Patient interface

Abstract

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

Description

Technical Field

[0001] Part of the disclosure of this patent document contains content protected by copyright. The copyright owner has no objection if anyone reproduces this patent document or this patent disclosure by fax, as long as it is as described in the patent file or record of the Patent Office and for the intended purpose. However, for other purposes, all copyrights are retained.

[0002] 1 Cross - reference to related applications This application claims the benefit of Australian Patent Application No. 2019902580 (filing date: July 22, 2019), Australian Patent Application No. 2019904852 (filing date: December 20, 2019), Singapore Patent Application No. 10202001774V (filing date: February 27, 2019), Australian Patent Application No. 2020901769 (filing date: May 29, 2019), and Australian Patent Application No. 2020901770 (filing date: May 29, 2019). The entire content of the same document is incorporated herein by reference.

[0003] 2 Background of the technology 2.1 Technical field This technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

Background Art

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

[0005] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchioles constitute the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0006] A range of respiratory diseases exist. Certain diseases can be characterized by specific presentations (e.g., apnea, hypopnea, and hyperpnea).

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

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by presentations such as closure or obstruction of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue area, and the normal loss of the soft palate and posterior oropharyngeal wall during sleep. Due to such a condition, the breathing cessation of affected patients typically lasts for 30 - 120 seconds, and sometimes the breathing stops 200 - 300 times a night. As a result, excessive daytime sleepiness occurs and can cause cardiovascular diseases and brain damage. This syndrome is a common disease, particularly common in middle-aged overweight men, but patients may have no awareness of the symptoms. See Patent Document 1 (U.S. Patent No. 4,944,310: Sullivan).

[0009] Respiratory insufficiency is a general term for respiratory disorders and refers to the inability of the lungs to perform sufficient oxygen inhalation or sufficient CO2 exhalation to meet the patient's needs. Respiratory insufficiency may include some or all of the following diseases: obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disease.

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

[0011] To treat or improve such conditions, a certain range of treatments are being used. Furthermore, in other respects, healthy individuals can also advantageously utilize the preventive treatment of respiratory diseases. However, there are multiple drawbacks in these.

[0012] 2.2.2 Treatment methods A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are being used for the treatment of one or more of the above respiratory diseases.

[0013] Continuous positive airway pressure (CPAP) therapy is being used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, the continuous positive pressure breathing therapy functions as an air sprint, thereby preventing the closure of the upper airway. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following regarding the device used for treatment provision, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, lack of aesthetic appeal.

[0014] 2.2.3 Treatment system These treatments can be provided by a treatment system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring without treating the disease.

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

[0016] As another form of treatment system, there is a mandibular repositioning device.

[0017] 2.2.3.1 Patient Interface The patient interface can be used to provide an interface to the wearer to a breathing apparatus, for example, by providing an air flow to the airway inlet. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can form a seal with, for example, an area of the patient's face, thereby promoting gas delivery at a sufficient distributed pressure together with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the atmospheric pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to promote the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O.

[0018] Certain other mask systems may be functionally inappropriate in this field. For example, in the case of a purely decorative mask, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the surroundings.

[0019] Certain masks may be clinically unfavorable in this technology (e.g., when the mask blocks the air flow through the nose and only allows the air flow through the mouth).

[0020] In certain masks, if the patient has to insert a part of the mask structure into the mouth and create and maintain a sealed state through the lips, it may be uncomfortable or impractical in this technology.

[0021] Certain masks may be impractical for use during sleep (e.g., when sleeping in bed on one's side with the head on a pillow).

[0022] There are several challenges in the design of patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory treatment.

[0023] Due to these challenges, in the case of some masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the reasons such as overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic mask can withstand their original uses, but in the case of such masks, they can be unacceptably uncomfortable for wearing over a long period (e.g., several hours). Due to such discomfort, the patient's compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0024] CPAP treatment is extremely effective in the treatment of certain respiratory diseases when the patient is committed to the treatment. If the mask is uncomfortable or difficult to use, the patient may not commit to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's compliance.

[0025] In the case of a mask for other uses (e.g., a pilot), since it may not be suitable for use in the treatment of sleep apnea, a mask designed for use in the treatment of sleep apnea may be suitable for other uses.

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

[0027] 2.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

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

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

[0030] A particular seal-forming structure can be designed for mass production so that one design fits a wide range of different face shapes and sizes and is comfortable and effective. To form a seal, it is necessary to conform one or both of the patient's face shape and the seal-forming structure of the mass-produced patient interface to the extent of any mismatch between them.

[0031] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when a force is applied to the patient interface with the seal-forming structure engaged against the patient's face. This seal-forming structure may include an air or fluid-filled cushion or may include a shaped or formed surface of an elastic sealing element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inappropriate, a gap can occur between the seal-forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0032] Another type of seal-forming structure uses a thin flap seal located around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied inside the mask. Similar to the previously described type of seal-forming portion, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, creases or buckling may occur in the seal-forming portion during use, causing leakage.

[0033] Another type of seal-forming structure may include a friction fit element that is inserted into the nostrils, for example, but there are also patients who find these seal-forming parts uncomfortable.

[0034] Another form of seal-forming structure may use an adhesive portion to achieve a seal. Among patients, there are also those who always feel it inconvenient to attach or remove the adhesive portion to their face.

[0035] Regarding the technology of a certain range of patient interface seal-forming structures, there is a disclosure in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0036] One form of nasal pillow can be found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of Patent Document 2 (U.S. Patent No. 4,782,832: Trimble et al.) assigned to Puritan-Bennett Corporation.

[0037] ResMed Limited manufactures the following products using nasal pillows: the SWIFT® Nasal Pillow Mask, the SWIFT® II Nasal Pillow Mask, the SWIFT® LT Nasal Pillow Mask, the SWIFT® FX Nasal Pillow Mask, and the MIRAGELIBERTY® Full Face Mask. The following patent applications assigned to ResMed Limited describe embodiments of nasal pillow masks: International Patent Application WO2004 / 073,778 (in particular, describing the appearance of ResMed Limited's SWIFT® nasal pillows), U.S. Patent Application No. 2009 / 0044808 (in particular, describing the appearance of ResMed Limited's SWIFT® LT nasal pillows); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (in particular, describing the appearance of ResMed Limited's MIRAGE LIBERTY® full face mask); International Patent Application WO2009 / 052,560 (in particular, describing the appearance of ResMed Limited's SWIFT® FX nasal pillows).

[0038] 2.2.3.1.2 Positioning and Stabilization The seal-forming structure of a patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that interfere with the seal. Therefore, various techniques are used to position the seal-forming structure and maintain the seal against the appropriate part of the face.

[0039] In one technique, an adhesive part is used. See, for example, U.S. Patent Application Publication US2010 / 0000534. However, when using an adhesive part, there may be discomfort.

[0040] In another technique, one or more straps and / or stabilization harnesses are used. In the case of a number of such harnesses, one or more of the following points apply: poor fit, bulky, uncomfortable, and difficult to handle.

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

[0042] Some patients find such an interface obstructive, and as a result, if they stop wearing it, patient compliance decreases. Further, when the conduit is connected to the interface in front of the patient's face, it may be prone to entanglement with bedding.

[0043] 2.2.3.1.4 Pressurized air conduit used for positioning / stabilizing the seal formation structure In a patient interface included in another type of treatment system attempting to address these problems, the tube responsible for delivering pressurized air to the patient airway also functions as part of a headgear for positioning and stably arranging the seal-forming portion of the patient interface on an appropriate part of the patient's face. This type of patient interface can also be referred to as using a "headgear tubing" or "tubing headgear". Using such a patient interface, a conduit in an air circuit providing a flow of pressurized air from a respiratory pressure treatment device can be provided to a patient interface located at a position other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. US2007 / 0246043. The content of this document is incorporated herein by reference for reference purposes. In this document, the conduit is connected to a tube in the patient interface through a port positioned on top of the patient's head during use.

[0044] Using a patient interface with headgear tubing can provide several advantages (e.g., avoiding tubes that connect to the patient interface in front of the patient's face, which can be obstructive and uncomfortable). However, a patient interface with headgear tubing is desirably comfortable while forming an effective seal with the patient's face when the patient wears it for extended periods while sleeping.

[0045] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device A Respiratory Pressure Therapy (RPT) device can be used individually for the delivery of one or more of the above-described therapies, or as part of a system, for example, by operating the device to generate an air delivery flow to an interface to the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

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

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

[0048] Designers of devices can be presented with countless options. Since design criteria often conflict, certain design choices may be far from convention or unavoidable. Furthermore, the comfort and effectiveness of a particular aspect can also be greatly affected by minor changes in one or more parameters.

[0049] 2.2.3.3 Humidifier When the delivery of the air flow is carried out without humidification, it may lead to drying of the airway. When a humidifier is used together with an RPT device and a patient interface, humidified gas is generated, so that the drying of the nasal mucosa is minimized and the comfort of the patient airway is increased. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort compared to the case of cold air.

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

[0051] Medical humidifiers are typically used to increase the humidity and / or temperature of the air flow relative to the ambient air when the patient is asleep or at rest (e.g., in a hospital), if necessary. A medical humidifier placed at the head of the bed may be small. A medical humidifier may be configured to only humidify and / or heat the air flow delivered to the patient, and not humidify and / or heat the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air taken into the patient's body by breathing, but in the case of these systems, since the entire room is also humidified and / or heated, it can be uncomfortable for the occupants. Furthermore, in the case of medical humidifiers, there may be more stringent safety constraints than industrial humidifiers.

[0052] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more defects. That is, in the case of such medical humidifiers, some may have inappropriate humidification, while some may be difficult or inconvenient for patients to use.

[0053] 2.2.3.4 Ventilation technology Some forms of treatment systems may include a ventilation section for expelling the exhaled carbon dioxide. This ventilation section enables a gas flow from the internal space (e.g., the plenum chamber) of the patient interface to the outside (e.g., the surroundings) of the patient interface.

[0054] This ventilation part may include an orifice, and during mask use, gas can flow through the orifice. In the case of a large number of such ventilation parts, the sound is noisy. In other cases, it may be blocked during use, resulting in insufficient extrusion. In the case of some ventilation parts, for example, due to sound or airflow concentration, it may interfere with the sleep of patient 1000 and roommate 1100.

[0055] ResMed Limited has developed a plurality of improved mask ventilation technologies. See the following: International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; US Patent No. 6,581,594; US Patent Application Publication No. US2009 / 0050156; US Patent Application Publication No. 2009 / 0044808.

[0056] Table of noises of conventional masks (ISO17510-2:2007, measured at 1 m under a pressure of 10 cmH2O)

Table 1

[0057] (*Measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample)

[0058] List the sound pressure values of various objects as follows

Table 2

Prior Art Documents

Patent Documents

[0059]

Patent Document 1

Patent Document 2

Summary of the Invention

Means for Solving the Problems

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

[0061] A first aspect of the present technology relates to an apparatus for use in screening, diagnosing, monitoring, improving, treating or preventing respiratory diseases.

[0062] Another aspect of the present technology relates to a method for use in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0063] One aspect of a particular form of the present technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

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

[0065] One aspect of the present technology includes a patient interface having a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber can be at least partially formed by a chassis portion and a seal-forming structure of the patient interface.

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

[0067] 3.1 Release Site within the Lateral Rear Region of the Seal-Forming Structure

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

[0069] One aspect of one form of the present technology is a patient interface, and the patient interface is a chassis portion that at least partially forms a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O exceeding the ambient air pressure, the chassis portion being configured to connect to a gas delivery tube and sized and structured to receive an air flow at the treatment pressure for the patient's breathing, and including a pair of laterally projecting connection portions, is a seal-forming structure provided on the chassis portion and at least partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against a patient's facial region surrounding an entrance to the patient's airway, the seal-forming structure having at least one hole therein such that an air flow at the treatment pressure is delivered at least to an entrance to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, is a vent portion that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the vent portion being sized and shaped to maintain the treatment pressure within the plenum chamber during use, and includes a vent portion. The seal-forming structure A central part configured to seal at least the nasal tip point, the alae nasi, and the upper lip of a patient during use, A pair of side rear regions provided on each rear outer side of the seal formation structure, each side rear region being, A release portion configured to at least partially release the connection from each of one connection portion that protrudes laterally from the central part of the seal formation structure, the release portion being provided within a part of the side rear region configured to be arranged in a direction away from the patient's face and not to contact the patient's face during use, the release portion, and A peripheral portion arranged adjacent to the release portion, at least a part of the peripheral portion being arranged behind the release portion, the peripheral portion, The release portion is higher in rigidity than the peripheral portion.

[0070] In an example, (a) the rigidity of each peripheral portion is higher than the rigidity of the central portion of the seal formation structure, (b) the rigidity of the decoupling portion in each side rear region is higher than the rigidity of the central portion of the seal formation structure, (c) the wall thickness of the peripheral portion in each side rear region is larger than the wall thickness of the central portion of the seal formation structure, (d) the wall thickness of the peripheral portion in each side rear region is larger than the wall thickness of the decoupling portion in each side rear region, (e) the wall thickness of the decoupling portion in each side rear region is larger than the wall thickness of the central portion of the seal formation structure, (f) the decoupling portion in each side rear region is C-shaped when viewed from the side of the seal formation structure, (g) each peripheral portion partially or entirely surrounds each decoupling portion, (h) each decoupling portion is formed by a recess in the inner surface of the seal formation structure within each side rear region, (i) the patient interface further includes a positioning and stabilization structure that provides a force for holding the seal formation structure in a therapeutically effective position on the patient's head, (j) the patient interface further includes a gas delivery tube portion, and a part of the positioning and stabilization structure is formed by the gas delivery tube portion, and each gas delivery tube portion is configured to convey an air flow from a position on the top of the patient's head to the inside of the chassis portion during use, (k) the central portion of the seal formation structure is formed from a textile material, (l) the central portion of the seal formation structure is formed from a silicone or another elastomeric material, (m) the side rear region is formed from a silicone or another elastomeric material, (n) the chassis portion is formed from a flexible material, (o) the chassis portion is formed from silicone, (p) the patient interface includes a removable cushion module, the removable cushion module includes the chassis portion and the seal formation structure, and / or (q) the chassis portion is formed from an elastomeric material.

[0071] One aspect of one form of this technology is a patient interface including a chassis portion and a seal-forming structure that at least partially together form a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure. The chassis portion may include a pair of laterally projecting connection portions. The pair of laterally projecting connection portions are configured to connect to a gas delivery tube portion and are sized and structured to receive an air flow at a treatment pressure for a patient's breathing. The seal-forming structure may be supported by the chassis portion and has at least one hole therein such that the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use.

[0072] The seal-forming structure may include a central portion. This central portion is configured to form a seal (without contacting the patient's nasal column) against the patient's face surrounding the patient's nostrils during use. The seal-forming structure may further include a pair of side-rear regions provided on each rear outer side of the seal-forming structure. Each side-rear region may include a release site configured to at least partially decouple from one of the laterally projecting connection portions of the central portion of the seal-forming structure. Each side-rear region may include a peripheral portion at least partially surrounding each release site. At least a part of the peripheral portion may be disposed behind each release site. The release site may be thicker than the peripheral portion.

[0073] 3.2 Stiffening portions within the seal-forming structure One aspect of one form of the present technology is a patient interface or a cushion module for a patient interface, including a chassis portion and a seal-forming structure that together form a plenum chamber. The seal-forming structure may include a central portion configured to seal, during use, a peripheral portion under the patient's nose surrounding the patient's nostrils. The seal-forming structure may further include central lateral portions on either side of the central portion, and the central lateral portions are configured to be disposed along the patient's nasal wings. The seal-forming structure may further include a stiffening portion disposed at least on the rear side of the seal-forming structure. The stiffening portion may be more rigid and / or thicker than the central lateral portions. The central lateral portions may be more rigid and / or thicker than the central portion.

[0074] One aspect of one form of the present technology is a patient interface, and the patient interface a chassis portion that at least partially forms a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O exceeding the ambient air pressure, the chassis portion being sized and structured to receive an air flow at the treatment pressure for the patient's breathing, the chassis portion; a seal-forming structure provided on the chassis portion, the seal-forming structure being constructed and arranged to form a seal against a patient's face region that partially forms the plenum chamber and surrounds an entrance to the patient's airway, the seal-forming structure having at least one hole therein such that the air flow at the treatment pressure is delivered at least to an entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, the seal-forming structure; a vent that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the vent being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the vent, and includes The seal-forming structure is A central part provided at the rear side of the seal forming structure, the central part being configured to seal at least the nasal tip point, the nasal wings and the upper lip of the patient during use, a central part; A pair of central side parts provided at the rear side of the seal forming structure, each central side part being provided on each side of the central part and configured to be arranged along each nasal wing of the patient's nose during use, each central side part being higher in rigidity than the central part, a pair of central side parts; A pair of stiffening parts, each stiffening part extending from the rear side of the seal forming structure to the front side of the seal forming structure, the seal forming structure being configured to be arranged in a direction away from the patient's face during use, each stiffening part being arranged on each side of the seal forming structure, each stiffening part being higher in rigidity than the central side part, a pair of stiffening parts, including.

[0075] In an example, (a) each stiffening portion has a negative curvature along a first path from the rear side of the seal-forming structure to the 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 portion provided on the front side of the seal-forming structure and a rear portion provided on the rear side of the seal-forming structure, the front portion being more rigid than the rear portion, (d) the thickness of the front portion of each stiffening portion is greater than the thickness of the rear portion of the stiffening portion, (e) each stiffening portion has a thickness that increases in a tapered manner between the rear portion of the stiffening portion and the front portion of the stiffening portion, (f) the rigidity of the front portion of the stiffening portion is higher than the rigidity of the adjacent portion of the seal-forming structure on the front side, (g) the thickness of the front portion of the stiffening portion is greater than the thickness of the adjacent portion of the seal-forming structure on the front side, (h) the rigidity of the rear portion of the stiffening portion is greater than the rigidity of the adjacent portion on the rear side of the seal-forming structure, (i) the thickness of the rear portion of the stiffening portion is greater than the thickness of the adjacent portion on the rear side of the seal-forming structure, (j) each stiffening portion includes a wall thickness greater than that of the adjacent region, the greater wall thickness being formed by an extra thickness on the inner surface of the seal-forming structure, (k) each stiffening portion is disposed adjacent to one of the patient's nasal wings during use, (l) the chassis portion includes a pair of laterally protruding connection portions configured to connect to the gas delivery tube portions, each gas delivery tube portion being configured to connect to one of each pair of gas delivery tube portions and receive a gas flow from one of each pair of gas delivery tube portions, (m) 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 the gas delivery tube portions, each gas delivery tube portion being configured to receive an air flow from a connection port on the upper part of the patient's head and deliver the air flow to one of each of the laterally protruding connection portions of the chassis portion, (n) each stiffening portion is disposed adjacent to one of the laterally protruding connection portions, (o) the chassis portion is formed from a flexible material, (p) the chassis portion is formed from silicone or another elastomeric material, (q) the central portion of the seal-forming structure is formed from a textile material, (r) the central portion of the seal-forming structure is formed from silicone or another elastomeric material, and / or (s) the stiffening portion is formed from silicone or another elastomeric material.

[0076] One aspect of one form of the present technology is a patient interface including a chassis portion and a seal-forming structure that at least partially together form a plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure. The seal-forming structure may be supported by the chassis portion and, by having at least one hole therein, allows the airflow at the treatment pressure to be delivered at least to the inlet to the patient's nostrils. The seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use.

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

[0078] 3.3 Central-side rear support in the seal-forming structure One aspect of one form of the present technology is a patient interface or a cushion module for a patient interface, including a chassis portion and a seal-forming structure that together form a plenum chamber. The seal-forming structure may include a central portion configured to seal the peripheral portion under the patient's nose surrounding the patient's nostrils during use. The seal-forming structure may further include central lateral portions on either side of the central portion and is configured to be disposed along the patient's nasal wings. The seal-forming structure may further include a pair of central-side rear support portions, each of these central-side rear support portions being disposed in proximity to the junction between the central portion and each central lateral portion. The rigidity and / or thickness that each central-side rear support portion may have is greater than the rigidity of the central portion and less than the rigidity of each central lateral portion.

[0079] One aspect of one form of the present technology is a patient interface, and the patient interface is A chassis portion that at least partially forms a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive an air flow at the treatment pressure for the patient's breathing, the chassis portion; A seal-forming structure provided on the chassis portion, the seal-forming structure being constructed and arranged to at least partially form the plenum chamber and form a seal against the patient's face area surrounding the inlet to the patient's airway, the seal-forming structure having at least one hole therein such that the air flow at the treatment pressure is delivered at least to the inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, the seal-forming structure; A ventilation portion that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation portion being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the ventilation portion, and The seal-forming structure is A central portion provided on the rear side of the seal-forming structure, the central portion being configured to seal at least the patient's nasal tip point, nasal wings, and upper lip during use; A pair of central lateral portions provided on the rear side of the seal-forming structure, each central lateral portion being provided on each lateral side of the central portion, each central lateral portion being more rigid than the central portion, the pair of central lateral portions; A pair of central posterolateral support portions provided on the rear side of the seal-forming structure, these central posterolateral support portions being provided respectively in proximity to the junction between the central portion and each central lateral portion and configured to be disposed in proximity to each rear outer corner portion of the base of the patient's nose during use, each central posterolateral support portion being more rigid than the central portion and less rigid than each central lateral portion.

[0080] In an example, (a) the seal-forming structure includes a pair of rear corner portions configured to engage the patient's face adjacent the nasolabial groove of the patient during use, each central-side rear support portion being less rigid than each rear corner portion, (b) the rigidity of each rear corner portion is higher than the rigidity of each central-side portion, (c) the thickness of each central-side portion is greater than the thickness of the central portion, (d) the thickness of each central-side rear support portion is greater than the thickness of the central portion, (e) the thickness of each central-side rear support portion is less than the thickness of each central-side portion, (f) the thickness of each central-side rear support portion is less than the thickness of each rear corner portion, (g) the thickness of each rear corner portion is greater than the thickness of the central-side portion, (h) the thickness of each central-side rear support portion is tapered and increased as it approaches each adjacent central-side portion, (i) the tapered thickness of each central-side rear support portion increases as it approaches the thickness of each adjacent central-side portion, (j) the thickness of each central-side support portion can be in the range of 0.3 to 0.7 mm, and / or (k) the thickness of each central-side support portion can be in the range of 0.4 to 0.6 mm.

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

[0082] 3.4 Chassis portion formed from a flexible material together with a rigidifying agent One aspect of one form of the present technology is a patient interface or a cushion module for a patient interface, including a chassis portion and a seal-forming structure that together form a plenum chamber. The chassis portion may include a laterally protruding connection portion configured for connection to a gas delivery tube portion. The seal-forming structure may include a central portion configured to seal the peripheral portion under the patient's nose surrounding the patient's nostrils during use. The chassis portion may be formed from a flexible material and stiffened by a stiffening member. The stiffening member may include a ventilation module.

[0083] One aspect of one form of the present technology is a patient interface, and the patient interface a chassis portion that at least partially forms a plenum chamber pressurizable to a treatment pressure of at least 6 cmH2O exceeding ambient air pressure, the chassis portion including a pair of laterally protruding connection portions sized and structured to receive an air flow at the treatment pressure for the patient's breathing, a seal-forming structure provided on the chassis portion, the seal-forming structure being constructed and arranged to form a seal against a patient's facial region that partially forms the plenum chamber and surrounds an inlet to the patient's airway, the seal-forming structure having at least one hole therein such that the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, 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 a pair of gas delivery tube portions, each gas delivery tube portion providing for receiving an air flow from a connection port on the upper portion of the patient's head and delivering the air flow to one of the connection portions protruding laterally from the chassis portion, A ventilation part that enables the gas exhaled by the patient to continuously flow from the inside of the plenum chamber to the surroundings, the ventilation part including a ventilation part sized and shaped to maintain the treatment pressure in the plenum chamber during use. The chassis part and the seal-forming structure are formed from a flexible material. The patient interface further includes a rigidifying member provided on the chassis part, the rigidifying member being configured to withstand deformation of the chassis part.

[0084] In the example, (a) the stiffener is provided on the front side of the chassis part, (b) the chassis part includes a front hole part configured to receive the stiffener, (c) the stiffener includes a ventilation module including a ventilation part, (d) through a plurality of ventilation holes included in the ventilation part, a continuous gas flow due to the patient's exhalation moves from the inside of the plenum chamber to the atmosphere, (e) the plurality of ventilation holes include upper ventilation holes and lower ventilation holes, (f) the plurality of lower ventilation holes include one or more upper ventilation holes and one or more lower ventilation holes, (g) one or more upper ventilation holes are configured to direct the exhaled gas in a direction having an angle upward with respect to an axis perpendicular to the front surface of the ventilation module, (h) one or more lower ventilation holes are configured to direct the exhaled gas in a direction having an angle downward with respect to an axis perpendicular to the front surface of the ventilation module, (i) the angle upward is larger 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 lower ventilation holes include a pair of upper ventilation holes, (n) the plurality of lower ventilation holes include a pair of lower ventilation holes, (o) the ventilation module is configured to support a diffuser, and through the diffuser, a continuous gas flow due to the patient's exhalation can move (when flowing to the atmosphere), (p) the ventilation module enables a continuous gas flow due to the patient's exhalation to move from the inside of the plenum chamber to the inside and outside of the diffuser to the atmosphere after passing through the upper ventilation holes, (q) the ventilation module is configured to enable a continuous gas flow due to the patient's exhalation to move from the inside of the plenum chamber to the inside and outside of the diffuser to the atmosphere before passing through the lower ventilation holes, and / or (r) the ventilation module is configured to enable a continuous gas flow due to the patient's exhalation to be moved by the diffuser from the inside of the plenum chamber to the atmosphere (without flowing inside the diffuser).

[0085] In a further example, (a) the ventilation module includes a peripheral channel configured to receive a portion of the chassis portion of the plenum chamber, (b) the chassis portion includes a lip configured to be received within the peripheral channel of the ventilation module, (c) the lip defines a front hole portion of the plenum chamber, (d) the lip is thicker than an adjacent portion of the chassis portion of the plenum chamber, (e) the lip is the thickest portion of the chassis portion, (f) the 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.

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

[0087] 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 at least the nasal tip point, nasal alae and upper lip of the patient during 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 exposed.

[0088] One aspect of one form of the present technology is a patient interface including a chassis portion and a seal-forming structure that at least partially together form a plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure. The chassis portion may include 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 treatment pressure for the patient's breathing. The seal-forming structure may be supported by the chassis portion and, by having at least one hole therein, allows the air flow at the treatment pressure to be delivered at least to the inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use.

[0089] The patient interface may include a ventilation portion that allows gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, and the ventilation portion is sized and shaped to maintain the treatment pressure within the plenum chamber during use. Through a plurality of ventilation holes that may be included in the ventilation portion, the gas flow due to the patient's exhalation moves from inside the plenum chamber to the atmosphere, and these ventilation holes include one or more upper ventilation holes and one or more lower ventilation holes. The one or more upper ventilation holes may be configured to direct the exhaled gas in a direction having an upward angle with respect to an axis perpendicular to the front surface of the ventilation module, and the one or more lower ventilation holes may be configured to direct the exhaled gas in a direction having a downward angle with respect to an axis perpendicular to the front surface of the ventilation module. This upward angle may be made larger than the downward angle.

[0090] 3.5 Upper / Lower of the Central Front of the Seal-Forming Structure Another aspect of one form of the present technology is a patient interface, and the patient interface is a chassis portion that at least partially forms a plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, wherein the chassis portion is sized and structured to receive an air flow at the treatment pressure for the patient's breathing, and the chassis portion A seal-forming structure provided in the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's face area surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole therein such that the airflow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure; A ventilation portion that enables the gas exhaled by the patient to continuously flow from the inside of the plenum chamber to the surroundings, the ventilation portion being sized and shaped to maintain the treatment pressure within the plenum chamber during use, including the ventilation portion; The seal-forming structure is; The central portion at the rear side of the seal-forming structure, the central portion being configured to seal at least the tip of the patient's nose, the alae nasi, and the upper lip during use, the central portion; The central front portion at the front side of the seal-forming structure, the central front portion being arranged close to the tip of the patient's nose below the tip of the patient's nose during use, the central front portion including an upper portion and a lower portion, and the lower portion being more rigid than the upper portion.

[0091] In an example, (a) the wall thickness at the lower part of the central front portion is greater than the wall thickness at the upper part of the central front portion, (b) the upper part of the central front portion has substantially the same wall thickness as the central part of the seal formation structure, (c) the seal formation structure includes a pair of central side portions at the rear side of the seal formation structure, each central side portion is provided on each lateral side of the central part, and each central side portion has higher rigidity than the central part, (d) the wall thickness of the central side portion is greater than the upper part of the central front portion, (e) the seal formation structure includes a pair of central side front portions at the front side of the seal formation structure, these central side front portions are provided on each lateral side of the central front portion, and the wall thickness of each of the pair of central side front portions is greater than the wall thickness of the central front portion, (f) the chassis portion includes a pair of laterally protruding connection portions, each of these laterally protruding connection portions is connected to a gas flow from one of each pair of gas delivery tube portions and is configured to receive this gas flow, and / or (g) the patient interface includes a positioning and stabilization structure for providing a force to hold the seal formation structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure includes the gas delivery tube portions, and each gas delivery tube portion is configured to receive an air flow from a connection port on the upper part of the patient's head and deliver the air flow to one of each of the laterally protruding connection portions of the chassis portion.

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

[0093] One aspect of one form of the present technology is a patient interface including a chassis portion and a seal-forming structure that at least partially together form a plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure. The seal-forming structure can be supported by the chassis portion and has at least one hole therein such that air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use.

[0094] The seal-forming structure can include a central portion on the rear side of the seal-forming structure and is configured to form a seal (without contact with the patient's nasal bridge) against the patient's face surrounding the patient's nostrils during use. The seal-forming structure can include a central front portion on the non-patient contact side of the seal formation and a pair of central side front portions provided on either side of the central front portion. The central front portion can include an upper portion and a lower portion, and the lower portion of the central front portion is thicker than the upper portion of the central front portion. Each of the central side front portions can have an upper portion and a lower portion, and the lower portion of each central side front portion is thicker than the upper portion of each central side front portion.

[0095] 3.6 Upper / Lower of Central Side Front Portion of Seal-Forming Structure Another aspect of one form of the present technology is a patient interface, and the patient interface is a chassis portion that at least partially forms a plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive air flow at the treatment pressure for the patient's breathing, the chassis portion and A seal-forming structure provided in the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's face area surrounding the inlet to the patient's airway, the seal-forming structure having at least one hole therein such that the airflow at the treatment pressure is delivered at least to the inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle, the seal-forming structure, A ventilation portion that enables the gas exhaled by the patient to continuously flow from the inside of the plenum chamber to the surroundings, the ventilation portion being sized and shaped to maintain the treatment pressure within the plenum chamber during use, including the ventilation portion, The seal-forming structure is The central portion at the rear side of the seal-forming structure, the central portion being configured to seal at least the patient's nasal tip point, nasal wings and upper lip during use, the central portion, The central front portion at the front side of the seal-forming structure, the central front portion being arranged below the nasal tip point in proximity to the nasal tip point during use, the central front portion, and A pair of central lateral front portions at the front side of the seal-forming structure, these central lateral front portions being respectively arranged on each lateral side of the central front portion, each central lateral front portion including an upper portion and a lower portion, the lower portion being more rigid than the upper portion.

[0096] In an example, (a) the wall thickness at the lower part of each central lateral front is greater than the wall thickness at the upper part of each central lateral front, (b) the wall thickness at the lower part of each central lateral front is greater than the wall thickness at the central front of the seal formation structure, (c) the wall thickness at the lower part of each central lateral front is greater than the wall thickness at the central rear part of the seal formation structure, (d) the wall thickness at the upper part of each central lateral front is greater than the wall thickness at the central front of the seal formation structure, (e) the wall thickness at the upper part of each central lateral front is greater than the wall thickness at the rear side of the seal formation structure, (f) the seal formation structure includes a pair of central lateral parts at the rear side of the seal formation structure, each central lateral part is provided on each lateral side of the central part, and the wall thickness of each central lateral part is greater than the wall thickness of the central part, (g) the wall thickness at the lower part of each central lateral front is greater than the wall thickness of the central lateral part at the rear side of the seal formation structure, (h) the wall thickness at the upper part of each central lateral front is greater than the wall thickness of the central lateral part at the rear side of the seal formation structure, (i) the chassis part includes a pair of laterally protruding connection parts, each of these laterally protruding connection parts is configured to connect to and receive the gas flow from one of each pair of gas delivery pipe parts, and / or (j) the patient interface includes a positioning and stabilization structure for providing a force to hold the seal formation structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure includes the gas delivery pipe parts, and each gas delivery pipe part is configured to receive an air flow from a connection port on the upper part of the patient's head and deliver the air flow to one of each of the laterally protruding connection parts of the chassis part.

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

[0098] One aspect of one form of the present technology is a patient interface including a chassis portion and a seal-forming structure that at least partially together form a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure. The seal-forming structure can be supported by the chassis portion and has at least one hole therein so that air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use.

[0099] The seal-forming structure can include a central portion on the rear side of the seal-forming structure and is configured to form a seal (without contact with the patient's nasal column) against the patient's face surrounding the patient's nostrils during use. The seal-forming structure can include a central front portion on the non-patient contact side of the seal formation and a pair of central lateral front portions provided on either side of the central front portion. Each of the central lateral front portions has an upper portion and a lower portion, and the lower portion of each central lateral front portion is thicker than the upper portion of each central lateral front portion. The seal-forming structure can further include a pair of central lateral portions on the rear side of the seal-forming structure, and these central lateral portions are each provided on each lateral side of the central portion and have a wall thickness larger than that of the central portion.

[0100] 3.7 Reinforcement on the Chassis Another aspect of one form of the present technology is a patient interface, and the patient interface is a chassis portion formed from a flexible material and at least partially forming a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the chassis portion including a pair of laterally protruding connection portions sized and structured to receive air flow at the treatment pressure for the patient's breathing, A seal-forming structure provided in the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's face area surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole therein such that the airflow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure; A ventilation portion enabling the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation portion being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the ventilation portion; A positioning and stabilization structure providing a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a pair of gas delivery tube portions, each gas delivery tube portion providing for receiving an air flow from a connection port on the upper part of the patient's head and delivering the air flow to respective one of the connection portions protruding laterally from the chassis portion, the positioning and stabilization structure; The seal-forming structure includes a central portion at the rear side of the seal-forming structure, the central portion being configured to seal at least the patient's nasal tip point, nasal wings and upper lip during use. The chassis portion includes a pair of upper chassis reinforcement portions, each of these upper chassis reinforcement portions being provided at each lateral and front side of the chassis portion, and each upper chassis reinforcement portion being of higher rigidity than one or more adjacent portions of the chassis portion.

[0101] In an example, (a) the chassis upper reinforcement is arranged adjacent to the seal forming structure, (b) each chassis upper reinforcement is arranged at each upper corner of the front hole of the chassis part, (c) the seal forming structure includes a central front part at the central front of the front side of the seal forming structure, and this central front part is arranged close to the nasal tip point of the patient and below the nasal tip point during use, and a pair of central side front parts at the front side of the seal forming structure, and these central side front parts are respectively arranged on each side of the central front part, and the chassis upper reinforcement is respectively arranged adjacent to each one of the central side front parts of the seal forming structure, (d) each central side front part of the seal forming structure includes an upper part and a lower part, and the chassis upper reinforcement is respectively arranged adjacent to each lower part, (e) the wall thickness of the chassis upper reinforcement is the same as the wall thickness of the lower part of the central side front part, (f) the wall thickness of the chassis upper reinforcement is 1 mm to 3 mm, (g) the wall thickness of the chassis upper reinforcement is 1.5 mm to 2 mm, (h) the wall thickness of the chassis upper reinforcement is 1.7 mm, (i) the seal forming structure is formed from a flexible material, (j) the seal forming structure does not enter the patient's nostrils, (k) the patient interface is configured to keep the patient's mouth exposed, and / or (l) the wall thickness of the chassis upper reinforcement is greater than that of one or more adjacent parts of the chassis part.

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

[0103] One aspect of one form of the present technology is a patient interface including a chassis portion and a seal-forming structure that at least partially together form a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure. The seal-forming structure can be supported by the chassis portion and, by having at least one hole therein, enables the airflow at the treatment pressure to be delivered at least to the entrance to the patient's nostrils. The seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use. The chassis portion can be formed from a flexible material and can include a pair of upper chassis reinforcements. These upper chassis reinforcements are provided respectively on each side and the front side of the chassis portion. Each of the upper chassis reinforcements can be more rigid than one or more adjacent portions of the chassis portion.

[0104] 3.8 Front / Back of the Upper Lip Portion of the Seal-Forming Structure Another aspect of one form of the present technology is a patient interface, which is a chassis portion formed from a flexible material and capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, and at least partially forming a plenum chamber, the chassis portion including a pair of laterally protruding connection portions sized and structured to receive the airflow at the treatment pressure for the patient's respiration, and a seal-forming structure provided on the chassis portion and at least partially forming the plenum chamber, the seal-forming structure being formed from a flexible material, the seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole therein such that the airflow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use. A ventilation part that enables the gas exhaled by the patient to continuously flow from the inside of the plenum chamber to the surroundings, the ventilation part being sized and shaped to maintain the therapeutic pressure in the plenum chamber during use, and the ventilation part; A positioning and stabilization structure that provides a force for holding the seal formation structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a pair of gas delivery pipe parts, each gas delivery pipe part receiving an air flow from a connection port above the upper part of the patient's head and delivering the air flow to each of the connection parts protruding laterally from the chassis part; The seal formation structure and at least most of the chassis part are formed from a single homogeneous piece of flexible material; The seal formation structure; A central part at the rear side of the seal formation structure, the central part being configured to seal at least the tip of the patient's nose, the nasal wings and the upper lip during use; A rear part configured to seal the patient's upper lip during use, and a front part adjacent to the chassis part, the front part being more rigid than the rear part of the upper lip part, and including the upper lip part;

[0105] In an example, (a) the thickness of the front part of the upper lip part is greater than the thickness of the rear part of the upper lip part, (b) the thickness of the rear part of the upper lip part is the same as the thickness of a part adjacent to the upper lip part in the central part of the seal formation structure, (c) the thickness of the rear part of the upper lip part is in the range of 0.1 mm to 0.5 mm, (d) the thickness of the rear part of the upper lip part is in the range of 0.2 mm to 0.3 mm, (e) the thickness of the rear part of the upper lip part is 0.25 mm, (f) the thickness of the front part of the upper lip part is in the range of 1.2 mm to 1.8 mm, (g) the thickness of the front part of the upper lip part is in the range of 1.4 to 1.6 mm, (h) the thickness of the front part of the upper lip part is 1.5 mm, (i) the seal formation structure includes a pair of side rear regions on each rear outer side of the upper lip part, the thickness of the rear part of the upper lip part is less than the thickness of the side rear region, and / or (j) the thickness of the front part of the upper lip part is the same as the thickness of the side rear region;

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

[0107] One aspect of one form of the present technology is a patient interface including a chassis part and a seal-forming structure that together at least partially form a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure. The seal-forming structure can be supported by the chassis part and has at least one hole therein such that air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use. The seal-forming structure includes a central part on the rear side of the seal-forming structure, the central part being configured to seal the patient's face surrounding the patient's airway, the central part including an upper lip part configured to seal the patient's upper lip, the upper lip part including a front part adjacent to the chassis part and a rear part configured to contact the patient's upper lip, the front part being thicker than the rear part. The chassis part can be formed from a flexible material.

[0108] 3.9 Cushion Module Connector Another aspect of one form of the present technology is a patient interface, the patient interface being a cushion module, the cushion module including a chassis part that at least partially forms a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the chassis part being sized and structured to receive air flow at the treatment pressure for the patient's breathing and including a pair of laterally projecting connection parts, the chassis part and A seal-forming structure provided in the chassis part and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's face area surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole therein so that the air flow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle, a seal-forming structure, and a cushion module including the same. A positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a pair of gas delivery tube parts, each gas delivery tube part being configured to receive an air flow from a connection port on the upper part of the patient's head and deliver the air flow to one respective connection part protruding laterally from the chassis part. A ventilation part that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation part being sized and shaped to maintain the treatment pressure within the plenum chamber during use, a ventilation part, and the same. Each gas delivery tube part of the positioning and stabilizing structure includes a tube end connector proximate to the tube end of the gas delivery tube part, and each tube end connector has at least one clip protrusion. The cushion module includes a pair of connectors, each connector being configured to fluidly connect one respective connection part protruding laterally from the chassis part to one respective gas delivery tube part, and each connector includes the following. A chassis connection part connected to one respective connection part protruding laterally from the chassis part, and A protruding connector part protruding in a direction away from the chassis connection part along the length of the connector, the protruding connector part including the following. A clip base part adjacent to the chassis connection part, and At least one clip arm that protrudes in a direction away from the clip base portion, the at least one clip arm including a recess configured to receive a clip protrusion of a tube end connector of each gas delivery tube portion and form a snap-fit connection with the tube end connector. The length of the clip base portion along the length of the connector is greater than or equal to the length of the clip arm between the clip base portion and the recess along the length of the connector.

[0109] In an example, (a) the length of the clip base portion is longer than the length of the clip arm between the clip base portion and the recess, (b) the ratio between the length of the clip base portion and the length of the clip arm between the clip base portion and the recess is 1.5, 1 or more, (c) the ratio is 1.7, 1 or more, (d) the ratio is 1.9, 1 or more, (e) the ratio is 2, 1 or more, (f) the force required to disconnect each connector of the cushion module from the tube end connector of each gas delivery tube portion exceeds 12 N, (g) the required force exceeds 20 N, (h) the required force exceeds 25 N, (i) the required force exceeds 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 cushion module includes a pair of clip arms that protrude in a direction away from the clip base portion, (m) each one of the pair of clip arms includes each recess configured to receive each clip protrusion, and / or (n) the chassis portion of the cushion module is formed from a flexible material.

[0110] 3.10 Middle / Lateral Portion of the Central Lateral Front Portion of the Seal Forming Structure Another aspect of one form of the present technology includes a patient interface, the patient interface including A chassis portion that is formed from a flexible material and at least partially forms a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive an air flow at the treatment pressure for a patient's respiration. A seal-forming structure provided in the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's face area surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole therein such that the airflow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle, the seal-forming structure; A ventilation portion that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation portion being sized and shaped to maintain the treatment pressure within the plenum chamber during use, including the ventilation portion; The seal-forming structure is The central portion at the rear side of the seal-forming structure, the central portion being configured to seal at least the patient's nasal tip point, nasal wings and upper lip during use, the central portion; The central front portion on the front side of the seal-forming structure is arranged below the nasal tip point in proximity to the nasal tip point during use. A pair of central lateral front portions on the front side of the seal-forming structure respectively arranged on each side of the central front portion, each central lateral portion including an intermediate portion arranged adjacent to the central front portion and a lateral portion arranged on the lateral side of the intermediate portion, and the intermediate portion of each central lateral front portion is more rigid than the lateral portion of the central lateral front portion.

[0111] In an example, (a) the rigidity of each of the middle portions of the central lateral front parts is higher than the rigidity of the central front part, (b) the wall thickness of each of the middle portions of the central lateral front parts is greater than the wall thickness of the central front part, (c) each of the lateral parts of the central lateral front parts includes an upper part and a lower part, and the lower part has a higher rigidity than the upper part, (d) the wall thickness of the lower part of the lateral part of each central lateral front part is greater than the wall thickness of the upper part, (e) the wall thickness of the middle part of the central lateral front part is greater than the wall thickness of the upper part of the lateral part of each central lateral front part, (f) the wall thickness of the middle part of the central lateral front part is smaller than the wall thickness of the lower part of each central lateral front part, (g) the chassis part includes a pair of upper chassis reinforcement parts respectively provided on each of the horizontal and front sides of the chassis part, and each of the upper chassis reinforcement parts has a higher rigidity than one or more adjacent parts of the chassis part, (h) the upper chassis reinforcement parts are arranged adjacent to the seal formation structure, (i) each of the upper chassis reinforcement parts is arranged adjacent to one of each of the central lateral front parts, (j) each of the upper chassis reinforcement parts is arranged adjacent to one of the lower parts of each of the central lateral front parts, (k) the wall thickness of each of the upper chassis reinforcement parts is greater than the wall thickness of the central lateral front part, and / or (l) the wall thickness of each of the upper chassis reinforcement parts is greater than the wall thickness of the middle part of the central lateral front part.

[0112] In a further example, (a) the chassis part includes a pair of laterally protruding connection parts, and each of these laterally protruding connection parts is configured to connect to and receive the gas flow from one of each of a pair of gas delivery pipe parts, (b) the patient interface includes a positioning and stabilization structure for providing a force to hold the seal formation structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure includes the gas delivery pipe parts, and each gas delivery pipe part is configured to receive an air flow from a connection port on the upper part of the patient's head and deliver the air flow to one of each of the laterally protruding connection parts of the chassis part, (c) the chassis part is formed from an elastomeric material, (d) the chassis part is formed from silicone, (e) the seal formation structure is at least partially formed from silicone, and / or (f) the seal formation structure is at least partially formed from a textile material.

[0113] 3.11 Upper / Lower Part of the Front of the Lateral Rear Region of the Seal Forming Structure Another aspect of one form of the present technology is a patient interface, which is a chassis part that is formed from a flexible material and at least partially forms a plenum chamber that can be pressurized up to a treatment pressure of at least 6 cmH2O exceeding the ambient air pressure, wherein the chassis part is sized and structured to receive an air flow at the treatment pressure for the patient's breathing, a chassis part; a seal forming structure provided on the chassis part and at least partially forming the plenum chamber, wherein the seal forming structure is constructed and arranged to form a seal against the patient's face region surrounding the entrance to the patient's airway, the seal forming structure having at least one hole therein so that the air flow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, the seal forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, a seal forming structure; a ventilation part that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation part being sized and shaped to maintain the treatment pressure within the plenum chamber during use, a ventilation part, and includes; the seal forming structure is a central part at the rear side of the seal forming structure, the central part being configured to seal at least the patient's nasal tip point, nasal wings and upper lip during use, a central part; a pair of lateral rear regions provided on each rear outer side of the front side of the seal forming structure, each lateral rear region including a front part and a rear part, the front part including an upper part and a lower part, and the upper part being more rigid than the lower part.

[0114] In an example, (a) the wall thickness at the upper part of the front of each side rear region is greater than the wall thickness at the rear part, (b) the wall thickness at the upper part of the front of each side rear region is greater than the wall thickness at the lower part of the front of each side rear region, (c) the seal forming structure includes a pair of central lateral front parts on the front side of the seal forming structure, and these central lateral front parts are respectively arranged on each lateral side of the seal forming structure, and the central lateral front parts are more rigid than the central part, (d) the wall thickness of each front part of the side rear region is greater than the wall thickness of each central lateral front part, (e) the wall thickness at the upper part of the front of each side rear region is greater than the wall thickness of each central lateral front part, (f) each central lateral front part includes an upper part and a lower part, and the lower part is more rigid than the upper part, (g) the wall thickness of the lower part of each central lateral front part is greater than the wall thickness of the upper part of the central lateral front part, and / or (h) the boundary between the upper part and the lower part of the front of each side rear region is arranged in the front / rear direction at the longest part of the side rear region.

[0115] In a further example, (a) the chassis part includes a pair of laterally protruding connection parts, and these laterally protruding connection parts are respectively configured to connect to and receive the gas flow from each one of a pair of gas delivery pipe parts, (b) the patient interface includes a positioning and stabilization structure for providing a force to hold the seal forming structure in a therapeutically effective position on the patient's head, and the positioning and stabilization structure includes the gas delivery pipe parts, and each gas delivery pipe part is configured to receive an air flow from a connection port on the upper part of the patient's head and deliver the air flow to each one of the laterally protruding connection parts of the chassis part, (c) the chassis part is formed from an elastomeric material, (d) the chassis part is formed from silicone, (e) the seal forming structure is at least partially formed from silicone, and / or (f) the seal forming structure is at least partially formed from a textile material.

[0116] 3.12 Front / Back of the Central Lateral Lower Part of the Seal Forming Structure Another aspect of one form of the present technology is a patient interface, and the patient interface is A chassis portion that at least partially forms a plenum chamber formed from a flexible material and pressurizable to a treatment pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive airflow at the treatment pressure for the patient's breathing, the chassis portion and, A seal-forming structure provided on the chassis portion and at least partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole therein such that airflow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, the seal-forming structure and, A vent that enables continuous flow of the gas exhaled by the patient from inside the plenum chamber to the surroundings, the vent being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the vent and, The seal-forming structure, The central portion at the rear side of the seal-forming structure, the central portion being configured to seal at least the patient's nasal tip point, nasal wings and upper lip during use, the central portion including an upper lip portion configured to seal the patient's upper lip during use, A pair of central lateral lower portions disposed on either side of the upper lip portion, each central lateral lower portion having a front portion and a rear portion adjacent to the chassis portion, the front portion of the central lateral lower portion being more rigid than the rear portion of the central lateral lower portion.

[0117] In an example, (a) the upper lip portion includes a front portion adjacent to the chassis portion and a rear portion configured to seal the patient's upper lip during use, (b) the front portion of the upper lip portion is higher in rigidity than the rear portion of the upper lip portion, (c) the front portion of the lower central side is higher in rigidity than the front portion of the upper lip portion, (d) the front portion of the lower central side is higher in rigidity than the rear portion of the upper lip portion, (e) the rear portion of the lower central side is higher in rigidity than the rear portion of the upper lip portion, (f) the thickness of each front portion of the lower central side is greater than the thickness of the rear portion of the lower central side, (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 lower central side is greater than the thickness of the front portion of the upper lip portion, (i) the thickness of the front portion of the lower central side is greater than the thickness of the rear portion of the upper lip portion, (j) the thickness of the rear portion of the lower central side 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 lower central side is greater than the thickness of the rear portion of the upper lip portion, (l) the chassis portion includes a pair of under-chassis reinforcement portions, each of these under-chassis reinforcement portions is disposed adjacent to one of each of the lower central sides, and each under-chassis reinforcement portion is higher in rigidity than the adjacent portion of the chassis portion, and / or (m) the thickness of each under-chassis reinforcement portion is greater than the thickness of the adjacent portion of the chassis portion.

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

[0119] 3.13 Chassis Lower Reinforcement Another aspect of one form of the present technology is a patient interface, which is a chassis portion that is formed from a flexible material and at least partially forms a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive air flow at the treatment pressure for the patient's breathing and including a pair of laterally projecting connection portions, a seal-forming structure provided on the chassis portion and at least partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's face region surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole therein such that air flow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, a vent portion that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the vent portion being sized and shaped to maintain the treatment pressure within the plenum chamber during use, and a positioning and stabilization structure that provides a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a pair of gas delivery tube portions, each gas delivery tube portion providing for receiving air flow from a connection port on the upper part of the patient's head and delivering the air flow to each of the laterally projecting connection portions of the chassis portion, The seal-forming structure includes a central portion on the rear side of the seal-forming structure, the central portion being configured to seal at least the patient's nasal tip point, nasal wings and upper lip during use, The chassis portion includes a pair of under-chassis reinforcement portions, and these under-chassis reinforcement portions are respectively provided on each horizontal and lower side of the chassis portion, and each under-chassis reinforcement portion is higher in rigidity than one or more adjacent portions of the chassis portion.

[0120] In an example, (a) the thickness of each of the under-chassis reinforcement portions is greater than the thickness of the adjacent portion of the chassis portion, (b) the under-chassis reinforcement portions are arranged adjacent to the seal formation structure, (c) the under-chassis reinforcement portions may have intermediate boundaries arranged at intervals, (d) each of the under-chassis reinforcement portions may have an intermediate boundary close to the central region below the chassis portion, (e) each of the under-chassis reinforcement portions may have a lateral boundary close to each side rear region of the seal formation structure, (f) the under-chassis reinforcement portions are shaped to follow the boundary between the chassis portion and the seal formation structure, and / or (g) the central portion includes an upper lip portion configured to seal the patient's upper lip during use and a pair of central lateral lower portions, and these central lateral lower portions are arranged on either side of the upper lip portion and are higher in rigidity than the upper lip portion, and each of the under-chassis reinforcement portions is arranged adjacent to one of each of the central lateral lower portions.

[0121] In a further example, (a) the chassis portion includes a pair of laterally protruding connection portions, and these laterally protruding connection portions are respectively configured to connect to and receive the gas flow from one of each of a pair of gas delivery tube portions, (b) the patient interface includes a positioning and stabilization structure for providing a force to hold the seal formation structure in a therapeutically effective position on the patient's head, and the positioning and stabilization structure includes gas delivery tube portions, and each gas delivery tube portion is configured to receive an air flow from a connection port on the upper part of the patient's head and deliver the air flow to one of each of the laterally protruding connection portions of the chassis portion, (c) the chassis portion is formed from an elastomeric material, (d) the chassis portion is formed from silicone, (e) the seal formation structure is at least partially formed from silicone, and / or (f) the seal formation structure is at least partially formed from a textile material.

[0122] 3.14 Chassis coupling release site Another aspect of one form of the present technology is a patient interface, which is a chassis portion that at least partially forms a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive an air flow at the treatment pressure for the patient's breathing, the chassis portion including a pair of laterally projecting connection portions configured to connect to a gas delivery tube, the chassis portion; a seal-forming structure provided on the chassis portion and at least partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's facial region surrounding an entrance to the patient's airway, the seal-forming structure having at least one hole therein such that the air flow at the treatment pressure is delivered at least to an entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, the seal-forming structure; a vent that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the vent being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the vent; and a positioning and stabilization structure that provides a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a pair of gas delivery tube portions, each gas delivery tube portion providing for receiving an air flow from a connection port on the upper part of the patient's head and delivering the air flow to each of the laterally projecting connection portions of the chassis portion, the positioning and stabilization structure; The seal-forming structure includes a central portion on the rear side of the seal-forming structure, the central portion being configured to seal at least the patient's nasal tip point, nasal wings, and upper lip during use. The chassis part includes a pair of decoupling parts, and these decoupling parts are respectively provided on each lateral side of the chassis part, and are less rigid than one or more adjacent parts of the chassis part. The decoupling parts are configured to at least partially decouple the central part from the force applied to the chassis part.

[0123] In an example, (a) each decoupling part is thinner than one or more adjacent parts of the chassis part, (b) the thickness of each decoupling part is 0.5 mm, (c) the thickness of the chassis part is 0.9 mm, (d) each decoupling part is provided on the front side of the chassis part, and / or (e) each decoupling part extends from the upper side to the lower side of the chassis part.

[0124] In a further example, (a) each decoupling part is at least partially surrounded by the peripheral part of the chassis part, and the peripheral part of the chassis part is more rigid than both the decoupling part and the adjacent part of the chassis part with respect to the peripheral part, (b) each peripheral part is thicker than both the decoupling part and the adjacent part of the chassis part with respect to the peripheral part, (c) the thickness of each peripheral part is in the range of 1.5 mm to 2 mm, and / or (d) the thickness of each peripheral part is 1.75 mm.

[0125] In a further example, (a) the chassis part includes two decoupling parts on each side of the chassis part, (b) on each side of the chassis part, the chassis part includes an intermediate decoupling part and a lateral decoupling part, and the lateral decoupling part is arranged laterally to the intermediate decoupling part, (c) the lateral decoupling part is configured to at least partially decouple the seal formation structure from the force applied to the connecting part protruding laterally, (d) the intermediate decoupling part is configured to at least partially decouple the seal formation structure from the force applied to the central region on the front side of the chassis part, (e) the cushion module includes a ventilation module including a ventilation part, the ventilation module is arranged in the central region on the front side of the chassis part, and the intermediate decoupling part is configured to at least partially decouple the seal formation structure from the force applied to the ventilation module.

[0126] In a further example, (a) the lateral release site is D-shaped, (b) the intermediate release site is crescent-shaped, (c) each lateral release site has a lateral side proximate to the distal end of the connecting portion protruding to each side and an intermediate side in a direction opposite to the lateral side, the intermediate side having a higher curvature than the lateral side, (d) the lateral side of each lateral release site is shaped to conform to the shape of each distal end of the connecting portion protruding to the side, (e) each intermediate release site has an intermediate side proximate to the ventilation module and a lateral side in a direction opposite to the intermediate side, the lateral side having a higher curvature than the intermediate side, (f) the intermediate side of each intermediate release site is curved to follow the curvature of the ventilation module, (g) each release site is at least partially surrounded by a peripheral portion of the chassis, the peripheral portion of the chassis being thicker than both the release site and the adjacent portion of the chassis to the peripheral portion, (h) at each side portion of the chassis, the chassis includes a first peripheral portion disposed in the intermediate direction adjacent to the lateral release site and a second peripheral portion disposed laterally adjacent to the intermediate release site, (i) at each side portion of the chassis, the first peripheral portion is curved to follow the curvature of the intermediate side of the lateral release site, (j) at each side portion of the chassis, the second peripheral portion is curved to follow the curvature of the lateral side of the intermediate release site, and / or (k) at each side portion of the chassis, the first peripheral portion and the second peripheral portion are closest at the intermediate point on the front side of the chassis and farthest at the upper side and / or lower side of the chassis.

[0127] 3.15 Further aspects Another aspect of a particular form of the present technology is a system for the treatment of respiratory diseases. The system includes a patient interface according to any one or more of the other aspects of the present technology, an air circuit, and an air source at positive pressure.

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

[0129] Another aspect of a particular form of the present technology is a patient interface configured to allow a patient to breathe from the atmosphere through their own mouth when there is no pressurized air flow through the plenum chamber inlet port.

[0130] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured to expose the patient's mouth during use.

[0131] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured such that a part of the seal-forming structure does not enter the oral cavity during use.

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

[0133] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured such that the seal-forming structure does not extend below the zygomatic arch region during use.

[0134] Another aspect of a particular form of the present technology is a patient interface constructed and arranged to expose the patient's eyes during use.

[0135] Another aspect of a particular form of the present technology is a patient interface constructed and arranged to allow a patient to breathe ambient air during a power outage.

[0136] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured to form a seal on the lower side of the patient's nose without contacting the nasal bridge region of the patient's nose.

[0137] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a ventilation portion and a plenum chamber. The patient interface is constructed and arranged such that gas from inside the plenum chamber can move to the surroundings through the ventilation portion.

[0138] Another aspect of a particular form of the present technology is a ventilation portion that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, and the ventilation portion is sized and shaped to maintain the therapeutic pressure in the plenum chamber during use. Another aspect of a particular form of the present technology is a ventilation portion that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, and the ventilation portion is sized and shaped to maintain the therapeutic pressure in the plenum chamber during use.

[0139] Another aspect of a particular form of the present technology is a patient interface. This patient interface is constructed and arranged such that the patient can lie comfortably in a lateral or side-lying sleep position during use of the patient interface.

[0140] Another aspect of a particular form of the present technology is a patient interface. This patient interface is constructed and arranged such that the patient can lie comfortably in a supine sleep position during use of the patient interface.

[0141] Another aspect of a particular form of the present technology is a patient interface. This patient interface is constructed and arranged such that the patient can lie comfortably in a prone sleep position during use of the patient interface.

[0142] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are not very dexterous or lack insight, or people with limited experience in using this type of medical device.

[0143] One aspect of one form of this technology is a patient interface that can be cleaned, for example, with soap water in the patient's home, and no special cleaning device is required.

[0144] Of course, some of the above aspects may form lower-level aspects of this technology. Also, various combinations of various ones of the lower-level aspects and / or aspects can be made, which may also constitute further aspects or lower-level aspects of this technology.

[0145] Other features of this technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

[0146] 4 Brief Description of the Drawings This technology is illustrated as a non-limiting example in the accompanying drawings. In the drawings, similar reference numerals include the following similar elements:

Brief Description of the Drawings

[0147]

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Embodiments for Carrying Out the Invention

[0148] 5 Detailed Description of Embodiments of the Present Technology Before explaining the present technology in more detail, it should be understood that the present technology is not limited to the specific embodiments that may be different described herein. It should also be understood that the terms used in the present disclosure are for the purpose of explaining the specific embodiments described herein and are not limiting.

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

[0150] 5.1 Treatment Method In one form, as shown in FIG. 1A, the present technology includes a method for treating a respiratory disease. The method includes the step of applying positive pressure to the entrance of the airway of patient 1000.

[0151] In certain embodiments of the present technology, an air supply at positive pressure is provided to the nasal passage of the patient via one or both of the nostrils.

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

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

[0154] 5.3 Patient Interface Referring to FIG. 3A, a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation portion 3400, one form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, 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 so as to facilitate the supply of air at positive pressure to the airway.

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

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

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

[0158] In some examples of the present technology, the component(s) forming the plenum chamber 3200 and / or the seal forming structure 3100 can be permanently attached to one or more headgear conduits. In some examples, the patient interface 3000 can include a removable cushion module 3150 disposed adjacent to the patient's airway inlet. The removable cushion module 3150 forms the plenum chamber 3200 in use and includes the seal forming structure 3100. The cushion module 3150 can be permanently attached to one or more gas delivery tubing portions. These gas delivery tubing portions are configured to be positioned relative to the patient's head in use and to convey an airflow for breathing by the patient from a position above the patient's head to the plenum chamber 3200. The removable cushion module 3150 can have a shape or size similar to the removable cushion module 3150 illustrated in FIGS. 8A-8H (or FIGS. 19A-19F, FIGS. 25A-25I, FIGS. 26A-26I, FIGS. 30A-30E, FIGS. 31A-31D or FIGS. 32A-32D) and described herein, but can be permanently connected to one or more gas delivery tubing portions.

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

[0160] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the ambient.

[0161] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the ambient.

[0162] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the ambient.

[0163] 5.3.1 Prenum Chamber The patient interface 3000 according to some embodiments of the present technology includes a prenum chamber 3200 that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure. The prenum chamber 3200 can receive an air flow at the treatment pressure for breathing by the patient.

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

[0165] Specifically, the chassis part 3210 can at least partially form a plenum chamber 3200 that can be pressurized to a treatment pressure of at least 6 cmH2O exceeding the ambient air pressure. The chassis part 3210 can include one or more laterally protruding connection parts 3212. These connection parts 3212 are configured to connect to the gas delivery pipe part 3350 and are sized and structured to receive an air flow at the treatment pressure for the patient's breathing. Due to the laterally protruding connection parts 3212, the plenum chamber 3200 can also be partially formed together with other parts of the cushion module 3150. The seal forming structure 3100 can be provided on the chassis part 3210 and can at least partially form the plenum chamber 3200. The connection of the seal forming structure 3100 to the chassis part 3210 can be made permanently or removably. The seal forming structure 3100 can be supported by the chassis part 3210.

[0166] In some forms, the plenum chamber 3200 is formed from a single homogeneous material piece. In some forms, the plenum chamber 3200 can be formed from a homogeneous material piece including a connector formed from another material.

[0167] In some examples, the cushion module 3150 can be formed from a single homogeneous material piece. In some forms, the cushion module 3150 can be formed from a homogeneous material piece including a connector formed from another material.

[0168] In a further example, the chassis part 3210 can be formed from a single homogeneous material piece. In some forms, the chassis part 3210 can be formed from a homogeneous material piece including a connector formed from another material.

[0169] In some forms of the present technology, such as the patient interface 3000 shown in FIGS. 7A-7G, the plenum chamber 3200 does not cover the patient's eye during use. In other words, when the patient wears the patient interface 3000, the patient's eye is outside the pressurized space defined by the plenum chamber. In such forms, treatment compliance can be improved because pressure is often reduced and / or the comfort of the wearer is increased.

[0170] In some forms of the present technology, the cushion module 3150 is constructed from at least partially transparent materials (e.g., silicone, thermoplastic elastomer, transparent polycarbonate). For example, in the examples shown in FIGS. 7A-7G, FIGS. 19A-19F, FIGS. 25A-25I, FIGS. 26A-26I, FIGS. 30A-30E, FIGS. 31A-31D, and FIGS. 32A-32D, most of the cushion module 3150 is formed from silicone. Specifically, in these examples, both the chassis portion 3210 and the seal-forming structure 3100 are formed from silicone. In the example shown in FIGS. 16A-16D, the front portions of the chassis portion 3210 and the seal-forming structure 3100 are formed from silicone. The use of transparent materials can reduce the pressure tightness of the patient interface compared to opaque materials, increasing the comfort of the patient when wearing the patient interface 3000, and as a result, assisting in improving treatment compliance. The use of transparent materials can assist the clinician in confirming the placement and function of the patient interface.

[0171] In a particular form of the present technology, the plenum chamber 3200 is composed of a translucent material. By using a translucent material, the pressure tightness of the patient interface 3000 can be reduced, and the improvement of compliance with treatment can be assisted.

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

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

[0174] 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 in the range of 0.7 mm to 1.5 mm (for example, for example, 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 the examples shown in FIGS. 9A to 9H, FIGS. 16A to 16D, FIGS. 19A to 19F, FIGS. 25A to 25I, FIGS. 26A to 26I, the wall thickness of most of the chassis part 3210 (including the connecting part 3212 protruding laterally (described below)) can be 1.25 mm. In another example (for example, the example shown in FIGS. 31A to 31D), the wall thickness of most of the chassis part 3210 is 0.9 mm.

[0175] As further described below, the chassis part 3210 may include an upper chassis reinforcement part 3220. The upper chassis reinforcement part 3220 may have a greater thickness (for example, 1.7 mm as described below with reference to FIGS. 19A to 19F) than most other parts of the chassis part 3210. Further, the chassis part 3210 may include a lower chassis reinforcement part 3221. The lower chassis reinforcement part 3221 may have a thickness (for example, 3 mm as described below with reference to FIGS. 30A to 30E and FIGS. 31A to 31D) greater than other parts of the chassis part 3210. Further, as will be described in more detail, the chassis part 3210 may include a front hole part 3215 and a lip 3230. The lip has a greater thickness (for example, 4 mm as described below) than most other parts of the chassis part 3210.

[0176] In a further example of the method of manufacturing the cushion module 3150, after the generation of the rear side part of the seal forming structure 3100, the front side parts of the chassis part 3210 and 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 may include a textile material and, in some forms, may include a laminate formed from one or more textiles and one or more non - textile layers. The cushion module 3150 generated by one such method is shown in FIGS. 16A to 16D.

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

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

[0179] In this example, the cushion module 3150 includes a pair of connectors 3214 configured to connect to the gas delivery pipe portion 3350 of the positioning and stabilizing structure 3300. In this example, the connectors 3214 are provided on either side of the chassis portion 3210. In this example, each connector 3214 is provided to a laterally projecting connection portion 3212 of each side of the chassis portion 3210. In this example, the connector 3214 is provided at the inlet of the laterally projecting connection portion 3212. FIGS. 7A-7G show the gas delivery pipe portion 3350 connected to the laterally projecting connection portion 3212. The laterally projecting connection portion 3212 will be described in more detail below.

[0180] Since the chassis part 3210 is flexible, the cushion module 3150 can be deformed to fit a wide range of patients. The flexible chassis part 3210 can enable the cushion module 3150 to fit a wider range of patients (than a cushion module 3150 with a rigid chassis part). For example, the cushion module 3150 may be able to expand to fit patients with relatively wide noses, and can also surround the sides inward to fit patients with relatively narrow noses. Although these advantageous effects are obtained due to the flexibility of the chassis part 3210 of the cushion module 3150, providing a certain level of rigidity in the chassis part 3210 is advantageous for the stability and support in the seal formation structure 3100. Thus, in some examples, by providing a rigidifying member to the chassis part 3210, the chassis part 3210 is made more rigid (while maintaining flexibility). In some examples, the chassis part 3210 and the seal formation structure 3100 are formed from a flexible material (such as silicone, TPE, etc.), and the chassis part 3210 includes a rigidifying member. Specifically, the patient interface 3000 or the cushion module 3150 may include a rigidifying member. The rigidifying member can be provided to the chassis part 3210. The rigidifying member can be configured to impart rigidity to the chassis part 3210. The rigidifying member can be configured to withstand the deformation of the chassis part 3210. The rigidifying member can be configured to provide support to the chassis part 3210.

[0181] In some examples, the stiffening member is a member that is more rigid than the chassis portion 3210 of the plenum chamber 3200. The stiffening member can be formed from a material different from that of the chassis portion 3210. The stiffening member can be formed from a material that is harder and / or more rigid than the material forming the chassis portion 3210. The stiffening member can be substantially rigid. The stiffening member can have sufficient rigidity so as not to deform with only finger pressure. The stiffening member can be formed, for example, from polycarbonate, polypropylene, or nylon. In some examples, the stiffening member can be adhered to the chassis portion 3210. In certain examples, the stiffening member can be overmolded onto the chassis portion 3210, or alternatively, the chassis portion 3210 can be overmolded onto the stiffening member. The stiffening member can be removable from the chassis portion 3210. The stiffening member can be provided on one or more sides of the chassis portion 3210. In some examples, the stiffening member is provided on the underside of the chassis portion 3210. In other examples, the stiffening member is provided on the front side of the chassis portion 3210. In certain examples, the stiffening member is provided outside the plenum chamber 3200. In other examples, the stiffening member is provided inside the plenum chamber 3200. In some examples, the plenum chamber 3200 is partially defined by the stiffening member.

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

[0183] As described below, the chassis portion 3210 and the seal forming structure 3100, or more generally the cushion module 3150, may include a plurality of regions, and one or more regions may be more rigid than other regions. Generally, to make a part of the cushion module 3150 more rigid than another part of the cushion module 3150, one or more of an increase in material thickness, an increase in material rigidity (e.g., an increase in Young's modulus), the presence of a rigidifying member, and a shape that provides higher rigidity may be performed. Unless otherwise specified in the context, when it is described that a first part of the cushion module 3150 is more rigid than a second part, each of the above methods for stiffening a part should be understood as being disclosed as an option for making the first part more rigid than the second part. In addition, in the form of the present technology, the first part may be made thicker than the second part by any one or more combinations of the above methods.

[0184] Unless otherwise specified in the context, when referring to the rigidity of a component or its part / region, it should be understood as referring to the rigidity of the structure (e.g., the influence of the rigidity of both materials forming the component or a part thereof and the shape (including thickness) of the component or a part thereof). However, unless otherwise specified in the context, when referring to the rigidity of a certain material, a material having a certain rigidity, etc., it should be understood as referring to a material property independent of the shape / size (e.g., Young's modulus) with respect to the rigidity.

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

[0186] Referring to FIGS. 8A - 8H and FIG. 11A, the front hole portion 3215 is disposed in the center within the chassis portion 3210. In use, the front hole portion 3215 is centered in the sagittal plane of the patient. In this example, the front hole portion 3215 is disposed at a position that is partially forward and partially downward in the chassis portion 3210 during use. In use, the front hole portion 3215 can be aligned with the upper lip of the patient on the upper posterior axis. The front hole portion 3215 can be disposed in front of the upper lip of the patient. The front hole portion 3215 can be disposed above the lower lip and / or the upper lip of the patient. In this example, the front hole portion 3215 is disposed on the opposite side of the chassis portion 3210 with respect to the seal - forming structure. In this example, the upper peripheral portion of the front hole portion 3215 is disposed adjacent to the central portion of the front side portion of the seal - forming structure 3100. Referring to FIGS. 9A - 9H, FIGS. 19A - 19F, FIGS. 25A - 25I and FIGS. 26A - 26I, the upper peripheral portion of the front hole portion 3215 can be adjacent to the central front portion 3115 of the seal - forming structure 3100. The lower peripheral portion of the front hole portion 3215 can be adjacent to the upper lip portion 3116 of the seal - forming structure 3100. The central front portion 3115 and the upper lip portion 3116 will be described in more detail below.

[0187] In some examples, such as the example shown in FIGS. 8A - 8H, the front hole portion 3215 opens partially forward and partially downward during use (however, during use, the front hole portion 3215 includes the ventilation module 3410). The upper peripheral portion of the front hole portion 3215 can be spaced apart in front of the lower peripheral portion of the front hole portion 3215. In use, the front hole portion 3215 can open at an angle of 25 degrees to 65 degrees with respect to the horizontal plane (e.g., Frankfurt horizontal plane) in the forward and downward directions. In some examples, this angle can be 35 degrees to 55 degrees or 40 degrees to 50 degrees. In some specific examples, the front hole portion 3215 can open at an angle of 45 degrees with respect to the horizontal plane in the downward and forward directions.

[0188] In some examples, such as the examples shown in FIGS. 8A to 8H, the front hole portion 3215 is wider than it is tall along the left - right axis. In this example, the upper peripheral portion of the front hole portion 3215 includes a straight portion, the lower peripheral portion of the front hole portion 3215 includes a straight portion, and the left and right side portions of the front hole portion 3215 are curved. In other examples, both the upper edge and the lower edge of the front hole portion 3215 can be curved. The front hole portion 3215 can be oval. In other examples, the front hole portion 3215 can be egg - shaped, circular, rectangular, or square. In some examples, the front hole portion 3215 can generally be a rectangular or square hole portion and includes curved corners. In the examples shown in FIGS. 8A to 8H, the peripheral portion of the front hole portion 3215 is defined by a planar curve (i.e., a curve that extends in a single plane rather than in a space curve).

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

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

[0191] To remove the ventilation module 3410, the patient or clinician can simply push the ventilation module 3410 out of the front hole portion 3215. Since the chassis portion 3210 is deformable, it is possible to remove the ventilation module 3410 from the front hole portion 3215. Since the chassis portion 3210 is deformable, the user can peel the lip 3230 away from the ventilation module 3410 to remove the ventilation module 3410. Since the chassis portion 3210 can be compressed, the deformation of the ventilation module 3410 is assisted. In some examples, the patient can at least partially release the lip 3230 from the peripheral channel 3430 of the ventilation module 3410 by compressing the chassis portion 3210.

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

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

[0194] Since the lip 3230 can be thick, a robust connection to the ventilation module 3410 is created. Further, since the lip 3230 can be thick, rigidity is imparted to the chassis part 3210. The thick lip 3230 can advantageously increase the resistance to torsion of the cushion module 3150. There are times when the cushion module 3150 can receive a torsional force, particularly during sleep in the lateral position or during movement (e.g., turning over) of the patient during sleep. Due to the increased rigidity made possible by the thickness of the lip 3230, resistance is obtained against excessive deformation caused by torsional forces or other forces that can interfere with the seal between the seal formation 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.

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

[0196] 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 from a material different from the rest of the chassis portion 3210 (i.e., the lip 3230 can be formed from a first material and the rest of the chassis portion 3210 can be formed from a second material). In some examples, the lip 3230 is overmolded onto the rest of the chassis portion 3210. In other examples, the chassis portion 3210 is overmolded onto the lip 3230.

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

[0198] In some examples, the chassis portion 3210 excluding the lip 3230 is formed from an elastomeric material (e.g., silicone, TPE) and the lip 3230 is formed from a more rigid material (e.g., polycarbonate, polypropylene, nylon).

[0199] In some examples, the chassis portion 3210 includes female features (e.g., grooves, peripheral channels) around the front hole portion 3215, and these female features are configured to receive complementary male features (e.g., lips, flanges) of the ventilation module 3410. In some examples, the ventilation module 3410 includes a flange around its peripheral portion, and this flange is configured to be received within complementary channels around the peripheral portion of the front hole portion 3215 of the cushion module 3150.

[0200] In other forms of this technology, the chassis portion 3210 of the cushion module 3150 may include a stiffening portion (in addition to the rigidizing ventilation module 3410). This stiffening portion takes the form of a thickened portion spaced apart from the front hole portion 3215. In one example, the chassis portion 3210 may include a stiffening portion that covers the front side portion of the cushion module 3150. In other examples, the chassis portion 3210 may include a stiffening member. The stiffening member may be formed from a material with higher rigidity than the material forming the chassis portion 3210 (e.g., silicone). The chassis portion 3210 may be overmolded onto the stiffening member or (alternatively, the reverse may be done). Alternatively, the stiffening member may be inserted into the chassis portion 3210 and snap-fitted to the chassis portion 3210 or fixed to the front side portion of the chassis portion 3210 in other ways.

[0201] It is advantageous to have sufficient resistance to excessive deformation, particularly due to torsion. However, providing a certain degree of independence between the sides of the cushion module 3150 is advantageous as it results in a decoupling effect, enabling the cushion module 3150 to withstand the force received on one side (without transmitting the force to the other side). As described above, since the chassis portion 3210 can be formed from a flexible material, it is possible to partially decouple one side of the cushion module 3150 from the other side. For example, the chassis portion 3210 can move at least partially in a decoupled manner the one laterally protruding connection portion 3212 from the other laterally protruding connection portion 3212.

[0202] 5.3.1.2 Ventilation Module Positioning Features The cushion module 3150 may include one or more features configured to enable easy positioning of the ventilation module 3410 and to avoid misalignment of the ventilation module 3410. Specifically, the cushion module 3150 may include one or more positioning features 3216 structured and / or arranged to clarify the correct orientation of the ventilation module 3410 for 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 fit with corresponding features of the ventilation module 3410.

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

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

[0205] In the examples shown in FIGS. 8A-8H, since the shapes of the front hole portion 3215 and the ventilation module 3410 are at least partially asymmetric, the possibility that the user causes misalignment of the ventilation module 3410 is reduced. Since the shapes of the front hole portion 3215 and the ventilation module 3410 are larger in height than in width, the ventilation module 3410 can be inserted into the front hole portion 3215 only in the horizontal direction. In some examples, the front hole portion 3215 may be asymmetric about at least one axis, and in some examples, the front hole portion 3215 is asymmetric about a plurality of axes. In some examples, since the front hole portion 3215 is asymmetric, there is only one direction in which the ventilation module 3410 can be fitted into the front hole portion 3215.

[0206] In some examples, the cushion module 3150 and / or the ventilation module 3410 includes a guide indicating the correct orientation of the ventilation module 3410 (e.g., alignment markings, depressions, or other visual or tactile features indicating the correct orientation of the ventilation module 3410).

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

[0208] Each upper chassis reinforcement portion 3220 is provided to each horizontal and front side of the chassis portion 3210. Each upper chassis reinforcement portion 3220 is arranged at an interval in the intermediate direction from the distal end of the connecting portion 3212 protruding to each side. For example, each upper chassis reinforcement portion 3220 may be arranged at an interval in the intermediate direction from each one of the connecting portions 3212 protruding to the side. Each upper chassis reinforcement portion 3220 may have a side boundary arranged at an interval from the distal end of each one of the connecting portions 3212 protruding to the side.

[0209] As described above, the chassis portion 3210 may be formed of a flexible material that may be an elastomeric material. The upper chassis reinforcement portion 3220 may be formed of the flexible material forming the chassis portion 3210. The seal forming structure 3100 may be formed of a flexible material. The upper chassis reinforcement portion 3220 may be integrally formed with the chassis portion 3210. For example, the upper chassis reinforcement portion 3220 may be formed together with an adjacent portion of the chassis portion 3210 in a single molding step. By the upper chassis reinforcement portion 3220, the plenum chamber 3200 may be partially defined together with other parts of the chassis portion 3210.

[0210] In the illustrated example, each upper chassis reinforcement portion 3220 is arranged at an upper position of the chassis portion 3210 (for example, generally above the front hole portion 3215). Each upper chassis reinforcement portion 3220 may be higher in rigidity than one or more adjacent portions of the chassis portion 3210. This higher rigidity may be obtained because the wall thickness of the upper chassis reinforcement portion 3220 is larger than the wall thickness of one or more adjacent portions of the chassis portion 3210. In some examples, the wall thickness of the upper chassis reinforcement portion 3220 is 1 mm to 3 mm. In some examples, the wall thickness is 1.2 mm to 2.5 mm or 1.5 mm to 2.3 mm. In the examples shown in FIGS. 19A to 19F, FIGS. 22B and FIGS. 31A to 31D, the wall thickness of the upper chassis reinforcement portion 3220 is 1.7 mm. In the examples shown in FIGS. 30A to 30E, the wall thickness of the upper chassis reinforcement portion 3220 is 2.1 mm.

[0211] The chassis upper reinforcement part 3220 can assist in increasing the stability of the cushion module 3150 (for example, when the patient is sleeping or in the bed) and the seal generated against the patient's face during dynamic movement of the patient's face. The chassis upper reinforcement part 3220 can also make the resistance to excessive flare from the seal forming structure 3100 higher when the patient's face, which has a slightly different outer shape from the seal forming surface of the seal forming structure 3100, comes into contact with the seal forming structure 3100. The existence of such a flare can cause the formation of a leakage path. In that case, the seal forming structure 3100 loses contact with the patient's face due to the chassis part 3210 (in the example of this technology, the chassis part 3210 is flexible). The chassis upper reinforcement part 3220 can also increase the torsional resistance. The chassis upper reinforcement part 3220 can avoid a situation where one side of the cushion module 3150 is twisted in a separated direction from the other side of the cushion module 3150 or twisted with respect to the other side of the cushion module 3150. Such a situation can lead to the loss of contact between the patient's nose and the leakage path.

[0212] As shown in FIGS. 19A-19F, FIGS. 30A-30E, FIGS. 31A-31D, and FIGS. 32A-32D, each chassis upper reinforcement part 3220 is provided laterally to the front hole part 3215 at an upper position. Each chassis upper reinforcement part 3220 is arranged adjacent to each upper corner part of the front hole part 3215. A part of each chassis upper reinforcement part 3220 can be arranged on the front surface of the connecting part 3212 protruding to each side.

[0213] Each chassis upper reinforcement 3220 can be disposed adjacent to the seal forming structure 3100 and in the chassis portion 3210 in front of the seal forming structure 3100. The chassis upper reinforcement 3220 can share a boundary with the seal forming structure 3100. Each chassis upper reinforcement 3220 can include an upper boundary that meets a part of the lower boundary at the front of the seal forming structure 3100. As shown in FIGS. 19E, 19F, 30A, and 31A, each chassis upper reinforcement 3220 can have a curved upper surface that matches the curvature of the lower boundary of the seal forming structure 3100. Each chassis upper reinforcement 3220 can have a curved lower surface that matches the curvature of the front hole portion 3215. As shown in FIGS. 19E and 19F, in one example, the outer side portions on the sides of each chassis upper reinforcement 3220 can have a sharp shape in the outer lateral direction.

[0214] In some examples, each chassis upper reinforcement 3220 can extend laterally outward with respect to the side portions of each connection portion 3212 of the chassis portion 3210. This is exemplarily shown in FIGS. 30A to 30E. In this example, each chassis upper reinforcement 3220 extends from the front hole portion 3215 in the chassis portion 3210 to the upper raised portion 3213 along each laterally protruding connection portion 3212. These upper raised portions 3213 will be described in more detail below. In use, each chassis upper reinforcement 3220 can be provided at a portion of the chassis portion 3210 that faces somewhat forward. In the example shown in FIGS. 30A to 30E, each chassis upper reinforcement 3220 is provided on the chassis portion 3210 along the boundary between the chassis portion 3210 and the seal forming structure 3100. Each chassis upper reinforcement 3220 can be wider in the vicinity of the middle portion of the chassis portion 3210 (e.g., in the front hole portion 3215 or the ventilation module 3410) than in the lateral portions of the chassis portion 3210.

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

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

[0217] In other examples of the present technology, the chassis upper reinforcement 3220 may be formed by a stiffener formed of a material having a higher rigidity than the material forming the remaining portion of the chassis portion 3210.

[0218] 5.3.1.4 Chassis Lower Reinforcement In some examples of the present technology, the cushion module 3150 may include a chassis lower reinforcement 3221. The cushion module 3150 may include the chassis lower reinforcement 3221 in addition to or as an alternative to the chassis upper reinforcement 3220. In other examples of the present technology, the cushion module 3150 may not include the chassis upper reinforcement 3220 or the chassis lower reinforcement 3221.

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

[0220] Each lower chassis reinforcement portion 3221 can be arranged at an intermediate direction spaced apart from the distal end of the connecting portion 3212 protruding laterally. For example, each lower chassis reinforcement portion 3221 can be arranged at an intermediate direction spaced apart from one of the connecting portions 3212 protruding laterally. Each lower chassis reinforcement portion 3221 can have a lateral boundary arranged at an interval from the distal end of one of the connecting portions 3212 protruding laterally.

[0221] As described above, the chassis portion 3210 can be formed from a flexible material that can be an elastomeric material. The lower chassis reinforcement portions 3221 can be formed from the flexible material forming the chassis portion 3210. The lower chassis reinforcement portions 3221 can be integrally formed with the chassis portion 3210. For example, the lower chassis reinforcement portions 3221 can be formed together with the adjacent portion of the chassis portion 3210 in a single molding step. The lower chassis reinforcement portions 3221 can partially define the plenum chamber 3200 together with other parts of the chassis portion 3210.

[0222] The under-chassis reinforcement part 3221 can be extended. As shown in FIGS. 30E and 31D, each of the under-chassis reinforcement parts 3221 extends laterally along the chassis part 3210 from an intermediate position near the upper lip part 3116 of the seal formation structure 3100 (described in more detail below) to a lateral position near the side rear region 3141 of the seal formation structure 3100. As shown in the figure, the under-chassis reinforcement part 3221 has intermediate boundaries arranged at intervals. The under-chassis reinforcement part 3221 can be shaped to follow the boundary between the chassis part 3210 and the seal formation structure.

[0223] Each of the under-chassis reinforcement parts 3221 can be higher in rigidity than the adjacent part 3210 of the chassis part. In the example shown in FIGS. 30A to 30E, the thickness of each of the under-chassis reinforcement parts 3221 is greater than the thickness of the adjacent part of the chassis part 3210. In this example, such a greater thickness provides higher rigidity. Similar advantages can be provided by the under-chassis reinforcement part 3221 to the upper-chassis reinforcement part 3220. By imparting rigidity from the under-chassis reinforcement part 3221 to the chassis part 3210, the conversion from the head gear force to the sealing force is promoted.

[0224] In the example shown in FIGS. 30A to 30E, the thickness of each under-chassis reinforcement part 3221 is 3 mm, and in other examples, the thickness can be 1.5 mm to 4.5 mm. Also in the example shown in FIGS. 31A to 31D, the thickness of the under-chassis reinforcement part 3221 is 3 mm. The thickness of the chassis part 3210 can change gradually between the under-chassis reinforcement part 3221 and the adjacent part. That is, the chassis part 3210 of the cushion module 3150 can include a location where the thickness changes in a tapered shape between each under-chassis reinforcement part 3221 and one or more adjacent parts. In other examples, the chassis part 3210 can include a location where the thickness changes stepwise at the boundary of the under-chassis reinforcement part 3221.

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

[0226] In some examples of the present technology, a plenum chamber inlet port may be defined by each laterally protruding connection portion 3212.

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

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

[0229] FIG. 24A is a cross-sectional view of the cushion module 3150 through the center of the cushion module 3150 as shown in FIG. 23. Line L is shown in FIG. 24A. Line L is a straight line 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, after moving one line to 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 rotating it around that point until it contacts a second point on the patient contact side, line L is obtained. In an example of the present technology, if such a line cannot be drawn in this way or there are multiple possible orientations for such a line, line L can be a center line drawn from the part of the seal forming structure 3100 that generally contacts the patient's upper lip across the patient contact side of the seal forming structure 3100 to the part of the seal forming structure 3100 that contacts the patient's nasal tip point.

[0230] FIG. 24B shows a line L1 that is a horizontal line perpendicular to line L. In FIG. 24B, the angle A between line L1 and line LA is also shown. Line LA indicates the direction in which the connection part 3212 protrudes in the plane of the drawing. Therefore, angle A is an angle in the plane of the drawing and does not represent an angle in three-dimensional space. Angle A can be regarded as a "height" angle. Angle A can be regarded as an upward angle of the connection part 3212 or the connector 3214.

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

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

[0233] The line L2 shown in FIG. 24C is another horizontal line perpendicular to the line L. In FIG. 24C, the angle B between the line L2 and the line LB is also shown. The line LB indicates the direction in which the connection portion protrudes in the plane of the drawing. Therefore, the angle B is an angle in the plane of the drawing and does not indicate an angle in three-dimensional space. The angle B can be regarded as a "depth" angle. The angle B can be regarded as the angle behind the connection portion 3212 or the connector 3214.

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

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

[0236] With these specific angles, when the connection portion 3212 is connected to the gas delivery pipe portion 3350 of the positioning and stabilizing structure 3300, the seal forming structure 3100 can be held in a sufficiently expanded state, so that the patient's nose is not pressed to an excessive extent (which causes obstruction of the patient's nasal airway). In an example of the present technology where the chassis portion 3210 is flexible, the seal forming structure 3100 may be more likely to be folded in the intermediate direction than when the chassis portion 3210 is rigid. Therefore, the angle of the connection portion 3212 that holds the seal forming structure 3100 in a sufficiently open state is useful in avoiding excessive intermediate force on the side of the patient's nose.

[0237] Line L shown in FIG. 24A can be oriented with respect to the Frankfort horizontal plane of the patient's head such that, when the patient interface 3000 is in use, the presentation angle of the seal-forming structure 3100 comes between line L and the Frankfort horizontal plane. More specifically, the presentation angle can be the angle between line L in use and a line extending in both the Frankfort horizontal plane and the sagittal plane of the patient's head. This presentation angle can be formed in use between line L of the patient interface 3000 and a line at the intersection of the Frankfort horizontal plane and the sagittal plane.

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

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

[0240] 5.3.1.6 Connector Figures 17A-17E show a connector 3214 according to an example of the present technology, Figures 27A-27C show a connector 3214 according to another example of the present technology, and Figures 33A-33B show a connector 3214 according to still another example of the present technology. The connector 3214 described with reference to Figures 17A-17E, Figures 27A-27C, and Figures 33A-33B can each be provided in any of the cushion modules 3150 described herein (for example, any of the cushion modules 3150 described with reference to Figures 8A-8H, Figures 9A-9H, Figures 16A-16D, Figures 19A-19F, Figure 20, Figure 23, Figures 24A-24C, Figures 25A-25I, Figures 26A-26I, Figures 30A-30E, Figures 31A-31D, and Figures 32A-32D, etc.). As described above, the connector 3214 can be provided at a connecting portion 3212 protruding to each side of the chassis portion 3210. In this example, the connector 3214 is provided at the entrance of the laterally protruding connecting portion 3212. Each of the connectors 3214 can be configured to connect to a corresponding connector on each one of the gas delivery pipe portions 3350. Specifically, each of the connectors 3214 is configured to connect each one of the connecting portions 3212 protruding to the side of the chassis portion 3210 to each one of the gas delivery pipe portions 3350.

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

[0242] As shown in Figures 17A-17E and Figures 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 a connecting portion 3212 protruding to each side of the chassis portion 3210.

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

[0244] For example, in the cross-sectional views shown in FIGS. 17C, 17E, and 27C, the outward-facing surface 3181a of the chassis connection portion 3181 can be substantially straight. For example, in these three dimensions shown in FIGS. 17A and 27A, the chassis connection portion 3181 can be curved around the outer peripheral portion 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 the connection portion 3212 protruding on each side of the chassis portion 3210.

[0245] As shown in FIGS. 17C, 17E, and 27C, the chassis connection portion 3181 includes an inward-facing surface 3181b (illustrated in FIG. 27C) on the opposite side of the outward-facing surface 3181a. The length of the inward-facing surface 3181b can be made shorter than the outward-facing surface 3181a. The cross-section of the inward-facing surface 3181b can be substantially linear and can be parallel to the length of the connector 3214. The cross-section of the inward-facing surface of the chassis connection portion 3181 can be parallel 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 peripheral portion of the chassis connection portion 3181.

[0246] Between the outer-facing surface 3181a and the inner-facing surface 3181b of each chassis connection part 3181 (for example, the side part of the connector 3214 inside the chassis part 3210) on the downstream side of the connector 3214, it is a substantially flat downstream end surface. By this downstream end surface, the downstream side part of the outer-facing surface 3181a and the inner-facing surface 3181b of the chassis connection part 3181 are connected.

[0247] Each connector 3214 includes a protruding connector part 3182. In the present form of the present technology, the protruding connector part 3182 extends in a direction away from the chassis part 3210. Each protruding connector part 3182 extends in the upstream direction. Each protruding connector part 3182 extends from the chassis connection part 3181 from the inner side with respect to the chassis connection part 3181. Specifically, the protruding connector part 3182 can protrude in a direction away from the chassis connection part 3181 along the length of the connector 3214. As shown in FIGS. 17E and 27C, each protruding connector part 3182 is arranged adjacent to the inner-facing surface 3181b of one chassis connection part 3181 of each connector 3214.

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

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

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

[0251] As shown in FIGS. 17E and 27C, the outer shoulder 3183 includes a wall portion 3183a that is substantially flat with respect to the length of the connector 3214. The flat wall portion 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 portion 3183a of the outer shoulder 3183 can be parallel to the downstream end wall portion of the chassis connection portion 3181 that connects the outward-facing surface 3181a and the inward-facing surface of the chassis connection portion 3181. As shown in FIGS. 17E and 27C, the protruding connector portion 3182 can include an outward-facing wall portion. This outward-facing wall portion is substantially flat and substantially parallel to the outward-facing surface 3181 of the chassis connection portion 3181. The flat wall portion 3183a of the outer shoulder 3183 can be substantially perpendicular to this outward-facing wall portion of the protruding connector portion 3182. A curved portion of the cross-section of the outer shoulder 3183 is provided between the flat wall portion 3183a of the outer shoulder 3183 and the outward-facing wall portion 3183a of the protruding connector portion 3182. In other examples, the transition between the flat wall portion 3183a and the protruding connector portion 3182 can be a sharp corner.

[0252] The outer shoulder 3183 can be configured to form a seal with the end of the gas delivery tube portion 3350 during use. Each gas delivery tube portion 3350 can include a substantially flat surface at its downstream end. This substantially flat surface engages with the outer shoulder 3183 of each connector 3214 and is configured to form a seal with the outer shoulder 3183 of each connector 3214. The outer shoulder 3183 extends around the perimeter of the connector 3214 and can be configured to engage with the sealing surface around the perimeter of the corresponding connector of each gas delivery tube portion 3350. The flat wall portion 3183a can be configured to engage with the flat surface of each gas delivery tube portion 3350. Since the recess 3185 can be spaced apart from the outer shoulder 3183, when a snap fit is formed between the recess 3185 and the corresponding portion of the connector on the gas delivery tube portion 3350, the compliant portion of the gas delivery tube portion 3350 is held closely against the outer shoulder 3183.

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

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

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

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

[0257] The clip base portion 3186 is adjacent to the chassis connection portion 3181 of the connector 3214. As shown in FIG. 27C, the clip base portion 3186 may extend from the inner peripheral portion of the chassis connection portion 3181. Since the cross-sectional shape of the clip base portion 3186 is similar to that of the chassis connection portion 3181 but smaller, a step occurs at the outer surface of the connector 3214 and at the boundary between the clip base portion 3186 and the chassis connection portion 3181. The chassis connection portion 3181 and the clip base portion 3186 may surround a hole passing through the connector 3214, and through this hole, breathable gas moves during use. For example, the chassis connection portion 3181 and the clip base portion 3186 may each be formed in an approximately D shape when viewed from a cross-section along the central axis passing through the inside of the connector 3214.

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

[0259] FIG. 29 shows the tube end 3314 of the gas delivery tube portion 3350 of the patient interface 3000 shown in FIGS. 7A-7G. The connector 3214 shown in FIGS. 17A-17E and FIGS. 27A-27C is configured to connect to this tube end 3314. Specifically, the protruding connector portion 3182 of the connector 3214 is configured to be received within the tube end 3314 and connect to the tube end connector 3302 within the tube end 3314. In the example shown in FIG. 29, the tube end connector 3302 is overmolded onto a clip overmold 3318, and the clip overmold 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 portion 3350 at the tube end 3314.

[0260] When a snap - fit connection is provided between the connector 3214 and a corresponding pipe - end connector 3302 provided at the pipe - end 3314 of the gas delivery pipe section 3350, in these examples, the clip arms 3187 deform so that the clip protrusions 3304 of the pipe - end connector 3302 slide on the surface facing outward of the clip arms 3187 and then are fitted into the recesses 3185 to form a snap - fit connection. To facilitate the snap - fit connection, the clip arms 3187 can each bend inwardly toward the central axis of the connector 3214. In some examples of the present technology, the pipe - end connector 3302 can also deform when making a snap - fit connection to the connector 3214. The pipe - end 3314 also includes a lip 3324 that forms a seal with the connector 3214. The lip 3324 can seal one or more of the protruding connector portion 3182, the outer shoulder 3183, the flat wall portion 3183a of the outer shoulder 3183, and the connection portion 3212 of the chassis portion 3210.

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

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

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

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

[0265] According to the discovery of the present applicant, by individually adjusting the lengths of the clip base portion 3186 and the clip arm 3187 without changing the distance (for example, distance C1 and distance C2) between the recess 3185 and the chassis connection portion 3181, an advantageous holding force of the connector 3214 when connecting to the gas delivery pipe portion 3350 is achieved. When the patient interface 3000 is in use, the cushion module 3150 is held in the sealing position by the gas delivery pipe portion 3350. (For example, when the patient pulls the gas delivery pipe portion 3350 to wear or adjust the patient interface 3000 during setup or when the patient moves during sleep during use), it is advantageous to make the force required to disconnect the gas delivery pipe portion 3350 high enough so that the gas delivery pipe portion 3350 is not inadvertently disconnected. Further, it is advantageous not to increase the force required to connect and disconnect the gas delivery pipe portion 3350 so much that it becomes difficult for the patient to disassemble and reassemble the patient interface 3000 (for example, during cleaning or replacement of the cushion module 3150).

[0266] The length of the clip arm 3187 is a factor in the force required to sufficiently deflect the clip arm 3187 during a snap-fit connection to the pipe end connector 3302. When the clip arm 3187 is longer, the force required to be applied to the free end to deflect the free end of the clip arm 3187 by a specific amount decreases. When connecting and disconnecting the gas delivery pipe portion 3350 to and from the connector 3214, the force from the pipe end connector 3302 is applied inwardly to each clip arm 3187 with respect to the connector 3214. A specific amount of deflection of each clip arm 3187 is required to enable connection and disconnection of the gas delivery pipe portion 3350 to and from the connector 3214. Thus, when the clip arm 3187 is longer, the force required to connect or disconnect the gas delivery pipe portion 3350 to and from the connector 3214 is lower. Similarly, when the clip arm 3187 is shorter, the force required to connect or disconnect the gas delivery pipe portion 3350 to and from the connector 3214 is higher.

[0267] Therefore, with respect to a given interval between the recess 3185 and the chassis connection part 3181 (for example, C1 in FIG. 28A and C2 in FIG. 28B), the length of the clip base part 3186 (for example, CB1 in FIG. 28A and CB2 in FIG. 28B) and the length of the clip arm 3187 between the clip base part 3186 and the recess 3185 (for example, CA1 in FIG. 28A and CA2 in FIG. 28B) can be adjusted individually so as to achieve the holding force of the connector 3214 while balancing the requirement of maintaining the connected state to the gas delivery pipe part 3350 when the connector 3214 is in use and enabling the patient to appropriately disconnect the connector 3214 from the gas delivery pipe part 3350.

[0268] In one form of the present technology such as the connector 3214 shown in FIGS. 17A to 17E and FIG. 28A, for example, the length CB1 of the clip base part 3186 is shorter than the length CA1 of the clip arm 3187 along the length of the connector 3214 between the clip base part 3186 and the recess 3185. According to the discovery of the present applicant, the cushion module 3150 including this connector 3214 can be connected to the gas delivery pipe part 3350, and a connection state with a sufficiently high holding force that enables a sufficiently stable connection during use can be maintained.

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

[0270] According to the discovery of the applicant, when the length of the clip base portion 3186 along the length of the connector 3214 is equal to or greater than the length of the clip arm 3187 along the length of the connector 3214 between the clip base portion 3186 and the recess 3185, particularly advantageous holding force can be obtained. The holding force (for example, the separating force that the connection can withstand before separation) is high enough to reduce the possibility of unintentional disconnection during setup or use, and is not excessively high such that it becomes difficult for the patient to intentionally disconnect the cushion module 3150 from the gas delivery tube portion 3350.

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

[0272] In some examples of the present technology, the force required to disconnect each connector 3214 of the cushion module 3150 from the tube end connector 3302 of each gas delivery tube portion 3350 can exceed 12 N. In further examples, the required force can exceed 20 N, 25 N, or 30 N. In some examples, the required force can be in the range of 12 N to 50 N. In further examples, the required force is in the range of 20 N to 40 N (e.g., in the range of 20 N to 30 N or in the range of 30 N to 40 N). In some examples, the required force is in the range of 25 N to 35 N. In some examples of the patient interface 3000 according to the present technology, the cushion module 3150 can be separable from the gas delivery tube portion 3350 of the patient interface 3000 (when a force exceeding or within the above-described range is applied), but can also include one or more connectors 3214 of a design other than the designs shown in FIGS. 17A to 17E, FIGS. 27A to 27C, or FIGS. 28A to 28B).

[0273] Referring to FIGS. 33A to 33B, the clip arm 3187 of the connector 3214 includes a clip arm corner 3188. Each clip arm 3187 can include a pair of clip arm corners 3188 at the distal end of the clip arm 3187 on the opposite side of the chassis connection portion 3181 of the connector 3214. In this example, the clip arm corner 3188 is curved. By making the clip arm corner 3188 curved, the stress at the clip arm corner 3188 during connection of the connector 3214 to the gas delivery tube portion 3350 can be reduced. If excessive stress exists at the clip arm corner 3188, it can lead to a decrease in the life or reliability of the cushion module 3150. By shaping the clip arm corner 3188 as described below, a connector 3214 with a low risk of chipping, cracking, or damage or defects in other forms during use can be advantageously obtained.

[0274] FIG. 33A is a view of the connector 3214 from the first side where the front clip arm 3187 and its clip arm corner 3188 are illustrated and described. The first side may be the front side of the connector 3214 during use. In other examples, the first side may be the rear side of the connector 3214 during use, and the illustrated clip arm 3187 may be the rear clip arm 3187. Each clip arm corner 3188 may be in an arc shape. This arc may have a transverse dimension CR1 in a direction orthogonal to the longitudinal axis of the connector 3214 (this longitudinal axis is substantially parallel to the direction of the gas flow passing through the connector 3214 during use) and a longitudinal dimension CR2 parallel to the longitudinal axis of the connector 3214.

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

[0276] FIG. 33B is a view of the connector 3214 from the second side where the rear clip arm 3187 and its clip arm corner 3188 are illustrated and described. The second side may be the rear side of the connector 3214 during use. In other examples, the second side may be the front side of the connector 3214 during use, and the illustrated clip arm 3187 may be the front clip arm 3187. Each clip arm corner 3188 may be in an arc shape. The above arc may have a transverse dimension CR3 in a direction orthogonal to the longitudinal axis of the connector 3214 and a longitudinal dimension CR4 parallel to the longitudinal axis of the connector 3214.

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

[0278] 5.3.1.7 Connection between the connector and the laterally protruding connection part FIG. 18A is a cross-sectional view through the chassis part 3210, showing the connection between the connector 3214 and the laterally protruding connection part 3212. As shown in the figure, the end of the laterally protruding connection part 3212 is joined to the chassis connection part 3181 of the connector 3214. The protruding connector part 3182 protrudes in a direction away from the laterally protruding connection part 3212.

[0279] As shown in FIG. 18A, each laterally protruding connection part 3212 can include an upper part that is convex when viewed from above and a lower part that is concave when viewed from below. Each laterally protruding connection part 3212 can be curved downward in a direction away from the seal forming structure 3100. This is also apparent from FIGS. 8D and 8H.

[0280] As shown in FIG. 21, each laterally protruding connection part 3212 includes an upper raised part 3213. Each upper raised part 3213 can extend horizontally over the length of the laterally protruding connection part 3212. Each upper raised part 3213 can extend longitudinally along the length of the laterally protruding connection part 3212. In this example of the present technology, each upper raised part 3213 extends over one of the laterally protruding connection parts 3212 in the horizontal direction and along one of the laterally protruding connection parts 3212 in the longitudinal direction. One end of each upper raised part 3213 can be arranged at an upper and front position with respect to the laterally protruding connection part 3212. The other end of each upper raised part 3213 can be arranged adjacent to the seal formation structure 3100 on the upper side and the rear side of the laterally protruding connection part 3212, as shown in FIG. 21.

[0281] 5.3.2 Positioning and stabilization structure The seal formation structure 3100 of the patient interface 3000 of the present technology can be held in the sealed position by the positioning and stabilization structure 3300 during use. Since the positioning and stabilization structure 3300 engages with the patient's head to hold the patient interface 3000 in the sealed position, it has and functions as a "headgear". In some examples of the present technology, the positioning and stabilization structure 3300 can include any one or more of the features described in International Application No. PCT / AU2019 / 050874. The entire content of this document is incorporated herein by reference.

[0282] In one form, the positioning and stabilization structure 3300 provides a holding force that is at least sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 for lifting off the face.

[0283] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the gravitational force on the patient interface 3000.

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

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

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

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

[0288] In one form of the present technology, the positioning and stabilization structure 3300 includes a release site disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. This release site is not resistant to compression and can be, for example, a flexible or flimsy strap. The release portion is constructed and arranged such that when the patient lies with their head on a pillow, the presence of the release portion can avoid a situation where a force to the rear is transmitted along the positioning and stabilization structure 3300 and the seal is obstructed.

[0289] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous such that moisture (e.g., sweat) can pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0290] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured to be taut during use and direct a force to bring the seal forming structure into close contact with a part of the patient's face, and in some embodiments, can be configured in combination with other straps or other structures. In one embodiment, the strap can be configured as a tie.

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

[0292] In one form of the present technology, the positioning and stabilization structure 3300 includes a first tie, and the first tie is constructed and arranged such that at least a part of its lower edge moves upward and passes over the upper ear base point of the patient's head and covers a part of the parietal bone and / or the frontal bone during use. The first tie can be provided as part of a patient interface including, for example, a cradle cushion, a nasal pillow, a nasal cushion, or a full face cushion (a nasal-sub full face cushion or a full face cushion that seals the patient's nose above the nasal tip point), a full face cushion, or an oro-nasal cushion.

[0293] In some examples of the present technology, the first type of the positioning and stabilization structure 3300 includes an upper first type portion and a lower first type portion. The upper first type portion can be placed on a part of the parietal bone and / or the frontal bone. The lower first type portion is placed on or covers the posterior part of the occipital bone of the patient's head. The first type can be branched. The first type can be branched into an upper first type portion and a lower first type portion. The first type can include a front portion configured to be placed on the side of the patient's head / face and a branched portion configured to be placed on the side, above and / or behind the patient's head. The front portion can be integrally formed with the upper first type portion. The lower first type portion can be connected to the joint between the front portion and the upper first type portion.

[0294] For example, as shown in FIGS. 7A to 7G, the positioning and stabilization structure 3300 includes a first type. This first type is a part that is connected to the cushion module 3150 and is arranged along the patient's head over the upper surface and the posterior surface of the patient's head during use. The first type is branched into an upper first type portion and a lower first type portion. The upper first type portion is provided by the upper part of each gas delivery tube portion 3350, and the lower first type portion is provided by the strap 3310 shown in FIG. 7A.

[0295] In one form of the present technology, the positioning and stabilization structure 3300 includes a second tie. The second tie is constructed and arranged such that at least a portion of its upper edge passes below the inferior subauricular point below the patient's head during use and covers or is placed below the occipital bone of the patient's head. The second tie may pass below the patient's ear. The second tie includes, for example, a full face cushion (which may or may not expose the patient's nasal tip point) or a nasal cushion. It may be provided as part of the patient interface. In other embodiments, the second tie may be provided as part of a patient interface including a cradle cushion or a nasal pillow cushion. The second tie may be placed laterally and / or posteriorly to the patient's neck during use and may be connected to the lower part of the frame of the positioning and stabilization structure 3300, the lower part of the cushion module 3150, or the lower part of the plenum chamber 3200.

[0296] In one form of the present technology, the positioning and stabilization structure 3300 includes a third tie constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move in a mutually separating direction. The third tie may be provided as part of a patient interface including a full face cushion (which may or may not leave the patient's nasal tip point exposed) or a nasal cushion. In other examples, the third tie may be provided as part of a patient interface including a cradle cushion or a nasal pillow cushion.

[0297] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is bendable and, for example, non-rigid. An advantage of this aspect is that the strap is more comfortable when the patient lies on their side during sleep. As shown in FIGS. 7A - 7G, the positioning and stabilization structure 3300 includes a pair of non-rigid gas delivery tube portions 3350. Further, the positioning and stabilization structure 3300 includes a non-rigid strap 3310.

[0298] As shown in FIGS. 7A-7G, the positioning and stabilization structure 3300 includes a pair of tabs 3320. In use, a strap 3310 (shown in FIG. 7A) can be connected between the tabs 3320. Since the strap 3310 is sufficiently flexible, it can be comfortably positioned against the patient's head by passing around the rear of the patient's head (even when under tension in use).

[0299] In certain forms of the technology, the positioning and stabilization structure 3300 includes a strap configured to be breathable such that water vapor can pass therethrough. The strap 3310 of the positioning and stabilization structure 3300 of the exemplary patient interface 3000 shown in FIGS. 7A-7G is constructed from a foam material coated within a textile material. In other examples, the strap 3310 can be formed from only a foam material, a textile material, or another material (e.g., a soft plastic material).

[0300] 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 is configured to provide a holding force for accommodating different sizes and / or ranges of shapes. For example, the system can include one form of the positioning and stabilization structure 3300 that is suitable for a large-sized head rather than a small-sized head and another form that is suitable for a small-sized head rather than a large-sized head.

[0301] 5.3.2.1 Headgear Tubing In some forms of the 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 plenum chamber 3200 and then to the patient's airway, for example, through the cushion module 3150 and the seal-forming structure 3100. The tubing 3350 can receive a flow of pressurized gas from a conduit that forms part of the air circuit 4170. This conduit can be connected to the RPT device 4000.

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

[0303] Since it is possible to accommodate and move air through the headgear tubing 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 is understood that an inflatable positioning and stabilization structure 3300 does not require all components of the positioning and stabilization structure 3300 to be inflatable. For example, in the example shown in FIGS. 7A-7G, the positioning and stabilization structure 3300 includes a headgear tube 3350 that is inflatable and a strap 3310 that is not inflatable.

[0304] In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 disposed adjacent to the upper, side, or rear of the patient's head. For example, in the form of the present technology shown in FIGS. 7A-7G, the connection port 3600 is disposed on top of the patient's head. In this example, the patient interface 3000 includes an elbow 3610 provided with the connection port 3600. The elbow 3610 may be rotatable relative to the positioning and stabilization structure 3300, and positions and stabilizes the movement of the conduit connected to the connection port 3600 away from the connection to the positioning and stabilization structure 3300. The elbow 3610 is configured to be fluidly connected to the conduit of the air circuit 4170.

[0305] In the case of a patient interface where the connection port is not disposed in front of the patient's face, it can be advantageous because there are patients who may find it obstructive and uncomfortable when the conduit is connected to a patient interface in front of the face. For example, a conduit connected to a patient interface in front of the face may be prone to entanglement with bedding or bed linen, especially when the conduit extends downward from the patient interface during use. According to the form of the present technology using a patient interface where the connection port is disposed adjacent to the upper part of the patient's head during use, when the patient lies or sleeps in one or more of the following positions, it can be easier or more comfortable compared to other types of patient interfaces: a lateral or horizontal position, a supine position (i.e., a face-up state), and a prone position (i.e., a face-down prostrate state). Furthermore, when the conduit is connected in front of the patient interface, a problem known as tubing drag can be exacerbated. In tubing drag, an undesirable pulling force can occur on the conduit relative to the patient interface, which can result in being pulled down from the face.

[0306] In some examples, at least one tube portion 3350 extends between the plenum chamber 3200 and the connection port 3600 across the patient's cheek region and above the patient's ear. A portion of the tube 3350 that connects 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 point on the base of the ear on the patient's head. Each of the one or more tubes 3350 may also be placed on one or both of the patient's sphenoid bone and / or temporal bone and the patient's frontal bone and parietal bone. The elbow 3610 may be positioned on the patient's parietal bone, frontal bone, or the junction therebetween during use.

[0307] In the form of the technology shown in FIGS. 7A-7G, 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 plenum chamber 3200 across each cheek region to the connection port 3600 at the top of the patient 1000's head above each ear (above the upper ear base point on the patient's head). In this form of the technology, it can be advantageous if the patient is lying on their side and one of the tubes is compressed such that the gas flow along that tube is blocked or partially blocked, as the other tube remains open and can supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes (e.g., one tube or three or more tubes). In an example where the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head (e.g., over one cheek region) during use, and the strap forms part of the positioning and stabilization structure 3300 and is positioned on the other side of the patient's head (e.g., over the other region) during use to assist in fixing the patient interface 3000 on the patient's head.

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

[0309] These tubes 3350 can be formed of a semi-rigid material such as an elastomeric material (e.g., silicone). These tubes 3350 can have a natural pre-formed shape and can bend or move to assume another shape when a force is applied to the tube. For example, these tubes can generally assume an arcuate or curved shape that resembles the outer contour of the patient's head between the upper part of the head and the nose or mouth region.

[0310] As described in U.S. Patent No. 6,044,844, the entire content of which is incorporated herein by reference, the tube 3350 can withstand crushing in order to avoid the flow of breathable gas passing through the tube when crushed during use (e.g., when crushed between the patient's face and the pillow). Since the pressurized gas in the tube can function as a spring to avoid or at least limit the crushing of the tube 3350 during use, a tube that can withstand crushing is not necessarily required in all cases. Using a tube that can withstand crushing can be advantageous when only a single tube 3350 is present during use. This is because when a single tube is blocked during use, the gas flow is restricted and the treatment stops or its effectiveness decreases.

[0311] Further 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 this document is incorporated herein by reference.

[0312] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be placed at a range of positions across the upper part of the patient's head, thereby enabling the patient interface 3000 to be positioned at a location suitable for the comfort or fit of an individual patient. The upper movement of the patient interface 3000 can be decoupled from the lower part of the patient interface 3000. This enables 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 separation can be achieved, for example, using a mechanism that allows components of the headgear tube 3350 to move or flex easily relative to other components of the patient interface 3000. Examples of such mechanisms are described below.

[0313] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 is generally positioned at the upper point of the patient's head during use. The connection port 3600 can be positioned within the sagittal plane and can be aligned with the upper ear base point within a plane parallel to the coronal plane.

[0314] 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 cushion. The seal-forming structure 3100 is generally positioned below the nose and seals around the perimeter of the nose. The positioning and stabilization structure 3300 can be structured and arranged to pull the seal-forming structure 3100 into the patient's face below the nose (by a sealing force vector having a posterior and upward direction (e.g., a posterior-upper direction)). The sealing force vector in the posterior-upper direction can facilitate the seal-forming structure 3100 to form a good seal on either side of the patient's nose and upper lip against both the perimeter around the patient's nose and the anterior surface of the patient's face.

[0315] 5.3.2.1.1 Fluid Connection of the Headgear Tube The two tubes 3350 are fluidly connected to the plenum chamber 3200 at their lower ends.

[0316] Examples of the connection portions protruding laterally of the cushion module 3150 which is the connection destination of the gas delivery tube portion 3350 in some forms of the present technology have been described above. In these forms, the gas delivery tube portion 3350 is configured to engage with such a connection portion of the cushion module 3150.

[0317] In a specific form of the present technology, the connection between the tube 3350 and the cushion module 3150 is achieved by the connection of two rigid components such that a patient can easily connect the two rigid components in a highly reliable manner. Using tactile feedback such as an audible click or a similar sound can make it easy for a patient to use and also enable the patient to know that the tube is correctly connected to the cushion module 3150. In one form, the tube 3350 is formed from silicone, and each lower end of the silicone tube 3350 is overmolded onto a rigid connector formed from, for example, polypropylene, polycarbonate, nylon, or the like. The rigid connector may include a female engagement feature configured to connect to a male engagement feature on the cushion module 3150. Alternatively, the rigid connector may include a male engagement feature configured to connect to a female engagement feature on the cushion module 3150.

[0318] In another embodiment, compression seals are used to connect each tube 3350 to the cushion module 3150. For example, when using an elastic flexible (e.g., silicone) tube 3350 without a rigid connector, it may be necessary to slightly compress the tube 3350 to reduce its diameter so that it can be pushed into a port in the cushion module 3150, and the inherent elasticity of the silicone presses the tube 3350 outward to airtight seal the tube 3350 in the port. When the engagement between the tube 3350 and the port is a rigid-to-rigid type of engagement, a pressure-activated seal such as a peripheral sealing flange may be used. When pressurized gas is supplied through the tube 3350, the sealing flange is pushed against the joint between the tube and the inner peripheral surface of the port of the cushion module 3150 to facilitate the seal therebetween. When the port is flexible and a rigid connector is provided to the tube 3350, the pressure-activated seal as described above may also be used to confirm that the connection is airtight. In another example, each tube 3350 is formed from an elastically flexible (e.g., silicone) material and overmolded onto a rigid connector so that this elastically flexible material fits over the rigid connector and this elastically flexible material itself functions as a gasket to seal the connection between the tube 3350 and the cushion module 3150 around the air flow path from the tube 3350 into the cushion module 3150.

[0319] 5.3.2.1.2 Extendable bellows structure The patient interface 3000 may include one or more extendable tube portions. In some examples, the extendable tube portion includes an extendable bellows structure. The patient interface 3000 may include a positioning and stabilization structure 3300 that includes at least one gas delivery tube having a tube wall portion with an extendable bellows structure. For example, the patient interface 3000 shown in FIGS. 7A-7G includes a tube 3350, and at the upper part of the tube 3350, extendable tube portions each in the form of an extendable bellows structure 3362 are provided. In other examples of the present technology, the patient interface 3000 includes a single tube portion 3350 having an extendable bellows structure 3362. Generally, any feature of the tube portion 3350 described herein may be applied to the patient interface 3000 having a single tube portion 3350, or alternatively, to each tube portion 3350 of a patient interface having a plurality of tube portions 3350.

[0320] Each extendable bellows structure 3362 may include a part of the tube 3350 having one or more folds, pleats, corrugations or bellows to form the extendable portion of the tube 3350. In the examples shown in FIGS. 7A-7G, each of the extendable bellows structures 3362 is in the form of an extendable bellows structure. The extendable bellows structure 3362 is separated by an elbow 3610 and a connection port 3600. The extendable bellows structure 3362 has a variable length. Specifically, each extendable bellows structure 3362 can be extended or contracted to change the length of each tube 3350.

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

[0322] The cross-sectional shape of the non-extendable tube portion 3363 of the tube 3350 may be circular, elliptical, oval, D-shaped, or rounded rectangular as described, for example, in U.S. Patent No. 6,044,844. The cross-sectional shape showing the flat surface of the tube on the side facing and contacting the patient's face or other part of the head may be more comfortably worn than, for example, a tube with a circular cross-section.

[0323] In some examples of the present technology, the non-extendable tube portion 3363 connects to the plenum chamber 3200 at a low angle. The headgear tube 3350 may extend downward along the side of the patient's head and then curve forward and in an intermediate direction to connect to the plenum chamber 3200 in front of the patient's face. Before being connected to the plenum chamber 3200, the tube 3350 may extend to the same vertical position as the connection to the plenum chamber 3200 or, in some examples, to a position below the connection to the cushion module 9150. That is, the tube 3350 may be connected to the plenum chamber 3200 after at least partially protruding upward. A part of the tube 3350 may be disposed below the plenum chamber 3200 and / or the seal-forming structure 3100. Since the tube 3350 is disposed downward in front of the patient's face, contact with the patient's face below the patient's cheekbone is promoted.

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

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

[0326] In the example shown in FIG. 7A, the strap 3310 of the positioning and stabilization structure 3300 is disposed on each side of the patient's head and is connected between two tubes 3350 that pass behind the patient's head (e.g., cover or enclose the back of the occipital bone of the patient's head during use). The strap 3310 connects to each tube above the patient's ear. In other embodiments, for example, as part of an oro-nasal patient interface, the positioning and stabilization structure 3300 includes an upper strap similar to the strap 3310 and at least one additional lower headgear strap. These lower headgear straps connect between the tubes and / or between the cushion modules, pass under the patient's ear, and pass behind the patient's head. Such lower headgear straps can also be connected to the upper strap (e.g., one similar to the strap 3310).

[0327] 5.3.3 Seal-Forming Structure In one aspect of the present technology, the seal formation structure 3100 may provide a target seal formation area and further provide a cushioning function. The target seal formation area is an area where sealing can occur in the seal formation structure 3100. The area where sealing actually occurs (i.e., the actual sealing surface) may vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement location of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0328] In one aspect, the target seal formation area is disposed on the outer surface of the seal formation structure 3100.

[0329] In a particular aspect of the present technology, the seal formation structure 3100 is composed of a biocompatible material (e.g., silicone rubber, textile material, or a combination of such materials).

[0330] The seal formation structure 3100 according to some embodiments of the present technology may be composed of a soft, flexible, and resilient material (e.g., silicone).

[0331] The seal formation 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 formation structure 3100 may include a front-facing portion, a side-facing portion, an upward-facing portion, and / or a downward-facing portion. These portions may not contact the patient's face.

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

[0333] When the seal formation structure 3100 includes a fabric or a fabric portion, the fabric may include a material formed by a fiber web and adapted to be impermeable to air. For example, the fabric may have an air-impermeable film on at least one of its surfaces.

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

[0335] In some forms, the seal formation structure 3100 is constructed to be substantially inelastic in at least one dimension. For example, if the fabric seal formation structure is constructed from a fabric, the seal formation structure may be able to substantially withstand elongation in one or both of the longitudinal warp direction or the transverse weft direction across the fabric.

[0336] The seal formation structure 3100 may be composed of a single layer or multiple layers. In forms where multiple layers are used, the individual layers may be formed using the same material or a variety of different materials each having unique material properties.

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

[0338] In some forms, the seal forming structure 3100 may exhibit a low spring constant (i.e., high adaptability) in both the warp and weft directions. In such forms, in contrast to conventional designs where patient face distortion can occur due to a fixed cushion (for the formation of an effective seal), in the case of the fabric membrane of the seal forming structure 3100, it may have a material spring constant and spring length such that the fabric seal forming structure 3100 is more compliant than the patient's skin that engages with the fabric seal forming structure 3100. Thereby, mask comfort can be improved and the formation of "hot spots" of local pressure can be reduced, which is advantageous.

[0339] In some forms, the surface of the fabric material of the seal forming structure 3100 that contacts the patient's face may have low friction properties. Thereby, the surface texture comfort of the fabric seal forming structure 3100 can be improved and the friction against the patient's face can be reduced, which is advantageous. In some forms, in the case of a fabric with higher friction, it may cause snagging or friction of the seal forming structure 3100 in the contact area of the patient's face 1300 during use. Such friction or snagging can cause distortion or deformation of the seal forming structure, which in that case leads to a decrease in seal effectiveness and the possibility of undesirable air leakage from the device.

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

[0341] The cushion module 3150 shown in FIGS. 16A-16D includes a seal-forming structure 3100 that includes a textile material. In this particular example, the seal-forming structure 3100 includes the textile material in a central portion 3111 of the portion of the seal-forming structure that faces the patient (i.e., the rear side). Other portions of the seal-forming structure 3100 (e.g., the front-facing surface and the upward-facing surface) can also be formed from silicone. In other examples, the entire seal-forming structure 3100 can be formed from a textile material. Advantageously, the seal-forming structure 3100 having a textile surface that makes contact with and seals against the patient's face can have the advantage of improved tactile comfort and can be more stretchable than silicone (e.g., by use of a woven pattern selected for stretchability). Further, in the case of the textile seal-forming structure 3100 or its seal-forming surface, it can have lower friction than silicone, which can lead to improved comfort and enable the seal to slide and conform hermetically to the complex surface of the patient's face. In the seal-forming structure 3100 that includes both a silicone portion and a textile portion, the silicone portion can advantageously function as an easily moldable support for the textile portion that forms a seal joint with the patient's face.

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

[0343] In certain forms of the technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to correspond to a different range of sizes and / or shapes. For example, the system can include one form of the seal-forming structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head.

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

[0345] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., from about 0.25 mm to about 0.45 mm). This member extends around the peripheral length of the plenum chamber 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

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

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

[0348] In one form, the seal forming structure has an adhesive surface or an adhesive face and / or includes a region having a high coefficient of friction compared to other surfaces.

[0349] In a particular form of the present technology, the seal forming structure can include one or more of a pressure assist sealing flange, a compression seal, a gasket seal, a tension portion, and a site having an adhesive surface or an adhesive face.

[0350] In some forms of the technology, the seal forming structure 3100 may include a low friction surface within one or more regions. This low friction surface may enable the seal forming structure 3100 to slide on the patient's skin and fit onto the patient's facial surface including complex geometries (e.g., in the vicinity of nasolabial folds and recesses that are often present where the patient's nasal wings meet the patient's face).

[0351] 5.3.3.2 Nasal bridge or nasal sill region In one form, the non-invasive patient interface 3000 includes a seal forming structure that forms a seal over the nasal bridge region or the nasal sill region of the patient's face during use.

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

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

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

[0355] 5.3.3.4 Jaw region In one form, the non-invasive patient interface 3000 includes a seal forming structure that forms a seal over the jaw region of the patient's face during use.

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

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

[0358] A nasal cushion according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the lower side of the patient's nose, the stem, and a flexible region on the lower side of the frustum of the cone, connecting the frustum of the cone to the stem. In addition, the structure to which the nasal cushion of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible region may function to facilitate a self-aligning structure. The self-aligning structure corresponds to the mutual movement of both the displacement and the angle of the frustum of the cone and the structure to which the nasal cushion is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stem is connected.

[0359] 5.3.3.6 Nasal Mask Cushion In one form, the non-invasive patient interface 3000 includes a seal-forming portion that forms a seal on the upper lip region (i.e., the upper lip), the nasal bridge region, and the cheek region of the patient's face during use. For example, the patient interface 3000 shown in FIG. 1B is the case here. This seal-forming portion delivers air supply or breathable gas to both nostrils of the patient 1000 through a single orifice. This type of seal-forming structure may also be referred to as a "nasal cushion" or a "nasal mask". In some embodiments of the present technology, the positioning and stabilization structure 3300 shown in FIGS. 7A-7G may be utilized to hold the nasal cushion in a sealed position on the patient's face.

[0360] 5.3.3.7 Full Face Mask Cushion In one form, the patient interface 3000 includes a seal-forming portion that forms a seal over either the jaw region, cheek region, and nasal bridge or sub-nasal region of the patient's face. For example, the patient interface 3000 shown in FIG. 1C is such a case. This seal-forming portion delivers air supply or breathable gas to both nostrils and the oral cavity of the patient 1000 through a single orifice or through individual orifices. This type of seal-forming structure may also be referred to as a "full-face mask" or "ultra-compact full-face mask". In some embodiments of the present technology, the positioning and stabilization structure 3300 shown in FIGS. 7A-7G may be utilized to hold the full-face cushion in a sealed position on the patient's face. The location of the seal-forming structure 3100 described below may be provided in a full-face mask cushion or a chassis that supports the full-face mask.

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

[0362] In certain forms of the present technology, the seal-forming structure 3100 includes a central portion configured to form a seal against the lower surface of the patient's nose. The central portion may seal the lower peripheral portion of the patient's nose (e.g., around the patient's nostrils and the patient's upper lip). In an example, the seal-forming structure 3100 may be configured to contact the patient's face at the lower side of the nasal bridge or at the lower side of the nasal tip point.

[0363] The seal-forming structure 3100 may be configured to enter the patient's nostrils during use. For example, the seal-forming structure 3100 may seal the patient's face without entering the patient's nostrils. The seal-forming structure 3100 may be configured to form a seal (without entering the patient's nostrils) with the area of the patient's face surrounding the patient's nostrils. In some examples, the seal-forming structure 3100 is configured to form a seal surrounding the patient's nostrils and nasal septum. The seal-forming structure 3100 may form a single contiguous seal surrounding both nostrils.

[0364] The seal-forming structure 3100 may be configured to seal against the front and / or lower surface of the patient's nasal tip during use. The seal-forming structure 3100 may seal the side and / or lower surface of the patient's nasal ala during use. The seal-forming structure 3100 may be configured to seal any one or more of the patient's nasal subpoint, the patient's nostrils, and the lower surface of the patient's nose between the upper lip and / or the area between the patient's upper lips.

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

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

[0367] 5.3.3.8.1 Central part The central part 3111 included in the seal formation structure 3100 is configured to seal the patient's face at the lower part of the patient's nose during use. In some examples of the present technology, the central part 3111 is configured to seal at least the apex of the patient's nose, the alae nasi, and the upper lip during use. The central part 3111 may seal the patient's nostrils and the peripheral part of the patient's nose around the patient's upper lip during use. The central part 3111 is provided at the rear side of the seal formation structure 3100. The central part 3111 may be bisected by a plane parallel to the sagittal plane of the patient during use. FIGS. 9A-9H, FIGS. 11A, 11B, FIGS. 19A-19F, FIGS. 25A-25I, FIGS. 26A-26I, FIGS. 30A-30E, FIGS. 31A-31D, and FIGS. 32A-32D show examples of the seal formation structure 3100 having the central part 3111 among other parts.

[0368] Most of the contact with the patient's nose may be constituted by the central part 3111. Some of the contact may be constituted by the central lateral part 3121. The central lateral part 3121 will be described below. In some examples, most of the seal formed by the peripheral part of the patient's nose from the seal formation surface 3100 may be constituted by the central part 3111.

[0369] It is understood that the actual amount of contact of the seal formation structure 3100 with the patient's face depends on the specific implementation of the present technology and the anatomical structure of a specific patient, particularly, the way the patient sets up the patient interface.

[0370] The two apertures 3272 included in the cushion module 3150 are configured to deliver an air flow to the patient's nostrils at a therapeutic pressure. These apertures 3272 are shown in FIGS. 8D - 8F. Each aperture 3272 is aligned with each of the patient's nostrils during use. In some examples, a single aperture 3272 that may be included in the cushion module 3150 is configured to deliver an air flow to both of the patient's nostrils. These apertures 3272 are formed within the seal - forming structure 3100 of the cushion module 3150. In some examples, the apertures 3272 are formed within the central portion 3111 of the seal - forming structure 3100.

[0371] In some examples, the wall thickness of the central portion 3111 can be from 0.15 mm to 0.4 mm. In some examples, the wall thickness of the central portion 3111 can be from 0.2 mm to 0.35 mm. In some examples, the wall thickness of the central portion 3111 can be substantially 0.25 mm.

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

[0373] In the examples shown in FIGS. 9A - 9H, FIGS. 19A - 19F, FIGS. 25A - 25I, FIGS. 26A - 26I, FIGS. 30A - 30E, FIGS. 31A - 31D, and FIGS. 32A - 32D, the seal - forming structure 3100 also includes an upper lip portion 3116. The upper lip portion 3116 can be provided within the central portion 3111 and can also contact the lower surface of the patient's nose along with the patient's upper lip.

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

[0375] The central portion 3111 and its upper lip portion 3116 may be of lower rigidity than most or all of the other portions of the seal forming structure 3100. In some examples of the present technology, such lower rigidity is provided by a wall thickness that is thinner than that of the other portions of the seal forming structure 3100. The tip of the nose, which is the lower surface of the patient's nose and upper lip, can have a complex geometry and can also be highly sensitive to pressure. Therefore, it is advantageous to make the regions of the plenum chamber 3200 that contact or seal against these positions flexible and compliant, avoiding excessive pressure generation on the face in these regions.

[0376] The lower rigidity of certain portions of the seal forming structure 3100 that can be provided by a thin wall thickness allows the seal forming structure 3100 to be easily deformed to seal the lower surface of the patient's nose (e.g., the forward tip of the nose, the lateral sides, and the alae of the upper lip).

[0377] In some examples of the present technology, the central portion 3111 may have a higher rigidity within the upper lip portion 3116 than within other regions of the central portion 3111. For example, the upper lip portion 3116 may be of higher rigidity than the portion of the central portion 3111 that surrounds the hole 3272. The cushion module 3150 shown in FIGS. 25A - 25I has an upper lip portion 3116 that is of higher rigidity than the other portions of the central portion 3111. Such higher rigidity can be provided by a greater wall thickness.

[0378] The cushion module 3150 shown in FIGS. 25A to 25I is wider than the cushion module 3150 shown in FIGS. 9A to 9H. The wall thickness of the upper lip portion 3116 of the cushion module 3150 shown in FIGS. 9A to 9H is the same as the wall thickness of the adjacent portion of the central portion 3111. The wall thickness of the upper lip portion 3116 of the cushion module 3150 shown in FIGS. 25A to 25I is larger than the wall thickness of the adjacent portion of the central portion 3111. The cushion module 3150 shown in FIGS. 25A to 25I and its upper lip portion 3116 are wider than the other cushion modules 3150, but the upper lip portion 3116 may be more likely to buckle or wrinkle due to being wider. By providing an extra thickness in the upper lip portion 3116 of the cushion module 3150, the likelihood of buckling can be reduced, which can result in good stability during use.

[0379] 5.3.3.8.1.2 Front and Rear Parts of the Upper Lip Portion For example, in some examples of the present technology shown in FIGS. 19A to 19F and FIGS. 22A, and in the examples shown in FIGS. 25A to 25I, FIGS. 26A to 26I, FIGS. 30A to 30E, and FIGS. 31A to 31D, the upper lip portion 3116 includes a front portion 3133 and a rear portion 3134. Since the chassis portion 3210 is curved rearward on either side of the chassis portion 3210, the front portion 3133 is disposed adjacent to the chassis portion 3210 and can be provided behind the chassis portion 3210 or at least behind the central portion of the chassis portion 3210. The rear portion 3134 is configured to seal the upper lip of the patient during use.

[0380] The front portion 3133 of the upper lip portion 3116 may be higher in rigidity than the rear portion 3134 of the upper lip portion 3116. In the examples shown in FIGS. 19A-19F, FIGS. 22A, FIGS. 25A-26I, FIGS. 26A-26I, FIGS. 30A-30E and FIGS. 31A-31D, such higher rigidity is provided 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 is greater than the thickness of the rear portion 3134 of the upper lip portion 3116. In other examples of the present technology, the cushion module 3150 may include a rigidifying member provided in the front portion 3133 of the upper lip portion 3116 to provide higher rigidity. This rigidifying member may be formed from a material with higher rigidity than other parts of the seal forming structure 3100 and may be overmolded onto the front portion 3133.

[0381] 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 the examples shown in FIGS. 19A-19F and FIGS. 26A-26I, the thickness of the rear portion 3134 is the same as the thickness of the remaining portion of the central portion 3111.

[0382] In other examples, the thickness of the rear portion 3134 of the upper lip portion 3116 may be made 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 FIGS. 25A-25I, the thickness of the rear portion 3134 is greater than other portions of the central portion 3111.

[0383] 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 (for example, 0.2 mm to 0.8 mm, 0.3 mm to 0.7 mm, 0.4 mm to 0.6 mm, 0.15 mm to 0.35 mm or 0.2 mm to 0.3 mm). In a particular example, the thickness of the rear portion 3134 may be 0.25 mm or 0.5 mm. In the examples shown in FIGS. 19A-19F, FIGS. 26A-26I, FIGS. 30A-30E and FIGS. 31A-31D, the thickness of the rear portion 3134 is 0.25 mm. In the examples shown in FIGS. 25A-25I, the thickness of the rear portion 3134 is 0.5 mm.

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

[0385] As will be described in more detail below, the seal forming structure 3100 can include a pair of side rear regions 3141 on each rear outer side of the upper lip portion 3116. In the examples shown in FIGS. 19A to 19F and FIG. 22A, the thickness of the rear portion 3134 of the upper lip portion 3116 is smaller than the thickness of the side rear region 3141. Specifically, the thickness of the rear portion 3134 of the upper lip portion 3116 is smaller than the thicknesses of both the decoupling site 3142 and the peripheral portion 3143 of each side rear region 3141. The decoupling site 3142 and the peripheral portion 3143 will be described in detail below.

[0386] In the examples shown in FIGS. 19A to 19F, the thickness of the front portion 3133 of the upper lip portion 3116 is substantially the same as the thickness of the side rear region 3141. Specifically, the thickness of the front portion 3133 of the upper lip portion 3116 is substantially the same as the thickness of the peripheral portion 3143 of the side rear region 3141. The thickness of the front portion 3133 of the upper lip portion 3116 is greater than the thickness of the decoupling site 3142 in this example. The front portion 3133 of the upper lip portion 3116 can be adjacent to the side rear region 3141.

[0387] In the examples shown in FIGS. 25A to 25I and FIGS. 26A to 26I, the thickness of the front portion 3133 of the upper lip portion 3116 is substantially the same as the thickness of the side rear region 3141. Specifically, the thickness of the front portion 3133 is substantially the same as the rear portion of each side rear region 3141. The front portion of each side rear region 3141 can have a greater thickness than the front portion 3133 of the upper lip portion 3116.

[0388] As shown in FIGS. 19A to 19F, FIG. 22A, FIGS. 25A to 25I, FIGS. 26A to 26I, FIGS. 30A to 30E, and FIGS. 31A to 31D, the boundary between the front portion 3133 and the rear portion 3134 of the upper lip portion 3116 is curved, and the central portion of this curve is provided forward of the end portion of the side portion of this curve. Such a boundary can be curved so as to generally correspond to the curved shape of the patient's upper lip. The cushion module 3150 may include a joint between the front portion 3133 of the upper lip portion 3116 and the chassis portion 3210. This joint can be curved. The curvature of this joint 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. This joint can be part of a longer joint between the chassis portion 3210 and the seal formation structure 3100. In other examples, the boundary between the front portion 3133 and the rear portion 3134 of the upper lip portion 3116 may include a more gradual curve or may be linear.

[0389] The difference in thickness between the front portion 3133 and the rear portion 3134 of the upper lip portion 3116 can be obtained by a sharp or stepped change in thickness. The change in thickness can be generated by a step formed in the material forming the seal formation structure 3100, and this step is formed within the inner surface of the seal formation structure 3100.

[0390] Making the thickness of the front portion 3133 larger than that of the rear portion 3134 of the upper lip portion 3116 is advantageous because (compared to the case where these portions have the same thickness as each other and / or the same thickness as the remaining portion of the central portion 3111), further anti-wrinkle properties can be imparted to the seal formation structure 3100. The front portion 3133 can avoid or at least prevent wrinkles in the seal formation structure 3100 in the vicinity of the joint between the seal formation structure 3100 and the chassis portion 3210. By increasing the thickness of the front portion 3133, the chassis portion 3210 in the vicinity of the upper lip portion 3116 can also be supplemented and stiffened, and the dynamic seal in the upper lip can be improved (for example, the stability of the seal formed with the patient's upper lip when the patient's head moves is improved).

[0391] 5.3.3.8.1.3 Central saddle part In this example, the central part 3111 is adjacent to the central front part 3115. The central front part 3115 is a part facing the front of the seal forming structure 3100. During use, the central front part 3115 can be arranged below the nasal tip point in the vicinity of the nasal tip point of the patient.

[0392] In the examples shown in FIGS. 9A to 9H and FIGS. 19A to 19F, the seal forming structure 3100 has a central saddle part 3112 that can seal the front region or the lower region of the nasal tip point of the patient in addition to the central part 3111. In this example, the central saddle part 3112 or a part thereof includes the same rigidity or similar rigidity as the central part 3111 and the central front part 3115. The central saddle part 3112 connects the central part 3111 and the central front part 3115. In the examples shown in FIGS. 25A to 25I and FIGS. 26A to 26I, the seal forming structure 3100 may also have a central saddle part 3112 (shown in FIGS. 25A and 26A). In these examples, the curvature of the central saddle part 3112 is smaller than that of the central saddle part 3112 of the seal forming structure 3100 shown in the previous FIGS. 9A to 9H and FIGS. 19A to 19F. In these examples, the central part 3111 or the central saddle part 3112 can seal the lower surface and / or the front surface of the nasal tip point of the patient.

[0393] The central part 3111 of the seal forming structure 3100 can be configured to conform to the lower surface and the peripheral part of the patient's nose by expanding. Thinning the wall of the seal forming structure 3100 in the upward-facing central part 3111 is advantageous for generating a good seal against the complex geometry in the lower and peripheral parts of the nose. This thin wall can be deformed and expanded under the pressure of the breathable gas in the plenum chamber 3200, conform to the surface of the patient's face, and generate an effective and comfortable seal.

[0394] Maintaining a thin wall thickness within the region configured to contact the highly sensitive tip of the nose and the upper lip region results in improved comfort and is advantageous. However, in the examples of the present technology, the wall thickness in these regions is not reduced to the extent that the seal formation structure 3100 can no longer maintain a stable seal against the patient's face. If the wall thickness in these regions is too thin, folds are likely to occur in the seal formation structure 3100, which can lead to seal failure and the generation of leakage paths, allowing air to flow around between the patient's face and the cushion.

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

[0396] The central front portion 3115 is provided on the front side of the seal formation structure 3100 (which may be the non - patient - contact side). The central front portion 3115 is disposed below and adjacent to the tip of the patient's nose during use. The central front portion 3115 can be at least partially oriented forward. For example, the central front portion 3115 can include a surface that is at least partially oriented forward. At least most of the central front portion 3115 can be provided on the front side of the seal formation structure 3100. A part 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 examples, the upper portion 3114 can be configured not to contact the patient's face during use.

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

[0398] The central front portion 3115 is usually a thin-walled and relatively flexible portion of the seal forming structure 3100 (compared to other portions of the seal forming structure). For example, in the examples shown in FIGS. 9A to 9H and FIGS. 19A to 19F, the central front portion 3115 is one of the thinnest and most flexible portions of the seal forming structure. Due to the flexibility of the central front portion 3115, the central front portion 3115 enables the seal forming structure 3100 to fit around the lower periphery of the patient's nose. However, since the central front portion 3115 has high flexibility, wrinkles may easily form. Since the lower portion 3113 of the central front portion 3115 is more rigid than the upper portion 3114, it provides support to the central front portion 3115. The lower portion 3113 of the central front portion 3115 can impart wrinkle resistance to the central front portion 3115.

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

[0400] In the examples shown in FIGS. 19A to 19F and FIGS. 22A to 22B, at the lower part 3113 of the central front part 3115, the wall thickness of a part of the seal formation structure 3100 is generally greater than that of one or more adjacent parts of the seal formation structure 3100. The wall thickness of the lower part 3113 of the central front part 3115 can be 0.3 mm to 1 mm. In some examples, the wall thickness of the lower part 3113 is 0.4 to 0.7 mm. In the examples shown in FIGS. 19A to 19F, the wall thickness of the lower part 3113 is substantially 0.5 mm. In the examples shown in FIGS. 19A to 19F, the wall thickness of the upper part 3114 can be 0.1 mm to 0.5 mm (for example, 0.2 mm to 0.3 mm, or 0.25 mm).

[0401] In other examples of the present technology, the lower part 3113 of the central front part 3115 may include a stiffening member, a part of the seal formation structure formed of a higher-rigidity material, or another suitable means for reinforcing rigidity.

[0402] As shown in FIG. 22A, the thickness of the central front part 3115 is changed stepwise between the lower part 3113 and the upper part 3114. In other examples, the thickness of the central front part 3115 may be tapered between the lower part 3113 and the upper part 3114.

[0403] More generally, any change in thickness between two parts of the seal formation structure 3100 or the chassis part 3210 exemplified as a stepwise thickness change in this specification may include a tapered thickness in other examples. Similarly, any thickness change exemplified by a tapered thickness may include a stepwise change in thickness in other examples.

[0404] In some examples of the present technology, a lower part 3113 having higher rigidity and / or thickness than the upper part 3114 can be provided at the central front part 3115 of the cushion module 3150 shown in FIGS. 25A to 25I and FIGS. 26A to 26I. In the form of these cushion modules 3150 shown in FIGS. 25A to 25I and FIGS. 26A to 26I, the thickness of the central front part 3115 is substantially uniform.

[0405] 5.3.3.8.2 Middle side part As shown in FIGS. 9A to 9H, FIGS. 19A to 19F, FIGS. 25A to 25I, FIGS. 26A to 26I, FIGS. 30A to 30E, and FIGS. 31A to 31D, the seal formation structure 3100 may also include a pair of central side portions 3121. The central side portions 3121 may be configured to face the patient's nasal wings or be disposed adjacent to the patient's nasal wings during use. The central side portions 3121 may be provided at the rear side of the seal formation structure 3100. Each central side portion 3121 may be provided on each side of the central portion 3111 and may be respectively configured to be disposed along each nasal wing of the patient's nose during use. As shown in FIGS. 9A to 9H, FIGS. 19A to 19F, FIGS. 25A to 25G, FIGS. 26A to 26G, FIGS. 30A to 30E, and FIGS. 31A to 31D, each central side portion 3121 may be disposed between the central portion 3111 and the lateral peripheral portion of the seal formation structure 3100.

[0406] Particularly as shown in FIGS. 9A, 9F, and 19A, each central side portion 3121 may have a crescent shape. Each central side portion 3121 includes an intermediate boundary and a lateral boundary. Each intermediate boundary may include a three-dimensional curve (e.g., a space curve). This three-dimensional curve (e.g., a space curve) is curved downward and in an intermediate direction at the front side of the cushion module 3150 near the central saddle portion 3112 from the perspective of generally moving forward along this curve. Each lateral boundary may also include a three-dimensional curve. This three-dimensional curve is curved in an intermediate direction at the front side of the cushion module 3150 from the perspective of generally moving forward along this curve. The central side portion 3121 may include a surface curvature that follows the curvature of the lower peripheral portion of the patient's nose.

[0407] Due to the curvature of the boundary of the central side portion 3121, the entire central side portion 3121 may be shaped to include a curved shape, whereby it is curved in the intermediate direction in the vicinity of the front side of the seal formation structure 3100 from the perspective of generally moving forward.

[0408] Due to the curve of the central lateral part 3121 and the curve of its boundary, a central lateral part 3121 that follows the shape of the area around the lower part of the patient's nose can be obtained. The central lateral part 3121 can be concave with respect to the patient's nose in the vicinity of the widest part of the patient's nose (for example, in the vicinity of the alae nasi). Each central lateral part 3121 can be curved in the lower and / or middle direction in the vicinity of the posterior corner part 3131 and / or the upper lip part 3116 (described later) from the perspective of moving along the central lateral part curve in the rearward direction.

[0409] Each central lateral part 3121 can extend such that one end is in the vicinity of the upper lip part 3116 and the other end is in the vicinity of the foremost part of the central part 3111. In the examples shown in FIGS. 9A to 9H and FIGS. 19A to 19F, one end of each central lateral part 3121 extends to the central saddle part 3112. The central saddle part 3112 can be arranged between the foremost parts of the central lateral parts. In this example, the foremost part of each central lateral part 3121 is pointed. The front joint between the intermediate boundary and the lateral boundary of each central lateral part 3121 includes a pointed shape. The intermediate boundary and the lateral boundary meet to form a pointed corner. In this example, the front joint of the intermediate boundary and the lateral boundary of each central lateral part 3121 are tapered toward one point.

[0410] In this example, the lateral boundary of each central lateral part is arranged between the part facing the middle of the seal formation s...

Claims

1. A patient interface comprising: A chassis part that at least partially forms a plenum chamber capable of being pressurized up to a therapeutic pressure of at least 6 cmH ２ O exceeding the ambient air pressure, the chassis part being configured to be connected to a gas delivery tube and having a size and structure such that it receives an air flow at the therapeutic pressure for the patient's breathing, and including a pair of laterally protruding connection parts A seal-forming structure provided in the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's face region surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole therein such that airflow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle; and A ventilation portion that enables continuous flow of the gas exhaled by the patient from inside the plenum chamber to the surroundings, the ventilation portion being sized and shaped to maintain the treatment pressure within the plenum chamber during use. The seal-forming structure comprises: A central portion configured to seal at least the patient's nasal tip point, nasal wings and upper lip during use; and A pair of side rear regions provided on each rear outer side of the seal-forming structure, each side rear region comprising: A release portion configured to at least partially decouple from one of each connection portion that protrudes laterally from the central portion of the seal-forming structure, the release portion being provided within a part of the side rear region configured to be disposed in a direction away from the patient's face and not in contact with the patient's face during use; and A peripheral portion disposed adjacent to the release portion, at least a part of the peripheral portion being disposed behind the release portion. The release portion is higher in rigidity than the peripheral portion. The patient interface.

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

3. The patient interface according to claim 1 or claim 2, wherein the rigidity of each release portion of the side rear region is higher than the rigidity of the central portion of the seal-forming structure.

4. The patient interface according to any one of claims 1 to 3, wherein the wall thickness of each peripheral portion of the side rear 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 each peripheral portion of the side rear region is greater than the wall thickness of each release portion of the side rear region.

6. The wall thickness of each of the decoupling sites in the side-rear regions is greater than the wall thickness at the center of the seal-forming structure, the patient interface according to claim 5.

7. Each of the decoupling sites in the side-rear regions is C-shaped when viewed from the side of the seal-forming structure, the patient interface according to any one of claims 1 to 6.

8. Each of the peripheral portions partially or entirely surrounds each of the decoupling sites, the patient interface according to any one of claims 1 to 7.

9. Each of the decoupling sites is formed by a recess in the inner surface of the seal-forming structure within each of the side-rear regions, the patient interface according to any one of claims 1 to 8.

10. Further comprising a positioning and stabilization structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the patient interface according to any one of claims 1 to 9.

11. Further comprising a gas delivery tube portion, wherein a part of the positioning and stabilization structure is formed by the gas delivery tube portion, and each gas delivery tube portion is configured to convey an air flow from a position on the top of the patient's head to the inside of the chassis portion during use, the patient interface according to claim 10.

12. The chassis portion is formed from a flexible material, the patient interface according to any one of claims 1 to 11.

13. Including a removable cushion module, the removable cushion module including the chassis portion and the seal-forming structure, the patient interface according to any one of claims 1 to 12.

14. A patient interface comprising: At least 6 cmH above ambient air pressure ２ A chassis part that at least partially forms a plenum chamber capable of being pressurized up to a therapeutic pressure of ２ , wherein the chassis part is sized and structured to receive an air flow at the therapeutic pressure for the patient's respiration, a chassis part, A seal-forming structure provided on the chassis portion, the seal-forming structure being constructed and arranged to form a seal against a face region of the patient that partially forms the plenum chamber and surrounds an inlet to the patient's airway, the seal-forming structure having at least one hole therein such that an air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure; A ventilation portion that enables the gas exhaled by the patient to continuously flow from the inside of the plenum chamber to the surroundings, the ventilation portion being sized and shaped to maintain the treatment pressure in the plenum chamber during use, the ventilation portion and, The seal forming structure is, A central portion provided on the rear side of the seal forming structure, the central portion being configured to seal at least the tip of the patient's nose, the nasal wings and the upper lip during use, the central portion and, A pair of central side portions provided on the rear side of the seal forming structure, each central side portion being provided on each side of the central portion, each central side portion being higher in rigidity than the central portion, a pair of central side portions, A pair of stiffening portions, each of the stiffening portions extending from the rear side of the seal forming structure to the front side of the seal forming structure, the seal forming structure being configured to be arranged in a direction away from the patient's face during use, each stiffening portion being arranged on each side of the seal forming structure, each stiffening portion being higher in rigidity than the central side portion, a pair of stiffening portions and, including a patient interface.

15. The patient interface according to claim 14, wherein each of the stiffening portions has a negative curvature along a first path from the rear side of the seal forming structure to the front side of the seal forming structure.

16. The patient interface according to claim 15, wherein each of the stiffening portions has a zero curvature or a negative curvature along a second path perpendicular to the first path.

17. Each of the stiffening portions includes a front portion provided on the front side of the seal forming structure and a rear portion provided on the rear side of the seal forming structure, the front portion being higher in rigidity than the rear portion, the patient interface according to any one of claims 14 to 16.

18. The patient interface according to claim 17, wherein the thickness of the front portion of each of the stiffening portions is greater than the thickness of the rear portion of the stiffening portion.

19. The patient interface according to claim 18, wherein each of the stiffening portions has a thickness that increases in a tapered manner between the rear portion and the front portion of the stiffening portion.

20. The patient interface according to any one of claims 14 to 19, wherein the rigidity of the front portion of the stiffening portion is higher than the rigidity of the adjacent portion of the front seal forming structure.

21. The patient interface according to claim 20, wherein the thickness of the front portion of the stiffening portion is greater than the thickness of the adjacent portion of the front seal forming structure.

22. The rigidity of the rear part of the stiffening portion is greater than the rigidity of the adjacent portion on the rear side of the seal forming structure, the patient interface according to any one of claims 14 to 21.

23. The thickness of the rear part of the stiffening portion is greater than the thickness of the adjacent portion on the rear side of the seal forming structure, the patient interface according to claim 22.

24. Each of the stiffening portions includes a wall thickness greater than that of the adjacent region, and the greater wall thickness is formed by the extra thickness of the inner surface of the seal forming structure, the patient interface according to any one of claims 14 to 23.

25. Each of the stiffening portions is arranged in proximity to one of the patient's nostrils during use, the patient interface according to any one of claims 14 to 24.

26. The chassis portion includes a pair of laterally protruding connection portions configured to connect to the gas delivery tube portions, and each of the gas delivery tube portions is configured to connect to one of the pair of gas delivery tube portions and receive a gas flow from one of the pair of gas delivery tube portions, the patient interface according to any one of claims 14 to 25.

27. The patient interface includes a positioning and stabilization structure for providing a force to hold the seal forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including the gas delivery tube portions, and each gas delivery tube portion is configured to receive an air flow from a connection port on the upper part of the patient's head and deliver the air flow to one of the laterally protruding connection portions of the chassis portion, the patient interface according to claim 26.

28. Each of the stiffening portions is arranged in proximity to one of the laterally protruding connection portions, the patient interface according to claim 26 or claim 27.

29. The chassis portion is formed from a flexible material, the patient interface according to any one of claims 14 to 28.

30. A patient interface comprising: At least 6 cmH exceeding the ambient air pressure ２ A chassis portion that at least partially forms a plenum chamber that can be pressurized to a treatment pressure of O, the chassis portion being sized and structured to receive an air flow at the treatment pressure for the patient's breathing, and including a pair of laterally projecting connection portions A seal-forming structure provided in the chassis part, the seal-forming structure being constructed and arranged to partially form the plenum chamber and form a seal against the patient's face area surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole therein so that the air flow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, the seal-forming structure; A positioning and stabilization structure that provides a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a pair of gas delivery tube parts, each gas delivery tube part receiving an air flow from a connection port on the upper part of the patient's head and delivering the air flow to each one of connection parts protruding laterally from the chassis part, the positioning and stabilization structure; A ventilation part that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation part being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the ventilation part; The chassis part and the seal-forming structure are formed from a flexible material. The patient interface further includes a rigidifying member provided in the chassis part, the rigidifying member being configured to withstand deformation of the chassis part, the patient interface.

31. The patient interface according to claim 30, wherein the rigidifying member is provided on the front side of the chassis part.

32. The patient interface according to claim 30 or claim 31, wherein the chassis part includes a front hole part configured to receive the rigidifying member.

33. The patient interface according to any one of claims 30 to 32, wherein the rigidifying member includes a ventilation module including the ventilation part.

34. The patient interface according to claim 33, wherein the ventilation part includes a plurality of ventilation holes through which the gas flow due to the patient's exhalation continuously moves from inside the plenum chamber to the atmosphere.

35. The patient interface according to claim 34, wherein the plurality of ventilation holes include an upward ventilation hole and a downward ventilation hole.

36. The plurality of downstream ventilation holes include one or more upstream ventilation holes and one or more downstream ventilation holes, the patient interface according to claim 35.

37. The one or more upstream ventilation holes are configured to direct exhaled gas in a direction having an angle upward with respect to an axis perpendicular to the front surface of the ventilation module, the patient interface according to claim 36.

38. The one or more downstream ventilation holes are configured to direct exhaled gas in a direction having an angle downward with respect to an axis perpendicular to the front surface of the ventilation module, the patient interface according to claim 37.

39. The angle in the upward direction is made larger than the angle in the downward direction, the patient interface according to claim 38.

40. The sum of the angle in the upward direction and the angle in the downward direction is within a range of 60 to 100 degrees, the patient interface according to claim 38 or claim 39.

41. The sum of the angle in the upward direction and the angle in the downward direction is within a range of 70 to 90 degrees, the patient interface according to claim 40.

42. The ventilation module is configured to support a diffuser, and through the diffuser, it is possible to move when a continuous gas flow due to the patient's exhalation flows into the atmosphere, the patient interface according to any one of claims 35 to 41.

43. The ventilation module is configured to move a continuous gas flow due to the patient's exhalation from the inside of the plenum chamber to the atmosphere, and to be able to flow inside and outside the diffuser after passing through the upstream ventilation holes, the patient interface according to claim 42.

44. The ventilation module is configured to move a continuous gas flow due to the patient's exhalation from the inside of the plenum chamber to the atmosphere, flow inside and outside the diffuser, and then pass through the downstream ventilation holes, the patient interface according to claim 42.

45. The ventilation module is configured to move a continuous gas flow due to the patient's exhalation from the inside of the plenum chamber to the atmosphere by the diffuser (without flowing through the diffuser), the patient interface according to any one of claims 42 to 44.

46. A patient interface, comprising A chassis part that is formed from a flexible material and is capable of being pressurized to a therapeutic pressure of at least 6 cmH ２ O above ambient air pressure, wherein the chassis part is sized and structured to receive an air flow at the therapeutic pressure for the patient's respiration, and the chassis part A seal-forming structure provided in the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's face area surrounding the inlet to the patient's airway, the seal-forming structure having at least one hole therein such that the airflow at the treatment pressure is delivered at least to the inlet to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle, the seal-forming structure; A ventilation portion that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation portion being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the ventilation portion; The seal-forming structure; A central portion at the rear side of the seal-forming structure, the central portion being configured to seal at least the patient's nasal tip point, nasal wings and upper lip during use, the central portion; A central front portion at the front side of the seal-forming structure, the central front portion being disposed adjacent to the nasal tip point below the nasal tip point of the patient during use, the central front portion including an upper portion and a lower portion, the lower portion being more rigid than the upper portion, the patient interface including the central front portion.

47. The wall thickness of the lower portion of the central front portion is greater than the wall thickness of the upper portion of the central front portion, the patient interface according to claim 46.

48. The upper portion of the central front portion has substantially the same wall thickness as the central portion of the seal-forming structure, the patient interface according to claim 46 or 47.

49. The seal-forming structure is a pair of central side portions provided at the rear side of the seal-forming structure, each central side portion being provided on each side of the central portion, and each central side portion being more rigid than the central portion, the patient interface according to any one of claims 46 to 48 including the pair of central side portions.

50. The wall thickness of the central side portion is greater than the upper portion of the central front portion, the patient interface according to claim 49.

51. The seal forming structure includes a pair of central lateral front portions on the front side of the seal forming structure, these central lateral front portions are provided on each lateral side of the central front portion, and the wall thickness of each of the pair of central lateral front portions is greater than the wall thickness of the central front portion. The patient interface according to any one of claims 46 to 50.

52. The chassis portion includes a pair of laterally protruding connection portions, and these laterally protruding connection portions are each configured to connect to and receive a gas flow from one of each of the pair of gas delivery tube portions. The patient interface according to any one of claims 46 to 51.

53. The patient interface includes a positioning and stabilization structure for providing 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 gas delivery tube portion, and each gas delivery tube portion is configured to receive an air flow from a connection port on the upper part of the patient's head and deliver the air flow to each one of the laterally protruding connection portions of the chassis portion. The patient interface according to claim 52.

54. A patient interface, Pressurizable to a therapeutic pressure of at least 6 cmH above the ambient air pressure ２ A chassis portion that at least partially forms a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH above 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's respiration, the chassis portion A seal forming structure provided on the chassis portion and partially forming the plenum chamber. The seal forming structure is constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's airway. The seal forming structure has at least one hole inside so that the air flow at the treatment pressure is delivered at least to the entrance to the patient's nostrils. The seal forming structure is constructed and arranged to maintain the treatment pressure in the plenum chamber throughout the patient's breathing cycle during use. A seal forming structure, A ventilation portion that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings. The ventilation portion is sized and shaped to maintain the treatment pressure in the plenum chamber during use. A ventilation portion, The seal forming structure is A central portion at the rear side of the seal forming structure. The central portion is configured to seal at least the patient's nasal tip point, nasal wings and upper lip during use. A central portion, A central front portion at the front side of the seal forming structure. This central front portion is arranged below and close to the patient's nasal tip point during use. A central front portion, A pair of central lateral front portions on the front side of the seal formation structure, each of these central lateral front portions being disposed on each lateral side of the central front portion, each central lateral front portion including an upper portion and a lower portion, the lower portion being of higher rigidity than the upper portion, and a pair of central lateral front portions.

55. The patient interface according to claim 54, wherein the wall thickness of the lower portion of each of the central lateral front portions is greater than the wall thickness of the upper portion of each of the central lateral front portions.

56. The patient interface according to claim 55, wherein the wall thickness of the lower portion of each of the central lateral front portions is greater than the wall thickness of the central front portion of the seal formation structure.

57. The patient interface according to claim 56, wherein the wall thickness of the lower portion of each of the central lateral front portions is greater than the wall thickness of the central portion on the rear side of the seal formation structure.

58. The patient interface according to any one of claims 54 to 57, wherein the wall thickness of the upper portion of each of the central lateral front portions is greater than the wall thickness of the central front portion of the seal formation structure.

59. The patient interface according to claim 58, wherein the wall thickness of the upper portion of each of the central lateral front portions is greater than the wall thickness on the rear side of the seal formation structure.

60. The seal formation structure includes a pair of central lateral portions on the rear side of the seal formation structure, each central lateral portion being provided on each lateral side of the central portion, and the wall thickness of each central lateral portion is greater than the wall thickness of the central portion. The patient interface according to any one of claims 54 to 59.

61. The patient interface according to claim 60, wherein the wall thickness of the lower portion of each of the central lateral front portions is greater than the wall thickness of the central lateral portion on the rear side of the seal formation structure.

62. The patient interface according to claim 61, wherein the wall thickness of the upper portion of each of the central lateral front portions is greater than the wall thickness of the central lateral portion on the rear side of the seal formation structure.

63. The patient interface according to any one of claims 54 to 62, wherein the chassis portion is formed of a flexible material.

64. A patient interface, A chassis part that is formed from a flexible material and can be pressurized to a therapeutic pressure of at least 6 cmH ２ O above ambient air pressure, the chassis part at least partially forming a plenum chamber, the chassis part including a pair of laterally projecting connection parts sized and structured to receive airflow at the therapeutic pressure for the patient's respiration A seal-forming structure provided in the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal against the patient's face area surrounding the entrance to the patient's airway, the seal-forming structure having at least one hole therein such that the airflow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle, the seal-forming structure; A ventilation portion that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation portion being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the ventilation portion; A positioning and stabilization structure that provides a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a pair of gas delivery tube portions, each gas delivery tube portion receiving an airflow from a connection port on the upper part of the patient's head and delivering the airflow to respective one of the connections protruding laterally from the chassis portion, the positioning and stabilization structure; The seal-forming structure includes a central portion on the rear side of the seal-forming structure, the central portion being configured to seal at least the patient's nasal tip point, nasal wings, and upper lip during use; The chassis portion includes a pair of upper chassis reinforcement portions, each of these upper chassis reinforcement portions being provided on each lateral and front side of the chassis portion, and each upper chassis reinforcement portion being of higher rigidity than one or more adjacent portions of the chassis portion, the patient interface;

65. The patient interface according to claim 64, wherein the upper chassis reinforcement portion is disposed adjacent to the seal-forming structure.

66. The patient interface according to claim 65, wherein each of the upper chassis reinforcement portions is disposed at each upper corner of the front hole of the chassis portion.

67. The seal-forming structure; A central front portion on the front side of the seal-forming structure, the central front portion being disposed adjacent to and below the nasal tip point of the patient during use, and A pair of central lateral front portions on the front side of the seal-forming structure, each of these central lateral front portions being disposed on each lateral side of the central front portion, the pair of central lateral front portions; The chassis upper reinforcement parts are each arranged adjacent to one of the central side front parts of the seal forming structure, the patient interface according to any one of claims 64 to 66.

68. The central side front parts of the seal forming structure each include an upper part and a lower part, and the chassis upper reinforcement parts are each arranged adjacent to the respective lower parts, the patient interface according to claim 67.

69. The wall thickness of the chassis upper reinforcement part is the same as the wall thickness of the lower part of the central side front part, the patient interface according to claim 68.

70. The wall thickness of the chassis upper reinforcement part is from 1 mm to 3 mm, the patient interface according to any one of claims 64 to 69.

71. The wall thickness of the chassis upper reinforcement part is from 1.5 mm to 2 mm, the patient interface according to claim 70.

72. The seal forming structure is formed from a flexible material, the patient interface according to any one of claims 64 to 71.

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