Patient interface and method for forming the 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 on November 15, 2013; U.S. Provisional Application No. 61 / 817,674, filed on April 30, 2013; U.S. Provisional Application No. 61 / 823,192, filed on May 14, 2013; U.S. Provisional Application No. 61 / 823,353, filed on May 14, 2013; U.S. Provisional Application No. 61 / 837,521, filed on June 20, 2013; and U.S. Provisional Application No. 61 / 839,916, filed on June 27, 2013. This application claims the benefit of Australian Provisional Application No. 2013900132, filed on January 16, 2013, and Australian Provisional Application No. 2013900168, filed on January 18, 2013. This application claims the benefit of New Zealand Application No. 605907, filed on January 16, 2013. Each of the previously - referenced applications is hereby incorporated by reference in its entirety into this application.

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

Background Art

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

[0004] The airway includes a series of branched tubes, which become thinner, shorter, and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, by which oxygen can move from the air into venous blood and carbon dioxide can move to the outside. The trachea divides into the left and right main bronchi, and further, the main bronchi ultimately divide into terminal bronchioles. The bronchi form the conducting airways and are not involved in gas exchange. Further division of the airway results in respiratory bronchioles and ultimately alveoli. The alveolar region of the lungs is the site where gas exchange takes place and is called the respiratory region.

[0005] There are a series 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 is caused by a combination of an abnormally small upper airway and a normal loss of muscle tone in the regions of the tongue, soft palate, and posterior oropharyngeal wall during sleep. Depending on the condition, affected patients generally stop breathing 200 - 300 times per night, sometimes for a duration of 30 - 120 seconds. This often causes excessive daytime sleepiness and can cause cardiovascular diseases and brain damage. The syndrome is particularly common in middle-aged and elderly obese men, but affected patients may not be aware of the problem. See Patent Document 1 (Sullivan) for this.

[0007] Cheyne-Stokes respiration (CSR) is a disease of the respiratory controller in patients in whom there are rhythmic alternating cycles of increasing and decreasing ventilation that cause repeated deoxygenation and reoxygenation of arterial blood. CSR is thought to be harmful due to recurrent hypoxia. In some patients, CSR is associated with repeated awakenings from sleep that cause severe sleep disruption, increased sympathetic activity, and increased afterload. See Patent Document 2 (Berthon-Jones) for this.

[0008] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic daytime hypercapnia in the absence of other known causes of hypoventilation. Symptoms include dyspnea, headache upon waking, 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 long expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0010] Neuromuscular disease (NMD) is a broad term that encompasses many diseases and conditions that directly or indirectly through an underlying myopathy or neuropathy reduce muscle function. Some NMD patients are characterized by progressive muscle dysfunction leading to loss of walking ability, confinement to a wheelchair, dysphagia, reduced respiratory muscle strength, and ultimately death due to respiratory failure. Neuromuscular diseases can be divided into rapidly progressive and slowly progressive. That is, (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 young people in their teens); (ii) variably or slowly progressive diseases: characterized by muscle dysfunction that worsens over years and slightly reduces life expectancy (e.g., limb-girdle muscular dystrophy, facioscapulohumeral muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include increasing general debility, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, headache upon waking, and difficulty concentrating and with mood changes.

[0011] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thorax. The disorders are typically characterized by restrictive impairment and share chronic hypercapnic respiratory failure. Severe scoliosis and / or kyphoscoliosis may cause severe respiratory failure. Symptoms of respiratory failure include dyspnea on exertion, peripheral edema, orthopnea, recurrent pulmonary infections, headache on awakening, fatigue, reduced quality of sleep, and loss of appetite.

[0012] Otherwise, healthy individuals may well utilize 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 continuous positive airway pressure can act as an air pressure splint and prevent upper airway obstruction by pushing the soft palate and tongue forward away from the posterior oropharyngeal wall.

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

[0016] 3.2.3 Patient Interface The application of a predetermined amount of positive pressure air to the entrance of a 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 at least one seal forming portion that covers at least the nostrils and the mouth or a plurality of seal forming portions that individually cover at least the nostrils and the mouth. A series of patient interface devices are known, but many of them suffer from one or more of the following problems: being very noticeable, aesthetically undesirable, poorly fitting, difficult to use, and uncomfortable, especially when worn for long periods or when the patient is unfamiliar with the system. Masks designed only for pilots, as part of personal protective equipment, or for the administration of anesthetic agents may be acceptable in their initial use, but nevertheless are uncomfortable and undesirable for long-term wear, for example during sleep.

[0017] 3.2.3.1 Seal Forming Structure A patient interface generally includes a seal forming structure.

[0018] One type of seal forming structure extends across the outer periphery of the patient interface and is adapted to seal against the user's face when a 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-filled cushion or a fluid-filled cushion, or a molded or formed surface of an elastic seal element made of an elastomer such as rubber. When using this type of seal forming structure, if the fit is not proper, there will be a gap between the seal forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0019] Other types of seal-forming structures incorporate a flap seal of thin material positioned across the outer perimeter of the mask to provide a self-sealing action against the user's face when positive pressure is applied within the mask. Without good conformity between the face and the mask, as in previous styles of seal-forming structures, additional force may be required to effect a seal, or the mask may leak. Also, if the shape of the seal-forming structure does not conform to the patient's shape, the seal-forming structure may fold or buckle during use, thereby causing leakage.

[0020] Other forms of seal-forming structures may use an adhesive to effect a seal. Some patients may find it inconvenient to constantly apply and remove the adhesive to their face.

[0021] A series of patient interface seal structure technologies are disclosed in the following patent applications assigned to ResMed Limited, namely Patent Document 3, Patent Document 4, and Patent Document 5.

[0022] 3.2.3.2 Positioning and Stabilization The seal-forming structure of a patient interface used for positive pressure air treatment is subject to the corresponding forces of air pressure that impede the seal. Accordingly, various techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0023] One technique is the use of an adhesive. See, for example, Patent Document 6 in this regard.

[0024] Other techniques are the use of one or more straps and stabilization harnesses. Many such harnesses suffer from one or more of being ill-fitting, bulky, uncomfortable, and difficult to use.

[0025] Rigid elements, also known as "rigidisers", have been used hitherto with extensible headgear. One known problem is associated with the fact that rigidisers that are removably attached (e.g., laminated or stitched) to a large area of extensible material limit the extensible length of the material and thus affect the elastic properties of the overall headgear. Another problem relates to the cleaning of the headgear where both the rigidisers and the extensible material need to be cleaned together since they are removably attached to each other.

[0026] 3.2.3.3 Vent technology Some forms of the patient interface system may include vents to allow for the outflow of exhaled carbon dioxide. Many such vents are noisy. Other vents may become blocked during use, resulting in inadequate outflow. Some vents may disrupt the sleep of the patient's bed partner, for example, by noise or focused airflow. Some vents cannot be cleaned properly and must be discarded after they become blocked. Some vents are designed to be used for a short duration, i.e., less than 3 months, and are thus manufactured from fragile materials to avoid cleaning or frequent cleaning and encourage more frequent vent replacement. ResMed Limited has developed many improved mask vent technologies. See Patent Documents 7, 8, 9, 10, and 11 for this.

[0027]

Table 1

[0028] Sound pressure level values for various subjects are listed below.

[0029]

Table 2

[0030] 3.2.3.4 Nasal pillow technology One form of nasal pillows is found in the Adam Circuit manufactured by Puritan Bennett. Other nasal pillows or nasal plugs are the subject of Patent Document 12 (Trimble and others) assigned to the Puritan Bennett Corporation.

[0031] ResMed Limited has manufactured the following products incorporating nasal pillows, namely, the SWIFT® Nasal Pillow Mask, SWIFT II® Nasal Pillow Mask, SWIFT LT® Nasal Pillow Mask, SWIFT FX® Nasal Pillow Mask, and the LIBERTY Full Face Mask. The following patent applications assigned to ResMed Limited, namely, National Patent Document 13 (among others, describing aspects of the ResMed SWIFT® Nasal Pillow Mask), Patent Document 11 (among others, describing aspects of the ResMed SWIFT LT Nasal Pillow Mask), Patent Documents 14 and 15 (among others, describing aspects of the ResMed LIBERTY® Full Face Mask), Patent Document 16 (among others, describing aspects of the ResMed SWIFT FX® Nasal Pillow Mask) describe nasal pillow masks.

[0032] 3.2.4 PAP Device Positive pressure air is generally supplied to the patient's airway by a PAP device such as a motor-driven blower. The outlet of the blower is connected to the aforementioned patient interface via a flexible delivery conduit.

[0033] 3.2.5 Mandibular Repositioning A mandibular repositioning device (MRD) is one of the treatment options for sleep apnea. This device is a custom-adjustable oral appliance available from a dentist that holds the mandible in a forward position during sleep. This mechanical protrusion widens the space behind the tongue, applies tension to the pharyngeal wall, reduces airway collapse, and reduces palatal vibration.

Prior Art Documents

Patent Documents

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

[0035] 4 (D) Brief Overview of the Technology This technology is directed to providing a medical device used in the diagnosis, improvement, treatment, or prevention of respiratory diseases, which has one or more of comfort, cost, effectiveness, ease of use, and manufacturability improvement.

Means for Solving the Problems

[0036] One aspect of this technology relates to a device used in the diagnosis, improvement, treatment, or prevention of respiratory diseases.

[0037] Another aspect of this technology relates to a method used in the diagnosis, improvement, treatment, or prevention of respiratory diseases.

[0038] One aspect of this technology is a patient interface having a seal-forming structure that can be removed for cleaning. The desire of this technology is to provide a patient interface that is lightweight compared to prior art patient interfaces, less obtrusive compared to prior art patient interfaces, and quieter during use compared to prior art patient interfaces. Also, it is desirable to provide a patient interface that is intuitively understandable to the patient when connecting the mask components before the start of treatment and is easy to adjust and wear for treatment.

[0039] One aspect of one form of this technology is a patient interface having a seal-forming structure that can be positioned at a predetermined location on the patient interface via a rigid-rigid indirect connection. Another aspect of one form of this technology is a seal-forming structure of a patient interface that can be removed for cleaning without the need to separate 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 connection portion, wherein the seal-forming structure and the plenum chamber are formed from a relatively flexible material, and the connection portion is formed from a relatively rigid material. In one form, the connection portion can be removably connected to the frame of the patient interface, for example, via a snap action, a toggle, or a bistable mechanism. In one form, the connection portion is insert-molded into the plenum chamber.

[0041] Another aspect of one form of the present technology is a patient interface that is shaped or otherwise configured with a clearly defined outer perimeter that is adapted to conform to the outer perimeter of the intended wearer (i.e., the patient) and to closely adhere to and conform to the face of the intended wearer.

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

[0043] Another aspect of the present technology is directed to a patient interface for delivering a predetermined amount of pressurized air or breathing gas to the entrance of a patient's airway. The patient interface may comprise a cushion member including a holding structure and a seal-forming structure non-removably connected to the holding structure, and a frame member, wherein the holding structure and the frame member are repeatedly removably attached to each other, a gas chamber is at least partially formed by the engagement of the cushion member and the frame member, and an increase in air pressure within the cushion member increases the 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 for treating sleep apnea. The patient interface is a seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nostrils of the patient are integrally formed, the plenum chamber includes a plenum connection region, and the seal-forming structure is configured to seal below the nasal bridge across the lower outer periphery of the patient's nose, a seal-forming structure; a frame that can be releasably attached to the plenum connection region; a connection port formed integrally with the frame; and a gas delivery tube non-removably coupled to the frame at the connection port. The gas delivery tube may be a helical coil composed of a plurality of adjacent coils, each coil being spaced apart by a width and having an outer surface that defines a coil diameter, a helical coil; and a web of material that is coaxial with the helical coil and is attached to the helical coil between adjacent coils of the plurality of adjacent coils and has at least one bent portion that extends radially outward between adjacent coils of the plurality of adjacent coils, the at least one bent portion being defined by a predetermined bending line.

[0046] In an embodiment, (a) the apex of the at least one bent portion may define the diameter of the bent portion, (b) when the gas delivery tube is in a neutral state, the coil diameter may be approximately equal to the diameter of the bent portion, and adjacent coils may be spaced apart from each other in the neutral state, (c) the gas delivery tube may assume one of three different states, namely, a neutral state in which the gas delivery tube has a neutral length, an extended state in which the gas delivery tube is stretched to an extended length that is longer than the neutral length along its longitudinal axis, and a compressed state in which the gas delivery tube is compressed to a compressed length that is shorter than the neutral length along its longitudinal axis, (d) the web of material may include at least one bent portion that extends radially outward along at least one longitudinal portion of the gas delivery tube, (e) the web of material may have an inclination angle that increases from the spiral coil to the apex of at least one bent portion when the gas delivery tube is in the neutral state, (f) the web of material may have an asymmetric cross-sectional shape near a predetermined bending line, (g) the predetermined bending line may be evenly spaced between adjacent coils among a plurality of adjacent coils, (h) the width for spacing adjacent coils among a plurality of adjacent coils may be approximately equal to the width of the spiral coil when the gas delivery tube is in the neutral state, (i) the spiral coil may occupy a larger surface area ratio of the gas delivery tube than at least one bent portion of the web of material, (j) the outer portion of the spiral coil may have a rounded outer shape, (k) the spiral coil may have a greater thickness than the web of material, (l) the web of material may have a substantially uniform thickness, (m) the spiral coil may include a thermoplastic elastomer (TPE) or a thermoplastic polyurethane (TPU), and / or the web of material may include a thermoplastic elastomer (TPE) or a thermoplastic polyurethane (TPU), (n) the gas delivery tube may be non-removably coupled to the frame at the connection port by insert molding the frame into the gas delivery tube, (o) the web of material and the spiral coil may be joined to form a uniform continuous inner surface of the gas delivery tube, (p) the at least one bent portion isIt may extend radially outwardly between every other coil among a plurality of adjacent coils, (q) the seal-forming structure may include a recess for receiving the top of the patient's nose, (r) the compliant region may be located above the recess, the compliant region being thinner and more flexible than the rest of the seal-forming structure, (s) the seal-forming structure may comprise a foam, a gel, and / or a low durometer silicone, (t) the thickness of the seal-forming structure may vary at a predetermined position around the nasal opening, (u) the seal-forming structure may comprise a pair of protruding end portions that extend symmetrically around the nasal opening, each protruding end portion being configured to seal against a facial region of the patient where the alar wing connects to the patient's face, (v) the seal-forming structure may comprise a pair of protruding end portion support portions that correspond to and support each protruding end portion, the pair of protruding end portion support portions extending at least partially into a gas chamber defined by the seal-forming structure, (w) the lower portion of the seal-forming structure may seal against the patient's upper lip and may be concave in a relaxed state to conform to the curvature of the patient's upper lip, and / or (x) 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 an air pressure seal.

[0047] Another aspect of the present technology is directed to a patient interface for delivering pressurized gas to a patient to treat sleep apnea. The patient interface is a seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nostrils of the patient are integrally formed, the plenum chamber includes a plenum connection region, and the seal-forming structure is configured to seal below the nasal bridge across the lower outer periphery of the patient's nose, a seal-forming structure; a frame that can be releasably attached to the plenum connection region, the frame comprising a first material, a frame; and a pair of rigidiser arms comprising a second material, the second material being different from the first material, and the frame and the pair of rigidisers may be non-removably 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 a pair of rigidizer arms to form a mechanical connection, (c) the mechanical connection may include an enclosable portion extending from each of the pair of rigidizer arms overmolded by the material of the frame, (d) the enclosable portion may have a hook and a part of a bend, (e) the first material may be used to be integrally bonded to the second material, (f) the first material may be a thermoplastic polyester elastomer and the second material may be a thermoplastic polymer, (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 rigidizer arms may include a protruding end configured to hold a pocket-shaped end of a strap of a positioning stabilizer structure, and the protruding end may be near the frame, (j) the first material may not be expandable, and each of the pair of rigidizer arms may be structured to be more flexible in a plane substantially parallel to the patient's Frankfort horizontal plane compared to other planes, (k) each of the rigidizer arms may include a body having a curvature substantially following the shape of the patient's cheek and a connection portion configured to connect to the frame, the connection portion being located at the distal end of the rigidizer arm, (l) the connection portion may include at least one protrusion and at least one void configured to be overmolded to connect to the frame, (m) the seal-forming structure may include a recess for receiving the top of the patient's nose, (n) the conforming region may be located above the recess, and the conforming region is thinner and more flexible compared to the rest of the seal-forming structure, (o) the seal-forming structure may include a foam, a gel, and / or a low durometer silicone, (p) the thickness of the seal-forming structure may vary at a predetermined position around the nasal opening, (q) the seal-forming structure may include a pair of protruding ends symmetrically extending around the nasal opening, and each protruding end may be configured to seal against the patient's facial region where the alae are connected to the patient's face.(r) The seal-forming structure may include a pair of protruding-end support portions structured to correspond to and support each protruding end portion, and at least a part of the pair of protruding-end support portions may extend into a gas chamber defined by the seal-forming structure. (s) The lower part of the seal-forming structure may be concave in a relaxed state so as to seal against the patient's upper lip and follow the curvature of the patient's upper lip, and / or (t) the seal-forming structure may include a double-wall cushion to prevent the seal-forming structure from collapsing when the seal-forming structure engages with the patient's nose to form an air-pressure seal.

[0049] Another aspect of the present technology is directed to a patient interface for delivering pressurized gas to a patient to treat sleep apnea. The patient interface is a seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nostrils of the patient are integrally formed, the plenum chamber includes a plenum connection region, and the seal-forming structure is configured to seal below the nasal bridge across the lower outer periphery of the patient's nose. The patient interface may include a seal-forming structure, a frame removably attachable to the plenum connection region, a connection port integrally formed with the frame, and at least one vent for outflow of exhaled air, the at least one vent being non-removably connected to the frame. The at least one vent may be formed of a cloth formed by intertwining plastic fibers, and the cloth has a porosity of a predetermined size.

[0050] In an embodiment, (a) at least one vent may comprise two vents that are non-removably connected to the frame on both sides of the connection port; (b) the two vents may comprise a first vent having a first air flow velocity and a second vent having a second air flow velocity different from the first air flow velocity; (c) the first air flow velocity and the second air flow velocity may be selected such that the average air flow velocity between the first air flow velocity and the second air flow velocity is within a predetermined range; (d) the first air flow velocity and / or the second air flow velocity may be obtained by thermally fusing a part of the first vent and / or the second vent to a porosity of a predetermined size respectively; (e) the plastic fibers may be formed of a thermoplastic polymer from any one of the group consisting of polypropylene, woven polypropylene material, polycarbonate, nylon, and polyethylene; (f) at least one vent may be non-removably 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; (g) at least one vent may have a semi-circular shape or a D shape; (h) the seal-forming structure may include a recess for receiving the top of the patient's nose; (i) the compliant region may be located above the recess, and the compliant region is thinner and more flexible than the rest of the seal-forming structure; (j) the seal-forming structure may comprise a foam, a gel, and / or a low durometer silicone; (k) the thickness of the seal-forming structure may vary at a predetermined position around the nasal opening; (l) the seal-forming structure may comprise a pair of protruding ends that extend symmetrically around the nasal opening, and each protruding end may be configured to seal against the patient's facial region where the nasal wing connects to the patient's face; (m) the seal-forming structure may comprise a pair of protruding end support portions that correspond to and support each protruding end, and at least a part of the pair of protruding end support portions may extend into a gas chamber defined at least in part by the seal-forming structure; (n) the lower part of the seal-forming structure may seal against the patient's upper lip and may be concave in a relaxed state to follow the curvature of the patient's upper lip, and / or(o) The seal-forming structure may include 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 an air pressure seal.,

[0051] Another aspect of the present technology is directed to a positioning and stabilizing structure for a patient interface device. The positioning and stabilizing structure may include at least one strap and at least one rigidizer arm, the at least one rigidizer arm including a body and an extension for connecting the body to the mask frame, and the positioning and stabilizing structure is arranged such that at least one rigidizer arm positions at least one strap and at least one rigidizer arm relative to each other such that at least a hardened portion of the at least one strap is movable relative to the at least one rigidizer arm, and the at least one rigidizer arm provides a predetermined shape to the at least one strap at the hardened portion of the at least one strap that allows the at least a hardened portion of the at least one strap to move relative to the at least one rigidizer arm, and the extension may be configured to prevent movement of the at least one rigidizer arm relative to the mask frame in a plane parallel to the sagittal plane of the patient.

[0052] In an embodiment, (a) at least one rigidizer arm may be attached to at least one strap at only one local point or region, (b) at least one rigidizer arm may be attached to at least one strap in a limited region of the at least one strap, (c) the limited region may be adjacent to a pocket or sleeve opening of the at least one strap, (d) at least one rigidizer arm may be deformable in multiple axial directions to conform to the contour of the patient's face, (e) at least one rigidizer arm may be formed to extend from the mask frame to a position near the patient's cheekbone or a position below the cheekbone, (f) at least one rigidizer arm may have a crescent-shaped side profile, (g) an end of the at least one rigidizer arm may be attached to the at least one strap, (h) at least one rigidizer arm may be attached to the at least one strap by sewing, welding, adhesion, heat staking, clamping, buttoning, snap-fastening a cover over an end, and / or snap-fastening to an external component, (i) the given predetermined shape may direct the pressure of the positioning and stabilizing structure to a predetermined portion of the wearer's face, (j) at least one rigidizer arm may not be stretchable and may have a relatively greater rigidity than the at least one strap, (k) the positioning and stabilizing structure may include two or more rigidizer arms symmetrically arranged on both sides of the patient's face, (l) at least one rigidizer arm may be completely removable from the at least one strap, (m) the at least one strap may include two pockets, each pocket receiving one rigidizer arm for releasably fixing the at least one strap to the rigidizer arm, (n) the at least one strap may include at least one retaining means, the retaining means including a loop, sleeve, and / or pocket for receiving the at least one rigidizer arm and holding the at least one rigidizer arm in a predetermined position, (o) at least one rigidizer arm may include at least one retaining means, the retaining means beingIt may include a loop, a sleeve, and / or a pocket for receiving at least one strap and holding the at least one strap in a predetermined position. (p) At least one rigidizer arm may be attached to a guiding element provided on the at least one strap. (q) The guiding element may be a loop-shaped part, a sheath-shaped part, a passage, or a pocket through which the at least one rigidizer arm enters and extends or passes through and extends. (r) The guiding element may allow longitudinal expansion or contraction of the at least one strap relative to the at least one rigidizer arm, and / or may allow substantially free movement or play of the at least one rigidizer arm relative to the at least one strap. (s) The extending portion may be configured to allow bending of the at least one rigidizer arm in a plane parallel to the Frankfort horizontal plane of the patient. (t) The extending portion may have a width substantially equal to that of the main body. (u) At least one strap may be substantially inelastic so that the length of the positioning and stabilizing structure can be adjusted by at least one of bending of the at least one rigidizer arm, a ladder lock clip, a buckle connection, and a hook-and-loop connection. (v) In a patient interface system for delivering a breathing gas flow that is continuously at a positive pressure relative to atmospheric pressure to an inlet of a patient's airway, including at least the inlet of the patient's nostrils, the patient interface is, for example, about 4 cmH above atmospheric pressure during use, 2 O to about 30 cmH 2 O above, for example, generally about 10 cmH 2configured to maintain a treatment pressure within a range that does not exceed O, and the patient interface system may include a positioning and stabilizing structure according to any one or more of the previous examples and a patient interface, the patient interface being a seal-forming structure for supplying pressurized gas to at least both nostrils of the patient and a plenum chamber pressurized at a pressure exceeding atmospheric pressure during use, the seal-forming structure and the plenum chamber being integrally formed, the plenum chamber including a plenum connection region, and the seal-forming structure being configured to seal below the nasal bridge across the lower outer periphery of the patient's nose, a seal-forming structure, and CO exhaled by the patient 2 To minimize rebreathing of, the CO exhaled by the patient 2 a gas outflow vent configured to allow flow of the patient interface to the outside of the patient interface, and a frame that can be releasably attached to the plenum connection region. (w) The extension may be non-removably fixed to the mask frame, and the body may be removable from the extension, and / or (x) the extension and the body may be integrally formed, 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 predetermined amount of pressurized air or breathing gas to the inlet of a patient's airway. The cushion member includes a retaining structure for engagement with and disengagement from a reusable frame member, and a seal-forming structure in which a nose opening for supplying pressurized gas to both nostrils of the patient and a plenum chamber are integrally formed, the seal-forming structure being configured to seal below the nasal bridge across the lower outer periphery of the patient's nose, and the seal-forming structure and the plenum chamber being non-removably connected to the retaining structure, and the seal-forming structure may include a seal-forming structure, the seal-forming structure being formed of a first material, the retaining structure being formed of a second material having mechanical properties different from those of 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 an embodiment, (a) the first material may be silicone, and the second material may be silicone having a higher durometer than the first material; (b) the cushion member may include a plenum chamber positioned between the holding structure and the seal-forming structure; (c) the cushion member may include a frame member formed of the second material; (d) the first material may be such that the seal-forming structure can easily adapt to finger pressure, and the second material may be such that the holding structure does not easily adapt to finger pressure; (e) the seal-forming structure may include a recess for receiving the top of the patient's nose; (f) the adaptation region may be located above the recess, and the adaptation region is thinner and more flexible than the rest of the seal-forming structure; (g) the seal-forming structure may include a foam, a gel, and / or a low durometer silicone; (h) the thickness of the seal-forming structure may vary at a predetermined position around the nasal opening; (i) the seal-forming structure may include a pair of protruding ends that extend symmetrically around the nasal opening, and each protruding end may be configured to seal against a facial region of the patient where the nasal wing connects to the patient's face; (j) the seal-forming structure may include a pair of protruding end support portions that correspond to and support each protruding end, and at least a part of the pair of protruding end support portions may extend into a gas chamber defined at least in part by the seal-forming structure; (k) the lower part of the seal-forming structure may seal against the patient's upper lip and may be concave in a relaxed state to follow the curvature of the patient's upper lip; (l) the seal-forming structure may include 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 an air pressure seal, and / or; (m) in a patient interface for delivering a breathing gas flow that is continuously positively pressurized with respect to atmospheric pressure to at least an inlet of the patient's airway including at least the inlet of the patient's nostrils in a sealed state, the patient interface is configured to improve sleep apnea by maintaining, throughout the entire patient's breathing cycle while the patient is asleep, a pressure of about 4 cmH 2 O to about 30 cmH 2configured to maintain a therapeutic pressure within a range that does not exceed O, the patient interface including any one of the cushion members of the previous examples, a positioning and stabilization structure for maintaining the cushion member in sealing contact with at least the area surrounding the patient's nasal airway entrance while maintaining the therapeutic pressure at least at the entrance to the patient's nasal airway, a plenum chamber pressurized at a pressure exceeding atmospheric pressure during use, and CO 2 To minimize rebreathing of the exhaled by the patient, the CO exhaled by the patient 2 and a gas outflow vent configured to allow the flow of the gas to the outside of the patient interface. A patient interface comprising

[0055] Another aspect of the present technology is directed to a patient interface for delivering breathing gas to a patient. The patient interface is a seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nostrils of the patient are integrally formed, the plenum chamber including a plenum connection region, and the seal-forming structure being configured to seal below the nasal bridge across the lower outer periphery of the patient's nose, and may include a frame having a frame connection region and a headgear connection region, the frame connection region being configured to attach to the plenum chamber at the plenum connection region, and a seal lip being configured to form an air pressure seal between the plenum connection region and the frame connection region.

[0056] In an embodiment, (a) the frame connection region may include at least one holding function part to facilitate connection with the plenum connection region, and the plenum connection region may include at least one complementary connection region to receive the corresponding at least one holding function part; (b) the at least one holding function part may be a hook-shaped part, the hook-shaped part may have a front surface and a rear surface, and the at least one complementary connection region may include a drawing-in surface and a holding surface; (c) the seal forming structure may include a recess for receiving the top of the patient's nose; (d) the conforming region may be located above the recess, and the conforming region is thinner and more flexible than the rest of the seal forming structure; (e) the seal forming structure may include a foam, a gel, and / or a low durometer silicone; (f) the thickness of the seal forming structure may vary at a predetermined position around the nasal opening; (g) the seal forming structure may include a pair of protruding end parts that symmetrically extend around the nasal opening, and each protruding end part may be configured to seal against the facial region of the patient where the nasal wing is connected to the patient's face; (h) the seal forming structure may include a pair of protruding end part support parts that correspond to and support each protruding end part, and at least a part of the pair of protruding end part support parts may extend into a gas chamber defined by the seal forming structure; (i) the lower part of the seal forming structure may seal against the patient's upper lip and may be concave in a relaxed state to follow the curvature of the patient's upper lip, and / or; (j) the seal forming structure may include 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 an air pressure seal.

[0057] Another aspect of the present technology is directed to a cushion member for a nasal cradle mask for delivering a predetermined amount of pressurized air or breathing gas to the inlet of a patient's airway. The cushion member includes a retention structure for engagement with and disengagement from a reusable frame member, and a seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nostrils of the patient are integrally formed, the seal-forming structure being configured to seal below the nasal bridge across the lower outer periphery of the patient's nose, and the seal-forming structure and the plenum chamber being non-removably connected to the retention structure. 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 retention structure and the frame member is higher than the detachment force for detaching the retention structure from the frame member.

[0058] In an embodiment, (a) the seal-forming structure may include a recess for receiving the top of the patient's nose, (b) the compliant region may be located above the recess, and the compliant region is thinner and more flexible than the rest of the seal-forming structure, (c) the seal-forming structure may comprise a foam, a gel, and / or a low durometer silicone, (d) the seal-forming structure may have a varying thickness at a predetermined position around the nasal opening, (e) the seal-forming structure may include a pair of protruding end portions that extend symmetrically around the nasal opening, and each protruding end portion may be configured to seal against the patient's facial region where the alae nasi connect to the patient's face, (f) the seal-forming structure may include a pair of protruding end portion support portions structured to correspond to and support each protruding end portion, and at least a part of the pair of protruding end portion support portions may extend into a gas chamber defined at least in part by the seal-forming structure, (g) the lower portion of the seal-forming structure may seal against the patient's upper lip and may be concave in a relaxed state to conform to the curvature of the patient's upper lip, (h) the seal-forming structure may include 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 an air pressure seal, and / or (i) in a patient interface for delivering a breathing gas flow that is continuously positively pressurized relative to atmospheric pressure to at least an inlet of the patient's airway including at least the patient's nostrils, the patient interface is configured to maintain a treatment pressure within a range above about 4 cmH 2 O to about 30 cmH 2 O during the entire respiratory cycle of the patient while the patient is sleeping to improve sleep apnea, and the patient interface includes any of the cushion members of the previous examples, a positioning and stabilizing structure for maintaining the cushion member in sealing contact with at least a region surrounding at least the inlet of the patient's nasal airway while maintaining the treatment pressure at the inlet of the patient's nasal airway, a plenum chamber pressurized at a pressure above atmospheric pressure during use, and CO 2 minimizing rebreathing of the exhaled by the patient, and CO 2A patient interface comprising a gas outflow vent configured to allow flow to the outside of the patient interface.

[0059] Another aspect of the technology is directed to a cushion member for a patient interface for delivering a predetermined amount of pressurized air or breathing gas to an inlet of a patient's airway. The cushion member includes a retention structure for engagement with and disengagement from a reusable frame member, and a seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nostrils of the patient are integrally formed, the seal-forming structure being configured to seal below the nasal bridge across the lower outer periphery of the patient's nose, and the seal-forming structure and the plenum chamber being non-removably connected to the retention structure, and the seal-forming structure may include a recess for receiving the top of the patient's nose, and the seal-forming structure includes a pair of protruding end portions symmetrically extending around the nasal opening, each protruding end portion being configured to seal against a facial region of the patient where the alae nasi connect to the patient's face.

[0060] In an embodiment, (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 an air pressure seal, (b) the compliant region may be located above the recess, the compliant region being thinner and more flexible than the rest of the seal-forming structure, (c) the seal-forming structure may comprise a foam, a gel, and / or a low durometer silicone, (d) the seal-forming structure may vary in thickness at a predetermined position around the nasal opening, (e) the seal-forming structure may include an overhang portion at the nasal opening of the seal-forming structure, the overhang portion being located near the recess, (d) 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 extending at least partially into a gas chamber defined by the seal-forming structure, (e) the lower portion of the seal-forming structure may seal against the patient's upper lip and be concave in a relaxed state to conform to the curvature of the patient's upper lip, (f) the lower portion may have a reduced material thickness relative to the rest of the seal-forming structure, and / or (g) in a patient interface for delivering a breathing gas flow that is continuously positively pressurized relative to atmospheric pressure to at least an inlet of the patient's airway including the patient's nostrils in a sealed state, the patient interface is configured to maintain a therapeutic pressure within a range above about 4 cmH 2 O to about 30 cmH 2 O above atmospheric pressure during use, the patient interface comprising a cushion member of any of the previous examples, a positioning stabilization structure for maintaining the cushion member in sealed contact with at least a region surrounding the inlet to the patient's nasal airway while maintaining the therapeutic pressure at least at the inlet to the patient's nasal airway, a plenum chamber pressurized at a pressure above atmospheric pressure during use, and CO 2 rebreathing by the patient to a minimum, and CO 2The patient interface may include a gas outflow vent configured to permit flow to the exterior of the patient interface.

[0061] Another aspect of the technology is directed to a patient interface system for delivering breathing gas to a patient. The patient interface may include a patient interface including a seal-forming structure for making a pneumatic connection to the patient's airway, and a positioning and stabilization structure including at least one strap and at least one rigidizer arm and configured to releasably hold the patient interface relative to the patient, where the at least one strap may be non-removably attached to the at least one rigidizer arm at an attachment point.

[0062] In an embodiment, (a) the attachment point may include ultrasonic welding, (b) the attachment point may include heat staking, (c) the attachment point may include a seam, (d) the attachment point may include a hinged mechanism, and / or (e) the attachment point may include a hook on the at least one rigidizer arm.

[0063] Another aspect of the technology is directed to a patient interface system for delivering breathing gas to a patient. The patient interface may include a patient interface including a seal-forming structure for making a pneumatic connection to the patient's airway, and a positioning and stabilization structure including at least one strap and at least one rigidizer arm and configured to releasably hold the patient interface relative to the patient, where the at least one strap may be removably attached to the at least one rigidizer arm.

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

[0065] Another aspect of the technology is directed to a patient interface system for delivering breathing gas to a patient. The patient interface may comprise a patient interface including a seal-forming structure for making an air pressure connection to the patient's airway, and a positioning stabilization structure including at least one strap and at least one rigidizer arm and configured to releasably hold the patient interface relative to the patient, wherein at least one rigidizer arm may be releasably attachable to a frame of the patient interface, the frame supporting the seal-forming structure relative to the patient's face.

[0066] In an embodiment, (a) at least one rigidizer arm can be releasably attached to a corresponding extension of the frame with a rotational lock structure, (b) the patient interface may further include a pin and a corresponding socket for releasably attaching at least one rigidizer arm to an extension of the frame, (c) at least one rigidizer may further include an arm and a protrusion supported on a shaft for releasably attaching at least one rigidizer arm to an extension of the frame at a shaft receiving portion and an arm receiving portion, (d) at least one rigidizer arm may include an extension for releasably attaching to a receiving portion of the frame by snap fit, (e) at least one rigidizer arm may include an extension for releasably attaching to a receiving portion of the frame by press fit, (f) at least one rigidizer arm may include an extension having a support for releasably attaching to a receiving portion of the frame by snap fit, and the extension may further include an end for preventing rotation about the longitudinal axis of the support, (g) the frame may include at least one slot, and for releasable attachment, a corresponding at least one rigidizer arm may be passed through the slot, and at least one rigidizer arm may include a locking end, (h) at least one rigidizer arm may include an extension having a pin for releasably attaching to a socket of the frame by snap fit, (i) for releasably attaching at least one rigidizer arm to the frame, at least one rigidizer arm may include a first magnet, and the frame may include a second magnet, (j) at least one rigidizer arm may include a first L-shaped portion having at least one post, the frame may include a second L-shaped portion having at least one hole, and at least one rigidizer arm may be releasably attached to the frame by engagement between at least one post and at least one hole, (k) the frame may include a boss, and at least one rigidizer arm may include a cavity for releasably attaching to the boss, and / or,(l) For releasable attachment between at least one rigidizer arm and the frame, the at least one rigidizer arm may comprise a protrusion and a hole, and the extension of the frame may comprise 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 delivering breathing gas to a patient. The patient interface includes a patient interface including a seal-forming structure for making a pneumatic connection to the patient's airway, and a positioning and stabilizing structure including at least one strap and at least one rigidizer arm and configured to releasably hold the patient interface against the patient, wherein the extension couples each of the at least one rigidizer arm to the frame of the patient interface, and the frame supports the seal-forming structure against the patient's face.

[0068] In an embodiment, (a) the at least one rigidizer arm may comprise ribs at the bent portion to resist deformation at the bent portion, (b) the extension may comprise ribs at the bent portion to resist deformation at the bent portion, and / or (c) the extension may comprise longitudinal ribs along the straight portion and the bent portion of the extension to resist deformation.

[0069] Another aspect of the present technology is directed to a patient interface for delivering a breathing gas stream that is continuously positively pressurized relative to atmospheric pressure to an inlet of a patient's airway, including at least the inlet of the patient's nostrils, in a sealed state. The patient interface is for improving sleep disordered breathing, such as sleep apnea, and during the patient's sleep, over the entire respiratory cycle of the patient, about 4 cmH 2 O to about 30 cmH 2 O above, for example, generally about 10 cmH 2configured to maintain a therapeutic pressure within a range above atmospheric pressure, the patient interface comprising a seal structure for forming a seal at least with the patient's nasal airway, a positioning and stabilization structure for maintaining the seal structure in sealing contact with at least a region surrounding an inlet to the patient's nasal airway while maintaining the therapeutic pressure at the inlet to the patient's nasal airway, a plenum chamber pressurized with a pressure above atmospheric pressure during use, and a gas outflow vent configured to allow flow of CO 2 exhaled by the patient to the exterior of the patient interface to minimize rebreathing of CO 2 exhaled by the patient.

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

[0071] Other features of the present technology will become apparent by considering the information included in the following detailed description, summary, drawings, and claims.

[0072] 5 (E) BRIEF DESCRIPTION OF SOME OF THE DRAWINGS The present technology is shown by way of example in the figures of the following attached drawings and is not shown in a limiting sense. In the figures, like reference numerals indicate like elements.

BRIEF DESCRIPTION OF THE DRAWINGS

[0073] 5.1 Treatment System

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【Figure 163]] A side view of a short tube in a curved state according to an example of the present technology is shown.

【Figure 164]] A cross-sectional view of a short tube along line 163-163 shown in Figure 163 according to an example of the present technology is shown.

【Figure 165]] A perspective view of a curved extended state short tube according to an example of the present technology is shown.

【Figure 166]] A perspective view showing a patient interface system according to one form of the present technology for a patient to wear and use.

【Figure 167]] A chart depicting the vertical plane airflow velocity (m / s) along the x-axis and z-axis from the vents of a SWIFT FX (registered trademark) nasal pillow mask by ResMed Limited.

【Figure 168]] A chart depicting the horizontal plane airflow velocity (m / s) along the x-axis and y-axis from the vents of a SWIFT FX (registered trademark) nasal pillow mask by ResMed Limited.

【Figure 169]] A chart depicting the vertical plane signal along the x-axis and y-axis from the vents of a SWIFT FX (registered trademark) nasal pillow mask by ResMed Limited.

【Figure 170]] A chart depicting the horizontal plane signal along the x-axis and y-axis from the vents of a SWIFT FX (registered trademark) nasal pillow mask by ResMed Limited.

【Figure 171]] A chart depicting the vertical plane airflow velocity (m / s) along the x-axis and z-axis from the vents of a patient interface system according to one form of the present technology.

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Mode for Carrying Out the Invention

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

[0075] 6.1 Treatment System In one form, the present technology comprises an apparatus for treating a respiratory disease. The apparatus may comprise a flow generator or blower for supplying a pressurized breathing gas, such as air, to a patient 1000 via an air circuit 4170 that leads 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 disease that comprises the step of applying a positive pressure to the inlet of a patient's airway 1000.

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

[0078] 6.3 Patient Interface 3000 Referring to FIG. 166, a non-invasive patient interface 3000 according to one aspect of the present technology comprises the following functional aspects, namely, a seal-forming structure 3100 (see, e.g., FIG. 4), a plenum chamber 3200, a positioning and stabilization 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 arranged to surround the inlet to the patient's airway 1000 to facilitate the supply of positive-pressure air to the airway.

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

[0080] The seal formation structure 3100 according to the present technology may be composed of a flexible, flexible, elastic material such as silicone. The seal formation structure 3100 may form part of a seal path for delivering air from the PAP device to the patient's nostrils.

[0081] Referring to FIG. 9, in one form of the present technology, the seal formation structure 3100 may include a seal flange 3110 and a support flange 3120. The seal flange 3110 may include 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 seal flange 3110. The support flange 3120 is a spring-like element or includes a spring-like element and functions to support the seal flange 3110 so as not to buckle during use. During use, the seal flange 3110 can easily respond to the system pressure in the plenum chamber 3200 acting on the lower surface of the seal flange to urge the seal flange into a tight seal engagement state with the face, for example, the patient's nostrils. The plenum chamber 3200 is formed of a soft material such as silicone.

[0082] 6.3.1.1 Nasal pillows In one form of the present technology, the seal formation structure 3100 of the non-invasive patient interface 3000 includes a pair of nasal puffs or a pair of nasal pillows 3130, and each nasal puff or nasal pillow is configured and arranged to form a seal with each nostril of the patient's nose by applying against the outer peripheral region of the patient's nostril, for example, to form a seal.

[0083] The nasal pillow 3130 (FIG. 9) according to one aspect of the present technology includes a frustum 3140, at least a part of which forms a seal on the lower surface of the patient's nose, for example, at the frustum part, a stem portion 3150, and an upper flexible region 3142 on the lower surface of the frustum 3140 that connects the frustum to the stem portion 3150. Further, the structure to which the nasal pillow 3130 of the present technology is connected includes a lower flexible region 3152 adjacent to the base of the stem portion 3150. The upper flexible region 3142 and the lower flexible region 3152 can cooperate to act so as to facilitate a universal joint structure that accommodates both relative movement-displacement and tilting 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 stem portion 3150 to which it is connected. In other examples, the frustum 3140 and the stem portion 3150 may not be coaxial (for example, offset). The nasal pillow 3130 may be sized and / or formed such that, as described later, they extend laterally beyond the wall of the plenum chamber 3200.

[0084] In one form of the technology, each stem portion 3150 may have variable stiffness so that the nasal pillow 3130 does not swing forward due to compression and / or bending of the stem portion 3150 during use. For example, the side of the stem portion 3150 that is away from the patient's face during use may be stiffer than the region of the stem portion 3150 that is close to the patient's face. In other words, different material stiffnesses on both sides of the stem portion 3150 provide greater resistance if the compression or bending of the stem portion 3150 is not in a predetermined direction. This makes it possible to even press the nasal pillow 3130 against the nostrils by preventing the pillow 3130 from swinging forward. Such a configuration can help resist buckling of the stem portion 3150 that causes the nasal pillow 3130 to swing forward. Also, the variable stiffness may be used to provide a weak point where rocking is promoted around the stem portion 3150 so that the stem portion 3150 buckles in a desired direction. In other words, it is even possible to achieve compression of the nasal pillow 3130. This configuration may localize the sealing force at the upper end of the nasal pillow 3130. Also, this configuration may gently relieve any deflection of the nasal pillow 3130. The nasal pillow 3130 may be formed to compress against the plenum chamber 3200 when pressed against the patient's face, and in that case, the nasal pillow 3130 can be wider laterally than the plenum chamber so that a portion of the plenum chamber 3200 does not extend beyond the pillow 3130. In other examples, the nasal pillows 3130 may be formed and / or sized such that their outer perimeters are in substantially the same plane as the outer perimeter of the plenum chamber 3200 when compressed. In a further example of the technology, the stem portion 3150 may be thinnest at the base of the frustum 3140.

[0085] In one example, to engage the pillow 3130 with the patient's airway inlet, the pillow 3130 is positioned at the nasal inlet. When the positioning stabilization structure 3300 is adjusted, tension begins to draw the pillow 3130 into the nasal cavity. Due to the continuous insertion of the pillow 3130 into the nasal cavity, the handle 3150 is crushed by a trampoline 3131 that moves the base of the pillow 3130 to the upper surface of the plenum chamber 3200. The handle 3150 of the nasal pillow 3130 may be connected to the plenum chamber 3200 and may include a thin-walled portion or a thickness reduction portion. The thin-walled portion allows the pillow 3130 to bounce easily or perform a trampoline action, thus enabling the pillow 3130 to more easily adapt to the alar angle of the patient 1000. The trampoline 3131 may be tilted 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 contemplated that nasal pillows 3130 of various sizes may be used with a plenum chamber having a commonly sized connection region and a plenum connection region. This has the advantage of being able to mate the patient with a plenum chamber 3200 and a pillow 3130 sized to best fit that patient's particular anatomy, such as the size and orientation of the nasal cavity.

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

[0088] 6.3.2 Nasal Cradle During use, a small portion of the nasal pillow 3130 may enter the patient's nostrils, but another form of the seal-forming structure 3100 is substantially outside the nose during 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 around both nostrils without entering the nostrils against the patient's airway. The seal-forming structure 3100 may handle both nostrils using a single orifice, such as a nasal cradle. In FIG. 34, the seal-forming structure 3100 according to the depicted example includes a nasal flange 3101 disposed over its outer 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 Figures 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. Figures 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 nasal wings and the nasal apex. This seal - forming structure 3100 may at least partially define a gas chamber 3104, which is discussed in more detail below. During treatment, breathing gas may be provided to the patient from the patient interface 3000 through the gas chamber 3104 to the nose. When the patient interface 3000 is worn by the patient, the seal - forming structure 3100 may at least partially define the gas chamber 3104 together with the patient's face, and it should be understood that breathing gas may be provided to the patient at positive pressure through the gas chamber 3104. For example, the seal - forming structure 3100 in the form of a nasal cradle may seal below the nasal bridge (e.g., in the transition region between the nasal bone and cartilage), or may seal at or below the patient's nasal apex, the sides of the nose, and / or the upper lip. According to other examples of the present technology, the seal - forming structure 3100 in the form of a nasal cradle cushion may be structured to seal around the lower nose. In other words, the seal may be formed with the lower surface of the patient's nose. It should also be understood that the nasal cradle cushion is different from a nasal pillow. This is because the nasal cradle cushion can handle both nostrils with a single orifice and can be structured not to enter the patient's nostrils. The seal - forming structure 3100 may be a single - wall cushion, or the seal - forming structure 3100 may be a double - wall cushion. For example, the seal - forming structure may include an under - cushion. Alternatively, in order to form a reliable air - pressure seal around the patient's nose, the under - cushion may be omitted and a roll - edge may be used around the opening of the seal - forming structure 3100.

[0090] Projecting end portions 3114 can be seen on both sides of the seal forming structure 3100. Each projecting end portion 3114 may be formed to extend from the patient interface 3000 so as to seal within the gap between each alar nose wing and nasolabial groove of the patient when worn by the patient 1000. FIG. 2c depicting the surface morphology of the face shows the positions of the alar nose wings and nasolabial grooves. The projecting end portions 3114 may bulge and / or deform partially so as to seal in this region. According to an example of the present technology, the concave lower portion 3212 of the seal forming structure 3100 that is below the opening to the gas chamber 3104 may seal against the upper lip of the patient. The concave lower portion 3212 may be curved to substantially conform to a part of the upper lip of the patient in order to form a seal in that region. 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 projecting end portions 3114. Since the upper lips of most patients are convex, the concave lower portion 3212 can be easily adapted to this part of the patient's face so as to form an effective seal. The rear portion of the seal forming structure 3100 that can seal against the upper lip of the patient and is below the opening to the gas chamber 3104 may be formed and dimensioned so as not to cover the nostrils of the patient during use in order to ensure a continuous path for the inflow of pressurized gas into the patient's airway. According to another example of the present technology, the seal forming structure 3100 may be softened in the rear lower region of the seal forming structure that seals against the upper lip of the patient, for example by reducing the thickness of the material.

[0091] Figures 233a - 233h show how a typical patient interface 3000 can seal against a patient 1000, particularly the nose. It should be understood that the seal - forming structure 3100 may be shaped concave so as to sandwich the patient's nose. The recess 3116 may receive the top of the patient's nose, and the protruding end portion 3114 may seal in the area of the nasal wing and nasolabial groove. The protruding end portion 3114 may seal against the patient's face and nose in the area where the nasal wing connects to the patient's face near the nasolabial groove. (See FIGS. 2c, 2d, 2f). In most patients, this area is concave in shape, and thus the protruding end portion 3114 extends into this area and is adapted to seal within this area. The protruding end - support portion 3208 may support the nasal cushion 3112 in the area of the protruding end portion 3114, helping to maintain the seal in this area and may function like an under - cushion. In another example, the seal - forming structure 3100 may include a rolled edge around the perimeter 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] Figures 223 - 232 also show that the recess 3116 may be included in the seal - forming structure 3100. This recess 3116 may include an inward - formed portion that extends into the nasal gas chamber 3104 to receive the top of the patient's nose when worn by the patient. The recess 3116 may enhance the seal around and below the top of the patient's nose during treatment by making the shape of the seal - forming structure 3100 fit better 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 so that the seal - forming structure can fit better to the top of the patient's nose and seal around the top of the patient's nose.

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

[0094] A patient interface 3000 according to an example of the present technology has a surface area occupation region on the face that is much less obtrusive by a significant percentage than a conventional nasal face mask. For some patients, it causes little to no claustrophobia. Also, certain areas with fewer obstructions are important. This is because when a bed partner sees the mask, the mask appears less medical and "opens up" the face, and it has been found that these areas have a fairly beneficial psychological effect on the bed partner. From the patient's perspective, a typical patient interface 3000 is not within or is significantly reduced from the patient's field of view. This is because the seal-forming structure 3100 seals below the nasal bridge. As a result, after wearing the patient interface 3000, a patient can wear glasses when reading a book or watching TV before going to sleep. By sealing below the nasal bridge, it is possible to avoid inflammation in areas where the skin is thin, pressure-sensitive, and there is a high chance of skin damage due to blood flow obstruction. Another advantage may be that it is not necessary to consider anthropometric variations among patients above the nasal bridge, and the focus for the mask fitting range can be directed to anthropometric variations around the upper lip region. Also, unlike some other full-face masks, the patient interface 3000 may not require a forehead support that may be needed for pressure point reduction. This can also avoid the problem that the forehead support can be 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, FIGS. 2h and 2i may be referred to for a view of the location of the transition region between the nasal bone and cartilage that may be understood to define the bridge of the nose. Thus, a typical seal-forming structure 3100 may seal across the perimeter of a patient's nose in contact with softer nasal tissues, such as adipose tissue or cartilage. By forming a seal with these soft tissues along with the nose, it may be possible to avoid inflammation of the patient's skin that would otherwise occur if a seal were formed around / over a harder nasal structure, i.e., the bone. In other words, by sealing below the bridge of the nose, patient discomfort can be minimized. Also, by positioning the seal of the seal-forming structure 3100 around this region of the nose, an effective seal can 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 is primarily conformable to the nose.

[0096] The seal function described above is at the site of the protruding end 3114 that abuts the patient's face 1000. Specifically, the protruding end 3114 may be an extension of the seal-forming structure 3100 that seals in the region between the nasolabial fold and the alar nose. These anatomical features can be seen in FIG. 2c. Depending on the individual facial structure of the patient, this region may correspond to a recess. Therefore, an extension from the seal-forming structure 3100 may be necessary to form an appropriate seal around the patient's nose. The protruding end 3114 is preferably capable of performing this function.

[0097] Another sealing functional part of the typical patient interface 3000 is a recess 3116 for receiving the top of the nose of the patient 1000 when the seal forming structure 3100 is worn by the patient. Specifically, as shown in FIGS. 233a to 233h, the top of the nose of the patient 1000 can be seen by a broken line in the area where the recess 3116 is located. The seal forming structure 3100 may be formed to seal against the outer periphery of the nose on the lower surface of the nose. In other words, the seal formed by the seal forming structure 3100 against the nose may be characterized as being against the lower outer peripheral part of the nose. Therefore, it can be understood that the seal surface of the seal forming structure 3100 may be concave as a whole to receive the nose or may form a pocket, and the seal surface of the seal forming structure may further include a recess 3116 for receiving the top of the nose.

[0098] The seal forming structure 3100 may seal against the top 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 breathing gas to enter the patient's airway through the nostrils.

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

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

[0101] The protruding end support portion 3208 can be seen on both sides of the seal - forming structure 3100. The protruding end support portion 3208 may be located below the protruding end 3114 of the seal - forming structure 3100. The protruding end support portion 3208 may be included to support the protruding end 3114 of the seal - forming structure 3100.

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

[0103] Figures 234a-234c show that the seal forming structure 3100 can curve slightly upward as it approaches the distal long side 3104.1 of the opening from the recess 3116 to the gas chamber 3104. The front upper part of the seal forming structure 3100 near the recess 3116 includes a slight depression or concave region at its center such that the seal forming structure 3100 is higher on both sides than at the center. Also shown in dashed lines is the outer shape of the nose to illustrate how the patient's nose can be positioned relative to the seal forming structure 3100. The top 3118 of the seal forming structure 3100 serves to seal in front of the nostrils. The top may be located further back, but may gradually increase in size to create a ballooning effect to seal against the nostrils. The distal long side 3104.1 may be turned up from the seal forming structure 3100, may enhance the seal at the nose apex by contacting the nose, or may provide a compressed air pressure seal by pinching the nose. Also shown is a recess 3116 formed to receive the top of the nose.

[0104] Figures 235a-235c also show the protruding end portions 3114 on both sides of the seal forming structure 3100. The outer shape of the seal forming structure 3100 may slope downward as it approaches the distal side 3104.1 opening from the recess 3116 to the gas chamber 3104. 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 side 3104.1 of the opening to the gas chamber 3104 compared to the example shown in Figures 234a-234c.

[0105] Figures 236a-236c show that the shape of the opening to the gas chamber 3104 may be more balloon-shaped and rounded than the examples shown in Figures 234a-234c and Figures 235a-235c. The seal forming structure 3100 may have straight side walls as opposed to side walls that curve smoothly from the top surface of the seal forming structure 3100. The straight side walls may have a predetermined upper edge and may also enhance 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. A linear sidewall of a typical nose cushion 3112 may be included.

[0107] Also, it should be understood that in FIGS. 234a - 234c, FIGS. 235a - 235c, and FIGS. 236a - 236c, a typical seal forming structure 3100 is shown in a substantially undeformed state. Some of the figures may show a small amount of deformation due to the conformity with the shape of the nose shown by the dashed line. Thus, the seal forming structure 3100 may have a concave shape as shown when not deformed.

[0108] Also, it should be understood that the seal forming structure 3100 may have a cross - section with a varying thickness as shown in FIGS. 238a - 238c. Thus, the region of the seal forming structure 3100 near the opening to the gas chamber 3104 may be thinner than the region where the seal forming structure 3100 attaches to the plenum chamber 3200. Preferably, this may provide greater comfort to the patient by providing a thinner and thus more compliant region of the cushion material at the site where a large 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 outer periphery of the nose cushion 3112.

[0110] In the seal forming structure 3100, a thickness that smoothly changes from region 3112.1 to region 3112.3 is provided. Also, the thickness x may be thinner than the thickness z. Region 3112.2 may be thicker more abruptly than regions 3112.1 and 3112.3. Also, the thickness x may be thinner than the thickness z, and the thickness y may be thicker than x and z. Region 3112.2 may be thicker more abruptly than regions 3112.1 and 3112.3. Also, the thickness z may be thinner than the thickness x, and the thickness y may be thicker than x and z.

[0111] FIG. 239 shows another exemplary seal forming structure 3100 according to the present technology, and the opening to the gas chamber 3104 and the protruding end 3114 are shown to enable an understanding of the direction of the seal forming structure 3100. To better show where the thickness of the seal forming structure 3100 can vary, regions of various thicknesses are hatched differently. Region 3113 may be the thinnest so as to easily conform to the top of the nose. Region 3113 may have a thickness of about 0.35 mm according to an 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 an example of the present technology. Region 3117 may be thicker than other regions to provide maximum support and resistance to deformation and to ensure an effective seal at the patient's nasal wings. Region 3117 may have a thickness of about 1 mm according to an example of the present technology.

[0112] The lower end corner of the seal forming structure 3100 may be more rigid compared to other regions of the seal forming structure 3100 to prevent or minimize deformation at the lower end corner. By having a higher level of rigidity at the lower end corner of the seal forming structure 3100, it is less likely to interfere with the seal at these positions of the seal forming structure 3100, especially when receiving tube torque.

[0113] Figures 245a - 245k depict further examples of the present technology. In these figures, the seal - forming structure 3100, the plenum chamber 3200, and the retaining structure 3242 are shown removed from a frame 3310 (not shown in these figures). These figures show a protruding - end support portion 3208 that extends inwardly from the seal - forming structure 3100 and the 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 that extends into the interior of the patient interface 3000. As can be seen in Figure 245d, the protruding - end support portion 3208 may be regarded as a pocket formed on the sides of the seal - forming structure 3100 and the plenum chamber 3200. The protruding - end support portion 3208 may be integrally formed with the seal - forming structure 3100 and the plenum chamber 3200. In another example, the protruding - end support portion 3208 may not be hollow, but rather a solid extension 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 a further support structure composed of a material harder than the seal - forming structure 3100 and the plenum chamber 3200. According to one example of the present technology, it should be understood that 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 engaged with the patient's nose in a sealed state. When the patient wears the patient interface 3000, the seal - forming structure 3100 and the plenum chamber 3200 may be deformed, and the protruding end 3114 may be pressed against the protruding - end support portion, thereby preventing the crushing of the protruding end and supporting the protruding end against the patient. For example, the protruding - end support portion 3208 may support each protruding end 3114 as the protruding end is deformed due to the sealed engagement with the patient's face at the junction between the alar and the facial surface.

[0115] Further, the protruding end support portion 3208 may have an outer shape such that the cross-sectional area of the protruding end support portion decreases as the protruding end support portion extends into the gas chamber 3104. As shown in FIGS. 245g and 245i to 245k, the end of the protruding end support portion 3208 extending into the gas chamber 3104 may be flat, or alternatively, the tip of the protruding end support portion may taper. The wall forming the protruding end support portion 3208 may increase or decrease in thickness toward the gas chamber 3104. Also, it is envisioned that the protruding end support portion 3208 may have a curved outer shape. For example, the protruding end support portion 3208 may have a curved outer shape that generally follows the outer shape of their respective protruding ends 3114 in a state where they do not directly contact the protruding ends when the seal forming structure 3100 is in a relaxed state. As can be seen in FIGS. 245g and 245i to 245k, for example, the protruding end support portion 3208 may have a generally curved outer shape away from their respective protruding ends 3114 and toward the holding structure 3242.

[0116] Figures 245f to 245h show that the seal forming structure 3100 may include thick portions 3204. These thick portions 3204 may provide additional support to the seal forming structure 3100 when the seal forming structure is in a sealed engagement with the patient's nose and face. The thick portions 3204 may be disposed on both sides of the seal forming structure 3100 at positions such that when the seal forming structure engages with the patient's face, the thick portions are near the nasolabial groove of the patient. The thick portions 3204 may help to seal around the alae of the patient's nose by preventing the collapse of the seal forming structure 3100 due to the sealing force. The thick portions 3204 may be formed integrally with the seal forming structure 3100. Also, the thick portions 3204 may be positioned on the seal forming structure 3100 such that when the seal forming structure engages with the patient's nose and face, the thick portions 3204 can be pressed at least partially against their respective protruding end support portions 3208. The thick portions 3204 may have a constant thickness that is greater than the thickness of the remaining portion of the seal forming structure 3100 throughout. Alternatively, the thick portions 3204 may have a thickness that can vary throughout their extent.

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

[0118] Figures 245a, 245b, 245d - 245f, 245h, 245i, and 245k illustrate examples of a seal - forming structure 3100 that may include a compliant region 3122. The compliant region 3122 is relatively flexible, pliable, and / or compliant compared to other portions of the seal - forming structure 3100. The relative flexibility of the compliant region 3122 can be advantageous in that it can help reduce discomfort to the patient in the region of the nasal apex and nasal septum. The compliant region 3122 may be relatively thin compared to other portions of the seal - forming structure 3100 and thus may function like a mechanical spring to maintain an effective seal at the nasal apex by conforming to and / or contacting the nasal apex. For example, as can be seen in Figure 245d, the compliant region 3122 may be located on the seal - forming structure 3100 at the upper apex where the seal - forming structure transitions into the plenum chamber 3200. The compliant region 3122 may be located on the seal - forming structure 3100 above the recess. Also, the compliant region 3122 may be integrated with the recess 3116. For example, as can be seen in Figure 245e, the compliant region 3122 may be located horizontally at approximately the center of the seal - forming structure. According to an example of the present technology, the seal - forming structure 3100 may have a thickness of about 0.35 mm in the compliant region 3122 and may be one of the thinnest regions of the seal - forming structure.

[0119] Also, the figures in Figures 245a - 245k show a retention structure 3242 having a notch 3295 and a tongue 3211. These figures also show a seal lip 3250.

[0120] Also, the seal - forming structure 3100 may include a visual indicator pad - printed on the seal - forming structure to indicate to the patient the proper insertion depth into the nose. For example, the visual indicator may include an outline of the nose to indicate to the patient where the patient's nose should be aligned with respect to the seal - forming structure 3100. Such a visual indicator may inform the patient of where the nose should be placed within the seal - forming structure 3100 so that the patient does not cause a sub - optimal seal by inserting the nose too deeply into the seal - forming structure.

[0121] 6.3.3 Plenum Chamber 3200 The plenum chamber 3200 according to one aspect of one form of the present technology functions to enable the flow of air between two nostrils and the supply of air from the PAP device 4000 via the 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 function alternately as an intake manifold during the intake portion of the breathing cycle and / or as an exhaust manifold during the exhalation portion of the breathing cycle.

[0122] The plenum chamber 3200 may be composed of an elastomeric material.

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

[0124] In one form of the plenum chamber 3200, the inlet / outlet manifold function and the cushioning function are performed by the same physical components, but in another form 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 as a single integral component, for example, by molding.

[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, as can be seen in FIGS. 18 and 19, the seal-forming structure 3100 is configured and arranged with respect to the rear wall 3220 such that the rear surface 3222 is spaced apart from the patient's nasal septum and / or upper lip during use. In one form, for example when the seal-forming structure 3100 includes nasal pillows 3130, this is achieved by arranging the rear wall 3220 such that the rear surface 3222, as shown in FIG. 8, is in front of the rearmost part 3130.1 of the nasal pillows 3130. Also, this configuration can concentrate the sealing force on the patient's 1000 nostrils since the nasal septum and / or upper lip is released from contact with the patient interface 3000.

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

[0129] In other aspects of the present technology, which can be seen in FIGS. 4, 7, 8, 10, and 11, the plenum chamber 3200 has a saddle region or a separation region 3236. As can be seen in FIG. 4, the bending region 3230 may include a separation region 3236 that may be located between a left bending region 3232 and a right bending region 3234. The separation region 3236 may have a concave shape and may extend from the front wall 3210 to the rear wall 3220. By forming the plenum chamber 3200 having the separation region 3236 as described above, the left bending region 3232 may be separated from the right bending region 3234 so 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 interfere with the right bending region 3234, and vice versa. Preferably, thereby, the nasal pillow 3130 associated with the bending region that does not interfere can remain in place over the corresponding nostril of the patient, even though the other bending region is interfered with. The separation region 3236 can avoid contact with the nasal septum by forming a concave shape between the handle portions 3150. Also, the separation region 3236 may be the thinnest region of the plenum chamber 3200 to allow for flexibility of a desired size in this region. Alternatively, the separation region 3236 may be the thickest region of the plenum chamber 3200. By giving a deep curvature to the saddle region 3236, contact with the nasal septum and / or the upper lip can be minimized or avoided, improving patient comfort. The saddle region 3236 may be U-shaped or V-shaped and may have a nasolabial angle of about 70° to about 120° at its apex. The saddle region 3236 may have a depth of about 0.5 mm to about 2.5 mm for clearance near the patient's nasal septum.

[0130] The rear wall 3220 may be disposed adjacent to the upper lip or the upper lip of the patient as in FIGS. 18 and 19 when the patient interface 3000 is in use.

[0131] In one form, the plenum chamber 3200 may further include a seal lip 3250 (FIG. 6). The seal lip 3250 may be composed of a flexible elastic material, such as silicone rubber having a Shore A hardness in the range of about 30 to about 50, thereby forming a relatively flexible component. As shown in FIGS. 5, 6, and 8, the seal lip 3250 may be located on the inner surface or inner circumference of the plenum chamber 3200 or formed as part of the inner surface or inner circumference, or may be located throughout the inner circumferential region of the plenum chamber 3200. However, it is also envisioned that the seal lip 3250 may be disposed across the outer surface or outer circumference of the plenum chamber 3200 or throughout the outer circumferential region of the plenum chamber 3200. The seal lip 3250 may form a pneumatic seal between the plenum chamber 3200 and the frame 3310, as will be described in more detail below. The seal lip 3250 and the plenum chamber 3200 may form an integral part. Other patient interface devices use a compression seal formed from an elastically deformable material, such as silicone, to compress the plenum chamber to engage the plenum chamber with the frame and at the same time provide a pneumatic seal. In contrast, one example of the present technology forms a pneumatic seal by interference from the seal lip 3250 that deflects against the frame 3310 when the plenum chamber 3200 is first fixed to the frame 3310. When the pressure in the plenum chamber 3200 is increased above atmospheric pressure to treat a respiratory disorder, the seal lip 3250 is pressed against the frame 3310 with a greater force, thus strengthening the pneumatic seal and increasing the seal force. The air pressure in the cushion / plenum chamber of these other patient interface devices does not affect the seal force between the cushion and the frame. Also, these other patient interface devices have a cushion with sidewalls for engaging the frame and a seal lip, and the sidewalls and the seal lip are soft, not hard, so that they can easily conform to finger pressure and can be elastically stretched or bent with little effort.In particular, since the size and aspect ratio of the nose cushion are relatively large, this contributes to the softness of the cushion. The side walls for frame engagement are very soft, so that the two sides of the cushion can be pinched together with very little finger force and brought into contact with each other. This ease of deformation of the side walls for frame engagement can be a major source of difficulty for patients with arthritis in the hands to quickly connect the cushion to the frame in these other patient interfaces. It should also be understood that by forming the features of the plenum chamber 3200 having sufficient rigidity, the stability of the seal formed by the seal forming structure may be improved. Also, the thickness of the plenum chamber 3200 may be varied such that the plenum chamber gradually becomes thinner from the plenum connection region 3240 towards the seal forming structure 3100. In one example of the present technology, the plenum chamber 3200 may be about 2-3 mm thick at or near the plenum connection region 3240, may be 1 mm thick at the point between the plenum connection region 3240 and the seal forming structure 3100, and may be 0.75 mm thick at or near the seal forming structure 3100. The formation of the plenum chamber 3200 having these features may be achieved by injection molding manufacturing. This gradual decrease in the 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 likelihood of seal failure.

[0132] Some nasal pillow patient interfaces have an assembly order of (i) a plenum chamber, (ii) a headgear connection, and (iii) a seal forming structure. On the other hand, one example of the patient interface 3000 of the present technology has an assembly order of (i) a headgear connection, (ii) a plenum chamber, and (iii) a seal forming structure. This difference in arrangement means that the headgear tension does not cause deformation of the plenum chamber 3200 and the seal forming structure 3000 that may interfere with the seal force.

[0133] 6.3.4 Frame 3310 As shown in FIGS. 4, 10, 75, 76, and 166, the frame 3310 functions as a central hub to which the short tube 4180, the plenum chamber 3200, and the positioning stabilization structure 3300 are connected in a removable or more permanent manner.

[0134] Also, FIGS. 31 - 33 show various views of the frame 3310 connected via the flexible joint 3305 to the positioning stabilization structure 3300 having the strap 3301. These views show the frame 3310 without the plenum chamber 3200 and the seal formation structure 3100. The connection port 3600 and the vent 3400, both of which are described in more detail below, may be disposed on the frame 3310.

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

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

[0137] In one example of the technology, the frame 3310 may be formed without any relief grooves so that it can be removed from the mold without buckling after it is molded.

[0138] 6.3.5 Connection between the plenum chamber and the frame In one form of the present technology, the plenum chamber 3200 can be removably attached to the frame 3310, for example, to facilitate cleaning or to be replaced for differently sized seal forming structures 3100. Thereby, the plenum chamber 3200 may be washed more frequently than the frame 3310 and the short tube 4180 so as to be cleanable. Also, thereby, the plenum chamber 3200 may be washed separately from the strap 3301 so as to be cleanable. 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 is harder than other parts of the plenum chamber 3200 and may be formed from the same material as the frame 3310, such as polypropylene or a polyamide such as Rilsan®. In other embodiments, the plenum connection region 3240 may be formed from nylon and the frame 3310 may be formed 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 each other, there is an audible click sound and a hard-hard connection. FIGS. 20-24 depict the shape of the retaining structure 3242 as being similar to a parabolic cylinder or a hyperbolic cylinder. The retaining structure 3242 is inextensible and does not stretch or shrink in order to maintain its general shape when it engages with the frame 3310 and when it disengages from the frame 3310. The shape of the retaining structure 3242 allows for a slight degree of bending but does not allow bending to the extent that the two sides of the retaining structure 3242 can touch each other when pinched together by finger pressure. In other words, the two sides of the retaining structure 3242 can only touch each other by a large clamping force intended by the patient 1000 that does not occur under normal treatment situations. In the illustrated example, the upper and lower edges of the retaining structure 3242 can be brought closer to each other / easily pinched together relative to the side edges of the retaining structure 3242 when using the same magnitude of clamping force. As can be seen in FIG. 18, the curvature of the frame 3310 and the retaining structure 3242 follows the natural curvature of the patient's upper lip, avoiding the concentration of contact pressure at any particular point on the patient's upper lip so that the contact pressure due to the headgear tension is spread evenly across the patient's upper lip. This can minimize or eliminate skin damage caused by long-term concentration of contact pressure. Another advantage in the curvature is that less material is required for the plenum chamber 3200 compared to a flat frame.The flat frame provides more material at the side edges of the plenum chamber 3200 such that the plenum chamber 3200 conforms to the patient's upper lip. Less material results in an overall weight reduction in the patient interface 3000. Also, the curvature minimizes any forward protrusion of the patient interface 3000 from the patient's face, thereby improving the inconspicuousness of the patient interface 3000. Also, the retention structure 3242 may be adhered (e.g., using an adhesive) to the plenum chamber 3200 after molding, according to one example of the technique. In other examples, an integral chemical bond (molecular adhesion) may be utilized between the retention structure 3242 and the plenum chamber 3200.

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

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

[0142] Another purpose of the retaining structure 3242 is to hold the plenum chamber 3200 against the frame 3310 by preventing relative lateral perpendicular movement between these two components. The plenum connection region 3240 may include at least one retaining feature 3244, and there may also be at least one complementary frame connection region 3312. The plenum connection region 3240 may include one or more retaining features 3244 (FIG. 10). In addition to preventing relative lateral perpendicular 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 components. The remaining portion of the plenum chamber 3200 may be provided with a more flexible material than the retaining structure 3242 and the plenum connection region 3240.

[0143] In one form, the plenum connection region 3240 is composed of 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 composed of a material different from other parts of the plenum chamber 3200. For example, the plenum connection region 3240 may be a separate component that is non-removably connected, integrally joined, or mechanically coupled to the connection portion 3202 (FIG. 10) of the plenum chamber 3200. Referring 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 portion 3211 configured and arranged to be received in a mating state by a channel portion 3211.1, such as a channel portion of the frame 3310. In this way, the channel portion 3211.1 can form a fitting function portion for the tongue portion 3211, and vice versa. Also, the tongue portion 3211 and the channel portion 3211.1 may be dimensioned to maximize the seal surface area in this region.

[0144] 6.3.5.1.1 Attachment of the Plenum Chamber and Removal from the Frame The plenum chamber 3200 may be fixedly attached to the frame 3310 or may be removably attached to the frame 3310. FIG. 12 shows the plenum chamber 3200 at the connection position to the frame 3310. The plenum connection region 3240 includes, in this example, only two retaining features 3244 located on both sides of the connection region 3240, for example, the rear side and the front side. FIGS. 12 and 13 show a cross-section through both hooked portions 3246, while FIG. 17 shows another cross-section where the hooked portion 3246 is absent, thereby forming, for example, a channel or groove 3211.1. The resilient hooked portion 3246 is a kind of snap-fit compression fitting member that provides a high holding force (to prevent accidental detachment) and also allows for relatively easy intentional removal. In FIG. 17, the plenum connection region 3240 and the frame 3310 easily fit together in a tongue-and-groove configuration. The frame 3310 and the retaining structure 3242 may be formed such that the tongue portion 3211 and the channel portion 3211.1 engage before the retaining feature 3244 engages the frame. This can help to align the retaining feature 3244 for connection.

[0145] Each holding functional part 3244 may be in the form of a hook-shaped part 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 the pulling-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 an engaged state with each other. When the holding functional part 3244 is pushed into a predetermined position, the holding functional part deforms. Also, the upper region and the lower region of the frame connection region 3312 of the frame 3310 and the interference region 3314 may also be slightly deformed. Also, the holding structure 3242 may also be slightly deformed particularly in the vicinity of the holding functional part 3244 (see, for example, the broken lines in Figs. 27 and 28). Referring to Figs. 195 to 198, the deformation of the frame connection region 3312 and the interference part 3314 of the frame 3310 is controlled by the use of the ribs 3294 with respect to the allowable amount of deformation and the region where the deformation is to occur. In one example of the present technology, there are six ribs 3294 spaced apart around the interference part 3314 and abutting against the interference part. The interval and position of the ribs 3294 limit the region of deformation of the interference part 3314 to only the region close to the holding functional part 3244. The ribs 3294 may abut against the inner surface of the plenum connection region 3240 and deform against the inner surface 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. Referring to Figs. 199 to 202, the plenum connection region 3240 of the plenum chamber 3200 has a notch 3295 for corresponding to the ribs 3294. The notch 3295 is a chamfer for minimizing the friction of the plenum connection region 3240 abutting against the ribs 3294 during the assembly of the plenum chamber 3200 and the frame 3310. When the hook-shaped part 3246 is pushed in by a sufficient amount, the hook-shaped part snaps radially outward so that the hook-shaped part 3246 takes the holding position shown in Fig. 13. The snapping action provides an audible sound such as a reassuring click to the user, thereby providing feedback to the user or patient that an appropriate connection has been established.In the holding position, as shown in FIG. 13, the rear surface 3246.2 of the hook portion 3246 engages with the holding surface 3312.2 of the frame connection region 3312. This reassuring click sound may, in one example of the technology, be facilitated by forming a plenum connection region 3240 with sufficient rigidity, which is greatest in the vicinity of the plenum connection region 3240. This rigidity may be achieved by overmolding manufacturing.

[0146] As can be seen in FIG. 13, the surfaces of the hook portion 3246 and the frame connection region 3312 are tilted in a specific manner to facilitate the sliding connection between the plenum chamber 3200 and the frame 3310. For example, as described above, the front surface 3246.1 and the retracting surface 3312.1 may be formed with corresponding angles with respect to each other such that these surfaces can slide engage with each other relatively easily. Similarly, the rear surface 3246.2 and the holding surface 3312.2 may be tilted with respect to each other to help hold the frame 3310 and the plenum chamber 3200 when connected. The angle between the rear surface 3246.2 and the holding surface 3312.2 is selected such that, for example, the tensile force applied substantially along the axis of the nasal pillow 3130 is sufficient to bend the hook portion 3246 inward to release the plenum chamber 3200 from the frame 3310. This tensile force does not require the patient 1000 to first bend the hook portion 3246 radially inward, for example, by squeezing the plenum chamber 3200 in the front-rear direction. Rather, due to the relevant angle, the radial deflection of the hook portion 3246 occurs only as a result of the applied axial tensile force. In one example of the technology, the plenum connection region 3240 is deflected, and the disassembly of the plenum chamber 3200 from the frame 3310 is performed by grasping 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 retaining feature 3244 is engaged with the frame connection region 3312 by the hook portion 3246. As also shown in this figure, the retaining surface 3312.2 of the frame connection region 3312 and the rear surface 3246.2 of the hook portion 3246 are engaged and are in the same plane with each other. In order for a patient to remove the plenum chamber 3200 from the frame 3310, the patient must pull the plenum chamber 3200 relative to the frame 3310 with sufficient force to overcome the resistance of the retaining surface 3312.2 against the rear surface 3246.2. In one example of the present technique, when the plenum chamber 3200 is pinched, the axial tensile force required to remove the plenum chamber 3200 from the frame 3310 is reduced. This resistance can be “adjusted” or selectively adjusted to a desired level by changing the angle at which these surfaces 3312.2, 3246.2 engage each other. The closer these surfaces 3312.2, 3246.2 are to being perpendicular to the direction of the 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 by which the rear surface 3246.2 is tilted with respect to the nominal vertical axis 3246.4 (corresponding to the axial tensile direction of the plenum chamber 3200 with respect to the frame 3310). As β increases, the force required to remove the plenum chamber 3200 from the frame 3310 increases. Also, as β increases, the removal is felt to be more abrupt for 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 a further example, β may vary from 30° to 110°, or from 40° to 90°, or from 65° to 85° in order to provide an ideal resistance level to removal. This has been selected to minimize the likelihood of accidental detachment and to permit 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, can also be "matched" or selectively adjusted in a similar manner so that a specific level of force is required when the patient 1000 attaches the plenum chamber 3200 to the frame 3310. As the angle α increases, the force required to engage the retaining feature 3244 with the frame connection region 3312 increases, and the attachment feel for the patient engaging these components 3244, 3312 also becomes more abrupt. In other words, when the front surface 3246.1 of the retaining feature 3244 slides along the recessed surface 3312.1 of the frame connection region 3312, the user can experience a smoother engagement feel as the angle α decreases. In one example, an angle α of about 30° has been found to produce a comfortable removal feel for the patient 1000. In a further example, the angle α can vary from 50° to 70°, or from 15° to 60°, in order to provide an ideal resistance level for removal.

[0149] Also, since the feel and force of engagement and disengagement between the plenum chamber 3200 and the frame connection region 3312 can be adjusted or selectively adjusted independently of each other, the angles α and β may be selected to give the patient a resistance level for attachment that is different from the resistance level for removal. In one example of the technology, the angles α and β may be selected such that the angle β is greater than the angle α, whereby the patient feels an attachment resistance between the plenum chamber 3200 and the frame 3310 that is less than the removal resistance. In other words, the patient may feel that it is 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 differently sized. In particular, this figure shows that the retention feature 3245 disposed at the front of the plenum connection region 3240 is narrower in width than the retention feature 3244 disposed at the rear of the plenum connection region 3240. By sizing the retention feature 3244 differently, the patient 1000 can attach the plenum chamber 3200 to the frame 3310 in only one direction. Such a configuration is shown in FIG. 10. This avoids patient frustration during attachment, minimizes damage to the patient interface 3000 that can occur due to incorrect attachment, and provides comfort by reducing or avoiding contact with the patient's nasal septum and / or upper lip such that the seal forming structure 3100 is in the correct orientation to provide an appropriate seal against the patient's airway.

[0151] FIG. 10 shows two frame connection regions 3312, 3313 engaged with corresponding holding function parts 3244, 3245. The example depicted here shows that the narrower front holding function part 3245 is dimensioned to correspond to the narrower front frame connection region 3313. Also, the wider rear holding function part 3244 is engaged with the correspondingly dimensioned rear frame connection region 3312. Such a configuration, where each holding function part is uniquely dimensioned to engage with a uniquely dimensioned frame connection region to which it corresponds, has the advantage that the patient can attach the plenum chamber 3200 to the frame 3310 in only one direction. By restricting the attachment direction, the patient 1000 is prevented from improperly assembling the patient interface 3000 and from receiving suboptimal treatment due to an improperly assembled patient interface 3000. The configuration described with respect to this particular example of the technology is such that the patient 1000 can fully assemble the patient interface 3000 only when the components are properly aligned, which is advantageous for a patient 1000 who may have difficulty seeing how to accurately engage the components due to a vision problem, or for a patient 1000 who may be assembling the patient interface 3000 in a dark room, such as a bedroom before bedtime.

[0152] As described above, the angles of the front surface 3246.1 and the rear surface 3246.2 in the hook portion 3246 are important for providing an optimal amount of resistance to the assembly and disassembly of the patient interface 3000. Also described above is the advantage of sizing the respective retaining functional portions 3244, 3245 and frame connection regions 3312, 3313 so as to ensure proper orientation of the components during assembly. Proper sizing of the retaining functional portions 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 retaining functional portions 3244, 3245 may be sized to fit closely together such that the outer perimeter of the frame connection region and the outer perimeter of the retaining functional portion 3244 help to orient and align the retaining functional portion 3244 to the frame connection region 3312. This can be beneficial for patients with limited dexterity due to a disease (e.g., arthritis), or for patients assembling the patient interface 3000 in a dark bedroom before bed or in a state where visibility is reduced either due to limited vision. Also, sizing the retaining functional portions 3244, 3245 and the frame connection regions 3312, 3313 to fit closely together serves to ensure that the seal between the plenum chamber 3200 and the frame 3310 is maintained by facilitating a strong connection between these two components. Also, the close fit between the retaining functional portions 3244, 3245 and the frame connection regions 3312, 3313 can help to facilitate equivalent alignment of the plenum chamber 3200 with respect to the frame 3310. In one example of the present technology, a difference of 0.3 mm to 2 mm can be incorporated between the retaining functional portions 3244, 3245 and the frame connection regions 3312, 3313.

[0153] It should also be understood that the connection between the frame 3310, described above and below, and the plenum chamber 3200 may be used with other types of masks. Such features may equally apply to nasal masks or full-face masks. Masks that seal below the nasal bridge, such as compact nasal masks or compact full-face masks, may incorporate the connection functional parts described herein. Also, masks lacking a forehead support may include these connection functional parts. It is also envisioned that examples of the present technology, including masks that seal below the nasal tip, such as masks having nasal pillows 3130 or nasal cradles / nasal flanges 3101, may use these connection functional parts.

[0154] 6.3.5.1.2 Attachment and detachment sequence of plenum chamber and frame Figs. 25 to 29 show a series of cross-sectional views of the connection part 3202 of the plenum chamber 3200 and the frame connection region 3312 of the frame 3310. These sequential figures show the process of attaching the plenum chamber 3200 to the frame 3310. Although these figures show only the attachment of one holding functional part 3244 to one frame connection region 3312, it should be understood that, as can be seen in Fig. 10 and as described above, there may be multiple holding functional parts 3244 and multiple frame connection regions 3312. Therefore, 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 portion 3202 of the plenum chamber 3200 and the frame connection region 3312 of the frame 3310, where in this case the connection portion 3202 and the frame connection region 3312 are located in the vicinity of each other but do not contact each other. The arrows indicate that the connection portion 3202 and the frame connection region 3312 are attempting to couple. Needless to say, for the sake of simplicity, these figures do not include further portions of the plenum chamber 3200 and the frame 3310. Therefore, as can be seen in FIG. 13 for example, it should also be understood that both the frame connection region 3312 and the interference portion 3314 of the frame connection region 3312 are part of the frame 3310. Also, it should be understood that the frame connection portion 3312 and the interference portion 3314 of the frame connection portion 3312 move relative to each other over the attachment sequence. Returning to FIG. 25, this figure shows that the seal lip 3250 is not deformed and the holding function portion 3244 is not deformed. This is because neither of these components 3250, 3244 contacts the frame 3310.

[0156] FIG. 26 shows the hook portion 3246 of the holding function portion 3244 that has just started to contact the frame connection region 3312 of the frame 3310. Specifically, this figure shows the front surface 3246.1 of the hook portion 3246 that contacts the drawing-in surface 3312.1 of the frame connection region 3312. In this figure, the holding function portion 3244 and the frame connection region 3312 are only in contact with each other so that the holding function portion 3244 is not deflected. Also, the seal lip 3250 is not deflected because it has not yet contacted the interference portion 3314 of the frame connection region 3312. As described above, the angle α of the front surface 3246.1 begins to affect the resistance felt by the user with respect to the engagement between the plenum chamber 3200 and the frame connection region 3312. This is because the front surface 3246.1 begins to engage in a friction contact state with the drawing-in surface 3312.1.

[0157] FIG. 27 shows the plenum chamber 3200 and the frame 3310 further along the attachment sequence such that 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 hook portion 3246 contacts a portion of the retraction surface 3312.1 that is closer to the retention surface 3312.2. In other words, the hook portion 3246 appears to have moved closer to attachment to the frame connection region 3312 and has moved relative to the position shown in FIG. 26. As described above, 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. Also, FIG. 27 shows that the retention feature 3244 has been deflected by contact with the frame connection region 3312, and the dashed line indicates the contour of the retention feature 3244 in its non-deformed state. Also, FIG. 27 shows that the seal lip 3250 is not yet in contact with the interference portion 3314 of the frame connection region 3312 and, thus, the seal lip 3250 has not been deformed. Although not shown in this figure, it should also be understood that the frame connection region 3312 may be deflected away from the retention feature 3244 due to the force that these portions 3312, 3244 push against each other.

[0158] In FIG. 28, the plenum chamber 3200 and the frame 3310 are substantially attached, and the retention feature 3244 is substantially fully engaged with the frame connection region 3312. In this figure, although the retention feature 3244 is still deformed, the hook portion 3246 contacts different portions of the frame connection region 3312. Specifically, at this time, the rear surface 3246.2 of the hook portion 3246 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 can be biased into an engaged state by the inherent tendency of the deformed retention feature 3244 to return to its non-deformed state, such that, in effect, these portions are drawn towards each other after reaching a particular insertion distance. Also, FIG. 28 shows the outline of the non-deformed retention feature 3244 by a dashed line. Also, in this figure, it can be seen that the seal lip 3250 is in contact with the interference portion 3314 of the frame connection region 3312. At this point in the attachment sequence, a seal may begin to form due to the contact between the seal lip 3250 and the interference portion 3314 of the frame connection region 3312. The seal lip 3250 may be slightly deflected by contact against the interference portion 3314 of the frame connection region 3312.

[0159] FIG. 29 shows a plenum chamber 3200 and a frame 3310 that are fully attached by the engagement of the hook portion 3246 of the holding functional portion 3244 and the frame connection region 3312. In this figure, the holding surface 3312.2 may be relatively closely attached to the rear surface 3246.2. Also, the holding functional portion 3244 can no longer be deflected by contact with the frame connection region 3312. The return of the holding functional portion 3244 from its deflected or deformed state as shown in FIG. 28 to the non-deformed state may generate an audible click sound as the hook portion 3246 and the holding functional portion 3244 move from the position shown in FIG. 28 to the position shown in FIG. 29. This reassuring audible click sound can be beneficial in that the click sound provides feedback to the patient 1000 that the plenum chamber 3200 and the frame 3310 are fully engaged. By providing this feedback to the patient 1000 at the completion of the engagement, the patient 1000 may be able to use the patient interface 3000 with the confidence that the plenum chamber 3200 and the frame 3310 are securely attached and will not separate while the patient 1000 is sleeping and receiving treatment.

[0160] Also, a desired level of seal contact may be achieved when the plenum chamber 3200 and the frame 3310 are attached as shown in FIG. 29. It can be seen that the seal lip 3250 is pressed against and deflected by the interference portion 3314 of the frame connection region 3312. By being deflected as shown, the seal lip 3250 may press itself against the interference portion 3314 of the frame connection region 3312 with sufficient force due to its tendency to return to its non-deformed state, thereby providing the desired seal between these components. Further, as the air pressure in the plenum chamber 3200 increases when treatment is being performed, the seal lip 3250 is forced to deflect towards the interference portion 3314 of the frame connection region 3312, thereby increasing the seal force in this region. Even if 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, a pressure-actuated seal that becomes stronger as the internal air pressure increases is also formed between the seal lip 3250 and the portion 3314 of the frame connection region 3312 during engagement. In a particular example, it may be assumed that the compression seal is not airtight, thereby allowing for unwanted leakage to occur.

[0161] Also, if a very large amount of compression of components is required to form a compression seal, this may prevent the easy attachment and detachment of the plenum chamber 3200 to and from the frame 3310, and as a result, in some cases, it may not be possible to perform the operation with one hand or may require a significant amount of labor. Thus, in one example of the present technology, the compression seal functions primarily for the purpose of retention rather than sealing, and the pressure-actuated seal functions primarily for the purpose of forming and maintaining an airtight seal. It should be understood that such sealing action may occur around the periphery of the joint between the plenum chamber 3200 and the frame 3310. For example, FIG. 17 shows a seal lip 3250 in a similarly deflected state that abuts against the frame connection region 3312 in a region separate from the retention functional portion 3244. Also, in FIG. 5, for example, it can be seen that the seal lip 3250 extends over the outer periphery of the plenum chamber 3200. By extending the seal lip 3250 inwardly around the periphery of the joint between the plenum chamber 3200 and the frame 3310, a desired level of seal can be obtained over the entire region, thereby preventing unwanted leakage of pressurized gas.

[0162] Also, needless to say, the seal lip 3250 may be pressed against the interference portion 3314 of the frame connection portion 3312 with a force that biases these portions to separate. However, the frictional force resulting from the structural engagement between the rear surface 3246.2 of the hook-shaped portion 3246 and the retention surface 3312.2 of the frame connection region 3312 must be sufficient to resist the force tending to return the seal lip 3250 to its non-deformed state and separate the plenum chamber 3200 from the frame 3310.

[0163] Regarding the removal of the plenum chamber 3200 and the frame 3310, it must be understood that this process is in almost the reverse order 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 the opposite direction, or the figure in FIG. 29 may be the start of the separation process, or FIG. 25 may represent a figure in which the plenum chamber 3200 and the frame 3310 are completely separated. Tightening the plenum chamber 3200 near the plenum connection region 3240 or tightening the plenum connection region 3240 to pull it away from the frame 3310 may help in removing the plenum chamber 3200 from the frame 3310. Also, it is envisioned that the patient 1000 may simply tighten the plenum chamber 3200 for the purpose of gripping it, for example, at the nasal pillow 3130 or the stem 3150 and simply pull it away from the frame 3310. A twisting motion while pulling may also help in detaching the plenum chamber 3200 from the frame 3310.

[0164] 6.3.5.1.3 Rigid-Rigid Indirect Connection The plenum connection region 3240 and the frame 3310 may be assembled and attached as shown in FIGS. 25-29. As described above, the plenum connection region 3240 and / or the holding structure 3242 may be composed of a semi-rigid material, 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 in the form of a continuous ring or two C-shaped clips in an elliptical shape, one C-shaped clip, or a single continuous piece, but only encloses a part of the plenum chamber 3200. The clip may function as a spring clip and may also be in the form of a C cross-section or a double C cross-section. The spring force of the spring clip may be provided by the elasticity with which the plenum connection region 3240 is extended against the frame connection regions 3312, 3313 or the interference portion 3314 of the frame 3310. In other examples, the clip form may not be necessary, and only the holding functional parts 3242, 3244 are directly and non-removably connected to the plenum chamber 3200 without the plenum connection region 3240 and / or the holding structure 3242 for engaging with the connection regions 3312, 3313. It is also assumed that one example of this technology may include that the frame 3310 is composed of the same or similar semi-rigid material as the plenum connection region 3240. By manufacturing the frame 3310 and the plenum connection region 3240 of the semi-rigid material, a "hard-hard" connection or bonding interface may be formed. This "hard-hard" connection, together with the structural features of the plenum connection region 3240 and the frame connection region 3312, may give the patient 1000 a confident feeling of the connection between the plenum chamber 3200 and the frame 3310 when assembling the patient interface 3000 (for example, by giving an audible snap fit or a click sound that gives a sense of security). A secure fit between the plenum chamber 3200 and the frame 3310 is beneficial because it helps the patient 1000 to receive optimal treatment through the patient interface 3000, and a structure that gives the patient 1000 the confidence that a secure fit has been achieved is beneficial.The hard-hard indirect connection described in this specification can also be beneficial in that it can add stability to the seal formed by the seal formation structure 3100. This is in contrast to a hard-soft or soft-soft indirect connection where either one or both of the plenum chamber and the frame are formed from a soft material, which makes it difficult to easily and properly engage the plenum chamber and the frame with arthritic hands, especially in a dark room.

[0165] The holding functional parts 3242, 3244 are described as being provided in the plenum chamber 3200, and the connection regions 3312, 3313 are provided in the frame 3310, but it is also conceivable to exchange their locations to the holding functional parts on the frame and the connection regions on the plenum chamber. Also, in one part, there may be a combination of a holding functional part and a connection region corresponding to the connection regions and the holding functional parts in the other part.

[0166] 6.3.6 Method of Forming a Plenum Chamber The process for manufacturing the plenum chamber 3200 may include a step of molding the plenum connection region 3240 in a first mold, removing the molded plenum connection region 3240 from the first mold, inserting the plenum connection region 3240 into a second mold, and molding a part of the plenum chamber 3200 having the connection part 3202 in the second mold. The plenum connection region 3240 may be chemically bonded and / or mechanically coupled to the connection part 3202.

[0167] In one form, the seal lip 3250 is configured and arranged to interfere with an 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 seal lip 3250 is elastically bent away from a rest position (FIG. 6) when assembled with the interference portion 3314 of the frame connection region 3212 and, as a result of being at least partially an elastic material, presses against the interference portion 3314 (FIG. 12) to resist or prevent air leakage between the seal lip 3250 and the interference portion 3314. Although the seal lip 3250 has been described as being provided in the plenum chamber 3200, the seal lip may be provided on the frame 3310. Although one seal lip has been described, it is contemplated that two or more seal lips may be provided. In that case, at least one seal lip is provided in the plenum chamber 3200 and at least one seal lip is provided on the frame 3310.

[0168] 6.3.7 Positioning Stabilization Structure 3300 In one form of the present technology, it should be noted that many structural features form part of the positioning stabilization structure 3300, such as a headgear assembly (which may sometimes be simply referred to as a 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 flexure joint 3305 may be located on the headgear or the frame 3310. Also, the extension 3350 may perform the same function as the flexure joint 3305, except that it is formed integrally with the rigidizer arm 3302.

[0169] The seal forming structure 3100 of the patient interface 3000 of the present technology may be held in the seal position by the positioning stabilization structure 3300 during use (FIGS. 75, 76, and 166). In one form, the positioning stabilization structure 3300 includes a headgear. Needless to say, the positioning stabilization structure 3300 may be referred to as a headgear in one form of the technology.

[0170] The headgear may be removably connected via a headgear connector to a part of a patient interface such as the positioning stabilization structure 3300.

[0171] 6.3.7.1 Strap The positioning stabilization structure 3300 may include at least one strap 3301 (see, for example, FIG. 65) and at least one rigidizer 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 extended, for example, by the stretching force applied by the patient, and return to or contract to its original length in a neutral state when the stretching force is released. The strap 3301 may be formed from or include 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 and other materials. The strap 3301 may be a single-layer or multi-layer strap. The strap 3301, particularly the side strap portions 3315, 3316 that come into contact with the patient 1000 during use, may be woven, knitted, braided, molded, extruded, or otherwise formed. The strap 3301 may include or be formed from a fabric material such as a woven material. Such a material may, on the one hand, include 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 extensible. Thereby, the overall length of the strap 3301 can be extended, thereby providing a comfortable force transfer profile. In order to extend the strap 3301 during use, the length of the strap 3301 may be less than the average 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 the strap 3301 may be provided to the patient depending on the head circumference of the patient, which may be gender-specific. For example, a small-sized strap may have a length of 490 mm, and a large-sized strap may have a length of 540 mm.In some situations, this means that the length of the strap 3301 need not be extended over a large distance (i.e., a small size strap for a large head circumference). Extension over a large distance results in an unnecessarily high headgear tension for such patients and also results in a less smooth force transfer profile as the small size strap 3301 is extended to a long length.

[0172] According to another example of the technology, the strap 3301 may not be elastic or may not be extensible enough. The rigidizer arm 3302 may or may not be included. According to these other examples, the length of the strap 3301 of the positioning stabilization structure 3300 may be adjustable using a ladder lock clip, a buckle, or a hook and loop material. The strap 3301 may be formed from a substantially non-elastic material such as plastic or cloth. The use of a non-elastic strap 3301 may be beneficial in that it can more easily maintain seal stability when the seal forming structure 3100 is a nose cradle cushion and tube torque is received by the patient interface 3000.

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

[0174] In one example, a strap 3301 including side strap portions 3315, 3316 and a back strap portion 3317 is formed by knitting a fabric material longitudinally. The strap 3301 is a 3D knitted fabric knitted by computer control as a single integrated piece. Changes in the yarn and seams may occur at various positions along the strap 3301 to adjust the elasticity, strength, and durability of the strap 3301 at specific locations. For example, at the openings, insertion points or buttonholes 3303, 3304, and at the locations of the branching points 3324 for the back strap portions 3317a, 3317b, additional yarn may be knitted to reinforce the strap 3301 at these locations where high stress is received when the strap 3301 is stretched during repeated long-term use, preventing defects / damage of the strap 3301. Both the knitting method (i.e., longitudinal knitting) of the strap 3301 and the elastic fabric material (e.g., elastane) contribute to the elastic recovery of the strap 3301 after washing and drying the strap 3301 in water. In other words, the elasticity of the strap 3301 can be maintained after long-term use by periodically washing the strap 3301, thus extending the service life of the strap.

[0175] In FIGS. 65 to 73, the strap 3301 is shown as a single continuous strap having two pocket-shaped ends 3311, 3313 for attachment directly to the frame 3310 or via a flexible joint 3305. However, it can be seen that the strap 3301 may comprise a plurality of individual straps that are directly connected to or connected to each other, for example, by stitching or ultrasonic welding. In FIG. 65, the strap 3301 and the positioning and stabilizing structure 3300 are shown without any adjustment means or changing means. However, such adjustment may be made by changing the location where the strap 3301 is fixed to the patient interface 3000 or other connecting elements, such as the flexible joint 3305, which is harder than the strap 3301. Referring to FIG. 72, in addition to or instead of this, the adjustment may be made by adding a mechanism such as a slide over the ladder lock clip 3305.1 (as shown, for example, in FIGS. 71 to 73) to the back strap portion 3317 or the side strap portions 3315, 3316, or otherwise by adjusting the stretching length of the strap 3301 and the positioning and stabilizing structure 3300, respectively. In the example shown in FIG. 65, the strap 3301 can be interpreted from the respective schematic views of FIGS. 68 to 70, which show an elliptical or circular shape, or from the respective marks 3321a to 3321d, 3323a to 3323e of a circular or elliptical shape, where the outer surface (visible) facing the observer is shown as a solid line and the inner wall (invisible) facing away from the observer is shown as a dashed line, and can also be interpreted by the cross-sectional view according to FIG. 66. However, it can be seen that the positioning and stabilizing structure 3300 may take any other shape, such as a flat or sheet-like shape, a single layer, a multi-layer or a laminated structure. The strap 3301 may have a longitudinal axis that may be understood to be an axis substantially parallel to the plane of the paper, along which the strap 3301 extends (see, for example, the dashed line in FIG. 65).

[0176] The strap 3301 may have reinforcing stitches to improve durability and minimize or prevent break points. For example, the areas of the strap 3301 at the button holes 3303, 3304 and the areas of the strap 3301 where the strap branches into two backstrap portions 3317a, 3317b at the branch point 3324 are also exposed to high stress during extension. The tendency of the material is to separate from each other in the split region 3326, and thus, reinforcing stitches in these areas are one way to address this concern. In one example, a center seam extends along the central longitudinal axis of the strap 3301 and functions as a reinforcing stitch. Also, the distal edge of the strap 3301 and the openings of the button holes 3303, 3304 may be ultrasonically welded to fuse any loose fibers in these areas to strengthen the strap 3301. Preferably, this also prevents fraying of the fibers of the strap 3301 after long-term use and repeated washing. Other techniques for reinforcing and strengthening the pocket-like end 3311, the distal edge, and the button hole 3303 are envisioned, and the technique may include additional materials such as tape. The tape may include brand information and logo information.

[0177] Figures 123-125 show increasingly detailed views of the split region 3326 between the upper backstrap portion 3317a and the lower backstrap portion 3317b. It should be understood that the edges of the upper backstrap portion 3317a and the lower backstrap portion 3317b are not completely smooth as a result of the knitting process, and it should be further understood that these figures show the edges at a large magnification so that defects can be seen. With the naked eye, the unevenness of the edges of the upper backstrap portion 3317a and the lower backstrap portion 3317b cannot be seen so easily, and generally, the patient 1000 cannot recognize it by contact. Further, in these figures, stippling is used to show the properties of the backstrap portions 3317a, 3317b, while the split region 3326 is shown as blank because there is no material in the split region 3326.

[0178] Figures 126 to 131 show various detailed views of a branch point 3324 where the upper backstrap portion 3317a and the lower backstrap portion 3317b are present at a location separated from the side strap portions 3315, 3316. Also visible in these figures is a reinforcing portion 3325 that may include further stitching or welding at or near the branch point 3324. The reinforcing portion 3325 can serve to prevent the side strap portions 3315, 3316 from cracking and / or tearing due to stress caused by repeated separation of the upper backstrap portion 3317a and the lower backstrap portion 3317b. In other words, the reinforcing portion 3325 can provide additional strength at the location of stress concentration near the branch point 3324. Also shown in these figures are the upper backstrap portion 3317a and the lower backstrap portion 3317b at various separation angles θ. It can be seen that these figures show that the reinforcing portion 3325 provides additional strength at the branch point 3324 when the upper backstrap portion 3317a and the lower backstrap portion 3317b are spread apart from each other at a large angle θ.

[0179] Referring to FIGS. 176 to 181, in one example of the present technology, the end of the strap 3301 has a reinforcing portion 3327 formed by folding the material 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 reinforcing portion 3327 may be different from the material of the strap 3301. The reinforcing portion 3327 can avoid or reduce the possibility that the patient 1000 tears or breaks the strap 3301 along its longitudinal axis starting from this area. The reinforcing portion 3327 helps to provide a visual and tactile indication to the patient 1000 regarding how to slide the strap 3301 on the rigidizer arm 3302 or how to remove the strap 3301 from the rigidizer arm 3302. This is because the reinforcing portion can help to identify the positions of the button holes 3303, 3304. The corners 3328 of the reinforcing portion 3327 are cut and rounded so that the corners 3328 substantially conform to the rounded corners of the free end 3302.1 of the distal end of the rigidizer arm 3302 (see FIGS. 50, 52, 55, 57, 58, 60). This results in a snap fit with the more aesthetically pleasing rigidizer arm 3302. The rounded corners 3328 provide a flexible edge to avoid facial scratches that could occur if they were sharp corners instead.

[0180] 6.3.7.2 Rigidizer Arm FIG. 67 shows an example of the rigidizer arm 3302. As shown, the rigidizer arm 3302 may be in a crescent or semi-circular shape. The rigidizer arm 3302 may have a generally elongated flat form. In other words, the rigidizer arm 3302 has a length and width (vertical direction within the paper plane) that are significantly larger than its thickness (direction towards the paper plane). The rigidizer 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 substantially uniform, but its height varies over its entire length. The purpose of the shape and dimensions of the rigidizer arm 3302 is to closely conform to the patient's cheek while remaining unobtrusive and blend in with the patient's face and cheek. The ends 3319a, 3319b of the rigidizer arm 3302 may be rounded and / or slightly tilted with respect to the rest of the rigidizer arm 3302. The rigidizer arm 3302 may be flat as shown by the paper plane of FIG. 67, but it can be seen that the rigidizer arm 3302 may also have a desired spatial form in the direction towards the paper plane of FIG. 67, especially to enable better alignment with the shape of the patient's face, such as the shape of the patient's cheek or the head side region (see, for example, FIGS. 71 and 72). The rigidizer arm 3302 may have a longitudinal axis that may be understood as an axis substantially parallel to the paper plane, and the rigidizer arm 3302 extends along this longitudinal axis (see the dashed line in FIG. 67).

[0181] The rigidizer arm 3302 is harder than the strap 3301 and less hard than the mask frame 3310. In particular, the rigidizer arm 3302 and / or the strap 3301, in a combined state, are such that the rigidizer arm 3302 gives shape to the strap 3301 and provides an improvement in stiffness in at least one direction or along at least one axis or around at least one axis. Also, the rigidizer arm 3302 guides or defines the extension direction or path for the strap 3301. In other words, the patient extends the strap 3301 in a direction substantially parallel to the longitudinal axis of the rigidizer arm 3302. Extension of the strap 3301 in other directions results in rotation of the rigidizer arm 3302 relative to the mask frame 3310, which is undesirable. The stiffness of the rigidizer arm 3302 biases the rigidizer arm 3302 into its natural non-rotated, non-twisted, non-deformed state. To some extent, this enables the positioning stabilization structure 3300 to be an auto-adjusting headgear. The auto-adjusting function avoids having to remember the adjusted length after manually shortening or lengthening the material length of the headgear strap. This has generally been a cumbersome process as the headgear straps on both sides of the face typically have to be shortened or lengthened one at a time. The auto-adjusting function can preclude the patient from over-tightening the headgear when such a high level of headgear tension is not required to maintain a good seal force. In the illustrated example, the strap 3301 has a tubular or sleeve-like form. In other words, the strap 3301 is hollow to receive the insertion of the rigidizer arm 3302 that slides into the strap 3301 through the buttonhole 3303. In other examples, the rigidizer arm 3302 may be non-removably connected to the strap 3301 at at least one location, such as an anchor point where the rigidizer arm is overmolded or adhered to form an integral chemical bond (molecular attachment) between the rigidizer arm 3302 and the strap 3301.

[0182] The strap 3301 includes side strap portions 3315, 3316 and a back strap portion 3317 positioned between the side strap portions 3315, 3316. As shown in FIGS. 4 to 8 and FIG. 166, the side strap portions 3315, 3316 are adapted to extend along both side surfaces of the patient's head when worn, while the back strap portion 3317 is adapted to extend along the back surface of the patient's head. The back strap portion 3317 may be composed of two, three, or more straps arranged in parallel to provide particularly stability. Although the smaller back strap portions 3317a, 3317b have been shown to be of equal length, it is envisioned that one back strap portion may be 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 smaller back strap portions 3317a, 3317b of the same size increases when the strap 3301 is manufactured, a greater tension is exerted on the side straps 3315, 3316 to be pulled towards each other by the back strap portions 3317a, 3317b. In the illustrated example, the side strap portions 3315, 3316 of the strap 3301 branch into two back strap portions 3317a, 3317b. In one example, each back strap portion 3317a, 3317b has half the amount of elastane material compared to each side strap portion 3315, 3316 of the strap 3301. In one example, the positioning and stabilizing structure 3300 is connected to the mask frame 3310 by a removable connection between the strap 3301 and the rigidizer arm 3302 via button holes 3303, 3304, and the rigidizer arm 3302 is non-removably connected to the mask frame 3310 by a mechanical connection. In other examples, a flexible joint 3305 formed from TPE may be non-removably connected to the rigidizer arm 3302 and the mask frame 3310.The flexible joint 3305 is overmolded with the mask frame 3310 for a non-removable connection, and the flexible joint 3305 is non-removably connected to the rigidizer arm 3302 by a mechanical connection. In other examples, the flexible joint 3305 may be formed of the same material as the rigidizer arm 3302, such as Hytrel®, and is integral with the rigidizer arm 3302, and the flexible joint 3305 is non-removably connected to the mask frame 3310 by a mechanical connection. The strap 3301 is removably connected to the rigidizer arm 3302 via button holes 3303, 3304.

[0183] The engagement of the strap 3301 with the rigidizer arm 3302 may occur at one location near the mask frame 3310. This type of engagement allows for the maximum range of movement, i.e., elongation, of the strap 3301. This engagement can be released to allow the strap 3301 to be completely removed from the rigidizer arm 3302 and thus from the mask frame 3310 to facilitate cleaning of the strap 3301. This engagement functions as an anchor point for the strap 3301 such that when the strap 3301 is extended, the extension force is directed outwardly away from the anchor point. Referring 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 rigidizer arm 3302 and / or a protruding end portion 3306 extending from the rigidizer arm 3302.

[0184] As will be appreciated by those skilled in the art, the rigidizer arm 3302 referred to herein may be harder than the strap 3301 and is configured to impart a shape to the strap 3301. The rigidizer arm 3302 may be harder at least along one axis or around an axis and cannot expand as opposed to the strap 3301 which may extend along at least one axis. In other examples, the rigidizer arm 3302 can expand / extend in a direction generally parallel to its longitudinal axis. Elastomers can generally expand, but some thermoplastic polyester elastomers, such as Hytrel® 5556 manufactured by DuPont®, do not expand but are flexible. For example, the rigidizer arm 3302 may have a scissor link structure or a telescopic structure that allows the rigidizer arm 3302 to move between a compressed position and a fully extended position. A rigidizer arm 3302 that can expand may fit better in a patient 1000 with a long face so as to appropriately adjust the length of the rigidizer arm 3302. Alternatively, the rigidizer arm 3302 may be referred to as a yoke and / or a reinforcement. The yoke may be understood as a rigid element adapted to support the strap 3301 of the positioning stabilization structure 3300. The rigidizer arm 3302 may be understood as a rigid element that imparts a shape to the strap 3301 of the positioning stabilization structure 3300 when worn on the face.

[0185] 6.3.7.3 Another Rigidizer Arm Figures 223 through 232 show the aforementioned exemplary patient interface system 3000. Figures 233a through 233h show such an exemplary patient interface system 3000 worn on a patient. Figures 240 through 244 show additional views of an exemplary patient interface system without strap 3301 to show features of the rigidizer arm 3302 included with the strap. The patient interface system 3000 shown in these figures may include a rigidizer arm 3302 to secure an effective seal to the patient's nose by the seal forming structure 3100. It should be understood that the seal forming structure 3100 described above in connection with Figures 223 through 239 may be included in an exemplary patient interface 3000 with the rigidizer arm 3302 shown in these drawings.

[0186] The rigidizer arm 3302 may be formed to minimize torsion and may also be more rigid than the rigidizer arm 3302 described elsewhere in this specification. A rigid rigidizer arm 3302 may be beneficial to include with a seal-forming structure 3100 in the form of a nasal cradle cushion. This is because a rigid rigidizer arm can secure an effective seal with this type of seal-forming structure. In an example where the seal-forming structure 3100 has a nasal pillow, the nasal pillow may serve to position and hold itself relative to the nostrils by extending into the nostrils. In an example where the seal-forming structure 3100 is a nasal cradle cushion, such a holding function may not be easily achieved. Thus, a rigidizer arm 3302 may be provided in a patient interface system 3000 having a nasal cradle cushion as the seal-forming structure 3100 so that the seal-forming structure can maintain an effective seal against the patient's nose. According to an example of the present technology, the extensions 3370, 3371 may be configured to prevent movement of the rigidizer arm 3302 in a plane parallel to the sagittal plane of the patient (see FIG. 2f), and / or the extensions may be configured to allow the rigidizer arm to bend in a plane parallel to the Frankfurt horizontal plane of the patient (see FIG. 2e). In other words, the rigidizer arm 3302 can be easily bent outwardly and inwardly relative to the patient's face compared to vertical movement relative to the mask frame 3310 to accommodate various face widths. In one example, the rigidizer arm 3302 is only allowed to bend outwardly and inwardly 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, particularly to enhance the stability of the patient interface 3000 when tube torque is received in the sagittal plane.

[0187] According to the examples shown in FIGS. 240 to 244, a typical rigidizer arm 3302 may be connected to the mask frame 3310 by a mechanical connection facilitated by overmolding the frame 3310 over a portion of the extensions 3370, 3371. The rigidizer arm 3302 may include a joint 3374 to connect the rigidizer arm 3302 to the extensions 3370, 3371. The rigidizer arm 3302 may be integrally formed from one material with the joint 3374 and the extensions 3370, 3371. The material selected for these examples of rigidizer arms may be the same as the materials used for other examples of rigidizer arms discussed elsewhere in this specification. Similarly, the frame 3310 may be formed from the same materials used with other examples disclosed herein. Thus, in order to couple the extensions 3370, 3371 to the frame 3310, an overmold connection may be required because the respective materials may not be bondable to each other. The respective materials of the rigidizer arm 3302 and the frame, as well as the overmold connection, will be described in further detail below.

[0188] In an example where the nose cradle cushion is used as the seal forming structure 3100, the extending portions 3370, 3371 may be wider in the vertical direction than the extending portion 3350 used in an example having a nasal pillow. The additional volume of the larger extending portions 3370, 3371 can provide resistance to the twisting described above, which can be beneficial when using a nose cradle cushion. This is because the same material is used for the rigidizer arm 3302 in any example, but in the example of the nose cradle cushion, more material is required to provide a desirable increase in rigidity. According to an example of the present technology, the extending portions 3370, 3371 may have a width in the vertical direction that is approximately equal to the width at the widest body portion of the body 3333 of the rigidizer arm 3302 to obtain the desired rigidity and resistance to twisting. According to another example of the present technology, the extending portions 3370, 3371 may be wider in the vertical direction than the body 3333 of the rigidizer arm 3302 to obtain the desired rigidity and resistance to twisting. Alternatively, reinforcing ribs may be formed on the extending portions 3370, 3371, the extending portions may be formed with a geometric shape having a greater resistance to twisting, and / or the rigidizer arm 3302 may be formed from a material having a higher rigidity.

[0189] Also, it should be understood that straps 3315, 3316 may be attached to the rigidizer arm 3302 in an example using a nose cradle cushion for the seal forming structure 3100 in a similar form as in the example using a nasal pillow, as shown in FIGS. 223 to 233h. This configuration will be described in more detail elsewhere in this specification.

[0190] The right extending portion 3370 shown in these drawings also includes an indicia 3372 that may be raised from the extending portion to provide the patient with visual and tactile references for properly orienting the patient interface 3000 when wearing the patient interface for treatment.

[0191] Figures 246a through 246g show several views of a typical patient interface 3000. These views show the patient interface 3000 without the strap 3301 of the positioning stabilization structure 3300 and without the short tube 4180.

[0192] Figures 246e through 246g show views of the patient interface 3000 where the protruding end support portion 3208 is visible.

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

[0194] 6.3.7.4 Attachment of the Strap and the Rigidizer 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 facing away from the patient 1000 when worn, and are adapted to receive the rigidizer arm 3302 for inserting the rigidizer arm 3302 into the tubular or sleeve-shaped strap 3301 or for removing the rigidizer 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 are oriented and / or formed such that the rigidizer arm 3302 can be inserted through such button holes 3303 and / or removed while still preventing accidental detachment or separation of the rigidizer arm 3302 from the strap 3301 in use to assemble the positioning stabilizer structure 3300. As shown in FIG. 65, this may be achieved by providing button holes 3303 having a slit-like form similar to button holes that may be oriented parallel to or laterally with respect to the strap 3301, for example. Alternatively, the button hole 3303 may be oriented across the strap 3301 as required. In other words, the elongated extensions of the button holes 3303, 3304 may extend substantially coaxial with the longitudinal axes of both the strap 3301 and the rigidizer arm 3302. This allows for easy insertion of the rigidizer arm 3302 into the tubular or sleeve-shaped strap or a portion of the strap 3301, particularly due to the elasticity of the strap 3301, while preventing accidental detachment of the rigidizer arm. The end of the strap 3301 between the distal end of the strap 3301 and the button hole 3303 covers and wraps around the edge of the rigidizer arm 3302 and functions as an anchor point. This edge or anchor point of the rigidizer arm 3302 may be a capture member. This end of the strap 3301 may be referred to as a pocket-like end 3311.This prevents the strap 3301 from slipping off the inserted rigidizer arm 3302 when the strap 3301 is extended and adjusted while the patient interface 3000 is being worn or removed.

[0195] Referring to FIGS. 185 and 186, the rigidizer arm 3302 may be inserted into the first button hole 3303 of the strap 3301. In other words, the strap 3301 may be slid over the rigidizer arm 3302 through the button hole 3303. The free end 3302.1 of the distal end of the rigidizer arm 3302 is first inserted into the strap 3301 through the button hole 3303. The rigidizer arm 3302 is further pushed into the strap 3301 until most or substantially the entire rigidizer arm 3302 is inserted into the strap 3301 so that the end of the strap 3301 can be firmly fixed to the edge of the rigidizer arm 3302. A part of the material of the strap 3301 near the button hole 3303 is adjusted to be located directly below the outer surface 3319 of the protrusion 3309 (see FIG. 38). As can be seen in FIGS. 6 - 8, the rigidizer arm 3302 may be left in a substantially unrestricted state of floating inside the strap 3301 when inserted into the strap 3301. Most importantly, the button hole 3303 must be above the attachment point. This is because the end of the strap 3301 is captured against the protruding end 3306 of the rigidizer arm 3302 to fix the strap 3301 to the rigidizer arm 3302, and when the strap 3301 is extended, the end of the strap 3301 pulls against the protruding end 3306. Generally, the position of the attachment point between the rigidizer arm 3302 and the strap 3301 is more important than the type of attachment using, for example, the button holes 3303, 3304 of the strap 3301. Referring to FIGS. 182 - 184, the type of attachment between the rigidizer arm 3302 and the strap 3301 may facilitate the easy removal of the strap 3301 from the rigidizer arm 3302 to enable individual cleaning of the strap 3301. In other words, the cleaning measures for the strap 3301 may be at a different time from the mask frame 3310. The patient 1000 slightly extends the strap 3301 around the button hole 3303 to remove the strap 3301 from the rigidizer arm 3302.After the distal end of the strap 3301 is removed, the strap 3301 may be completely detached from the rigidizer arm 3302 through the buttonhole 3303.

[0196] In addition to or instead of this, the rigidizer arm 3302 is attached to the strap 3301. The attachment may be performed by attaching or fixing the second end of the rigidizer arm 3302 near the buttonhole 3303 to the strap 3301 of the positioning and stabilizing structure 3300 after insertion. The fixing may be local, as discussed in the preamble part of the specification text. Here, the connection between the rigidizer arm 3302 and the strap 3301 is not distributed along the length of the strap 3301, but is locally performed in the area adjacent to the buttonhole 3303. Alternatively, such a connection may be provided in the area adjacent to the buttonhole 3304. The attachment may be performed by sewing, welding, gluing, heat caulking, clamping, buttoning, snapping a cover over the ends, or snapping to an external component such as an external clip that holds both ends of the strap and the rigidizer arm 3302 by pushing the rigidizer arm 3302 into the strap 3301 and holding both ends of the strap and the rigidizer arm. Alternatively, the strap 3301 may be chemically bonded to the rigidizer 3302. Also, the clip may be used to attach the ends of the strap 3301 to the respective ends of the mask frame 3310. Thus, the clip may be part of the mask frame 3310 itself.

[0197] Using this technique, it is still possible to extend the strap substantially along its entire length while the strap 3301 is arranged to conform to the shape of the rigidizer arm 3302. Thus, the rigidizer arm 3302 gives the required shape to direct the pressure of the positioning stabilizer structure 3300 to the required part of the face, while the elastic positioning stabilizer structure 3300 maintains its overall operating length and can freely extend over the rigidizer arm 3302. In addition, the rigidizer arm 3302 may disconnect the tube torque within the frontal plane. In particular, the sharp bend 3307 of the rigidizer arm 3302 may also serve to handle and disconnect any tube torque within the sagittal plane. At the same time, the strap 3301 of the positioning stabilizer structure 3300 may cover the rigidizer arm 3302 and also provides a soft feel and high comfort.

[0198] The sharp bend 3307 provides stability to the patient interface 3000. When the patient 1000 is lying on their side, the rigidizer arm 3302 that contacts the side of the face on the bedding is pressed inward. The sharp bend 3307 disconnects this movement within the frontal plane and prevents interference with the seal force. The sharp bend 3307 has a tighter bend on its upper surface (facing away from the patient's face) compared to its lower surface (facing the patient's face). The lower surface of the sharp bend 3307 has a larger radius (is flatter) than the upper surface of the sharp bend 3307, thereby smoothing the lower surface and avoiding or minimizing face markings on the patient 1000. This is because when there is any contact (due to nasal drooping caused by tube weight or tube torque) on the patient's nasal septum and / or upper lip, the contact pressure is hardly concentrated. The distance between the two sharp bends 3307 is approximately 50 mm.

[0199] Although illustrated and discussed with respect to specific examples shown in FIGS. 65-70, it can be seen that each of the strap 3301, or the side strap portions 3315, 3316 of the strap, may be provided with only one button hole 3303, 3304. However, two or more button holes may be provided. Alternatively or in addition, the strap 3301 may not be tubular or sleeve-shaped and may have a flat single-layer or laminated form. Here, the rigidizer arm 3302 may be positioned relative to the strap 3301 by comprising holding means including one or more loops, sleeve-shaped portions, or pockets provided on the outer surface of the strap 3301 (e.g., the surface facing away from the patient during use).

[0200] In addition to or instead of this, combinations of different connection mechanisms described herein may be provided. For example, the rigidizer arm 3302 may be held adjacent to the strap 3301 by comprising a loop or sleeve-like element provided on the outer surface of the strap 3301, for example in the regions of marks 3321b, 3323b, and may be fixed to the strap 3301 at a single point or in a local region adjacent to, for example, the pocket-like ends 3311, 3313 of the strap 3301 as described above. In other words, the rigidizer arm 3302 may be connected to the strap 3301 by functioning as an additional guiding element for the strap 3301 while fixing it at only one local point or region. Such a guiding element function may be provided by a loop or sheath-like portion or passage or pocket of the strap 3301 into which or through which the rigidizer arm 3302 enters and 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 rigidizer arm 3302 may be arranged without being attached within one or more pockets (for example, a single pocket with an open end of a sheath of considerable length that supports the rigidizer arm somewhere in the middle, or a pair of pockets each supporting a corresponding end of the rigidizer arm) or within a plurality of loops distributed along the length of the strap 3301. Such a guiding element function allows for substantially free movement or play of the rigidizer arm 3302 with respect to the strap 3301, whether or not it is attached at one end. Such a configuration allows for the same advantages and benefits as the configurations described above. Also, according to an example of the technology, the rigidizer arm 3302 does not extend or bend in the same direction as the strap 3301. Rather, the rigidizer arm 3302 may extend or bend in a plane substantially perpendicular to its longitudinal axis.

[0201] In the example illustrated and discussed, the rigidizer arm 3302 does not extend beyond the end of the strap 3301. However, according to another aspect, the rigidizer arm 3302 may extend beyond the strap 3301 and be fixed to the strap 3301, for example, at a point or region adjacent to each of the pocket-like ends 3311, 3313. In such a configuration, the rigidizer arm 3302 may impart shape, geometry, and / or rigidity to the strap 3301 and may also include structural means such as a flexible joint 3305 for connecting to the patient interface 3000. Thereby, the rigidizer arm 3302 can perform both the function as a rigidizer arm 3302 and the function as a connector for connecting the strap 3301 and the positioning stabilizer structure 3300 to the frame 3310, the plenum chamber 3200, or the seal forming structure 3100, respectively.

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

[0203] Figure 115 shows a view similar to Figure 114 but is a more detailed view to better show the relationship between the flange 3359 and the pocket-shaped end 3313. Also, Figure 116 shows a view similar to Figure 113 but is a more detailed view to better show the mark 3358 and the button hole 3303 of the pocket-shaped end 3313.

[0204] FIG. 117 shows a further detailed view of FIG. 114 to better illustrate the button hole 3303 of the pocket-shaped end 3313. FIG. 118 shows a further detailed view of FIG. 113 to better illustrate the button hole 3303 of the pocket-shaped end 3313.

[0205] FIGS. 119 to 122 show features similar to those shown in FIGS. 113 to 118, but in these figures, the flange 3359 is withdrawn from the button hole 3303 to better show its form. FIGS. 119 to 122 show a rigidizer arm 3302 including an imprint 3358 on an outer surface 3355 extending from the button hole 3303 of the pocket-shaped end 3311. FIG. 122 should be understood to show a more detailed view of FIG. 119. FIGS. 120 and 121 show other rigidizer arms 3302 that may not include an imprint. FIG. 121 should be understood to show a more detailed view of FIG. 120.

[0206] Figures 262A and 262B show another example of the present technology where the strap 3301 includes an elastic tube 3301.1 for attaching the strap to the rigidizer arm 3302. According to this example, the strap 3301 may include an elastic tube 3301.1 fixed to an end of the strap. Figure 262A shows the strap 3301 and the elastic tube 3301.1 removed from the rigidizer arm 3302, and for simplicity, a portion of the rigidizer arm is not shown. To attach the strap 3301 to the rigidizer arm 3302, the patient slides the elastic tube 3301.1 along the length of the rigidizer arm until the elastic tube reaches the raised stopper 3302.6 on the rigidizer arm. Although not shown in Figures 262A and 262B, it should be understood that a predetermined length of the rigidizer arm 3302 is received inside the strap 3301 until it reaches the point of the raised stopper 3302.6. The raised stopper 3302.6 may prevent the patient from pushing the strap 3301 too far along the length of the rigidizer arm 3302 and may allow the strap to be attached to the rigidizer arm at the desired position to maintain the intended stretchable length of the strap. The shape, size, and material of the elastic tube 3301.1 may be selected such that sufficient holding force due to friction is generated between the elastic tube and the rigidizer arm 3302 when the elastic tube reaches the raised stopper 3302.6. In other words, the frictional force between the elastic tube 3301.1 and the rigidizer arm 3302 should be less than the frictional force that holds the elastic tube on the rigidizer arm due to the tension in the strap 3301 when the patient wears the patient interface 3000, and thus, must be high enough to prevent the elastic tube from being pulled away from the rigidizer arm. The elastic tube 3301.1 may be formed from a material having a relatively high coefficient of static friction with the material of the rigidizer arm 3302 to keep the strap 3301 held on the rigidizer arm.Also, the material of the elastic tube 3301.1 must be extensible so that the elastic tube can deform when the elastic tube is slid down the rigidizer arm 3302 towards the raised stopper 3302.6.

[0207] Figure 263 shows another example of the present technique in which a tab 3470 may be formed on the rigidizer arm 3302 to hold the strap 3301 on the rigidizer arm using a hook-loop connection. The tab 3470 may be fixed to the rigidizer arm 3302 and / or may be integrally formed with the rigidizer arm 3302, and the tab may also include a 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-loop connection. To attach the strap 3301 to the rigidizer arm 3302, the patient may slide the strap along the length of the rigidizer arm to lift the tab 3470, slide the strap under the tab, and release 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 such that when worn by the patient, a sufficient area of the hook material engages the strap 3301 to create a holding force high enough to resist the tension of the strap. In this example, the entire strap 3301 may be manufactured to have loop material on its outer surface to save the cost of manufacturing the strap. Thus, in such an example, the loop material must be flexible enough to avoid inflammation of the patient's skin. Also, it should be understood that the tab 3470 may include loop material instead of hook material, in which case the strap 3301 may have a portion of hook material for attachment to the loop material of the tab. Also, it should be understood that the tab 3470 may be formed from an elastic material such that the tab can be pulled away from the rigidizer 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] Figures 264A and 264B show another example of the present technique where the strap 3301 may include a lock 3301.2 for engaging a notch 3302.2 on the rigidizer arm 3302. According to this example of the present technique, the lock 3301.2 may be positioned at an 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 a corresponding notch 3302.2 of the rigidizer arm 3302. In this example, the strap 3301 must be sufficiently elastic at its end such that when the patient interface 3000 is worn by a patient, the lock 3301.2 is held within the corresponding notch 3302.2 of the rigidizer arm 3302 with sufficient force to resist the tension of the strap. Figures 264A and 264B show an example of the present technique where one notch 3302.2 at the upper edge of the rigidizer arm 3302 and one notch at the lower edge of the rigidizer arm cooperate with corresponding locks 3301.2 in the strap 3301, but it should be understood that any number and / or position of corresponding locks and notches may be used as long as sufficient holding force is maintained.

[0209] Figure 265 shows an example of the present technology where the strap 3301 includes a loop material 3301.3 of a predetermined length and a piece of hook material 3301.4 at or near the end 3301.5 of the strap. The rigidizer 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 rigidizer arm 3302, the strap is first passed through the first slot 3302.7 and then looped back through the second slot 3302.8. To fix the strap 3301 to the rigidizer arm 3302, the hook material 3301.4 at the end 3301.5 of the strap is coupled to the loop material 3301.3. This example of the present technology may allow for some adjustment of the extendable 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 positions of the hook material 3301.4 and the loop material 3301.3 may be replaceable.

[0210] The examples shown in FIGS. 262A to 265 include a strap 3301 that can be removed from the rigidizer arm 3302 and inverted so that both sides of the strap can be used to contact the patient. This can be advantageous in that it may not be necessary to completely use up the strap 3301 when the surface on one side of the strap is worn. Rather, the patient may simply invert the strap 3301 to extend the useful life of the strap.

[0211] Also, in any of the aforementioned examples where the strap 3301 of the positioning and stabilization structure 3300 is detachable, the detachability of the strap may be beneficial for the overall life cycle of the patient interface 3000. For example, the strap 3301 may have a shorter service life than the assembly of the frame 3310 and the short tube 4180 so that the expiration of the strap does not require the replacement of the entire patient interface 3000. In other words, the strap 3301 can be replaced when it expires, and a new strap can be used with the remaining part of the patient interface 3000 that has not expired.

[0212] 6.3.7.4.1 Non-removable attachment alternatives Figures 266 to 270 show another example of the present technology in which the strap 3301 can be non-removably attached to the rigidizer arm 3302, that is, the patient cannot remove the strap from the rigidizer. The non-removable attachment of the strap 3301 to the rigidizer arm 3302 may be beneficial in that the patient does not need to pass the strap over the rigidizer arm and there is no possibility of the strap coming off the rigidizer arm.

[0213] Figure 266 shows an example of the present technology in which the strap 3301 is non-removably fixed to the rigidizer arm 3302 at the attachment point 3304. According to this example, the attachment point 3304 may be formed by ultrasonic welding of the strap 3301 to the rigidizer arm 3302. Two attachment points 3304 are shown on the surface of the rigidizer arm 3302 facing away from the patient during use, but it should be understood that the number, size, shape, and / or position of the attachment points 3304 may be changed as long as the desired stretchable length of the strap 3301 with respect to the rigidizer arm 3302 is maintained.

[0214] Figure 267 shows an example of the present technology similar to the example shown in Figure 266. However, the example shown in Figure 267 includes an attachment point 3304 formed by heat caulking instead of ultrasonic welding. Also, it should be understood that the size, shape, number, and / or position of the attachment point 3304 may be changed as long as the desirable stretchable length of the strap 3301 relative to the rigidizer arm 3302 is maintained.

[0215] Figure 268 shows a further example of the present technology similar to the example shown in Figure 266. However, the example shown in Figure 268 includes an attachment point 3304 formed by stitching. Also, it should be understood that the size, shape, number, and / or position of the attachment point 3304 may be changed as long as the desirable stretchable length of the strap 3301 relative to the rigidizer arm 3302 is maintained.

[0216] Figure 269 shows another example of the present technology where the attachment point 3304 is fixed to the rigidizer arm 3302 in a hinge configuration to non - removably fix the strap 3301 to the rigidizer arm. For example, the attachment point 3304 may perforate the fabric of the strap 3301 to form a non - removable attachment.

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

[0218] 6.3.7.5 Stretch of the Strap with Respect to the Rigidizer Arm As can be seen in the example shown in FIG. 68, two rigidizer arms 3302 are inserted into side strap portions 3315, 3316 of a strap 3301 of a positioning stabilization structure 3300. The rigidizer 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 extend or move relative to the rigidizer arms 3302. Preferably, this extensible portion is a substantial part. This is because the strap 3301 is fixed to the rigidizer arms 3302 only at the anchor points. In some examples, the movement of the rigidizer arms 3302 is generally restricted when one of the ends 3319a or 3319b of the rigidizer arms 3302 moves into and abuts against respective pocket-like ends 3311 of the strap 3301, as in the case of FIG. 69. For example, when the positioning stabilization structure 3300 is not on the patient's head and the strap 3301 is loose, if the inserted rigidizer arms 3302 move extremely towards the back strap portions 3317a, 3317b, the end 3319b thereof may enter the open end of one of these back strap portions 3317a, 3317b. Since the width of the back strap portions 3317a, 3317b is smaller than the width of the rigidizer arms 3302, the end 3319b of the rigidizer arms 3302 abuts against the respective back strap portions 3317a, 3317b, thereby restricting further movement of the rigidizer arms in this direction.

[0219] The attachment of the strap 3301 to the rigidizer arm 3302 described in the previous section may also affect the size of the head that the positioning and stabilizing structure 3300 can accept. In other words, by providing a longer length of the strap 3301 along the rigidizer arm 3302, it may be possible to increase the overall extendable length of the positioning and stabilizing structure 3300, thereby being able to accept a head with a considerably large circumference without the need to enhance the elasticity of the strap 3301. Also, the location where the strap 3301 is connected may be changed along the length of the rigidizer arm 3302. Thereby, it is possible to accept a considerably large head size range and head circumference range without the need to change the elasticity of the strap 3301.

[0220] The length of the strap 3301 is about 400 mm to 700 mm. The length of the strap 3301 may be about 490 mm. The strap 3301 can provide a comfortable level of headgear tension for most head sizes. There may be two gender-specific lengths or sizes for the strap, with one for the male population being 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 extended from 490 mm to 526 mm for patient 1000 with a small head circumference, the headgear tension measured using an Instron testing machine is 2 Newtons. When the strap 3301 is extended from 490 mm to 662 mm for patients with a large head circumference, the headgear tension measured using an Instron testing machine is 4.4 Newtons. For measurement, the button holes 3303, 3304 of the strap 3301 are attached to a clamp fixture. A tensile testing machine with a 100 Newton load cell is used. The strap 3301 is stretched and held at predetermined extension points (e.g., 90.5 mm, 73 mm, and 108 mm) for 1 minute, and the force value (in Newtons) is recorded for each extension point. Such measurements do not take into account any friction of the material of the strap 3301 against the patient's face or hair.

[0221] The length of the division area 3326 defined between the two backstrap portions 3317a and 3317b is from about 180 mm to about 220 mm. The length of the division area 3326 may be 200 mm. If the length of the division area 3326 is not long enough, the two backstrap portions 3317a and 3317b cannot surround the back of the patient's head, and thus their positions cannot be maintained during treatment, and the headgear tension still does not match the patient's preference. If the length of the division area 3326 is too long, the two backstrap portions 3317a and 3317b are separated in front of the user's ears and become uncomfortable. This is because the backstrap portion passes across above the ears rather than above / around the ears, thereby reducing the maximum angular range between the two backstrap portions 3317a and 3317b with respect to each other.

[0222] In the neutral, non - extended state of the strap 3301, the two back - strap portions 3317a, 3317b form an angle θ of about 0° to about 10° with each other. After the patient interface 3000 is worn, the two back - strap portions 3317a, 3317b may be separated from each other such that the angle θ can be up to about 180°. This allows for a maximum angle range of 180°, whereby a large reduction range of headgear tension is provided by gradually spreading and separating the two back - strap portions 3317a, 3317b. 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 away from or closer to each other under the currently acting tension on the back of their head. By moving the two back - strap portions 3317a, 3317b further apart from each other, the split region 3326 expands, whereby the headgear tension is reduced from a non - split range of 2.5 to 5 Newtons. The headgear tension may be reduced from about 30%, according to one example up to about 50%, or in other examples up to about 40%, as measured by a load cell. In other words, for a patient with a small head circumference, the headgear tension may be reduced from 2 Newtons to 1.2 Newtons by increasing the distance interval between the two back - strap portions 3317a, 3317b. For a patient with a large head circumference, the headgear tension may be reduced from 4.4 Newtons to 2.64 Newtons by increasing the distance interval between the two back - strap portions 3317a, 3317b.

[0223] Accordingly, the rigidizer arm 3302 may be made to be movable along the length of the strap 3301 almost unrestrictedly, may be attached to the strap 3301, or may be adjacent to one of the ends of the strap.

[0224] The form under discussion allows the strap 3301, and thus the positioning and stabilizing structure 3300, to extend in length. Such extension is not limited to the portion of the strap 3301 that does not contact or is not parallel to the rigidizer arm 3302. The extension of the strap 3301, particularly the elastic extension, is also achieved in the region of the rigidizer arm 3302. This can be easily derived from the comparison between the length of the rigidizer arm 3302 in FIGS. 68 and 70 (where the strap 3301 remains the same length while being extended) and the marks 3321a - 3321d, 3323a - 3323e that visualize the length of the strap 3301 relative to the length of the rigidizer arm 3002. In FIG. 68 in the non - extended state, it can be easily derived from the comparison between FIGS. 68 and 70 that the rigidizer arm 3302 extends along each of the marks 3321a - 3321c and 3323a - 3323d. In contrast, in the extended state according to FIG. 70, the rigidizer arm 3302 extends only along the marks 3321a - 3321b and 3323a - 3323c. From this, it becomes clear that the strap 3301 is extended along the region where the rigidizer arm 3302 is accommodated within the strap 3301. However, during the extension of the strap 3301, the rigidizer arm 3302 remains unextended.

[0225] Needless to say, the positioning and stabilizing structure 3300 may include one or more rigidizer arms 3302. The previous discussion has focused on the relationship between the rigidizer arm 3302 and the strap 3301, but it should be noted that the examples shown in FIGS. 68 - 70 include two rigidizer arms 3302, with one rigidizer arm provided within each of the respective side - strap portions 3315, 3316 of the strap 3301. Thus, although the previous comments ultimately refer to one rigidizer arm 3302, they are equally applicable to two or more rigidizer arms 3302 connected to the mask frame 3310.

[0226] As described above, one advantage in allowing the strap 3301 to extend relative to the rigidizer arm 3302 is that the patient interface 3000 may be removably worn by the patient 1000 with the positioning stabilization structure 3300 without the need to remove any straps or other connection features. This can be useful for the patient 1000 using the device 3000 in a dark bedroom before or after sleep in that the patient does not need to see the connection or disconnection of various components to attach or remove the patient interface 3000. Rather, the patient 1000 simply dons or doffs the patient interface 3000 and the positioning stabilization structure 3300, and may also need to position the seal-forming structure 3100 when wearing. However, this can all be accomplished by feel and does not require seeing.

[0227] However, it may still continue to be advantageous to enable removal of the plenum chamber 3200 or the seal-forming structure 3100 from the positioning stabilization structure 3300. For example, it may be desirable to clean the plenum chamber 3200 or the seal-forming structure 3100 without wetting the positioning stabilization structure 3300. This can be facilitated by making these components removable for such purposes.

[0228] 6.3.7.6 Rigidizer Arm and Mask Frame Figures 47-60 show the rigidizer arm 3302 and the mask frame 3310 according to further examples of the present technique.

[0229] Figures 47 to 49 and Figure 54 show cross-sectional views of a rigidizer arm 3302 and a mask frame 3310 according to an example of the present technology and the connection therebetween. In the vicinity of the sharp bent portion 3307 of the rigidizer arm 3302, an extension portion 3350 is connected by a joint 3356. Also, in the vicinity of the sharp bent portion 3307, there is a protruding end portion 3306 of the rigidizer arm 3302 that may hold the pocket-shaped end portion of the side strap portion 3316 of the positioning stabilizer structure 3300. In these figures, it can be seen that the mask frame 3310 is formed around the enclosable portion 3354 of the extension portion 3350 and the hook 3353. An opening 3335 may be formed in the mask frame 3310 in the vicinity of the location 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 fixed around the enclosable portion 3354 of the rigidizer arm 3302. The rigidizer arm 3302 according to this example may be formed from Hytrel (registered trademark), and the mask frame 3310 may be formed from polypropylene (PP). Hytrel (registered trademark) is desirable for forming the rigidizer arm 3302. This is because this material exhibits resistance to creep. Since these materials cannot be integrally bonded, in this example, the mask frame 3310 may be overmolded onto the rigidizer arm 3302 to form a reliable connection. Also, it should be noted that in this example, the extension portion 3350 and the rigidizer arm 3302 may be integrally molded. The mask frame 3310 may be connected by respective extension portions 3350 located on the opposite side of the free end portion 3302.1 of the distal end with respect to the rigidizer arm 3302. The extension portion 3350 may include a straight portion 3351 coupled to a bent portion 3352 coupled to the hook 3353. A part of the hook 3353 and the bent portion 3352 may form the enclosable portion 3354.

[0230] A joint 3356 connecting the extension portion 3350 to the rigidizer arm 3302 may provide a flexible target point, and it should be understood that the joint may be formed and shaped to allow bending in a desired direction and to a desired degree. Thus, when the patient interface 3000 is worn and the rigidizer arm 3302 is stressed by the tension from the strap of the positioning and stabilizing structure 3300, the rigidizer arm 3302 bends at the joint 3356, whereby the rigidizer arm can hold the mask frame 3310 in a desired position relative to the patient's face while maintaining the craniofacial shape.

[0231] Figures 50 and 51 respectively show a perspective view and a detailed perspective view of a rigidizer arm 3302 connected to a mask frame 3310 according to an example of the present technology. FIG. 51 further shows in dashed lines an encapsulable portion 3354 overmolded by the mask frame 3310 to fix the mask frame to the end of the rigidizer arm 3302. Similar to the case of FIGS. 47 - 49, an opening 3335 can be seen that forms a passage completely through the hook 3353 of the rigidizer arm 3302 and the mask frame 3310.

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

[0233] Figures 55 to 57 respectively show a side view, a front view, and a perspective view of a rigidizer arm 3302 and a mask frame 3310 according to an example of the present technology. In FIG. 55, dimension H indicates the height of the rigidizer arm 3302 in the illustrated direction. Preferably, the nominal height H of the rigidizer arm 3302 is 33 mm. The rigidizer arm 3302 and the extension portion 3350 may be connected to the mask frame 3310 by overmolding the mask frame 3310 onto the enclosable portion 3354 of the extension portion 3350 of the rigidizer arm 3302 after being formed as an integral part. The extension portion 3350 receives the nasal droop by bending in a vertical rotation or pivoting manner with respect to the rigidizer arm 3302. The extension portion 3350 has a smaller height and less material than the remaining portion of the rigidizer arm 3302 and is separated from the remaining portion of the rigidizer arm 3302 by a sharp bending portion 3307, so that the bending of the extension portion 3350 occurs locally before the remaining portion of the rigidizer arm 3302 begins to bend. This reduces the possibility of interfering with the sealing force.

[0234] Figures 58 and 59 respectively show a partial exploded view and a detailed partial exploded view of a rigidizer 3302 and a mask frame 3310 according to an example of the present technology. It can be seen that the hook 3353 and the enclosable portion 3354 of the extending portion 3350 are separated from the mask frame 3310. In these figures, the shapes of the hook 3353 and the enclosable portion 3354 can be seen, and it should be understood that these portions are formed to ensure a stronger mechanical connection 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 flare-shaped end by the hook 3353 to provide a surface for holding against the mask frame 3310. In other examples of the present technology, the enclosable portion 3354 may include an opening for holding the rigidizer arm 3302 in the mold during overmolding of the mask frame 3310. To stabilize the rigidizer arm 3302 when the mask frame 3310 is overmolded around the rigidizer, a mold may be inserted through this opening. This can be beneficial because the rigidizer arm 3302 may move during the molding process due to the overmolding pressure such that a less than ideal mechanical connection with the mask frame 3310 is formed.

[0235] Figure 60 shows a perspective view of a rigidizer arm 3302 according to an example of the present technology. This figure shows the rigidizer arm 3302 before a non-removable connection with the mask frame 3310. As just discussed, the rigidizer arm 3302 may include a hook 3353 and an enclosable portion 3354 to enable connection to the mask frame 3310 by a mechanical connection. This non-removably connects the rigidizer arm 3302 to the frame 3310. That the rigidizer arm 3302 and the frame 3310 are non-removably connected to each other means that there are few detachable parts and the possibility of losing parts during assembly / disassembly of the patient interface 3000 during cleaning is low.

[0236] 6.3.7.6.1 Improvement in stability between the frame and the rigidizer arm According to certain examples of the present technology, it may be desirable to couple the frame 3310 and the rigidizer arm 3302 in a manner that enhances the stability of the patient interface 3000.

[0237] FIG. 260A shows an example of the present technology in which the rigidizer arm 3302 is formed on the frame 3310. The frame 3310 and the rigidizer arm 3302 may be integrally formed. This example does not include the extension 3350 provided in other examples to provide a bending strength of a desired magnitude at the joint between the frame 3310 and the rigidizer arm 3302. Rather, an extension arm 3302.3 is formed to couple the rigidizer arm 3302 to the frame 3310. As part of the forming process, a void 3302.4 may be formed between the extension arms 3302.3 to remove unnecessary material. By spreading and separating the upper and lower extension arms 3302.3, it should be understood that the moment of inertia at the location where the extension arms are coupled to the frame can be increased about the axis X-X shown in FIG. 260A. The equation for the moment of inertia of this joint about X-X may be simplified to I = bh 3 / 12. Thus, an increase in h, i.e., an increase in the space between the upper and lower extension arms 3302.3, results in a greater increase in the moment of inertia I about X-X compared to an increase in b, i.e., the thickness of the extension arms. Also, by optimizing the geometric shape of the rigidizer arm, the rigidizer arm 3302 and / or the extension arm 3302.3 can be made thinner.

[0238] FIG. 260B shows another example of the present technology in which the rigidizer 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 having comparable rigidity. Also, the rigidizer arm 3302 of this example may be formed from a relatively rigid material such as nylon.

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

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

[0241] 6.3.7.7 Positioning Stabilization Structure Worn by the Patient Figures 71 to 73 show an example of the present technology. Here, the positioning and stabilization structure 3300 includes a strap 3301 having side strap portions 3315 and 3316 and a back strap portion 3317, and the back strap portion 3317 includes two back strap portions 3317a and 3317b that extend parallel along the back of the patient's head. The positioning and stabilization structure 3300 includes two rigidizer arms (not shown) each housed within a respective side strap portion 3315, 3316 of the strap 3301 which is each sleeve-shaped or tubular. The rigidizer arms 3302 impart a predetermined shape or a desired shape and / or rigidity to the strap 3301 and thus to the positioning and stabilization structure 3300. For example, the side strap portions 3315, 3316 of the strap 3301 have a specific curvature (see the curvature of reference numeral 3323 in FIGS. 52, 54, 58, and 60) to conform to a desired contour around the patient's face, which is achieved by providing correspondingly formed rigidizer arms 3302. In the illustrated example, the positioning and stabilization structure 3300 is connected to the frame 3310, the plenum chamber 3200, or the seal-forming structure 3100 to supply breathing gas such as air, and thus pressurized breathing gas, to the patient's airway. In the illustrated example, such breathing gas is supplied via a hose or tube 4180 connected to the patient interface 3000. The other end (not shown) of the tube 4180 may be connected to a breathing gas source such as a blower or a ventilator for supplying pressurized breathing gas. The patient interface 3000 may include a frame portion or a frame 3310 to provide structural integrity to the patient interface 3000 and / or to connect to the positioning and stabilization structure 3300. The positioning and stabilization 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 strap 3301 and / or the rigidizer arms 3302.

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

[0243] 6.3.7.7.1 Attachment of the rigidizer arm to the patient interface According to a further example of the present technology, the rigidizer arm 3302 may be detachable. By enabling the rigidizer arm to be removed from the patient interface 3000, the rigidizer arm 3302 is subject to little distortion during transportation and storage. If the rigidizer arm 3302 is detachable, the patient interface 3000 can be more compactly packaged in a manner that appropriately supports each individual component. Also, by making the rigidizer arm 3302 separable, the rigidizer arm can be separated for cleaning. In some examples, it should be understood that the extension portion 3350 may be removed from the frame 3310. In other examples, the rigidizer arm 3302 may be removed from the extension portion 3350, in which case the extension portion may be non-removably attached to the frame 3310. A further advantage of the detachable rigidizer arm 3302 may be that the attachment mechanism can be formed to provide an audible click sound to the patient, which gives the patient a sense of security that the components are effectively fixed. Such an audible click sound may be facilitated, for example, by a hard-hard indirect connection between the rigidizer arm 3302 and the frame 3310. The hard-hard indirect connection can be beneficial for patients suffering from fine motor skills. This is because the hard-hard indirect connection allows the patient to more easily assemble the patient interface 3000 and be confident that they have assembled it. Also, the detachable rigidizer arm 3302 can be beneficial for the patient in that the patient can customize the patient interface 3000 due to component compatibility. For example, the patient interface 3000 may be sold with a set of many rigidizer arms 3302 having different curvature profiles, shapes, lengths, and / or stiffnesses, from which the patient may select the most suitable set based on facial geometry and comfort. This can provide a better fit and greater comfort, thereby enhancing patient treatment compliance. Also, the set of rigidizer arms 3302 may be provided in different colors so as to give the patient aesthetically diverse options.

[0244] Figures 248A and 248B show an example of a rigidizer arm 3302 that is removed from the patient interface 3000 at the extension portion 3350 and attached to the patient interface 3000. A protrusion 3380 with a locking wing portion 3381 may be provided at the protruding end portion 3306 of the rigidizer arm 3302, and the protrusion 3380 may be supported by a shaft (not shown). An opening 3382 having a notch 3383 may be provided in the straight portion 3351 of the extension portion 3350. A stopper 3384 may be provided in the straight portion 3351 of the extension portion 3350. The opening 3382 and the notch 3383 may be dimensioned and formed corresponding to the protrusion 3380 and the wing portion 3381. To assemble the rigidizer arm 3302 to the extension portion 3350, the protrusion 3380 and the wing portion 3381 are extended through the corresponding opening 3382 and notch 3383 and then rotated until the wing portions abut against their respective stoppers 3384. Therefore, the length of the shaft should be dimensioned to be slightly larger than the width of the straight portion 3351 of the extension portion 3350 so as to minimize the play between the rigidizer arm 3302 and the extension portion 3350 when attached. It should be understood that the rigidizer arm 3302 may be fixed by rotation in only one direction. This may be achieved, for example, by positioning the stoppers 3384 on each side of the opening 3382 such that the rigidizer arm 3302 is fixed by clockwise rotation as shown in Figure 248B. Also, to prevent misassembly of the rigidizer arm 3302, that is, to prevent the case where the right rigidizer arm is attached to the left extension portion and vice versa, it should be understood that the corresponding protrusion-wing portion and opening-notch combinations may be dimensioned differently. Therefore, the patient can only reliably attach the right rigidizer arm 3302 to the right extension portion 3350 and the left rigidizer arm to the left extension portion.

[0245] Figures 249A and 249B illustrate another example of the present technology where the rigidizer arm 3302 may be detachable. In this example, the extension 3350 may be provided with a pair of pins 3385 extending from the extension. Each pin 3385 may have a head on a shaft, and the shaft is fixed to the extension 3350. The head of each pin 3385 may be larger in diameter than the shaft of each pin to enable attachment to a socket 3386 formed in the protruding end 3306 of the rigidizer arm 3302. The socket 3386 may include a slit to allow for flexing of the material of the protruding end 3306 such that the head of the pin 3385 can pass through each 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 when the rigidizer arm 3302 is attached. Also, the pins 3385 and the corresponding sockets 3386 may be spaced or dimensioned differently to prevent misassembly of the rigidizer arm 3302. For example, the spacing and / or positioning between the pins 3385 and the corresponding sockets 3386 of the right rigidizer arm 3302 and the extension 3350 may be different from the left side such that a patient cannot attach the left rigidizer arm to the right extension and vice versa. In another example, the pins 3385 and sockets 3386 of the left rigidizer arm 3302 and the extension 3350 may be dimensioned differently from the pins and sockets of the right rigidizer arm and extension such that a patient cannot attach the left rigidizer arm to the right extension and vice versa.

[0246] Figures 250A - 250C show other examples of the detachable rigidizer arm 3302 according to the present technology. In this example, the rigidizer arm 3302 includes a protrusion 3393 having an arm 3394 for fixing the rigidizer arm to the extension part 3350. The arm 3394 and the protrusion 3393 may extend from a shaft 3395 on the rigidizer arm 3302, and the arm, the protrusion, and the shaft may be integrally formed with the rigidizer arm 3302. Accordingly, a slot 3392 is provided in the extension part 3350, and the arm 3394 and the protrusion 3393 are passed through the slot 3392 during attachment. Also, in the extension part 3350, a shaft receiving part 3390 and an arm receiving part 3391 are also formed to receive the shaft 3395 and the arm 3394, respectively. To attach the rigidizer arm 3302 to the extension part 3350, the shaft 3395, the protrusion 3393, and the arm 3394 are passed through the slot 3392, and the shaft and the protrusion are drawn into engagement with the shaft receiving part 3390 and the arm receiving part 3391, respectively. The arm receiving part 3391 may be narrower than the shaft 3395 and the arm 3394 to ensure a secure friction fit when the arm engages the arm receiving part. To remove the rigidizer arm 3302 from the extension part 3350, the patient slides the rigidizer arm 3302 in a direction opposite to the attachment direction. Also, it should be understood that the diameter of the protrusion 3393 may be larger than the diameter of the shaft receiving part 3390 to prevent disassembly. To prevent assembly errors, the arm 3394 and the protrusion 3393 of the right rigidizer arm 3302 may be dimensioned and / or formed to fit only into the arm receiving part 3391 and the shaft receiving part 3390 of the right extension part 3350, and the arm and the protrusion of the left rigidizer arm may be dimensioned and / or formed to fit only into the arm receiving part and the shaft receiving part of the left extension part.

[0247] FIG. 251A and FIG. 251B show another example of the rigidizer arm 3302 which may be detachable. According to this example, the extension portion 3350 may be formed integrally with the rigidizer arm 3302. The extension portion 3350 may include a flared end 3387 that attaches to a receiving portion 3388 on the frame 3310. The flared end 3387 may be slid into a slot 3389 in the receiving portion 3388 to attach the extension portion 3350 and the rigidizer arm 3302, and the engagement may be a press fit. The receiving portion 3388 may be a separate component from the frame 3310 attached to the frame, or the receiving portion may be formed integrally with the frame. To prevent assembly errors, the right flared end 3387 and slot 3389 may be dimensioned and / or formed differently from the left flared end and slot.

[0248] Figures 252A - 252C show another example of the detachable rigidizer arm 3302. According to this example, the extension portion 3350 may be integrally formed with the rigidizer arm 3302. The extension portion 3350 may be formed to perform a snap - type engagement with the receiving portion 3310.1. The receiving portion 3310.1 may be a separate component from the frame 3310 attached to the frame, or the receiving portion may be integrally formed with the frame. The receiving portion 3310.1 may include a pocket 3310.2 and a recess 3310.3 to receive the extension portion 3350 for attachment of the rigidizer arm 3302. The extension portion 3350 includes a bent portion 3396 that facilitates snap - type engagement. The extension portion 3350 may be formed of an elastic material, and the extension portion may be dimensioned such that when the extension portion is disposed within the receiving portion 3310.1, the extension portion is compressed by a decrease in the angle of the bent portion 3396. This compression of the extension portion 3350 pushes the protrusion 3397 into the recess 3310.3 when the bent portion 3396 is pushed into the pocket 3310.2. A tab 3398 may be provided to facilitate detachment. The patient can remove the rigidizer arm 3302 by pressing the tab 3398 to further compress the bent portion 3396 and release the protrusion 3397 from the recess 3310.3. Also, to prevent assembly errors, the right - hand extension portion 3350 and the corresponding receiving portion 3310.1 may be dimensioned and / or formed differently from the left - hand extension portion and the corresponding receiving portion.

[0249] Figures 253A to 253C show another example of the rigidizer arm 3302 that may be detachable. According to this example, the extension portion 3350 may be formed integrally with the rigidizer arm 3302. The extension portion 3350 may be formed to perform a snap engagement with the receiving portion 3310.1. In this example, the extension portion 3350 may be held by the receiving portion 3310.1 using a friction fit. The receiving portion 3310.1 may be a separate component from the frame 3310 attached to the frame, or the receiving portion may be formed integrally with the frame. In this example, a support 3399 may be provided near the end 3350.1 of the extension portion 3350. To attach the extension portion 3350, the support 3399 is inserted into the pocket 3310.2 of the receiving portion 3310.1. The support 3399 may have a circular cross-sectional shape to engage with the complementary depression 3310.4 of the pocket 3310.2. Cross-sectional shapes of the support 3399 other than circular, such as square, rectangular, triangular, elliptical, etc., are similarly assumed. In this example, since these respective surfaces may be curved, an end receiving portion 3310.5 may be provided in the pocket 3310.2 to receive the end 3350.1 of the extension portion 3350. The engagement between the end receiving portion 3310.5 and the end 3350.1 of the extension portion 3350 can prevent unwanted rotation of the extension portion 3350 and the rigidizer arm 3302 about the longitudinal axis of the support 3399. Therefore, this can ensure that the movement of the rigidizer arm 3302 is only due to the deflection caused by the deformability of the rigidizer arm 3302 and the extension portion 3350, and not due to the play in the engagement between the extension portion and the receiving portion 3310.1. Therefore, to prevent assembly errors, the right extension portion 3350 and the corresponding receiving portion 3310.1 may be dimensioned and / or formed differently from the left extension portion and the receiving portion.

[0250] Figures 254A and 254B show another example of a rigidizer arm 3302 that may be detachable. This example may not include an extension 3350 formed with the rigidizer arm 3302. Rather, the rigidizer arm 3302 may be formed with a first bend 3340, a first straight portion 3341, a second bend 3342, a second straight portion 3343, and a lock end 3344 formed at an end of the second straight portion 3343. Slots 3345 may be provided on both sides of the frame 3310, and each rigidizer arm 3302 is passed through the slot 3345 for attachment to the frame. Each slot 3345 may be dimensioned and formed to allow each rigidizer arm 3302 to pass through the slot, but each slot may be smaller than each lock end to prevent the rigidizer arm from being pulled out through the slot. To prevent assembly errors, the right rigidizer arm 3302 and the corresponding slot 3345 may be formed and / or dimensioned differently from the left rigidizer arm and slot. Also, it should be understood that the portions of the rigidizer arm 3302 referred to above as the first straight portion 3341 and the second straight portion 3343 need not be straight, and these portions may alternatively be curved as needed to provide a desired shape / profile. Also, the rigidizer arm 3302 may have other curved portions and / or bends as desired, as long as the rigidizer arm can be passed through the slot.

[0251] Figures 255A and 255B show another example of the removable rigidizer arm 3302. According to this example, the extension portion 3350 may be formed integrally with the rigidizer arm 3302. This example includes a pin 3385 whose head is supported by the extension portion 3350 by a shaft. The head of the pin 3385 may have a diameter larger than that of the shaft. Sockets 3386 may be integrally formed on both sides of the frame 3310 for snap engagement with the respective pins 3385. To prevent assembly errors, the pin 3385 and the corresponding socket 3386 of the right rigidizer arm 3302 may be dimensioned and / or formed differently from the left pin and socket.

[0252] Figures 256A - 256C show another example of the removable rigidizer arm 3302. According to this example, the extension portion 3350 may be formed integrally with the rigidizer arm 3302. A receiving portion 3410 and a first magnet 3412 may be provided on the frame 3310. A second magnet 3413 may be provided on the extension portion 3350 to fix the rigidizer 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. A post 3411 may be provided on the extension portion 3350 near the second magnet 3413 to engage with the receiving portion 3410 and ensure that the extension portion is properly positioned in the receiving portion. Also, it should be understood that to prevent assembly errors, the right post 3411 and the receiving portion 3410 may be formed and / or dimensioned differently from the left post and receiving portion. To prevent assembly errors, the magnetic poles of the right first magnet 3412 and the second magnet 3413 may be oriented opposite to the magnetic poles of the left first magnet and the second magnet, such that magnetic attraction occurs only when the respective left and right magnets are engaged, and magnetic repulsion prevents engagement when the patient attempts to place the left rigidizer arm 3302 into the right receiving portion 3410 or vice versa.

[0253] FIG. 257A and FIG. 257B show another example of the rigidizer arm 3302 that may be detachable. The frame 3310 may include the first L-shaped portion 3420 on both sides, and the second L-shaped portion 3423 may be formed on each rigidizer arm 3302. In order to attach the frame 3310 to the rigidizer arm 3302, the first L-shaped portion 3420 is brought into an engaged state with the second L-shaped portion 3423 by moving the L-shaped portions in opposite vertical directions toward each other. 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 overlapping portion 3424 may engage with the first recess 3421, and the first overlapping portion 3422 may engage with the second recess 3425. The peg 3426 may be provided in the first recess 3421 and the second recess 3425. In order to fix the first L-shaped portion 3420 and the second L-shaped portion 3423, each peg 3426 may engage with the hole 3427 provided in the first overlapping portion 3422 and the second overlapping portion 3424. The holes 3427 in these examples are shown by 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 another example, the holes can extend completely through. Also, it should be understood that the engagement between each peg 3426 and the hole 3427 may include press fitting or friction fitting to ensure a secure connection. In yet another example, the peg 3426 may be provided with a hook at the end of the shaft, and each corresponding hole 3427 may extend completely through the first overlapping portion 3422 and the second overlapping portion 3424 so that the hook of each peg locks into the respective hole during engagement. Also, in another example, it should be understood that the peg 3426 can be provided in the first overlapping portion 3422 and the second overlapping portion 3424, and the hole 3427 can be provided in the first recess 3421 and the second recess 3425.

[0254] Figures 258A and 258B show another example of a rigidizer arm 3302 that may be detachable. According to this example, the extension 3350 may be formed integrally with the rigidizer arm 3302. The bosses 3430 may be formed on both sides of the frame 3310, and cavities 3431 may be formed at the ends of each extension 3350 to receive the bosses. The bosses 3430 and the cavities 3431 may be formed and dimensioned to form a secure friction fit. Also, in another example, it should be understood that the bosses 3430 may be formed on the extension 3350 and the cavities 3431 may be provided in the frame 3310. Also, to prevent assembly errors, the right bosses 3430 and cavities 3431 may be formed and / or dimensioned differently from the left bosses and cavities.

[0255] Figures 259A - 259C show other examples of the rigidizer arm 3302 that may be detachable. A post 3452 and a pair of slots 3453 may be provided in the extension 3350. The rigidizer arm 3302 may be provided with a hole 3451 for receiving the post 3452, and a pair of protrusions 3450 may be provided on the rigidizer arm 3302 for engaging with the respective slots 3453. To attach the rigidizer arm 3302 to the extension 3350, first the protrusions 3450 are passed through the corresponding slots 3453 of the extension, and then the post 3452 engages with the hole 3451 to prevent separation of the rigidizer arm from the extension. The bent shape of the protrusions 3450 may help to secure the protrusions when passed through the openings 3453. Also, the post 3452 may include a head that is enlarged relative to the shaft of the post to ensure that the post engages firmly with the hole 3451. In other examples, as long as complementary components are positioned such that the protrusions engage with the slots and the posts engage with the holes, it is to be understood that it is not necessary to provide the post 3452 and the slots 3453 on the extension 3350, nor is it necessary to provide the hole 3451 and the protrusions 3450 on the rigidizer arm 3302. Also, a plurality of posts 3452 and a plurality of holes 3451 may be provided as long as a complementary number is provided. Also, more or fewer corresponding protrusions 3450 and slots 3453 than two may be provided as long as a complementary number is provided. Further, to prevent assembly errors, it is to be understood that the number of protrusions 3450 and slots 3453, and the number of posts 3452 and holes 3451, may be different between the left extension 3350 and rigidizer arm 3302 and the right extension 3350 and rigidizer arm 3302. Alternatively, to prevent assembly errors, the size and / or shape of the protrusions 3450 and slots 3453, and the size and / or shape of the posts 3452 and holes 3451, may be different between the left extension 3350 and rigidizer arm 3302 and the right extension 3350 and rigidizer arm 3302.

[0256] 6.3.7.8 Split Backstrap of the Positioning Stabilization StructureAccording to one aspect, the structure of the strap 3301 and the positioning and stabilizing structure 3300 is beneficial. In particular, providing two elastic straps or backstrap portions 3317a, 3317b on the back can surround the head, and by properly positioning these straps, for example, by spreading the straps, the tension vector can be adjusted. Also, providing two backstrap portions 3317a, 3317b can obtain better support and stability, and can increase flexibility while avoiding particularly sensitive areas on the back of the head. The backstrap portions 3317a, 3317b are configured to surround the head at the calvaria to maintain position and engagement. In one example, depending on the specific head shape of the patient and the size of the division of the backstrap portions 3317a, 3317b, the upper backstrap portion 3317a is positioned near the parietal bone, and the lower backstrap portion 3317b is positioned near the occipital bone or the upper fibers of the sternocleidomastoid muscle (i.e., near the upper or dorsal cervical region of the neck). The lower backstrap portion 3317b may be configured to engage the patient's head at a position on or below the external occipital protuberance. Different from the conventional mask headgear that requires adjustment of the material length (shortening or lengthening), the tension provided by the positioning and stabiliz...

Claims

1. A patient interface configured to deliver, in a sealed state, the supply of breathable gas pressurized to a positive pressure continuously with respect to the ambient air pressure to the nostrils of a patient, wherein the patient interface is configured to maintain a treatment pressure in a range of about 4 cmH ２ O to about 30 cmH ２ O higher throughout the patient's respiratory cycle while the patient is asleep, in order to improve sleep disordered breathing The patient interface comprises: a frame; a seal-forming structure connected to the frame, the seal-forming structure being configured to contact the patient's face below the bridge of the nose, on the sides of the patient's nose, and on the patient's upper lip, the seal-forming structure being a seal-forming structure that is formed on the seal-forming structure and configured to deliver the supply of pressurized breathable gas to the patient's nostrils, the seal-forming structure comprising: a first region (3112.1) disposed proximal to the opening on each side of the opening, the first region (3112.1) being configured to contact the patient's nose; a second region (3112.2) disposed laterally outward adjacent to the first region (3112.1), the second region (3112.2) being thicker than the first region (3112.1); a third region (3112.3) disposed laterally outward adjacent to the second region (3112.2), the third region (3112.3) having a different thickness relative to the second region (3112.2), the seal-forming structure having a curved shape extending from the first region, through the second region, to the third region, the apex of the curved shape being located in the second region; a seal-forming structure; including at least one vent hole and configured to allow the flow of CO ２ emitted from the patient interface to the surroundings, a gas outflow vent; a positioning and stabilization structure including a strap and connected to the frame, the positioning and stabilization structure being configured to maintain the seal-forming structure in sealed contact with the patient's face while maintaining the treatment pressure in the patient's nasal cavity; A patient interface comprising the above.

2. The patient interface according to claim 1, wherein the third region is thicker than the second region.

3. The patient interface according to claim 1, wherein the third region is thinner than the second region and thicker than the first region.

4. The patient interface according to claim 1, wherein the third region is thinner than the first region and the second region.

5. The patient interface according to any one of claims 1 to 4, wherein a plenum chamber is joined to the seal-forming structure to at least partially form a gas chamber.

6. The patient interface according to claim 5, wherein the plenum chamber includes a retaining structure configured to releasably engage with the frame and releasably fix the seal forming structure and the plenum chamber to the frame.

7. The seal forming structure and the plenum chamber are made of a one-piece first material, the retaining structure is made of a second material, the first material is silicone, and the second material is silicone having a higher durometer than the first material. As a result, the retaining structure is more rigid than the seal forming structure and the plenum chamber. The patient interface according to claim 6.

8. The frame of the patient interface according to claim 7 is composed of a third material that is less flexible than the first material and the second material.

9. The patient interface according to any one of claims 6 to 8, wherein the retaining structure is permanently joined to the plenum chamber by a chemical bond between the first material and the second material.

10. The frame further includes ribs, and the plenum chamber further includes notches corresponding to the ribs. The patient interface according to any one of claims 5 to 9.

11. The plenum chamber further includes a seal lip configured to contact the frame, and the seal lip is configured such that the sealing force of the seal lip against the frame increases when the air pressure in the gas chamber increases. The patient interface according to any one of claims 5 to 10.

12. The patient interface according to any one of claims 1 to 11, wherein the seal forming structure is configured to seal around both nostrils of the patient around the lower part of the patient's nose.

13. The patient interface according to any one of claims 1 to 12, wherein the seal forming structure is configured not to enter the patient's nostrils during use.

14. The patient interface according to any one of claims 1 to 13, wherein the seal forming structure does not have an under-cushion.

15. The seal-forming structure includes a recess configured to receive the tip of the patient's nose, and the recess is located in a region of the seal-forming structure that is thinner than a region of the seal-forming structure that is laterally adjacent to the recess and configured to contact the patient's nasal wings. The patient interface according to any one of claims 1 to 14.

16. The seal-forming structure includes an adaptation region configured to be located in front of the recess with respect to the patient during use, and the adaptation region is thin and flexible with respect to the rest of the seal-forming structure. The patient interface according to claim 15.

17. The seal-forming structure has various thicknesses adjacent to the nasal opening at a predetermined position around the nasal opening. The patient interface according to any one of claims 1 to 16.

18. The seal-forming structure includes a pair of protruding ends that extend symmetrically with respect to the opening, and each protruding end is configured to seal against a region of the patient's face where the nasal wing joins the patient's face. The patient interface according to any one of claims 1 to 17.

19. The lower part of the seal-forming structure seals the patient's upper lip and is concave in a relaxed state so as to follow the curvature of the patient's upper lip. The patient interface according to any one of claims 1 to 18.

20. The positioning and stabilizing structure further includes a pair of rigidizer arms each joined to a corresponding side surface of the frame. The patient interface according to any one of claims 1 to 19.

21. The strap has two ends, and each end is removably connected to a corresponding one of the rigidizer arms. The patient interface according to claim 20.

22. The pair of rigidizer arms is composed of a material different from the material of the frame. The patient interface according to claim 20 or 21.

23. The pair of rigidizer arms is permanently joined to the frame by a mechanical connection. The patient interface according to any one of claims 20 to 22.

24. The gas outflow vent further includes two groups of vent holes, and each of the groups is arranged on a corresponding side surface of the frame. The patient interface according to any one of claims 1 to 23.

25. The frame further includes a port and a tube connected to the frame at the port, the tube being configured to direct a supply of pressurized breathable gas into the gas chamber through the port. The patient interface according to any one of claims 1 to 24. **Claim 26** The seal-forming structure further includes a pair of thick portions, each of the thick portions being disposed on a corresponding side surface of the seal-forming structure so as to contact the patient's face at or proximal to a corresponding nasolabial groove of the patient during use. The patient interface according to any one of claims 1 to 25. **Claim 27** The thick portion is thicker than an adjacent portion of the seal-forming structure. The patient interface according to claim 26. **Claim 28** The seal-forming structure consists of a single nasal opening configured to provide a supply of pressurized breathable gas to both nostrils of the patient during use. The patient interface according to any one of claims 1 to 27.

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