Patient interface and method for making that patient interface

Abstract

To provide a patient interface and a method for making the patient interface.SOLUTION: A patient interface for delivery of a prescribed amount of pressurised air or breathable gas to an entrance of a patient's airways comprises: a cushion member that includes a retaining structure and a seal-forming structure permanently connected to the retaining structure; a frame member attachable to the retaining structure; and a positioning and stabilizing structure attachable to the frame member.SELECTED DRAWING: Figure 4

Description

[Technical field]

[0001] 2(B) CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 61 / 904,974, filed November 15, 2013, U.S. Provisional Application No. 61 / 817,674, filed April 30, 2013, U.S. Provisional Application No. 61 / 823,192, filed May 14, 2013, U.S. Provisional Application No. 61 / 823,353, filed May 14, 2013, U.S. Provisional Application No. 61 / 837,521, filed June 20, 2013, and U.S. Provisional Application No. 61 / 839,916, filed June 27, 2013. This application claims the benefit of Australian Provisional Application No. 2013900132, filed January 16, 2013, and Australian Provisional Application No. 2013900168, filed January 18, 2013. This application claims the benefit of New Zealand Application No. 605907, filed January 16, 2103. Each of the above-referenced applications is hereby incorporated by reference in its entirety.

[0002] 3(C) Background of Technology 3.1(1) Technology field The present technology relates to one or more of the diagnosis, treatment, and amelioration of respiratory disorders, as well as procedures for preventing respiratory disorders. In particular, the present technology relates to medical devices and uses of the medical devices for treating and preventing respiratory disorders. [Background technology]

[0003] 3.2(2) Description of Related Art The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0004] The airways contain a series of branches that become thinner, shorter and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from the air into the venous blood and carbon dioxide to move out. The trachea divides into left and right main bronchi, which eventually divide into terminal bronchioles. The bronchi form the conducting airways and do not participate in gas exchange. Further division of the airways gives rise to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange takes place and is called the respiratory zone.

[0005] There is a range of respiratory diseases.

[0006] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by the obstruction of the upper airway during sleep. It results from an abnormally small upper airway combined with the normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall regions during sleep. The condition causes affected patients to stop breathing, typically for periods lasting 30-120 seconds, sometimes 200-300 times per night. This often causes excessive daytime somnolence and may lead to cardiovascular disease and brain damage. The syndrome is particularly common in middle-aged and older obese men, but sufferers may not be aware of the problem. See US Pat. No. 5,399,363 (Sullivan).

[0007] Cheyne-Stokes respiration (CSR) is a disorder of the patient's respiratory controller in which there are rhythmic alternating periods of increase and decrease in ventilation, causing repeated deoxygenation and reoxygenation of arterial blood. CSR is considered harmful due to recurrent hypoxia. In some patients, CSR is associated with repeated arousals from sleep, causing severe sleep disruption, increased sympathetic activity, and increased afterload. See US Patent No. 5,399,993 (Berthon-Jones).

[0008] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0009] Chronic obstructive pulmonary disease (COPD) encompasses any group of lower airway diseases that share certain characteristics. These characteristics include increased resistance to air movement, a prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0010] Neuromuscular diseases (NMD) is a broad term that encompasses many diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through nerve pathology. Some NMD patients are characterized by progressive muscle dysfunction resulting in loss of walking ability, wheelchair confinement, swallowing problems, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular diseases can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive diseases: characterized by muscle dysfunction that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variably or slowly progressive diseases: characterized by muscle dysfunction that worsens over years and leads to only a small decrease in life expectancy (e.g., limb-girdle muscular dystrophies, facioscapulohumeral muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include increasing generalized weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and changing moods.

[0011] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the rib cage. The disorders are usually characterized by restrictive disorders and share long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may cause severe respiratory failure. Symptoms of respiratory failure include dyspnea on exertion, peripheral edema, orthopnea, recurrent pulmonary infections, morning headache, fatigue, poor quality of sleep, and decreased appetite.

[0012] Otherwise, healthy individuals may successfully utilize the systems and devices to prevent the onset of respiratory diseases.

[0013] 3.2.1 System One known product used to treat SDB is the S9 Sleep Therapy System manufactured by ResMed.

[0014] 3.2.2 Treatment Nasal continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The premise is that CPAP can act as a pneumatic splint and prevent upper airway obstruction by forcing the soft palate and tongue forward and away from the posterior oropharyngeal wall.

[0015] Non-invasive ventilation (NIV) has been used to treat OHS, COPD, MD, and chest wall disease.

[0016] 3.2.3 Patient Interface The application of a volume of positive pressure air to the entrance of the patient's airway is facilitated by the use of a patient interface, such as a nasal mask, a full face mask, nasal pillows, or a nasal cradle mask. A full face mask includes a mask having one or more seal forming portions that cover at least the nostrils and mouth individually. A range of patient interface devices are known, but many of them suffer from one or more of being highly noticeable, aesthetically undesirable, awkward to fit, difficult to use, and uncomfortable, especially when worn for extended periods of time or when the patient is new to the system. Masks designed for aviators, as part of personal protective equipment, or solely for the administration of anaesthetic drugs may be acceptable in their initial use, but are nevertheless uncomfortable and undesirable to wear for extended periods of time, for example while sleeping.

[0017] 3.2.3.1 Seal-forming structure The patient interface generally includes a seal-forming structure.

[0018] One type of seal-forming structure extends around the periphery of the patient interface and is adapted to seal against the user's face when force is applied to the patient interface with the seal-forming structure in abutting engagement with the user's face. The seal-forming structure may include an air- or fluid-filled cushion or a molded or formed surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is not proper, there will be gaps between the seal-forming structure and the face and additional force will be required to press the patient interface against the face to achieve a seal.

[0019] Other types of seal-forming structures incorporate a flap seal of thin material positioned around the periphery of the mask to self-seal against the user's face when positive pressure is applied within the mask. As with previous styles of seal-forming structures, if the fit between the face and the mask is not good, additional force may be required to create a seal or the mask may leak. Also, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may fold or buckle during use, causing leakage.

[0020] Other forms of seal-forming structures may use adhesives to effect a seal, which some patients may find inconvenient to constantly apply and remove from their face.

[0021] A series of patient interface seal structure technologies are disclosed in the following patent applications assigned to ResMed Limited: US Pat. No. 5,393,633; US Pat. No. 5,493,663; and US Pat. No. 5,593,721.

[0022] 3.2.3.2 Positioning stabilization The seal-forming structures of patient interfaces used for positive air pressure therapy are subjected to the corresponding forces of air pressure which can compromise the seal, and therefore various techniques have been used to position the seal-forming structure and maintain it in sealing relationship with the appropriate portion of the face.

[0023] One technique is the use of adhesives, see for example US Pat.

[0024] Another technique is the use of one or more strap and stabilizing harnesses. Many such harnesses suffer from one or more of the following: they are ill-fitting, bulky, uncomfortable, and difficult to use.

[0025] Rigid elements, also known as "rigidizers", have been used in the past with expandable headgear. One known problem is associated with the fact that rigidizers, which are permanently attached (e.g., laminated or sewn) to a large area of ​​expandable material, limit the length the material can stretch, thus affecting the elastic properties of the entire headgear. Another problem relates to cleaning the headgear, where both the rigidizers and the expandable material need to be washed together since they are permanently attached to each other.

[0026] 3.2.3.3 Venting technology Some forms of patient interface systems may include vents to allow the outflow of exhaled carbon dioxide. Many such vents are noisy. Other vents may become blocked during use resulting in insufficient outflow. Some vents may disturb the sleep of the patient's bed partner, for example, by noise or focused airflow. Some vents cannot be properly cleaned and must be discarded after they become blocked. Some vents are intended to be used for short durations, i.e., less than three months, and are therefore manufactured from fragile materials to avoid cleaning or frequent cleaning and encourage more frequent replacement of the vent. ResMed Limited has developed many improved mask vent technologies, see U.S. Patent Nos. 5,133, 5,136, 5,138, 5,143, 5,151, 5,163, 5,171, 5,182, 5,193, 6,166, 6,177, 6,189, 7,196, 7,197, 8,198, 9,103, 9,104, 10,111.

[0027] [Table 1]

[0028] Various target sound pressure level values ​​are listed below.

[0029] [Table 2]

[0030] 3.2.3.4 Nasal pillow technique One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of US Pat. No. 5,399,323 (Trimble et al.), assigned to the Puritan Bennett Corporation.

[0031] ResMed Limited has manufactured the following products incorporating nasal pillows: the SWIFT® nasal pillows mask, the SWIFT® II nasal pillows mask, the SWIFT® LT nasal pillows mask, the SWIFT® FX nasal pillows mask, and the LIBERTY full face mask. The following patent applications assigned to ResMed Limited describe nasal pillows masks: U.S. Patent No. 6,399,433 (which describes, among other things, aspects of the ResMed SWIFT® nasal pillows mask), U.S. Patent No. 6,399,433 (which describes, among other things, aspects of the ResMed SWIFT® LT nasal pillows mask), U.S. Patent No. 6,399,433 and U.S. Patent No. 6,399,433 (which describes, among other things, aspects of the ResMed LIBERTY® full face mask), and U.S. Patent No. 6,399,433 (which describes, among other things, aspects of the ResMed SWIFT® FX nasal pillows mask).

[0032] 3.2.4 PAP device Positive pressure air is typically supplied to the patient's airway by a PAP device, such as a motor-driven blower, the outlet of which is connected via a flexible delivery conduit to the patient interface previously described.

[0033] 3.2.5 Mandibular repositioning A mandibular repositioning device (MRD) is one treatment option for sleep apnea. It is a custom-made adjustable oral appliance available from a dentist that holds the mandible in a forward position during sleep. This mechanical protrusion increases the space behind the tongue and exerts tension on the pharyngeal walls, reducing airway collapse and decreasing palatal vibration. [Prior art documents] [Patent documents]

[0034] [Patent Document 1] U.S. Pat. No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 [Patent Document 3] International Publication No. 1998 / 004,310 Brochure [Patent Document 4] International Publication No. 2006 / 074,513 Brochure [Patent Document 5] International Publication No. 2010 / 135,785 Brochure [Patent Document 6] U.S. Patent Application No. 2010 / 0000534 [Patent Document 7] International Publication No. 1998 / 034,665 Pamphlet [Patent Document 8] International Publication No. 2000 / 078,381 Brochure [Patent Document 9] U.S. Patent No. 6,581,594 [Patent Document 10] US Patent Application No. 2009 / 0050156 [Patent Document 11] US Patent Application No. 2009 / 0044808 [Patent Document 12] U.S. Pat. No. 4,782,832 [Patent Document 13] International Publication No. 2004 / 073 Brochure [Patent Document 14] International Publication No. 2005 / 063,328 Brochure [Patent Document 15] International Publication No. 2006 / 130,903 Brochure [Patent Document 16] International Publication No. 2009 / 052,560 Brochure Summary of the Invention [Problem to be solved by the invention]

[0035] 4. (D) Brief Overview of the Technology The present technology is directed to providing medical devices for use in the diagnosis, amelioration, treatment, or prevention of respiratory diseases that have one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability. [Means for solving the problem]

[0036] One aspect of the present technology relates to devices for use in the diagnosis, amelioration, treatment, or prevention of respiratory disease.

[0037] Other aspects of the technology relate to methods for use in the diagnosis, amelioration, treatment, or prevention of respiratory disorders.

[0038] One aspect of the present technology is a patient interface with a seal-forming structure that is removable for cleaning. It is a desire of the present technology to provide a patient interface that is lighter than prior art patient interfaces, less obtrusive than prior art patient interfaces, and quieter in use than prior art patient interfaces. It is also desirable to provide a patient interface that is intuitive for the patient to connect the mask components before treatment begins, and easy to adjust and wear for treatment.

[0039] One aspect of one form of the present technology is a patient interface having a seal-forming structure that can be positioned in place on the patient interface via a rigid-to-rigid connection. Another aspect of one form of the present technology is a seal-forming structure of the patient interface that can be removed for cleaning without requiring separation of the headgear portion of the patient interface.

[0040] One aspect of one form of the present technology is a patient interface comprising a seal-forming structure, a plenum chamber, and a connecting portion, where the seal-forming structure and the plenum chamber are formed from a relatively flexible material and the connecting portion is formed from a relatively rigid material. In one form, the connecting portion is removably connectable to a frame of the patient interface via, for example, a snap action, toggle, or bi-stable mechanism. In one form, the connecting portion is insert molded into the plenum chamber.

[0041] Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured with a clearly defined circumferential shape that is adapted to match the circumferential shape of the intended wearer (i.e., patient) and to fit closely against the face of the intended wearer.

[0042] One aspect of one form of the present technology is a method of manufacturing the patient interfaces described herein. It is a desire of the present technology to provide a manufacturing method that is less complex than prior art methods of manufacturing patient interfaces, uses less raw materials, and requires less assembly time by the operator to increase manufacturing efficiency.

[0043] Another aspect of the present technology is directed to a patient interface for delivering a volume of pressurized air or breathable gas to an entrance of a patient's airway. The patient interface may comprise a cushion member including a retaining structure and a seal-forming structure permanently connected to the retaining structure, and a frame member, wherein the retaining structure and the frame member are repeatedly and releasably attached to one another, a gas chamber is at least partially formed by engagement of the cushion member and the frame member, and increasing air pressure within the cushion member increases a sealing force between the seal-forming structure and the frame member.

[0044] One aspect of one form of the present technology is a method of manufacturing a patient interface.

[0045] Another aspect of the present technology is directed to a patient interface for delivering pressurized gas to a patient to treat sleep disordered breathing. The patient interface may comprise a seal-forming structure integrally formed with a nasal opening and a plenum chamber for supplying pressurized gas to both nares of the patient, the plenum chamber including a plenum connection area, the seal-forming structure configured to seal below the bridge of the nose around a lower circumference of the patient's nose, a frame releasably attachable to the plenum connection area, a connection port integrally formed with the frame, and a gas delivery tube permanently coupled to the frame at the connection port, the gas delivery tube may comprise: a helical coil comprised of a plurality of adjacent coils, each of the coils spaced apart by a width and having an outer surface defining a coil diameter; and a web of material coaxial with the helical coil and attached to the helical coil between adjacent coils of the plurality of adjacent coils, the web having at least one fold extending radially outward between adjacent coils of the plurality of adjacent coils, the at least one fold defined by a predetermined fold line.

[0046] In an embodiment, (a) an apex of the at least one fold may define a fold diameter; (b) a coil diameter may be approximately equal to the fold diameter when the gas delivery tube is in a neutral state, with adjacent coils spaced apart from one another in the neutral state; and (c) the gas delivery tube may be configured to have three distinct states: a neutral state in which the gas delivery tube has a neutral length; an extended state in which the gas delivery tube is extended along its longitudinal axis to an extended length that is greater than the neutral length; and an extended state in which the gas delivery tube is extended along its longitudinal axis to an extended length that is greater than the neutral length. (d) the web of material may include at least one fold extending radially outwardly along at least one length of the gas delivery tube; (e) the web of material may have an increasing slope angle from the helical coil to an apex of the at least one fold when the gas delivery tube is in a neutral state; (f) the web of material may have an asymmetric cross-sectional shape about the predetermined fold line; and (g) the predetermined fold line is formed by a fold line extending radially outwardly from adjacent ones of the plurality of adjacent coils. (h) a width separating adjacent coils of the plurality of adjacent coils may be approximately equal to a width of the helical coil when the gas delivery tube is in a neutral state; (i) the helical coil may occupy a greater percentage of the surface area of ​​the gas delivery tube than at least one fold of the web of material; (j) an outer portion of the helical coil may have a rounded profile; (k) the helical coil may have a greater thickness than the web of material; (l) the web of material may have a substantially uniform thickness; (m) the helical coil may comprise a thermoplastic elastomer (TPE) or a thermoplastic polyurethane (TPU), and / or the web of material may comprise a thermoplastic elastomer (TPE) or a thermoplastic polyurethane (TPU); (n) the gas delivery tube may be permanently joined to the frame at the connection port by insert molding the frame to the gas delivery tube; (o) the web of material and the helical coil may be joined to form a uniform, continuous inner surface of the gas delivery tube; and (p) the at least one fold comprises(q) the seal-forming structure may include a recess for receiving the tip of the patient's nose, (r) a compliant region may be located above the recess, the compliant region being thin and flexible relative to the remainder of the seal-forming structure, (s) the seal-forming structure may comprise foam, gel, and / or low durometer silicone, (t) the seal-forming structure may vary in thickness at predetermined locations around the nasal opening, (u) the seal-forming structure may comprise a pair of protruding ends extending symmetrically around the nasal opening, each protruding end extending symmetrically around the nasal opening, each protruding end extending symmetrically around the nasal opening, each protruding end extending symmetrically around the patient's face region where the ala of the nose joins the patient's face. (v) the seal-forming structure may comprise a pair of protruding end support portions structured to correspond to and support each protruding end, the pair of protruding end support portions may extend into a gas chamber defined at least in part by the seal-forming structure, (w) a lower portion of the seal-forming structure may be concave in a relaxed state to seal against and follow the curvature of the patient's upper lip, and / or (x) the seal-forming structure may comprise a dual-walled cushion to prevent collapse of the seal-forming structure when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal.

[0047] Another aspect of the present technology is directed to a patient interface for delivering pressurized gas to a patient to treat sleep disordered breathing. The patient interface may comprise a seal-forming structure integrally formed with a nasal opening and a plenum chamber for supplying pressurized gas to both nares of the patient, the plenum chamber including a plenum connection region, the seal-forming structure configured to seal below the bridge of the nose across a lower periphery of the patient's nose, a frame releasably attachable to the plenum connection region, the frame comprising a first material, and a pair of rigidiser arms comprising a second material, the second material being different from the first material, the frame and the pair of rigidiser arms being permanently connected.

[0048] In an embodiment, (a) the first material may be relatively more elastically flexible than the second material; (b) the frame may be overmolded onto the pair of rigidiser arms to form a mechanical connection; (c) the mechanical connection may comprise an enclosable portion extending from each of the pair of rigidiser arms that is overmolded with the material of the frame; (d) the enclosable portion may have a hook and a portion of a bend; (e) the first material may be operable to be integrally bonded with the second material; and (f) the first material may be a thermoplastic polyester elastomer. (g) the thermoplastic polymer may be polypropylene (PP); (h) the first material may be a fiber reinforced composite polypropylene material and the second material may be polypropylene; (i) each of the pair of rigidiser arms may include a protruding end configured to hold a pocketed end of a strap of the positioning and stabilising structure, the protruding end may be near the frame; (j) the first material may be non-expandable, and each of the pair of rigidiser arms may be configured to have a protruding end that is in a plane that is inflated relative to the other plane. (k) each of the rigidiser arms may comprise a body having a curvature to generally follow a cheek shape of the patient and a connection portion configured to connect to the frame, the connection portion being located at a distal end of the rigidiser arm; (l) the connection portion may comprise at least one protrusion and at least one void configured to be overmolded to connect to the frame; and (m) the seal-forming structure may define a recess for receiving the tip of the patient's nose. (n) a compliant region may be located above the recessed portion, the compliant region being thin and flexible relative to the remainder of the seal-forming structure; (o) the seal-forming structure may comprise foam, gel, and / or low durometer silicone; (p) the seal-forming structure may vary in thickness at predetermined locations around the nasal opening; (q) the seal-forming structure may comprise a pair of protruding ends extending symmetrically around the nasal opening, each protruding end configured to seal against an area of ​​the patient's face where the ala of the nose joins the patient's face;(r) the seal-forming structure may comprise a pair of protruding end support portions structured to correspond to and support each protruding end, the pair of protruding end support portions may extend into a gas chamber defined at least in part by the seal-forming structure, (s) a lower portion of the seal-forming structure may be concave in a relaxed state to seal against and follow the curvature of the patient's upper lip, and / or (t) the seal-forming structure may comprise a dual-walled cushion to prevent collapse of the seal-forming structure when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal.

[0049] Another aspect of the present technology is directed to a patient interface for delivering pressurized gas to a patient to treat sleep disordered breathing. The patient interface may include a seal-forming structure integrally formed with a nasal opening and a plenum chamber for supplying pressurized gas to both nares of the patient, the plenum chamber including a plenum connection area, the seal-forming structure configured to seal below the bridge of the nose across a lower periphery of the patient's nose, a frame releasably attachable to the plenum connection area, a connection port integrally formed with the frame, and at least one vent for outflow of exhaled air, the vent permanently connected to the frame, the at least one vent formed from a fabric formed by intertwining plastic fibers, the fabric having a predetermined amount of porosity.

[0050] In an embodiment, (a) the at least one vent may comprise two vents permanently connected to the frame on either side of the connection port; (b) the two vents may comprise a first vent having a first airflow velocity and a second vent having a second airflow velocity different from the first airflow velocity; (c) the first airflow velocity and the second airflow velocity may be selected such that an average airflow velocity of the first airflow velocity and the second airflow velocity is within a predetermined range; and (d) the first airflow velocity and / or the second airflow velocity may be selected such that a portion of the first vent and / or the second vent is air-conditioned. (e) the plastic fibers may be formed of a thermoplastic polymer selected from the group consisting of polypropylene, woven polypropylene material, polycarbonate, nylon, and polyethylene; (f) the at least one vent may be permanently connected to the frame by molecular adhesion using any one of the group consisting of overmolding, co-injection molding, and two-shot (2K) injection molding; and (g) the at least one vent may be semi-insulated. (h) the seal-forming structure may include a recess for receiving the tip of the patient's nose, (i) a compliant region may be located above the recess, the compliant region being thin and flexible relative to the remainder of the seal-forming structure, (j) the seal-forming structure may comprise foam, gel, and / or low durometer silicone, (k) the seal-forming structure may vary in thickness at predetermined locations around the nasal opening, and (l) the seal-forming structure comprises a pair of protruding ends extending symmetrically around the nasal opening. (m) the seal-forming structure may comprise a pair of protruding end support portions structured to correspond to and support each protruding end, the pair of protruding end support portions may extend into a gas chamber defined at least in part by the seal-forming structure; (n) a lower portion of the seal-forming structure may be concave in a relaxed state to seal against and follow the curvature of the patient's upper lip; and / or(o) the seal-forming structure may comprise a double-walled cushion to prevent collapse of the seal-forming structure when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal.

[0051] Another aspect of the present technology is directed to a positioning and stabilising structure for a patient interface device, the positioning and stabilising structure may comprise at least one strap and at least one rigidiser arm, the at least one rigidiser arm including a body and an extension for connecting the body to a mask frame, the positioning and stabilising structure arranged to position the at least one strap and the at least one rigidiser arm relative to each other such that the at least one rigidiser arm imparts a predetermined shape to the at least one strap at a stiffened portion of the at least one strap that allows the at least one stiffened portion of the at least one strap to move relative to the at least one rigidiser arm, the extension may be configured to prevent movement of the at least one rigidiser arm relative to the mask frame in a plane parallel to the sagittal plane of the patient.

[0052] In embodiments, (a) the at least one rigidiser arm may be attached to the at least one strap only at one localized point or area, (b) the at least one rigidiser arm may be attached to the at least one strap at a limited area of ​​the at least one strap, (c) the limited area may be adjacent to a pocket or sleeve opening of the at least one strap, (d) the at least one rigidiser arm may be multi-axially deformable to conform to the contours of the patient's face, and (e) the at least one rigidiser arm may be multi-axially deformable to conform to the contours of the patient's face. The rigidiser arms may be configured to extend from the mask frame to a location proximate or below the patient's cheekbones, (f) the at least one rigidiser arm may have a crescent shaped side profile, (g) an end of the at least one rigidiser arm may be attached to the at least one strap, and (h) the at least one rigidiser arm may be attached to the at least one strap by sewing, welding, gluing, heat staking, clamping, buttoning, snapping a cover over the end, and / or snapping to an external component. (i) the given predetermined shape may direct pressure of the positioning and stabilising structure towards a predetermined portion of the wearer's face; (j) the at least one rigidiser arm may be non-extensible and have a relatively greater stiffness than the at least one strap; (k) the positioning and stabilising structure may comprise two or more rigidiser arms symmetrically positioned on either side of the patient's face; (l) the at least one rigidiser arm may be fully detachable from the at least one strap; (m) the at least one strap may comprise two pockets, each pocket receiving one rigidiser arm for releasably securing the at least one strap to the rigidiser arm; (n) the at least one strap may comprise at least one retaining means, which may comprise a loop, sleeve and / or pocket for receiving the at least one rigidiser arm and holding the at least one rigidiser arm in place; (o) the at least one rigidiser arm may comprise at least one retaining means, which(p) the at least one rigidiser arm may be attached to a guide element on the at least one strap, (q) the guide element may be a loop or sheath or passage or pocket into or through which the at least one rigidiser arm extends, (r) the guide element may allow longitudinal expansion or contraction of the at least one strap relative to the at least one rigidiser arm and / or may allow substantially free movement or floating of the at least one rigidiser arm relative to the at least one strap, (s) the extension may be attached to a Frankfort (t) the extension may be configured to permit bending of the at least one rigidiser arm in a plane parallel to a horizontal plane, (u) the at least one strap may be substantially inelastic to allow adjustment of the length of the positioning and stabilising structure by at least one of bending of the at least one rigidiser arm, a ladder lock clip, a buckle connection and a hook and loop connection, (v) a patient interface system for sealingly delivering a flow of breathable gas at a continuous positive pressure relative to atmospheric pressure to an entrance to a patient's airways including at least the entrances of the patient's nares, the patient interface being configured to maintain a positive pressure relative to atmospheric pressure in use at about 4 cmH above atmospheric pressure during the patient's entire respiratory cycle while the patient is asleep to ameliorate sleep disordered breathing, e.g. sleep apnea, 2 O~about 30cmH 2 O above 10 cmH 2and a patient interface configured to maintain a therapeutic pressure within a range above atmospheric pressure, said patient interface system comprising: a positioning and stabilising structure according to any one or more of the preceding examples; and a patient interface, the patient interface configured to stabilise and control CO2 exhaled by the patient, said patient interface comprising: a seal-forming structure for supplying pressurised gas to at least both nares of the patient and to a plenum chamber which is pressurised in use at a pressure above atmospheric pressure, the seal-forming structure and the plenum chamber being integrally formed, the plenum chamber including a plenum connection region, the seal-forming structure configured to seal below the bridge of the nose around a lower periphery of the patient's nose; 2 To minimize rebreathing of exhaled CO 2 a patient interface system comprising: a gas outflow vent configured to allow flow of the gas to an exterior of the patient interface; and a frame releasably attachable to the plenum connection region; (w) the extension may be permanently fixed to the mask frame and the body may be removable from the extension; and / or (x) the extension and body may be integral and the extension is removable from the mask frame.

[0053] Another aspect of the present technology is directed to a cushion member for a patient interface for delivering a volume of pressurized air or breathable gas to an entrance of a patient's airway, the cushion member may comprise a retaining structure for repeatable engagement and disengagement with a frame member, and a seal-forming structure integrally formed with a nasal opening and a plenum chamber for delivering pressurized gas to both nares of the patient, the seal-forming structure configured to seal below the nasal bridge around a lower perimeter of the patient's nose, the seal-forming structure and the plenum chamber permanently connected to said retaining structure, the seal-forming structure formed from a first material and the retaining structure formed from a second material having mechanical properties different from the first material, the second material being harder than the first material, and an increase in air pressure within the cushion member increases the sealing force between the seal-forming structure and the frame member.

[0054] In embodiments, (a) the first material may be silicone and the second material may be silicone having a higher durometer than the first material, (b) the cushioning member may comprise a plenum chamber located between the retaining structure and the seal-forming structure, (c) the cushioning member may comprise a frame member formed from the second material, (d) the first material may allow the seal-forming structure to readily conform to finger pressure and the second material may prevent the retaining structure from readily conforming to finger pressure, (e) the first material may be silicone and the second material may be silicone having a higher durometer than the first material, (b) the cushioning member may comprise a plenum chamber located between the retaining structure and the seal-forming structure, (c) the cushioning member may comprise a frame member formed from the second material, (d) the first material may allow the seal-forming structure to readily conform to finger pressure and the second material may prevent the retaining structure from readily conforming to finger pressure, (f) the first material may be silicone and the second material may be silicone having a higher durometer than the first material, (g) the cushioning member may comprise a frame member formed from the second material, (h) the first material may allow the seal-forming structure to readily conform to finger pressure and the second material may prevent the retaining structure from readily conforming to finger pressure, (i) the first material may be silicone and the second material may be silicone having a higher durometer than the first material, (i) the cushioning member may comprise a plenum chamber located between the retaining structure and the seal-forming structure, (i) the cushioning member may comprise a frame member formed from the second material, (i) the first material may allow the seal-forming structure to readily conform to finger pressure and the second material may prevent the retaining structure from readily conforming to finger pressure, (i) the cushioning member may comprise a frame member formed from the second material ... ) the seal-forming structure may include a recess for receiving the tip of the patient's nose, (f) a compliant region may be located above the recess, the compliant region being thin and flexible relative to the remainder of the seal-forming structure, (g) the seal-forming structure may comprise foam, gel, and / or low durometer silicone, (h) the seal-forming structure may vary in thickness at predetermined locations around the nasal opening, (i) the seal-forming structure may comprise a pair of protruding ends extending symmetrically around the nasal opening, each the protruding ends may be configured to seal against a region of the patient's face where the nasal ala joins the patient's face; (j) the seal-forming structure may comprise a pair of protruding end support portions structured to correspond to and support each protruding end, the pair of protruding end support portions may extend into a gas chamber defined at least in part by the seal-forming structure; (k) a lower portion of the seal-forming structure may be concave in a relaxed state to seal against and follow the curvature of the patient's upper lip; (l) the seal-forming structure may comprise a double walled cushion to prevent collapse of the seal-forming structure when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal; and / or (m) a patient interface for sealingly delivering a flow of breathable gas at a continuous positive pressure relative to atmospheric pressure to an entrance to a patient's airways including at least the entrances of the patient's nares, the patient interface being configured to provide a pressure of about 4 cmH above atmospheric pressure in use throughout the patient's respiratory cycle while the patient is asleep to ameliorate sleep disordered breathing. 2 O~about 30cmH 2and a patient interface configured to maintain a therapeutic pressure within a range above atmospheric pressure, the patient interface comprising a cushion member as in any of the previous examples; a positioning and stabilising structure for maintaining the cushion member in sealing contact with at least an area surrounding an entrance to the patient's nasal airways while maintaining a therapeutic pressure at at least at the entrance to the patient's nasal airways; a plenum chamber pressurised at a pressure above atmospheric pressure in use; and a patient interface adapted to urge CO2 exhaled by the patient against the cushion member. 2 To minimize rebreathing of exhaled CO 2 and a gas escape vent configured to allow flow of the gas to an exterior of the patient interface.

[0055] Another aspect of the present technology is directed to a patient interface for providing breathable gas to a patient, the patient interface may comprise a seal-forming structure integrally formed with a nasal opening and a plenum chamber for providing pressurized gas to both nares of the patient, the plenum chamber including a plenum connection region, the seal-forming structure configured to seal below the bridge of the nose around a lower periphery of the patient's nose, and a frame including a frame connection region and a headgear connection region, the frame connection region configured to attach to the plenum chamber at the plenum connection region, the sealing lip forming a pneumatic seal between the plenum connection region and the frame connection region.

[0056] In embodiments, (a) the frame connection region may comprise at least one retention feature to facilitate connection with the plenum connection region, and the plenum connection region may comprise at least one complementary connection region to receive the corresponding at least one retention feature; (b) the at least one retention feature may be a barb, and the barb may have a front surface and a rear surface, and the at least one complementary connection region may comprise a lead-in surface and a retention surface; (c) the seal-forming structure may include a recess for receiving the tip of the patient's nose; (d) a compliant region may be located above the recess, and the compliant region is thin and flexible relative to the remainder of the seal-forming structure; (e) the seal-forming structure may comprise foam, gel, and / or low durometer silicone; and (f) the seal-forming structure may comprise a perimeter aperture around the nasal opening. (g) the seal-forming structure may comprise a pair of protruding ends extending symmetrically around the nasal opening, each protruding end configured to seal against an area of ​​the patient's face where the ala of the nose joins the patient's face, (h) the seal-forming structure may comprise a pair of protruding end support portions structured to correspond to and support each protruding end, the pair of protruding end support portions may extend into a gas chamber defined at least in part by the seal-forming structure, (i) a lower portion of the seal-forming structure may be concave in a relaxed state to seal against and follow the curvature of the patient's upper lip, and / or (j) the seal-forming structure may comprise a dual-walled cushion to prevent collapse of the seal-forming structure when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal.

[0057] Another aspect of the present technology is directed to a cushion member for a nasal cradle mask for delivering a volume of pressurized air or respiratory gas to an entrance of a patient's airway, the cushion member may comprise a retaining structure for repeatable engagement and disengagement with a frame member, and a seal-forming structure integrally formed with a nasal opening and a plenum chamber for delivering pressurized gas to both nares of the patient, the seal-forming structure configured to seal below the nasal bridge around a lower perimeter of the patient's nose, the seal-forming structure and the plenum chamber permanently connected to said retaining structure, wherein an increase in air pressure within the cushion member increases the sealing force between the seal-forming structure and the frame member, and the retention force between the retaining structure and the frame member is higher than a disengagement force for disengaging the retention structure from the frame member.

[0058] In embodiments, (a) the seal-forming structure may include a recess for receiving the tip of the patient's nose, (b) a compliant region may be located above the recess, the compliant region being thin and flexible relative to the remainder of the seal-forming structure, (c) the seal-forming structure may comprise foam, gel, and / or low durometer silicone, (d) the seal-forming structure may vary in thickness at predetermined locations around the nasal opening, (e) the seal-forming structure may comprise a pair of protruding ends extending symmetrically around the nasal opening, each protruding end configured to seal against a region of the patient's face where the ala of the nose joins the patient's face, and (f) the seal-forming structure may comprise a pair of protruding end support portions structured to correspond to and support each protruding end. and wherein the pair of protruding end support portions may extend at least in part into a gas chamber defined by the seal-forming structure; (g) a lower portion of the seal-forming structure may be concave in a relaxed state to seal against and follow the curvature of the patient's upper lip; (h) the seal-forming structure may comprise a double walled cushion to prevent collapse of the seal-forming structure when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal; and / or (i) a patient interface for sealingly delivering a flow of breathable gas at a continuous positive pressure relative to atmospheric pressure to an entrance to a patient's airways including at least the entrances of the patient's nares, the patient interface being configured to provide a pressure of about 4 cmH above atmospheric pressure in use throughout the patient's respiratory cycle while the patient is asleep to ameliorate sleep disordered breathing. 2 O~about 30cmH 2 and a patient interface configured to maintain a therapeutic pressure within a range above atmospheric pressure, the patient interface comprising a cushion member of any of the previous examples; a positioning and stabilising structure for maintaining the cushion member in sealing contact with at least an area surrounding an entrance to the patient's nasal airways while maintaining a therapeutic pressure at least at the entrance to the patient's nasal airways; a plenum chamber pressurised at a pressure above atmospheric pressure in use; and a patient interface configured to maintain a therapeutic pressure within a range above atmospheric pressure, the patient interface comprising a cushion member of any of the previous examples; a positioning and stabilising structure for maintaining the cushion member in sealing contact with at least an area surrounding an entrance to the patient's nasal airways while maintaining a therapeutic pressure at at least at the entrance to the patient's nasal airways; 2 To minimize rebreathing of exhaled CO 2and a gas escape vent configured to allow flow of the gas to an exterior of the patient interface.

[0059] Another aspect of the present technology is directed to a cushion member for a patient interface for delivering a volume of pressurized air or breathable gas to an entrance of a patient's airway, the cushion member may comprise a retaining structure for repeatable engagement and disengagement with a frame member, and a seal-forming structure integrally formed with a nasal opening and a plenum chamber for delivering pressurized gas to both nares of the patient, the seal-forming structure configured to seal below the bridge of the nose around a lower perimeter of the patient's nose, the seal-forming structure and the plenum chamber permanently connected to the retaining structure, said seal-forming structure including a recess for receiving the tip of the patient's nose, said seal-forming structure comprising a pair of protruding ends extending symmetrically around the nasal opening, each protruding end configured to seal against an area of ​​the patient's face where the alae of the nose join the patient's face.

[0060] In embodiments, (a) the seal-forming structure may comprise a double wall cushion to prevent collapse of the seal-forming structure when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal, (b) a compliant region may be located above the recessed portion, the compliant region being thin and flexible relative to the remainder of the seal-forming structure, (c) the seal-forming structure may comprise foam, gel, and / or low durometer silicone, (d) the seal-forming structure may vary in thickness at predetermined locations around the nasal opening, (e) the seal-forming structure may include an overhang at the nasal opening of the seal-forming structure, the overhanging portion being located near the recessed portion, and (d) the seal-forming structure may be configured to accommodate and support each protruding end. (e) a lower portion of the seal-forming structure may be concave in a relaxed state to seal against and follow the curvature of a patient's upper lip, (f) the lower portion may have a reduced material thickness relative to a remainder of the seal-forming structure, and / or (g) a patient interface for sealingly delivering a flow of breathable gas at a continuous positive pressure relative to atmospheric pressure to an entrance to a patient's airways including at least the entrances of the patient's nares, the patient interface configured to provide a pressure of about 4 cmH above atmospheric pressure in use throughout the patient's respiratory cycle while the patient is asleep to ameliorate sleep disordered breathing. 2 O~about 30cmH 2 and a patient interface configured to maintain a therapeutic pressure within a range above atmospheric pressure, the patient interface comprising a cushion member of any of the previous examples; a positioning and stabilising structure for maintaining the cushion member in sealing contact with at least an area surrounding an entrance to the patient's nasal airways while maintaining a therapeutic pressure at least at the entrance to the patient's nasal airways; a plenum chamber pressurised at a pressure above atmospheric pressure in use; and a patient interface configured to maintain a therapeutic pressure within a range above atmospheric pressure, the patient interface comprising a cushion member of any of the previous examples; a positioning and stabilising structure for maintaining the cushion member in sealing contact with at least an area surrounding an entrance to the patient's nasal airways while maintaining a therapeutic pressure at at least at the entrance to the patient's nasal airways; 2 To minimize rebreathing of exhaled CO 2and a gas escape vent configured to allow flow of the gas to an exterior of the patient interface.

[0061] Another aspect of the present technology is directed to a patient interface system for providing breathable gas to a patient, the patient interface may comprise a patient interface including a seal-forming structure for making a pneumatic connection to a patient's airway, and a positioning and stabilising structure including at least one strap and at least one rigidiser arm and configured to releasably hold the patient interface to the patient, the at least one strap may be permanently attached to the at least one rigidiser arm at an attachment point.

[0062] In embodiments, (a) the attachment points may comprise ultrasonic welding, (b) the attachment points may comprise heat staking, (c) the attachment points may comprise stitching, (d) the attachment points may comprise a hinged mechanism, and / or (e) the attachment points may comprise a hook on at least one rigidiser arm.

[0063] Another aspect of the present technology is directed to a patient interface system for providing breathable gas to a patient, the patient interface may comprise a patient interface including a seal-forming structure for making a pneumatic connection to the patient's airway, and a positioning and stabilising structure including at least one strap and at least one rigidiser arm and configured to releasably hold the patient interface to the patient, the at least one strap may be releasably attached to the at least one rigidiser arm.

[0064] In embodiments, (a) the at least one strap may comprise an elastic tube and the at least one rigidiser arm may comprise a raised stop; (b) the at least one rigidiser arm may comprise a tab for releasably attaching the at least one strap with a hook and loop connection; (c) the at least one strap may comprise at least one lock and the at least one rigidiser arm may comprise at least one notch corresponding to the at least one lock; and / or (d) the at least one strap may comprise an end having hook material for forming a hook and loop connection with the loop material on the at least one strap by looping the at least one strap through a first slot and a second slot of the at least one rigidiser arm.

[0065] Another aspect of the present technology is directed to a patient interface system for providing breathable gas to a patient, the patient interface may comprise a patient interface including a seal-forming structure for pneumatically connecting to a patient's airway, and a positioning and stabilising structure including at least one strap and at least one rigidiser arm and configured to releasably hold the patient interface to the patient, the at least one rigidiser arm may be releasably attachable to a frame of the patient interface, the frame supporting the seal-forming structure against the patient's face.

[0066] In an embodiment, (a) the at least one rigidiser arm can be releasably attached to a corresponding extension of the frame with a rotation lock arrangement, (b) the patient interface may further comprise a pin and corresponding socket for releasably attaching the at least one rigidiser arm to the extension of the frame, and (c) the at least one rigidiser comprises an arm and a projection supported on a shaft for releasably attaching the at least one rigidiser arm to the extension of the frame at a shaft receiving portion and an arm receiving portion. (d) the at least one rigidiser arm may include an extension for releasably attaching to the receiver of the frame by a snap fit, (e) the at least one rigidiser arm may include an extension for releasably attaching to the receiver of the frame by a press fit, (f) the at least one rigidiser arm may include an extension having a post for releasably attaching to the receiver of the frame by a snap fit, the extension may further include an end to prevent rotation about a longitudinal axis of the post, and (g) the at least one rigidiser arm may include an extension having a post for releasably attaching to the receiver of the frame by a snap fit, the extension may further include an end to prevent rotation about a longitudinal axis of the post. (h) the at least one rigidiser arm may comprise an extension having a pin for releasably attaching to a socket of the frame by a snap fit; (i) the at least one rigidiser arm may comprise a first magnet and the frame may comprise a second magnet for releasably attaching the at least one rigidiser arm to the frame; (j) the at least one rigidiser arm may comprise a first L-shaped portion having at least one post and the frame may comprise a second L-shaped portion having at least one hole and the at least one rigidiser arm may be releasably attached to the frame by engagement between the at least one post and the at least one hole; (k) the frame may comprise a boss and the at least one rigidiser arm may comprise a cavity for releasably attaching to the boss; and / or(l) For releasable attachment between the at least one rigidiser arm and the frame, the at least one rigidiser arm may include a protrusion and a hole, and the extension of the frame may include a slot corresponding to the protrusion and a post corresponding to the hole.

[0067] Another aspect of the present technology is directed to a patient interface system for providing breathable gas to a patient, the patient interface may comprise a patient interface including a seal-forming structure for pneumatically connecting to a patient's airway, and a positioning and stabilising structure including at least one strap and at least one rigidiser arm and configured to releasably hold the patient interface to the patient, with extensions coupling each of the at least one rigidiser arm to a frame of the patient interface, the frame supporting the seal-forming structure against the patient's face.

[0068] In embodiments, (a) at least one rigidiser arm may include ribs at the bend to resist deformation at the bend, (b) the extension may include ribs at the bend to resist deformation at the bend, and / or (c) the extension may include longitudinal ribs along straight portions and bends of the extension to resist deformation.

[0069] Another aspect of the present technology is directed to a patient interface for sealingly delivering a flow of breathable gas at a continuous positive pressure relative to atmospheric pressure to an entrance to a patient's airways, including at least the entrance to the patient's nares, the patient interface providing a continuous positive pressure flow relative to atmospheric pressure at a pressure approximately 4 cmH above atmospheric pressure in use throughout the patient's respiratory cycle while the patient is asleep to ameliorate sleep disordered breathing, e.g., sleep apnea. 2 O~about 30cmH 2 O above 10 cmH 2The patient interface is configured to maintain a therapeutic pressure within a range above atmospheric pressure, the patient interface comprising a sealing structure for forming a seal with at least the patient's nasal airways, a positioning and stabilising structure for maintaining the sealing structure in sealing contact with at least an area surrounding an entrance to the patient's nasal airways while maintaining a therapeutic pressure at at least the entrance to the patient's nasal airways, a plenum chamber pressurised at a pressure above atmospheric pressure in use, and a patient interface adapted to urge CO2 exhaled by the patient against the therapeutic pressure. 2 To minimize rebreathing of exhaled CO 2 and a gas escape vent configured to allow flow of the gas to an exterior of the patient interface.

[0070] Of course, some of the aspects may form sub-aspects of the technology, and various examples of the sub-aspects and / or aspects may be combined in various ways and form further aspects or sub-aspects of the technology.

[0071] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims.

[0072] 5 (E) Brief description of some of the figures in the drawing The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings in which like reference numerals indicate similar elements and in which: [Brief description of the drawings]

[0073] 5.1 Treatment System [Figure 1a] Shown is a system according to the present technology: A patient 1000 wearing a patient interface 3000 is supplied with air at positive pressure from a PAP device 4000. Air from the PAP device 4000 is humidified in a humidifier 5000 and passed along an air circuit 4170 towards the patient 1000. [Figure 1b] A PAP device 4000 is shown for use with a patient 1000 with a nasal mask. [Figure 1c]Shown is a PAP device 4000 for use with a patient 1000 with a full face mask. 5.2 Treatment 5.2.1 Respiratory System [Figure 2a] A general diagram of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2b] Shown is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilages, alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. 5.2.2 Facial Anatomy [Figure 2c] FIG. 1 is a front view of a face with several features of the surface anatomy identified including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, eye corners, nostrils, nasolabial folds, and corners of the mouth. [Figure 2d] FIG. 1 is a side view of the head with several features of the surface anatomy identified, including the glabella, root of the nose, tip of the nose, nasal spine, upper lip, lower lip, upper jaw, nasal ridge, superior ear base, and inferior ear base. Also shown are the superior and inferior, and anterior and posterior directions. [Figure 2e] FIGURE 2 is a further lateral view of the head, showing the approximate location of the Frankfort horizontal plane and the nasolabial angle; [Figure 2f] A bottom view of the nose is shown. [Figure 2g] 1 shows a side view of the surface features of a nose. [Figure 2h] Shown are the subcutaneous structures of the nose including the lateral cartilages, septal cartilage, greater alar cartilage, lesser alar cartilage, and fibroadipose tissue. [Figure 2i] Showing a medial nasal avulsion approximately 7 mm from the sagittal plane, particularly showing the septal cartilage and the medial crus of the greater alar cartilage. [Figure 2j] Shown is a frontal view of the bones of the skull, including the frontal, temporal, nasal, and cheekbones. The nasal turbinates are shown, as well as the maxilla, mandible, and mental protuberance. [Figure 2k]Shows a lateral view of the skull with the head surface outline and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2l] An anterior lateral view of the nose is shown. 5.3 PAP Machines and Humidifiers [Figure 3a]

[0036] Fig. 2 shows an exploded view of a PAP device according to an example of the present technology. [Figure 3b] FIG. 1 shows a perspective view of a humidifier in accordance with one form of the present technology. [Figure 3c] FIG. 5 shows a schematic diagram of the pneumatic circuit of a PAP device in accordance with one form of the present technology. Upstream and downstream directions are indicated. 5.4 Patient Interface [Figure 4] FIG. 13 is a front view of a plenum chamber in accordance with one form of the present technology. [Diagram 5] 5 is a cross-section taken along line 5-5 of FIG. [Figure 6] FIG. 6 is an enlarged detail view taken from FIG. [Figure 7] FIG. 5 is a top perspective view of the plenum chamber shown in FIG. [Figure 8] 8 is a cross-section taken along line 8-8 of FIG. 7. [Figure 9] FIG. 9 is an enlarged detail view taken from FIG. [Figure 10] FIG. 13 is a front perspective view of a plenum chamber in accordance with one example of the present technology. [Figure 11] FIG. 5 is a diagram of the plenum chamber shown in FIG. [Figure 12] 12 is a cross-section taken along line 12-12 of FIG. [Figure 13] FIG. 13 is an enlarged detail view taken from FIG. 12. [Figure 14] FIG. 2 is an enlarged cross-sectional view of the plenum connection area. [Figure 15] FIG. 12 is a side view of the patient interface shown in FIG. [Figure 16] 16 is a cross-section taken along line 16-16 of FIG. [Figure 17] FIG. 17 is an enlarged detail view taken from FIG. 16. [Figure 18] FIG. 13 is a side view of the patient interface in place on a model patient's head without any positioning and stabilising structure shown. [Figure 19] FIG. 13 is a partial underside view of a portion of a patient interface according to one form of the present technology in place on a model patient's head, although for clarity only a portion of the positioning and stabilising structure that connects to the frame is shown. [Figure 20] FIG. 13 is a side view of a plenum connection region of a plenum chamber in accordance with one form of the present technology. [Figure 21] FIG. 2 is a top view of the plenum connection area of ​​the plenum chamber. [Figure 22] FIG. 13 is a front view of a plenum connection area of ​​the plenum chamber. [Diagram 23] FIG. 13 is a bottom view of a plenum connection area of ​​the plenum chamber. [Figure 24] FIG. 2 is a perspective view of a plenum connection area of ​​the plenum chamber. [Diagram 25] FIG. 13 is a cross-sectional view of the connection and frame connection area without the plenum chamber and frame being engaged. [Figure 26] FIG. 13 is a cross-sectional view of the connection and frame connection area where the plenum chamber and frame contact but are not fully engaged. [Figure 27] FIG. 13 is a cross-sectional view of the connection and frame connection area where the plenum chamber and frame nearly fully engage one another such that the retention feature is deflected. [Figure 28] FIG. 13 is a cross-sectional view of the connection and frame connection area where the plenum chamber and frame are engaged but separated such that the retention feature is deflected. [Figure 29] FIG. 13 is a cross-sectional view of the connection and frame connection area with the plenum chamber and frame fully engaged. [Diagram 30] FIG. 144 is a rear perspective view of a patient interface with the plenum chamber and seal-forming structure removed in accordance with an example of the present technology. [Diagram 31] FIG. 13 is a front perspective view of a patient interface with the plenum chamber and seal-forming structure removed in accordance with an example of the present technology. [Diagram 32] FIG. 14 is a rear view of a patient interface with the plenum chamber and seal-forming structure removed in accordance with an example of the present technology. [Diagram 33] FIG. 13 is a side view of a patient interface with the plenum chamber and seal-forming structure removed in accordance with an example of the present technology. [Diagram 34] FIG. 14 shows a perspective view of a patient interface according to another example of the present technology showing attachment of an exemplary seal-forming structure and plenum chamber to a frame of the patient interface. [Diagram 35]

[0036] Fig. 13 shows a cross section of a patient interface including a mask frame, flexible joint, and rigidiser arm according to an example of the present technology. [Diagram 36] FIG. 14 shows a perspective view of a patient interface including a mask frame, flexible joints, and rigidiser arms according to an example of the present technology. [Figure 37]

[0036] Fig. 13 shows an exploded view of a patient interface including a mask frame, flexible joints, and rigidiser arms according to an example of the present technology. [Figure 38]

[0046] Fig. 13 shows a detailed view of the end of a rigidiser arm according to an example of the present technology. [Figure 39] FIG. 14 shows a perspective view of a patient interface including a mask frame, flexible joints, and rigidiser arms according to an example of the present technology. [Diagram 40]

[0036] Fig. 13 shows a cross section of a patient interface including a mask frame, flexible joint, and rigidiser arm according to an example of the present technology. [Diagram 41]

[0036] Fig. 13 shows a perspective view of a rigidiser arm according to an example of the present technology. [Diagram 42]

[0036] Fig. 13 shows a cross section of a patient interface including a mask frame, flexible joint, and rigidiser arm according to an example of the present technology. [Diagram 43]FIG. 14 shows a perspective view of a patient interface including a mask frame, flexible joints, and rigidiser arms according to an example of the present technology. [Diagram 44]

[0036] Fig. 13 shows an exploded view of a patient interface including a mask frame, flexible joints, and rigidiser arms according to an example of the present technology. [Diagram 45]

[0046] Fig. 13 shows a detailed view of the end of a rigidiser arm according to an example of the present technology. [Figure 46]

[236] Fig. 13 shows a detailed view of a flexible joint and an end of a rigidiser arm according to an example of the present technology. [Figure 47]

[236] Fig. 13 shows a cross section of a rigidizer and mask frame according to an example of the present technology. [Figure 48]

[0036] Fig. 13 shows a detailed cross section of a rigidiser arm and mask frame according to an example of the present technology. [Figure 49]

[0036] Fig. 13 shows a cross section of a rigidiser arm and mask frame according to an example of the present technology. [Figure 50]

[0036] Fig. 13 shows a perspective view of a rigidiser arm and mask frame according to an example of the present technology. [Figure 51]

[0033] Fig. 13 shows a detailed perspective view of a connection between a rigidizer and a mask frame according to an example of the present technology. [Figure 52] FIG. 13 shows a top view of a rigidiser arm and mask frame according to an example of the present technology, showing the bending of the rigidiser arm in a lateral-lateral direction in the frontal plane with dashed lines. [Diagram 53]

[0033] Fig. 13 shows a detailed top view of a connection between a rigidizer and a mask frame according to an example of the present technology. [Figure 54]

[0036] Fig. 13 shows a cross-sectional perspective view of a rigidiser arm and mask frame according to an example of the present technology. [Figure 55]

[0036] Fig. 13 shows a side view of a rigidiser and mask frame according to an example of the present technology, showing the bending of the rigidiser arms in a vertical downward direction in the sagittal plane with dashed lines. [Figure 56]

[236] Fig. 13 shows a front view of a rigidizer and mask frame according to an example of the present technology. [Figure 57]

[0036] Fig. 13 shows a perspective view of a rigidiser arm and mask frame according to an example of the present technology. [Figure 58]

[236] Fig. 12 shows a partially exploded perspective view of a rigidiser arm and mask frame according to an example of the present technology. [Figure 59]

[0033] Fig. 13 shows a detailed partially exploded perspective view of a rigidizer and mask frame according to an example of the present technology. [Figure 60]

[0033] Fig. 13 shows a perspective view of a rigidizer according to an example of the present technology. [Figure 61] FIG. 13 shows a diagram of a rigidiser arm according to an example of the present technology plotted on a grid in the XY plane. [Figure 62] FIG. 13 shows a diagram of a rigidiser arm according to an example of the present technology plotted on a grid in the XZ plane. [Figure 63] FIG. 13 shows a diagram of a rigidiser arm according to an example of the present technology plotted on a grid in the YZ plane. [Figure 64]

[0036] Fig. 13 shows a diagram of a rigidiser arm plotted in three dimensions according to an example of the present technology. [Figure 65]

[0033] Fig. 13 shows a schematic perspective view of a positioning and stabilising structure according to an example of the present technology. [Figure 66] A cross-sectional view of the positioning and stabilising structure taken along line 66-66 in Figure 65 is shown. [Figure 67] FIG. 1 shows a schematic side view of an exemplary rigidiser arm for a positioning and stabilising structure in accordance with the present technology. [Figure 68] FIG. 1 shows a schematic perspective view of an exemplary positioning and stabilising structure including a rigidiser arm in accordance with the present technology in a first state. [Figure 69] FIG. 1 shows a schematic perspective view of an exemplary positioning and stabilising structure including a rigidiser arm in accordance with the present technology in a second state. [Figure 70] FIG. 13 shows a schematic perspective view of an exemplary positioning and stabilising structure including a rigidiser arm according to the present technology in a third state. [Figure 71] FIG. 13 shows a perspective view of an exemplary positioning and stabilising structure in accordance with the present technology worn by a patient. [Figure 72] FIG. 13 shows a front view of an exemplary positioning and stabilising structure in accordance with the present technology worn by a patient. [Figure 73]FIG. 13 shows a side view of an exemplary positioning and stabilising structure in accordance with the present technology worn by a patient. [Figure 74] FIG. 13 shows a perspective view of an exemplary positioning and stabilising structure in accordance with the present technology worn by a patient. [Figure 75] FIG. 13 shows a front view of an exemplary positioning and stabilising structure in accordance with the present technology worn by a patient. [Figure 76] FIG. 13 shows a side view of an exemplary positioning and stabilising structure in accordance with the present technology worn by a patient. [Figure 77] FIG. 13 shows a bottom perspective view of an exemplary positioning and stabilising structure in accordance with the present technology worn by a patient. [Figure 78] 13 shows a graph of the elongation (in mm) of a strap of a positioning and stabilising structure according to an example of the present technology subjected to a series of loads (in Newtons). [Figure 79]

[214] Fig. 114 shows a top view of a strap of a positioning and stabilising structure during an intermediate manufacturing stage according to an example of the present technology. [Figure 80] FIG. 80 shows a cross-sectional view taken through line 80-80 in FIG. 79 of a strap of a positioning and stabilising structure according to an example of the present technology during an intermediate manufacturing stage. [Figure 81]

[214] Fig. 11 shows a top view of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 82]

[0033] Fig. 13 shows a detailed top view of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 83] FIG. 83 shows a cross section taken through line 83-83 in FIG. 81 of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 84]

[0033] Fig. 1 shows a series of perspective views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 85]

[0033] Fig. 1 shows a series of perspective views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 86]

[0033] Fig. 1 shows a series of perspective views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 87]

[0033] Fig. 1 shows a series of perspective views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 88]

[0033] Fig. 1 shows a series of perspective views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 89]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 90]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 91]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 92]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 93]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 94]

[0036] Fig. 1 shows a series of front views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 95]

[0036] Fig. 1 shows a series of front views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 96]

[0036] Fig. 1 shows a series of front views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 97]

[0036] Fig. 1 shows a series of front views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 98]

[0036] Fig. 1 shows a series of front views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 99]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 100]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 101]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 102]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 103]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 104]

[0036] Figure 1 shows a series of side views of a patient wearing a positioning and stabilising structure in accordance with an example of the present technology. [Figure 105]

[0036] Fig. 13 shows a series of perspective views of a patient adjusting a patient interface in accordance with an example of the present technology. [Fig. 106]

[0036] Fig. 13 shows a series of perspective views of a patient adjusting a patient interface in accordance with an example of the present technology. [Figure 107]

[0036] Fig. 13 shows a series of perspective views of a patient adjusting a patient interface in accordance with an example of the present technology. [Figure 108]

[0036] Fig. 13 shows a series of rear views of a patient adjusting a positioning and stabilising structure in accordance with an example of the present technology. [Fig. 109]

[0036] Fig. 13 shows a series of rear views of a patient adjusting a positioning and stabilising structure in accordance with an example of the present technology. [Figure 110]

[0036] Fig. 13 shows a series of rear views of a patient adjusting a positioning and stabilising structure in accordance with an example of the present technology. [Figure 111]

[0036] Fig. 13 shows a series of rear views of a patient adjusting a positioning and stabilising structure in accordance with an example of the present technology. [Figure 112]

[0036] Fig. 13 shows a series of rear views of a patient adjusting a positioning and stabilising structure in accordance with an example of the present technology. [Figure 113]

[0036] Fig. 13 shows a detailed view of a connection between a strap of a positioning and stabilising structure and a rigidiser arm in accordance with an example of the present technology. [Fig. 114]

[0036] Fig. 13 shows another detailed view of the connection between a strap and a rigidiser arm of a positioning and stabilising structure in accordance with an example of the present technology. [Fig. 115]

[0036] Fig. 13 shows another detailed view of the connection between a strap and a rigidiser arm of a positioning and stabilising structure in accordance with an example of the present technology. [Fig. 116]

[0036] Fig. 13 shows another detailed view of the connection between a strap and a rigidiser arm of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 117]

[0036] Fig. 13 shows another detailed view of the connection between a strap and a rigidiser arm of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 118]

[0036] Fig. 13 shows another detailed view of the connection between a strap and a rigidiser arm of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 119]

[0036] Fig. 13 shows a detailed view of a connection between a strap of a positioning and stabilising structure and a rigidiser arm in accordance with an example of the present technology. [Figure 120]

[0036] Fig. 13 shows another detailed view of the connection between a strap and a rigidiser arm of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 121]

[0036] Fig. 13 shows another detailed view of the connection between a strap and a rigidiser arm of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 122]

[0036] Fig. 13 shows another detailed view of the connection between a strap and a rigidiser arm of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 123]

[0036] Fig. 13 shows a detailed view of a split region of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 124]

[0036] Fig. 13 shows another detailed view of a split region of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Fig. 125]

[0036] Fig. 13 shows another detailed view of a split region of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Fig. 126]

[113] Fig. 11 shows a detailed view of a branch of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 127]

[0036] Fig. 13 shows another detailed view of a branch of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 128]

[0036] Fig. 13 shows another detailed view of a branch of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Figure 129]

[0036] Fig. 13 shows another detailed view of a branch of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Fig. 130]

[0036] Fig. 13 shows another detailed view of a branch of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Fig. 131]

[0036] Fig. 13 shows another detailed view of a branch of a strap of a positioning and stabilising structure in accordance with an example of the present technology. [Fig. 132] FIG. 13 shows a perspective view of a positioning and stabilising structure manufactured in accordance with an example of the present technology. [Fig. 133] 1 illustrates a process for forming positioning and stabilising structure straps from a continuous roll in accordance with an example of the present technology. [Fig. 134] 1 shows a prior art example depicting a knitting process according to an example of the present technology. [Fig. 135] 1 shows a prior art example depicting a knitting process according to an example of the present technology. [Fig. 136] 1 shows a basic warp knit fabric according to an example of the present technology. [Fig. 137] 137 is a schematic representation of the basic warp knit fabric of FIG. 136. [Figure 138] 1 shows a basic warp knit fabric according to an example of the present technology. [Figure 139] 1 shows a basic warp knit fabric according to an example of the present technology. [Fig. 140] FIG. 14 is a side view of a positioning and stabilising structure positioned on a patient's head in accordance with an example of the present technology. [Fig. 141] FIG. 141 shows the changing direction of course or grain of the positioning and stabilising structure of FIG. 140 in accordance with an example of the present technology. [Fig. 142] 13 shows increasing elongation in the course direction of a knitted positioning and stabilising structure according to an example of the present technology. [Fig. 143] 13 shows 3D printed links used to form a positioning and stabilising structure in accordance with an example of the present technology. [Fig. 144] 13 shows a 3D printed positioning and stabilising structure fragment including a rigidizer according to an example of the present technology. [Fig. 145] 14 shows 3D printed positioning and stabilising structure straps and clips according to an example of the present technology. [Fig. 146]

[0033] FIG. 14 shows a rear perspective view of a vent for a patient interface in accordance with one form of the present technology. [Fig. 147]

[0033] FIG. 14 shows a front perspective view of a vent for a patient interface in accordance with one form of the present technology. [Fig. 148]

[0033] FIG. 14 shows a rear perspective view of a vent for a patient interface in accordance with one form of the present technology. [Figure 149]

[0033] FIG. 14 shows a side perspective view of a vent for a patient interface in accordance with one form of the present technology. [Fig. 150]

[0033] FIG. 14 shows a side perspective view of a vent for a patient interface in accordance with one form of the present technology. [Fig. 151]

[0033] FIG. 14 shows a side perspective view of a vent for a patient interface in accordance with one form of the present technology. [Fig. 152]

[0033] FIG. 1 shows a top perspective view of a vent for a patient interface in accordance with one form of the present technology. [Fig. 153] FIG. 13 is a process flow diagram depicting a method for manufacturing a patient interface for treatment of respiratory disorders in accordance with an example of the present technology. [Fig. 154] FIG. 154 is a system diagram generally illustrating the equipment used to carry out the method of FIG. 153. [Fig. 155] FIG. 13 is a top view of fabric depicting a vent portion after heat staking in accordance with an example of the present technology. [Fig. 156] FIG. 13 is a close-up top view of a peripheral edge of a vent portion before heat staking in accordance with an example of the present technology. [Fig. 157] FIG. 13 is a close-up top view of a peripheral edge of a vent after heat staking in accordance with an example of the present technology. [Fig. 158] FIG. 136 is a close-up cross-sectional side view of a peripheral edge of a vent portion before heat staking in accordance with an example of the present technology. [Fig. 159] FIG. 136 is a close-up cross-sectional side view of a peripheral edge of a vent portion after heat staking in accordance with an example of the present technology. [Fig. 160] 13 shows a short tube in a neutral state according to an example of the present technology. [Fig. 161]

[236] Fig. 124 shows a side view of a short tube in a compressed state in accordance with an example of the present technology. [Fig. 162]

[236] Fig. 124 shows a side view of a short tube in an extended state according to an example of the present technology. [Fig. 163]

[236] Fig. 12 shows a side view of a short tube in a curved state according to an example of the present technology. [Fig. 164] FIG. 163 shows a cross section of a short tube along line 163-163 shown in FIG. 163 according to an example of the present technology. [Fig. 165]

[236] Fig. 13 shows a perspective view of a short tube in a curved, elongated state according to an example of the present technology. [Fig. 166] FIG. 13 shows a perspective view of a patient interface system worn and used by a patient in accordance with one form of the present technology. [Fig. 167] 1 is a chart depicting vertical plane air velocity (m / s) along the x-axis and z-axis from the vent of the SWIFT® FX nasal pillows mask by ResMed Limited. [Fig. 168] 1 is a chart depicting horizontal plane airflow velocity (m / s) along the x and y axes from the vent of the SWIFT® FX nasal pillows mask by ResMed Limited. [Fig. 169] 1 is a chart depicting vertical plane signals along the x and y axes from a vent of the SWIFT® FX nasal pillows mask by ResMed Limited. [Fig. 170] 1 is a chart depicting horizontal plane signals along the x and y axes from the vent of the SWIFT® FX nasal pillows mask by ResMed Limited. [Fig. 171] FIG. 13 is a chart depicting vertical plane air velocity (m / s) along the x and z axes from a vent of a patient interface system in accordance with one form of the present technology. [Fig. 172] FIG. 13 is a chart depicting horizontal plane air velocity (m / s) along the x and y axes from a vent of a patient interface system in accordance with one form of the present technology. [Fig. 173] FIG. 13 is a chart depicting vertical plane signals along the x and y axes from a vent of a patient interface system in accordance with one form of the present technology. [Fig. 174] FIG. 13 is a chart depicting horizontal plane signals along the x and y axes from a vent of a patient interface system in accordance with one form of the present technology. [Fig. 175] 13 is a chart comparing velocity (m / s) along the vent axis according to distance (mm) from the vent of a vent in a patient interface system in accordance with one form of the present technology and a SWIFT® FX nasal pillows mask by ResMed Limited. [Fig. 176]FIG. 13 is a bottom perspective view of a reinforcement folded over the end of a strap of a positioning and stabilising structure in accordance with one form of the present technology. [Fig. 177] FIG. 13 is a top view of a reinforcement folded over an end of a strap of a positioning and stabilising structure in accordance with one form of the present technology. [Fig. 178] FIG. 13 is a side perspective view of a reinforcement folded over an end of a strap of a positioning and stabilising structure in accordance with one form of the present technology. [Fig. 179] FIG. 13 is a flat side view of a reinforcement folded over an end of a strap of a positioning and stabilising structure in accordance with one form of the present technology. [Fig. 180] FIG. 179 is an enlarged view of FIG. [Fig. 181] This is an enlarged view of FIG. 177. [Fig. 182] 13A-13D show a series of steps for removing a strap from a rigidiser arm of a positioning and stabilising structure in accordance with one form of the present technology. [Fig. 183] 13A-13D show a series of steps for removing a strap from a rigidiser arm of a positioning and stabilising structure in accordance with one form of the present technology. [Fig. 184] 13A-13D show a series of steps for removing a strap from a rigidiser arm of a positioning and stabilising structure in accordance with one form of the present technology. [Fig. 185] 13 shows a series of steps for attaching a strap to a rigidiser arm of a positioning and stabilising structure in accordance with one form of the present technology. [Fig. 186] 13 shows a series of steps for attaching a strap to a rigidiser arm of a positioning and stabilising structure in accordance with one form of the present technology. [Fig. 187] FIG. 13 is a planar side view of a rigidiser arm of a positioning and stabilising structure in accordance with one form of the present technology showing a visual indicator. [Fig. 188] FIG. 13 is a planar side view of a rigidiser arm of a positioning and stabilising structure in accordance with one form of the present technology showing a visual indicator. [Fig. 189] FIG. 13 is a flat front view of a frame and rigidiser arm in accordance with one form of the present technology showing visual and tactile indicators. [Fig. 190] FIG. 13 is a top view of a seal-forming structure in accordance with one form of the present technology showing a visual indicator. [Fig. 191] FIG. 14 is a rear view of a seal-forming structure in accordance with one form of the present technology showing a visual indicator. [Fig. 192] FIG. 14 is a top perspective view of a seal-forming structure in accordance with one form of the present technology showing a visual indicator. [Fig. 193] 193 is a cross-sectional view taken through line 193-193 of FIG. 192. [Fig. 194] 194 is a cross-sectional view taken through line 194-194 of FIG. 192. [Fig. 195] FIG. 13 is a rear view of a frame in accordance with one form of the present technology. [Fig. 196] FIG. 13 is a plan view of a frame in accordance with one form of the present technology. [Figure 197] FIG. 13 is a rear perspective view of a frame in accordance with one form of the present technology. [Figure 198] FIG. 13 is a planar side view of a frame in accordance with one form of the present technology. [Figure 199] FIG. 13 is a rear view of a retention structure at a plenum connection region in accordance with one form of the present technology. [Figure 200] FIG. 13 is a bottom view of a retention structure at a plenum connection region in accordance with one form of the present technology. [Figure 201] FIG. 13 is a rear perspective view of a retention structure at a plenum connection region in accordance with one form of the present technology. [Fig. 202] FIG. 13 is a planar side view of a retention structure for a plenum connection region in accordance with one form of the present technology. [Fig. 203] FIG. 13 shows a tube in accordance with one form of the present technology where the bottom end of the tube is held in place with the longitudinal axis of the tube at the bottom end perpendicular to the direction of stretching before stretching begins. [Fig. 204] FIG. 1 shows a tube according to one form of the present technology being stretched to a length of 30 mm, where the bottom end of the tube is held in place with the longitudinal axis of the tube at the bottom end perpendicular to the direction of stretching before stretching begins. [Fig. 205]FIG. 1 shows a tube according to one form of the present technology being stretched to a length of 60 mm, where the bottom end of the tube is held in place with the longitudinal axis of the tube at the bottom end perpendicular to the direction of stretching before stretching begins. [Fig. 206] FIG. 1 shows a tube according to one form of the present technology being stretched to a length of 90 mm, where the bottom end of the tube is held in place with the longitudinal axis of the tube at the bottom end perpendicular to the direction of stretching before stretching begins. [Fig. 207] FIG. 1 shows a tube according to one form of the present technology being stretched to a length of 120 mm, where the bottom end of the tube is held in place with the longitudinal axis of the tube at the bottom end perpendicular to the direction of stretching before stretching begins. [Fig. 208] 1 shows the ResMed® SWIFT® FX nasal pillows mask tubing where the lower end of the tubing is held in place with the longitudinal axis of the tubing at the lower end perpendicular to the direction of stretching before stretching begins. [Fig. 209] FIG. 1 shows the ResMed® SWIFT® FX nasal pillows mask tube being stretched a length of 30 mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 210] 1 shows the ResMed® SWIFT® FX nasal pillows mask tube being stretched to a length of 60 mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 211] FIG. 1 shows the ResMed® SWIFT® FX nasal pillows mask tube being stretched to a length of 90 mm, with the lower end of the tube held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 212]FIG. 1 shows the ResMed® SWIFT® FX nasal pillows mask tube being stretched to a length of 120 mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 213] FIG. 1 shows a Philips® Respironics® GoLife® Nasal Pillows Mask Tube where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of elongation before elongation begins. [Fig. 214] FIG. 1 shows a Philips® Respironics® GoLife® Nasal Pillows Mask Tube being stretched a length of 30mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 215] FIG. 1 shows a Philips® Respironics® GoLife® Nasal Pillows mask tube being stretched to a length of 60 mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 216] FIG. 1 shows a Philips® Respironics® GoLife® Nasal Pillows Mask Tube being stretched to a length of 90mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 217] FIG. 1 shows a Philips® Respironics® GoLife® Nasal Pillows Mask Tube being stretched to a length of 120 mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 218]1 shows the Philips® Respironics® Wisp® nasal pillows mask tube where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretching before stretching begins. [Fig. 219] FIG. 1 shows a Philips® Respironics® Wisp® nasal pillows mask tube being stretched to a length of 30 mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 220] FIG. 1 shows a Philips® Respironics® Wisp® nasal pillows mask tube being stretched to a length of 60 mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 221] FIG. 1 shows a Philips® Respironics® Wisp® nasal pillows mask tube being stretched to a length of 90 mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 222] FIG. 1 shows a Philips® Respironics® Wisp® nasal pillows mask tube being stretched to a length of 120 mm, where the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end perpendicular to the direction of stretch before stretching begins. [Fig. 223]

[0036] Fig. 13 shows a front view of a patient interface system according to an example of the present technology. [Fig. 224]

[0036] Fig. 13 shows a top view of a patient interface system in accordance with an example of the present technology. [Fig. 225]

[0036] Fig. 13 shows a left side view of a patient interface system according to an example of the present technology. [Fig. 226]

[0036] Fig. 13 shows a right side view of a patient interface system according to an example of the present technology. [Fig. 227]

[0036] Fig. 13 shows another left side view of a patient interface system in accordance with an example of the present technology. [Fig. 228]

[0036] Fig. 13 shows another top view of a patient interface system in accordance with an example of the present technology. [Fig. 229]

[0036] Fig. 13 shows another top view of a patient interface system in accordance with an example of the present technology. [Fig. 230]

[0036] Fig. 13 shows a rear view of a patient interface system in accordance with an example of the present technology. [Fig. 231]

[0036] Fig. 13 shows another rear view of a patient interface system in accordance with an example of the present technology. [Fig. 232]

[0033] Fig. 13 shows a rear perspective view of a patient interface system according to an example of the present technology. [Figure 233a]

[0033] Fig. 13 shows a front view of a patient interface system worn by a patient according to an example of the present technology. [Fig. 233b]

[0033] Fig. 13 shows a top view of a patient interface system worn by a patient according to an example of the present technology. [Fig. 233c] FIG. 13 shows a left side view of a patient interface system according to an example of the present technology worn by a patient. [Fig. 233d]

[0033] Fig. 13 shows a front perspective view of a patient interface system worn by a patient according to an example of the present technology. [Figure 233e] FIG. 13 shows a right side perspective view of a patient interface system according to an example of the present technology worn by a patient. [Fig. 233f] FIG. 13 shows a detailed right side perspective view of a patient interface system according to an example of the present technology worn by a patient. [Figure 233g] FIG. 13 shows another right side perspective view of a patient interface system according to an example of the present technology worn by a patient. [Figure 233h]

[0033] Fig. 13 shows a top view of a patient interface system worn by a patient according to an example of the present technology. [Fig. 234a]

[0036] Fig. 13 shows a top view of a nasal cradle cushion of a patient interface in accordance with an example of the present technology. [Fig. 234b]FIG. 234c shows a bottom cross-sectional view taken through line 234c-234c of FIG. 234a of a nasal cradle cushion of a patient interface in accordance with an example of the present technology. [Fig. 234c]

[00116] Fig. 234c shows a side cross-sectional view taken through line 234c-234c in Fig. 234a of a nasal cradle cushion of a patient interface in accordance with an example of the present technology, with the patient's nose shown in dashed lines. [Fig. 235a] FIG. 13 shows a top view of another nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Fig. 235b] FIG. 235c shows a bottom cross-sectional view taken through line 235c-235c of FIG. 235a of another nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Fig. 235c]

[00116] Fig. 235c shows a side cross-sectional view taken through line 235c-235c in Fig. 235a of another nasal cradle cushion of a patient interface in accordance with an example of the present technology, with the patient's nose shown in dashed lines. [Fig. 236a] FIG. 13 shows a top view of another nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Fig. 236b] FIG. 236c shows a bottom cross-sectional view taken through line 236c-236c of FIG. 236a of another nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Fig. 236c]

[00116] Fig. 236c shows a side cross-sectional view taken through line 236c-236c of Fig. 236a of another nasal cradle cushion of a patient interface in accordance with another example of the present technology, with the patient's nose shown in dashed lines. [Fig. 237a]

[0036] Fig. 13 shows a top view of a nasal cradle cushion of a patient interface in accordance with an example of the present technology. [Fig. 237b]

[0036] Fig. 13 shows a top view of a nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Fig. 237c]

[0036] Fig. 13 shows a top view of a nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Fig. 237d] FIG. 13 shows a top view of a nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Fig. 238a]FIG. 234a shows a cross section of a nasal cushion taken through line 238a-238a in FIG. 234a according to an example of the present technology. [Fig. 238b] FIG. 239 shows a cross section of a nasal cushion taken through line 238b, 238c-238b, 238c in FIG. 239 according to an example of the present technology. [Fig. 238c] FIG. 239 shows a cross section of a nasal cushion taken through line 238b, 238c-238b, 238c in FIG. 239 according to an example of the present technology. [Fig. 239]

[0036] Fig. 13 shows a top view of a nasal cradle cushion of a patient interface in accordance with an example of the present technology. [Fig. 240]

[0033] Fig. 13 shows a top view of a patient interface system worn by a patient according to an example of the present technology. [Fig. 241]

[0033] Fig. 14 shows a side view of a patient interface system worn by a patient according to an example of the present technology. [Fig. 242] FIG. 13 shows an exploded perspective view of a patient interface system according to an example of the present technology worn by a patient. [Fig. 243]

[0033] Fig. 14 shows a close up side view of a patient interface system according to an example of the present technology worn by a patient. [Fig. 244]

[0036] Fig. 13 shows a close up front view of a patient interface system according to an example of the present technology worn by a patient. [Fig. 245a]

[214] Fig. 1 shows a front perspective view of a seal-forming structure, plenum chamber, and retaining structure according to an example of the present technology. [Fig. 245b]

[0033] Fig. 13 shows a top view of a seal-forming structure, plenum chamber, and retaining structure according to an example of the present technology. [Fig. 245c]

[214] Fig. 13 shows a bottom view of a seal-forming structure, plenum chamber, and retaining structure according to an example of the present technology. [Fig. 245d]

[214] Fig. 13 shows a side view of a seal-forming structure, plenum chamber, and retaining structure according to an example of the present technology. [Figure 245e]

[214] Fig. 13 shows a rear view of a seal-forming structure, plenum chamber, and retaining structure according to an example of the present technology. [Fig. 245f]

[214] Fig. 13 shows a front view of a seal-forming structure, plenum chamber, and retaining structure according to an example of the present technology. [Figure 245g] FIG. 245f shows a cross section view of a seal-forming structure, plenum chamber, and retaining structure taken through line 245g-245g in FIG. 245f according to an example of the present technology. [Figure 245h]

[0033] Fig. 13 shows another front perspective view of a seal-forming structure, plenum chamber, and retaining structure according to an example of the present technology. [Figure 245i] FIG. 245i shows a cross section view of a seal-forming structure, plenum chamber, and retaining structure taken through line 245i-245i in FIG. 245b according to an example of the present technology. [Figure 245j] FIG. 245f shows a cross section view of a seal-forming structure, plenum chamber, and retaining structure taken through line 245j-245j in FIG. 245f according to an example of the present technology. [Figure 245k] FIG. 245k shows a cross section view of a seal-forming structure, plenum chamber, and retaining structure taken through line 245k-245k in FIG. 245c according to an example of the present technology. [Fig. 246a]

[0033] Fig. 13 shows a front perspective view of a patient interface system according to an example of the present technology. [Fig. 246b]

[0036] Fig. 13 shows a view of a patient interface system from an inferior and posterior perspective according to an example of the present technology. [Fig. 246c]

[0036] Fig. 13 shows a view of a patient interface system according to an example of the present technology viewed from an anterior and superior angle. [Fig. 246d]

[0036] Fig. 13 shows a view of a patient interface system according to an example of the present technology from a front and inferior perspective. [Figure 246e]

[0036] Fig. 13 shows a side view of a patient interface system according to an example of the present technology. [Fig. 246f]

[0033] Fig. 13 shows a bottom perspective view of a patient interface system according to an example of the present technology. [Fig. 246g]

[0036] Fig. 13 shows another bottom perspective view of a patient interface system in accordance with an example of the present technology. [Fig. 247a]

[0033] Fig. 13 shows a top perspective view of a patient interface system according to an example of the present technology. [Fig. 247b]

[0036] Fig. 13 shows a side view of a patient interface system according to an example of the present technology. [Fig. 247c]

[0033] Fig. 13 shows a top perspective view of a patient interface system according to an example of the present technology. [Figure 248A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Fig. 248B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Fig. 249A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Fig. 249B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Fig. 250A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Figure 250B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Fig. 250C]

[0043] Fig. 13 shows a rear perspective view of a frame for a patient interface and detachable rigidiser arm according to an example of the present technology. [Figure 251A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Fig. 251B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Figure 252A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Fig. 252B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Figure 252C]FIG. 252C shows a cross-sectional view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology taken through line 252C-252C in FIG. 252B. [Figure 253A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Figure 253B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Figure 253C] FIG. 253C shows a cross-sectional view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology taken through line 253C-253C in FIG. [Fig. 254A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Fig. 254B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Figure 255A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Figure 255B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Figure 256A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Fig. 256B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Figure 256C]

[0036] Fig. 13 shows a detailed top view of a detachable rigidiser arm attached to a frame for a patient interface in accordance with an example of the present technology. [Figure 257A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Figure 257B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Figure 258A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Figure 258B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Figure 259A]

[0043] Fig. 14 shows a perspective view of a frame and detachable rigidiser arm for a patient interface according to an example of the present technology. [Fig. 259B]

[0043] Fig. 14 shows a perspective view of a detachable rigidiser arm attached to a frame for a patient interface according to an example of the present technology. [Figure 259C]

[0036] Fig. 13 shows a detailed rear perspective view of a frame and detachable rigidiser arm for a patient interface in accordance with an example of the present technology. [Figure 260A]

[0036] Fig. 13 shows a perspective view of a frame and rigidiser arm for a patient interface according to an example of the present technology. [Figure 260B]

[0036] Fig. 13 shows a perspective view of a frame and rigidiser arm for a patient interface according to an example of the present technology. [Figure 261A]

[0036] Fig. 13 shows a perspective view of a frame and rigidiser arm for a patient interface according to an example of the present technology. [Fig. 261B]

[0036] Fig. 13 shows a perspective view of a frame and rigidiser arm for a patient interface according to an example of the present technology. [Figure 262A]

[0036] Fig. 13 shows a perspective view of a strap and rigidiser arm for a positioning and stabilising structure for a patient interface system in accordance with an example of the present technology. [Figure 262B] FIG. 133 shows a perspective view of a strap for a positioning and stabilising structure attached to a rigidiser arm for a patient interface system in accordance with an example of the present technology. [Fig. 263]FIG. 133 shows a perspective view of a strap for a positioning and stabilising structure attached to a rigidiser arm for a patient interface system in accordance with an example of the present technology. [Fig. 264A]

[0036] Fig. 13 shows a perspective view of a rigidiser arm for a patient interface system in accordance with an example of the present technology. [Fig. 264B] FIG. 133 shows a perspective view of a strap for a positioning and stabilising structure attached to a rigidiser arm for a patient interface system in accordance with an example of the present technology. [Fig. 265] FIG. 133 shows a perspective view of a strap for a positioning and stabilising structure attached to a rigidiser arm for a patient interface system in accordance with an example of the present technology. [Fig. 266] FIG. 133 shows a perspective view of a strap for a positioning and stabilising structure attached to a rigidiser arm for a patient interface system in accordance with an example of the present technology. [Fig. 267] FIG. 133 shows a perspective view of a strap for a positioning and stabilising structure attached to a rigidiser arm for a patient interface system in accordance with an example of the present technology. [Fig. 268] FIG. 133 shows a perspective view of a strap for a positioning and stabilising structure attached to a rigidiser arm for a patient interface system in accordance with an example of the present technology. [Fig. 269] FIG. 133 shows a perspective view of a strap for a positioning and stabilising structure attached to a rigidiser arm for a patient interface system in accordance with an example of the present technology. [Fig. 270] FIG. 133 shows a perspective view of a strap for a positioning and stabilising structure attached to a rigidiser arm for a patient interface system in accordance with an example of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0074] 6 (F) Detailed Description of the Embodiments of the Technology Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific embodiments which may vary herein. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the specific embodiments discussed herein, and is not intended to be limiting.

[0075] 6.1 Treatment System In one form, the technology comprises an apparatus for treating a respiratory disorder. The apparatus may comprise a flow generator or blower for supplying pressurized respiratory gas, such as air, to a patient 1000 via an air circuit 4170 leading to a patient interface 3000, as shown in FIG. 1a.

[0076] 6.2 Treatment In one form, the present technology comprises a method for treating a respiratory disorder comprising applying positive pressure to an entrance of an airway of a patient 1000.

[0077] 6.2.1 Nasal CPAP for OSA In one form, the present technology comprises a method of treating obstructive sleep apnea in a patient by applying nasal continuous positive airway pressure to the patient.

[0078] 6.3 Patient Interface 3000 166, a non-invasive patient interface 3000 according to one embodiment of the present technology comprises the following functional aspects: a seal-forming structure 3100 (see, e.g., FIG. 4), a plenum chamber 3200, a positioning and stabilising structure 3300, and a connection port 3600 for connection to a short tube 4180 of an air circuit 4170. 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 positioned to surround an entrance to the airways of the patient 1000 to facilitate the delivery of air at positive pressure to the airways.

[0079] 6.3.1 Seal-forming structure 3100 In one form of the present technology, the seal-forming structure 3100 provides a seal-forming surface and may further provide a cushioning function.

[0080] The seal-forming structure 3100 of the present technology may be constructed from a soft, flexible, elastic material such as silicone. The seal-forming structure 3100 may form part of a sealing pathway for delivery of air from the PAP device to the patient's nares.

[0081] 9, in one form of the present technology, a seal-forming structure 3100 may comprise a sealing flange 3110 and a support flange 3120. The sealing flange 3110 may comprise a relatively thin member having a thickness of less than about 1 mm, for example about 0.25 mm to about 0.45 mm. The support flange 3120 may be relatively thicker than the sealing flange 3110. The support flange 3120 is or includes a spring-like element, which functions to support the sealing flange 3110 against buckling in use. In use, the sealing flange 3110 may readily respond to system pressure within the plenum chamber 3200 acting on an underside of the sealing flange to urge the sealing flange into tight sealing engagement with the face, for example the patient's nares. The plenum chamber 3200 is formed from a soft material, such as silicone.

[0082] 6.3.1.1 Nasal pillow In one form of the present technology, the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs or a pair of nasal pillows 3130, each constructed and arranged to form a seal with a respective nostril of the patient's nose, for example by applying a seal against the circumferential regions of the patient's nostrils.

[0083] A nasal pillow 3130 (FIG. 9) in accordance with one aspect of the present technology includes a frustum 3140, at least a portion of which forms a seal with the underside of a patient's nose, e.g., at the frustum portion, a stalk 3150, and an upper flexible region 3142 on the underside of the frustum 3140 and connecting the frustum to the stalk 3150. The structure to which the nasal pillow 3130 of the present technology is connected also includes a lower flexible region 3152 adjacent the base of the stalk 3150. The upper flexible region 3142 and the lower flexible region 3152 may act in concert to facilitate a universal joint structure that accommodates relative movement - both displacement and tilt - between the frustum 3140 and the structure to which the nasal pillow 3130 is connected. In one example, the frustum 3140 may be coaxial with the stalk 3150 to which it is connected. In other examples, the frustum 3140 and the stem 3150 may not be coaxial (e.g., offset). The nasal pillows 3130 may be sized and / or shaped such that they extend laterally beyond the wall of the plenum chamber 3200, as described below.

[0084] In one form of the present technology, each stalk 3150 may be provided with a variable stiffness so that the nasal pillows 3130 do not swing forward due to compression and / or bending of the stalk 3150 during use. For example, the side of the stalk 3150 away from the patient's face during use may be stiffer than the area of ​​the stalk 3150 closer to the patient's face. In other words, the different material stiffness on either side of the stalk 3150 provides more resistance unless compression or bending of the stalk 3150 is done in a pre-determined direction. This may even allow the pillow 3130 to be pressed against the nostrils by preventing the pillow 3130 from swinging forward. Such a configuration may help resist buckling of the stalk 3150 which would result in the nasal pillows 3130 swinging forward. The variable stiffness may also be used to provide a weak point around which swing is encouraged so that the stalk 3150 buckles in a desired direction. In other words, compression of the nasal pillows 3130 may even be achieved. This configuration may allow for localization of the sealing force at the top of the nasal pillows 3130. This configuration may also allow for any flexing of the nasal pillows 3130 to be gentle. The nasal pillows 3130 may be formed to compress against the plenum chamber 3200 when pressed against the patient's face, where the nasal pillows 3130 may be wider laterally than the plenum chamber so that no portion of the plenum chamber 3200 extends beyond the pillows 3130. In other examples, the nasal pillows 3130 may be formed and / or dimensioned such that when compressed, their perimeter is generally flush with the perimeter of the plenum chamber 3200. In a further example of the technique, the stem 3150 may be thinnest at the base of the frustum 3140.

[0085] In one example, the pillow 3130 is placed at the entrance to the nostril to engage the pillow 3130 with the entrance to the patient's airway. As the positioning and stabilizing structure 3300 is adjusted, tension begins to pull the pillow 3130 into the nostril. Continued insertion of the pillow 3130 into the nostril causes the stem 3150 to collapse with the trampoline 3131 moving the base of the pillow 3130 to the top surface of the plenum chamber 3200. The stem 3150 of the nasal pillow 3130 may be connected to the plenum chamber 3200 and may also include a thinned or reduced thickness portion. The thinned portion allows the pillow 3130 to easily bounce or trampoline, thus allowing the pillow 3130 to more easily conform to the alar angle of the patient 1000. The trampoline 3131 may be angled away from the bottom of the pillow 3130 or the nasal septum and / or upper lip of the patient 1000. This improves the comfort and stability of the patient interface device 3000.

[0086] It is also envisioned that various sizes of nasal pillows 3130 may be used with plenum chambers having a commonly sized connection area and plenum connection area, which has the advantage of allowing a patient to be matched with a plenum chamber 3200 and pillows 3130 sized to best fit the patient's particular anatomy, e.g., nostril size and orientation.

[0087] In one form of the present technology, the seal-forming structure 3100 forms a seal at least partially with the columella region of the patient's nose.

[0088] 6.3.2 Nasal Cradle While a small portion of the nasal pillows 3130 may enter the patient's nares in use, another form of the seal-forming structure 3100 is substantially outside the nose in use. In one form of the present technology shown in FIG. 34, the seal-forming structure 3100 of the patient interface 3000 is configured and arranged to form a seal with the patient's airway that encompasses both nares without entering the nares. The seal-forming structure 3100 may address both nares using a single orifice, e.g., a nasal cradle. In FIG. 34, the seal-forming structure 3100 according to the depicted example includes a nasal flange 3101 arranged around its periphery. This figure also shows the attachment of the plenum chamber 3200 and the seal-forming structure 3100 to the frame 3310.

[0089] 6.3.2.1 Nasal cushion for nasal cradle 223-232 show several views of a typical patient interface system 3000 having a seal-forming structure 3100 in the form of a nasal cradle cushion. FIG. 233a-233h show several views of a typical patient interface system 3000 having a seal-forming structure 3100 in the form of a nasal cradle cushion worn on a patient 1000. The seal-forming structure 3100 may seal around the lower part of the patient's nose, particularly around the ala and tip of the nose. This seal-forming structure 3100 may define, at least in part, a gas chamber 3104, which will be discussed in more detail below. During treatment, breathable gas may be provided to the patient from the patient interface 3000 through the gas chamber 3104 towards the nose. It should be understood that when the patient interface 3000 is worn on the patient, the seal-forming structure 3100 may at least in part define a gas chamber 3104 with the patient's face, through which breathable gas may be provided to the patient at positive pressure. For example, the seal-forming structure 3100 in the form of a nasal cradle may seal below the bridge of the nose (e.g., at the transition area between the nasal bone and cartilage), or may seal at or below the tip of the nose, the side of the nose, and / or the upper lip of the patient. According to another example of the present technology, the seal-forming structure 3100 in the form of a nasal cradle cushion may be structured to seal around the undernose. In other words, a seal may be formed with the underside of the patient's nose. It should also be understood that the nasal cradle cushion is different from the nasal pillow, since the nasal cradle cushion may be structured to serve both nares with a single orifice and not enter the patient's nares. The seal-forming structure 3100 may be a single-wall cushion, or the seal-forming structure 3100 may be a dual-wall cushion, for example, the seal-forming structure may include an undercushion. Alternatively, the undercushion may be omitted and a rolled edge may be used around the opening of the seal-forming structure 3100 to form a reliable pneumatic seal around the patient's nose.

[0090] A protruding end 3114 can be seen on either side of the seal-forming structure 3100. Each protruding end 3114 may be formed to extend from the patient interface 3000 to seal within the gap between the patient's respective ala and nasolabial fold when worn by the patient 1000. FIG. 2c, depicting the facial surface morphology, shows the location of the ala and nasolabial fold. The protruding end 3114 may partially bulge and / or deform to seal in this area. According to one example of the present technology, a concave lower portion 3212 of the seal-forming structure 3100 below the opening to the gas chamber 3104 may seal against the upper lip. The concave lower portion 3212 may be curved to approximately fit a portion of the patient's upper lip to form a seal in that area. The shape of the concave lower portion 3212 can be seen, for example, in FIG. 245c, where the seal-forming structure 3100 curves inward from the protruding end 3114. Since most patients have a convex upper lip, the concave lower portion 3212 can easily conform to this area of ​​the patient's face to form an effective seal. The rear portion of the seal-forming structure 3100 that may seal against the patient's upper lip below the opening to the gas chamber 3104 may be shaped and sized to not cover the patient's nares in use to ensure a continuous path for the inflow of pressurized gas to the patient's airway. In accordance with another example of the present technology, the seal-forming structure 3100 may be softened, for example by reducing the thickness of the material, in the rear lower region of the seal-forming structure that seals against the patient's upper lip.

[0091] 233a-h show how an exemplary patient interface 3000 may seal against the patient 1000, particularly the nose. It should be understood that the seal-forming structure 3100 may be concave in shape to pinch the patient's nose. The recess 3116 may receive the tip of the patient's nose and the protruding end 3114 may seal in the area of ​​the ala and nasolabial folds. The protruding end 3114 may seal against the patient's face and nose in the area where the ala joins the patient's face near the nasolabial folds. (See Figs. 2c, 2d, 2f) In most patients, this area is concave in shape and therefore the protruding end 3114 extends into and seals in this area. The protruding end support portion 3208 may support the nasal cushion 3112 in the area of ​​the protruding end 3114 to help maintain a seal in this area and may function like an undercushion. In another example, the seal-forming structure 3100 may include a rolled edge around the periphery of the opening to the gas chamber 3104 without including the protruding end support portion 3208. In yet another example, the seal-forming structure 3100 may not be provided with a rolled edge or a protruding end support portion 3208.

[0092] 223-232 also show that a recess 3116 may be included in the seal-forming structure 3100. This recess 3116 may comprise an inwardly molded portion that extends into the nasal gas chamber 3104 to receive the tip of the patient's nose when worn by the patient. The recess 3116 may enhance the seal around and under the tip of the patient's nose during treatment by allowing the shape of the seal-forming structure 3100 to better conform to the patient's nose. The seal-forming structure 3100 may include an overhang near the recess 3116 at the opening to the seal-forming structure that allows the seal-forming structure to better conform to the tip of the patient's nose and seal around the tip of the patient's nose.

[0093] The seal-forming structure 3100 may surround a portion of the nose, particularly the tip of the nose, of the patient 1000. A gas chamber 3104 may be formed by the seal-forming structure 3100 and the patient's face.

[0094] The patient interface 3000 according to an example of the present technology has a surface area footprint on the face that is a significant percentage less obtrusive than a conventional nasal face mask. For some patients, it also feels less claustrophobic. Also, the specific areas with fewer obstructions are important because these areas have been found to have a significant beneficial psychological effect on the bed partner as the mask looks less medical and "opens up" the face when the bed partner looks at it. From the patient's perspective, the typical patient interface 3000 is not in the patient's field of view or is significantly reduced from the patient's field of view. This is because the seal-forming structure 3100 seals below the bridge of the nose. This allows the patient to wear glasses when reading a book or watching television before falling asleep after putting on the patient interface 3000. By sealing below the bridge of the nose, irritation is avoided in an area where the skin is thin and sensitive to pressure and has a high chance of skin damage due to blood flow obstruction. Another advantage may be that it does not have to consider anthropometric variations between patients above the bridge of the nose, and the focus for the mask fit range can be directed to anthropometric variations around the upper lip area. Also, unlike some other full face masks, the patient interface 3000 may not require forehead support, which may be required to provide pressure point relief. This also avoids the problem of forehead support being a source of pressure points and skin damage. This type of seal-forming structure 3100 may also be beneficial in that it provides an alternative for respiratory therapy patients who do not find nasal pillows comfortable.

[0095] Anatomically, Figures 2h and 2i may be referred to for indications regarding the location of the transition area between the nasal bone and cartilage, which may be understood to define the nasal bridge. In this manner, the exemplary seal-forming structure 3100 may seal around the periphery of the patient's nose in contact with the softer tissues of the nose, such as fatty tissue or cartilage. By forming a seal with the nose with these soft tissues, irritation of the patient's skin may be avoided that would otherwise occur if the seal were formed around / on the harder nasal structures, i.e., bones. In other words, by sealing below the bridge of the nose, discomfort for the patient may be minimized. Also, positioning the seal of the seal-forming structure 3100 around this area of ​​the nose allows for an effective seal to be formed. This is because the nasal tissue and the seal-forming structure 3100 can conform to each other to form a seal. The seal-forming structure 3100 can conform primarily to the nose.

[0096] The aforementioned sealing feature is the portion of the protruding end 3114 that rests against the patient's 1000 face. Specifically, the protruding end 3114 may be an extension of the seal-forming structure 3100 that seals in the area between the nasolabial fold and the ala of the nose. These anatomical features can be seen in FIG. 2c. Depending on the patient's individual facial structure, this area may correspond to a recess. As such, an extension from the seal-forming structure 3100 may be necessary to form a proper seal around the patient's nose. The protruding end 3114 may preferably perform this function.

[0097] Another seal feature of the exemplary patient interface 3000 is a recess 3116 for receiving the tip of the nose of the patient 1000 when the seal-forming structure 3100 is worn by the patient. Specifically, as shown in Fig. 233a-h, the tip of the nose of the patient 1000 can be seen in dashed lines in the area where the recess 3116 is located. The seal-forming structure 3100 may be formed to seal against the periphery of the nose at the underside of the nose. In other words, the seal formed by the seal-forming structure 3100 against the nose may be characterized as against the lower periphery of the nose. Thus, it can be understood that the sealing surface of the seal-forming structure 3100 may be generally concave or form a pocket for receiving the nose, and the sealing surface of the seal-forming structure may further include a recess 3116 for receiving the tip of the nose.

[0098] The seal-forming structure 3100 may seal against the tip of the nose of the patient 1000. The gas chamber 3104 may be defined, at least in part, by the seal-forming structure 3100, the plenum chamber 3200, and the patient's nose to provide a sealed path for breathable gas to enter the patient's airways via the nares.

[0099] In one example, the seal-forming structure 3100 of the present technology is constructed from a soft, flexible, elastic material such as silicone. In another example of the present technology, the seal-forming structure 3100, such as the seal-forming structure 3100 and its overhang 3206, may be formed from foam. The seal-forming structure 3100 may be formed from other materials, including foam, gel, and / or low durometer silicone, according to further examples of the present technology.

[0100] 245a, 245d, and 245g-k show examples of protruding end support portions 3208. The protruding end support portions 3208 may be associated with respective protruding ends 3114 of the seal-forming structure 3100. The protruding end support portions 3208 may be understood to extend into a gas chamber 3104 defined at least in part by the seal-forming structure 3100 and the plenum chamber 3200. Such a configuration may allow the protruding end support portions 3208 to provide sufficient support for the protruding ends 3114 to seal against the patient's face.

[0101] The protruding end support portions 3208 can be seen on either side of the seal-forming structure 3100. The protruding end support portions 3208 may be located under the protruding ends 3114 of the seal-forming structure 3100. The protruding end support portions 3208 may be included to support the protruding ends 3114 of the seal-forming structure 3100.

[0102] As shown in Figs. 234a-239, protruding ends 3114 may be included on both sides of the seal-forming structure 3100. The gas chamber 3104 and the opening to the gas chamber can also be seen. As shown in Figs. 237a-237d, the opening to the nasal gas chamber 3104 may have a generally rectangular, diamond, or trapezoidal shape that may be curved at its respective short sides 3104.2 and long sides 3104.1, 3104.3. The curved short sides 3104.2 of the opening may be near the respective ala of the nose when placed against the patient's nose. Also in this example, the distal long side 3104.1 of the opening may be distal to the patient's upper lip near the tip of the nose, while the proximal long side 3104.3 may be proximal to the patient's upper lip. A recess 3116 formed to receive the tip of the nose is also shown.

[0103] Fig. 234a-c show that the seal-forming structure 3100 may curve slightly upward as it approaches the distal long side 3104.1 of the opening to the gas chamber 3104 from the recess 3116. The front top of the seal-forming structure 3100 near the recess 3116 includes a slight depression or concave area in its center such that the seal-forming structure 3100 is higher on both sides than in the center. This figure also shows the outline of the patient's nose in dashed lines to show how the nose may be positioned relative to the seal-forming structure 3100. The apex 3118 on the seal-forming structure 3100 serves to seal in front of the nostril. The apex may be located further back, but may transition gradually larger to create a balloon effect to seal against the nostril. The distal long side 3104.1 may be everted from the seal-forming structure 3100 and may contact the nose to enhance the seal at the tip of the nose and may pinch the nose to provide a compressed air pressure seal. Also shown is a recess 3116 that is formed to receive the tip of the nose.

[0104] 235a-c also show protruding ends 3114 on either side of the seal-forming structure 3100. The profile of the seal-forming structure 3100 may slope downwards as it approaches the distal edge 3104.1 opening to the gas chamber 3104 from the recess 3116. This example of the seal-forming structure 3100 lacks a depression in the front region near the recess. In other words, this example shows that the seal-forming structure 3100 may be more circular / more rounded in the region from the recess 3116 to the distal edge 3104.1 of the opening to the gas chamber 3104 compared to the example shown in FIGS. 234a-c.

[0105] Figures 236a-c show that the shape of the opening to the gas chamber 3104 may be more balloon-like and rounded than the examples shown in Figures 234a-c and 235a-c. The seal-forming structure 3100 may have straight sidewalls as opposed to sidewalls that smoothly curve from the top surface of the seal-forming structure 3100. Straight sidewalls may have a predetermined top edge and may increase the stability and strength of the seal-forming structure 3100.

[0106] In other examples, the seal-forming structure 3100 may lack a depression in the front region near the recess 3116. Straight side walls of a typical nasal cushion 3112 may be included.

[0107] It should also be understood that the exemplary seal-forming structure 3100 is shown in a substantially undeformed state in Figures 234a-c, 235a-c, and 236a-c. Some figures may show a small amount of deformation due to conformity with the shape of the nose, shown in dashed lines. Thus, the seal-forming structure 3100 may have a concave shape as shown when undeformed.

[0108] It should also be appreciated that the seal-forming structure 3100 may have a cross-section that varies in thickness as shown in Figures 238a-c. Thus, the area of ​​the seal-forming structure 3100 near the opening to the gas chamber 3104 may be thinner than the area where the seal-forming structure 3100 attaches to the plenum chamber 3200. Advantageously, this may provide greater comfort to the patient by providing a thinner, and therefore more compliant, area of ​​cushioning material in an area where a greater amount of contact is made with the patient's nose.

[0109] Region 3112.1 may be near the opening to the gas chamber 3104, and region 3112.3 may be near the connection with the plenum chamber 3200. Region 3112.2 may be the highest region near the upper periphery of the nasal cushion 3112.

[0110] The seal-forming structure 3100 is provided with a smoothly varying thickness from region 3112.1 to region 3112.3. Also, thickness x may be less than thickness z. Region 3112.2 may be more abruptly thicker than regions 3112.1 and 3112.3. Also, thickness x may be less than thickness z and thickness y may be greater than x and z. Region 3112.2 may be more abruptly thicker than regions 3112.1 and 3112.3. Also, thickness z may be less than thickness x and thickness y may be greater than x and z.

[0111] FIG. 239 shows another exemplary seal-forming structure 3100 according to the present technology, with the opening to the gas chamber 3104 and the protruding end 3114 shown to allow for understanding of the orientation of the seal-forming structure 3100. The regions of various thickness are hatched differently to better show where the thickness of the seal-forming structure 3100 may vary. Region 3113 may be the thinnest to easily conform to the tip of the nose. Region 3113 may have a thickness of about 0.35 mm according to one example of the present technology. Region 3115 may be thicker to provide more support to the seal-forming structure 3100. Region 3115 may have a thickness of about 0.5 mm according to one example of the present technology. Region 3117 may be thicker than the other regions to provide maximum support, resistance to deformation, and ensure an effective seal at the patient's nasal ala. Region 3117 may have a thickness of about 1 mm according to one example of the present technology.

[0112] The bottom corners of the seal-forming structure 3100 may be stiffer than other areas of the seal-forming structure 3100 to prevent or minimize deformation at the bottom corners. Having a higher level of stiffness at the bottom corners of the seal-forming structure 3100 reduces the likelihood of seals being compromised at these locations of the seal-forming structure 3100, especially when subjected to tube torque.

[0113] Fig. 245a-k depict further examples of the present technology. In these figures, the seal-forming structure 3100, plenum chamber 3200, and retaining structure 3242 are shown detached from the frame 3310 (not shown in these figures). These figures show the protruding end support portion 3208 extending inwardly from the seal-forming structure 3100 and plenum chamber 3200 to support the protruding end 3114 when engaged with the patient's nose. The protruding end support portion 3208 may be in the form of a hollow protrusion extending into the interior of the patient interface 3000. As can be seen in Fig. 245d, the protruding end support portion 3208 may be considered a pocket formed in the side of the seal-forming structure 3100 and plenum chamber 3200. The protruding end support portion 3208 may be formed integrally with the seal-forming structure 3100 and plenum chamber 3200. In another example, the protruding end support portion 3208 may not be hollow, but rather may be a solid extension that is integrally formed with the seal-forming structure 3100 and the plenum chamber 3200.

[0114] It is also envisioned that the protruding end support portion 3208 may include an additional support structure comprised of a harder material than the seal-forming structure 3100 and the plenum chamber 3200. It should be understood that, according to one example of the present technology, the sides of the protruding end support portion 3208 may be spaced apart from the seal-forming structure 3100 and the plenum chamber 3200 when the patient interface 3000 is not sealingly engaged with the patient's nose. When the patient interface 3000 is worn by the patient, the seal-forming structure 3100 and the plenum chamber 3200 may be deformed and the protruding ends 3114 may be pressed against the protruding end support portion, thereby preventing collapse of the protruding ends and supporting the protruding ends against the patient. For example, the protruding end support portion 3208 may support each protruding end 3114 as the protruding ends are deformed due to sealing engagement with the patient's face at the junction between the ala of the nose and the face.

[0115] Also, the protruding end support portions 3208 may have a profile such that the cross-sectional area of ​​the protruding end support portions decreases as the protruding end support portions extend into the gas chamber 3104. The ends of the protruding end support portions 3208 that extend into the gas chamber 3104 may be flat, or alternatively, the protruding end support portions may taper, as shown in Fig. 245g and Fig. 245i-k. The walls forming the protruding end support portions 3208 may increase or decrease in thickness toward the gas chamber 3104. It is also envisioned that the protruding end support portions 3208 may have a curved profile. For example, the protruding end support portions 3208 may have a curved profile to generally follow the profile of their respective protruding ends 3114 without direct contact with the protruding ends when the seal-forming structure 3100 is in a relaxed state. As can be seen in FIGS. 245g and 245i-245k, for example, the protruding end support portions 3208 may have a profile that is generally curved away from the respective protruding ends 3114 and toward the retaining structure 3242.

[0116] 245f-h show that the seal-forming structure 3100 may include thickened portions 3204. These thickened portions 3204 may provide additional support to the seal-forming structure 3100 when the seal-forming structure is in sealing engagement with the patient's nose and face. The thickened portions 3204 may be located on either side of the seal-forming structure 3100 in a position such that the thickened portions are near the patient's nasolabial folds when the seal-forming structure engages with the patient's face. The thickened portions 3204 may help seal around the ala of the patient's nose by preventing the seal-forming structure 3100 from collapsing due to sealing forces. The thickened portions 3204 may be integrally formed with the seal-forming structure 3100. Also, the thickened portions 3204 may be positioned on the seal-forming structure 3100 such that the thickened portions 3204 may be at least partially pressed against the respective protruding end support portions 3208 when the seal-forming structure engages with the patient's nose and face. The increased thickness 3204 may have a constant thickness throughout that is greater than the thickness of the remainder of the seal-forming structure 3100. Alternatively, the increased thickness 3204 may have a thickness that may vary throughout its range.

[0117] Figures 245a, 245c-f, 245h, 245i and 245k also show that the seal-forming structure 3100 may include a flared portion 3206 for sealing against the tip of the patient's nose. The flared portion 3206 may have a reduced thickness relative to the remainder of the seal-forming structure 3100, and the flared portion may be positioned and structured to form a seal around the front of the patient's nose, e.g., the tip of the nose. The flared portion 3206 may extend a significant distance, for example, the flared portion can be seen in the side view of Figure 245d.

[0118] 245a, 245b, 245d-f, 245h, 245i and 245k show examples of the seal-forming structure 3100 that may include a compliant region 3122. The compliant region 3122 is relatively soft, flexible and / or compliant compared to other portions of the seal-forming structure 3100. The relative flexibility of the compliant region 3122 may be advantageous in that it may help reduce discomfort to the patient in the area of ​​the tip of the nose and nasal septum. The compliant region 3122 may be relatively thin compared to other portions of the seal-forming structure 3100 and therefore may act like a mechanical spring to maintain an effective seal at the tip of the nose by cradling and / or contacting the tip of the nose. For example, as seen in FIG. 245d, the conforming region 3122 may be located on the seal-forming structure 3100 at the top where the seal-forming structure transitions into the plenum chamber 3200. The conforming region 3122 may be located on the seal-forming structure 3100 above the recessed portion. The conforming region 3122 may also be integrated into the recessed portion 3116. For example, as seen in FIG. 245e, the conforming region 3122 may be located horizontally at approximately the center of the seal-forming structure. The seal-forming structure 3100 may have a thickness of approximately 0.35 mm at the conforming region 3122 according to one example of the present technology and may be one of the thinnest regions of the seal-forming structure.

[0119] The views in Figures 245a-245k also show the retention structure 3242 with the notch 3295 and the tongue 3211. These views also show the sealing lip 3250.

[0120] The seal-forming structure 3100 may also include visual indicators pad printed onto the seal-forming structure to indicate to the patient the appropriate insertion depth of the nose. For example, the visual indicators may include the outline of a nose to indicate to the patient where the patient's nose should be aligned relative to the seal-forming structure 3100. Such visual indicators may inform the patient where to place their nose within the seal-forming structure 3100 to prevent the patient from inserting their nose too deeply into the seal-forming structure, resulting in a suboptimal seal.

[0121] 6.3.3 Plenum Chamber 3200 The plenum chamber 3200 according to one aspect of one form of the present technology functions to allow air flow between the two nostrils and air supply from the PAP device 4000 via a short tube 4180. The short tube 4180 is generally part of an air circuit 4170 that connects to the frame 3310 via a long tube (further gas delivery tube) 4178 connected to the PAP device 4000 and a connection port 3600. In this way, the plenum chamber 3200 can alternately function as an inhalation manifold during the inhalation portion of the breathing cycle and / or an exhaust manifold during the exhalation portion of the breathing cycle.

[0122] The plenum chamber 3200 may be constructed from an elastomeric material.

[0123] The plenum chamber 3200 provides a cushioning function between the seal-forming structure 3100 and the positioning and stabilising structure 3300, according to another aspect of one form of the present technology.

[0124] In one form of the plenum chamber 3200, the inlet / outlet manifold function and the cushioning function are performed by the same physical component, while in other forms of the present technology these functions are formed by two or more components.

[0125] The seal-forming structure 3100 and the plenum chamber 3200 may be formed, for example molded, as a single, integral component.

[0126] The plenum chamber 3200 includes a front wall 3210 and a rear wall 3220 .

[0127] The rear wall 3220 includes a rear surface 3222 (see FIG. 8). In one form of the present technology, the seal-forming structure 3100 is configured and positioned relative to the rear wall 3220 such that, in use, the rear surface 3222 is spaced away from the patient's nasal septum and / or upper lip, as seen in FIGS. 18 and 19. In one form, for example when the seal-forming structure 3100 includes nasal pillows 3130, this is achieved by positioning the rear wall 3220 such that the rear surface 3222 is forward of the posteriormost portion 3130.1 of the nasal pillows 3130, as shown in FIG. 8. This configuration can also focus the sealing force at the nares of the patient 1000, as the nasal septum and / or upper lip are released from contact with the patient interface 3000.

[0128] The plenum chamber 3200 also comprises a flex region 3230 (FIG. 9) which forms a connection with the seal-forming structure 3100. The flex region 3230 may be a separate region from the front wall 3210 and / or rear wall 3220. Alternatively, part or all of the respective front wall 3210 and rear wall 3220 may form part of the flex region 3230. In one form of the present technology where the seal-forming structure 3100 comprises respective left and right nasal pillows 3130, there are corresponding respective left and right flex regions 3232 and 3234 (FIG. 4). The flex regions 3230, 3232, 3234 are constructed and arranged to bend and / or flex in response to forces encountered during use of the patient interface 3000, such as tube resistance forces, or in response to movement of the patient's head, such as pressing the patient interface 3000 against a bed pillow. Flexion region 3230, left flexion region 3232, and / or right flexion region 3234 may be constructed from silicone rubber having an A-type indentation hardness, for example, in the range of about 35 to about 45. However, a wider range is possible if the thickness of walls 3210, 3220 is adjusted accordingly to achieve similar levels of force.

[0129] In another aspect of the present technology, which can be seen in Figures 4, 7, 8, 10, and 11, the plenum chamber 3200 has a saddle region or separation region 3236. As seen in Figure 4, the bending region 3230 may include a separation region 3236 that may be located between the left bending region 3232 and the right bending region 3234. The separation region 3236 may be concave in shape and may extend from the front wall 3210 to the rear wall 3220. By forming the plenum chamber 3200 with the separation region 3236 as described above, the left bending region 3232 may be separated from the right bending region 3234 such that movement in one of the bending regions does not substantially affect the other bending region. In other words, deformation and / or buckling of the left bending region 3232 does not impede the right bending region 3234 and vice versa. Advantageously, this allows the nasal pillow 3130 associated with the unobstructed flexion region to remain in place over the patient's corresponding nostril despite the other flexion region being obstructed. The separation region 3236 may be concave between the stalks 3150 to avoid contact with the nasal septum. The separation region 3236 may also be the thinnest region of the plenum chamber 3200 to allow for a desired amount of flexibility in this region. Alternatively, the separation region 3236 may be the thickest region of the plenum chamber 3200. The saddle region 3236 may be given a deep curvature to minimize or avoid nasal septum and / or upper lip contact to improve patient comfort. The saddle region 3236 may be U-shaped or V-shaped and have a nasolabial angle at its apex of about 70° to about 120°. The saddle region 3236 may be about 0.5 mm to about 2.5 mm deep for clearance near the patient's nasal septum.

[0130] The rear wall 3220 may be positioned adjacent to the patient's upper lip or upper lip when the patient interface 3000 is in use, as in FIGS.

[0131] In one form, the plenum chamber 3200 may further comprise a sealing lip 3250 (FIG. 6). The sealing lip 3250 may be constructed of a flexible, resilient material, such as silicone rubber having a type A hardness in the range of about 30 to about 50, thereby forming a relatively pliable component. As shown in FIGS. 5, 6, and 8, the sealing lip 3250 may be located on or formed as part of the inner surface or periphery of the plenum chamber 3200, or may be located throughout the inner periphery region of the plenum chamber 3200. However, it is also contemplated that the sealing lip 3250 may be disposed over the outer surface or periphery of the plenum chamber 3200 or over the entire periphery region of the plenum chamber 3200. The sealing lip 3250 may form a pneumatic seal between the plenum chamber 3200 and the frame 3310, as described in more detail below. The sealing lip 3250 and the plenum chamber 3200 may form an integral part. Other patient interface devices form a pneumatic seal between the plenum chamber and the frame using a compression seal formed from an elastically deformable material such as silicone to engage the plenum chamber to the frame and simultaneously compress the plenum chamber to provide a pneumatic seal. Meanwhile, one example of the present technology forms a pneumatic seal by interference from a sealing lip 3250 that flexes against the frame 3310 when the plenum chamber 3200 is first secured to the frame 3310. When the pressure in the plenum chamber 3200 is increased above atmospheric pressure to treat a respiratory disorder, the sealing lip 3250 is forced against the frame 3310 with a greater force, thus enhancing the pneumatic seal and increasing the sealing force. The air pressure in the cushion / plenum chamber of these other patient interface devices does not affect the sealing force between the cushion and the frame. Also, these other patient interface devices have a cushion with side walls and sealing lips for engaging the frame, where the side walls and sealing lips are soft, not rigid, so that they easily conform to finger pressure and can be elastically stretched or bent with little effort.In particular, the size and aspect ratio of the nasal cushion is relatively large, which contributes to the softness of the cushion. The frame-engaging sidewalls are so soft that very little finger force is required to pinch the two sides of the cushion together to contact each other. This ease of deformation of the frame-engaging sidewalls may be the primary source of difficulty for patients with arthritis in their hands to quickly connect the cushion to the frame in these other patient interfaces. It should also be appreciated that forming the aforementioned plenum chamber 3200 features with sufficient rigidity may improve the stability of the seal formed by the seal-forming structure. The thickness of the plenum chamber 3200 may also be varied so that the plenum chamber becomes thinner from the plenum connection region 3240 to the seal-forming structure 3100. In one example of the present technology, the plenum chamber 3200 may be approximately 2-3 mm thick at or near the plenum connection area 3240, 1 mm thick at a point between the plenum connection area 3240 and the seal-forming structure 3100, and 0.75 mm thick at or near the seal-forming structure 3100. Formation of the plenum chamber 3200 with these characteristics may be accomplished by injection molding manufacturing. This gradual reduction in thickness of the plenum chamber 3200 allows for greater deformability of the silicone material closer to the stem 3150 and the patient's nose, enhancing comfort and reducing the chance of seal disruption.

[0132] Some nasal pillow patient interfaces have an assembly sequence of (i) plenum chamber, (ii) headgear connection, and (iii) seal-forming structure, whereas one example patient interface 3000 of the present technology has an assembly sequence of (i) headgear connection, (ii) plenum chamber, and (iii) seal-forming structure, this difference in arrangement means that headgear tension does not cause deformation of the plenum chamber 3200 and seal-forming structure 3000 which may compromise the sealing force.

[0133] 6.3.4 Frame 3310 As shown in Figures 4, 10, 75, 76, and 166, the frame 3310 acts as a central hub to which the short tubes 4180, the plenum chamber 3200, and the positioning and stabilising structure 3300 are removably or more permanently connected.

[0134] 31-33 also show various views of a frame 3310 connected via a flexible joint 3305 to a positioning and stabilising structure 3300 having straps 3301. These views show the frame 3310 without the plenum chamber 3200 and the seal-forming structure 3100. A connection port 3600 and a vent 3400, both of which are described in more detail below, may be located on the frame 3310.

[0135] In one example technique, the frame 3310 may be formed from polypropylene.

[0136] In other examples of the technology, the frame 3310 may be formed in one size, but the plenum chamber 3200 and the seal-forming structure 3100 may be formed in multiple sizes that can be attached to a single frame by commonly dimensioned connection features as described herein.

[0137] In one example technique, the frame 3310 may be molded without any undercuts so that after it is molded it can be removed from the mold without bending.

[0138] 6.3.5 Connection between plenum chamber and frame In one form of the present technology, the plenum chamber 3200 may be removably attached to the frame 3310, for example for ease of cleaning or to exchange for a differently sized seal-forming structure 3100. This may allow the plenum chamber 3200 to be washed and cleaned more frequently than the frame 3310 and short tube 4180. It may also allow the plenum chamber 3200 to be washed and cleaned separately from the straps 3301. In another form, the plenum chamber 3200 cannot be easily removed from the frame 3310.

[0139] The plenum chamber 3200 may include a plenum connection region 3240 (FIG. 6). The retaining structure 3242 of the plenum connection region 3240 has a shape and / or form that is complementary to the shape and / or form of the corresponding frame connection region 3312 (FIG. 10). The retaining structure 3242 of the plenum chamber 3200 may be stiffer than the rest of the plenum chamber 3200 and may be made from the same material as the frame 3310, for example polypropylene or a polyamide such as Rilsan®. In other embodiments, the plenum connection region 3240 may be made from nylon and the frame 3310 may be made from polypropylene. Nylon, polyamide, and polypropylene are not soft materials and do not readily conform to finger pressure. Thus, when the plenum connection region and the frame are engaged with one another, there is an audible click and a rigid-rigid connection. In FIGS. 20-24, the shape of the retaining structure 3242 is depicted as resembling a parabolic or hyperbolic cylinder. The retention structure 3242 is non-stretchable and non-retractable in order to maintain its general shape when it engages and disengages from the frame 3310. The shape of the retention structure 3242 allows for a small degree of bending, but not to the extent that the two sides of the retention structure 3242 can touch each other when pinched together by finger pressure. In other words, the two sides of the retention structure 3242 can only come into contact with each other with a large clamping force intended by the patient 1000, which does not occur under normal treatment conditions. In the illustrated example, the top and bottom edges of the retention structure 3242 can be pinched closer / easier to each other than the side edges of the retention structure 3242 using the same amount of clamping force. As can be seen in FIG. 18, the curvature of the frame 3310 and retention structure 3242 is adapted to follow the natural curvature of the patient's upper lip, avoiding concentration of contact pressure at any particular point on the patient's upper lip such that the contact pressure from headgear tension is spread evenly across the patient's upper lip. This can minimize or eliminate skin damage caused by concentrated contact pressure over time. Another advantage of the curve is that less material is required for the plenum chamber 3200 compared to a flat frame.A flat frame provides more material at the side edges of the plenum chamber 3200 so that the plenum chamber 3200 conforms to the patient's upper lip. Less material provides an overall weight reduction in the patient interface 3000. The curvature also minimizes any forward protrusion of the patient interface 3000 from the patient's face, thereby improving the low profile of the patient interface 3000. The retention structure 3242 may also be bonded (e.g., using an adhesive) to the plenum chamber 3200 after molding, according to one example technique. In another example, an integral chemical bond (molecular adhesion) may be utilized between the retention structure 3242 and the plenum chamber 3200.

[0140] In one example of a technique, the retaining structure 3242 may be molded without any relief grooves so that it can be removed from the mold after it is molded without bending. The retaining structure 3242 has a continuous perimeter edge on the front side that contacts the frame 3310. This continuous perimeter edge is exposed so that it contacts and engages the frame 3310 in a rigid-rigid manner. This is in contrast to most soft-rigid connections, where in some conventional masks there is a front lip of the seal-forming structure that covers and overlaps most of the removable rigid retaining structure. The front lip is formed from LSR and wraps over the retaining structure to hold the retaining structure together. However, in such conventional masks, wrapping the front lip over the removable clip is difficult and cumbersome, and the clip can be misplaced, resulting in an inability to connect the seal-forming structure to the frame.

[0141] One purpose of the retaining structure 3242 is to align the plenum chamber 3200 when engaged with the frame 3310. This is because the shape of the retaining structure 3242 of the plenum chamber 3200 is retained (possibly at various depths) within the space defined between the frame connection region 3312 and the interference portion 3314 of the frame 3310 (FIG. 29).

[0142] Another purpose of the retaining structure 3242 is to retain the plenum chamber 3200 to the frame 3310 by preventing relative lateral vertical relative movement between these two parts. The plenum connection region 3240 may comprise at least one retaining feature 3244, and there may be at least one complementary frame connection region 3312. The plenum connection region 3240 may comprise one or more retaining features 3244 (FIG. 10). In addition to preventing relative lateral vertical movement between the plenum chamber 3200 and the frame 3310, another purpose of the retaining feature 3244 is to prevent relative longitudinal movement between these two parts. The remaining portion of the plenum chamber 3200 may comprise a material that is more flexible than the retaining structure 3242 and the plenum connection region 3240.

[0143] In one form, the plenum connection region 3240 is constructed from a rigid or semi-rigid material, such as high durometer silicone or TPE, plastic, nylon, temperature resistant material, polypropylene, and / or polycarbonate. The plenum connection region 3240 may be constructed from a different material than the rest of the plenum chamber 3200. For example, the plenum connection region 3240 may be a separate component that is permanently connected, integrally bonded, or mechanically coupled with the connection portion 3202 (FIG. 10) of the plenum chamber 3200. With reference to FIG. 6, the connection portion 3202 of the plenum chamber 3200 may have approximately the same thickness as the retaining structure 3242 of the plenum connection region 3240. The plenum connection region 3240 may include a tongue 3211 configured and arranged to be matingly received by a channel portion 3211.1, such as a channel portion of the frame 3310. In this manner, the channel portion 3211.1 can form a mating feature for the tongue portion 3211, or vice versa. The tongue portion 3211 and the channel portion 3211.1 may also be dimensioned to maximize the sealing surface area in this region.

[0144] 6.3.5.1.1 Installation and removal of plenum chamber from frame The plenum chamber 3200 may be fixedly attached to the frame 3310, but may also be removably attached to the frame 3310. FIG. 12 shows the plenum chamber 3200 in a connected position to the frame 3310. The plenum connection area 3240 includes only two retention features 3244, which in this example are located on both sides of the connection area 3240, e.g., the rear and the front. FIGS. 12 and 13 show a cross section through both barbs 3246, while FIG. 17 shows another cross section in which the barbs 3246 are absent, thereby forming, for example, a channel or groove 3211.1. The resilient barbs 3246 are a kind of snap-on compression fit that provides a high retention force (to prevent accidental disengagement) while also allowing relatively easy intentional removal. In FIG. 17, the plenum connection area 3240 and the frame 3310 simply fit together in a tongue-and-groove manner. The frame 3310 and retention structure 3242 may be formed such that the tongues 3211 and channel portions 3211.1 engage before the retention features 3244 engage with the frame. This may help align the retention features 3244 for connection.

[0145] Each retention feature 3244 may be in the form of a barb 3246 (FIGS. 6 and 13) having a front surface 3246.1 and a rear surface 3246.2. The front surface 3246.1 is adapted to engage with a lead-in surface 3312.1 of the frame connection region 3312 of the frame 3310 as the plenum chamber 3200 and the frame 3310 are moved into engagement with one another. As the retention feature 3244 is pressed into place, it deforms. The upper and lower regions of the frame connection region 3312 of the frame 3310 and the interference region 3314 may also deform slightly. The retention structure 3242 may also deform slightly, particularly near the retention feature 3244 (see, for example, dashed lines in FIGS. 27 and 28). 195-198, the deformation of the frame connection region 3312 and the interference portion 3314 of the frame 3310 is controlled in terms of the amount of deformation allowed and also in terms of the area where deformation is allowed to occur through the use of ribs 3294. In one example of the present technology, there are six ribs 3294 spaced around and against the interference portion 3314. The spacing and location of the ribs 3294 limits the area of ​​deformation of the interference portion 3314 to only the area close to the retention feature 3244. The ribs 3294 may abut and deform against the inner surface of the plenum connection region 3240 to provide a stronger engagement between the plenum connection region 3240 and the frame connection region 3312 at these contact points when the plenum chamber 3200 is engaged with the frame 3310. 199-202, the plenum connection area 3240 of the plenum chamber 3200 has a notch 3295 to mate with the rib 3294. The notch 3295 is a chamfer to minimize friction of the plenum connection area 3240 against the rib 3294 during assembly of the plenum chamber 3200 and the frame 3310. Once the barbs 3246 are pressed in a sufficient amount, they snap radially outward such that the barbs 3246 assume the retaining position shown in FIG. 13. The snap action provides an audible sound, such as a reassuring click, to the user, thereby providing feedback to the user or patient that a proper connection has been established.In the retaining position, as shown in Figure 13, the rear surface 3246.2 of the barb 3246 engages the retaining surface 3312.2 of the frame connection region 3312. This reassuring click may be facilitated, in one example technique, by forming the plenum connection region 3240 with sufficient rigidity, the rigidity being greatest near the plenum connection region 3240. This rigidity may be achieved by overmolding.

[0146] As can be seen in FIG. 13, the surfaces of the barb 3246 and the frame connection region 3312 are angled in a particular manner to facilitate a sliding connection between the plenum chamber 3200 and the frame 3310. For example, as previously mentioned, the front surface 3246.1 and the lead-in surface 3312.1 may be formed with corresponding angles to each other so that these surfaces can relatively easily slide into engagement with each other. Similarly, the rear surface 3246.2 and the retaining surface 3312.2 may be angled relative to each other to help retain the frame 3310 and the plenum chamber 3200 once connected. The angle between the rear surface 3246.2 and the retaining surface 3312.2 is selected such that a pulling force applied, for example, generally along the axis of the nasal pillows 3130, is sufficient to bend the barb 3246 inwardly, thereby releasing the plenum chamber 3200 from the frame 3310. This tension does not require the patient 1000 to first deflect the barbs 3246 radially inward, for example by squeezing the plenum chamber 3200 in a front-to-back direction. Rather, due to the angles involved, radial deflection of the barbs 3246 occurs only as a result of the applied axial tension force. In one example of the present technology, the plenum connection region 3240 is deflected and disassembly of the plenum chamber 3200 from the frame 3310 is performed by pinching the plenum chamber 3200 and pulling the plenum chamber 3200 away from the frame 3310.

[0147] As can be seen in Fig. 13, the plenum chamber 3200 is attached to the frame 3310 via the plenum connection region 3240, and the retention feature 3244 is engaged with the frame connection region 3312 by the barb 3246. As also shown in this figure, the retention surface 3312.2 of the frame connection region 3312 and the rear surface 3246.2 of the barb 3246 are engaged and are flush with each other. In order for the patient to remove the plenum chamber 3200 from the frame 3310, the patient must pull the plenum chamber 3200 against the frame 3310 with enough force to overcome the resistance of the retention surface 3312.2 against the rear surface 3246.2. In one example of the present technology, pinching the plenum chamber 3200 reduces the axial pulling force required to remove the plenum chamber 3200 from the frame 3310. This resistance can be "tuned" or selectively adjusted to a desired level by varying the angle at which these surfaces 3312.2, 3246.2 engage with one another. The closer these surfaces 3312.2, 3246.2 are to perpendicular to the direction of force applied by the patient 1000 to remove the plenum chamber 3200 from the frame 3310, the greater the force required to effect removal. This angle is shown in FIG. 14 as β, where the rear surface 3246.2 is angled relative to a nominal vertical axis 3246.4 (corresponding to the axial pulling direction of the plenum chamber 3200 relative to the frame 3310). As β is increased, the force required to remove the plenum chamber 3200 from the frame 3310 increases. Also, as β increases, the removal feels more abrupt to the patient 1000. In one example, an angle β of about 75° has been found to produce a comfortable removal feel for the patient. In further examples, β may vary from 30° to 110°, or from 40° to 90°, or from 65° to 85° to provide an ideal level of resistance to removal, which has been selected to minimize the possibility of accidental dislodgement and to allow only intentional removal by the patient 1000.

[0148] The angle α, which is the angle between the nominal vertical axis 3246.4 and the front surface 3246.1, may similarly be "tuned" or selectively adjusted to require a particular level of force when the patient 1000 attaches the plenum chamber 3200 to the frame 3310. As the angle α is increased, the force required to engage the retention feature 3244 with the frame connection region 3312 increases, as well as the attachment feel to the patient engaging these components 3244, 3312 becoming more abrupt. In other words, as the front surface 3246.1 of the retention feature 3244 slides along the lead-in surface 3312.1 of the frame connection region 3312, the user may experience a smoother engagement feel as the angle α decreases. In one example, an angle α of approximately 30° has been found to produce a comfortable removal feel for the patient 1000. In further examples, the angle α may vary from 50° to 70°, or from 15° to 60° to provide an ideal level of resistance to removal.

[0149] Also, because the feel and force of engagement and disengagement of the plenum chamber 3200 and the frame connection region 3312 can be matched or selectively adjusted independently of one another, the angles α and β may be selected to cause the patient to experience a different level of resistance to attachment than the level of resistance to removal. In one example technique, the angles α and β may be selected such that the angle β is greater than the angle α, such that the patient experiences a smaller resistance to attachment of the plenum chamber 3200 to the frame 3310 than the resistance to removal. In other words, the patient may experience it as being more difficult to remove the plenum chamber 3200 from the frame 3310 than to connect them.

[0150] As can be seen in FIG. 4, one example of the technology includes a pair of retention features 3244, 3245. Also, as shown in this figure, the exemplary retention features 3244, 3245 are sized differently. In particular, this figure shows that the retention feature 3245 located in front of the plenum connection area 3240 is narrower than the retention feature 3244 located in the rear of the plenum connection area 3240. By sizing the retention features 3244 differently, the patient 1000 can only attach the plenum chamber 3200 to the frame 3310 in one orientation. Such a configuration is shown in FIG. 10. This avoids patient frustration during attachment, minimizes possible damage to the patient interface 3000 due to incorrect attachment, and provides comfort by reducing or avoiding contact with the nasal septum and / or upper lip of the patient 1000 by ensuring that the seal-forming structure 3100 is correctly oriented to provide a proper seal against the patient's airway.

[0151] In FIG. 10, two frame connection regions 3312, 3313 are shown engaged with corresponding retention features 3244, 3245. The depicted example shows that the narrower anterior retention feature 3245 is sized to correspond to the narrower anterior frame connection region 3313. Also, the wider posterior retention feature 3244 is engaged with the correspondingly sized posterior frame connection region 3312. Such an arrangement, where one retention feature is uniquely sized to engage with a corresponding uniquely sized frame connection region, has the advantage that the patient can only attach the plenum chamber 3200 to the frame 3310 in one orientation. By limiting the attachment orientation, the patient 1000 is prevented from improperly assembling the patient interface 3000 and receiving suboptimal treatment due to an improperly assembled patient interface 3000. The configuration described with respect to this particular example of the technology is advantageous for a patient 1000 who may have difficulty seeing how to correctly engage the components due to vision issues, or who may be assembling the patient interface 3000 in a darkened room, such as a bedroom before going to sleep, because the patient 1000 can only fully assemble the patient interface 3000 if the components are properly aligned.

[0152] As mentioned above, the angles of the front 3246.1 and rear 3246.2 faces of the barb 3246 are important to provide an optimal amount of resistance to assembly and disassembly of the patient interface 3000. Also mentioned above are the advantages of correspondingly dimensioning the respective retention features 3244, 3245 and frame connection regions 3312, 3313 to ensure proper orientation of the components during assembly. Properly dimensioning the retention features 3244, 3245 and frame connection regions 3312, 3313 can help guide the plenum chamber 3200 towards the frame 3310. In other words, the frame connection regions 3312, 3313 and the retention features 3244, 3245 may be dimensioned to fit closely together such that the periphery of the frame connection regions and the periphery of the retention feature 3244 help to orient and align the retention feature 3244 to the frame connection region 3312. This may be beneficial for patients with limited dexterity due to illness (e.g., arthritis) or who assemble the patient interface 3000 in conditions where visibility is reduced, whether in a dark bedroom prior to sleep or due to limited eyesight. Also, by closely fitting and dimensioning the retention features 3244, 3245 and the frame connection regions 3312, 3313 to one another, this serves to ensure that the seal between the plenum chamber 3200 and the frame 3310 is maintained by facilitating a robust connection between these two components. Also, the close fit between the retention features 3244, 3245 and the frame connection regions 3312, 3313 may help to facilitate equal alignment of the plenum chamber 3200 to the frame 3310. In one example of the present technology, a difference of 0.3 mm to 2 mm may be incorporated between the retention features 3244, 3245 and the frame connection regions 3312, 3313.

[0153] It should also be understood that the connections between the frame 3310 and the plenum chamber 3200 described above and below may be used with other types of masks. Such features may be applicable to nasal masks or full face masks as well. Masks that seal under the bridge of the nose, such as compact nasal masks or compact full face masks, may incorporate the connection features described herein. Masks lacking a forehead support may also include these connection features. It is also envisioned that examples of the present technology that include masks that seal under the tip of the nose, such as masks with nasal pillows 3130 or nasal cradle / nasal flange 3101, may use these connection features.

[0154] 6.3.5.1.2 Plenum chamber and frame installation and removal sequence 25-29 show a series of cross-sectional views of the connection 3202 of the plenum chamber 3200 and the frame connection region 3312 of the frame 3310. These sequential views show the process of attachment of the plenum chamber 3200 to the frame 3310. Although these views only show the attachment of one retention feature 3244 to one frame connection region 3312, it should be understood that there may be multiple retention features 3244 and multiple frame connection regions 3312, as seen in FIG. 10 and as previously described. Thus, during the attachment sequence of the plenum chamber 3200 and the frame 3310, multiple instances of the illustrated attachment sequence may be performed to achieve a complete attachment of the plenum chamber 3200 and the frame 3310.

[0155] FIG. 25 shows a cross-sectional view of the connection 3202 of the plenum chamber 3200 and the frame connection region 3312 of the frame 3310, where the connection 3202 and the frame connection region 3312 are adjacent to each other but do not touch. The arrows indicate that the connection 3202 and the frame connection region 3312 are about to join. Of course, for these figures, for simplicity, further parts of the plenum chamber 3200 and the frame 3310 are not included. Thus, it should also be understood that the frame connection region 3312 and the interference portion 3314 of the frame connection region 3312 are both part of the frame 3310, as can be seen, for example, in FIG. 13. It should also be understood that the frame connection portion 3312 and the interference portion 3314 of the frame connection portion 3312 move relative to each other throughout the installation sequence. Returning to FIG. 25, this view shows that the sealing lip 3250 is not deformed and the retention feature 3244 is not deformed. This is because neither of these components 3250 , 3244 contacts the frame 3310 .

[0156] FIG. 26 shows the barb 3246 of the retention feature 3244 beginning to contact the frame connection region 3312 of the frame 3310. Specifically, this view shows the front surface 3246.1 of the barb 3246 contacting the lead-in surface 3312.1 of the frame connection region 3312. In this view, the retention feature 3244 and the frame connection region 3312 are only in contact with each other such that the retention feature 3244 is not deflected. Also, the sealing lip 3250 has not been deflected because it has not yet contacted the interference portion 3314 of the frame connection region 3312. As previously discussed, the angle α of the front surface 3246.1 begins to affect the resistance felt by the user to the engagement of the plenum chamber 3200 with the frame connection region 3312. This is because the front surface 3246.1 begins to engage the lead-in surface 3312.1 in frictional contact.

[0157] 27 shows the plenum chamber 3200 and frame 3310 further along the attachment sequence as the retention feature 3244 is deflected by contact with the frame connection region 3312. As can be seen in this figure, the frame connection region 3312 and the interference portion 3314 of the frame connection region 3312 are closer to the connection portion 3202. Also, as shown in this figure, the front surface 3246.1 of the barb 3246 contacts a portion of the lead-in surface 3312.1 that is closer to the retention surface 3312.2. In other words, the barb 3246 appears to have been moved closer to attachment with the frame connection region 3312 and relative to the position shown in FIG. 26. As previously mentioned, the connection portion 3202 of the plenum chamber 3200 and the plenum connection region 3240 may be deflected by the clamping force generated by the patient 1000. Figure 27 also shows that the retention feature 3244 has been deflected by contact with the frame connection region 3312, with the dashed line showing the outline of the retention feature 3244 in an undeformed state. Figure 27 also shows that the sealing lip 3250 has not yet contacted the interfering portion 3314 of the frame connection region 3312, and therefore the sealing lip 3250 is not deformed. Although not shown in this view, it should also be understood that the frame connection region 3312 may deflect away from the retention feature 3244 due to forces pushing these portions 3312, 3244 towards one another.

[0158] In FIG. 28, the plenum chamber 3200 and the frame 3310 are nearly attached and the retention feature 3244 is nearly fully engaged with the frame connection region 3312. In this view, the retention feature 3244 is still deformed, but the barb 3246 now contacts a different portion of the frame connection region 3312. Specifically, the rear surface 3246.2 of the barb 3246 now contacts the retention surface 3312.2 of the frame connection region 3312. Also, due to the angle at which the rear surface 3246.2 and the retention surface 3312.2 contact each other, the retention feature 3244 and the frame connection region 3312 may be biased toward an engaged state by the inherent tendency of the deflected retention feature 3244 to return to its undeformed state, which in effect draws the portions together after a certain insertion distance is reached. FIG. 28 also shows the outline of the retention feature 3244 in its undeformed state in dashed lines. It can also be seen in this view that the sealing lip 3250 is in contact with the interference 3314 of the frame connection region 3312. At this point in the installation sequence, a seal may begin to form by contact between the sealing lip 3250 and the interference 3314 of the frame connection region 3312. The sealing lip 3250 may be slightly deflected by contact against the interference 3314 of the frame connection region 3312.

[0159] FIG. 29 shows the plenum chamber 3200 and frame 3310 fully attached by engagement of the barb 3246 of the retention feature 3244 with the frame connection region 3312. In this view, the retention surface 3312.2 may rest relatively flush against the rear surface 3246.2, and the retention feature 3244 may no longer be deflected by contact with the frame connection region 3312. The return of the retention feature 3244 from its deflected or deformed state as shown in FIG. 28 to its undeformed state may produce an audible click as the barb 3246 and retention feature 3244 move from the position shown in FIG. 28 to the position shown in FIG. 29. This reassuring audible click may be beneficial in that the click provides feedback to the patient 1000 that the plenum chamber 3200 and frame 3310 are fully engaged. By providing this feedback to the patient 1000 when engagement is complete, the patient 1000 may be able to use the patient interface 3000 with confidence that the plenum chamber 3200 and frame 3310 are securely attached and will not become separated while the patient 1000 is sleeping and receiving treatment.

[0160] Also, the desired level of sealing contact may be achieved when the plenum chamber 3200 and frame 3310 are attached as shown in FIG. 29. The sealing lip 3250 is seen to be deflected against the interference 3314 of the frame connection region 3312. By being deflected as shown, the sealing lip 3250 may press itself against the interference 3314 of the frame connection region 3312 with sufficient force due to the tendency of the sealing lip 3250 to return to its undeformed state, thereby providing the desired seal between these components. Furthermore, as air pressure increases within the plenum chamber 3200 as treatment is administered, the sealing lip 3250 is forced to deflect towards the interference 3314 of the frame connection region 3312, thereby increasing the sealing force in this region. Even though a compression seal is formed between the retaining structure 3242 and the frame connection region 3312 when the plenum chamber 3200 is engaged with the frame 3310, upon engagement a pressure actuated seal is also formed between the sealing lip 3250 and the portion 3314 of the frame connection region 3312 that becomes stronger as the air pressure inside increases. In certain instances, it may be envisioned that the compression seal is not air tight, thereby resulting in undesirable leakage.

[0161] Also, if a significant amount of compression of the components is required to form a compression seal, this may prevent easy installation and removal of the plenum chamber 3200 from the frame 3310, possibly requiring more than one hand or a significant amount of effort to perform the operation. Thus, in one example of the present technology, the compression seal functions primarily for retention purposes rather than sealing, and the pressure actuated seal functions primarily for creating and maintaining an airtight seal. It should be understood that such sealing action may occur around the perimeter of the joint between the plenum chamber 3200 and the frame 3310. For example, FIG. 17 shows the sealing lip 3250 in a similarly deflected state against the frame connection area 3312 in an area separate from the retention feature 3244. Also in FIG. 5, for example, it can be seen that the sealing lip 3250 extends around the perimeter of the plenum chamber 3200. By having the sealing lip 3250 extend inwardly around the periphery of the joint between the plenum chamber 3200 and the frame 3310, a desired level of sealing can be obtained around this entire area, thereby preventing undesired leakage of pressurized gas.

[0162] It should also be appreciated that the sealing lip 3250 may bear against the interfering portion 3314 of the frame connection region 3312 with a force biasing the portions apart. However, the frictional force resulting from the structural engagement of the rear surface 3246.2 of the barb 3246 with the retention surface 3312.2 of the frame connection region 3312 must be sufficient to resist the force tending to cause the sealing lip 3250 to return to its undeformed state and separate the plenum chamber 3200 from the frame 3310.

[0163] With regard to removing the plenum chamber 3200 and the frame 3310, it should be understood that this process is generally the reverse of the process described above. In other words, the user may separate the plenum chamber 3200 from the frame 3310 by pulling these components in opposite directions, and the view in FIG. 29 may be the beginning of the separation process, and FIG. 25 may represent a view where the plenum chamber 3200 and the frame 3310 are completely separated. Clamping the plenum chamber 3200 near or at the plenum connection area 3240 and pulling it away from the frame 3310 may aid in removing the plenum chamber 3200 from the frame 3310. It is also envisioned that the patient 1000 may simply clamp the plenum chamber 3200 at any location, for example, at the nasal pillows 3130 or the handle 3150, in order to grip it and pull it away from the frame 3310. A pulling and twisting action may also help disengage the plenum chamber 3200 from the frame 3310.

[0164] 6.3.5.1.3 Rigid-to-rigid connections The plenum connection region 3240 and the frame 3310 may be assembled and attached as shown in Figures 25-29. As previously mentioned, the plenum connection region 3240 and / or the retaining structure 3242 may be constructed of semi-rigid materials, such as high durometer silicone (higher durometer than the plenum chamber 3200) / TPE, plastic, nylon, polypropylene, polyamide, and / or polycarbonate. The plenum connection region 3240 may be constructed of two C-shaped clips in a continuous ring or oval shape, one C-shaped clip, or in the form of a single continuous piece but surrounding only a portion of the plenum chamber 3200. The clip may function as a spring clip and may be in the form of a C-section or double C-section. The spring force of the spring clip may be provided by the resilience of the plenum connection region 3240 stretching against the frame connection region 3312, 3313 or interference 3314 of the frame 3310. In other examples, a clip form may not be required and only the retention features 3242, 3244 are permanently connected directly to the plenum chamber 3200 without the plenum connection region 3240 and / or the retention structure 3242 to engage the connection regions 3312, 3313. It is also envisioned that one example of the present technology may include the frame 3310 being constructed from the same or similar semi-rigid material as the plenum connection region 3240. By fabricating the frame 3310 and plenum connection region 3240 from a semi-rigid material, a "rigid-to-rigid" connection or bonded interface may be formed. This "rigid-to-rigid" connection, in conjunction with the structural features of the plenum connection region 3240 and frame connection region 3312, may provide the patient 1000 with a confident feeling of connection between the plenum chamber 3200 and the frame 3310 when assembling the patient interface 3000 (e.g., by providing an audible snap-fit ​​or reassuring click). Because a secure fit between the plenum chamber 3200 and the frame 3310 helps to ensure that the patient 1000 receives optimal treatment via the patient interface 3000, a structure that provides the patient 1000 with confidence that a secure fit has been achieved is beneficial.The hard-to-hard connection described herein can also be beneficial in that it can add stability to the seal formed by the seal-forming structure 3100. This is in contrast to hard-to-soft or soft-to-soft connections where either or both of the plenum chamber and frame are formed from soft materials, making it difficult to easily properly engage the plenum chamber and frame with arthritic hands, especially in a dark room.

[0165] Although the retention features 3242, 3244 are described as being provided on the plenum chamber 3200 and the connection regions 3312, 3313 are provided on the frame 3310, it is envisioned that the locations could be swapped with retention features on the frame and connection regions on the plenum chamber. Also, there could be a combination of retention features and connection regions on one part that correspond to the connection regions and retention features on the other part.

[0166] 6.3.6 Methods for forming plenum chambers A process for manufacturing the plenum chamber 3200 may include molding the plenum connection region 3240 in a first mold, removing the molded plenum connection region 3240 from the first mold, and inserting the plenum connection region 3240 into a second mold to mold a portion of the plenum chamber 3200 with the connection portion 3202 in the second mold. The plenum connection region 3240 may be chemically bonded and / or mechanically coupled to the connection portion 3202.

[0167] In one form, the sealing lip 3250 is configured and arranged to interfere with the interference portion 3314 of the frame connection region 3312 when the plenum chamber 3200 and the frame 3310 are assembled together (FIG. 13). In use, the sealing lip 3250 is resiliently deflected away from a rest position (FIG. 6) when assembled with the interference portion 3314 of the frame connection region 3212 and presses against the interference portion 3314 (FIG. 12) as a result of at least partially being a resilient material to resist or prevent air leakage between the sealing lip 3250 and the interference portion 3314. Although the sealing lip 3250 has been described as being provided on the plenum chamber 3200, the sealing lip may also be provided on the frame 3310. Although one sealing lip has been described, it is envisioned that more than one sealing lip may be provided. In that case, at least one sealing lip is provided on the plenum chamber 3200 and at least one sealing lip is provided on the frame 3310.

[0168] 6.3.7 Positioning and Stabilising Structure 3300 It is noted that in one form of the present technology, many of the structural features form part of the positioning and stabilising structure 3300, such as the headgear assembly (which may simply be referred to as headgear). In another form of the present technology, one or more of these features are located on the frame 3310. For example, all or part of the flex joint 3305 may be located on the headgear or the frame 3310. Also, the extension 3350 may perform the same function as the flex joint 3305, except that it is formed integrally with the rigidiser arm 3302.

[0169] The seal-forming structure 3100 of the patient interface 3000 of the present technology may, in use, be held in a sealing position by a positioning and stabilising structure 3300 (Fig. 75, Fig. 76 and Fig. 166). In one form, the positioning and stabilising structure 3300 comprises head gear. It will be appreciated that the positioning and stabilising structure 3300 may, in one form of the technology, be referred to as head gear.

[0170] The headgear may be removably connectable to a part of the patient interface, such as the positioning and stabilising structure 3300, via a headgear connector.

[0171] 6.3.7.1 Straps The positioning and stabilising structure 3300 may comprise at least one strap 3301 (see, for example, FIG. 65) and at least one rigidiser arm 3302 (see, for example, FIG. 67). The strap 3301 may be formed from an elastic material and may have elastic properties. In other words, the strap 3301 may be elastically stretched, for example by a stretching force applied by the patient, and may return to its original length in a neutral state or retract upon release of the stretching force. The strap 3301 may be formed from or comprise any elastomeric material, such as elastane, TPE, silicone, etc. The material of the strap 3301 may correspond to a combination of any of the aforementioned materials with other materials. The strap 3301 may be a single layer or a multi-layer strap. The strap 3301, particularly the side strap portions 3315, 3316 that contact the patient 1000 during use, may be woven, knitted, braided, molded, extruded, or otherwise formed. The strap 3301 may comprise or be formed from a textile material, such as a woven material. Such a material may, on the one hand, comprise synthetic or natural fibers, thereby providing desirable beneficial surface properties, such as tactile properties, and skin comfort. On the other hand, the material of the strap 3301 may include an elastomeric material to provide desirable elastomeric properties. The entire strap 3301, including the side strap portions 3315, 3316 and the back strap portion 3317, may all be stretchable. This allows the entire length of the strap 3301 to be stretched, thereby resulting in a comfortable force transfer profile. In order to stretch the strap 3301 during use, the length of the strap 3301 may be less than the average small head circumference of the patient. For example, the length of the strap 3301 may be less than 590 mm in one example and less than 500 mm in another example. However, different lengths of straps 3301 may be provided to a patient depending on the patient's head circumference, which may be gender specific. For example, a small size strap may be 490 mm in length and a large size strap may be 540 mm.In some circumstances this means that the length of the strap 3301 does not need to be stretched over a large distance (i.e., a small size strap for a large head circumference), which would result in unnecessarily high headgear tension for such patients, as well as a less smooth force transfer profile as the small size strap 3301 is stretched to a longer length.

[0172] According to another example of the present technology, the strap 3301 may be inelastic or may not be fully stretchable. A rigidiser arm 3302 may or may not be included. According to these other examples, the length of the strap 3301 of the positioning and stabilising structure 3300 may be adjustable using ladder lock clips, buckles or hook and loop material. The strap 3301 may be formed from a substantially inelastic material such as plastic or fabric. The use of an inelastic strap 3301 may be beneficial in that the seal-forming structure 3100 is a nasal cradle cushion and the tube torque is received by the patient interface 3000, the seal stability may be more easily maintained.

[0173] The strap 3301 is stiffened in certain areas, for example from the frame 3310 to a position close to the patient's cheekbone, by the inserted rigidiser arm 3302. The strap 3301 may be in the form of a hollow ribbon. The strap 3301 may be considered to be threaded over the rigidiser arm 3302 when it is slid onto the rigidiser arm 3302 and secured to one end of the rigidiser arm 3302 close to the frame 3310.

[0174] In one example, the strap 3301, including the side strap portions 3315, 3316 and the back strap portion 3317, is formed by warp knitting a textile material. The strap 3301 is a 3D knitted fabric that is computer controlled knitted as a single, integral piece. Yarn and stitch variations may occur at various locations along the strap 3301 to adjust the elasticity and strength and durability of the strap 3301 at specific locations. For example, at the openings, insertion points or button holes 3303, 3304 and at the branching points 3324 for the back strap portions 3317a, 3317b, additional yarns may be knitted to reinforce the strap 3301 at these locations that are subject to high stress as the strap 3301 is stretched during repeated, prolonged use to prevent failure / breakage of the strap 3301. The braiding method (i.e., warp knit) and the elastic fabric material (e.g., elastane) of the strap 3301 both contribute to the elastic recovery of the strap 3301 after it is washed in water and dried. In other words, regular washing of the strap 3301 can maintain the elasticity of the strap 3301 after prolonged use, thus extending the service life of the strap.

[0175] In Figures 65-73, the strap 3301 is shown to be a single continuous strap having two pocketed ends 3311, 3313 for attachment to the frame 3310 directly or via a flexible joint 3305. However, it will be appreciated that the strap 3301 may comprise a number of individual straps which are or may be directly connected to one another, for example by stitching or ultrasonic welding. In Figure 65, the strap 3301 and positioning and stabilising structure 3300 are shown without any means of adjustment or variation. However, such adjustment may be made by varying where the strap 3301 is secured relative to the patient interface 3000 or other connection element which is stiffer than the strap 3301, for example the flexible joint 3305. 72, additionally or alternatively, adjustment may be made possible by adding a mechanism such as a slide over ladder lock clip 3305.1 to the back strap portion 3317 or the side strap portions 3315, 3316 (e.g. as shown in Figs. 71-73) or otherwise adjusting the stretch length of the strap 3301 and the positioning and stabilising structure 3300, respectively. In the example shown in Fig. 65, the strap 3301 has a tubular form as can be interpreted from the respective schematic diagrams of Figs. 68-70 showing an elliptical or circular shape, or from the respective circular or elliptical markings 3321a-3321d, 3323a-3323e showing the outer surface (visible) facing towards the viewer as a solid line and the inner wall (not visible) facing away from the viewer as a dashed line, and from the cross-sectional view according to Fig. 66. However, it is understood that the positioning and stabilising structure 3300 may take any other form such as a flat or sheet-like form, a single layer, multi-layer or laminated structure, etc. The strap 3301 may have a longitudinal axis, which may be understood to be an axis generally parallel to the plane of the paper, along which the strap 3301 extends (see e.g. the dashed line in Fig. 65).

[0176] The strap 3301 may have reinforcing stitching to improve durability and minimize or prevent failure points. For example, the areas of the strap 3301 at the button holes 3303, 3304 and also where the strap splits into two back strap portions 3317a, 3317b at the split point 3324 are subject to high stresses during stretching. The tendency of the material is to split away from each other at the split area 3326, therefore reinforcing stitching in these areas is one way to address this concern. In one example, a center stitch runs along the central longitudinal axis of the strap 3301 and acts as a reinforcing stitching. The distal edges of the strap 3301 and the openings of the button holes 3303, 3304 may also be ultrasonically welded to fuse any loose fibers in these areas and strengthen the strap 3301. Advantageously, this also prevents fraying of the fibers of the strap 3301 after extended use and repeated washing. Other techniques for reinforcing and strengthening the pocket end 3311, the distal edge, and the buttonhole 3303 are envisioned and may include additional materials such as tape. The tape may include branding and logo information.

[0177] 123-125 show increasingly detailed views of the split region 3326 between the upper and lower backstrap portions 3317a, 3317b. It should be understood that the edges of the upper and lower backstrap portions 3317a, 3317b are not perfectly smooth as a result of the knitting process, and it should be further understood that these views show the edges at a large magnification so that imperfections can be seen. The unevenness of the edges of the upper and lower backstrap portions 3317a, 3317b is not so easily seen by the naked eye, and generally cannot be recognized by touch by the patient 1000. Additionally, in these views, stippling is used to show the nature of the backstrap portions 3317a, 3317b, while the split region 3326 is shown blank due to the absence of material in the split region 3326.

[0178] 126-131 show various detailed views of the bifurcation point 3324 present where the upper and lower back strap portions 3317a, 3317b separate from the side strap portions 3315, 3316. Also visible in these views is a reinforcement 3325 which may include additional stitching or welding at or near the bifurcation point 3324. The reinforcement 3325 may help prevent the side strap portions 3315, 3316 from cracking and / or splitting due to stresses from repeated separation of the upper and lower back strap portions 3317a, 3317b. In other words, the reinforcement 3325 may provide additional strength at the location of stress concentration near the bifurcation point 3324. Also shown in these views are the upper and lower back strap portions 3317a, 3317b at various separation angles θ. It can be seen from these figures that the reinforcement section 3325 provides additional strength at the branch point 3324 when the upper and lower backstrap sections 3317a, 3317b are diverged from each other at a large angle θ.

[0179] 176-181, in one example of the present technology, the end of the strap 3301 has a reinforcement 3327 where material is folded over at the end of the strap 3301. This provides additional reinforcement in this area in addition to the welded ends 3311.1, 3313.1 (see FIG. 81). The material of the reinforcement 3327 may be a different material than the strap 3301. The reinforcement 3327 may avoid or reduce the possibility of the patient 1000 tearing or breaking the strap 3301 along its longitudinal axis starting from this area. The reinforcement 3327 helps to give the patient 1000 a visual and tactile indication of how to slide the strap 3301 over or remove it from the rigidiser arm 3302. This is because the reinforcement may help to identify the location of the button holes 3303, 3304. The corners 3328 of the reinforcement 3327 have been cut and rounded so that they approximately match the rounded corners of the distal free end 3302.1 of the rigidiser arm 3302 (see Figs. 50, 52, 55, 57, 58, 60). This provides an aesthetically more pleasing snug fit with the rigidiser arm 3302. The rounded corners 3328 provide soft edges to avoid facial scratches that may occur if they were sharp corners instead.

[0180] 6.3.7.2 Rigidiser Arm FIG. 67 shows an example of a rigidiser arm 3302. As shown, the rigidiser arm 3302 may be crescent or semicircular in shape. The rigidiser arm 3302 may have a generally elongated flat configuration. In other words, the rigidiser arm 3302 is much longer and wider (up and down in the plane of the paper) than it is thicker (into the plane of the paper). The rigidiser arm 3302 has a three-dimensional shape with curvature in all three axes (X, Y, and Z). The thickness of the register arm 3302 may be generally uniform, but its height varies over its entire length. The purpose of the shape and dimensions of the rigidiser arm 3302 is to fit closely against the patient's cheek while remaining unobtrusive and blend in with the patient's face and cheek. The ends 3319a, 3319b of the rigidiser arm 3302 may be rounded and / or slightly angled relative to the remainder of the rigidiser arm 3302. It will be appreciated that the rigidiser arm 3302 may be flat as indicated by the page of Fig. 67, however, the rigidiser arm 3302 may have a desired spatial configuration also into the page of Fig. 67 to allow for improved alignment with the shape of the patient's face, particularly the shape of the patient's cheek or head region (see, for example, Figs. 71 and 72). The rigidiser arm 3302 may have a longitudinal axis, which may be understood to be an axis generally parallel to the page, along which the rigidiser arm 3302 extends (see dashed line in Fig. 67).

[0181] The rigidiser arm 3302 is stiffer than the strap 3301 and less stiff than the mask frame 3310. In particular, the rigidiser arm 3302 and / or the strap 3301 are such that in combination, the rigidiser arm 3302 provides shape and increased stiffness to the strap 3301 in at least one direction or at least one axis or around at least one axis. The rigidiser arm 3302 also guides or defines the extension direction or path for the strap 3301. In other words, the patient extends the strap 3301 in a direction that is generally parallel to the longitudinal axis of the rigidiser arm 3302. Extension of the strap 3301 in other directions would result in rotation of the rigidiser arm 3302 relative to the mask frame 3310, which is undesirable. The rigidity of the rigidiser arms 3302 biases them to their natural, non-rotated, non-twisted, non-deformed state. To some extent, this allows the positioning and stabilising structure 3300 to be a self-adjusting headgear. The self-adjusting feature avoids having to manually shorten or lengthen the headgear straps' material length and then remember the adjusted length, which was typically a cumbersome process as one would have to shorten or lengthen the headgear straps on either side of the face one by one. The self-adjusting feature may eliminate the patient being able to over-tighten the headgear when such a high level of headgear tension is not required to maintain a good seal. In the illustrated example, the straps 3301 have a tubular or sleeve-like form. In other words, the straps 3301 are hollow to receive the insertion of the rigidiser arms 3302 which are slid into the straps 3301 via the button holes 3303. In other examples, the rigidiser arm 3302 may be permanently connected to the strap 3301 at at least one location, such as at an anchor point where the rigidiser arm is overmolded or glued to form an integral chemical bond (molecular attachment) between the rigidiser arm 3302 and the strap 3301.

[0182] The strap 3301 comprises side strap portions 3315, 3316 and a back strap portion 3317 located between the side strap portions 3315, 3316. As shown in Figs. 4-8 and 166, the side strap portions 3315, 3316 are adapted to extend along the sides of the patient's head when worn, while the back strap portion 3317 is adapted to extend along the back of the patient's head. The back strap portion 3317 may be comprised of two, three or more straps arranged in parallel, particularly to provide stability. Although the smaller back strap portions 3317a, 3317b have been shown as being equal in length, it is envisioned that one back strap portion is longer than the other. The greater the number of smaller back strap portions 3317a, 3317b in the back strap portion 3317, the greater the spring effect provided. In other words, as the number of small back strap portions 3317a, 3317b of the same size increases when the strap 3301 is manufactured, more tension is exerted on the side straps 3315, 3316 which must be pulled together by the back strap portions 3317a, 3317b. In the illustrated example, the side strap portions 3315, 3316 of the strap 3301 branch off into two back strap portions 3317a, 3317b. In one example, each back strap portion 3317a, 3317b has half the amount of elastane material as each side strap portion 3315, 3316 of the strap 3301. In one example, the positioning and stabilising structure 3300 is connected to the mask frame 3310 by a releasable connection between the strap 3301 and the rigidiser arm 3302 via button holes 3303, 3304, and the rigidiser arm 3302 is permanently connected to the mask frame 3310 by a mechanical interlock. In another example, a flexible joint 3305 formed from TPE may permanently connect to the rigidiser arm 3302 and mask frame 3310.The flexible joint 3305 is overmolded with the mask frame 3310 for permanent connection and the flexible joint 3305 is permanently connected to the rigidiser arm 3302 by a mechanical linkage. In another example, the flexible joint 3305 may be made of the same material as the rigidiser arm 3302, such as Hytrel®, and is integral with the rigidiser arm 3302 and the flexible joint 3305 is permanently connected to the mask frame 3310 by a mechanical linkage. The strap 3301 is releasably connected to the rigidiser arm 3302 via the button holes 3303, 3304.

[0183] The engagement of the strap 3301 to the rigidiser arm 3302 may be at one location near the mask frame 3310. This type of engagement allows the maximum range of movement, i.e., stretching, of the strap 3301. This engagement can be released to allow the strap 3301 to be completely removed from the rigidiser arm 3302 and thus the mask frame 3310 to facilitate cleaning of the strap 3301. This engagement serves as an anchor point for the strap 3301, such that when the strap 3301 is stretched, the stretching force is directed outward, away from the anchor point. With reference to FIGS. 48-60, the end of the strap 3301 located at the anchor point is held by at least the distal edge of the rigidiser arm 3302 and / or the protruding end 3306 extending from the rigidiser arm 3302.

[0184] As will be appreciated by those skilled in the art, the rigidiser arm 3302 referred to herein may be stiffer than the strap 3301 and allow the rigidiser arm to impart a shape to the strap 3301. The rigidiser arm 3302 may be stiffer in or around at least one axis and may not be extensible in contrast to the strap 3301 which may be stretched along at least one axis. In other examples, the rigidiser arm 3302 may be extensible / stretchable in a direction generally parallel to its longitudinal axis. Although elastomers are generally stretchable, some thermoplastic polyester elastomers, such as Hytrel® 5556 manufactured by DuPont®, are not stretchable but are flexible. For example, the rigidiser arm 3302 may have a scissor link structure or a telescoping structure that allows the rigidiser arm 3302 to move between a compressed position and a fully extended position. The expandable rigidiser arm 3302 may better fit on a patient 1000 with a long face so that the length of the rigidiser arm 3302 can be properly adjusted. Alternatively, the rigidiser arm 3302 may be referred to as a yoke and / or stiffener. A yoke may be understood to be a rigid element adapted to support the strap 3301 of the positioning and stabilising structure 3300. A rigidiser arm 3302 may be understood to be a rigid element that gives shape to the strap 3301 of the positioning and stabilising structure 3300 when worn on the face.

[0185] 6.3.7.3 Alternative Rigidiser Arms Figures 223-232 show an exemplary patient interface system 3000 as previously described. Figures 233a-233h show such an exemplary patient interface system 3000 worn on a patient. Figures 240-244 show further views of the exemplary patient interface system without the straps 3301 to illustrate the feature of the rigidiser arms 3302 included with the straps. The patient interface system 3000 shown in these figures may include rigidiser arms 3302 to ensure an effective seal against the patient's nose by the seal-forming structure 3100. It should be understood that the seal-forming structure 3100 described above in relation to Figures 223-239 may be included in the exemplary patient interface 3000 along with the rigidiser arms 3302 shown in these figures.

[0186] The rigidiser arm 3302 may be shaped to minimise twisting and may be stiffer than the rigidiser arm 3302 described elsewhere herein. Stiffer rigidiser arms 3302 may be beneficial to include with a seal-forming structure 3100 in the form of a nasal cradle cushion as stiffer rigidiser arms may ensure an effective seal with this type of seal-forming structure. In examples having nasal pillows as the seal-forming structure 3100, the nasal pillows may help to position and hold themselves against the nasal passages by extending into the nasal passages. In examples where the seal-forming structure 3100 is a nasal cradle cushion, such a retention function may not be easily achieved. Thus, a patient interface system 3000 having a nasal cradle cushion as the seal-forming structure 3100 may be provided with rigidiser arms 3302 to enable the seal-forming structure to maintain an effective seal against the patient's nose. According to one example of the present technology, the extensions 3370, 3371 may be configured to prevent movement of the rigidiser arm 3302 in a plane parallel to the patient's sagittal plane (see FIG. 2f) and / or the extensions may be configured to allow the rigidiser arm to bend in a plane parallel to the patient's Frankfort horizontal plane (see FIG. 2e). In other words, the rigidiser arm 3302 can bend outward and inward relative to the patient's face with ease compared to vertical movement relative to the mask frame 3310 to accommodate different face widths. In one example, the rigidiser arm 3302 may only be allowed to bend outward and inward relative to the patient's face and may not be able to move in any other direction or may have a high resistance to movement in any other direction to increase the stability of the patient interface 3000, especially when tube torque is experienced in the sagittal plane.

[0187] According to the example shown in Figs. 240-244, the exemplary rigidiser arm 3302 may be connected to the mask frame 3310 by a mechanical interlocking facilitated by overmolding the frame 3310 over a portion of the extensions 3370, 3371. The rigidiser arm 3302 may include a joint 3374 to connect the rigidiser arm 3302 to the extensions 3370, 3371. The rigidiser arm 3302 may be integrally formed with the joint 3374 and the extensions 3370, 3371 from one material. The material selected for the rigidiser arm in these examples may be similar to the material used for the rigidiser arm in other examples discussed elsewhere herein. Similarly, the frame 3310 may be formed from the same material used with other examples disclosed herein. Thus, an overmolded connection may be required to couple the extensions 3370, 3371 to the frame 3310, as the respective materials may not be able to be bonded to each other. The respective materials of the rigidiser arm 3302 and frame, as well as the overmolded connections, are described in further detail below.

[0188] The extensions 3370, 3371 may be wider in the vertical direction than the extensions 3350 used in the example with nasal pillows in the example using a nasal cradle cushion as the seal-forming structure 3100. The additional volume of the larger extensions 3370, 3371 may provide resistance to twisting as mentioned above, which may be beneficial when using a nasal cradle cushion. This is because the same material is used for the rigidiser arm 3302 in both examples, but more material is needed in the nasal cradle cushion example to provide the desired increase in stiffness. According to one example of the present technology, the extensions 3370, 3371 may have a width in the vertical direction approximately equal to the width of the body 3333 of the rigidiser arm 3302 at its widest body portion to provide the desired stiffness and resistance to twisting. According to other examples of the present technology, the extensions 3370, 3371 may be vertically wider than the body 3333 of the rigidiser arm 3302 to provide the desired stiffness and resistance to twisting. Alternatively, the extensions 3370, 3371 may be formed with reinforcing ribs, the extensions may be formed with a geometry that is more resistant to twisting, and / or the rigidiser arm 3302 may be formed from a stiffer material.

[0189] It should also be understood that the rigidiser arm 3302 in an example using a nasal cradle cushion for the seal-forming structure 3100 may have straps 3315, 3316 attached in a similar fashion to the example using nasal pillows as shown in Figures 223-233h, this configuration is described in further detail elsewhere herein.

[0190] The right side extension 3370 shown in these figures also includes indicia 3372 which may be raised from the extension to provide the patient with a visual and tactile reference for properly orienting the patient interface 3000 when donning the patient interface for treatment.

[0191] Figures 246a-g show several views of an exemplary patient interface 3000. These figures show the patient interface 3000 without the straps 3301 of the positioning and stabilising structure 3300 and without the short tube 4180.

[0192] 246e-g show views of the patient interface 3000 in which the protruding end support portions 3208 are visible.

[0193] The rigidiser arm 3302 may be used as a visual indicator for the patient as to the proper insertion depth of the nose into the seal-forming structure 3100. For example, the length of the rigidiser arm 3302 may be an indication of the proper position of the patient interface 3000 relative to the ear such that the seal-forming structure is optimally positioned against the nose to form an effective seal.

[0194] 6.3.7.4 Attaching the Strap to the Rigidiser Arm The side strap portions 3315, 3316 of the strap 3301 shown in FIG. 65 each include two button holes 3303, 3304. The button holes 3303, 3304 may be located on the outer surface of the strap 3301, i.e., the surface that faces away from the patient 1000 when worn, and are adapted to receive the rigidiser arm 3302 for insertion into the interior of the tubular or sleeve-like strap 3301 or for removal of the rigidiser arm from the strap. Alternatively, the button holes 3303, 3304 may be located on the inner surface of the strap 3301. The button holes 3303, 3304 may be oriented and / or shaped such that the rigidiser arm 3302 can be inserted and / or removed through such button holes 3303 to assemble the positioning and stabilising structure 3300 while still preventing accidental dislodging or separation of the rigidiser arm 3302 from the strap 3301 during use. As shown in FIG. 65, this may be achieved by providing a buttonhole 3303 having a slit-like configuration similar to a buttonhole, which may be oriented, for example, parallel to the strap 3301 or transversely to the strap 3301. Alternatively, the buttonhole 3303 may be oriented across the strap 3301, if desired. In other words, the elongated extensions of the buttonholes 3303, 3304 may extend approximately coaxially with the longitudinal axis of both the strap 3301 and the rigidiser arm 3302. This allows easy insertion of the rigidiser arm 3302 into a tubular or sleeve-like strap or portion of the strap 3301, particularly due to the elasticity of the strap 3301, while at the same time preventing accidental dislodging of the rigidiser arm. The end of the strap 3301 between the distal end of the strap 3301 and the buttonhole 3303 wraps over the edge of the rigidiser arm 3302 and serves as an anchor point. This edge or anchor point of the rigidiser arm 3302 may be the capture member. This end of the strap 3301 may be referred to as the pocketed end 3311.This prevents the strap 3301 from slipping off the inserted rigidiser arm 3302 when the strap 3301 is stretched and adjusted while the patient interface 3000 is being donned or doffed.

[0195] 185 and 186, the rigidiser arm 3302 may be inserted into a first buttonhole 3303 of the strap 3301. In other words, the strap 3301 may be slid over the rigidiser arm 3302 through the buttonhole 3303. The distal free end 3302.1 of the rigidiser arm 3302 is first inserted into the strap 3301 through the buttonhole 3303. The rigidiser arm 3302 is pushed further into the strap 3301 until most or nearly the entire rigidiser arm 3302 is inserted into the strap 3301 such that the end of the strap 3301 can be firmly fixed to the edge of the rigidiser arm 3302. A portion of the material of the strap 3301 near the buttonhole 3303 is adjusted to be directly under the outer surface 3319 of the protrusion 3309 (see FIG. 38). As can be seen in Figures 6-8, the rigidiser arm 3302, once inserted within the strap 3301, may be left to float generally unrestrained inside the strap 3301. Most importantly, the button hole 3303 must be above the attachment point, as the end of the strap 3301 is captured against the protruding end 3306 of the rigidiser arm 3302 to secure the strap 3301 to the rigidiser arm 3302, and the end of the strap 3301 pulls against the protruding end 3306 as the strap 3301 is stretched. In general, the location of the attachment point between the rigidiser arm 3302 and the strap 3301 is more important than the type of attachment, for example using the button holes 3303, 3304 of the strap 3301. 182-184, the type of attachment between the rigidiser arm 3302 and the strap 3301 may facilitate easy removal of the strap 3301 from the rigidiser arm 3302 to allow separate cleaning of the strap 3301. In other words, the cleaning regimen for the strap 3301 may be at a different time than the mask frame 3310. The patient 1000 slightly stretches the strap 3301 around the button hole 3303 to release the strap 3301 from the rigidiser arm 3302.After the distal end of the strap 3301 is released, the strap 3301 may be pulled completely away from the rigidiser arm 3302 via the buttonhole 3303.

[0196] Additionally or alternatively, the rigidiser arm 3302 is attached to the strap 3301. The attachment may be done by attaching or fastening the second end of the rigidiser arm 3302 near the buttonhole 3303 to the strap 3301 of the positioning and stabilising structure 3300 after insertion. The fastening may be localised, as discussed in the introductory part of the present description, where the connection between the rigidiser arm 3302 and the strap 3301 is not distributed along the length of the strap 3301 but is made locally in the area adjacent to the buttonhole 3303. Alternatively, such a connection may be made in the area adjacent to the buttonhole 3304. Attachment may be by sewing, welding, gluing, heat staking, clamping, buttoning, snapping a cover over the ends, or snapping to an external part by pressing the rigidiser arm 3302 into the strap 3301 and fastening both the strap and the rigidiser arm 3302 to an external component such as an external clip that holds both the strap and the respective ends of the rigidiser arm. Alternatively, the strap 3301 may be chemically bonded to the rigidiser 3302. Clips may also be used to attach the ends of the strap 3301 to the respective ends of the mask frame 3310. Thus, the clips may be part of the mask frame 3310 itself.

[0197] With this technology, it is still possible to stretch the straps 3301 along almost their entire length, with the straps 3301 positioned to take the shape of the rigidiser arms 3302. Thus, the rigidiser arms 3302 provide the required shape to direct the pressure of the positioning and stabilising structure 3300 to the required part of the face, while the elastic positioning and stabilising structure 3300 maintains its entire working length and can stretch freely over the rigidiser arms 3302. In addition, the rigidiser arms 3302 may decouple tube torque in the frontal plane. Also, especially the sharp bends 3307 of the rigidiser arms 3302 may help to handle and decouple any tube torque in the sagittal plane. At the same time, the straps 3301 of the positioning and stabilising structure 3300 may cover the rigidiser arms 3302 and provide a soft feel and high comfort.

[0198] The sharp bend 3307 provides stability to the patient interface 3000. When the patient 1000 sleeps on their side, the rigidiser arms 3302 against the sides of their face on the bedding are pressed inwards. The sharp bend 3307 isolates this movement in the frontal plane to prevent compromising the sealing force. The sharp bend 3307 has a tighter bend on its top surface (facing away from the patient's face) compared to its bottom surface (facing towards the patient's face). The bottom surface of the sharp bend 3307 has a larger radius (flatter) than the top surface of the sharp bend 3307, which smooths the bottom surface and avoids or minimizes facial markings on the patient 1000. This is because there is less contact pressure concentrated on the patient's nasal septum and / or upper lip if there is any contact (due to nasal droop caused by tube weight or tube torque). The distance between the two sharp bends 3307 is about 50 mm.

[0199] Although illustrated and discussed with respect to the specific example shown in Figures 65-70, it will be appreciated that only one button hole 3303, 3304 may be provided on the strap 3301, or each of the side strap portions 3315, 3316 of the strap. However, more than one button hole may be provided. Alternatively or additionally, the strap 3301 may not be tubular or sleeve-like, but may have a flat single layer or laminated form. Here, the rigidiser arm 3302 may be positioned relative to the strap 3301 by providing a retaining means comprising one or more loops, sleeve-like portions or pockets provided on an outer surface of the strap 3301 (e.g., the surface facing away from the patient in use).

[0200] Additionally or alternatively, a combination of the different connection mechanisms described herein may be provided. For example, the rigidiser arm 3302 may be fixed to the strap 3301 at a single point or localized area, e.g. adjacent to the pocket-like ends 3311, 3313 of the strap 3301, as described above, while being held adjacent to the strap 3301 by having a loop or sleeve-like element provided on the outer surface of the strap 3301, e.g. in the area of ​​the marks 3321b, 3323b. In other words, the rigidiser arm 3302 may be connected to the strap 3301 by fixing it only at one localized point or area, while acting as an additional guide element for the strap 3301. Such a guide element function may be provided by a loop or sheath-like portion or passage or pocket of the strap 3301 into or through which the rigidiser arm 3302 extends based on the shape of the strap 3301 shown in FIG. 66. The strap 3301 may be tubular, but not necessarily cylindrical. This allows for the longest possible extension path for the strap 3301. Alternatively, the rigidiser arm 3302 may be placed unattached in one or more pockets (e.g., a single open ended pocket of a substantial length of sheath supporting the rigidiser arm somewhere in the middle, or a pair of pockets each supporting a corresponding end of a rigidiser arm) or in multiple loops distributed along the length of the strap 3301. Such guide element function allows for a substantially free movement or floating of the rigidiser arm 3302 relative to the strap 3301, whether attached at one end or not. Such a configuration allows for the same advantages and benefits as the previously described configuration. Also, according to one example of technology, the rigidiser arm 3302 does not extend or bend in the same direction as the strap 3301. Rather, the rigidiser arm 3302 may extend or bend in a plane generally perpendicular to its longitudinal axis.

[0201] In the illustrated and discussed example, the rigidiser arm 3302 does not extend beyond the end of the strap 3301. However, according to another embodiment, the rigidiser arm 3302 may extend beyond the strap 3301 and be, for example, fixed to the strap 3301 at a point or area adjacent the respective pocket-like end 3311, 3313. In such a configuration, the rigidiser arm 3302 may provide shape, geometry and / or stiffness to the strap 3301 while at the same time providing a structural means such as a flexible joint 3305 for connecting with the patient interface 3000. This allows the rigidiser arm 3302 to function both as a rigidiser arm 3302 and as a connector for connecting the strap 3301 and the positioning and stabilising structure 3300 to the frame 3310, the plenum chamber 3200 or the seal-forming structure 3100, respectively.

[0202] 113-122 show detailed views of the connection between the pocketed ends 3311, 3313 and the rigidiser arm 3302. FIGS. 113 and 114 show the pocketed ends 3311, 3313 around the respective protruding ends 3306 of the rigidiser arm 3302. In these views, the protruding ends 3306 are not visible as they are covered by the pocketed ends 3311, 3313. A straight portion 3351 of an extension 3350 (described further below) of the rigidiser arm 3302 is shown with indicia 3358 on an outer surface 3355 of the extension 3350. The indicia 3358 may be a pad printed raised surface or embossed to help orient the device 3000 during use when the patient 1000 is in a dark environment. A straight portion 3351 of the extension 3350 may be seen extending outwardly from the buttonhole 3303 of each pocket-like end 3311, 3313. The straight portion 3351 is part of the rigidiser arm 3302 as shown in Figs. 47-60, and the rigidiser arm 3302 facilitates the connection between the strap 3301 and the mask frame 3310. Fig. 114 shows a similar view to Fig. 113, but the outer surface 3355 of the straight portion 3351 is without indicia. It should be understood that Fig. 113 depicts the connection between one rigidiser arm 3302 and each pocket-like end 3311, while Fig. 114 depicts the connection between the other rigidiser arm 3302 and each other pocket-like end 3313. By placing the indicia 3358 on only one exterior surface 3355, the patient 1000 can use their sense of touch to determine the orientation of the device 3000 to aid in fitting in a dark environment. FIG. 114 also shows a flange 3359 visible through the buttonhole 3303.

[0203] FIG. 115 shows similar features to FIG. 114 but in further detail to better show the relationship between the flange 3359 and the pocket end 3313. And FIG. 116 shows similar features to FIG. 113 but in further detail to better show the indicia 3358 and the buttonhole 3303 in the pocket end 3313.

[0204] FIG. 117 shows a further detail of FIG. 114 to better illustrate the buttonhole 3303 of the pocket end 3313. FIG. 118 shows a further detail of FIG. 113 to better illustrate the buttonhole 3303 of the pocket end 3313.

[0205] 119-122 show similar features as shown in FIGS. 113-118, but in these figures the flange 3359 has been pulled out of the buttonhole 3303 to better show its configuration. FIGS. 119-122 show a rigidiser arm 3302 including indicia 3358 on an outer surface 3355 extending from the buttonhole 3303 of the pocketed end 3311. FIG. 122 should be understood to show a more detailed view of FIG. 119. FIGS. 120 and 121 show an alternative rigidiser arm 3302 that may not include indicia. FIG. 121 should be understood to show a more detailed view of FIG. 120.

[0206] 262A and 262B show another example of the present technology where a strap 3301 includes an elastic tube 3301.1 for attaching the strap to a rigidiser arm 3302. According to this example, the strap 3301 may include an elastic tube 3301.1 secured to an end of the strap. FIG. 262A shows the strap 3301 and elastic tube 3301.1 detached from the rigidiser arm 3302, and for simplicity, a portion of the rigidiser arm is not shown. To attach the strap 3301 to the rigidiser arm 3302, the patient slides the elastic tube 3301.1 down the length of the rigidiser arm until the elastic tube reaches the raised stop 3302.6 on the rigidiser arm. Although not shown in FIGS. 262A and 262B, it should be understood that a length of the rigidiser arm 3302 is received inside the strap 3301 up to the point of the raised stop 3302.6. The raised stop 3302.6 may prevent the patient from pushing the strap 3301 too far down the length of the rigidiser arm 3302, and may allow the strap to be attached to the rigidiser arm at a desired location so that the strap retains its intended stretchable length. The shape, size and material of the elastic tube 3301.1 may be selected such that sufficient retention due to friction is created between the elastic tube and the rigidiser arm 3302 when the elastic tube reaches the raised stop 3302.6. In other words, the frictional force between the elastic tube 3301.1 and the rigidiser arm 3302 must be high enough so that when the patient wears the patient interface 3000, the tension in the strap 3301 is less than the frictional force holding the elastic tube on the rigidiser arm, thereby preventing the elastic tube from being pulled away from the rigidiser arm. The elastic tube 3301.1 may be formed from a material that has a relatively high coefficient of static friction with the material of the rigidiser arm 3302 to ensure that the strap 3301 is held on the rigidiser arm.Additionally, the material of the elastic tube 3301.1 must be stretchable to allow the elastic tube to deform as it is slid down the rigidiser arm 3302 towards the raised stop 3302.6.

[0207] 263 shows another example of the present technology where a tab 3470 may be formed on the rigidiser arm 3302 to hold the strap 3301 on the rigidiser arm with a hook and loop connection. The tab 3470 may be fixed to and / or formed integrally with the rigidiser arm 3302 and the tab may include hook material 3471. Thus, at least a portion of the outer surface of the strap 3301 may be formed from loop material on at least a portion of its outer surface to engage the tab 3470 with a hook and loop connection. To attach the strap 3301 to the rigidiser arm 3302, the patient may slide the strap down the length of the rigidiser arm and lift the tab 3470, thereby sliding the strap under the tab and releasing the tab so that the loop material portion of the strap engages the hook material 3471 on the strap. The size of the tab 3470 should be selected so that a sufficient area of ​​hook material engages with the strap 3301 to create a high enough retention force to resist tension on the strap when worn by the patient. In this example, the entire strap 3301 may be manufactured with loop material on its outer surface to save on the cost of manufacturing the strap. Thus, in such an example, the loop material must be sufficiently flexible to avoid irritation of the patient's skin. It should also be understood that the tab 3470 may include loop material rather than hook material, in which case the strap 3301 may have a portion of hook material to attach to the loop material of the tab. It should also be understood that the tab 3470 may be formed from an elastic material such that the tab can be pulled away from the rigidiser arm 3302 to attach the strap 3301, and then upon release, the tab can engage the strap with sufficient force to maintain the hook loop connection.

[0208] 264A and 264B show another example of the present technology where the strap 3301 may include a lock 3301.2 to engage with a notch 3302.2 on the rigidiser arm 3302. According to this example of the present technology, the lock 3301.2 may be located at the end of the strap 3301 and the strap may include an elastic material at this end to bias the lock 3301.2 into engagement with the corresponding notch 3302.2 of the rigidiser arm 3302. In this example, the strap 3301 must be sufficiently elastic at its end to ensure that the lock 3301.2 is held in the corresponding notch 3302.2 of the rigidiser arm 3302 with enough force to resist tension on the strap when the patient interface 3000 is worn by the patient. 264A and 264B show an example of the present technology where one notch 3302.2 on the top edge of the rigidiser arm 3302 and one notch on the bottom edge of the rigidiser arm cooperate with corresponding locks 3301.2 on the strap 3301, it should be understood that any number and / or positions of corresponding locks and notches may be used as long as sufficient holding force is maintained.

[0209] FIG. 265 shows an example of the present technology where a strap 3301 includes a length of loop material 3301.3 and a piece of hook material 3301.4 at or near the end 3301.5 of the strap. The rigidiser arm 3302 according to this example of the present technology includes a first slot 3302.7 and a second slot 3302.8. To attach the strap 3301 to the rigidiser arm 3302, the strap is first threaded through the first slot 3302.7 and then looped back through the second slot 3302.8. To secure the strap 3301 to the rigidiser arm 3302, the hook material 3301.4 at the end 3301.5 of the strap is bonded to the loop material 3301.3. This example of the present technology may allow some adjustment in the stretchable length of the strap 3301 based on where the hook material 3301.4 is attached to the loop material 3301.3. It should also be understood that the locations of the hook material 3301.4 and the loop material 3301.3 may be interchangeable.

[0210] The example shown in Figures 262A-265 includes a strap 3301 that can be detached from the rigidiser arm 3302 and can be reversed to allow both sides of the strap to be used for contact with the patient. This can be advantageous in that the strap 3301 does not have to be completely worn out when the surface of one side of the strap becomes worn down. Rather, the patient may simply reverse the strap 3301 so that the strap's useful life can be extended.

[0211] Also, in any of the above mentioned examples where the straps 3301 of the positioning and stabilising structure 3300 are detachable, the detachability of the straps may be beneficial to the overall life cycle of the patient interface 3000. For example, the straps 3301 may have a shorter useful life than the frame 3310 and short tube 4180 assembly such that expiration of the straps does not require replacement of the entire patient interface 3000. In other words, the straps 3301 can be replaced when they expire and the new straps can be used with the remainder of the patient interface 3000 that has not expired.

[0212] 6.3.7.4.1 Permanent mounting alternatives 266-270 show another example of the present technology where the strap 3301 can be permanently attached to the rigidiser arm 3302, i.e. the patient cannot remove the strap from the rigidiser. Permanent attachment of the strap 3301 to the rigidiser arm 3302 can be beneficial in that the patient does not have to thread the strap over the rigidiser arm and there is no chance of the strap becoming detached from the rigidiser arm.

[0213] 266 shows an example of the present technology where a strap 3301 is permanently secured to a rigidiser arm 3302 at an attachment point 3304. According to this example, the attachment points 3304 may be formed by ultrasonic welding of the strap 3301 to the rigidiser arm 3302. Although two attachment points 3304 are shown on the surface of the rigidiser arm 3302 that faces away from the patient in use, it should be understood that the number, size, shape and / or location of the attachment points 3304 may be varied so long as the desired extensible length of the strap 3301 to the rigidiser arm 3302 is maintained.

[0214] Fig. 267 shows an example of the present technology similar to the example shown in Fig. 266. However, the example shown in Fig. 267 includes attachment points 3304 formed by heat staking rather than ultrasonic welding. It should also be understood that the size, shape, number and / or location of the attachment points 3304 may be varied so long as the desired extensible length of the strap 3301 relative to the rigidiser arm 3302 is maintained.

[0215] Fig. 268 shows a further example of the present technology which is similar to the example shown in Fig. 266. However, the example shown in Fig. 268 includes attachment points 3304 formed by stitching. It should also be understood that the size, shape, number and / or location of the attachment points 3304 may be varied so long as the desired extensible length of the strap 3301 relative to the rigidiser arm 3302 is maintained.

[0216] 269 ​​shows another example of the present technology where the attachment points 3304 are secured to the rigidiser arm 3302 in a hinge configuration to permanently secure the strap 3301 to the rigidiser arm. For example, the attachment points 3304 may perforate the fabric of the strap 3301 to form a permanent attachment.

[0217] 270 shows another example of the present technology where the permanent attachment of the strap 3301 to the rigidiser arm 3302 uses a barb at the attachment point 3304. The barb of the attachment point 3304 may be integrally formed with the rigidiser arm 3302 and oriented such that when the strap 3301 is initially slid onto the rigidiser arm, the relatively flexible fabric of the strap is gripped by the barb and permanently attached. In other words, the barb of the attachment point 3304 may be oriented to face in the opposite direction to the tension of the strap 3301 when the patient interface 3000 is worn by the patient.

[0218] 6.3.7.5 Strap Stretch on Rigidiser Arm As can be seen in the example shown in Fig. 68, the two rigidiser arms 3302 are inserted into the side strap portions 3315, 3316 of the strap 3301 of the positioning and stabilising structure 3300, the rigidiser arms 3302 are held in place by the surrounding strap 3301, and at the same time, the sleeve-like form of the strap 3301 allows at least a portion of the strap 3301 to be stretchable or moveable relative to the rigidiser arms 3302. Preferably, this stretchable portion is a substantial portion, since only at the anchor points the strap 3301 is fixed to the rigidiser arms 3302. In some examples, the restriction of the movement of the rigidiser arms 3302 is generally imposed when one of the ends 3319a or 3319b of the rigidiser arms 3302 moves and abuts against the respective pocket-like end 3311 of the strap 3301, as in Fig. 69. For example, when the positioning and stabilising structure 3300 is not on the patient's head and the strap 3301 is loose, the inserted rigidiser arm 3302 may move too far towards the back strap portions 3317a, 3317b, causing its end 3319b to enter the open end of one of these back strap portions 3317a, 3317b. Because the width of the back strap portions 3317a, 3317b is smaller than the width of the rigidiser arm 3302, the end 3319b of the rigidiser arm 3302 will abut against the respective back strap portion 3317a, 3317b, thereby restricting further movement of the rigidiser arm in this direction.

[0219] The attachment of the strap 3301 to the rigidiser arm 3302 described in the previous section may also affect the size of head that the positioning and stabilising structure 3300 can accommodate. In other words, by providing a longer length of the strap 3301 along the rigidiser arm 3302, the overall stretchable length of the positioning and stabilising structure 3300 may be increased, which may allow for a much larger head circumference to be accommodated without needing to increase the elasticity of the strap 3301. Also, the location where the strap 3301 connects may be varied along the length of the rigidiser arm 3302, which allows for a much larger range of head sizes and head circumferences to be accommodated without needing to change the elasticity of the strap 3301.

[0220] The length of the strap 3301 is about 400mm to 700mm. The length of the strap 3301 may be about 490mm. The strap 3301 can provide a comfortable level of headgear tension for most head sizes. The strap may be available in two gender specific lengths or sizes, one for the male population longer than the female version. Preferably, there may be two sizes / lengths of the strap 3301 for each gender. The comfortable level of headgear tension is about 2 Newtons to about 5 Newtons. The comfortable level of headgear tension is about 2.2 Newtons to about 4.7 Newtons. When the strap 3301 is stretched from 490mm to 526mm for a patient 1000 with a small head circumference, the headgear tension measured using an Instron tester is 2 Newtons. When the strap 3301 is stretched from 490mm to 662mm for a patient with a large head circumference, the headgear tension measured using an Instron tester is 4.4 Newtons. For the measurement, the button holes 3303, 3304 of the strap 3301 are attached to a clamp fixture. A tensile tester with a 100 Newton load cell is used. The strap 3301 is stretched and held at predefined extension points (e.g., 90.5 mm, 73 mm, and 108 mm) for one minute, and the force value (in Newtons) is recorded for each extension point. Such measurements do not take into account any friction of the strap 3301 material against the patient's face or hair.

[0221] The length of the split area 3326 defined between the two back strap portions 3317a, 3317b is about 180 mm to about 220 mm. The length of the split area 3326 may be 200 mm. If the length of the split area 3326 is not long enough, the two back strap portions 3317a, 3317b cannot encircle the back of the patient's head and therefore cannot maintain their position during treatment, and the headgear tension remains unsuited to the patient's preference. If the length of the split area 3326 is too long, the two back strap portions 3317a, 3317b will separate in front of the user's ears, which is uncomfortable. This is because the back strap portions pass across the ears instead of above / around the ears, thereby reducing the maximum angular range of the two back strap portions 3317a, 3317b relative to each other.

[0222] In a neutral, unstretched state of the strap 3301, the two back strap portions 3317a, 3317b form an angle θ of about 0° to about 10° from each other. After donning the patient interface 3000, the two back strap portions 3317a, 3317b may be separated from each other such that the angle θ may be up to about 180°. This allows a maximum angle range of 180°, thereby providing a large range of reduction in headgear tension by progressively spreading the two back strap portions 3317a, 3317b apart. The angle range may be narrowed from a default angle of 10° to a maximum angle of 120°. The patient may use one or both hands to move the two back strap portions 3317a, 3317b apart or closer together on the back of their head under the tension now acting on them. By moving the two back strap portions 3317a, 3317b further away from each other, the split area 3326 is widened, thereby reducing the headgear tension from the unsplit range of 2.5 to 5 Newtons. The headgear tension may be reduced by about 30% to about 50% according to one example, or about 40% in another example, as measured by a load cell. In other words, for patients with small head circumferences, the headgear tension may be reduced from 2 Newtons to 1.2 Newtons by widening the distance separation between the two back strap portions 3317a, 3317b. For patients with large head circumferences, the headgear tension may be reduced from 4.4 Newtons to 2.64 Newtons by widening the distance separation between the two back strap portions 3317a, 3317b.

[0223] Thus, the rigidiser arm 3302 may be allowed nearly unlimited movement along the length of the strap 3301 and may be attached to the strap 3301 or adjacent to one of the ends of the strap.

[0224] The discussed configuration allows the strap 3301 and thus the positioning and stabilising structure 3300 to stretch and expand in length as shown in Fig. 70. Such stretch is not limited to the parts of the strap 3301 that are not in contact with or parallel to the rigidiser arm 3302, but the stretch, especially the elastic stretch, of the strap 3301 is also achieved in the area of ​​the rigidiser arm 3302. This can be easily derived from a comparison of the length of the rigidiser arm 3302 (where the strap 3301 is stretched but remains the same) in Fig. 68 and Fig. 70 with the marks 3321a-3321d, 3323a-3323e visualising the length of the strap 3301 relative to the length of the rigidiser arm 3002. It can be easily derived by comparing Fig. 68 with Fig. 70 that in the non-stretched state the rigidiser arm 3302 extends along the marks 3321a-3321c and 3323a-3323d respectively. In contrast, in the stretched state according to Fig. 70 the rigidiser arm 3302 extends only along the marks 3321a-3321b and 3323a-3323c. From there it becomes clear that the strap 3301 is stretched along the area where the rigidiser arm 3302 is accommodated within the strap 3301. However, during the stretching of the strap 3301 the rigidiser arm 3302 remains unstretched.

[0225] It will be appreciated that the positioning and stabilising structure 3300 may comprise one or more rigidiser arms 3302. While the above discussion has focused on the relationship between the rigidiser arms 3302 and the straps 3301, it should be noted that the example shown in Figures 68-70 comprises two rigidiser arms 3302, one rigidiser arm provided in each side strap portion 3315, 3316 of each of the straps 3301. Thus, the above comments, although ultimately referring to one rigidiser arm 3302, equally apply to two or more rigidiser arms 3302 connected to the mask frame 3310.

[0226] One potentially advantageous attribute of allowing the straps 3301 to stretch relative to the rigidiser arms 3302 as previously discussed may be that the patient interface 3000 may be donned and doffed by the patient 1000 along with the positioning and stabilising structure 3300 without the need to remove any straps or other connection features. This may be helpful for a patient 1000 using the device 3000 in a dark bedroom before or after sleep in that the patient does not need to be able to see the connection or disconnection of the various components to attach or remove the patient interface 3000. Rather, the patient 1000 need only don or doff the patient interface 3000 and positioning and stabilising structure 3300 and, if donned, may also need to position the seal-forming structure 3100. However, this can all be achieved by feel and does not need to be seen.

[0227] However, it may still remain advantageous to allow removal of the plenum chamber 3200 or the seal-forming structure 3100 from the positioning and stabilising structure 3300. For example, to clean the plenum chamber 3200 or the seal-forming structure 3100, it may be desirable to clean the plenum chamber or the seal-forming structure without wetting the positioning and stabilising structure 3300. This may be facilitated by allowing these components to be removed for such purposes.

[0228] 6.3.7.6 Rigidiser Arm and Mask Frame 47-60 show a rigidiser arm 3302 and mask frame 3310 according to a further example of the present technology.

[0229] 47-49 and 54 show cross-sectional views of a rigidiser arm 3302 and a mask frame 3310 and the connection therebetween according to an example of the present technology. Proximate the sharp bend 3307 of the rigidiser arm 3302, an extension 3350 is connected by a joint 3356. Also proximate the sharp bend 3307 is a protruding end 3306 of the rigidiser arm 3302 that may hold a pocket-like end of a side strap portion 3316 of the positioning and stabilising structure 3300. In these figures, it can be seen that the mask frame 3310 is formed around the enclosable portion 3354 and hooks 3353 of the extension 3350. The mask frame 3310 may be formed with an opening 3335 proximate where the mask frame 3310 surrounds the enclosable portion 3354. The opening 3335 may be formed as a result of an overmolding process by which the mask frame 3310 is formed and secured around the enclosable portion 3354 of the rigidiser arm 3302. The rigidiser arm 3302 in this example may be formed from Hytrel® and the mask frame 3310 may be formed from polypropylene (PP). Hytrel® is preferred for forming the rigidiser arm 3302 because this material is resistant to creep. Since these materials cannot be integrally bonded, in this example the mask frame 3310 may be overmolded to the rigidiser arm 3302 to form a secure connection. It should also be noted that in this example the extension 3350 and the rigidiser arm 3302 may be integrally molded. The mask frame 3310 may be connected to the rigidiser arms 3302 at respective extensions 3350 located opposite the distal free ends 3302.1. The extensions 3350 may comprise a straight portion 3351 connected to a bent portion 3352 connected to a hook 3353. The hooks 3353 and a portion of the bent portion 3352 may form an enclosable portion 3354.

[0230] It should be appreciated that the joint 3356 connecting the extension 3350 to the rigidiser arm 3302 may provide a target point of flexibility and may be shaped and formed to allow bending in a desired direction and to a desired degree. Thus, when the patient interface 3000 is donned and the rigidiser arm 3302 is stressed by tension from the straps of the positioning and stabilising structure 3300, the rigidiser arm 3302 bends at the joint 3356, which allows the rigidiser arm to retain the facial bone shape whilst helping to hold the mask frame 3310 in a desired position relative to the patient's face.

[0231] 50 and 51 show a perspective view and a detailed perspective view, respectively, of a rigidiser arm 3302 connected to a mask frame 3310 according to an example of the present technology. Fig. 51 further shows in dashed lines an enclosable portion 3354 that is overmolded by the mask frame 3310 to secure the mask frame to the end of the rigidiser arm 3302. As in Figs. 47-49, the hook 3353 of the rigidiser arm 3302 and the opening 3335 that forms a passageway completely through the mask frame 3310 can be seen.

[0232] 52 and 53 show plan and detailed plan views, respectively, of a mask frame 3310 connected to a rigidiser arm 3302 according to an example of the present technology. In Fig. 52, the dimension L indicates the length of the rigidiser arm 3302 in the direction shown. Preferably, the nominal length L of the rigidiser arm 3302 is 114 mm. These figures particularly well show how the joint 3356 can connect the extension 3350 to the rigidiser arm 3302 between the protruding end 3306 and the sharp bend 3307.

[0233] 55-57 show side, front and perspective views, respectively, of the rigidiser arm 3302 and mask frame 3310 according to an example of the present technology. In FIG. 55, dimension H indicates the height of the rigidiser arm 3302 in the illustrated direction. Preferably, the nominal height H of the rigidiser arm 3302 is 33 mm. The rigidiser arm 3302 and extension 3350 may be formed as a single piece and then connected to the mask frame 3310 by overmolding the mask frame 3310 to the encapsulable portion 3354 of the extension 3350 of the rigidiser arm 3302. The extension 3350 accommodates the droop by bending in a vertical rotation or pivotal manner relative to the rigidiser arm 3302. Because the extension 3350 has a smaller height and less material than the rest of the rigidiser arm 3302 and is separated from the rest of the rigidiser arm 3302 by a sharp bend 3307, any bending of the extension 3350 occurs in a localized manner before the rest of the rigidiser arm 3302 begins to bend. This reduces the chance of compromising the sealing force.

[0234] 58 and 59 show a partial exploded view and a detailed partial exploded view, respectively, of the rigidiser 3302 and the mask frame 3310 according to one example of the present technology. It can be seen that the hook 3353 and the enclosable portion 3354 of the extension 3350 are separated from the mask frame 3310. It should be understood that the shapes of the hook 3353 and the enclosable portion 3354 can be seen in these figures and that these portions are formed to ensure a stronger mechanical interlock with the mask frame 3310 when the mask frame 3310 is overmolded. Specifically, these figures show that the enclosable portion 3354 may be formed with a flared end at the hook 3353 to provide a surface for retention against the mask frame 3310. In another example of the present technology, the enclosable portion 3354 may include an opening to hold the rigidiser arm 3302 in the mold during overmolding of the mask frame 3310. A mold may be inserted through this opening to stabilize the rigidiser arms 3302 as the mask frame 3310 is overmolded around the rigidiser. This can be beneficial as the pressure of the overmolding may cause the rigidiser arms 3302 to move during the molding process such that a less than ideal mechanical interlock with the mask frame 3310 is formed.

[0235] 60 shows a perspective view of a rigidiser arm 3302 according to an example of the present technology. This view shows the rigidiser arm 3302 before permanent connection with the mask frame 3310. As just discussed, the rigidiser arm 3302 may include a hook 3353 and an enclosable portion 3354 to allow connection to the mask frame 3310 by a mechanical interlock. This permanently connects the rigidiser arm 3302 to the frame 3310. Having the rigidiser arm 3302 and the frame 3310 permanently connected to each other means that there are fewer detachable parts and less chance of losing parts during assembly / disassembly of the patient interface 3000 for cleaning.

[0236] 6.3.7.6.1 Improved stability between frame and rigidiser arm In accordance with certain examples of the present technology, it may be desirable to couple the frame 3310 and the rigidiser arms 3302 in a manner that increases the stability of the patient interface 3000.

[0237] FIG. 260A shows an example of the present technology where the rigidiser arm 3302 is molded to the frame 3310. The frame 3310 and rigidiser arm 3302 may be formed as one piece. This example does not include the extension 3350 provided in other examples to provide a desired amount of bending strength at the joint between the frame 3310 and the rigidiser arm 3302. Rather, the extension arm 3302.3 is molded to connect the rigidiser arm 3302 to the frame 3310. As part of the molding process, a gap 3302.4 may be formed between the extension arms 3302.3 to remove unnecessary material. It should be appreciated that by spreading the upper and lower extension arms 3302.3 apart, the moment of inertia where the extension arms connect to the frame can be increased about the axis XX shown in FIG. 260A. The equation for the moment of inertia of this joint about XX is I=bh 3 / 12. Thus, increasing h, i.e., increasing the space between the upper and lower extension arms 3302.3, results in a larger increase in the moment of inertia I about XX compared to increasing b, i.e., the thickness of the extension arms. Also, by optimizing the geometry of the rigidiser arms, the rigidiser arms 3302 and / or the extension arms 3302.3 can be made thinner.

[0238] 260B shows another example of the present technology where the rigidiser arm 3302 may be coupled to the frame 3310 by a rod 3302.5. The rod 3302.5 may be metal or other similar material with a similar degree of stiffness. Also, the rigidiser arm 3302 in this example may be formed from a relatively stiff material such as nylon.

[0239] 261A shows another example of the present technology where it may be desirable to increase the stability of the rigidiser arm 3302 and extension 3350. A pair of rigidiser arm ribs 3460 may be provided at the sharp bend 3307 of the rigidiser arm 3302 to increase stiffness. A pair of extension ribs 3461 may be provided at the extension bend 3352 to increase stiffness. The sharp bends 3307 and bends 3352 may be prone to undesirable flexing when the patient interface 3000 is worn by the patient. Thus, these ribs may prevent excessive bending of the rigidiser arm 3302 and / or extension 3350.

[0240] 261B shows another example of the present technology where it may be desirable to increase the stability of the extension 3350. In this example, a longitudinal rib 3462 is provided longitudinally along a portion of the extension 3350. The longitudinal rib 3462 may extend past the bend 3352 into the straight portion 3351. The longitudinal rib 3462 may increase the stiffness of the extension 3350 to prevent excessive bending.

[0241] 6.3.7.7 Patient-worn positioning and stabilising structures 71-73 show an example of the present technology. Here, the positioning and stabilising structure 3300 comprises a strap 3301 having side strap portions 3315, 3316 and a back strap portion 3317, the back strap portion 3317 comprising two back strap portions 3317a, 3317b extending parallel along the back of the patient's head. The positioning and stabilising structure 3300 comprises two rigidiser arms (not shown) each housed within a respective side strap portion 3315, 3316 of the sleeve-like or tubular strap 3301. The rigidiser arms 3302 impart a predefined or desired shape and / or stiffness to the strap 3301 and thus to the positioning and stabilising structure 3300. For example, the side strap portions 3315, 3316 of the strap 3301 have a particular curvature to follow a desired contour around the patient's face, which is achieved by providing correspondingly shaped rigidiser arms 3302 (see curvature at reference numeral 3323 in Fig. 52, Fig. 54, Fig. 58 and Fig. 60). In the illustrated example, the positioning and stabilising structure 3300 is connected to the frame 3310, plenum chamber 3200 or seal-forming structure 3100 for providing a breathable gas, such as air, and thus a pressurised breathable gas, to the patient's airway. In the illustrated example, such a breathable gas is provided via a hose or tube 4180 which is connected to the patient interface 3000. The tube 4180 may be connected at its other end (not shown) to a breathable gas source, such as a blower or ventilator for supplying pressurised breathable gas. The patient interface 3000 may comprise a frame portion or frame 3310 to provide structural integrity to the patient interface 3000 and / or for connection to the positioning and stabilising structure 3300. The positioning and stabilising structure 3300 may be connected to the frame 3310, the plenum chamber 3200 or the seal-forming structure 3100 via separate connector means (not shown) provided on the straps 3301 and / or the rigidiser arms 3302.

[0242] Figures 74-77 show similar features to those shown in Figures 71-73, however the examples shown in Figures 74-76 and 77 depict different connections between the positioning and stabilising structure 3300 and the mask frame 3310. At each end of the side strap portions 3315, 3316 there is a pocket-like end 3311, 3313 as shown in Figures 65 and 81. These pocket-like ends 3311, 3313 are held on the rigidiser arms 3302 (not visible in these figures as the rigidiser arms are within the side strap portions 3315, 3316) by the protruding ends 3306 of the respective rigidiser arms as shown for example in Figures 47-60. Although not visible in Figures 74-77, it should be understood that in this example the welded ends 3311.1, 3313.1 depicted in Figure 81 serve to close the pocketed ends 3311, 3313 so that they may be held against the protruding end 3306. The rigidiser arm 3302 is then permanently mechanically secured to the mask frame 3310 by overmolding, for example, as described in connection with Figures 47-60.

[0243] 6.3.7.7.1 Attaching the Rigidiser Arm to the Patient Interface According to a further example of the present technology, the rigidiser arm 3302 may be detachable. By allowing the rigidiser arm to be detached from the patient interface 3000, the rigidiser arm 3302 is subject to less distortion during shipping and storage. Having the rigidiser arm 3302 detachable allows the patient interface 3000 to be packaged more compactly with proper support for each individual component. Also, by making the rigidiser arm 3302 separable, the rigidiser arm can be separated for cleaning. It should be appreciated that in some examples, the extension 3350 may be detached from the frame 3310. In other examples, the rigidiser arm 3302 may be detached from the extension 3350, in which case the extension may be permanently attached to the frame 3310. A further advantage of a detachable rigidiser arm 3302 may be that the attachment mechanism may be configured to provide an audible click, which is a reassuring indication to the patient that the components have been effectively secured. Such an audible click may be facilitated by, for example, a hard-to-hard connection between the rigidiser arms 3302 and the frame 3310. A hard-to-hard connection may be beneficial for patients who struggle with fine motor skills because it allows the patient to more easily assemble the patient interface 3000 and gives the patient confidence that they have assembled it. A detachable rigidiser arm 3302 may also be beneficial to the patient in that the patient may customize the patient interface 3000 due to the interchangeability of parts. For example, the patient interface 3000 may be sold with many sets of rigidiser arms 3302 having different curvature profiles, shapes, lengths, and / or stiffness from which the patient may select the most suitable set based on facial geometry and comfort. This may provide a better fit and greater comfort, thereby increasing patient compliance with treatment. The sets of rigidiser arms 3302 may also be offered in different colors to provide a variety of aesthetic options for the patient.

[0244] 248A and 248B show an example of a rigidiser arm 3302 detached from and attached to the patient interface 3000 at the extension 3350. The protruding end 3306 of the rigidiser arm 3302 may be provided with a protrusion 3380 with locking wings 3381, which may be supported by a shaft (not shown). The straight portion 3351 of the extension 3350 may be provided with an opening 3382 having a notch 3383. The straight portion 3351 of the extension 3350 may be provided with a stopper 3384. The opening 3382 and the notch 3383 may be sized and formed corresponding to the protrusion 3380 and the wings 3381. To assemble the rigidiser arm 3302 to the extension 3350, the projection 3380 and wings 3381 are extended through the corresponding openings 3382 and notches 3383 and then rotated until the wings abut their respective stops 3384. Thus, the length of the shaft should be dimensioned to be slightly greater than the width of the straight portion 3351 of the extension 3350 to minimize play between the rigidiser arm 3302 and the extension 3350 when attached. It should be understood that the rigidiser arm 3302 may be fixed by rotation in only one direction. This may be achieved, for example, by locating stops 3384 on either side of the opening 3382 such that the rigidiser arm 3302 is fixed by rotation in a clockwise direction as shown in FIG. 248B. It should also be understood that the corresponding protrusion-wing and aperture-notch sets may be differently sized to prevent misassembly of the rigidiser arms 3302, i.e., where the right rigidiser arm is attached to the left extension and vice versa, so that the patient can only reliably attach the right rigidiser arm 3302 to the right extension 3350 and the left rigidiser arm to the left extension.

[0245] 249A and 249B show another example of the present technology where the rigidiser arm 3302 may be detachable. In this example, the extension 3350 may be provided with a pair of pins 3385 extending therefrom. The pins 3385 may each have a head on a shaft, which is fixed to the extension 3350. The head of each pin 3385 may be larger in diameter than the shaft of each pin to allow attachment to a socket 3386 formed in the protruding end 3306 of the rigidiser arm 3302. The socket 3386 may include a slit to allow flexure of the material of the protruding end 3306 so that the head of the pin 3385 can pass through the respective socket. Thus, the length of the shaft of the pin 3385 should be dimensioned to be slightly larger than the width of the protruding end 3306 to minimize play once the rigidiser arm 3302 is attached. Also, the pins 3385 and corresponding sockets 3386 may be spaced or sized differently to prevent misassembly of the rigidiser arm 3302. For example, the spacing and / or positioning of the pins 3385 and corresponding sockets 3386 of the right side rigidiser arm 3302 and extension 3350 may be different than the left side such that the patient cannot attach the left side rigidiser arm to the right side extension and vice versa. In another example, the pins 3385 and sockets 3386 of the left side rigidiser arm 3302 and extension 3350 may be sized differently than the pins and sockets of the right side rigidiser arm and extension such that the patient cannot attach the left side rigidiser arm to the right side extension and vice versa.

[0246] 250A-250C show another example of a detachable rigidiser arm 3302 according to the present technology. In this example, the rigidiser arm 3302 includes a protrusion 3393 having an arm 3394 for securing the rigidiser arm to an extension 3350. The arm 3394 and the protrusion 3393 may extend from a shaft 3395 on the rigidiser arm 3302, and the arm, the protrusion and the shaft may be integrally formed with the rigidiser arm 3302. Thus, the extension 3350 is provided with a slot 3392 through which the arm 3394 and the protrusion 3393 pass during attachment. The extension 3350 is also formed with a shaft receiving portion 3390 and an arm receiving portion 3391 for receiving the shaft 3395 and the arm 3394, respectively. To attach the rigidiser arm 3302 to the extension 3350, the shaft 3395, protrusion 3393 and arm 3394 are threaded through the slot 3392 and the shaft and protrusion are pulled into engagement with the shaft receiver 3390 and arm receiver 3391, respectively. The arm receiver 3391 may be narrower than the shaft 3395 and arm 3394 to ensure a secure friction fit when the arm is engaged with the arm receiver. To remove the rigidiser arm 3302 from the extension 3350, the patient slides the rigidiser arm 3302 in the opposite direction to the attachment direction. It should also be appreciated that the diameter of the protrusion 3393 may be larger than the diameter of the shaft receiver 3390 to prevent disassembly. To prevent misassembly, the arm 3394 and protrusion 3393 of the right rigidiser arm 3302 may be sized and / or shaped to fit only into the arm receiving portion 3391 and shaft receiving portion 3390 of the right extension 3350, and the arm and protrusion of the left rigidiser arm may be sized and / or shaped to fit only into the arm receiving portion and shaft receiving portion of the left extension.

[0247] 251A and 251B show another example of a rigidiser arm 3302 that may be detachable. According to this example, an extension 3350 may be integrally formed with the rigidiser arm 3302. The extension 3350 may include a flared end 3387 that attaches to a receiver 3388 on the frame 3310. The flared end 3387 may be slid into a slot 3389 in the receiver 3388 to attach the extension 3350 and rigidiser arm 3302, and the engagement may form a press fit. The receiver 3388 may be a separate component from the frame 3310 that is attached to the frame, or the receiver may be integrally formed with the frame. To prevent misassembly, the right flared end 3387 and slot 3389 may be sized and / or shaped differently than the left flared end and slot.

[0248] 252A-252C show another example of a rigidiser arm 3302 that may be detachable. According to this example, an extension 3350 may be integrally formed with the rigidiser arm 3302. The extension 3350 may be formed to provide a snap-fit ​​engagement with a receiver 3310.1. The receiver 3310.1 may be a separate component from the frame 3310 that is attached to the frame, or the receiver may be integrally formed with the frame. The receiver 3310.1 may include a pocket 3310.2 and a recess 3310.3 to receive the extension 3350 for attachment of the rigidiser arm 3302. The extension 3350 includes a bend 3396 to facilitate the snap-fit ​​engagement. The extension 3350 may be formed from a resilient material and may be dimensioned such that when the extension is placed into the receiver 3310.1, it is compressed by the reduction in the angle of the bend 3396. This compression of the extension 3350 forces the protrusion 3397 into the recess 3310.3 as the bend 3396 is forced into the pocket 3310.2. A tab 3398 may be provided to facilitate disengagement. The patient may depress the tab 3398 to further compress the bend 3396, thereby releasing the protrusion 3397 from the recess 3310.3 and removing the rigidiser arm 3302. Also, the right side extension 3350 and corresponding receiver 3310.1 may be dimensioned and / or formed differently than the left side extension and corresponding receiver to prevent misassembly.

[0249] 253A-C show another example of a rigidiser arm 3302 that may be detachable. According to this example, an extension 3350 may be formed integrally with the rigidiser arm 3302. The extension 3350 may be formed for a snap-fit ​​engagement with the receiver 3310.1. In this example, the extension 3350 may be held by the receiver 3310.1 using a friction fit. The receiver 3310.1 may be a separate component from the frame 3310 that is attached to the frame, or the receiver may be formed integrally with the frame. In this example, a post 3399 may be provided near the end 3350.1 of the extension 3350. The post 3399 is inserted into a pocket 3310.2 of the receiver 3310.1 to attach the extension 3350. The post 3399 may be circular in cross-sectional shape to engage a complementary formed recess 3310.4 in the pocket 3310.2. Other cross-sectional shapes of the post 3399 than circular, such as square, rectangular, triangular, elliptical, etc. are envisioned as well. In this example, an end receiver 3310.5 may be provided in the pocket 3310.2 to receive the end 3350.1 of the extension 3350, as these respective surfaces may be curved. The engagement of the end receiver 3310.5 with the end 3350.1 of the extension 3350 may prevent undesired rotation of the extension 3350 and rigidiser arm 3302 about the longitudinal axis of the post 3399. This may therefore ensure that movement of the rigidiser arm 3302 is due solely to flexure provided by the deformability of the rigidiser arm 3302 and the extension 3350, and not due to play in the engagement between the extension and receiver 3310.1. Therefore, to prevent misassembly, the right side extension 3350 and corresponding receiver 3310.1 may be sized and / or shaped differently than the left side extension and receiver.

[0250] 254A and 254B show another example of a rigidiser arm 3302 that may be detachable. This example may not include an extension 3350 formed with the rigidiser arm 3302. Rather, the rigidiser arm 3302 may be formed with a first bent portion 3340, a first straight portion 3341, a second bent portion 3342, a second straight portion 3343, and a locking end 3344 formed at the end of the second straight portion 3343. Slots 3345 may be provided on either side of the frame 3310 through which each rigidiser arm 3302 passes to attach to the frame. Each slot 3345 may be sized and formed to allow each rigidiser arm 3302 to pass through the slot, but each slot may be smaller than each locking end to prevent the rigidiser arm from being pulled through the slot. To prevent mis-assembly, the right side rigidiser arm 3302 and corresponding slot 3345 may be shaped and / or sized differently than the left side rigidiser arm and slot. It should also be understood that the portions of the rigidiser arm 3302 referred to above as the first straight portion 3341 and the second straight portion 3343 do not have to be straight and may instead be curved as needed to provide the desired shape / profile. The rigidiser arm 3302 may also have other curves and / or bends as desired, so long as the rigidiser arm can be threaded through the slot.

[0251] 255A and 255B show another example of a rigidiser arm 3302 that may be detachable. According to this example, an extension 3350 may be integrally formed with the rigidiser arm 3302. This example includes a pin 3385 whose head is supported on the extension 3350 by a shaft. The head of the pin 3385 may be of larger diameter than the shaft. A socket 3386 may be integrally formed on each side of the frame 3310 for snap-fit ​​engagement with the respective pin 3385. To prevent misassembly, the pin 3385 and corresponding socket 3386 of the right rigidiser arm 3302 may be sized and / or shaped differently than the pin and socket on the left side.

[0252] 256A-256C show another example of the rigidiser arm 3302, which may be detachable. According to this example, the extension 3350 may be integrally formed with the rigidiser arm 3302. The receiving portion 3410 and the first magnet 3412 may be provided on the frame 3310. The second magnet 3413 may be provided on the extension 3350 to fix the rigidiser arm 3302 to the frame 3310. Thus, the respective magnetic poles of the first magnet 3412 and the second magnet 3413 may be oriented such that the first magnet and the second magnet are attracted to each other. The extension 3350 may be provided with a post 3411 near the second magnet 3413 to engage with the receiving portion 3410 and ensure that the extension is properly positioned at the receiving portion. It should also be appreciated that the right side post 3411 and receiver 3410 may be shaped and / or sized differently than the left side post and receiver to prevent misassembly. To prevent misassembly, the magnetic poles of the right side first magnet 3412 and second magnet 3413 may be oriented opposite to the magnetic poles of the left side first magnet and second magnet, such that magnetic attraction occurs only when the respective left and right magnets are engaged, and magnetic repulsion prevents engagement if the patient attempts to place the left rigidiser arm 3302 into the right receiver 3410 or vice versa.

[0253] 257A and 257B show another example of a rigidiser arm 3302 that may be detachable. The frame 3310 may include a first L-shaped portion 3420 on each side, and a second L-shaped portion 3423 may be formed on each rigidiser arm 3302. To attach the frame 3310 to the rigidiser arm 3302, the first L-shaped portion 3420 is brought into engagement with the second L-shaped portion 3423 by moving the L-shaped portions toward each other in opposite vertical directions. The first L-shaped portion 3420 and the second L-shaped portion 3423 are then rotated relative to each other and fixed in place. The second overlap portion 3424 may engage the first recess 3421, and the first overlap portion 3422 may engage the second recess 3425. Pegs 3426 may be provided in the first recess 3421 and the second recess 3425. Each peg 3426 may engage with a hole 3427 provided in the first overlapping portion 3422 and the second overlapping portion 3424 to secure the first L-shaped portion 3420 and the second L-shaped portion 3423. The holes 3427 in these examples are shown in dashed lines to indicate that they do not extend completely through the first overlapping portion 3422 and the second overlapping portion 3424, but it should be understood that according to alternative examples the holes can extend completely through. It should also be understood that the engagement between each peg 3426 and hole 3427 may include a press fit or friction fit to ensure a secure connection. In yet another example, the peg 3426 may include a barb at the end of the shaft and each corresponding hole 3427 may extend completely through the first and second overlapping portions 3422, 3424 such that the barb of each peg locks into its respective hole when engaged. It should also be understood that in another example, the peg 3426 may be provided in the first and second overlapping portions 3422, 3424 and the holes 3427 may be provided in the first and second recesses 3421, 3425.

[0254] 258A and 258B show another example of a rigidiser arm 3302 that may be detachable. According to this example, an extension 3350 may be formed integrally with the rigidiser arm 3302. A boss 3430 may be formed on either side of the frame 3310, and a cavity 3431 may be formed at the end of each extension 3350 to receive the boss. The bosses 3430 and cavities 3431 may be shaped and dimensioned to form a secure friction fit. It should also be understood that in another example, the boss 3430 may be formed on the extension 3350, and the cavity 3431 may be provided on the frame 3310. Also, the right side boss 3430 and cavity 3431 may be shaped and / or dimensioned differently than the left side boss and cavity to prevent misassembly.

[0255] 259A-259C show another example of a rigidiser arm 3302 that may be detachable. A post 3452 and a pair of slots 3453 may be provided on the extension 3350. The rigidiser arm 3302 may be provided with a hole 3451 to receive the post 3452, and a pair of protrusions 3450 may be provided on the rigidiser arm 3302 to engage with the respective slots 3453. To attach the rigidiser arm 3302 to the extension 3350, the protrusions 3450 are first passed through the corresponding slots 3453 on the extension, and then the post 3452 engages with the holes 3451 to prevent separation of the rigidiser arm from the extension. The bent shape of the protrusion 3450 may help to secure the protrusion when it is passed through the opening 3453. The post 3452 may also include a head that is enlarged relative to the shaft of the post to ensure that the post is firmly engaged with the hole 3451. In other examples, it should be understood that the posts 3452 and slots 3453 need not be provided on the extension 3350 and the holes 3451 and the projections 3450 need not be provided on the rigidiser arm 3302, as long as the complementary components are positioned such that the projections engage the slots and the posts engage the holes. Also, multiple posts 3452 and multiple holes 3451 may be provided, as long as complementary numbers are provided. Also, more or less than two corresponding projections 3450 and slots 3453 may be provided, as long as complementary numbers are provided. Furthermore, it should be understood that the number of projections 3450 and slots 3453, as well as the number of posts 3452 and holes 3451 may be different between the left extension 3350 and rigidiser arm 3302 and the right extension 3350 and rigidiser arm 3302 to prevent misassembly. Alternatively, to prevent assembly errors, the size and / or shape of the protrusion 3450 and slot 3453, and the size and / or shape of the post 3452 and hole 3451 may be different between the left extension 3350 and rigidiser arm 3302 and the right extension 3350 and rigidiser arm 3302.

[0256] 6.3.7.8 Split backstraps for positioning and stabilising structuresAccording to one embodiment, the structure of the strap 3301 and the positioning and stabilizing structure 3300 is beneficial. In particular, the two elastic straps or back strap portions 3317a, 3317b at the back can encircle the head and the tension vector can be adjusted by proper positioning of the straps, for example by spreading the straps. The two back strap portions 3317a, 3317b can also provide better support and stability and can increase flexibility avoiding particularly sensitive areas at the back of the head. The back strap portions 3317a, 3317b are adapted to encircle the head at the crown to maintain position and engagement. In one example, depending on the patient's particular head shape and the size of the division of the back strap portions 3317a, 3317b, the upper back strap portion 3317a is adapted to be located near the parietal bone and the lower back strap portion 3317b is adapted to be located near the occipital bone or the upper fibers of the trapezius muscle (i.e., near the upper cervical or dorsal cervical portion of the neck). The lower back strap portion 3317b may be configured to engage the patient's head at a location on or below the external occipital protuberance. Unlike conventional mask headgear that requires material length adjustment (shortening or lengthening), the tension provided by the positioning and stabilising structure 3300 can be adjusted by simply opening or closing the relative angle between the two back strap portions 3317a, 3317b. When the patient interface 3000 is worn, to reduce headgear tension, the two back strap portions 3317a, 3317b are spaced further apart on the back of the head. To increase headgear tension, the two back strap portions 3317a, 3317b are moved closer together. This adjustment feature is advantageous over notched straps that allow only preset incremental adjustments of headgear tension, Velcro® (a continuous loop fabric) straps that require several attempts of tightening and unfastening until the desired headgear tension is achieved, or looping straps through buckles, where it is easier to increase headgear tension than to decrease it due to the action of pulling the straps through the buckles to tighten.Also, the patient 1000 may make mistakes with the headgear tension or may be reluctant to change the headgear tension.

[0257] The two smaller straps at the back of the head, i.e. the back strap portions 3317a, 3317b, may be of equal length and are not adjustable except by elasticity of the material or by shortening the overall length of the positioning and stabilising structure 3300 at the side strap portions 3315, 3316, thereby increasing the tightness of both back strap portions equally. For example, a sliding mechanism (not shown) may be provided which allows the straps 3301 to overlap to different degrees, thereby changing the overall length of the positioning and stabilising structure 3300. With the independently adjustable strap lengths, the two back strap portions 3317a, 3317b can necessarily centre themselves on the crown of the head. The two back strap portions 3317a, 3317b may be symmetrical or asymmetrical. In other words, the upper back strap portion 3317a may necessarily rest on the crown of the head, while the lower back strap portion 3317b may necessarily rest on the back of the head near or below the occipital lobe. This may reduce the possibility of manually over-tightening one strap to compensate for the other being too loose, thereby resulting in a mis-fit of the positioning and stabilising structure 3300. Furthermore, this may not only result in discomfort, but may also negatively affect treatment compliance. The combined width of both back strap portions 3317a, 3317b may be approximately equal to the width of the side strap portion 3315. This is aesthetically pleasing and gives the patient a visual cue to adjust the back strap portions 3317a, 3317b when donning the patient interface 3000. Although two back strap portions 3317a, 3317b have been described, a greater number may be envisaged, thereby providing different degrees of adjustment of the headgear tension. When the strap 3301 is in a neutral state and not stretched, the two back strap portions 3317a, 3317b are partially spaced apart such that a gap exists between the two back straps to prompt or suggest to the patient to adjust the back strap portions 3317a, 3317b when donning the patient interface 3000.This enhances the intuition for adjusting the headgear tension as well as providing a visual cue of how the headgear tension can be adjusted, which is sometimes lacking with conventional masks....

Claims

1. 1. A patient interface configured to deliver in a sealed manner a supply of breathable gas pressurized at a continuous positive pressure relative to ambient air pressure to a patient's nares, the patient interface providing a continuous positive pressure relative to ambient air pressure at a pressure greater than approximately 4 cmH above ambient air pressure in use throughout the patient's respiratory cycle while the patient is asleep to ameliorate sleep disordered breathing. ２ About 30cmH from O ２ configured to maintain a therapeutic pressure in the upper range; The patient interface includes: CO vomited by the patient ２ to the outside of the patient interface to allow for the flow of CO2 exhaled by the patient ２ a frame member including a gas escape vent configured to minimize rebreathing of a cushion member configured to deliver a supply of pressurized breathable gas to the patient's nares; Equipped with The cushion member is a seal-forming structure and a plenum chamber at least partially forming a gas chamber, said seal-forming structure configured to seal against the patient's face around both nostrils around a lower portion of the patient's nose such that said seal-forming structure contacts the patient's face under the bridge of the nose, at the lateral sides of the patient's nose and at the patient's upper lip, said seal-forming structure configured not to enter the patient's nares during use, said seal-forming structure having no undercushion; a retaining structure configured to releasably engage the frame member to releasably secure the seal-forming structure and the plenum chamber to the frame member; Further comprising: The patient interface includes: a positioning and stabilising structure configured to maintain the seal-forming structure in sealing contact with the patient's face while maintaining the treatment pressure at the patient's nares, the seal-forming structure and the plenum chamber being made from a one-piece first material and the retention structure being made from a second material, the first material being silicone, the second material being silicone having a higher durometer than the first material, such that the retention structure is more rigid than the seal-forming structure and the plenum chamber; The patient interface, wherein the plenum chamber further includes a sealing lip configured to contact the frame member, the sealing lip configured such that an increase in air pressure in the gas chamber increases a sealing force of the sealing lip against the frame member.

2. The patient interface of claim 1 , wherein the plenum chamber is disposed between the retaining structure and the seal-forming structure.

3. 3. A patient interface according to claim 1 or 2, further comprising a frame member made from a third material that is less flexible than the first and second materials.

4. A patient interface according to claim 1 , wherein the first material is more flexible than the second material.

5. the seal-forming structure includes a recess configured to receive a tip of the patient's nose; 5. A patient interface according to any one of claims 1 to 4, wherein the recess is located in a region of the seal-forming structure which is thinner than a laterally adjacent region of the seal-forming structure configured to contact the patient's nasal ala.

6. 6. A patient interface according to claim 5, wherein the seal-forming structure includes a conformable region disposed over the recess, the conformable region being thin and flexible relative to the remainder of the seal-forming structure.

7. A patient interface according to any one of claims 1 to 6, wherein the seal-forming structure has a varying thickness adjacent the nasal opening at predetermined locations around the nasal opening.

8. 8. A patient interface according to any one of claims 1 to 7, wherein the seal-forming structure includes a pair of protruding ends extending symmetrically about the nasal opening, each protruding end configured to seal against an area of ​​the patient's face where the ala of the nose joins the patient's face.

9. 9. A patient interface according to any one of the preceding claims, wherein a lower portion of the seal-forming structure is concave in a relaxed state to seal against and follow the curvature of the patient's upper lip.

10. 10. A patient interface according to any one of the preceding claims, wherein the frame member further comprises a rib, and the plenum chamber further comprises a notch corresponding to the rib.

11. 11. A patient interface according to any one of claims 1 to 10, wherein the retention structure is permanently joined to the plenum chamber by a chemical bond between the first material and the second material.

12. 12. A patient interface according to any one of the preceding claims, wherein the positioning and stabilising structure further comprises a pair of rigidiser arms, each of the rigidiser arms joined to a corresponding side of the frame member.

13. 13. A patient interface according to claim 12, wherein the positioning and stabilising structure further comprises a strap having two ends, each end releasably connected to a corresponding one of the rigidiser arms.

14. 14. A patient interface according to claim 12 or 13, wherein the pair of rigidiser arms are constructed from a material different from a material of the frame member.

15. 15. A patient interface according to any one of claims 12 to 14, wherein the pair of rigidiser arms are permanently coupled to the frame member by a mechanical linkage.

16. 16. A patient interface according to any one of claims 1 to 15, wherein the gas escape vent further comprises two groups of vent holes, each of the groups being located on a corresponding side of the frame member.

17. 17. A patient interface according to any one of claims 1 to 16, wherein the frame member further includes a port and a tube connected to the frame member at the port, the tube configured to direct a supply of pressurized breathable gas through the port to the gas chamber.

18. 18. A patient interface according to any one of claims 1 to 17, wherein the seal-forming structure further comprises a pair of thickened portions, each of the thickened portions positioned on a corresponding side of the seal-forming structure so as to contact the patient's face at or proximal to a corresponding nasolabial fold of the patient during use.

19. 20. A patient interface according to claim 18, wherein the thickened portion is thicker than an adjacent portion of the seal-forming structure.

20. 20. A patient interface according to any one of claims 1 to 19, wherein the seal-forming structure consists of a single nasal opening configured to provide a supply of pressurized breathable gas to both of the patient's nares in use.

Images