the chassis connection portion 3181. The flat wall 3183a of the outer shoulder 3183 can be parallel to the downstream end wall of the chassis connection portion 3181, and the downstream end wall of the chassis connection portion 3181 connects the outward-facing surface 3181a and the inward-facing surface of the chassis connection portion 3181. As Figure 17E and 27C shown, the protruding connector portion 3182 can include an outward-facing wall that is substantially flat and substantially parallel to the outward-facing surface 3181a of the chassis connection portion 3181. The flat wall 3183a of the outer shoulder 3183 can be substantially perpendicular to the outward-facing wall of the protruding connector portion 3182. Between the flat wall 3183a of the outer shoulder 3183 and the outward-facing wall 3183a of the protruding connector portion 3182, in cross-section, is a curved portion of the outer shoulder 3183. In other instances, the transition between the flat wall 3183a and the protruding connector portion 3182 can be a sharp corner.

[0543] The outer shoulder 3183 can be configured to form a seal with the end of the gas delivery tube 3350 in use. Each gas delivery tube 3350 can include a substantially flat surface at its downstream end that is configured to engage and form a seal with the outer shoulder 3183 of the corresponding connector 3214. The outer shoulder 3183 extends around the perimeter of the connector 3214 and can be configured to engage a sealing surface around the perimeter of the corresponding connector of the corresponding gas delivery tube 3350. The flat wall 3183a can be configured to mate with the flat surface of the corresponding gas delivery tube 3350. The recess 3185 can be spaced apart from the outer shoulder 3183 such that when a snap fit is formed between the recess 3185 and the corresponding portion of the connector on the gas delivery tube 3350, the compliant portion of the gas delivery tube 3350 is held tightly against the outer shoulder 3183.

[0544] In some instances, the portion of the protruding connector portion 3182 near the outer shoulder 3183 can also form a seal with the end of the gas delivery tube 3350 in use. In some instances, the gas delivery tube 3350 includes a radially inwardly protruding lip at its end that can form a seal with one or more of the protruding connector portion 3182, the chassis connection portion 3181 (e.g., the flat wall 3183a), and the outer shoulder 3183.

[0545] The gas delivery tube 3350 can also be sealed against multiple portions of the chassis part 3210, such as the ends of the laterally protruding connection part 3212. Advantageously, the chassis part 3210 can be formed of a soft material (such as silicone, TPE, etc.). The gas delivery tube 3350 can also be formed of a soft material (such as silicone, TPE, etc.), thereby forming a soft-to-soft connection between the gas delivery tube 3350 and the chassis part 3210. In other examples, the connection can be a soft-to-hard connection (for example, if the end of the gas delivery tube 3350 is formed of a hard component, or the end of the gas delivery tube 3350 is soft but they are joined to the hard part of the chassis part 3210, such as the hard connector 3214). In a further example, the connection can be a hard-to-hard connection (for example, the ends of the gas delivery tube 3350 are formed of hard components and they are connected to the hard part of the chassis part 3210, such as the hard connector 3214).

[0546] The inner shoulder 3184 includes a easement curve in cross-section. The inner shoulder 3184 includes a easement curved transition between the inward-facing wall of the chassis connection part 3181 and the inward-facing wall of the protruding connector part 3182. The inward-facing wall of the protruding connector part 3182 can be substantially parallel to the inward-facing wall of the chassis connection part 3181. The inward-facing wall of the protruding connector part 3182 can also be parallel to the outward-facing wall of the protruding connector part 3182. The inward-facing wall of the protruding connector part 3182 can be perpendicular to the downstream end surface of the chassis connection part 3181 and / or the flat wall 3183a of the outer shoulder 3183. Each recess 3185 of the protruding connector part 3182 can be recessed with respect to the outward-facing wall of the protruding connector part 3182.

[0547] As Figures 17A - 17E As shown in FIGS. 27A-27C, the connectors 3214 in these examples each include a clamping seat portion 3186 and a pair of clamping arms 3187. In these examples, the protruding connector part 3182 includes a clamping seat portion 3186 and clamping arms 3187.

[0548] The clamping seat portion 3186 is adjacent to the chassis connection part 3181 of the connector 3214. The clamping seat portion 3186 can extend from the inner periphery of the chassis connection part 3181, as Figure 27CAs shown. The clip seat portion 3186 may include a cross-sectional shape similar to but smaller than that of the chassis connection portion 3181, such that there is a step in the outer surface of the connector 3214 and at the boundary between the clip seat portion 3186 and the chassis connection portion 3181. The chassis connection portion 3181 and the clip seat portion 3186 may surround a hole through the connector 3214 through which breathable gas passes during use. For example, when viewed in a cross-section along the central axis passing through the interior of the connector 3214, the chassis connection portion 3181 and the clip seat portion 3186 may each be formed in a generally D shape.

[0549] The protruding connector portion 3182 may include a pair of clip arms 3187 protruding away from the clip seat portion 3186. In contrast to the clip seat portion 3186, each clip arm 3187 may only partially surround a hole through the connector 3214 through which breathable gas passes during use. In Figures 17A - 17E the examples shown in FIGS. 27A - 27C, each clip arm 3187 includes a recess 3185 configured to receive a clip protrusion 3304 (described below) of the tube end connector 3302 of the gas delivery tube 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 corresponding recess 3185 configured to receive the corresponding clip protrusion 3304.

[0550] Figure 29 is shown Figures 7A - 7G the tube end 3314 of the gas delivery tube 3350 of the patient interface 3000 shown in FIGS. Figures 17A - 17E The connector 3214 shown in FIGS. 27A - 27C is configured to be connected to the 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 connected to the tube end connector 3302 within the tube end 3314. In Figure 29 the example shown, the tube end connector 3302 is overmolded onto a clip overmolding 3318, and the clip overmolding 3318 itself is overmolded within the tube end 3314. In other examples, the clip is directly overmolded onto the flexible material forming the gas delivery tube 3350 at the tube end 3314.

[0551] When a snap - fit connection is formed between the connector 3214 and a corresponding pipe - end connector 3302 disposed on a pipe end 3314 of the gas delivery pipe 3350, the clamping arms 3187 in these examples deform to allow the clamping protrusion 3304 of the pipe - end connector 3302 to slide on the outward - facing surface of the clamping arms 3187 and then fit into the recess 3185 to form a snap - fit connection. To facilitate the snap - fit connection, the clamping arms 3187 can each bend inwardly towards the central axis of the connector 3214. In some examples of the present technology, the pipe - end connector 3302 can also deform during the process of snap - fitting to the connector 3214. The pipe end 3314 also includes a lip 3324 to form a seal with the connector 3214. The lip 3324 can seal to one or more of the protruding connector portion 3182, the outer shoulder 3183, the flat wall 3183a of the outer shoulder 3183, and the connecting portion 3212 of the chassis portion 3210.

[0552] Figure 28A Shows Figures 17A - 17E A partial side view of the connector 3214 shown in, with some dimensions marked. Figure 28B Shows Figures 27A - 27C A partial side view of the connector 3214 shown in, with some dimensions marked.

[0553] When the recess 3185 in the connector 3214 receives the clamping protrusion 3304 when the pipe end 3314 is connected to the connector 3214, the position of the recess 3185 in the connector 3214 corresponds to the position of the clamping protrusion 3304 of the pipe - end connector 3302. The distance C1 marked in Figure 28A is the distance between the recess 3185 and the Figures 17A - 17E chassis connection portion 3181 in the connector 3214 shown in. The distance C2 marked in Figure 28B is the distance between the recess 3185 and the Figures 27A - 27C chassis connection portion 3181 in the connector 3214 shown in. The distances C1 and C2 can be substantially equal to each other and can be substantially equal to the distance between the clamping protrusion 3304 and the end wall of the pipe end 3314. Thus, when the clamping protrusion 3304 fits into the Figure 28A recess 3185 of the connector 3214 shown in or 28B, the outermost end of the pipe wall 3314 abuts against the chassis connection portion 3181 of the connector 3214 or the connecting portion 3212 of the chassis portion 3210.

[0554] Referring to Figure 28A, the distance C1 between the recess 3185 and the chassis connection portion 3181 is divided into two marked distances CB1 and CA1. The distance CB1 is the length of the socket portion 3186 along the length of the connector 3214, and the distance CA1 is the length of the clamping arm 3187 between the socket portion 3186 and the recess 3185.

[0555] Reference Figure 28B , the distance C2 between the recess 3185 and the chassis connection portion 3181 is divided into two marked distances CB2 and CA2. The distance CB2 is the length of the socket portion 3186 along the length of the connector 3214, and the distance CA2 is the length of the clamping arm 3187 between the socket portion 3186 and the recess 3185.

[0556] The applicant has found that, without changing the spacing between the recess 3185 and the chassis connection portion 3181 (e.g., distances C1 and C2), the lengths of the socket portion 3186 and the clamping arm 3187 can be customized to achieve a favorable holding force of the connector 3214 when the connector 3214 is connected to the gas delivery tube 3350. In the use of the patient interface 3000, the gas delivery tube 3350 holds the gasket module 3150 in a sealed position. Advantageously, the force required to disconnect the gas delivery tube 3350 is high enough such that the gas delivery tube 3350 does not accidentally disconnect, for example, when the patient pulls on the gas delivery tube 3350 to put on or adjust the patient interface 3000 during setup, or when the patient moves while sleeping during use. Additionally, advantageously, the force required to connect and disconnect the gas delivery tube 3350 is not so high that it is difficult for the patient to disassemble and reassemble the patient interface 3000, for example, to clean or replace the gasket module 3150.

[0557] The length of the clamping arm 3187 is a factor in the force required to fully deflect the clamping arm 3187 during a snap - fit connection to the tube end connector 3302. A longer clamping arm 3187 will result in a smaller force being required to be applied to the free end of the clamping arm 3187 to deflect the free end a specific amount. During the connection and disconnection of the gas delivery tube 3350 and the connector 3214, the tube end connector 3302 will apply a force inwardly on each clamping arm 3187 relative to the connector 3214. Each clamping arm 3187 needs to be deflected a specific amount to allow the gas delivery tube 3350 to be connected and disconnected from the connector 3214. Thus, a longer clamping arm 3187 will result in a smaller force being required to connect or disconnect the gas delivery tube 3350 from the connector 3214. Similarly, a shorter clamping arm 3187 will result in a greater force being required to connect or disconnect the gas delivery tube 3350 from the connector 3214.

[0558] Therefore, for a given spacing between the recess 3185 and the chassis connection portion 3181 (e.g., Figure 28AC1 in and Figure 28B C2 in), the length of the clamping seat portion 3186 can be customized (e.g., Figure 28A CB1 in and Figure 28B CB2 in), as well as the length of the clamping arm 3187 between the clamping seat portion 3186 and the recess 3185 (e.g., Figure 28B CB2 in) to achieve the holding force of the connector 3214, which balances the requirement for the connector 3214 to remain connected to the gas delivery tube 3350 during use and the patient's ability to disconnect the connector 3214 from the gas delivery tube 3350 from time to time.

[0559] In one form of the present technology, such as in the connector 3214 shown in Figures 17A - 17E and 28A, the length CB1 of the clamping seat portion 3186 is less than the length CA1 of the clamping arm 3187 between the clamping seat portion 3186 and the recess 3185 along the length of the connector 3214. The applicant has found that the gasket module 3150 including the connector 3214 can be connected to the gas delivery tube 3350 and held in connection with a sufficiently high holding force to provide a sufficiently stable connection during use.

[0560] In another form of the present technology, such as in the connector 3214 shown in Figures 27A - 27C and 28B, the length CB2 of the clamping seat portion 3186 is greater than the length CA2 of the clamping arm 3187 between the clamping seat portion 3186 and the recess 3185 along the length of the connector 3214.

[0561] The applicant has found that the length of the clamping seat portion 3186 along the length of the connector 3214 being equal to or greater than the length of the clamping arm 3187 between the clamping seat portion 3186 and the recess 3185 along the length of the connector 3214 results in a particularly advantageous holding force. The holding force (e.g., the separating force that can be withstood before separation) is high enough such that the likelihood of accidental disconnection during setup or use is low, but not so high that it is too difficult for the patient to intentionally disconnect the gasket module 3150 from the gas delivery tube 3350.

[0562] Therefore, in some instances of the present technology, the length of the clamping seat portion 3186 is greater than the length of the clamping arm 3187 between the clamping seat portion 3186 and the recess 3185. The relationship between the length of the clamping seat portion 3186 and the length of the clamping arm 3187 between the clamping seat portion 3186 and the recess 3185 can also be expressed as a ratio. In some instances, the ratio of the length of the clamping seat portion 3186 to the length of the clamping arm 3187 between the clamping seat portion 3186 and the recess 3185 is equal to or greater than 1.2:1 or 1.3:1. In further instances, the ratio is greater than about 1.5:1, 1.7:1 or 1.9:1. In Figure 28BIn the example shown, the ratio is about 2:1.

[0563] In some examples of the present technology, the force required to disconnect each connector 3214 of the gasket module 3150 from the tube end connector 3302 of the corresponding gas delivery tube 3350 can be greater than 12 N. In further examples, the required force can be greater than 20 N, 25 N, or greater than 30 N. In some examples, the required force is in the range of 12 N - 50 N. In further examples, the required force is in the range of 20 N - 40 N, such as in the range of 20 N - 30 N or in the range of 30 N - 40 N. In some examples, the required force is in the range of 25 N - 35 N. In some examples of the patient interface 3000 according to the present technology, the gasket module 3150 can be separated from the gas delivery tube 3350 of the patient interface 3000 when a force as specified above or within the range specified above is applied, but can include one or more connectors 3214 that are different from Figures 17A - 17E those designs shown in 27A - 27C or 28A - 28B.

[0564] Referring to Figures 33A - 33B , the clamping arm 3187 of the connector 3214 includes a clamping arm corner 3188. Each clamping arm 3187 can include a pair of clamping arm corners 3188 that are located at the distal end of the clamping arm 3187 opposite the chassis connection portion 3181 of the connector 3214. In this example, the clamping arm corners 3188 are rounded. The rounded clamping arm corners 3188 can reduce the stress in the clamping arm corners 3188 during the process of connecting the connector 3214 to the gas delivery tube 3350. Excessive stress in the clamping arm corners 3188 may reduce the service life or reliability of the gasket module 3150. The clamping arm corners 3188 formed in the manner described below can advantageously reduce the risk of the connector 3214 cracking, breaking, or otherwise being damaged or malfunctioning during use.

[0565] Figure 33A A view of the connector 3214 as seen from a first side is shown, where the front side clamping arm 3187 and its clamping arm corners 3188 are visible and marked. The first side can be the front side of the connector 3214 during use. In other examples, the first side can be the rear side of the connector 3214 during use, and the shown clamping arm 3187 can be the rear side clamping arm 3187. Each clamping arm corner 3188 can be formed in an arc shape. The arc can have a transverse dimension CR1 that is orthogonal to the longitudinal axis of the connector 3214 (the longitudinal axis is substantially parallel to the direction of the airflow passing through the connector 3214 during use) and a longitudinal dimension CR2 that is parallel to the longitudinal axis of the connector 3214.

[0566] The transverse dimension CR1 of the arc of the arm corner 3188 of the front side clamping arm 3187 can be in the range of 2 - 5 mm, for example, in the range of 2.5 - 4 mm. In Figure 33A the illustrated example, the dimension CRl is 3 mm. The longitudinal dimension CR2 of the arc of the arm corner 3188 of the front side clamping 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 arm corner 3188 of the front side clamping arm 3187 can be in the range of 2 - 5 mm, for example, in the range of 2.5 - 4 mm. In Figure 33A the illustrated example, the dimension CR2 is 3 mm.

[0567] Figure 33B A view of the connector 3214 as seen from the second side is shown, in which the rear side clamping arm 3187 and its arm corner 3188 are visible and marked. The second side can be the rear side of the connector 3214 in use. In other examples, the second side can be the front side of the connector 3214 in use, and the illustrated clamping arm 3187 can be the front side clamping arm 3187. Each arm corner 3188 can be formed into an arc. The arc can 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.

[0568] The transverse dimension CR3 of the arc of the arm corner 3188 of the rear side clamping arm 3187 can be in the range of 1 - 4 mm, for example, in the range of 1.5 - 3 mm. In Figure 33B the illustrated example, the dimension CR3 is 2 mm. The longitudinal dimension CR4 of the arc of the arm corner 3188 of the rear side clamping 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 arm corner 3188 of the rear side clamping arm 3187 can be in the range of 2 - 5 mm, for example, in the range of 2.5 - 4 mm. In Figure 33B the illustrated example, the dimension CR4 is 3 mm.

[0569] 5.3.1.7 Connection between the connector and the laterally protruding connecting part

[0570] Figure 18A A cross-sectional view through the chassis portion 3210 is shown to illustrate the connection of the connector 3214 to the laterally protruding connecting part 3212. As shown, the end of the laterally protruding connecting part 3212 is bonded to the chassis connecting part 3181 of the connector 3214. The protruding connector part 3182 protrudes outwardly away from the laterally protruding connecting part 3212.

[0571] AsFigure 18A As shown, each laterally protruding connecting portion 3212 may include an upper portion that protrudes when viewed from the upper side direction and a lower portion that is recessed when viewed from the lower side direction. Each laterally protruding connecting portion 3212 may be bent in a direction away from the lower side of the seal forming structure 3100. This is also apparent from Figure 8D and 8H as well.

[0572] As Figure 21 shown, each laterally protruding connecting portion 3212 includes an upper ridge 3213. Each upper ridge 3213 may extend transversely across the length of the corresponding laterally protruding connecting portion 3212. Each upper ridge 3213 may extend longitudinally along the length of the corresponding laterally protruding connecting portion 3212. In this example of the present technology, each upper ridge 3213 extends transversely across and longitudinally along a corresponding one of the laterally protruding connecting portions 3212. One end of each upper ridge 3213 may be positioned at a position on the upper front side with respect to the laterally protruding connecting portion 3212. The other end of each upper ridge 3213 may be positioned adjacent to the seal forming structure 3100 located on the upper rear side of the laterally protruding connecting portion 3212, as Figure 21 shown.

[0573] 5.3.2 Positioning and Stabilizing Structure

[0574] The seal forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by a positioning and stabilizing structure 3300 during use. The positioning and stabilizing structure 3300 may include and act as a "headband" 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 entire content of which is incorporated herein by reference.

[0575] In one form, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the effect of the positive pressure in the inflatable chamber 3200 that lifts away from the face.

[0576] In one form, the positioning and stabilizing structure 3300 provides a holding force to overcome the effect of gravity on the patient interface 3000.

[0577] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effect of disturbing forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0578] In one form of the present technology, a positioning and stabilizing structure 3300 is provided, which is configured in a manner that conforms to being worn by a patient during sleep. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0579] In one form of the present technology, a positioning and stabilizing structure 3300 is provided, which is configured to not be so large and bulky that the patient cannot lie flat in a supine position with the back region of the patient's head against a pillow.

[0580] In one form of the present technology, a positioning and stabilizing structure 3300 is provided, which is configured to not be so large and bulky that the patient cannot lie flat in a lateral position with the side region of the patient's head against a pillow.

[0581] In one form of the present technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front portion of the positioning and stabilizing structure 3300 and the rear portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible strap or a loose strap. The decoupling portion is constructed and arranged such that when the patient lies flat with their head against a pillow, the presence of the decoupling portion prevents the force acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disturbing the seal.

[0582] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a terry material to engage with a hook material portion.

[0583] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are extensible, such as elastically extensible. For example, the straps can be configured to be in a tensioned state during use and to direct forces to pull the seal-forming structure into sealing contact with a portion of the patient's face, in some instances, in combination with other straps or other structures. In one example, the straps can be configured as laces.

[0584] Laces will be considered structures designed to resist tension. In use, the laces are part of the positioning and stabilizing structure 3300 that is under tension. As will be described, some laces will exert an elastic force due to this tension. The laces can be used to hold the seal-forming structure 3100 in a therapeutically effective position on the patient's head.

[0585] In one form of the present technology, the positioning and stabilization structure 3300 includes a first strap that is configured and arranged such that in use, at least a portion of its lower edge passes above the supra-auricular reference point of the patient's head and covers a portion of the parietal bone and / or the frontal bone. The first strap may be provided as part of a patient interface that includes, for example, a support cushion, a nasal pillow, a nasal cushion, or a full-face cushion (either a full-face sub-nasal cushion or a full-face cushion that seals to the patient's nose above the nasion).

[0586] In some examples of the present technology, the first strap of the positioning and stabilization structure 3300 includes an upper first strap portion and a lower first strap portion. The upper first strap portion may cover a portion of the parietal bone and / or the frontal bone. The lower first strap portion may cover or be located below the occipital bone of the patient's head. The first strap may be bifurcated. The first strap may bifurcate into an upper first strap portion and a lower first strap portion. The first strap may include a front portion configured to cover one side of the patient's head / face and a bifurcated portion configured to cover the lateral, upper, and / or posterior sides of the patient's head. The front portion may be integrally formed with the upper first strap portion. The lower first strap portion may be connected to the junction between the front portion and the upper first strap portion.

[0587] For example, as Figures 7A - 7G shown, the positioning and stabilization structure 3300 includes a first strap that is connected to the cushion module 3150 and is, in use, located beside the patient's head and on the upper surface and the posterior surface of the patient's head. The first strap bifurcates into an upper first strap portion and a lower first strap portion. The upper first strap portion is provided by the upper side portion of each air tube 3350, and the lower first strap portion is provided by Figure 7A the strap 3310 shown.

[0588] In one form of the present technology, the positioning and stabilization structure 3300 includes a second strap that is configured and arranged such that in use, at least a portion of its upper edge passes below the infra-auricular reference point of the patient's head and covers or is located below the occipital bone of the patient's head. The second strap may pass under the patient's ears. The second strap may be provided as part of a patient interface that includes, for example, a full-face cushion (which may or may not cover the patient's nasion) or a nasal cushion. In other examples, the second strap may be provided as part of a patient interface that includes a support cushion or a nasal pillow cushion. The second strap may, in use, cover the lateral and / or posterior sides of the patient's neck and be connected to the lower side portion of the frame of the positioning and stabilization structure 3300, the lower side portion of the cushion module 3150, or the lower side portion of the inflation chamber 3200.

[0589] In one form of the technology, the positioning and stabilization structure 3300 includes a third strap configured and arranged to interconnect a first strap and a second strap to reduce the tendency of the first strap and the second strap to separate from each other. The third strap may be provided as part of a patient interface that includes a full-face cushion (which may or may not cover the patient's nasion) or a nasal cushion. In other instances, the third strap may be provided as part of a patient interface that includes a support cushion or a nasal pillow cushion.

[0590] In certain forms of the technology, the positioning and stabilization structure 3300 includes a bendable and, for example, non-rigid strap. An advantage of this aspect is that when the patient is sleeping, it is more comfortable for the patient to lie flat while wearing the strap. As Figures 7A - 7G shown, the positioning and stabilization structure 3300 includes a pair of non-rigid gas delivery tubes 3350. Additionally, the positioning and stabilization structure 3300 includes a non-rigid strap 3310.

[0591] As Figures 7A - 7G shown, the positioning and stabilization structure 3300 includes a pair of tabs 3320. In use, the strap 3310 ( Figure 7A as shown therein) may be connected between the tabs 3320. The strap 3310 can be flexible enough to wrap around the back of the patient's head and rest comfortably on the patient's head, even when under tension during use.

[0592] In certain forms of the technology, the positioning and stabilization structure 3300 includes a strap configured to be breathable to allow moisture to transmit through the strap. Figures 7A - 7G The strap 3310 of the positioning and stabilization structure 3300 of the exemplary patient interface 3000 shown is composed of a foam material covered in a fabric material. In other instances, the strap 3310 may be formed of only a foam material, a textile material, or other materials (such as a flexible plastic material).

[0593] In certain forms of the technology, a system is provided that includes more than one positioning and stabilization structure 3300, each positioning and stabilization structure 3300 being configured to provide a holding force corresponding to a different range of sizes and / or shapes. For example, the system may include one form of the positioning and stabilization structure 3300 that is suitable for a large-sized head but not for a small-sized head, while another form of the positioning and stabilization structure is suitable for a small-sized head and not for a large-sized head.

[0594] 5.3.2.1 Headband Tube

[0595] In some forms of the present technology, the positioning and stabilization structure 3300 includes one or more tubes 3350 that deliver pressurized air received from the air circuit 4170 to the inflation chamber 3200 and then to the patient's airway, for example, via the gasket module 3150 and the seal-forming structure 3100. These tubes 3350 can receive a pressurized gas flow from a conduit that forms part of the air circuit 4170. The conduit can be connected to the RPT device 4000.

[0596] In Figures 7A - 7G In the form of the present technology shown, the positioning and stabilization structure 3300 includes two gas delivery tubes 3350 that deliver air from the air circuit 4170 to the inflation chamber 3200. In this example, the tubes 3350 are removably connected to the gasket module 3150. In other examples, the tubes 3350 can be permanently connected to the gasket module 3150 of the patient interface 3000 that at least partially forms the inflation chamber 3200. The tubes 3350 are an integral part of the positioning and stabilization structure 3300 of the patient interface 3000, forming part of a headband to position and stabilize the seal-forming structure 3100 of the patient interface to the appropriate part of the patient's face (e.g., the nose and / or mouth). This allows the conduit of the air circuit 4170 that provides the pressurized air flow to be connected 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 unsightly for some people in front of the patient's face.

[0597] Because air can be contained and pass through the headband tubes 3350 to deliver pressurized air from the air circuit 4170 to the patient's airway, the positioning and stabilization structure 3300 can be described as being inflatable. It should be understood that not all components of the inflatable positioning and stabilization structure 3300 need to be inflatable. For example, in Figures 7A - 7G the example shown, the positioning and stabilization structure 3300 includes inflatable headband tubes 3350 and non-inflatable straps 3310.

[0598] In certain forms of the present technology, the patient interface 3000 can include a connection port 3600 located near the top, side, or rear of the patient's head. For example, in Figures 7A - 7G the form of the present technology shown, the connection port 3600 is located at the top of the patient's head. In this example, the patient interface 3000 includes an elbow 3610, and the connection port 3600 is provided on the elbow 3610. The elbow 3610 can rotate relative to the positioning and stabilization structure 3300 so as to decouple the movement of the conduit connected to the connection port 3600 from the positioning and stabilization structure 3300. The elbow 3610 is configured to be in fluid connection with the conduit of the air circuit 4170.

[0599] A patient interface in which the connection port is not positioned in front of the patient's face may be advantageous because some patients find the tubing connected to a patient interface positioned in front of the face to be unsightly and obtrusive. For example, tubing connected to a patient interface positioned in front of the face may be prone to tangling in sheets or bedding, especially if the tubing extends downward from the patient interface during use. Compared to other types of patient interfaces, the form of the present technology in which the connection port of the patient interface is positioned near the top of the patient's head during use may make it easier or more comfortable for the patient to lie down or sleep in one or more of the following positions: on the side or in a lateral position; in a supine position (i.e., on the back, facing generally upward); and in a prone position (i.e., face down, facing generally downward). Additionally, connecting the tubing to the front side of the patient interface can exacerbate a problem known as tube drag, where the tubing may exert an undesirable drag force on the patient interface, causing it to move away from the face.

[0600] In some instances, at least one tube 3350 spans the patient's cheek region and extends between the inflation chamber 3200 and the connection port 3600 above the patient's ear. A portion of the tube 3350 connected to the cushion module 3150 covers the maxillary region of the patient's head during use, and a portion of the tube 3350 covers the region of the patient's head above the supraauricular reference point on the patient's head. Each of the one or more tubes 3350 may also be located on one or both of the patient's sphenoid and / or temporal bones and the patient's frontal and parietal bones. The elbow tube 3610 may be located on the patient's parietal bone, frontal bone, or the junction therebetween during use.

[0601] In Figures 7A - 7G In the form of the present technology shown, the positioning and stabilization structure 3300 includes two tubes 3350. Each tube 3350 is positioned on a different side of the patient's head during use and extends from the inflation chamber 3200 across the corresponding cheek region, above the corresponding ear (above the supraauricular reference point on the patient's head) to the connection port 3600 on the top of the head of the patient 1000. This form of the technology may be advantageous because if the patient sleeps on their side with their head and one of the tubes is compressed and blocked or partially blocked to flow of gas along the tube, the other tube remains open to supply pressurized gas to the patient. In other instances of the present technology, the patient interface 3000 may include a different number of tubes, such as one tube, or three or more tubes. In one instance 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., across one cheek region), and a strap forms part of the positioning and stabilization structure 3300 and is positioned on the other side of the patient's head during use (e.g., across another region) to help secure the patient interface 3000 to the patient's head.

[0602] In Figures 7A - 7GIn the form of the present technology shown, two tubes 3350 are fluidly connected to each other at their upper ends and fluidly connected to a connection port 3600. In one form, the two tubes are integrally formed, while in other forms, the tubes are separate components that are connected together in use and can be disconnected, for example for cleaning, storage or replacement. In the case of using separate tubes, they can be indirectly connected together, for example each can be connected to an intermediate conduit, such as a T-shaped conduit, which has two conduit arms that can each be fluidly connected to the tube 3350 and a third conduit arm or opening that serves as the connection port 3600 in use and can be connected to the air circuit 4170.

[0603] The tube 3350 can be formed of a semi-rigid material, such as an elastomeric material, such as silicone. The tube 3350 can have a natural, preformed shape and be able to be bent or moved into another shape if a force is applied to the tube. For example, the tube can be generally arcuate or curved, with a shape approximating the contour of a patient's head between the top of the head and the nasal or oral region.

[0604] As described in U.S. Patent No. 6,044,844, the content of which is incorporated herein, if either tube 3350 is flattened during use (e.g., if it is squeezed between the patient's face and a pillow), the tube 3350 can be crush-resistant to prevent breathable gas flow through the tube. Crush-resistant tubes may not be necessary in all cases, as the pressurized gas in the tube can be used as a splint to prevent or at least limit the tube 3350 from being flattened during use. Crush-resistant tubes may be advantageous in the case where there is only a single tube 3350, as if the single tube is blocked during use, the gas flow will be restricted and the treatment will stop or be less effective.

[0605] More features of the positioning and stabilization structure 3300 according to some examples of the present technology are described in U.S. Provisional Patent Application No. 62 / 764,995, the entire content of which is incorporated herein by reference.

[0606] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned at a series of positions across the top of the patient's head, such that the patient interface 3000 can be positioned to be suitable for the comfort or fit of an individual patient. The movement of the upper portion of the patient interface 3000 can be decoupled from the lower portion of the patient interface 3000. This can enable the cushion module 3150 to form an effective seal with the patient's face, regardless of the position of the connection port 3600 on the patient's head. Such decoupling can be achieved using, for example, an arrangement that allows the various parts of the headband tube 3350 to move or bend easily relative to other parts of the patient interface 3000. Examples of such arrangements will be described below.

[0607] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 is generally positioned at the apex of the patient's head in use. The connection port 3600 may be positioned in the sagittal plane and aligned with the supratarsal base point in a plane parallel to the coronal plane.

[0608] As described above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle gasket that is generally positioned below the nose and seals to the lower lateral perimeter of the nose. The positioning and stabilization structure 3300 may be constructed and arranged to pull the seal-forming structure 3100 into the patient's face below the nose with a sealing force vector having a backward and upward direction (e.g., a posterior-superior direction). A sealing force vector having a posterior-superior direction may facilitate the seal-forming structure 3100 to form a good seal both on the lower lateral perimeter of the patient's nose and on the anterior-facing surface of the patient's face on either side of the patient's nose and upper lip.

[0609] 5.3.2.1.1 Headband Tube Fluid Connection

[0610] Two tubes 3350 are fluidly connected to the inflation chamber 3200 at their lower ends.

[0611] Examples of the laterally projecting connection portion of the gasket module 3150 have been described above, and the gas delivery tubes 3350 are connected to such laterally projecting connection portion in a particular form of the present technology. In these forms, the gas delivery tubes 3350 are configured to engage such connection portion of the gasket module 3150.

[0612] In certain forms of the technology, the connection between the tube 3350 and the gasket module 3150 is achieved by the connection of two rigid components such that the patient can easily connect the two components together in a reliable manner. Tactile feedback such as a're-confirmation click' sound may facilitate patient use or facilitate the patient's awareness that the tube has been correctly connected to the gasket module 3150. In one form, the tube 3350 is formed of silicone, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector may include a concave mating feature configured to connect to a convex mating feature on the gasket module 3150. Alternatively, the rigid connector may include a convex mating feature configured to connect to a concave mating feature on the gasket module 3150.

[0613] In another embodiment, a compression seal is used to connect each tube 3350 to the gasket module 3150. For example, an elastomeric flexible (e.g., silicone) tube 3350 without a rigid connector may need to be slightly squeezed to reduce its diameter such that it can be snapped into a port in the gasket module 3150, and the inherent elasticity of the silicone pushes the tube 3350 outward to seal the tube 3350 in an airtight manner within the port. In a hard-to-hard engagement between the tube 3350 and the port, a pressure-actuated seal, such as a peripheral seal flange, can be used. When pressurized gas is supplied through the tube 3350, the seal flange is pushed against the junction between the tube and the inner circumferential surface of the port of the gasket module 3150 to enhance the seal therebetween. If the port is soft and a rigid connector is provided on the tube 3350, the pressure-actuated seal as described above can also be used to ensure that the connection is airtight. In another example, each tube 3350 is formed of an elastomeric flexible (e.g., silicone) material that is overmolded onto a rigid connector such that the elastomeric flexible material mates over the rigid connector and serves as its own gasket to seal the connection between the tube 3350 and the gasket module 3150 around the perimeter of the airflow passage entering the gasket module 3150 from the tube 3350.

[0614] 5.3.2.1.2 Expandable bellows structure

[0615] The patient interface 3000 can include one or more expandable tube segments. In some examples, the expandable tube segments include an expandable bellows structure. The patient interface 3000 can include a positioning and stabilizing structure 3300 that includes at least one gas delivery tube having a wall with an expandable bellows structure. For example, Figures 7A - 7G the patient interface 3000 shown in includes a tube 3350, the upper side portion of the tube 3350 including extendable tube portions each in the form of an expandable bellows structure 3362. In other examples of the present technology, the patient interface 3000 includes a single tube 3350 having an expandable bellows structure 3362. Generally, any feature of the tube 3350 described herein can be applied to the patient interface 3000 having a single tube 3350, or can be applied to each tube 3350 of a patient interface having multiple tubes 3350.

[0616] Each expandable bellows structure 3362 can include a portion of the tube 3350 having one or more folded portions, pleats, corrugations, or bellows to form an extendable portion of the tube 3350. In Figures 7A - 7GIn the illustrated example, the extendable accordion structures 3362 each take the form of an extendable accordion structure. The extendable accordion structures 3362 are separated by the elbow tubes 3610 and the connection ports 3600. The extendable accordion structures 3362 are capable of changing length. In particular, each extendable accordion structure 3362 can be extended or contracted to change the length of the corresponding tube 3350.

[0617] 5.3.2.1.3 Non-extendable headband tubes

[0618] The patient interface 3000 can include one or more non-extendable tube portions 3363. For example, Figures 7A - 7G the illustrated patient interface 3000 includes the tubes 3350. The lower side portion of each tube 3350 includes a non-extendable tube portion 3363. The non-extendable tube portion 3363 is configured to cover the patient's cheek and can be configured to contact the patient's face below the patient's cheekbone. Each non-extendable tube portion 3363 can be located on a curve that extends downward from the connection between the corresponding headband tubes 3350 and then extends forward and partially inward along a portion toward the inflation chamber 3200 to avoid the patient's cheekbone.

[0619] The cross-sectional shape of the non-extendable tube portion 3363 of the tube 3350 can be circular, oval, egg-shaped, D-shaped, or rounded rectangular, for example as described in U.S. Patent No. 6,044,844. A cross-sectional shape presenting a flat surface of the tube on the side facing and contacting the patient's face or other parts of the head can be more comfortable to wear than, for example, a tube having a circular cross-section.

[0620] In some examples of the present technology, the non-extendable tube portion 3363 is connected to the inflation chamber 3200 at a low angle. The headband tube 3350 can extend downward to the side of the patient's head and then bend forward and inward to connect to the inflation chamber 3200 in front of the patient's face. Before connecting to the inflation chamber 3200, the tube 3350 can extend to a position at the same vertical position as the connection portion of the inflation chamber 3200, or in some examples, a position below the connection portion of the inflation chamber 3200. That is, the tube 3350 can project in at least a partially upward direction before connecting to the inflation chamber 3200. A portion of the tube 3350 can be located below the inflation chamber 3200 and / or the seal-forming structure 3100. The low position of the tube 3350 in front of the patient's face facilitates contact with the patient's face below the patient's cheekbone.

[0621] Each non-extendable tube portion 3363 can be permanently or removably connected to the cushion module 3150 of the patient interface that at least partially forms the inflation chamber 3200.

[0622] 5.3.2.2 Headband straps

[0623] In certain forms of the present technology, the positioning and stabilization structure 3300 includes at least one headband strap in addition to the tube 3350 for positioning and stabilizing the seal-forming structure 3100 at the entrance of the patient's airway. As Figure 7A shown, the patient interface 3000 includes a strap 3310 that forms part of the positioning and stabilization structure 3300. For example, the strap 3310 may be referred to as a rear strap or a rear headband strap. In other instances of the present technology, one or more additional straps may be provided. For example, a patient interface 3000 having a full-face or nasal-oral cushion module according to an example of the present technology may have a second lower strap configured to cover the back of the patient's neck.

[0624] In Figure 7A the example shown, the strap 3310 of the positioning and stabilization structure 3300 is connected between two tubes 3350 that are positioned on each side of the patient's head and bypass the back of the patient's head, for example, covering or being located under the occipital bone of the patient's head in use. The strap 3310 is connected to each tube above the patient's ear. In other embodiments, for example, as part of a nasal-oral patient interface, the positioning and stabilization structure 3300 includes an upper strap similar to the strap 3310 and at least one additional lower headband strap that is connected between the tubes and / or cushion module and passes under and bypasses the back of the patient's head below the patient's ears. Such a lower headband strap may also be connected to the upper strap (e.g., similar to the strap 3310).

[0625] 5.3.3 Seal-Forming Structure

[0626] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The area where the actual seal occurs - the actual seal surface - may vary within a given treatment session, from day to day, and between different patients, depending on a range of factors, including, for example, the position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face.

[0627] In one form, the target seal-forming area is located on the outer surface of the seal-forming structure 3100.

[0628] In certain forms of the present technology, the seal-forming structure 3100 is composed of a biocompatible material such as silicone rubber, textile material, or a combination of such materials.

[0629] The seal-forming structure 3100 according to some examples of the present technology may be constructed of a soft, flexible, and elastic material such as silicone.

[0630] The seal-forming structure 3100 according to some examples of the present technology may include a non-patient contact portion and a patient contact portion. In some examples, the seal-forming structure 3100 may include front-facing, side-facing, upward-facing, and / or downward-facing portions that may not contact the patient's face.

[0631] The seal-forming structure 3100 according to further examples of the present technology may be composed of a textile material. In some examples, the front side of the seal-forming structure 3100 may be formed of an elastomeric material, such as silicone of TPE, and the back side may be formed of a textile material.

[0632] In cases where the seal-forming structure 3100 includes a textile or a textile portion, the textile may include a material formed of a fiber network and adapted to be airtight. For example, the textile may have an airtight film on at least one of its surfaces.

[0633] In some forms, the seal-forming structure 3100 is configured to elastically stretch in at least one dimension. For example, when the textile seal-forming structure is constructed of a fiber network, the seal-forming structure may be capable of elongating in either or both the longitudinal warp direction or the transverse weft direction of the textile. In some forms, the textile seal-forming structure 3100 is configured to elastically elongate to a greater extent than can be achieved by a conventional silicone seal-forming structure.

[0634] In some forms, the seal-forming structure 3100 is configured to be substantially inelastic in at least one dimension. For example, when the textile seal-forming structure is constructed of a woven textile, the seal-forming structure may be capable of substantially resisting elongation in either or both the longitudinal warp direction or the transverse weft direction of the textile.

[0635] The seal-forming structure 3100 may be made of a single layer or multiple layers. In forms using multiple layers, each layer may be formed using the same material or a variety of different materials, each having unique material properties.

[0636] In some forms, the textile seal-forming structure 3100 may include at least one layer that exhibits substantially airtight characteristics while maintaining the material properties required for comfort and minimal pressure points. In some forms, the textile seal-forming structure 3100 may include an airtight material formed on the inner surface of the textile material. In some forms, the airtight material may be laminated to the textile material. In some forms, the airtight material and the textile material may be selected such that the resulting textile material can exhibit a predetermined overall elasticity or resistance to elasticity as needed.

[0637] In some forms, the textile seal-forming structure 3100 can exhibit a low spring constant (i.e., high compliance) in both the warp and weft yarns. In this form, unlike in traditional designs where a fixed gasket may distort the skin of the patient's face to form an effective seal, the textile material of the seal-forming structure 3100 can have a material spring constant and spring length such that the textile seal-forming structure 3100 is more compliant than the patient's skin to which the seal-forming structure 3100 engages. This can advantageously improve the comfort of the face mask and reduce the formation of local pressure "hot spots".

[0638] In some forms, the surface of the textile material of the seal-forming structure 3100 that contacts the patient's face can have low friction characteristics. This can advantageously improve the comfort of the surface texture of the textile seal-forming structure 3100 and reduce friction relative to the patient's face. In some forms, textiles with greater friction may cause the seal-forming structure 3100 to clamp or rub the contacted area of the patient's face 1300 during use. The friction or clamping may cause the seal-forming structure to distort or deform, thereby reducing the effectiveness of the seal and allowing air to leak from the device, which is undesirable.

[0639] In some forms, the total thickness of the textile material of the seal-forming structure 3100 is 0.275 mm or less.

[0640] Figures 16A - 16D A gasket module 3150 including the seal-forming structure 3100 is shown, and the seal-forming structure 3100 includes a textile material. In this particular example, the seal-forming structure 3100 includes the textile material in a central portion 3111 of the patient-facing portion (i.e., the rear side) of the seal-forming structure. Other portions of the seal-forming structure 3100, such as the front-facing and upward-facing surfaces, can also be formed of silicone. In other examples, the entire seal-forming structure 3100 can be formed of a textile material. Advantageously, the seal-forming structure 3100 having a textile surface that contacts and seals to the patient's face can have the benefit of enhanced tactile comfort and can also be more stretchable than silicone (e.g., by using a weave pattern selected for stretchability). Additionally, the textile seal-forming structure 3100 or its seal-forming surface can achieve less friction than silicone, which can improve comfort and allow the seal to slidably and sealingly conform to the complex surface of the patient's face. In the seal-forming structure 3100 including both silicone and textile portions, the silicone portion can advantageously serve as an easily moldable support for the textile portion that makes sealing contact with the patient's face.

[0641] Described in more detail below Figures 16A - 16D The illustrated textile seal-forming structure 3100.

[0642] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure configured to correspond to a different range of sizes and / or shapes. For example, the system can include one form of seal-forming structure 3100 that is suitable for a large-sized head but not for a small-sized head, and another that is suitable for a small-sized head but not for a large-sized head.

[0643] 5.3.3.1 Sealing mechanism

[0644] In one form, the seal-forming structure 3100 includes a seal flange that utilizes a pressure-assisted sealing mechanism. In use, the seal flange can readily respond to the positive pressure within the system inside the inflatable chamber 3200 acting on its underside, thereby forming a tight sealing engagement with the face. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0645] In one form, the seal-forming structure 3100 includes a seal flange and a support flange. The seal flange includes a relatively thin member having a thickness less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, that extends around the perimeter of the inflatable chamber 3200. The support flange can be relatively thicker than the seal flange. The support flange is disposed between the seal flange and the marginal edge of the inflatable chamber 3200 and extends around at least a portion of the path of the perimeter. The support flange is or includes a spring-like element and acts to support the seal flange against bending in use.

[0646] In one form, the seal-forming structure can include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged to be in a compressed state, for example, due to the elastic tension in the positioning and stabilizing structure.

[0647] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is held in tension, for example, by adjacent regions of the seal flange.

[0648] In one form, the seal-forming structure includes regions having a sticky or adhesive surface and / or a higher coefficient of friction compared to other surfaces.

[0649] In certain forms of the present technology, the seal-forming structure can include one or more of a pressure-assisted seal flange, a compression seal portion, a gasket seal portion, a tensioning portion, and a portion having a sticky or adhesive surface.

[0650] In some forms of the present technology, the seal-forming structure 3100 can include low-friction surfaces in one or more regions. The low-friction surfaces can enable the seal-forming structure 3100 to slide on the patient's skin to fit onto a surface of the patient's face that includes complex geometries, such as near the nasolabial folds and depressions that typically exist at the location where the patient's nasal wings meet the patient's face.

[0651] 5.3.3.2 Nasal bridge or nasal ridge region

[0652] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the nasal bridge region or nasal ridge region of the patient's face during use.

[0653] In one form, the seal-forming structure includes a saddle-shaped region that is configured to form a seal on the nasal bridge region or nasal ridge region of the patient's face during use.

[0654] 5.3.3.3 Upper lip region

[0655] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0656] In one form, the seal-forming structure includes a saddle-shaped region that is configured to form a seal on the upper lip region of the patient's face during use.

[0657] 5.3.3.4 Chin region

[0658] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the chin region of the patient's face during use.

[0659] In one form, the seal-forming structure includes a saddle-shaped region that is configured to form a seal on the chin region of the patient's face during use.

[0660] 5.3.3.5 Nasal pillows

[0661] In one form, the seal-forming structure 3100 of the non-invasive patient interface 3000 includes a pair of nasal nozzles or nasal pillows, each of which is constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0662] A nasal pillow according to one aspect of the technology includes: a frustum of a cone that forms a seal on at least a portion of the underside of a patient's nose; a stem; and a flexible region located at the underside of the frustum of the cone that connects the frustum of the cone to the stem. Additionally, the structure connected to the nasal pillow of the technology includes a flexible region adjacent to the base of the stem. The flexible regions can cooperate to facilitate a gimbal structure that can accommodate relative movement of both displacement and angle between the frustum of the cone and the structure connected to the nasal pillow. For example, the frustum of the cone can be axially moved towards the structure connected to the stem.

[0663] 5.3.3.6 Nasal Cushion

[0664] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region (i.e., the upper lip), the nasal bridge region, and the cheek regions of the patient's face during use. This is the case for the patient interface 3000 shown, for example. Figure 1B The seal-forming portion delivers an air or breathable gas supply to the two nostrils of the patient 1000 through a single orifice. Such a seal-forming structure can be referred to as a "nasal cushion" or a "nasal mask". In some instances of the technology, Figures 7A - 7G the positioning and stabilization structure 3300 shown can be used to hold the nasal cushion in a sealed position on the patient's face.

[0665] 5.3.3.7 Full-Face Mask Cushion

[0666] In one form, the patient interface 3000 includes a seal-forming portion that forms a seal on the chin region, the cheek regions, and the nasal bridge region or the region below the nose of the patient's face during use. This is the case for the patient interface 3000 shown, for example. Figure 1C The seal-forming portion delivers an air or breathable gas supply to the nostrils and mouth of the patient 1000 through a single orifice or through separate orifices. Such a seal-forming structure can be referred to as a "full-face mask" or an "ultra-compact full-face mask". In some instances of the technology, Figures 7A - 7G the positioning and stabilization structure 3300 shown can be used to hold the full-face cushion in a sealed position on the patient's face. Portions of the seal-forming structure 3100 described below can be incorporated into the full-face mask cushion or into a chassis for supporting the full-face mask.

[0667] 5.3.3.8 Nasal Support

[0668] In one form of the technology, for example as Figures 7A - 7GAs shown, the seal-forming structure 3100 of the patient interface 3000 is configured to form a seal with the underside of the nose around the nostrils 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. Such a seal-forming structure may be referred to as a "propping", "nasal propping gasket", "sub-nasal gasket" or "sub-nasal liner". The shape of the seal-forming structure 3100 may be configured to match or closely follow the underside of the patient's nose. In one form of nasal propping gasket, the seal-forming structure 3100 includes a bridge portion defining two apertures, each of which supplies air or breathable gas to a different one of the patient's nostrils in use. The bridge portion may be configured to contact or abut against the columella of the patient's nose to form a seal in use. In some forms of the technology, the seal-forming structure 3100 is configured to form a seal on the underside of the patient's nose without contacting the bridge region of the patient's nose.

[0669] In certain forms of the technology, the seal-forming structure 3100 includes a central portion configured to form a seal to the underside surface of the patient's nose. The central portion may seal to the perimeter of the underside of the patient's nose (e.g., around the patient's nostrils and to the patient's lips). In an example, the seal-forming structure 3100 may be configured to contact the patient's face below the bridge of the nose or below the nasal tip.

[0670] The seal-forming structure 3100 may be configured not to enter the patient's nostrils in use. For example, the seal-forming structure 3100 may seal to the patient's face without entering the patient's nostrils. The seal-forming structure 3100 may be configured to form a seal with the area of the patient's face surrounding the patient's nostrils without entering the patient's nostrils. In some examples, the seal-forming structure 3100 is configured to form a seal around the patient's nostrils and columella. The seal-forming structure 3100 may form a single continuous seal around both nostrils.

[0671] The seal-forming structure 3100 may be configured to seal to the anterior surface and / or underside surface of the patient's nasal tip in use. The seal-forming structure 3100 may seal against the lateral surface and / or underside surface of the patient's nasal ala in use. The seal-forming structure 3100 may be configured to seal any one or more of the sub-nasal point of the patient's nasal septum, the underside surface of the patient's nose between the patient's nostrils and upper lip, and / or the patient's upper lip.

[0672] In some examples, the seal-forming structure 3100 is configured to leave the patient's nasal tip uncovered in use. The seal-forming structure 3100 may be configured to leave the patient's nasal bridge uncovered in use. In some forms, the seal-forming structure 3100 may not seal to the lateral cartilages of the patient's nose (at Figure 2HThe surface of any patient's face above the (identified in Figure 2H ). In another form, the seal-forming structure 3100 may not be sealed to the major alar cartilages of the patient's nose (above the

[0673] Figures 8A - 8H The cushion module 3150 is shown separately, Figures 9A - 9H The cushion module 3150 with certain parts identified is shown. Figures 19A - 19F 25A - 25I, 26A - 26I, 30A - 30E, 31A - 31D, and 32A - 32D show cushion modules 3150 according to further examples of the present technology. The connector 3214 is not shown in Figures 9A - 9H or 19A - 19F. The features of the cushion module 3150 according to these and other examples of the present technology are described below.

[0674] 5.3.3.8.1 Central Portion

[0675] The seal-forming structure 3100 includes a central portion 3111 configured to seal to the patient's face at the lower side portion of the patient's nose in use. In some examples of the present technology, the central portion 3111 is configured to seal at least against the patient's nasal tip, alae nasi, and upper lip in use. The central portion 3111 may be configured to seal around the patient's nostrils and against the patient's upper lip to the lower side perimeter of the patient's nose. The central portion 3111 is disposed at 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 Examples of the seal-forming structure 3100 having the central portion 3111 and other parts are shown in 11A, 11B, 19A - 19F, 25A - 25I, 26A - 26I, 30A - 30E, 31A - 31D, and 32A - 32D.

[0676] Most of the contact with the patient's nose may be made by the central portion 3111. Some contact may also be formed by the intermediate lateral portions 3121 described below. In some examples, most of the seal to the lower side perimeter of the patient's nose formed by the seal-forming structure 3100 may be formed by the central portion 3111.

[0677] It should be understood that the actual amount of contact of the seal-forming structure 3100 with the patient's face will depend on the specific implementation of the present technology and the anatomy of the specific patient, etc., such as, for example, the way the patient sets up the patient interface.

[0678] The gasket module 3150 includes two holes 3272 that are configured to allow an airflow under treatment pressure to be delivered to the patient's nostrils. The holes 3272 are identified in Figures 8D - 8F Each hole 3272 is aligned with a corresponding nostril of the patient in use. In some instances, the gasket module 3150 may include a single hole 3272 that is configured to allow an airflow to be delivered to both nostrils of the patient. The holes 3272 are formed in the seal-forming structure 3100 of the gasket module 3150. In some instances, the holes 3272 are formed in the central portion 3111 of the seal-forming structure 3100.

[0679] In some instances, the central portion 3111 may include a wall thickness between 0.15 mm and 0.4 mm. In some instances, the wall thickness of the central portion 3111 may be between 0.2 mm and 0.35 mm. In some instances, the wall thickness of the central portion 3111 may be substantially 0.25 mm.

[0680] 5.3.3.8.1.1 Upper Lip Portion

[0681] In one form, the patient interface 3000 includes a seal-forming structure 3100 that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face in use. In one form, the seal-forming structure 3100 includes a saddle-shaped region that is configured to form a seal on the upper lip region of the patient's face in use.

[0682] In Figures 9A - 9H the instances shown in, 19A-19F, 25A-25I, 26A-26I, 30A-30E, 31A-31D, and 32A-32D, the seal-forming structure 3100 further includes an upper lip portion 3116. The upper lip portion 3116 may be disposed within the central portion 3111 and may contact the lower surface of the patient's nose and the patient's upper lip.

[0683] In some instances, the upper lip portion 3116 has the same stiffness as the remainder of the central portion 3111. Figures 9A - 9H The gasket module 3150 shown includes a seal-forming structure 3100 in which the upper lip portion 3116 and the other parts of the central portion 3111 have substantially the same stiffness.

[0684] The central portion 3111 and its upper lip portion 3116 may have a lower stiffness than most or all of the other portions of the seal-forming structure 3100. In some examples of the present technology, the lower stiffness is achieved by having a smaller wall thickness than the other portions of the seal-forming structure 3100. The nasal tip, the lower surface of the patient's nose, and the upper lip may have complex geometries and may also be very sensitive to pressure. Thus, it is advantageous that the regions of the inflatable chamber 3200 that will contact or abut to seal these locations are flexible and compliant to avoid applying excessive pressure to the face at these regions.

[0685] The low stiffness of certain portions of the seal-forming structure 3100 (which can be achieved by a small wall thickness) enables the seal-forming structure 3100 to deform easily to seal against the surface on the lower side of the patient's nose, e.g., against the nasal tip in the anterior direction, the alae on either lateral side, and the upper lip.

[0686] In some examples of the present technology, the central portion 3111 may have a greater stiffness in the upper lip portion 3116 than in other regions of the central portion 3111. For example, the upper lip portion 3116 may be stiffer than the portion of the central portion 3111 surrounding the aperture 3272. Figures 25A - 25I A gasket module 3150 is shown having an upper lip portion 3116 that is stiffer than other portions of the central portion 3111. The greater stiffness can be achieved by a greater wall thickness.

[0687] Figures 25A - 25I The gasket module 3150 shown is wider than Figures 9A - 9H the gasket module 3150 shown. And as Figures 9A - 9H shown, the upper lip portion 3116 of the gasket module 3150 has the same wall thickness as the adjacent portion of the central portion 3111. As Figures 25A - 25I shown, the wall thickness of the upper lip portion 3116 of the gasket module 3150 is greater than the wall thickness of the adjacent portion of the central portion 3111. Because Figures 25A - 25I the gasket module 3150 shown and its upper lip portion 3116 are wider than other gasket modules 3150, the upper lip portion 3116 may be more prone to buckling or wrinkling due to its increased width. The additional thickness in the upper lip portion 3116 of the gasket module 3150 can reduce the buckling susceptibility and can result in good stability in use.

[0688] 5.3.3.8.1.2 Anterior and posterior portions of the upper lip portion

[0689] In some examples of the present technology, such as Figures 19A - 19F the examples shown in and 22A, and Figures 25A - 25I, in the examples shown in 26A - 26I, 30A - 30E, and 31A - 31D, the upper lip portion 3116 includes a front portion 3133 and a rear portion 3134. The front portion 3133 is positioned adjacent to the chassis portion 3210 and may be located behind the chassis portion 3210 or at least behind the central portion of the chassis portion 3210, since the chassis portion 3210 bends rearward in a rearward direction on either lateral side of the chassis portion 3210. The rear portion 3134 is configured to seal against the patient's upper lip during use.

[0690] The stiffness of the front portion 3133 of the upper lip portion 3116 may be greater than the stiffness of the rear portion 3134 of the upper lip portion 3116. In Figures 19A - 19F , in the examples shown in 22A, 25A - 26I, 26A - 26I, 30A - 30E, and 31A - 31D, the greater stiffness is achieved by a greater wall thickness of the seal - forming structure 3100. In these examples, the thickness of the front portion 3133 of the upper lip portion 3116 may be greater than the thickness of the rear portion 3134 of the upper lip portion 3116. In other examples of the present technology, the gasket module 3150 may include a rigid member disposed on the front portion 3133 of the upper lip portion 3116 to increase the stiffness. The rigid member may be a portion formed of a material harder than other portions of the seal - forming structure 3100 and may be overmolded onto the front portion 3133.

[0691] The thickness of the rear portion 3134 of the upper lip portion 3116 may be the same as the thickness of one or more portions of the central portion 3111 adjacent to the upper lip portion 3116. In Figures 19A - 19F and the examples shown in 26A - 26I, the thickness of the rear portion 3134 is the same as the thickness of the remaining portion of the central portion 3111.

[0692] In other examples, the thickness of the rear portion 3134 of the upper lip portion 3116 may be greater than the thickness of one or more portions of the central portion 3111 adjacent to the upper lip portion 3116. In the examples shown in 25A - 25I, the thickness of the rear portion 3134 is greater than other portions of the central portion 3111.

[0693] The thickness of the rear portion 3134 of the upper lip portion 3116 may be in the range of 0.1 mm to 1 mm, such as between 0.2 mm - 0.8 mm, 0.3 mm - 0.7 mm, 0.4 mm - 0.6 mm, 0.15 mm - 0.35 mm, or 0.2 mm - 0.3 mm. In a particular example, the thickness of the rear portion 3134 may be 0.25 mm or 0.5 mm. In Figures 19A - 19F , in the examples shown in 26A - 26I, 30A - 30E, and 31A - 31D, the rear portion 3134 has a thickness of 0.25 mm. InFigures 25A - 25I In the illustrated example, the thickness of the rear side portion 3134 is 0.5 mm.

[0694] The thickness of the front side portion 3133 of the upper lip portion 3116 may be in the range of 0.4 mm - 2 mm, such as between 0.5 mm - 1.6 mm, 0.9 mm - 1.3 mm, or 1.4 mm - 1.6 mm. In a specific example, the thickness of the front side portion 3133 may be 1.5 mm, 1.2 mm, 1.15 mm, or 0.5 mm. In Figures 19A - 19F In the illustrated example, the thickness of the front side portion 3133 of the upper lip portion 3116 is 1.5 mm. In Figures 31A - 31D In the illustrated example, the thickness of the front side portion 3133 is 1.2 mm, in Figures 25A - 25I and in the examples shown in 26A - 26I, the thickness of the front side portion 3133 is 1.15 mm. In Figures 30A - 30E In the illustrated example, the front side portion 3133 of the upper lip portion 3116 is 0.5 mm.

[0695] As described in more detail below, the seal forming structure 3100 may include a pair of laterally rearward regions 3141 on the respective sides of the upper lip portion 3116, rearward. In Figures 19A - 19F and in the example shown in 22A, the thickness of the rear side portion 3134 of the upper lip portion 3116 is less than the thickness of the laterally rearward region 3141. In particular, the thickness of the rear side portion 3134 of the upper lip portion 3116 is less than the thickness of both the decoupling portion 3142 and the outer peripheral portion 3143 of each laterally rearward region 3141. The decoupling portion 3142 and the outer peripheral portion 3143 will be described in detail below.

[0696] In Figures 19A - 19F In the illustrated example, the thickness of the front side portion 3133 of the upper lip portion 3116 is substantially the same as the thickness of the laterally rearward region 3141. In particular, the thickness of the front side portion 3133 of the upper lip portion 3116 is substantially the same as the thickness of the outer peripheral portion 3143 of the laterally rearward region 3141. In this example, the thickness of the front side portion 3133 of the upper lip portion 3116 is greater than the thickness of the decoupling portion 3142. The front side portion 3133 of the upper lip portion 3116 may be adjacent to the laterally rearward region 3141.

[0697] In Figures 25A - 25I and in the examples shown in 26A - 26I, the thickness of the front side portion 3133 of the upper lip portion 3116 is substantially the same as the thickness of the laterally rearward region 3141. In particular, the thickness of the front side portion 3133 is substantially the same as the thickness of the rear side portion of each laterally rearward region 3141. The thickness of the front side portion of each laterally rearward region 3141 may be greater than the thickness of the front side portion 3133 of the upper lip portion 3116.

[0698] As Figures 19A - 19F shown in, for example, 22A, 25A - 25I, 26A - 26I, 30A - 30E, and 31A - 31D, the boundary between the front portion 3133 and the rear portion 3134 of the upper lip portion 3116 is curved, wherein the central portion of the curve is more forward than the ends of the lateral portions of the curve. The boundary can be curved to generally correspond to the curvature of the patient's upper lip. The gasket module 3150 can include a junction between the front portion 3133 of the upper lip portion 3116 and the chassis portion 3210. The junction can be curved. The curvature of the junction can have a larger radius of curvature than the boundary between the front portion 3133 and the rear portion 3134 of the upper lip portion 3116. The junction can be part of a longer junction 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 portion 3116 can include a more gentle curve or can be straight.

[0699] The thickness difference between the front portion 3133 and the rear portion 3134 of the upper lip portion 3116 can be created by a sharp or stepped thickness change. The thickness change can be created by a step formed in the material of the seal - forming structure 3100, which step is formed in the inner surface of the seal - forming structure 3100.

[0700] The upper lip portion 3116 having a greater thickness in the front portion 3133 relative to the rear portion 3134 can advantageously provide additional wrinkle resistance to the seal - forming structure 3100, compared to these portions having the same thickness as each other and / or the rest of the central portion 3111. The front portion 3133 can prevent or at least resist wrinkling of the seal - forming structure 3100 near the junction between the seal - forming structure 3100 and the chassis portion 3210. The increased thickness of the front portion 3133 can also strengthen the chassis portion 3210 near the upper lip portion 3116 and can improve the dynamic seal at the upper lip (e.g., improve the stability of the seal formed with the patient's upper lip during patient head movement).

[0701] 5.3.3.8.1.3 Central saddle portion

[0702] In this example, the central portion 3111 abuts 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 can be positioned near and below the patient's nasion.

[0703] In Figures 9A - 9H and Figures 19A - 19FIn the illustrated example, the seal-forming structure 3100 has a central saddle portion 3112 which, in addition to the central portion 3111, can also seal the anterior or lower regions of the patient's nasal prominence point. In this example, the central saddle portion 3112 or a part thereof has a low stiffness that is the same as or similar to that of the central portion 3111 and the central anterior portion 3115. The central saddle portion 3112 connects the central portion 3111 to the central anterior portion 3115. In Figures 25A - 25I and the examples shown in 26A-26I, the seal-forming structure 3100 can also have a central saddle portion 3112 (shown in Figure 25A and 26A ). The central saddle portion 3112 in these examples has a smaller curvature than the central saddle portion 3112 of the seal-forming structure 3100 shown in Figures 9A - 9H and Figures 19A - 19F . In these examples, the central portion 3111 or the central saddle portion 3112 can be sealed to the lower and / or anterior surfaces of the patient's nasal prominence point.

[0704] The central portion 3111 of the seal-forming structure 3100 can be configured to be inflated to conform to the lower surface and perimeter of the patient's nose. The thin wall of the seal-forming structure 3100 in the upward-facing central portion 3111 is advantageous in creating a good seal against the complex geometry under and around the nose. This thin wall can deform and inflate under the pressure of breathable gas from the inflation chamber 3200 to conform to the surface of the patient's face to create an effective and still comfortable seal.

[0705] While maintaining a small wall thickness in the areas configured to contact the sensitive nasal prominence point and upper lip region has the advantage of comfort, in the examples of this technology, the wall thickness in these areas is not reduced to the extent that the seal-forming structure 3100 can no longer maintain a stable seal against the patient's face. If the wall thickness in these areas is too small, the seal-forming structure 3100 may be prone to wrinkling, which can disrupt the seal and create leak paths through which air can flow into the surrounding environment between the patient's face and the cushion.

[0706] 5.3.3.8.1.4 Central anterior portion

[0707] In some examples of this technology, the central anterior portion 3115 includes an upper portion 3114 and a lower portion 3113, as shown in Figures 19A - 19F and 22A-22B.

[0708] The central front portion 3115 is on the front side of the seal-forming structure 3100, and the front side of the seal-forming structure 3100 can be the non-patient contact side. It is positioned adjacent to and below the patient's nasion during use. The central front portion 3115 can be at least partially forward-facing. For example, the central front portion 3115 can include at least a partially forward-facing surface. At least a majority of the central front portion 3115 is on the front side of the seal-forming structure 3100. A portion of the central front portion 3115 can be configured not to contact the patient's face during use. The lower portion 3113 of the central front portion 3115 can be configured not to contact the patient's face during use. In some instances, the upper portion 3114 can be configured not to contact the patient's face during use.

[0709] In Figures 19A - 19F the example of the present technology shown in FIGS. 22A - 22B, the lower portion 3113 of the central front portion 3115 has a greater stiffness than 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 can also be referred to as a stiffening portion or a stiffening band. The lower portion 3113 can extend across the front side of the seal-forming structure 3100. The lower portion 3113 can be disposed adjacent to the junction between the seal-forming structure 3100 and the chassis portion 3210.

[0710] Compared to other parts of the seal-forming structure, the central front portion 3115 is a thin and relatively flexible part of the seal-forming structure 3100 in other aspects. For example, in Figures 9A - 9H the example shown in FIGS. 19A - 19F, the central front portion 3115 is one of the thinnest and most flexible parts of the seal-forming structure. Due to being flexible, the central front portion 3115 allows the seal-forming structure 3100 to follow the lower perimeter of the patient's nose. However, due to its high flexibility, the central front portion 3115 may be prone to wrinkling. The lower portion 3113 of the central front portion 3115 is harder than the upper portion 3114 to provide support for the central front portion 3115. The lower portion 3113 of the central front portion 3115 can provide anti-wrinkle property for the central front portion 3115.

[0711] In Figures 19A - 19F the example shown in FIGS. 22A - 22B, the upper portion 3114 of the central front portion 3115 has substantially the same stiffness and wall thickness as the central portion 3111 on the rear side of the seal-forming structure 3100.

[0712] In Figures 19A - 19FIn the examples shown in FIGS. 22A - 22B, the lower portion 3113 of the central front portion 3115 includes a portion of the seal - forming structure 3100 having a wall thickness greater than that of one or more adjacent portions of the seal - forming structure 3100. The lower portion 3113 of the central front portion 3115 may have a wall thickness between 0.3 mm and 1 mm. In some examples, the lower portion 3113 has a wall thickness between 0.4 and 0.7 mm. In Figures 19A - 19F the example shown, the lower portion 3113 has a wall thickness of substantially 0.5 mm. The upper portion 3114 may have a wall thickness between 0.1 mm and 0.5 mm, such as between 0.2 mm and 0.3 mm, or 0.25 mm in the Figures 19A - 19F example shown.

[0713] In other examples of the present technology, the lower portion 3113 of the central front portion 3115 may include a stiffening member, a part of the seal - forming structure formed of a rigid material or other suitable stiffening means.

[0714] As Figure 22A shown, the central front portion 3115 has a stepped thickness change between the lower portion 3113 and the upper portion 3114. In other examples, the central front portion 3115 may have a tapered thickness between the lower portion 3113 and the upper portion 3114.

[0715] More generally, any difference in thickness between two portions of the seal - forming structure 3100 or the chassis portion 3210, exemplified herein by a stepped thickness change, may include a tapered thickness in other examples. Similarly, any difference in thickness exemplified by a tapered thickness may include a stepped thickness change in other examples.

[0716] In some examples of the present technology, the lower portion 3113 having a greater hardness and / or thickness than the upper portion 3114 may be provided in the central front portion 3115 of the gasket module 3150 shown in FIGS. 25A - 25I and 26A - 26I. In Figures 25A - 25I these forms of the gasket modules 3150 shown in FIGS. 26A - 26I, the central front portion 3115 has a substantially uniform thickness.

[0717] 5.3.3.8.2 Intermediate Lateral Portion

[0718] As Figures 9A - 9H, as shown in 19A - 19F, 25A - 25I, 26A - 26I, 30A - 30E, and 31A - 31D, the seal - forming structure 3100 may further include a pair of intermediate lateral portions 3121. The intermediate lateral portions 3121 may be configured to be positioned against or near the alae of the patient's nose in use. The intermediate lateral portions 3121 may be provided at the rear side of the seal - forming structure 3100. Each intermediate lateral portion 3121 may be provided on the respective lateral side of the central portion 3111 and may each be configured to be located beside the respective ala of the patient's nose in use. As Figures 9A - 9H , 19A - 19F, 25A - 25G, 26A - 26G, 30A - 30E, and 31A - 31D, each intermediate lateral portion 3121 may be located between the central portion 3111 and the lateral perimeter of the seal - forming structure 3100.

[0719] In particular, as Figure 9A , 9F and as shown in 19A, each intermediate lateral portion 3121 may have a crescent - shape. Each intermediate lateral portion 3121 includes an inner boundary and a lateral boundary. Each inner boundary may include a three - dimensional curve (e.g., a space curve) that curves in a downward and medial direction at the front side of the cushion module 3150 near the central saddle portion 3112 when viewed from an angle moving generally along the curve forward. Each lateral boundary may also include a three - dimensional curve that curves in a medial direction at the front side of the cushion module 3150 when viewed from an angle moving generally along the curve forward. The intermediate lateral portion 3121 may include a surface curvature to follow the curvature of the lower perimeter of the patient's nose.

[0720] Due to the curvature of the boundaries of the intermediate lateral portion 3121, each intermediate lateral portion 3121 as a whole may include a curved shape that curves in a medial direction at the front side of the seal - forming structure 3100 when viewed from an angle moving generally forward.

[0721] The curves of the intermediate lateral portion 3121 and their boundaries may enable the intermediate lateral portion 3121 to follow the shape of the lower perimeter of the patient's nose. The intermediate lateral portion 3121 may be concave with respect to the patient's nose at the widest part of the patient's nose (e.g., near the alae). When viewed from an angle moving generally in the front - side direction along the curve of the intermediate lateral portion, each intermediate lateral portion 3121 may curve in a downward and / or medial direction near the rear - side corner portion 3131 (described below) and / or the upper - lip portion 3116.

[0722] Each intermediate lateral portion 3121 may extend such that one end is near the upper - lip portion 3116 and the other end is near the foremost part of the central portion 3111. InFigures 9A - 9H and Figures 19A - 19F In the example shown in , one end of each intermediate lateral portion 3121 extends to the central saddle portion 3112. The central saddle portion 3112 may be located between the foremost portions of the intermediate lateral portions. In this example, the foremost portion of each intermediate lateral portion 3121 is sharp. The front joint between the inner boundary and the lateral boundary of each intermediate lateral portion 3121 has a tip shape. The inner boundary and the lateral boundary meet to form a sharp corner. In this example, the front joint of the inner boundary and the outer boundary of each intermediate lateral portion 3121 tapers into a point.

[0723] In this example, the lateral boundary of each intermediate lateral portion is located between the inward-facing side of the seal-forming structure 3100 and the laterally-facing side of the seal-forming structure 3100. The seal-forming structure 3100 may include an upper ridge 3117 (shown in Figures 8A - 8H ) that separates the inward-facing and rearward-facing sides of the seal-forming structure 3100 from the laterally-facing and forward-facing sides. The upper ridge 3117 may include the central saddle portion 3112. The lateral boundary of each intermediate lateral portion 3121 may be positioned close to the upper ridge 3117. The lateral boundary of each intermediate lateral portion 3121 may be positioned close to and inside the upper ridge 3117. Figures 8A - 8H In the examples shown in -

[0724] , the intermediate lateral portion 3121 is generally C-shaped, particularly as shown in Figure 25A and Figure 25G . In these examples, the central front portion 3115 and the central saddle portion 3112 are wider than the examples shown in 26G and Figures 9A - 9H . As shown in FIGS. 25G and 26G, the centr...

Claims

1. A patient interface, characterized in that, The patient interface includes: a chassis portion that partially forms an inflatable chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than ambient air pressure, the chassis portion including a pair of laterally projecting connection portions configured to be connected to a gas delivery tube and sized and configured to receive an air flow at the treatment pressure for the patient to breathe; and a seal-forming structure disposed on the chassis portion and partially forming the inflatable chamber, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet, the seal-forming structure having at least one aperture therein such that the air flow at the treatment pressure is delivered at least to the inlet of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's breathing cycle; a vent that allows gas exhaled by the patient to flow from the interior of the inflatable chamber to the surrounding environment, the vent being sized and shaped to maintain the treatment pressure in the inflatable chamber during use; wherein the seal-forming structure includes: a central portion configured to seal against at least the patient's nasal bridge point, nasal wings, and upper lip during use; and a pair of lateroposterior regions disposed on respective lateroposteriors of the seal-forming structure, each lateroposterior region including: a decoupling portion configured to at least partially decouple the central portion of the seal-forming structure from a respective one of the laterally projecting connection portions, the decoupling portion being located in a portion of the lateroposterior region configured to face away from and not contact the patient's face during use; and a peripheral portion disposed adjacent to the decoupling portion, at least a portion of the peripheral portion being located behind the decoupling portion, wherein the stiffness of the decoupling portion is less than the stiffness of the peripheral portion.

2. The patient interface according to claim 1, wherein, The stiffness of each peripheral portion is greater than the stiffness of the central portion of the seal-forming structure.

3. The patient interface according to claim 1 or claim 2, wherein, The stiffness of the decoupling portion of each lateroposterior region is greater than the stiffness of the central portion of the seal-forming structure.

4. The patient interface according to claim 1 or claim 2, wherein, The wall thickness of the peripheral portion of each lateroposterior region is greater than the wall thickness of the central portion of the seal-forming structure.

5. The patient interface according to claim 4, wherein, The wall thickness of the peripheral portion of each lateroposterior region is greater than the wall thickness of the decoupling portion of each lateroposterior region.

6. The patient interface according to claim 5, wherein, The wall thickness of the decoupling portion of each lateroposterior region is greater than the wall thickness of the central portion of the seal-forming structure.

7. The patient interface according to claim 1 or claim 2, wherein, When viewed from the lateral side of the seal-forming structure, the decoupling portion of each lateroposterior region is C-shaped.

8. The patient interface according to claim 1 or claim 2, wherein Each peripheral portion partially or completely surrounds the respective decoupling portion.

9. The patient interface according to claim 1 or claim 2, wherein, Each decoupling portion is formed by a depression in the inner surface of the seal-forming structure within the respective lateroposterior region.

10. The patient interface according to claim 1 or claim 2 further comprises 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.

11. The patient interface according to claim 10 further includes the gas delivery tube, wherein, The gas delivery tube forms part of the positioning and stabilizing structure, and each gas delivery tube is configured to deliver the air flow from a position above the patient's head to the interior of the chassis portion during use.

12. The patient interface according to claim 1 or claim 2, wherein, The chassis portion is formed of a flexible material.

13. The patient interface according to claim 12, wherein, The chassis portion and the seal-forming structure are integrally formed.

14. The patient interface according to claim 1 or claim 2, wherein, The seal-forming structure (3100) includes a pair of rear-side corner portions (3131) configured to engage the patient's face near the nasolabial groove of the patient during use, and each rear-side corner portion (3131) is disposed near a corresponding one of the peripheral portions (3143).

15. The patient interface according to claim 14, wherein, When viewed from the side, each decoupling portion has a curvature corresponding to the curvature of the seal-forming structure at a corresponding one of the rear-side corner portions.

16. The patient interface according to claim 14, wherein, Each of the peripheral portions includes a curvature following the curvature of a corresponding one of the decoupling portions and a corresponding one of the rear-side corner portions.

17. The patient interface according to claim 1 or claim 2, wherein, The patient interface includes a removable cushion module that includes the chassis portion and the seal-forming structure.

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