Patient Interface

Abstract

This technology relates to medical devices for treating and preventing respiratory diseases, and to the use of said medical devices. [Solution] A patient interface for supplying respiratory gas to a patient, comprising a plenum chamber assembly comprising a nasal plenum chamber that at least partially defines an upper gas chamber, an oral plenum chamber that at least partially defines a lower gas chamber, and a separation structure that at least partially connects the nasal plenum chamber and the oral plenum chamber and at least partially defines a flow path; a top plate including at least one connecting function configured to releasably hold a first portion of a positioning and stabilizing structure; and a face plate configured to releasably hold a second portion of a positioning and stabilizing structure.

Description

Technical Field

[0006] , , , ,

[0005]

[0001] 1 Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 61 / 823,353, filed on May 14, 2013, and U.S. Provisional Application No. 61 / 954,201, filed on March 18, 2014, each of which is hereby incorporated by reference in its entirety.

[0002] 2 Background of the Technology 2.1 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] 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 consists of a series of branching tubes that 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 leads to respiratory bronchioles and ultimately to alveoli. The alveolar region of the lungs is where gas exchange takes place and is referred to as the respiratory zone. For this, refer to Respiratory Physiology - the essentials.

[0005] A series of respiratory diseases exist.

[0006] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by obstruction of the upper airway during sleep. OSA results from a combination of an abnormally small upper airway and a normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall during sleep. Depending on the condition, affected individuals typically experience 200 to 300 cessations of breathing per night, sometimes lasting 30 to 120 seconds. This often leads to excessive daytime sleepiness and can cause cardiovascular disease and brain damage. While this syndrome is particularly common in middle-aged and older obese men, affected individuals may be unaware of their problem. See U.S. Patent No. 4,944,310 (Sullivan) for further information.

[0007] Cheyne-Stokes respiration (CSR) is a respiratory control disorder in patients characterized by a rhythmic alternating cycle of increased and decreased ventilation, leading to repeated deoxygenation and reoxygenation of arterial blood. CSR is considered harmful due to its recurrent hypoxia. In some patients, CSR is associated with repeated awakenings from sleep, resulting in severe sleep disturbance, increased sympathetic nervous system activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones) for further information.

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

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

[0010] Neuromuscular diseases (NMDs) are a broad term encompassing many conditions and illnesses that impair muscle function, either directly through intrinsic muscle lesions or indirectly through nerve lesions. Some NMD patients are characterized by progressive muscle dysfunction leading to loss of walking ability, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular diseases can be classified into rapidly progressive and slowly progressive types: (i) rapidly progressive diseases: characterized by muscle dysfunction that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); and (ii) variable-progressive or slowly progressive diseases: characterized by muscle dysfunction that worsens over years and only slightly reduces life expectancy (e.g., limb-girdle muscular dystrophy, facioscapulohumeral muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include progressive general weakness, dysphagia, dyspnea at exertion and rest, fatigue, drowsiness, morning headache, and difficulty concentrating and adjusting to emotional changes.

[0011] Chest wall disorders are a group of thoracic deformities that result in inefficient connections between the respiratory muscles and the rib cage. The disorders are usually characterized by restrictive impairment and share chronic hypercapnic respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include exertional dyspnea, peripheral edema, orthopnea, recurrent lung infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0012] Otherwise, healthy individuals may make good use of the systems and devices to prevent the onset of respiratory diseases.

[0013] 2.2.1 System One known product used to treat sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed.

[0014] 2.2.2 Treatment Continuous positive nasal airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The premise is that continuous positive airway pressure can prevent upper airway obstruction by acting as an air pressure splint and pushing the soft palate and tongue forward away from the posterior oral-pharyngeal wall.

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

[0016] 2.2.3 Patient Interface The application of a predetermined volume of positive pressure air to the entrance of a patient's airway is facilitated by the use of patient interfaces such as nasal masks, full-face masks, or nasal pillows. A range of patient interface devices are known, but many suffer from one or more of the following problems: they are highly conspicuous and aesthetically undesirable, poorly fitted, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. Masks designed for pilots, as part of personal protective equipment, or solely for the administration of anesthetics may be acceptable in their initial application, but nevertheless, they are uncomfortable and undesirable to wear for extended periods, for example, during sleep.

[0017] Traditional mouth and nose masks are full-face masks or ResMed LIBERTY full-face masks. These mouth-nasal masks, due to their size and volume, are less comfortable and more cumbersome than other masks for physiological reasons, including claustrophobia or phobia of enclosed spaces. Mouth-nasal masks are generally bulky and heavy, which can impair patient comfort and may interfere with the wearing of eyeglasses.

[0018] 2.2.3.1 Seal forming section The patient interface generally includes a seal-forming section.

[0019] One type of seal-forming section extends around the periphery of the patient interface and seals against the user's face when force is applied to the patient interface while the seal-forming section is abutted and engaged with the user's face. The seal-forming section may consist of a molded or formed surface of an elastic seal element made from an air-filled cushion, a fluid-filled cushion, or an elastomer such as rubber. With this type of seal-forming structure, if the fit is not proper, a gap will exist between the seal-forming section and the face, and additional force will be required to press the patient interface against the face and achieve a seal.

[0020] Other types of seal-forming sections incorporate a flap seal made of a thin material positioned around the perimeter of the mask to provide a self-sealing effect against the user's face when positive pressure is applied inside the mask. As with previous styles of seal-forming sections, if the fit between the face and the mask is not good, additional force may be required to seal, or the mask may leak. Also, if the shape of the seal-forming section does not conform to the patient's shape, the seal-forming section may bend or buckle during use, resulting in leakage.

[0021] Other forms of seal-forming devices may use adhesives to create a seal. Some patients may find it inconvenient to constantly apply and remove adhesives from their faces.

[0022] A series of patient interface seal formation technologies are disclosed in the following patent applications, which have been assigned to ResMed Limited: International Patent Publication No. 1998 / 004,310; International Patent Publication No. 2006 / 074,513; and International Patent Publication No. 2010 / 135,785.

[0023] 2.2.3.2 Positioning Stabilization

[0024] The seal-forming portion of a patient interface used for positive pressure therapy is exposed to the corresponding forces of air pressure that interfere with the seal. Therefore, various techniques have been used to position the seal-forming portion and maintain it in a sealing relationship with the appropriate portion of the face.

[0025] One technique is the use of adhesives. For this, see, for example, U.S. Patent Application Publication No. 2010 / 0000534.

[0026] Other techniques are the use of one or more straps and stabilization harnesses. Many such harnesses are subject to one or more of being ill-fitting, bulky, uncomfortable, and difficult to use.

[0027] 2.2.3.3 Venting Technology Some forms of patient interface systems 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 insufficient outflow. Some vents may disrupt the sleep of the patient's bed partner, for example, due to noise or focused air flow.

[0028] ResMed Limited has developed many improved mask venting technologies. For this, see International Patent Application Publication No. 1998 / 034,665; International Patent Application Publication No. 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. 2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0029]

Table 1

[0030] Sound pressure level values for various subjects are listed below.

[0031]

Table 2

[0032] 2.2.3.4 Nasal pillow technique One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Other nasal pillows or nasal puffs are the subject of U.S. Patent No. 4,782,832 (Trimble and Others), assigned to Puritan Bennett Corporation.

[0033] ResMed Limited has manufactured the following products that incorporate a nasal pillow: 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, which have been assigned to ResMed Limited, namely, International Patent Publication No. 2004 / 073,778 (describes in particular aspects of the ResMed SWIFT nasal pillow), U.S. Patent Publication No. 2009 / 0044808 (describes in particular aspects of the ResMed SWIFT LT nasal pillow), International Patent Publication No. 2005 / 063,328 and International Patent Publication No. 2006 / 130,903 (describes in particular aspects of the ResMed LIBERTY full face mask), and International Patent Publication No. 2009 / 052,560 (describes in particular aspects of the ResMed SWIFT FX nasal pillow) This section describes nose pillow masks. [Overview of the project] [Problems that the invention aims to solve]

[0034] 3. A brief overview of the technology This technology aims to provide medical devices used in diagnosis, treatment, or prevention of respiratory diseases that have one or more improvements in comfort, cost, effectiveness, ease of use, and manufacturability. [Means for solving the problem]

[0035] One aspect of this technology may be directed to a patient interface for supplying respiratory gas to a patient. The patient interface may comprise a plenum chamber assembly comprising a nasal plenum chamber that at least partially defines a first gas chamber, wherein the nasal plenum chamber is constructed to contact the patient's nose below the bridge of the nose and over the lower outer circumference of the nose; an oral plenum chamber that at least partially defines a second gas chamber, wherein the oral plenum chamber is constructed to seal around the patient's mouth; and a separation structure that at least partially connects the nasal plenum chamber and the oral plenum chamber and at least partially defines a flow path between the nasal plenum chamber and the oral plenum chamber, wherein the separation structure is located at the nasal end of the nose. The patient interface comprises a separation structure configured to separate relative motion between the plenum chamber and the oral plenum chamber, and the patient interface may include a top plate operably connected to the plenum chamber assembly in the nasal plenum chamber, the top plate including at least one connecting function configured to releasably hold a first portion of the positioning and stabilizing structure, and the patient interface may also include a faceplate operably connected to the plenum chamber assembly in the oral plenum chamber, the faceplate configured to releasably hold a second portion of the positioning and stabilizing structure, and the top plate and faceplate are rigider than the plenum chamber assembly.

[0036] In one example, (a) the flow path may be pneumatically connected to a first gas chamber and a second gas chamber; (b) the top plate and the face plate may be releasably attached to the plenum chamber assembly; (c) the positioning stabilization structure may include a rigidizer arm assembly having a pair of rigidizer arms, the rigidizer arm assembly may be connected to the top plate; (d) each of the pair of rigidizer arms may be bendable in a plane parallel to the patient's cross-section, and the pair of rigidizer arms may be bendable in a plane parallel to the patient's cross-section. Each of the residizer arms may be constructed to resist bending, twisting, and / or stretching in a plane perpendicular to the patient's cross-section; (e) each of the residizer arms may have an elliptical shape to conform to the curvature of the patient's cheek; (f) the nasal plenum chamber may include a nasal flange defining a nasal opening, and the nasal flange may be configured to form a seal with at least the patient's nose; (g) the nasal flange may include a recess for receiving the tip of the patient's nose; (h) the mouth The plenum chamber may be provided with a mouth flange defining an oral opening, and the mouth flange may be configured to form a seal with at least the patient's mouth, (i) the mouth flange may be formed around the entire circumference of the mouth plenum chamber, or near two opposing sides of the outer circumference of the mouth plenum chamber, or over most of the outer circumference of the mouth plenum chamber, (j) the mouth plenum chamber may be provided with a pair of mouth undercushion portions, each positioned on one side of the mouth plenum chamber to support the mouth flange, (k) the mouth plenum chamber may be provided with mouth undercushion portions positioned around the mouth plenum chamber and extending radially from both ends of the separation structure to support the mouth flange, (j) the separation structure may connect the nasal flange and the mouth flange, (k) the separation structure may be provided with an upper surface, a lower surface, and a connecting surface, the connecting surface having higher rigidity than the upper and lower surfaces, and (l) the separation structure may be more rigid on the side opposite the patient's face than on the side adjacent to the patient's face.(m) The separation structure may have rigidity that increases radially from the portion adjacent to the patient's face toward the portion opposite to the patient's face; (n) The nasal contact portion of the nasal flange may have greater rigidity in the portion that does not contact the patient's nose than in the portion of the nasal flange that does not contact the patient's nose; (o) The nasal flange may have increased rigidity toward the outside of the nasal opening; (p) The rigidity of the nasal flange may vary at a predetermined position around the nasal opening; (q) The lower part of the nasal flange near the separation structure may be concave to seal against the patient's upper lip; (r) The nasal flange may have a pair of protruding ends that extend symmetrically around the nasal opening, each protruding end configured to seal against the corresponding ala of the patient's nose; (s) The nasal plenum chamber may have a pair of nasal undercushion portions, each of which is a pair of protruding ends (t) each of the nasal undercushion portions may be positioned on top of the oral plenum chamber, (u) the patient interface may include a headgear for releasably securing the patient interface to the patient, the headgear including a pair of upper straps configured to connect to the nasal plenum chamber and a pair of lower straps configured to connect to the oral plenum chamber, (v) the top plate may be permanently connected to the nasal plenum chamber, (w) the top plate may be removably attached to a flexible connection area of ​​the nasal plenum chamber, (x) the top plate may be removably attached to a rigid connection area of ​​the nasal plenum chamber, and / or (y) the top plate and the rigidizer arm form a single unit, the rigidizer arm being more flexible than the top plate in a plane parallel to the patient's cross-section.

[0037] Another aspect of this technology may be directed towards a patient interface for supplying respiratory gas to a patient. The patient interface may include a nasal cushion for at least partially defining a nasal gas chamber, a mouth cushion for at least partially defining a separate mouth gas chamber, a separation structure positioned between the nasal cushion and the mouth cushion, a pair of upper mounting functions configured to releasably attach a top plate and a pair of upper side straps of a positioning and stabilizing structure fixed to the nasal cushion to the top plate, and a pair of lower mounting functions configured to releasably attach a face plate and a pair of lower side straps of a positioning and stabilizing structure fixed to the mouth cushion.

[0038] In one example, (a) the separation structure may form a pneumatic connection between the nasal gas chamber and the oral gas chamber; (b) the separation structure may have an upper surface, a lower surface, and a connecting surface, with the connecting surface having higher rigidity than the upper and lower surfaces; (c) the separation structure may have a radially variable rigidity along its outer circumference such that the distal end relative to the patient's face is more rigid than the proximal end relative to the patient's face; and the nasal cushion may be structured to move independently of the oral cushion; (d) (e) The nasal contact portion of the nasal cushion may be less rigid than the portion of the nasal cushion that does not contact the patient's nose; (f) The nasal cushion may be more rigid in the portion of the nasal cushion that does not contact the patient's nose than in the nasal contact portion; (g) The nasal cushion may have a recess for sealing against the patient's upper lip; (h) The nasal cushion may have a pair of protruding ends, each of which is between the nasal ala and nasolabial fold of the patient's face. The nose cushion may be configured to form a seal between them, (i) the nose cushion comprises a pair of under-nose cushion portions, each of which is positioned below the respective protruding end to support the respective protruding end against the patient's face, (j) the nose cushion may have wings on both sides of the nose cushion to seal against the patient's nostrils, (k) the mouth cushion may have under-nose cushion portions extending radially around the mouth cushion from both ends of the separation structure to support the mouth cushion against the patient's face, (l) the mouth cushion comprises a pair of under-nose cushion portions, each of which is positioned on each side of the mouth cushion to support the mouth cushion against the patient's face, (m) the nose cushion may be formed to include a recess configured to receive the tip of the patient's nose, (n) the nose cushion may be configured to contact the lower outer circumference of the patient's nose below the bridge of the nose, and (o) the nose cushion, the mouth cushion, and the separation structure may form a single integrated component.(p) The top plate may be permanently connected to the nasal plenum chamber, (q) The top plate may be removablely attached to a flexible connection area of ​​the nasal plenum chamber, (r) The top plate may be removablely attached to a rigid connection area of ​​the nasal plenum chamber, (s) The top plate and the rigidizer arm assembly form a single unit, and the pair of rigidizer arms of the rigidizer arm assembly are more flexible than the top plate in a plane parallel to the patient's cross-section, (t) The positioning stabilization structure may include a rigidizer arm assembly that is removablely attached to the top plate at an upper mounting function, (u) The patient interface may further include a frame that is removablely attached to the faceplate, and a lower mounting function may be located on the frame, (v) Each of the lower mounting functions is (w) The patient interface may include a mating portion having a mating portion magnet for releasably connecting to a corresponding clip of the positioning stabilization structure, and each of the corresponding clips may include a clip magnet, the clip magnets being oriented such that the mating portion is coupled to the corresponding clip when each of the clip magnets is magnetically attracted to each mating portion magnet, and (w) the patient interface may include a top plate buffer for damping vibrations at the connection between the top plate and the rigidizer arm assembly, and a face plate buffer for damping vibrations at the connection between the face plate and the frame, and / or (x) the frame may be formed to couple around the outer circumference of the face plate, the frame may include a catch, the face plate may include a notch, and the frame may couple to the face plate by engagement between the catch and the notch.

[0039] Other embodiments of the technology may be directed to a patient interface for supplying respiratory gas to a patient. The patient interface comprises a plenum chamber assembly comprising a nasal plenum chamber that at least partially defines a first gas chamber, the nasal plenum chamber being configured to seal to the patient over the lower outer circumference of the patient's nose below the nasal bridge, and an oral plenum chamber that at least partially defines a second gas chamber and is operably connected to the nasal plenum chamber, wherein the patient interface comprises an integrated plate member having an upper portion that is releasably attachable to the nasal plenum chamber and a lower portion that is releasably attachable to the oral plenum chamber, the upper portion of the plate member comprising at least one connecting function configured to releasably hold a first portion of a positioning and stabilizing structure having a pair of rigidizer arms, and the lower portion of the plate member configured to releasably hold a second portion of the positioning and stabilizing structure.

[0040] In one example, (a) the plenum chamber assembly may include a separation structure that at least partially connects the nasal plenum chamber and the oral plenum chamber, the separation structure at least partially defines the flow path between the nasal plenum chamber and the oral plenum chamber, and (b) each of a pair of rigidizer arms is capable of bending in a plane parallel to the patient's cross-section, and each of the pair of rigidizer arms is constructed to resist bending in a plane perpendicular to the patient's cross-section, resist twisting, and / or resist stretching. (c) Each of the at least one connecting function portion may be hinged such that a corresponding rigidizer arm of a pair of rigidizer arms can rotate the upper part of the integral plate member relative to a rigid top plate in a plane parallel to the patient's cross-section; (d) The first portion of the positioning stabilization structure may include a hook for rotatably connecting to the upper connecting function portion of the integral plate member; (e) The nasal plenum chamber may be provided with a nasal flange defining a nasal opening, and the nasal flange may seal at least the patient's nose. (e) The nasal flange may be configured to form a mouth flange, (f) the mouth plenum chamber may have a mouth flange defining a mouth opening, and the mouth flange may be configured to form a seal with at least the patient's mouth, (g) the mouth flange may be formed around the entire circumference of the mouth plenum chamber, or near two opposing sides of the outer circumference of the mouth plenum chamber, or over most of the outer circumference of the mouth plenum chamber, (f) the mouth plenum chamber may have a pair of mouth undercushion portions, each positioned on each side of the mouth plenum chamber to support the mouth flange, (g) the mouth plenum chamber may have mouth undercushion portions positioned around the mouth plenum chamber and extending radially from both ends of the separation structure to support the mouth flange, (h) the separation structure may connect the nasal flange and the mouth flange, and (i) the separation structure may be more rigid on the side opposite to the patient's face than on the side adjacent to the patient's face.(j) The separation structure may have rigidity that increases radially from the portion adjacent to the patient's face toward the portion opposite to the patient's face; (k) The nasal contact portion of the nasal flange may have higher rigidity in the portion that does not contact the patient's nose than in the portion of the nasal flange that does not contact the patient's nose; (l) The nasal flange may have increased rigidity toward the outside from the nasal opening; (m) The rigidity of the nasal flange may change at a predetermined position around the nasal opening; (n) The lower part of the nasal flange near the separation structure may be concave to seal against the patient's upper lip; (o) The nasal flange may comprise a pair of projecting ends extending symmetrically around the nasal opening, each projecting end configured to seal to the corresponding ala of the patient's nose; (p) the nasal plenum chamber may comprise a pair of nasal undercushion portions, each corresponding to each projecting end to support it; (q) each of the nasal undercushion portions may be positioned above the oral plenum chamber; and / or (r) each of the pair of rigidizer arms may have an elliptical curvature between its first and second ends.

[0041] Another aspect of this technology may be directed to a cushion assembly for a patient interface for the treatment of sleep-disordered breathing in a patient, the cushion assembly comprising: a nasal cushion connected to a nasal plenum chamber, the nasal cushion being constructed to seal around the lower outer circumference of the patient's nose; a mouth cushion connected to an oral plenum chamber, the mouth cushion being constructed to seal around the patient's mouth; a separator connecting the nasal cushion and nasal plenum chamber to the mouth cushion and oral plenum chamber, the separator being configured to allow the nasal cushion and nasal plenum chamber to move relative to the mouth cushion and oral plenum chamber; and a pair of lateral supports, the pair of lateral supports each The patient interface comprises a pair of lateral supports located on both sides of the nasal cushion and connecting each side of the nasal cushion to the mouth cushion, a pair of under cushion support walls provided to support a protruding end located on the rear side of the nasal cushion, and a pair of pockets, each of which is located on both sides of the nasal cushion, with each pocket including an upper surface defined by the nasal cushion and the nasal plenum chamber, and each pocket including a lower surface defined by the mouth cushion and the oral plenum chamber, and each pocket including a side defined by the separation structure and the corresponding lateral support of the pair of lateral supports, wherein when the patient interface is worn by the patient, the openings of each of the pair of pockets are located on the opposite side of the patient's face.

[0042] In one example, (a) each of the pair of lateral supports may include a notch that provides a pivot point for relative movement between the nose cushion and the mouth cushion; (b) each of the notches in the pair of lateral supports may open in the direction away from the patient's face when the patient interface is worn by the patient; (c) the nose cushion may have a pair of reinforcing portions, each of which may be located on the sides of the nose cushion, and the reinforcing portions may be more rigid than the rest of the nose cushion; (d) the pair of reinforcing portions may be thicker than the rest of the nose cushion; and (e) the pair of reinforcing portions may not cause the outer surface of the nose cushion to bulge. (f) The nasal cushion may extend inward relative to the nasal cushion and nasal plenum chamber, the nasal cushion may be provided with a nasal sling, the nasal sling being formed in the same plane as the nasal cushion and structured to contact the patient's columella, (g) the nasal cushion and nasal sling may define a pair of nostril ports, each of which is structured to communicate pneumatically with a corresponding nostril of the patient, and (h) the nasal sling may be structured to prevent the tip of the patient's nose from extending into the nasal gas chamber, the nasal gas chamber being at least partially defined by the nasal cushion and nasal plenum chamber.

[0043] Another aspect of the present technology is directed to a patient interface system for supplying respiratory gases to a patient. The patient interface comprises a cushion assembly which may include a nasal cushion for at least partially defining a nasal gas chamber, an oral cushion for at least partially defining an oral gas chamber separate from the nasal gas chamber, and a separation structure positioned between the nasal cushion and the oral cushion; a positioning and stabilizing structure with a pair of lower side straps; and a pair of lower attachment functions configured to releasably attach corresponding lower side straps of a pair of lower side straps of the positioning and stabilizing structure to the cushion assembly, each of the pair of lower attachment functions comprising a thermoplastic elastomer, and a first magnet embedded within each of the pair of lower attachment functions.

[0044] In one example, (a) the patient interface system further comprises a faceplate fixed to a mouth cushion and a frame releasably attachable to the faceplate, with a pair of lower attachment functions fixed to the frame; (b) the frame may be made of a material harder than thermoplastic elastomer; (c) the pair of lower attachment functions may be molded onto the frame; (d) the positioning stabilization structure may comprise a pair of clips for attaching corresponding lower side straps of a pair of lower side straps to corresponding lower attachment functions of a pair of lower attachment functions; and (e) each of the pair of clips is a pair of clips (f) Each of the pair of clips may be provided with a second magnet for attaching it to the corresponding lower mounting part of a pair of lower mounting parts; (g) Each of the pair of clips may be provided with a notch, and each of the pair of lower mounting parts may be provided with a projection, the projection of which may engage with the notch when each of the pair of clips engages with the corresponding lower mounting part of a pair of lower mounting parts; (h) Each of the pair of lower mounting parts may be provided with a bending point, and each of the pair of lower mounting parts may be bent at the bending point, and / or (h) Each of the pair of lower mounting parts may include a thickness reduction region at the bending point.

[0045] Another aspect of this technology is directed to a patient interface system for supplying respiratory gas to a patient. The patient interface comprises a nasal cushion for at least partially defining a nasal gas chamber, a mouth cushion for at least partially defining a separate mouth gas chamber, a separation structure positioned between the nasal cushion and the mouth cushion, a top plate fixed to the nasal cushion, and a rigidizer arm assembly that can be releasably attached to the top plate, wherein the rigidizer arm assembly and the top plate engage at least three contact points.

[0046] In one example, (a) the top plate may have a pair of upper mounting functions, and the rigidizer arm assembly may have a pair of connecting functions, each of which may be structured to engage with a corresponding upper mounting function of the pair of upper mounting functions; (b) the rigidizer arm assembly may have ribs for engaging with the top plate when the rigidizer arm assembly engages with the top plate; (c) the patient interface may have a top plate buffer for damping vibrations in the engagement portion between the rigidizer arm assembly and the top plate. (d) The nose buffer may be positioned on the front side of the top plate so as to contact the rear side of the rigidizer arm assembly, (e) the rigidizer arm assembly may comprise a pair of rigidizer arms, each of which may be configured to receive an upper side strap of the positioning stabilization structure, and / or (f) each of the pair of rigidizer arms may be provided with a pad to cushion the pair of rigidizer arms against the patient's face.

[0047] Another aspect of this technology is directed towards a patient interface for supplying respiratory gas to a patient. The patient interface comprises a nasal cushion for at least partially defining a nasal gas chamber, a mouth cushion for at least partially defining an oral gas chamber separate from the nasal gas chamber, and a separation structure positioned between the nasal cushion and the mouth cushion, wherein the separation structure comprises an upper surface for connecting the separation structure to the nasal cushion, a lower surface for connecting the separation structure to the mouth cushion, and a connecting surface for connecting the upper and lower surfaces, the upper and lower surfaces being substantially equal in thickness, and the connecting surface being thicker than the upper and lower surfaces.

[0048] In one example, (a) the connecting surface may be about twice as thick as the top and bottom surfaces, (b) the separating structure may be structured to be flexible so that the top and bottom surfaces can be positioned at a maximum angle of 50° relative to each other, and / or (c) the top and bottom surfaces may be about 0.5 mm thick and the connecting surface is about 1.2 mm thick.

[0049] Another aspect of one embodiment of this technology is a patient interface that is molded or otherwise configured with a clearly defined outer shape to conform to the outer shape of the intended wearer. The patient interface system may have fewer parts than currently available patient interface systems. The patient interface system may allow the patient's mouth area to be visible if the faceplate is translucent or transparent. The patient interface system is a mouth-nasal mask, meaning it covers the nasal airway and mouth. The mouth-nasal mask may not obstruct the patient's line of sight and may be considered physiologically non-intimidating, while also improving patient selection and adherence to treatment of the system. The patient interface system may be flexible to accommodate changes in jaw movement and head position throughout the night. The patient interface system may supply a predetermined amount of pressurized air or breathing gas to the patient's nasal passages and may prevent or reduce mouth leakage by providing an effective seal with both the patient's mouth and the patient's nasal passages.

[0050] Another aspect of one form of this technology is a patient interface with less skin contact area and fewer overall contact points with the face compared to known full-face masks. This allows for a considerably smaller amount of headgear tension to be applied, thereby significantly improving patient comfort. Patient comfort can be further enhanced by removing any mass particularly close to the eyes, thus reducing the likelihood of the patient experiencing claustrophobia.

[0051] Another aspect of one form of this technology is a patient interface that can be quickly and easily installed by all customer segments, including patients, home medical device dealers, and physicians. Due to its superior ease of use (installation, sealing, size selection, and sometimes remotely), this patient interface can simplify mask selection by physicians and dealers, and its intuitive assembly and installation can enable fairly successful remote setup in an unassisted environment without instructions. The patient interface may have one primary size that fits the majority of the general adult patient population and only two additional sizes. It is assumed that the three sizes of the patient interface can fit at least 90% of the general adult population.

[0052] Of course, some aspects of the present invention may form a sub-inventory of the present invention. Furthermore, various sub-inventory and / or aspects of the present invention may be combined in various ways, and may constitute further embodiments or sub-inventory of the present invention.

[0053] Other features of this technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims.

[0054] 4. Brief explanation of some of the figures in the drawing. This technology is illustrated as an example in the attached drawings below, and is not limited to its application. In the diagram, similar reference numbers indicate the same elements. [Brief explanation of the drawing]

[0055] 4.1 Treatment System [Figure 1a] The system relating to this technology is shown. A patient 1000 wearing a patient interface 3000 receives a supply of positive-pressure air from a PAP device 4000. The air from the PAP device is humidified by a humidifier 5000 and passes through an air circuit 4170 toward the patient 1000. A bed partner 1100 is also shown. [Figure 1b] This shows a PAP device used for patients with nasal masks. [Figure 1c] This shows a PAP device used for patients wearing a full face mask. 4.2 Treatment 4.2.1 Respiratory System [Figure 2a] This diagram shows the entire human respiratory system, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2b] This diagram shows the upper respiratory tract of a human being, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. 4.2.2 Facial Biological Structure [Figure 2c] This is a frontal view of a face with several distinctive features of surface biological structures, including the upper lip, upper lip red, lower lip red, lower lip, mouth width, inner corner of the eye, nasal wings, nasolabial folds, and corners of the mouth. [Figure 2d] This is a lateral view of the head, showing several features of identified surface biological structures, including the glabella, nasal root, nasal tip, nasal spine, upper lip, lower lip, maxilla, nasal ridge, superior earlobe, and inferior earlobe. The superior and inferior, as well as the anterior and posterior directions, are also shown. [Figure 2e] This is a further lateral view of the head. The approximate positions of the Frankfort horizontal plane and the nasolabial angle are shown. [Figure 2f] A diagram of the base of the nose is shown. [Figure 2g] A lateral view of the surface features of the nose is shown. [Figure 2h] This shows the subcutaneous structure of the nose, including the lateral nasal cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, and fibroadipose tissue. [Figure 2i] In particular, it shows medial nasal dissection extending a few millimeters from the sagittal plane, revealing the medial crura of the septal cartilage and the greater alar cartilage. [Figure 2j] This shows a frontal view of the skull bones, including the frontal, temporal, nasal, and zygomatic bones. The nasal conchae are shown, as are the maxilla, mandible, and mental protuberance. [Figure 2k]A lateral view of the skull is shown, showing the contour of the head surface and several muscles. The following bones are shown: the frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is shown. The following muscles are shown: the digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2l] Anterior lateral view of the skull structure and tissue structure is shown. 4.3 Patient Interface [Figure 3a] A perspective view of a patient interface related to an example of this technology is shown. [Figure 3b] This shows a front view of a patient interface related to an example of this technology. [Figure 3c] This shows a rear view of a patient interface related to an example of this technology. [Figure 3d] A plan view of a patient interface related to an example of this technology is shown. [Figure 3e] This shows a bottom view of a patient interface related to an example of this technology. [Figure 3f] A side view of a patient interface related to an example of this technology is shown. [Figure 3g] A perspective view of a patient interface including an air circuit, which is an example of this technology, is shown. [Figure 3h] This shows a rear view of a patient interface including an air circuit, which is an example of this technology. [Figure 3i] This shows a front view of a patient interface including an air circuit, which is an example of this technology. [Figure 3j] A plan view of a patient interface including an air circuit, which is an example of this technology, is shown. [Figure 3k] This shows a bottom view of a patient interface including an air circuit, which is an example of this technology. [Figure 3l] This shows an aspect of a patient interface, including an air circuit, related to an example of this technology. [Figure 3m] A perspective view of a patient interface, including an air circuit worn by a patient, is shown as an example of this technology. [Figure 3n] This shows a front view of a patient interface, including an air circuit, worn by a patient, as an example of this technology. [Figure 3o] This shows a side view of a patient interface, including an air circuit, worn by a patient, as an example of this technology. [Figure 3p] This shows a plan view of a patient interface, including an air circuit, worn by a patient, as an example of this technology. [Figure 3q] This image shows a side cross-sectional view of a patient interface, an example of this technology, in a state where the patient interface is positioned against the patient's face. The patient is shown with a cross-sectional view of their trajectory. [Figure 3r] A detailed frontal perspective view of a portion of the patient interface, an example of this technology, is shown. The patient interface is shown with dashed lines, while the patient's nose, mouth, and chin are shown with solid lines. [Figure 3s] An exploded perspective view of a patient interface related to an example of this technology is shown. [Figure 3t] This shows an exploded front view of a patient interface related to an example of this technology. [Figure 3u] This shows an exploded rear view of a patient interface related to an example of this technology. [Figure 4a] This shows a plan view of a nasal cradle cushion, a patient interface related to an example of this technology. [Figure 4b] Figure 4a shows a bottom cross-section of a nasal cradle cushion, a patient interface related to an example of this technology, taken through line 4c-4c. [Figure 4c] Figure 4a shows a lateral cross-sectional view of a nasal cradle cushion, a patient interface related to an example of this technology, taken through line 4c-4c. The patient's nose is shown by a dashed line. [Figure 5a] The following is a plan view of another nasal cradle cushion for a patient interface relating to another example of this technology. [Figure 5b] Figure 5a shows a bottom cross-section of another nasal cradle cushion of a patient interface relating to another example of this technology, taken through line 5c-5c. [Figure 5c] Figure 5a shows a lateral cross-sectional view of another nasal cradle cushion of a patient interface relating to an example of this technology, taken through line 5c-5c. The patient's nose is shown by a dashed line. [Figure 6a] The following is a plan view of another nasal cradle cushion for a patient interface relating to another example of this technology. [Figure 6b] Figure 6a shows a bottom cross-section of another nasal cradle cushion of a patient interface relating to another example of this technology, taken through line 6c-6c. [Figure 6c] Figure 6a shows a lateral cross-sectional view of another nasal cradle cushion in a patient interface relating to another example of this technology, taken through line 6c-6c. The patient's nose is shown as a dashed line. [Figure 7a] This shows a posterior perspective view of a plenum chamber assembly of a patient interface related to an example of this technology. [Figure 7b] This shows a side perspective view of a plenum chamber assembly of a patient interface related to an example of this technology. [Figure 7c] This shows a front perspective view of a plenum chamber assembly of a patient interface related to an example of this technology. [Figure 7d] This shows a rear view of a plenum chamber assembly of a patient interface related to an example of this technology. [Figure 7e] This shows a front view of a plenum chamber assembly of a patient interface related to an example of this technology. [Figure 7f] This shows a plan view of a plenum chamber assembly of a patient interface related to an example of this technology. [Figure 7g] This shows a bottom view of a plenum chamber assembly of a patient interface related to an example of this technology. [Figure 7h] This shows a side view of a plenum chamber assembly of a patient interface related to an example of this technology. [Figure 8a] This diagram shows a plan view of a plenum chamber assembly of a patient interface relating to an example of this technology, and includes several lines defining various cross-sections. [Figure 8b] Figure 8a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through the line 8b-8b. [Figure 8c]Figure 8a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through line 8c-8c. [Figure 8d] Figure 8a shows a side cross-sectional view of a plenum chamber assembly of a patient interface related to an example of this technology, taken through the line 8d-8d. [Figure 8e] Figure 8a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through the line 8e-8e. [Figure 8f] Figure 8a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through the line 8f-8f. [Figure 8g] Figure 8a shows a cross-sectional view of a plenum chamber assembly of a patient interface, an example of this technology, taken through the line 8g-8g. [Figure 8h] Figure 8a shows a cross-sectional view of a plenum chamber assembly of a patient interface related to an example of this technology, taken through the line 8h-8h. [Figure 8i] Figure 8a shows a cross-sectional view of a plenum chamber assembly of a patient interface related to an example of this technology, taken through the line 8i-8i. [Figure 8j] Figure 8a shows a cross-sectional view of a plenum chamber assembly of a patient interface related to an example of this technology, taken through line 8j-8j. [Figure 8k] Figure 8a shows a side cross-sectional view of a plenum chamber assembly of a patient interface related to an example of this technology, taken through the line 8k-8k. [Figure 8l] Figure 8a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through the line 8l-8l. [Figure 9a] This diagram shows a plan view of a plenum chamber assembly of a patient interface relating to an example of this technology, and includes several lines defining various cross-sections. [Figure 9b] Figure 9a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through line 9b-9b. [Figure 9c] Figure 9a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through line 9c-9c. [Figure 9d] Figure 9a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through the line 9d-9d. [Figure 9e] Figure 9a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through the line 9e-9e. [Figure 9f] Figure 9a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through line 9f-9f. [Figure 9g] Figure 9a shows a side cross-sectional view of a plenum chamber assembly of a patient interface related to an example of this technology, taken through the line 9g-9g. [Figure 9h] Figure 9a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to an example of this technology, taken through the line 9h-9h. [Figure 9i] Figure 9a shows a side cross-sectional view of a plenum chamber assembly of a patient interface relating to one embodiment of this technology, taken through the line 9i-9i. [Figure 10a] This shows a plan view of the nasal cushion of a patient interface related to an example of this technology. [Figure 10b] A plan view of a nasal cushion for a patient interface relating to another example of this technology is shown. [Figure 10c] A plan view of a nasal cushion for a patient interface relating to another example of this technology is shown. [Figure 10d] A plan view of a nasal cushion for a patient interface relating to another example of this technology is shown. [Figure 11a] This shows a cross-sectional view of a nose cushion taken through line 11a-11a in Figure 4a, which is an example of this technology. [Figure 11b] Figure 13 shows a cross-sectional view of a nose cushion taken through lines 11b and 11c, which is an example of this technology. [Figure 11c]Figure 13 shows a cross-sectional view of a nose cushion taken through lines 11b and 11c, which is an example of this technology. [Figure 12a] This shows a rear view of a mouth cushion with an undercushion, which is a typical seal-forming structure related to this technology. [Figure 12b] This shows a rear view of a mouth cushion with an undercushion, which is another typical seal-forming structure related to this technology. [Figure 12c] This shows a rear view of a mouth cushion with an undercushion, which is another typical seal-forming structure related to this technology. [Figure 12d] This shows a rear view of a mouth cushion with an undercushion, which is another typical seal-forming structure related to this technology. [Figure 13] This shows a plan view of a nasal cradle cushion, a patient interface related to an example of this technology. [Figure 14] This shows an exploded rear view of a patient interface related to an example of this technology. [Figure 15a] This shows a front view of a seal-forming structure, a top plate, and a rigidizer arm related to an example of this technology. [Figure 15b] Front views of a seal-forming structure, top plate, and rigidizer arm relating to other examples of this technology are shown. [Figure 15c] This shows a front view of a seal-forming structure, a top plate, and a rigidizer arm related to an example of this technology. [Figure 15d] This shows a front view of a seal-forming structure, a top plate, and a rigidizer arm related to an example of this technology. [Figure 15e] This shows a front view of a seal-forming structure, a top plate, and a rigidizer arm related to an example of this technology. [Figure 16a] A plan perspective view of a seal-forming structure and a plenum chamber related to an example of this technology is shown. [Figure 16b] An example of this technology is shown, along with a bottom perspective view of a seal-forming structure and a plenum chamber. [Figure 16c] Further plan perspective views of a seal-forming structure and plenum chamber relating to an example of this technology are shown. [Figure 16d] This shows a front view of a seal-forming structure and a plenum chamber related to an example of this technology. [Figure 16e] This shows a rear view of a seal-forming structure and a plenum chamber related to an example of this technology. [Figure 16f] A plan view of a seal-forming structure and a plenum chamber related to an example of this technology is shown. [Figure 16g] This shows a bottom view of a seal-forming structure and a plenum chamber related to an example of this technology. [Figure 16h] This shows a side view of a seal-forming structure and a plenum chamber related to an example of this technology. [Figure 16i] Figure 16d shows a cross-sectional view of a seal-forming structure and a plenum chamber taken through line 16i-16i, which is an example of this technology. [Figure 16j] Figure 16f shows a cross-sectional view of a seal-forming structure and a plenum chamber taken through line 16j-16j, which is an example of this technology. [Figure 16k] Figure 16h shows a cross-sectional view of a seal-forming structure and a plenum chamber taken through the line 16k-16k, which is an example of this technology. [Figure 16l] Figure 16d shows a cross-sectional view of a seal-forming structure and a plenum chamber taken through line 16l-16l, which is an example of this technology. [Figure 16m] Figure 16g shows a cross-sectional view of a seal-forming structure and a plenum chamber taken through the line 16m-16m, which is an example of this technology. [Figure 16n] A detailed front perspective view of a seal-forming structure and plenum chamber related to an example of this technology is shown. [Figure 16o] Figure 16d shows a cross-sectional view of a seal-forming structure and a plenum chamber taken through line 16o-16o in an example of this technology. [Figure 17a] A perspective view of a patient interface related to an example of this technology is shown. [Figure 17b] This shows a front view of a patient interface related to an example of this technology. [Figure 17c]This shows a rear view of a patient interface related to an example of this technology. [Figure 17d] A plan view of a patient interface related to an example of this technology is shown. [Figure 17e] This shows a bottom view of a patient interface related to an example of this technology. [Figure 17f] A side view of a patient interface related to an example of this technology is shown. [Figure 18a] A perspective view of a seal-forming structure with a top plate and face plate, which is an example of this technology, is shown. [Figure 18b] This shows a front view of a seal-forming structure with a top plate and a face plate, which is an example of this technology. [Figure 18c] This shows a side view of a seal-forming structure with a top plate and a face plate, which is an example of this technology. [Figure 18d] A plan view of a seal-forming structure with a top plate and face plate, which is an example of this technology, is shown. [Figure 18e] This shows a rear view of a seal-forming structure with a top plate and face plate, which is an example of this technology. [Figure 18f] Figure 18d shows a cross-sectional view of a seal-forming structure with a top plate and a face plate, as an example of this technology, taken through the line 18f-18f. [Figure 19a] A perspective view of a rigidizer arm assembly relating to an example of this technology is shown. [Figure 19b] A front view of a rigidizer arm assembly relating to an example of this technology is shown. [Figure 19c] A side view of a rigidizer arm assembly relating to an example of this technology is shown. [Figure 19d] A plan view of a rigidizer arm assembly relating to an example of this technology is shown. [Figure 19e] This shows a rear view of a rigidizer arm assembly, an example of this technology. [Figure 19f] A plan view of a rigidizer arm assembly relating to an example of this technology is shown. [Figure 19g]Another plan view of a rigidizer arm assembly relating to an example of this technology is shown. [Figure 19h] This shows a rear view of a rigidizer arm assembly, an example of this technology. [Figure 20a] An example of this technology is shown in the perspective view of the faceplate frame, lower mounting function part, and clip. [Figure 20b] This shows a front view of a faceplate frame, lower mounting function section, and clip related to an example of this technology. [Figure 20c] This shows a rear view of a faceplate frame, lower mounting function section, and clip related to an example of this technology. [Figure 20d] This shows a side view of a faceplate frame, a lower mounting function section, and a clip related to an example of this technology. [Figure 20e] This shows a plan view of a faceplate frame, lower mounting function section, and clip related to an example of this technology. [Figure 20f] This shows a partially exploded perspective view of a faceplate frame, lower mounting function part, and clip related to an example of this technology. [Figure 20g] This shows an exploded perspective view of the faceplate frame, lower mounting function, and clip, which are examples of this technology. [Figure 20h] An exploded perspective view of a faceplate frame, lower mounting function, and clip related to an example of this technology is shown. [Figure 20i] A perspective view of a faceplate frame relating to an example of this technology is shown. [Figure 20j] This shows a front view of a faceplate frame relating to an example of this technology. [Figure 20k] This shows a rear view of a faceplate frame relating to an example of this technology. [Figure 20l] A side view of a faceplate frame relating to an example of this technology is shown. [Figure 20m] A plan view of a faceplate frame relating to an example of this technology is shown. [Figure 20n]This shows a rear view of a faceplate frame relating to an example of this technology. [Figure 20o] This shows an exploded perspective view of the faceplate frame, lower mounting function, and clip, which are examples of this technology. [Figure 20p] An exploded perspective view of a faceplate frame, lower mounting function, and clip related to an example of this technology is shown. [Figure 20q] A plan view of a faceplate frame relating to an example of this technology is shown. [Figure 20r] A plan view of a faceplate frame relating to an example of this technology is shown. [Figure 20s] A plan view of a faceplate frame relating to an example of this technology is shown. [Figure 21a] A perspective view of a top plate related to an example of this technology is shown. [Figure 21b] This shows a front view of a top plate related to an example of this technology. [Figure 21c] This shows a rear view of a top plate related to an example of this technology. [Figure 21d] A plan view of a top plate related to an example of this technology is shown. [Figure 21e] A side view of a top plate relating to an example of this technology is shown. [Figure 22a] A perspective view of a faceplate relating to an example of this technology is shown. [Figure 22b] This shows a front view of a faceplate relating to an example of this technology. [Figure 22c] This shows a rear view of a faceplate related to an example of this technology. [Figure 22d] A side view of a faceplate relating to an example of this technology is shown. [Figure 22e] A plan view of a faceplate relating to an example of this technology is shown. [Figure 23a] This shows a front perspective view of the lower mounting functional support body, an example of this technology. [Figure 23b] Another front perspective view of the lower mounting functional support body, an example of this technology, is shown. [Figure 23c]This shows a rear view of the lower mounting functional support body, an example of this technology. [Figure 23d] This shows a plan perspective view of the lower mounting functional support body, an example of this technology. [Figure 23e] This shows a side perspective view of the lower mounting functional support body, an example of this technology. [Figure 23f] Another side perspective view of the lower mounting functional support body, an example of this technology, is shown. [Figure 23g] Another perspective view of the lower mounting functional support unit, an example of this technology, is shown. [Figure 23h] Another perspective view of the lower mounting functional support unit, an example of this technology, is shown. [Figure 23i] Another perspective view of the lower mounting functional support unit, an example of this technology, is shown. [Figure 23j] Another perspective view of the lower mounting functional support unit, an example of this technology, is shown. [Figure 23k] Another perspective view of the lower mounting functional support unit, an example of this technology, is shown. [Figure 23l] Another perspective view of the lower mounting functional support unit, an example of this technology, is shown. [Figure 23m] Another perspective view of the lower mounting functional support unit, an example of this technology, is shown. [Figure 24a] This shows a front perspective view of the connector of the lower mounting function part, which is an example of this technology. [Figure 24b] This shows another front perspective view of the connector for the lower mounting function part, which is an example of this technology. [Figure 24c] This shows the rear view of the connector of the lower mounting function part related to an example of this technology. [Figure 24d] This shows a plan perspective view of the connector of the lower mounting function part, which is an example of this technology. [Figure 24e] This shows a side perspective view of the connector of the lower mounting function part, which is an example of this technology. [Figure 24f] This shows another rear perspective view of the connector for the lower mounting function part, which is an example of this technology. [Figure 25a]This shows a front perspective view of a clip related to an example of this technology. [Figure 25b] Another front perspective view of a clip relating to an example of this technology is shown. [Figure 25c] This shows a rear perspective view of a clip related to an example of this technology. [Figure 25d] A planar perspective view of a clip related to an example of this technology is shown. [Figure 25e] A side perspective view of a clip relating to an example of this technology is shown. [Figure 25f] Another rear perspective view of a clip relating to an example of this technology is shown. [Figure 25g] A planar perspective view of a clip related to an example of this technology is shown. [Figure 25h] Another front perspective view of a clip relating to an example of this technology is shown. [Figure 25i] This shows a rear perspective view of a clip related to an example of this technology. [Figure 25j] A planar perspective view of a clip related to an example of this technology is shown. [Figure 25k] A side perspective view of a clip relating to an example of this technology is shown. [Figure 25l] Another rear perspective view of a clip relating to an example of this technology is shown. [Figure 26a] A perspective view of a tube separation structure related to an example of this technology is shown. [Figure 26b] This shows a front view of a tube separation structure related to an example of this technology. [Figure 26c] This shows a rear view of a tube separation structure related to an example of this technology. [Figure 26d] This figure shows a cross-sectional view of a tube separation structure taken through line 26d-26d in Figure 26c, which is an example of this technology. [Figure 27a] A perspective view of a seal-forming structure with a top plate and face plate, which is an example of this technology, is shown. [Figure 27b] This shows a front view of a seal-forming structure with a top plate and a face plate, which is an example of this technology. [Figure 27c]This shows a side view of a seal-forming structure with a top plate and a face plate, which is an example of this technology. [Figure 27d] A plan view of a seal-forming structure with a top plate and face plate, which is an example of this technology, is shown. [Figure 27e] This shows a rear perspective view of a seal-forming structure with a top plate and face plate, which is an example of this technology. [Figure 27f] Figure 27d shows a cross-sectional view taken through line 27f-27f of a seal-forming structure with a top plate and a face plate, which is an example of this technology. [Figure 28a] A perspective view of a top plate related to an example of this technology is shown. [Figure 28b] This shows a front view of a top plate related to an example of this technology. [Figure 28c] This shows a rear view of a top plate related to an example of this technology. [Figure 28d] A plan view of a top plate related to an example of this technology is shown. [Figure 28e] A side view of a top plate relating to an example of this technology is shown. [Figure 29a] A perspective view of a patient interface related to an example of this technology is shown. [Figure 29b] This shows a front view of a patient interface related to an example of this technology. [Figure 29c] This shows a rear view of a patient interface related to an example of this technology. [Figure 29d] A plan view of a patient interface related to an example of this technology is shown. [Figure 29e] This shows a bottom view of a patient interface related to an example of this technology. [Figure 29f] A side view of a patient interface related to an example of this technology is shown. [Modes for carrying out the invention]

[0056] 5. Detailed Description of Examples of the Technology Before further detailing the present technology, it should be understood that the present technology is not limited to any particular embodiment, which may vary, as described herein. It should also be understood that the terms used in this disclosure are for the sole purpose of describing the particular embodiment discussed herein, and are not intended to limit it.

[0057] The following description is given in relation to various embodiments that may share one or more common properties and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or multiple embodiments. Also, any single feature or combination of features in any embodiment may constitute a further embodiment.

[0058] 5.1 Treatment System In one embodiment, the technology comprises a device for treating respiratory diseases. In one example, the device comprises a flow generator or blower for supplying pressurized breathing gas, such as air, to a patient 1000 via an air delivery tube leading to a patient interface 3000.

[0059] 5.2 Treatment In one embodiment, the technology comprises a method for treating a respiratory disease, comprising the step of applying positive pressure to the airway entrance of 1000 patients.

[0060] 5.2.1 Nasal CPAP for OSA In one embodiment, the technology comprises a method for treating obstructive sleep apnea in a patient by applying continuous positive nasal airway pressure to the patient.

[0061] 5.3 Patient Interface A non-invasive patient interface according to one aspect of this technology comprises the following functional aspects: a seal-forming structure, a plenum chamber, a positioning and stabilizing structure, and a connection port for connection to an air circuit. In some embodiments, the functional aspects may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional aspects. When in use, the seal-forming structure is positioned to surround the entrance to the patient's airway to facilitate the supply of positive-pressure air to the airway.

[0062] Figure 3a shows a front perspective view of a patient interface 3000 according to an example of the present technology. The patient interface 3000 may include a seal-forming structure 3100, an oral plenum chamber 3200, a nasal plenum chamber 3202, and components of a positioning and stabilizing structure 3300.

[0063] 5.3.1 Plenum Chamber and Seal Forming Structure As also shown in Figure 3a, the upper part of the seal-forming structure 3100 may include a nasal cushion or flange 3112 for sealing around the lower part of the patient's nose, particularly around the wings and apex of the nose. This nasal cushion 3112 may, at least in part, define an upper gas chamber, which will be discussed in more detail below.

[0064] Figure 3a also shows that the seal-forming structure 3100 may include a mouth cushion or flange 3110 for sealing around the patient's mouth. The mouth cushion 3110 may be attached to the mouth plenum chamber 3200 over its outer circumference 3210.

[0065] The rear view of Figure 3c shows a portion of the seal-forming structure 3100 that may come into contact with the patient's face during use. The nasal cushion 3112 is shown connected to the upper part of the mouth cushion 3110 by a separation structure 3106. The separation structure 3106 may be understood as an intermediate structure that connects the nasal cushion 3112 and the mouth cushion 3110. The separation structure 3106 may allow the nasal cushion 3112 and the mouth cushion 3110 to move relative to each other while maintaining an air pressure channel between them. The nasal cushion 3112 may define a nasal gas chamber 3104, and the nasal gas chamber opening 3103 of the nasal cushion 3112 may receive a portion of the patient's nose during use. During treatment, respiratory gas may be supplied to the patient from the patient interface 3000 through the nasal gas chamber 3104 towards the nose. The mouth cushion 3110 may include a mouth gas chamber 3102 and a mouth gas chamber opening 3101 to supply respiratory gas to the patient's mouth during treatment. The faceplate 3204 and port 3600 can be seen through the mouth gas chamber 3102 of the mouth cushion 3110. When the patient interface 3000 is worn by the patient, it should be understood that the faceplate 3204, plenum chamber 3200, mouth cushion 3110, nasal cushion 3112, and separation structure 3106 define the nasal gas chamber 3104 and mouth gas chamber 3102 together with at least partially the patient's face, and that respiratory gas may be supplied to the patient at positive pressure through these gas chambers.

[0066] In Figure 3d, protruding ends 3114 can be seen on both sides of the nasal cushion 3112. Each protruding end 3114 may be formed to extend from the patient interface 3000 to seal within the gap between the patient's respective nostrils and nasolabial folds when worn by the patient. Figure 2c, which depicts the facial surface features, shows the location of the nostrils and nasolabial folds. The details of the seal provided by the protruding ends 3114 are described in more detail below. The protruding ends 3114 may be partially bulging and / or deformed to seal in this area.

[0067] Figure 3r shows how a typical patient interface 3000 can seal to a patient, particularly the nose. In this detailed front perspective view, the patient's nose, mouth, and chin are shown with solid lines, and the nasal cushion 3112, which is shown to rest against the nose, is shown with a dashed line. It should be understood that the nasal cushion 3112 may be concave in shape to cradle the patient's nose. A recess 3116 that receives the tip of the nose is shown, and a protruding end 3114 that seals in the area of ​​the nasal ala and nasolabial fold can be seen. A nasal undercushion support wall 3208 may support the nasal cushion 3112 in the area of ​​the protruding end 3114, helping to maintain the seal in this area, or it may function like an undercushion. A nasal plenum chamber 3202 is also shown. For clarity, the oral components of the patient interface 3000 are not shown in this figure.

[0068] Figure 3d also shows a recess 3116 that may be included on the nasal cushion 3112. This recess 3116 may have an inwardly molded portion that extends into the nasal gas chamber 3104 to receive the tip of the patient's nose when worn by the patient. The recess 3116 may provide a high seal around and below the tip of the patient's nose during treatment by allowing the shape of the nasal cushion 3112 to better fit the patient's nose. The recess 3116 will be described in more detail below.

[0069] In Figures 3m and 3n, the mouth cushion 3110 can be seen surrounding the mouth of patient 1000. The mouth gas chamber 3102 may be formed by the mouth cushion 3110 surrounding the mouth of patient 1000, the mouth plenum chamber 3200, and the faceplate 3204. When in use, an air circuit 4170 may be connected to a PAP device 4000 (not shown in this figure) to supply breathing gas to patient 1000 through the mouth gas chamber 3102 of the patient interface 3000 and through the patient's mouth.

[0070] The figure also shows a nasal cushion 3112 surrounding a portion of patient 1000's nose, specifically the nasal tip. Thus, the nasal gas chamber 3104 is formed by the nasal cushion 3112 and the patient's face. In this example, the respiratory gas from the air circuit 4170 may pass through the oral gas chamber 3102 and then enter the nasal gas chamber 3104 through an opening defined by the separation structure 3106. The line BB shown in Figure 3m is intended to indicate the transition between the nasal cartilage and nasal bone, extending from the nasal skeleton of patient 1000. The nasal cushion 3112, depicted with this typical patient interface 3000, is intended to seal around the patient's nose below line BB. In other words, the nasal cushion 3112 may seal below the nasal bridge.

[0071] A patient interface 3000, an example of this technology, occupies a surface area of ​​4896 mm² on the face, which is about 30% less noticeable than a conventional full-face mask (for example, the ResMed Quattro FX full-face mask occupies a surface area of ​​7007.89 mm² on the face). For some patients, it may cause almost no claustrophobia. Certain areas with low obstruction are also important. This is because these specific areas have been shown to have a considerably beneficial psychological effect on the bed partner, as the mask does not look very medical when viewed and appears to "open" the face. From the patient's perspective, a typical patient interface 3000 is either not in the patient's field of vision or is significantly reduced from it. This is because the nose cushion 3112 seals below the bridge of the nose. This allows the patient to wear glasses when reading a book or watching television before falling asleep after wearing the patient interface 3000. By sealing below the nasal bridge, inflammation can be avoided in areas where the skin is thin, pressure-sensitive, and / or at high risk of skin damage due to impaired blood flow. Another advantage may be that it eliminates the need to consider inter-patient anthropometric variability above the nasal bridge, and allows the focus for mask fit to be directed towards anthropometric variability around the upper lip area. Also, unlike some other full-face masks, the Patient Interface 3000 may not require a frontal support necessary for pressure point reduction. This also avoids the problem that the frontal support is a source of pressure points and skin damage.

[0072] Anatomically, Figures 2h and 2i may be referenced for illustrating the location of the transitional area between the nasal bone and cartilage. Thus, a typical nasal cushion 3112 is designed to seal around the periphery of the patient's nose in contact with the softer tissues of the nose, such as adipose tissue or cartilage. By forming a seal with the nose in these soft tissues, it may be possible to avoid inflammation of the patient's skin that would otherwise occur if the seal were formed around / on the bone, which is a harder nasal structure. In other words, by sealing below the nasal bridge, patient discomfort can be minimized. Also, a better seal may be formed by positioning the seal of the nasal cushion 3112 around this area of ​​the nose, because the nasal tissues and the nasal cushion 3112 can fit together to form a seal. The nasal cushion 3112 should primarily fit into the nose.

[0073] The aforementioned sealing function, as seen in Figure 3m, is the portion of the protruding end 3114 that comes into contact with the face of patient 1000. Specifically, the protruding end 3114 may be an extension of the nasal cushion 3112 that seals in the area between the nasolabial fold and the nasal ala. These anatomical features can be seen in Figure 2c. Depending on the individual facial structure of the patient, this area may correspond to a recess 3116. Therefore, an extension from the nasal cushion 3112 may be necessary to form a proper seal around the patient's nose. The protruding end 3114 depicted in Figure 3m can preferably perform this function.

[0074] Other sealing functions of the typical patient interface 3000 depicted can be seen in Figure 3p. The nasal cushion 3112 includes a recess 3116 for receiving the tip of the patient's nose when worn by the patient, as previously mentioned. Specifically, the tip of the patient's nose can be seen as a dashed line in the area where the recess 3116 is located. The figure also shows how the nasal cushion 3112 may be formed on its underside to seal against the outer circumference of the nose. In other words, the seal formed on the nose by the nasal cushion 3112 may be characterized as being against the lower outer circumference of the nose. Thus, it can be seen from this figure that the sealing surface of the nasal cushion 3112 may be concave or form a pocket to receive the nose as a whole, and the sealing surface of the nasal cushion may further include a recess 3116 for receiving the tip of the nose.

[0075] Figure 3q illustrates various contact points that may be formed by the patient interface 3000 to seal against the patient's face. The patient interface 3000 is shown in a lateral cross-sectional view. Specifically, the nasal cushion 3112, nasal plenum chamber 3202, mouth cushion 3110, and mouth plenum chamber 3200 are shown in cross-section. Figures 2b to 2f may be referenced for the description of relevant anatomical features. The nasal cushion 3112 is shown sealing against the tip of the patient's nose. The connection area 3106.2 between the mouth cushion 3110 and the nasal cushion 3112 is shown sealing against the patient's upper lip. It should be noted that the connection area 3106.2 may be positioned below the nostrils and above the mouth to seal against the patient's upper lip so as not to obstruct the airflow toward the airway. The connection area 3106.2 may connect the posterior part of the mouth cushion 3110 to the nasal cushion 3112. The connecting region 3106.2 may be positioned to maintain a seal to the patient's upper lip below the nostrils, while allowing relative movement between the structures of the oral gas chamber 3102 and the nasal gas chamber 3104 (e.g., the oral cushion 3110 and the nasal cushion 3112, respectively). The connecting region 3106.2 may also function in cooperation with the separating structure 3106 to facilitate this relative movement.

[0076] The nasal gas chamber 3104 may be considered to be at least partially defined by the nasal cushion 3112, the nasal plenum chamber 3202, and the patient's nose, providing a sealed pathway for respiratory gases to enter the patient's airway through the nostrils or nasal passages. A gap 3106.1 can also be seen between the oral plenum chamber 3200 and the nasal plenum chamber 3202. The gap 3106.1 will be discussed in more detail below, but it should be understood that despite the independent movement of the nasal cushion 3112 and the oral cushion 3110, the gap 3106.1 can facilitate the maintenance of seals to the nose and mouth in part. It may be advantageous to maintain the seal of the nasal cushion 3112 to the nose, the seal of the connection area 3106.2 to the upper lip, and the seal of the oral cushion 3110 around the mouth, while allowing these components to move independently of each other and accommodating anthropometric variations and a wide range of patients.

[0077] As shown in Figure 3q, the oral gas chamber 3102 may be considered to be at least partially defined by the oral cushion 3110, the oral plenum chamber 3200, and the patient's mouth to provide a sealed pathway for breathing gas to enter the patient's airway through the mouth. The seal and / or contact at the patient's lower lip may be formed by the oral cushion 3110. Although not shown in this figure, it should be understood that when the positioning stabilization structure 3300 presses the patient interface 3000 against the patient's face, the oral under cushion 3120 may further support the thinner oral cushion 3110 against the lower lip. In such a situation, the oral under cushion 3120 is biased to contact the corresponding portion of the oral cushion 3110.

[0078] In one embodiment of this technology, the seal-forming structure 3100 may provide a seal-forming surface and further provide a cushioning function.

[0079] In one example, the seal-forming structure 3100 according to this technology may be made of a flexible, pliable, elastic material such as silicone. In another example of this technology, the seal-forming structure 3100, for example, the mouth cushion 3110, the nose cushion 3112, and / or their respective under cushions, may be made of foam.

[0080] In one example, the plenum chamber 3200 has a periphery 3210 formed to be complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber 3200 is located in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend over the entire periphery 3210 of the plenum chamber 3200 during use.

[0081] Figures 7a to 7h illustrate several diagrams of the seal-forming structure 3100 and the plenum chamber 3200. These diagrams show the seal-forming structure 3100 and the plenum chamber 3200 without the top plate 3206 and the face plate 3204, as well as without any associated positioning and stabilizing structures 3300.

[0082] Figure 7a shows a rear perspective view of the seal-forming structure 3100 and the plenum chamber 3200. The typical seal-forming structure 3100 shown in this figure includes a mouth cushion 3110 and a nose cushion 3112. In this figure, it can be seen that the connecting region 3106.2 connects the mouth cushion 3110 and the nose cushion 3112. The position of the separation structure 3106 is also shown between the mouth cushion 3110 and the nose cushion 3112.

[0083] It can be seen that the mouth cushion 3110 and the mouth plenum chamber 3200 partially define the mouth gas chamber 3102. The opening 3101 to the mouth gas chamber 3102, defined by the mouth cushion 3110, can also be seen.

[0084] Figure 7a also shows a nasal plenum chamber 3202 that partially defines the nasal gas chamber 3104 together with the nasal cushion 3112. This typical nasal cushion 3112 can also be seen including the protruding ends 3114 on both sides. A recess 3116 that receives the tip of the nose can also be seen. The figure also shows a nasal undercushion support wall 3208. The nasal undercushion support wall 3208 is associated with each protruding end 3114 and may provide support for the protruding ends 3114 when the protruding ends seal against the patient's nasal wings and nasolabial folds.

[0085] Figure 7b shows a side perspective view of a typical seal-forming structure 3100 and plenum chamber 3200. Figure 7b depicts features similar to those shown in Figure 7a. However, this figure also depicts that the connecting region 3106.2 may have a concave shape. In other examples, the connecting region 3106.2 may have a non-concave shape. By forming a concave connecting region 3106.2, the mouth cushion 3110 may be able to seal better around the patient's mouth, and the nasal cushion may be able to seal better around and below the patient's nose. Alternatively, a completely convex cushion may function similarly. Part of the outer circumference 3210 of the mouth plenum chamber 3200 is also visible in this figure. The location of the separation structure 3106 is also shown.

[0086] Figure 7b shows a nasal undercushion support wall 3208 associated with each of the protruding ends 3114 of the nasal cushion 3112. The nasal undercushion support wall 3208 extends beyond the outer circumference of the nasal plenum chamber 3202. Such a configuration may allow the nasal undercushion support wall 3208 to provide sufficient support for the protruding ends 3114 to seal against the patient's face. The lower half of the nasal undercushion support wall 3208 may act as a hinge or pivot point for the separation structure 3106. The upper half of the nasal undercushion support wall 3208 may help position the top plate 3206.

[0087] Figure 7c shows a front perspective view of a typical seal-forming structure 3100 and plenum chamber 3200. This figure particularly illustrates the anterior portion of the nasal plenum chamber 3202 and the nasal undercushion support wall 3208 that supports the protruding end 3114 of the nasal cushion 3112.

[0088] Figure 7d shows a typical side perspective view of the seal-forming structure 3100 and plenum chamber 3200. This figure shows similar features to those shown in Figure 7a. On both sides of the nasal cushion 3112, portions of each nasal undercushion support wall 3208 can be seen. This figure also shows how the connection region 3106.2 can connect the mouth cushion 3110 to the nasal cushion 3112. The location of the separation structure 3106 is also shown.

[0089] Figure 7e shows a typical front view of the seal-forming structure 3100 and plenum chamber 3200. This figure particularly clearly shows the mouth cushion 3110 positioned over the outer circumference 3210 of the mouth plenum chamber 3200. It can also be seen that the mouth gas chamber 3102 is defined by the mouth cushion 3110 and the mouth plenum chamber 3200. This figure also shows the front of the separation structure 3106 that connects the nose cushion 3112 to the mouth cushion 3110. Nose undercushion support walls 3208 can be seen on both sides of the nose cushion 3112. The mouth undercushion 3120 is also visible in this figure. This figure also shows that the mouth undercushion 3120 may terminate in tapered regions 3122 near both sides of the nose cushion 3112. Therefore, an undercushion may not be present in the connection region 3106.2 (not shown in this figure) between the mouth cushion 3110 and the nose cushion 3112. Preferably, this may further increase the flexibility in the connection region 3106.2, thereby easily maintaining the seal to the upper lip shown in Figure 3q despite the movement of the mouth cushion and nose cushions 3110, 3112.

[0090] Figures 12a to 12d show further typical configurations of the mouth under cushion 3120 according to this technology. These figures show various forms of the mouth under cushion 3120, including the mouth cushion 3110 and the opening 3101 to the mouth gas chamber 3102, which are shown in a punctate state. For simplicity, additional features associated with the seal forming structure 3100 have been omitted from these figures.

[0091] Figure 12a depicts an example of a mouth cushion 3110 in which the mouth under cushion 3120 surrounds the entire circumference of the mouth cushion 3110. Figure 12b depicts an example of a mouth cushion 3110 in which there are two parts of the mouth under cushion 3120, one on each side of the mouth cushion. Figure 12c depicts an example in which the mouth under cushion 3120 surrounds the entire circumference of the mouth cushion 3110 except for a part near the upper region of the mouth cushion 3110. Figure 12d depicts an example similar to Figure 12c, but the part of the mouth cushion 3110 in which the mouth under cushion 3120 is absent is the lower region of the mouth cushion 3110.

[0092] Figure 7f shows a plan view of a typical seal-forming structure 3100 and plenum chamber 3200. This figure shows the nasal cushion 3112 with its protruding end 3114 and recessed portion 3116, and the nasal gas chamber 3104 partially defined by the nasal cushion 3112. This figure also partially shows the pneumatic connection between the oral gas chamber 3102 and the nasal gas chamber 3104 defined by the separation structure 3106.

[0093] Figure 7g shows a bottom view of a typical seal-forming structure 3100 and plenum chamber 3200. This figure shows the mouth cushion 3110 attached to the mouth plenum chamber 3200. The protruding end 3114 of the nose cushion 3112 can also be seen.

[0094] Figure 8a shows another plan view of a typical seal-forming structure 3100 and plenum chamber 3200. This figure also shows many section lines to illustrate the cross-sections depicted in subsequent drawings, namely Figures 8b to 8l. This figure is similar to Figure 7f, and therefore depicts similar components. However, to avoid confusion, reference figures and leader lines have been removed.

[0095] Figures 8b-8d show typical cross-sectional views of the seal-forming structure 3100 and plenum chamber 3200 taken along lines 8b, 8c, 8d-8b, 8c, 8d. It can be seen that the nasal cushion 3112 is connected to the mouth cushion 3110 by a connecting region 3106.2. It can be seen that the mouth gas chamber 3102 is partially defined by the mouth plenum chamber 3200 and the mouth cushion 3110. It can be seen that the nasal gas chamber 3104 is partially defined by the nasal plenum chamber 3202 and the nasal cushion 3112. The protruding end 3114 and recessed end 3116 of the nasal cushion 3112 are also shown. Furthermore, this figure also shows how the connection region 3106.2 in one example of the present technology does not necessarily have to include an undercushion, although the mouth cushion 3110 may include a nasal undercushion support wall 3208 (not shown in these figures) for supporting the mouth undercushion 3120 and the protruding end 3114. The gap 3106.1 formed by the mouth plenum chamber 3200, the nasal plenum chamber 3202, and the hinged configuration of the separation structure 3106 can also be seen. In other examples of the present technology, the mouth undercushion 3120 may include two discontinuous sides present on either side of the mouth cushion 3110, but there is no mouth undercushion portion in the connection region 3106.2 or the lower central part of the mouth cushion 3110. Alternatively, as shown in Figure 7e, the mouth undercushion 3120 may terminate near the nasal cushion 3112 in the tapered regions 3122 on either side thereof.

[0096] Figures 8b and 8c also show the sweep angles α and β relative to the connection region 3106.2, respectively. Figure 8b shows that α is the angle from the nose cushion 3112 to the bottom of the mouth cushion 3110. α may be in the range of approximately 80° to approximately 180°, and in one example of this technology, α may be approximately 142°. Figure 8c shows that β is the angle from the nose cushion 3112 to the top of the mouth cushion 3110. β may be in the range of approximately 80° to approximately 170°, and in one example of this technology, β may be approximately 120°. The cushions 3110, 3112 and the plenum chambers 3200, 3202 are formed as a single unit.

[0097] Figure 8e shows another cross-sectional view of a typical seal-forming structure 3100 and plenum chamber 3200 taken along line 8e-8e. In this figure, as before, it can be seen that the mouth cushion 3110 includes the mouth under cushion 3120. In this example of the art, the connection region 3106.2 is shown without the under cushion. The gap 3106.1 formed by the hinged configuration of the mouth plenum chamber 3200, the nose plenum chamber 3202, and the separation structure 3106 can also be seen. The side portion 3106.3 of the separation structure 3106 can also be seen.

[0098] Figure 8f shows another cross-sectional view of a typical seal-forming structure 3100 and plenum chamber 3200 taken along line 8f-8f. This figure exhibits similar features to the example depicted in Figure 8e. However, this figure also shows a portion of the nasal undercushion support wall 3208 positioned to support the protruding end 3114 of the nasal cushion 3112. Here, a side portion 3106.3 of the separation structure 3106 can be seen near the nasal undercushion support wall 3208.

[0099] Figure 8g shows another cross-sectional view of a typical seal-forming structure 3100 and plenum chamber 3200 taken along line 8g-8g. Figure 8g also exhibits features similar to those in Figures 8e and 8f, as before. However, this figure also more clearly shows the nasal undercushion support wall 3208 located below the protruding end 3114 of the nasal cushion 3112.

[0100] Figure 8h shows another cross-sectional view of a typical seal-forming structure 3100 and plenum chamber 3200 taken along line 8h-8h. This figure also shows similar features to those depicted in Figure 8g. In this figure, each protruding end 3114 can be seen with its respective nose undercushion support wall 3208 located beneath it.

[0101] Figure 8i shows another cross-sectional view of a typical seal-forming structure 3100 and plenum chamber 3200 taken along line 8i-8i. This figure also shows similar features to those depicted in Figure 8h.

[0102] Figure 8j shows another cross-sectional view of a typical seal-forming structure 3100 and plenum chamber 3200 taken along line 8j-8j. This figure also shows similar features to those depicted in Figure 8f.

[0103] Figure 8k shows another cross-sectional view of a typical seal-forming structure 3100 and plenum chamber 3200 taken along line 8k-8k. This figure also shows similar features to those depicted in Figure 8d. Figure 8k particularly well shows that in this depicted example of the art, the connection region 3106 may have a concave shape so as to fit against the patient's upper lip.

[0104] Figure 8l shows another cross-sectional view of a typical seal-forming structure 3100 and plenum chamber 3200 taken along line 8l-8l. This figure also shows similar features to those depicted in Figure 8d.

[0105] Figure 9a shows another front view of a typical seal-forming structure 3100 and plenum chamber 3200. This figure also shows many section lines to illustrate the cross-sections depicted in subsequent drawings, namely Figures 9b to 9i. This figure is similar to Figure 7e and therefore depicts similar components. However, to avoid confusion, reference figures and leader lines have been removed.

[0106] Figure 9b shows a typical cross-sectional view of the seal-forming structure 3100 and plenum chamber 3200 taken along line 9b-9b. Figure 9b also depicts features similar to those shown in Figures 8b to 8d.

[0107] Figure 9c shows a typical cross-sectional view of the seal-forming structure 3100 and plenum chamber 3200 taken along line 9c-9c. This figure particularly shows a cross-section of the nasal undercushion support wall 3208, which may be included to support the protruding end 3114 of the nasal cushion 3112.

[0108] Figure 9d shows a typical cross-sectional view of the seal-forming structure 3100 and plenum chamber 3200 taken along line 9d-9d. The cross-sectional view shown here is taken at a predetermined angle so that part of the nose cushion 3112 is not shown. This figure also depicts the mouth under cushion 3120 of the mouth cushion 3110 particularly well. In the example shown in this figure, the tapered region 3122 of the mouth under cushion 3120 can also be seen.

[0109] Figure 9e shows a typical cross-sectional view of the seal-forming structure 3100 and plenum chamber 3200 taken along line 9e-9e. Figure 9e is taken along a similar cross-section as Figure 9d and therefore depicts similar features.

[0110] Figure 9f shows a cross-sectional view of a typical seal-forming structure 3100 and plenum chamber 3200 taken along line 9f-9f. This figure particularly well depicts the mouth cushion 3110 and the under-mouth cushion 3120, and how these two cushions 3110 and 3120 can share similar shapes to seal against the patient's face.

[0111] Figure 9g shows a typical cross-sectional view of the seal-forming structure 3100 and plenum chamber 3200 taken along line 9g-9g. Figure 9g is taken along a similar cross-section as Figure 9f and therefore depicts similar features.

[0112] Figure 9h shows a typical cross-sectional view of the seal-forming structure 3100 and plenum chamber 3200 taken along line 9h-9h. Figure 9h depicts features similar to those shown in Figure 9c, including a cross-section of the nasal undercushion support wall 3208.

[0113] Figure 9i shows a typical cross-sectional view of the seal-forming structure 3100 and plenum chamber 3200 taken along line 9i-9i. Figure 9i depicts features similar to those shown in Figure 9b.

[0114] Figures 16a to 16o show some diagrams of other seal-forming structures 3100 and plenum chambers 3200 related to an example of this technology.

[0115] The seal-forming structure 3100 and plenum chamber 3200 in this example include pockets 3208.1 on both sides of the nasal cushion 3112 near the lateral portion 3106.3 and below the protruding end 3114. See Figures 16a, 16d, 16i, 16k, 16m-16o for details. The pockets 3208.1 may be defined at least partially by the separation structure 3106, the undercushion support wall 3208, the lateral portion 3106.3, the nasal plenum chamber 3202, and the lateral support 3207. The pockets 3208.1 may open in front of the seal-forming structure 3100 and plenum chamber 3200. The pockets 3208.1 may provide resistance to deformation of the nasal cushion 3112 in all directions. The pockets 3208.1 may provide compression resistance to the nasal cushion 3112. This compression resistance may help reduce leakage at the corners of the nasal region where the pocket 3208.1 can support the nasal cushion 3112 and / or the protruding end 3114 when the nasal cushion 3112 is in contact with the patient's nose. According to one example of the art, it may be advantageous for the nasal cushion 3112 to deform in areas other than the protruding end 3114 that can be supported by the pocket 3208.1. The pocket 3208.1 and the separation structure 3106 may help resist deformation of the nasal cushion 3112, or they may help allow deformation to occur in the target region.

[0116] The lateral support 3207 shown in the examples depicted in Figures 16a to 16o may be formed integrally with the seal-forming structure 3100 and the plenum chamber 3200. Therefore, in examples where the seal-forming structure 3100 and the plenum chamber 3200 are formed from silicone, the lateral support 3207 is also formed from silicone. The lateral support 3207 may serve a reinforcing purpose to improve the seal between the seal-forming structure and the patient's face. For example, the lateral support 3207 may help to support the nasal cushion 3112 against the patient's nasal wings on both sides, and / or the lateral support may help to support the protruding end 3114 against the area of ​​the patient's face where the nasal wings connect near the nasolabial folds. The lateral support 3207 may also control the deformation of the nasal cushion 3112 so that a particular area of ​​the nasal cushion deforms in front of other areas. The lateral support 3207 may control the degree of deformation in a particular area of ​​the nasal cushion 3112. The lateral support 3207 can bend when compressed due to contact with the patient's face, thereby facilitating controlled deformation of the nose cushion 3112. The lateral support 3207 may also reinforce the sides of the nose cushion 3112 to decouple the facial compressive force resisting the nose cushion 3112 and prevent the nose cushion 3112 from collapsing toward the separation structure 3106.

[0117] Each of the side supports 3207 may include a notch 3209. The notch 3209 of the side support 3207 may provide a pivot point between the nose cushion 3112 and the mouth cushion 3110. The pocket 3208.1 may also serve to control the position of the pivot point.

[0118] The side support 3207 may provide mounting points for the top plate 3206. The top plate 3206 may be integrally and / or chemically bonded to the seal-forming structure 3100 and the plenum chamber 3200. In one example, the silicon of the seal-forming structure 3100 and the plenum chamber 3200 may be formed and / or molded around the top plate 3206. According to one example of this technology, a mechanical connection between the top plate 3206 and the seal-forming structure 3100 and the plenum chamber 3200 may not be necessary. Alternatively, a chemical and / or integral bond may not be present, in which case a mechanical connection between the top plate 3206 and the seal-forming structure 3100 and the plenum chamber 3200 is necessary. The top plate 3206 may define a pivot point at least partially between the nose cushion 3112 and the mouth cushion 3110.

[0119] Furthermore, it may be desirable to reduce or control deformation of the nose cushion 3112 in a specific area relative to other areas by reinforcing or strengthening the nose cushion 3112 to provide localized support. Examples of reinforcement may include increasing the relative thickness of the nose cushion 3112 that is to be reinforced. Alternatively, reinforcing ribs or other reinforcing structures may be formed on the nose cushion 3112 to provide localized support at a desired level and location.

[0120] Figures 16i, 16k-16m, and 16o show that the nasal cushion 3112 may include thickened nasal cushion portions 3124 on its sides. The thickened nasal cushion portions 3124 may generally be thickened portions of the nasal cushion 3112 that extend inward toward the nasal gas chamber 3104. These thickened nasal cushion portions 3124 may provide additional support for the nasal cushion 3112 when the nasal cushion is in a sealed engagement with the patient's nose and face. The thickened nasal cushion portions 3124 may be positioned in predetermined locations on both sides of the nasal cushion 3112 such that the thickened nasal cushion portions are near the patient's nasolabial folds when the seal-forming structure engages with the patient's face. The thickened nasal cushion portions 3124 may help seal around the nostrils of the patient's nose by preventing the nasal cushion 3112 from collapsing due to sealing forces. The thickened nasal cushion portions 3124 may be formed integrally with the nasal cushion 3112. Furthermore, the thickened nasal cushion portion 3124 may be positioned on the nasal cushion 3112 so that it can at least partially press against the respective undercushion support walls 3208 when the seal-forming structure engages with the patient's nose and face. The thickened nasal cushion portion 3124 may have a constant thickness throughout that is greater than the thickness of the rest of the nasal cushion 3112. Alternatively, the thickened nasal cushion portion 3124 may have a variable thickness over its area.

[0121] In another example of this technology, the thickened nose cushion portion 3124 may not be provided, and other structures may be provided in these areas to increase rigidity. For example, in areas where the thickened nose cushion portion 3124 is expected to serve to reinforce the nose cushion 3112, ribs or other reinforcing structures may be provided on the nose cushion 3112 in those areas.

[0122] Figure 16k also shows an example of the art in which the mouth plenum chamber 3200 includes thickened mouth plenum chamber portions 3212. These thickened mouth plenum chamber portions 3212 may provide additional support for the mouth plenum chamber 3200 to help resist collapse of the mouth plenum chamber.

[0123] Furthermore, Figures 16j and 16k show cross-sectional views penetrating the seal-forming structure 3100 and the plenum chamber 3200. These figures show that, in the examples depicted, the connection region 3106.2 may be thicker than the connection regions shown in Figures 8a-8l and 9a-9l. The thickness of the connection region 3106.2 shown in Figures 16j and 16k may be consistent along its width and height. Due to tube torque from the air circuit 4170, the mouth cushion 3110 may pull the nose cushion 3112 through the separation structure 3106, causing the connection region 3106.2 to extend substantially vertically. Stretching of the connection region 3106.2 may cause disruption of the seal of the nose cushion 3112. The connecting region 3106.2 may be made thicker and its thickness consistent throughout to resist this stretching of the connecting region 3106.2, and disruption of the seal at the nose cushion 3112 may be prevented and / or reduced.

[0124] Figures 16b, 16c, 16e, 16f, 16j, and 16o show a nasal cushion 3112 including a nasal sling 3119 that divides the opening 3103 to the nasal gas chamber 3104 into the nasal port 3105. The nasal sling 3119 may seal along the columella of the patient's nose (see Figure 2f) so that each nostril can be sealed individually. Alternatively, the nasal sling 3119 may form a columella relief by contacting the patient's columella without forming a seal. The nasal sling 3119 may also prevent the tip of the patient's nose from penetrating the nasal cushion 3112 and extending into the nasal gas chamber 3104. The nasal sling 3119 may also provide support for the nasal cushion 3112 to prevent deformation of the nasal cushion 3112 in the direction of the longitudinal axis of the nasal sling 3119.

[0125] The seal-forming structure 3100 may include an adaptable region. The adaptable region is not shown in these examples. Further examples and descriptions of adaptable regions are given in International Patent Application Publication PCT / AU2014 / 000026. The adaptable region is relatively flexible, pliable, and / or adaptable compared to the rest of the seal-forming structure 3100. The relative pliability of the adaptable region may be advantageous in that it may help reduce discomfort to the patient in the area of ​​the nasal tip and nasal septum. The adaptable region may be relatively thin compared to the rest of the seal-forming structure 3100 and therefore may function like a mechanical spring to maintain an effective seal at the nasal tip by pressing against and wrapping around the nasal tip and / or contacting the nasal tip. The adaptable region may be located in the seal-forming structure 3100 at the upper apex where the seal-forming structure 3100 transitions to the plenum chambers 3200, 3202. The adaptation region may be located in the seal-forming structure 3100 above the recessed area 3116. The adaptation region may be integrated with the recessed area 3116. The adaptation region may be located horizontally approximately in the center of the seal-forming structure 3100. According to one example of this technology, the seal-forming structure 3100 may have a thickness of about 0.35 mm in the adaptation region, or the adaptation region may be one of the thinnest regions of the seal-forming structure 3100.

[0126] 5.3.1.1 Typical nose cushion Figures 4a-4c, 5a-5c, and 6a-6c illustrate various examples of the nose cushion 3112 related to this technology.

[0127] Figure 4a shows a plan view of a typical nasal cushion 3112. Projecting ends 3114 can be seen on both sides of the nasal cushion 3112. The nasal gas chamber 3104 and the opening 3103 to the nasal gas chamber are also visible. The opening 3103 to the nasal gas chamber 3104 may generally have a rectangular, rhomboid, or trapezoidal shape, which may be curved at its respective short and long sides 3104.2. The curved short sides 3104.2 of the nasal opening 3103 are located near each ala of the nose when positioned against the patient's nose. In this example as well, one of the pair of long sides, specifically the distal end side 3104.1 of the nasal opening 3103, is distal to the patient's upper lip near the tip of the nose, while the other of the pair of long sides, i.e., the proximal end side 3104.3, is proximal to the patient's upper lip. A recess 3116 formed to receive the tip of the nose is also shown.

[0128] Figure 4b shows a bottom view of a typical nasal cushion 3112, cut along line 4c-4c in Figure 4a. This figure also shows the nasal gas chamber 3104 and its associated opening 3103.

[0129] Figure 4c shows a lateral perspective view of a typical nasal cushion 3112, cut along line 4c-4c in Figure 4a. This figure also shows the nasal gas chamber 3104 and the opening 3103 to the nasal gas chamber. The recess 3116 is also shown. Of particular note in this figure is the contour of the nasal cushion 3112 along the cross-sectional line 4c-4c. It can be seen that the nasal cushion 3112 curves slightly upward as it approaches the distal end side 3104.1 of the opening 3103 from the recess 3116 to the nasal gas chamber 3104. Also, as can be seen in this figure and Figure 4b, the anterior upper part of the nasal cushion 3112 near the recess 3116 contains a slight depression or concave area in its center through which line 4c passes, such that the nasal cushion 3112 is higher on both sides than in the center. This figure also shows the outline of the nose with a dashed line to show how the patient's nose may be positioned relative to the nasal cushion 3112. The apex 3118 of the cushion 3112 may serve to seal the front of the nostrils. The apex 3118 may be located further posteriorly, but may gradually increase in size to create a balloon effect. The distal end long side 3104.1 can be turned up from the cushion 3112 to enhance the seal at the nasal tip. This is because the distal end long side makes contact with the nose more quickly and causes both a compression seal and a pneumatic seal by embracing the nose. A recess 3116 formed to receive the nasal tip is also shown.

[0130] Figure 5a shows a plan view of a typical nasal cushion 3112. The protruding ends 3114 can be seen on both sides of the nasal cushion 3112. The nasal gas chamber 3104 and the opening 3103 to the nasal gas chamber are also visible. The shape of the opening 3103 to the nasal gas chamber 3104 may be similar to the shape shown in Figure 4a. A recess 3116 formed to receive the tip of the nose is also shown.

[0131] Figure 5b shows a bottom view of a typical nasal cushion 3112, cut along line 5c-5c in Figure 5a. This figure also shows the nasal gas chamber 3104 and its associated opening 3103.

[0132] Figure 5c shows a lateral perspective view of a typical nasal cushion 3112, cut along line 5c-5c in Figure 5a. This figure also shows the nasal gas chamber 3104 and the opening 3103 to the nasal gas chamber. The recess 3116 is also shown. Of particular note in this figure is the shape of the nasal cushion 3112 along the cross-sectional line 5c-5c. In contrast to the shape of the nasal cushion 3112 in Figure 4c, in this figure it can be seen that the nasal cushion slopes downward as it approaches the distal end side 3104.1 of the opening 3103 from the recess 3116 to the nasal gas chamber 3104. It can also be seen that this example of the nasal cushion 3112 lacks the recess in the anterior region near the recess 3116 that can be seen in the examples shown in Figures 4b and 4c. In other words, this example shows that the nasal cushion 3112 may be more circular / rounded in the region from the recess 3116 to the distal end side 3104.1 of the opening 3103 to the nasal gas chamber 3104 compared to the example shown in Figure 4c. This figure also shows the outline of the nose with a dashed line to illustrate how the patient's nose may be positioned relative to the nasal cushion 3112.

[0133] Figure 6a shows a plan view of a typical nose cushion 3112. The protruding ends 3114 can be seen on both sides of the nose cushion 3112. The nasal gas chamber 3104 and the opening 3103 to the nasal gas chamber are also visible. The shape of the opening 3103 to the nasal gas chamber 3104 may be the same as the shape shown in Figure 4a. In Figures 4a to 4c, the shape is more balloon-like and rounded than the examples shown in Figures 6a to 6c.

[0134] Figure 6b shows a bottom view of a typical nasal cushion 3112 cut along line 6c-6c in Figure 6a. This figure also shows the nasal gas chamber 3104 and its associated opening 3103. As can be seen in this figure, the nasal cushion 3112 has straight side walls 3121, in contrast to the smoothly curved side walls of the nasal cushion 3112 shown in Figures 4a-4c and 5a-5c. The straight side walls 3121 may have a defined upper edge and are thought to increase the stability and strength of the nasal cushion 3112.

[0135] Figure 6c shows a lateral perspective view of a typical nasal cushion 3112, cut along line 6c-6c in Figure 6a. This figure also shows the nasal gas chamber 3104 and the opening 3103 to the nasal gas chamber. The recessed area 3116 is also shown. Of particular note in this figure is the shape of the nasal cushion 3112 along the cross-sectional line 6c-6c. As in the case of Figure 5c, it can be seen that this example of the nasal cushion 3112 lacks the depression in the anterior region near the recessed area that can be seen in the examples shown in Figures 4b and 4c. The straight side wall 3121 of this typical nasal cushion 3112 can also be seen in this figure. This figure also shows the outline of the nose with a dashed line to show how the patient's nose may be positioned relative to the nasal cushion 3112.

[0136] It should also be understood that the typical nose cushion 3112 depicted in Figures 4a-4c, 5a-5c, and 6a-6c is shown in a nearly undeformed state. Figures 4c, 5c, and 6c may show slight deformation due to their fit with the shape of the nose, indicated by the dashed lines. Therefore, the nose cushion 3112 may have a concave shape as shown when it is not deformed.

[0137] It should also be understood that the nasal cushion 3112 may have a cross-section of variable thickness. Therefore, the region of the nasal cushion 3112 near the opening 3103 to the nasal gas chamber 3104 may be thinner than the region where the nasal cushion 3112 attaches to the plenum chamber 3202. Preferably, this may provide greater comfort to the patient by providing a thinner, and therefore more adaptable, region of the cushioning material in the area where a large amount of contact is made with the patient's nose.

[0138] Figures 10a to 10d further illustrate further nasal cushions 3112 relating to further examples of this technology. These figures depict further variations in the possible shapes of the opening 3103 to the nasal gas chamber 3104.

[0139] Figures 11a to 11c illustrate various cross-sectional shapes of the nasal cushion 3112 according to an example of this technology. Region 3112.1 may be near the opening 3103 to the nasal gas chamber 3104, and region 3112.3 may be near the connection to the nasal plenum chamber 3202. Region 3112.2 may be the highest region near the upper outer circumference of the nasal cushion 3112.

[0140] Figure 11a shows a cross-section of the nose cushion 3112 taken across the line 11a-11a in Figure 4a. This cross-section shows the smoothly changing thickness of the nose cushion 3112 from region 3112.1 to region 3112.3. Furthermore, the thickness x may be thinner than the thickness z.

[0141] Figure 11b shows a cross-section of the nose cushion 3112 taken across the line 11b,c-11b,c in Figure 13. This cross-section shows that region 3112.2 may become thicker more abruptly than regions 3112.1 and 3112.3. Furthermore, thickness x may be thinner than thickness z, and thickness y may be thicker than thicknesses x and z.

[0142] Figure 11c shows a cross-section of the nose cushion 3112 taken across the line 11b,c-11b,c in Figure 13. Region 3112.2 may be reinforced with respect to the other regions 3112.1 and 3112.3. This cross-section shows that region 3112.2 may become thicker more abruptly than regions 3112.1 and 3112.3. Also, thickness z may be thinner than thickness x, and thickness y may be thicker than thicknesses x and z.

[0143] Figure 13 shows a plan view of another typical nasal cushion 3112 relating to this technology. The opening 3103 to the nasal gas chamber 3104 and the protruding end 3114 are shown to allow for an understanding of the orientation of the nasal cushion 3112. Areas of varying thicknesses are hatched differently to better indicate where the rigidity and / or thickness of the nasal cushion 3112 may vary. Area 3113 may be the thinnest to allow for a quick fit to the tip of the nose. According to an example of this technology, area 3113 may have a thickness of about 0.35 mm. Area 3115 may be even thicker to provide greater support for the nasal cushion 3112. According to an example of this technology, area 3115 may have a thickness of about 0.5 mm. Area 3117 may be thicker than the other areas to provide maximum support, resistance to deformation, and ensure an effective seal at the patient's nasal ala. According to an example of this technology, area 3117 may have a thickness of about 1 mm.

[0144] 5.3.2 Separate structures The separation structure 3106 shown in Figure 3c may provide a connection between the nasal cushion 3112 and the mouth cushion 3110. The separation structure 3106 may also define a pneumatic connection between the mouth gas chamber 3102 and the nasal gas chamber 3104. Therefore, during treatment in which the patient is supplied with positive-pressure breathing gas, the gas may enter the patient interface via port 3600 and flow directly into the plenum chamber 3200, faceplate 3204, mouth cushion 3110, and the mouth gas chamber 3102, which is at least partially defined by the separation structure 3106. The gas then flows into the patient's mouth. The breathing gas may also be supplied to the patient's nose via the nasal gas chamber opening 3103 and through the nasal cushion 3112, nasal plenum chamber 3202, and the nasal gas chamber 3104, which is at least partially defined by the separation structure 3106. To reach the nasal gas chamber 3104, the gas must flow from the oral gas chamber 3102 through the pneumatic passage defined by the separation structure 3106 before flowing into the nasal gas chamber 3104. However, it should be understood that ports may be provided on the top plate 3206 or the nasal cushion 3112 to receive the respiratory gas. In that case, the flow pattern through the patient interface 3000 may simply be reversed.

[0145] Regarding the separation structure 3106 depicted in FIG. 3c, this feature may allow the nose cushion 3112 and the mouth cushion 3110 to move independently of each other when worn by a patient. When the nose cushion 3112 is worn by a patient together with a positioning and stabilization structure 3300 (such as a headgear), as will be described in more detail below, it may be pressed against the patient's face, particularly against the nose, by the force transmitted to the nose cushion 3112 via the top plate 3206 along the rigidizer arm 3302. Also, the mouth cushion 3110 may be pressed against the patient's face, particularly against the mouth, by the force transmitted from the headgear strap 3306 to the face plate 3204. Since different sets of the headgear strap 3306 can press different parts of the patient interface 3000 (such as the nose cushion 3112 and the mouth cushion 3110) against different parts of the patient's face (such as the nose and the mouth, respectively), it may be advantageous to allow the nose cushion 3112 and the mouth cushion 3110 to move independently of each other due to the separation structure 3106.

[0146] The separation structure 3106 may be used to connect the mouth cushion 3110 and the nose cushion 3112 so as to facilitate this independent movement. By enabling independent movement of the cushions 3110, 3112, a better seal can be achieved for a wider variety of patient face shapes, and it can help maintain the seal against the patient's face despite movement in different regions of the face, movement of the air circuit 4170, or external forces. Also, due to the fact that the patient interface 3000 can seal against two separate regions of the face, the nose, and the mouth, two separate openings must be provided to supply breathing gas to the patient. By enabling the seal structures (such as the mouth cushion 3110 and the nose cushion 3112) to move independently, it is possible to maintain the seal around the nose independently of the seal around the mouth and prevent unwanted leakage and thus pressure loss through one or both of the openings.

[0147] The separation structure 3106 may form a part of the walls of the oral plenum chamber 3200 and the nasal plenum chamber 3202 in the forward direction. The separation structure 3106 may be elastically flexible to allow relative movement and / or length elongation between the structures that define the oral gas chamber 3102 and the nasal gas chamber 3104. Thus, the oral plenum chamber 3200 and the nasal plenum chamber 3202 may extend away from each other or be pressed against each other, while the pneumatic connection is maintained between the oral gas chamber 3102 and the nasal gas chamber 3104. Also, the separation structure 3106 may allow these structures (e.g., the oral plenum chamber 3200 and the nasal plenum chamber 3202) to be tilted relative to each other, while the pneumatic connection is maintained between the oral gas chamber 3102 and the nasal gas chamber 3104, and a seal with the patient's face is maintained.

[0148] The separation structure 3106 may include an upper surface 3106.4, a connection surface 3106.5, and a lower surface 3106.6. The connection surface 3106.5 may be relatively more rigid than the upper surface 3106.4 and the lower surface 3106.6. The lower surface 3106.6 may be understood as a surface separate from the oral cushion 3110. The upper surface 3106.4 may be understood as a surface separate from the nasal cushion 3112. The greater rigidity of the connection surface 3106.5 may be created by reinforcing ribs or other reinforcing structures or by making the connection surface 3106.5 thicker than the upper surface 3106.4 and the lower surface 3106.6. According to one example, the upper surface 3106.4 and the lower surface 3106.6 may each have a thickness of 0.5 mm, and the connection surface 3106.5 may have a thickness of 1.2 mm. According to a further example of the present technology, specific numerical values may be changed while maintaining the same thickness ratio between the upper surface 3106.4, the connection surface 3106.5, and the lower surface 3106.6.

[0149] In a further example of this technology, the relative thicknesses of the upper surface 3106.4, the connecting surface 3106.5, and the lower surface 3106.6 may be selected to allow a desired degree of flexibility of the separation structure 3106. In one example, the separation structure 3106 may be bent such that the upper surface 3106.4 and the lower surface 3106.6 are positioned at a maximum angle of about 45° to about 50° relative to each other.

[0150] Furthermore, according to a further example of this technology, the angle between the upper surface 3106.4 and the connecting surface 3106.5 may be approximately 80° to approximately 140°. Also, according to yet another example of this technology, the angle between the upper surface 3106.4 and the connecting surface 3106.5 may be approximately 90°. It should be understood that the angle between the upper surface 3106.4 and the connecting surface 3106.5 may vary over the length of the separating structure 3106 due to the curved shape of the separating structure. In a given example, if the angle between the upper surface 3106.4 and the connecting surface 3106.5 is greater than 90°, it may be easier to separate the nose structure and the mouth structure from each other. In a given example, if the angle between the upper surface 3106.4 and the connecting surface 3106.5 is less than 90°, it may be easier to press the nose structure and the mouth structure towards each other.

[0151] In a further example of this technology, the angle between the lower surface 3106.6 and the connecting surface 3106.5 may be approximately 80° to approximately 140°. In yet another further example of this technology, the angle between the lower surface 3106.6 and the connecting surface 3106.5 may be approximately 90°. In a given example, if the angle between the lower surface 3106.6 and the connecting surface 3106.5 is greater than 90°, it may be even easier to separate the nose structure and the mouth structure from each other. In a given example, if the angle between the lower surface 3106.6 and the connecting surface 3106.5 is less than 90°, it may be even easier to press the nose structure and the mouth structure towards each other.

[0152] Another advantageous feature of this typical patient interface 3000 can also be seen in Figure 3m. This feature is that the nasal cushion 3112 and the mouth cushion 3110 can each independently form a seal with respect to the patient's respective anatomical features. As already discussed, the nasal cushion 3112 is designed to seal with respect to the patient's nose, and the mouth cushion 3110 is designed to seal with respect to the patient's mouth. The separating structure 3106 shown in Figure 3c may, for example, allow the nasal cushion 3112 and the mouth cushion 3110 to move independently and seal independently of each other. The nasal cushion 3112 may be pressed against the nose of the patient 1000 when the patient interface 3000 is worn by attaching a pair of upper straps 3310 to the nasal cushion 3112 via a top plate 3206. Alternatively, a pair of lower straps 3312 may press the mouth cushion 3110 around the patient's mouth by connecting them to their faceplates 3204.

[0153] It should be understood that each pair of the upper strap 3310 and lower strap 3312 corresponds to a separate vector pair, and that tensile force is directed along the vector pair to hold each part of the patient interface 3000 in contact with the patient's face. In other words, the upper strap 3310 holds the nose cushion 3112 in contact with the nose, and the lower strap 3312 holds the mouth cushion 3110 in contact with the mouth. The separation structure 3106 allows for pneumatic connection between the two cushions 3110 and 3112, although these cushions may move independently of each other. Thus, the patient interface 3000 can accommodate a variety of different patient head and facial shapes. It should also be understood that the patient interface 3000 can maintain these seals despite patient movement by independently forming separate seals.

[0154] Figure 7h shows a side view of a typical seal-forming structure 3100 and plenum chamber 3200. This figure shows a nasal cushion 3112 attached to the nasal plenum chamber 3202 and a protruding end 3114 supported by a nasal undercushion support wall 3208 located near the side 3106.3 of the separator structure 3106. The oral plenum chamber 3200 is shown with the oral cushion 3110 positioned around its outer circumference 3210. This figure also shows that the separator structure 3106 connects the oral cushion 3110 to the nasal cushion 3112. This figure particularly illustrates the hinge-like configuration that the nasal plenum chamber 3202 and nasal cushion 3112 can adopt relative to the oral plenum chamber 3200 and oral cushion 3110 through the connection via the separator structure 3106 and the connection region 3106.2 (not shown in this figure). It should be understood that this hinged configuration may allow the nasal plenum chamber 3202 and nasal cushion 3112 to tilt in response to the force applied by the patient's face when the complete patient interface 3000 is placed on the patient. Thus, the oral plenum chamber 3200 and nasal plenum chamber 3202 can move closer to each other within the gap 3106.1.

[0155] As shown in this figure, by providing a gap 3106.1 between the front portions of the oral plenum chamber 3200 and the nasal plenum chamber 3202, it is conceivable that the components of the oral plenum chamber 3200 and the nasal plenum chamber 3202 can move independently of each other with some degree of freedom before contacting each other. It should also be understood that by providing the separator structure 3106 with a radially variable thickness or varying stiffness, it may be facilitated that the nasal cushion 3112 and the oral cushion 3110 can move independently of each other while maintaining an effective seal. Therefore, the separator structure 3106 may be thinnest or least stiff in the portion that contacts the patient's upper lip, and its thickness / stiffness may increase radially toward the front of the separator structure 3106. This configuration allows for maintaining an effective seal against the upper lip while also providing sufficient support and structure to the cushions 3110 and 3112. The separation structure 3106 may be thicker at its apex near the open end of the gap 3106.1 than at the closed end of the gap 3106.1. This variation can prevent distortion and improve hinge operation. This is because the thicker portion of the separation structure 3106 at the closed end of the gap 3106.1 can function as a pivot point.

[0156] Figure 14 shows another example of the technology in a partially exploded side view. This example may include mouth and nose cushions 3110, 3112 and mouth and nose plenum chambers 3200, 3202 connected by a separation structure 3106 in a manner similar to other examples disclosed herein. It can be seen that the upper or top plate 3206 and the lower or face plate 3204 have been removed from the nose plenum chamber 3202 and the mouth plenum chamber 3200, respectively. It can also be seen that the mounting function 3252 is connected to the connecting function 3304 of the rigidizer arm 3302, which has been partially cut off for clarity. The figure also shows a central or connecting portion 3205 which may connect the top plate 3206 and the face plate 3204 to form an integrated plate member. The connector 3205 may be formed and dimensioned to substantially conform to the shape of the separator structure 3106 so that the connector 3205 may be substantially coplanar with the separator structure 3106 when the integrated components of the top plate 3206, face plate 3204, and connector 3205 are attached to the nasal plenum chamber 3202 and oral plenum chamber 3200. To allow the oral and nasal plenum chambers 3200 and 3202 to move relative to each other as described elsewhere in this specification, it may be advantageous to form the connector 3205 from silicone or any suitable flexible, pliable, airtight, and biocompatible material.

[0157] In other examples of this technology, the portion of the separation structure 3106 near gap 3106.1 may be excluded so that only the undercushion support wall 3208 and / or connection area 3106.2 connect the mouth and nose plenum chambers 3200, 3202 to the mouth and nose cushions 3110, 3112. In such examples, the connection portion 3205 may perform a sealing function to provide a pneumatically sealed connection between the mouth gas chamber 3102 and the nose gas chamber 3104. In other words, the connection portion 3205 may effectively replace the excluded portion of the separation structure 3106 when the integrated members of the top plate 3206, connection portion 3205, and faceplate 3204 are attached to the mouth and nose plenum chambers 3200, 3202. In this example as well, it may be desirable to form the connection portion 3205 from silicone or any other similar material.

[0158] 5.3.3 Top plate and face plate connection function unit, rigidizer arm, and positioning stabilization structure A rigid top plate 3206 may be attached to the nasal plenum chamber 3202 on the anterior side of the nasal cushion 3112, which faces the patient's face during use. The top plate 3206 may be formed from a rigid material such as EMS-Grivory Grilamid® TR 90. The top plate 3206 may include at least one upper mounting function 3252. In one example, a pair of upper mounting functions 3252 may be positioned on either side of the top plate 3206 to releasably and rotatably connect each rigidizer arm 3302 of the positioning stabilization structure 3300. UBE America Inc.'s Ubesta® nylon, Hytrel®, TPE, and polypropylene and other flexible polymers and flexible materials supplied by DuPont® are possible materials for the rigidizer arm 3302. Other materials that are substantially non-stretchable while allowing the rigidizer arm 3302 to bend may be used for the rigidizer arm 3302. The rigidizer arm 3302 may be flexible in a direction parallel to the patient's frontal plane (see Figure 2e), but substantially inflexible in other directions. The connection of the rigidizer arm 3302 may be hinged so that the connecting function 3304 of the rigidizer arm rotates around the mounting function 3252 of the top plate 3206. In one example of this technology, the rigidizer arm 3302 may rotate up to 90° around the hinged upper mounting function 3252. In one example, the rigidizer arm 3302 may rotate more than 180° around the hinged upper mounting function 3252. The rotation may be provided by a ball and socket connection, a living hinge, a free gimble, or by overmolding with silicone, TPE, or TPU. At each opposite end of the rigidizer arm 3302, there may be an opening 3308 for receiving each headgear strap 3306 of the positioning stabilization structure 3300, which will be discussed in more detail below. Between each end of the rigidizer arm 3302, there may be a curved portion formed to substantially conform to the curvature of the patient's face.

[0159] Figures 3s to 3u show further examples of the patient interface 3000 with the rigidizer arm 3302 disassembled to illustrate a typical hinged connection between the respective mounting function 3252 and connection function 3304. As previously noted, it should be understood that the rigidizer arm 3302 may be able to rotate up to 90° or, in other examples, more than 180° in a plane parallel to the patient's frontal plane.

[0160] On the opposite side of the mouth cushion 3110, a faceplate or lower plate 3204 may be attached to the mouth plenum chamber 3200. The means of attachment may include overmolding and pressing in a material ranging from flexible to rigid, or it may include a cushion clip to depend on hoop stress. The faceplate 3204 may include a port 3600 to facilitate connection to an air circuit 4170 (not shown in this figure). The faceplate 3204 may also include at least one lower mounting function 3250 for attaching each headgear strap of the positioning stabilization structure 3300, which will be discussed in more detail below. The lower mounting function 3250 shown in this example may be a female clip receiving structure for receiving a male clip to be attached to the headgear strap 3306. Alternatively, this embodiment may include a male structure for receiving a female clip.

[0161] A typical patient interface 3000 shown in the front view of Figure 3b includes a top plate 3206 connected to a nasal cushion 3112 and having at least one upper mounting function 3252 on each side. Rigidizer arms 3302 are shown connected to each upper mounting function 3252 via a connecting function 3304. In this figure, too, the faceplate 3204 is seen connected to the front of the oral plenum chamber 3200. A port 3600 shown on the faceplate 3204 is circular for pneumatic connection to an air circuit 4170 (for example, via a tube separation structure 3500, which will be discussed further below). Lower mounting function 3250 can also be seen on both sides of the faceplate 3204. The separation structure 3106 is shown in this figure, and the side portion 3106.3 of the separation structure can also be seen.

[0162] Figure 3c shows a rear view of a typical patient interface 3000. In this figure, a pair of rigidizer arms 3302 extend from their respective upper mounting functions 3252 at their respective connection functions 3304 and connect to the upper mounting functions. At each opposite end of the rigidizer arms 3302, an opening 3308 can be seen for connection to the headgear strap 3306 of the positioning stabilization structure 3300. In this figure, the location of the separation structure 3106 is shown along with the connection area 3106.2 between the mouth cushion 3110 and the nose cushion 3112.

[0163] Figure 3d shows a plan view of a patient interface 3000 according to an example of this technology. From this plan view, the portion of the nasal cushion 3112 that contacts the patient's nose and the opening 3103 into the nasal gas chamber 3104 can be seen. This plan view also shows the connection function 3304 of the rigidizer arm 3302, which is connected to the upper mounting function 3252 on both sides of the top plate 3206, and is not visible in this particular figure. It can also be seen that the oral plenum chamber 3200 is connected to the faceplate 3204 along the outer circumference 3210 of the plenum chamber. The lower mounting function 3250 is shown on both sides of the faceplate 3204. A port 3600 can also be seen on the faceplate 3204.

[0164] Figure 3e shows a bottom view of a typical patient interface 3000 relating to this technology. This figure shows an oral plenum chamber 3200 connected to a faceplate 3204 along its outer circumference 3210. The faceplate 3204 can be seen with the lower mounting functional section 3250 extending from it. A port 3600 on the faceplate 3204 can also be seen. In this figure, an oral cushion 3110 and a nasal cushion 3112 are shown along with the protruding end 3114 of the nasal cushion 3112. A rigidizer arm 3302 is also shown, although the connection of the rigidizer arm 3302 to the top plate 3206 is not visible in Figure 3e.

[0165] Figure 3f shows a side view of a typical patient interface 3000 relating to this technology. The rigidizer arm 3302 extends from a connecting function 3304 attached to the upper mounting function 3252 of the top plate 3206. Figure 3f also depicts the oral plenum chamber 3200 connected to the faceplate 3204 along its outer circumference 3210. The lower mounting function 3250 and connection port 3600 are visible on the faceplate 3204. The nasal cushion 3112 and oral cushion 3110 are also visible. The figure also depicts the position of the separation structure 3106 and one of its side sections 3106.3. A gap 3106.1 between the nasal plenum chamber 3202 and the oral plenum chamber 3200 is also shown, allowing these components to bend or move toward each other while maintaining their connection. The gap 3106.1 may be understood as the distance between the oral plenum chamber 3200 and the nasal plenum chamber 3202, and therefore the gap 3106.1 may define the distance at which these structures can approach each other. The gap 3106.1 may extend laterally between the oral plenum chamber 3200 and the nasal plenum chamber 3202, and the gap 3106.1 may face forward.

[0166] Figure 3m shows a further front perspective view of a typical patient interface 3000. This figure depicts features similar to those shown in Figure 3g and shows the patient interface 3000 worn by patient 1000. The headgear strap 3306 of the positioning stabilization structure 3300 is shown to releasably secure the patient interface 3000 to patient 1000. The headgear strap 3306 is shown with at least one upper strap 3310 connected to the corresponding rigidizer arm 3302 at its corresponding opening 3308. In the example shown, each of the upper straps 3310 loops through the corresponding opening 3308, which in this example is the opening of the rigidizer arm 3302. The example also shows at least one lower strap 3312 connected to the corresponding lower mounting function 3250 by looping through part of a clip 3314 which is releasably attached to the lower mounting function 3250.

[0167] Figure 3n shows another front view of a typical patient interface 3000 held by patient 1000. In this figure, the patient interface 3000 is held in place against the face of patient 1000 by an upper strap 3310 and a lower strap 3312. The upper strap 3310 is attached to a rigidizer arm 3302, and the lower strap 3312 is attached to a lower mounting function 3250 by a clip 3314. In this example as well, the nose cushion 3112 seals against the nose of patient 1000, and the mouth cushion 3110 seals against the mouth of patient 1000. The figure shows a separator structure 3106, and a side view 3106.3 of the separator structure 3106 can also be seen.

[0168] Figure 3o depicts another side view of the patient interface 3000. In this figure, the patient interface 3000 is held in a state applied to the face of the patient 1000 by the headgear strap 3306. The upper strap 3310 is connected to the rigidizer arm 3302 to press the nose cushion 3112 against the nose, and the lower strap 3312 is connected to the faceplate 3204 to press the mouth cushion 3110 against the mouth of the patient 1000. In this figure, it can be seen that the lower strap 3312 extends below the ear of the patient 1000, and it can also be seen that the upper strap 3310 extends above the ear of the patient and below the eye. As described above, the rigidizer arm 3302 may be formed of a relatively rigid material such as nylon. Therefore, the rigidizer arms 3302 may cause inflammation to the patient's face when they rub against the face of the patient 1000 and / or come into direct contact with the face. Therefore, Figure 3o also depicts a sheath 3316 that can surround the rigidizer arm 3302 to buffer the rigidizer arm against the face of the patient 1000. This figure also depicts the position of the separation structure 3106. Instead of adding a sheath, the rigidizer arm 3302 may incorporate a face pad 3305 or the face pad 3305 may be formed on the rigidizer arm 3302.

[0169] Figure 3p shows another plan view of a typical patient interface 3000. In this figure, the patient interface 3000 can be held in a state applied to the face of the patient 1000 by the headgear strap 3306. It can be seen that the upper strap 3310 is connected to each opening 3308 of the rigidizer arm 3302, and it can also be seen that the lower strap 3312 is connected to the lower attachment functional part 3250 by a clip 3314.

[0170] In one example, the seal forming structure 3100 of the patient interface 3000 of the present technology is held in the seal position by the positioning and stabilizing structure 3300 during use.

[0171] In one embodiment of this technology, the rigidizer arm 3302 described above may be provided as a component of the positioning stabilization structure 3300. Alternatively, the rigidizer arm 3302 may be provided as a component of the patient interface 3000.

[0172] The positioning stabilization structure 3300 may include a headgear strap 3306. The headgear may include at least an upper side strap 3310, a lower side strap 3312, and a rear section. The headgear strap 3306 may also comprise a single composite of flexible and pliable material. One layer of the headgear, for example, an outer layer that does not come into contact with the patient's skin when worn, may be connected to tabs of material that are secured to the respective ends of the upper and lower side straps 3310, 3312. This connection may include a hook-and-loop connection, or the outer layer may comprise loop material. This connection may allow the side straps 3310, 3312 to loop through the attachment function of the patient interface 3000 to releasably and / or adjustably hold the patient interface relative to the patient's head via the headgear strap 3306. Other connections may include ladder locks or sliders that are not hook-and-loop.

[0173] The upper strap 3310 of the positioning and stabilizing structure 3300 may be advantageously positioned by including a rigidizer arm 3302 in the patient interface 3000 and attaching the rigidizer arm to the nasal plenum chamber 3202 by a top plate 3206. As mentioned above, it may be desirable to press the nasal cushion 3112 against the underside of the nose in a substantially upward position in order to effectively seal the patient's nose. The rigidizer arm 3302 may allow the tensile force vector generated by the upper strap 3310 of the positioning and stabilizing structure 3300 to be appropriately directed so that the strap 3310 does not pass across the patient's eye, while also allowing these straps 3310 to be separated from the nasal plenum chamber 3202. In other words, the sufficiently rigid rigidizer arm 3302 allows the upper strap 3310 of the positioning and stabilizing structure 3300 to effectively pull the nose cushion 3112 against the patient's nose, while positioning the strap 3310 away from the patient's face so that the patient can be more comfortable, wear glasses, and see more easily.

[0174] Figures 15a to 15e illustrate the connections of various top plates 3206 and rigidizer arms 3302 to the seal forming structure 3100, following the example of this technology.

[0175] Figure 15a shows the seal-forming structure 3100 in a dotted state. In the depicted example, the rigidizer arm 3302 and the top plate 3206 are integral parts. It can be seen that the mounting function part 3252 and the connection function part 3304 are not shown. Therefore, the connection between the top plate 3206 and the rigidizer arm 3302 may be flexible so that the rigidizer arm 3302 can bend due to tension from the positioning stabilization structure 3300. Also, in this example, the top plate 3206 is permanently connected to the seal-forming structure 3100.

[0176] It should be understood that by permanent connection, the top plate 3206 may be coupled to the nasal plenum chamber 3202 and / or the faceplate 3204 may be coupled to the oral plenum chamber 3200. Permanent connection may be facilitated by molding to form a mechanical connection, or the components may be bonded chemically. Permanent connection may be understood as a connection where the removal of the components is irreversible, such that the components cannot be returned to their connected state. Removal of such a permanent connection may involve, for example, tearing, damaging, or destroying one or more of the components so that they cannot be reconnected in an operational manner.

[0177] Alternatively, the top plate 3206 may be coupled to the nasal plenum chamber 3202 and / or the faceplate 3204 may be coupled to the oral plenum chamber 3200 by a non-permanent connection. The non-permanent connection may include a connection that allows the components to be detached from each other and reattached in a reversible manner. In other words, the separation of the connection does not require, for example, tearing, damaging, or destroying one or more of the components so that they cannot be reattached in an operational manner. With a non-permanent connection, the device is returned to an operational state when the detached components are reattached.

[0178] Figure 15b shows an example similar to Figure 15a. In this example, the top plate 3206 may be connected to the seal-forming structure 3100 by a rigid-to-flexible connection in the flexible connection region 3130. In other words, the top plate 3206 and the rigidizer arm 3302 are removable.

[0179] Figure 15c shows another variation of the example shown in Figure 15a. In Figure 15c, this example includes a mounting function 3252 on the top plate 3206 and a connecting function 3304 on the rigidizer arm 3302. Thus, the top plate 3206 is permanently fixed to the seal forming structure 3100, while the rigidizer arm 3302 may be rotatable and detachable from the top plate 3206.

[0180] Figure 15d shows an example similar to Figure 15b. In this example, there is a rigid-to-rigid connection of the top plate 3206 to the rigid connection region 3132.

[0181] Figure 15e shows an example including a rigid-to-rigid connection of the top plate 3206 to a rigid connection area 3132. This example also includes a mounting function 3252 on the top plate 3206 and a connecting function 3304 on the rigidizer arm 3302. Thus, the top plate 3206 is removable from the seal forming structure 3100, while the rigidizer arm 3302 may be rotatable, removable from or separated from the top plate 3206.

[0182] Other examples of this technology may include a magnetic lower mounting function 3250 provided on a living hinge, such as the example described in International Patent Application Publication PCT / AU2014 / 000021. The living hinge allows the lower mounting function 3250 to move within one plane (e.g., a plane parallel to the patient's cross-section), and the direction of this movement may be around one axis. Such a configuration may result in a greater degree of control over the attachment of the positioning stabilization structure 3300 to the lower mounting function 3250, and may also provide greater stability with respect to the sealing of the mouth cushion 3110 against the patient's face.

[0183] Figures 17a to 17f and 19a to 19h show components of a rigidizer arm assembly 3301 according to other examples of the present technology. The rigidizer arm assembly 3301 may be removable from the top plate 3206. The connecting function portion 3304 of the rigidizer arm assembly 3301 in these examples may have holes formed to fit the corresponding upper mounting function portion of the upper mounting function portion 3252.

[0184] The rigidizer arm assembly 3301 may comprise two components. The rigidizer arm 3302 and the top plate cover 3303 may be formed integrally, with a connecting function 3304 and an opening 3308 also molded therein. Nylon or Hytrel® may be used to form the rigidizer arm 3302 and the top plate cover 3303. A pad 3305 may also be overmolded onto each rigidizer arm 3302. The pad 3305 may be formed from a thermoplastic elastomer. The pad 3305 may provide cushioning for the patient's face (e.g., cheek) against the rigidizer arm 3302 and may prevent marking of the patient's skin when the patient interface 3000 is worn for several hours (e.g., during treatment).

[0185] For example, as can be seen in Figure 19d, the rigidizer arm 3302 may be formed with an elliptical curvature. Furthermore, the rigidizer arm 3302 may be structured to be flexible only in directions parallel to the patient's frontal plane (see Figure 2e), for example, only medially and laterally relative to the patient's face. In other words, the rigidizer arm 3302 may be flexible within a single plane substantially parallel to the patient's cross-section. This may allow the rigidizer arm 3302 to accommodate various patient facial widths. Additionally, the rigidizer arm 3302 may resist stretching along their respective longitudinal axes. Furthermore, the rigidizer arm 3302 may resist twisting around their respective longitudinal axes. In addition, the rigidizer arm 3302 may resist upward or downward bending relative to the patient's face, for example, upward or downward. The rigidizer arm 3302's resistance to deformation in these directions may be beneficial for the stability of the patient interface 3000 when the patient interface is worn by the patient.

[0186] In an example of this technology, it may be advantageous to fix the rigidizer arm assembly 3301 to the top plate 3206 so as to minimize the relative motion between the top plate 3206 and the rigidizer arm assembly 3301 when they engage with each other. To ensure that the relative motion between the top plate 3206 and the rigidizer arm assembly 3301 is properly controlled, these components may be structured to engage with each other at at least three points. The connecting function 3304 may have two contact points, and other structures located on the rigidizer arm assembly 3301 between the connecting function 3304 may have a third contact point.

[0187] Figures 19d and 19e also show that the rigidizer arm assembly 3301 may include a rib 3307. When the rigidizer arm assembly 3301 is attached to the top plate 3206, the rib 3307 may help reduce the relative motion between the top plate 3206 and the nose cushion 3112 when engaged with the rigidizer arm assembly 3301. The rib 3307 may have a triangular cross-sectional shape to guide the rigidizer arm assembly 3301 into the engaged state with the top plate 3206. The rib 3307 may also help reduce the bending and / or twisting between the rigidizer arm assembly 3301 and the top plate 3206 when they engage. Thus, the rib 3307 and the connecting function 3304 may provide three contact points on the rigidizer arm assembly that engage with the top plate 3206.

[0188] In a further example of this technology, in addition to the connecting function, structures other than the rib 3307 may be provided for a third contact point. For example, the top plate 3206 and the rigidizer arm assembly 3301 may engage at the third contact point into which the rod is inserted.

[0189] Figures 19f to 19h show another example of the rigidizer arm assembly 3301. In this example, a claw 3309 may be provided on the rear side of the rigidizer arm assembly 3301 near where the top plate cover 3303 meets each rigidizer arm 3302. The claw 3309 may engage with the corresponding side support 3207 to secure the rigidizer arm assembly 3301 to the nose cushion 3112.

[0190] Figures 29a to 29f illustrate other examples of the present technology. These figures show features similar to those shown in Figures 17a to 17f. However, the isolation structure 3500 is not depicted in Figures 29a to 29f. It should be understood, however, that the isolation structure 3500, as described elsewhere in this specification, may be attached to the connection port 3600.

[0191] 5.3.3.1 Top plate and faceplate With respect to the faceplate 3204 and topplate 3206 described above, it may be advantageous to select a material that is relatively rigid to, for example, the nose cushion 3112, which may be formed from a flexible material such as silicone. The selection of a relatively rigid material may provide an effective fixing point for the positioning stabilization structure 3300 (e.g., the rigidizer arm 3302) so that the positioning stabilization structure 3300 can be attached to the seal forming structure 3100 in a predetermined position. If the positioning stabilization structure 3300 is directly connected to the seal forming structure 3100, which may be formed from a relatively flexible material such as silicone, this configuration may cause undesirable deformation of the mouth and nose cushions 3110, 3112 when worn by the patient, as tension is applied by the positioning stabilization structure 3300. Tension may be applied particularly in the anterior / posterior direction. Examples of positioning stabilization structures 3300 may be formed from Breathe-O-Prene®, Soft Edge®, and / or elastic fabric.

[0192] Furthermore, by forming the faceplate 3204 and topplate 3206 from a relatively rigid material, these components can be formed to have approximately the same curvature as the patient's face, thereby ensuring an even better seal by properly supporting the seal-forming structure 3100. This may also ensure an effective seal to the patient's airway when the positioning and stabilizing structure 3300 generates a tensile force vector V substantially parallel to the Frankfort horizontal plane shown in Figure 3o.

[0193] Forming the faceplate 3204 and topplate 3206 from a relatively rigid material can be beneficial in that such a rigid material can prevent deformation of the outer portion of the seal-forming structure 3100 up to the point where the outer circumference bends inward toward the face. This configuration may also help ensure that the sealing pressure is applied uniformly across the patient's face by the seal-forming structure 3100. The headgear strap 3306 of the positioning and stabilizing structure 3300 may generate a tension vector for sealing the seal-forming structure 3100 against the patient's face, but the faceplate 3204 and topplate 3206 may help spread these sealing forces across the mouth cushion 3110 and nose cushion 3112. By spreading these sealing forces over a wider area, pressure and / or deformation are not locally concentrated in specific areas of the mouth cushion 3110 and nose cushion 3112, for example, near where the headgear strap 3306 is attached.

[0194] Furthermore, by forming the top plate 3206 from a relatively rigid material, this may prevent undesirable vertical bending of the rigidizer arm 3302 when the patient interface 3000 is worn, while still allowing rotation of the rigidizer arm 3302 in a plane parallel to the patient's frontal plane. It should be understood that slight vertical bending may be permitted.

[0195] Furthermore, forming the faceplate 3204 from a relatively rigid material may make it easier for the patient to attach the lower strap 3312 of the positioning and stabilizing structure 3300. This is because the lower attachment function 3250 can be held in a relatively fixed position when the patient interface 3000 is worn by the patient.

[0196] Furthermore, if the positioning stabilization structure 3300 is not directly connected to the seal forming structure 3100, disassembly and assembly of the patient interface 3000 and the positioning stabilization structure 3300 (for example, for cleaning purposes) may be even easier for the patient.

[0197] By providing separate attachment points on the upper strap 3310 and lower strap 3312 that pass through the top plate 3206 and faceplate 3204, the seal of the nasal cushion 3112 against the nose can be better controlled. For example, by separating the nasal cushion 3112, the upper strap 3310 may be able to apply a target pressure upward against the underside of the nose and / or inward against the face. The height of the nasal cushion 3112 relative to the nose and the lateral position of the nasal cushion (e.g., left vs. right) may also be controlled. Furthermore, the rotation of the nasal cushion 3112 relative to the nose and the rotation of the nasal cushion 3112 around an axis parallel to the longitudinal axis of the top plate 3206 may also be controlled. These features can provide advantages that may not be possible when all the straps of the positioning stabilization structure 3300 are connected to one common front plate. Thus, the examples disclosed herein can result in a more effective and stable seal around the patient's nose. It should also be understood that by connecting the nasal plenum chamber 3202 to the oral plenum chamber 3200 via the separation structure 3106, the relative height of the oral cushion 3110 may be controlled by the upper strap 3310 of the positioning and stabilizing structure 3300.

[0198] In examples of this technology, various headgear configurations may be used with the typical patient interface 3000 described herein. One example of this technology may utilize a headgear similar to the headgear disclosed in U.S. Patent Application Publication No. 2012 / 0138061. Further variations may include an upper strap 3310 that is shorter than the upper strap disclosed in the aforementioned publication, thanks to their connection to the rigidizer arm 3302.

[0199] In further examples of this technology, the positioning stabilization structure 3300 may include features disclosed in International Patent Application Publication PCT / AU2013 / 000830 or U.S. Patent Application Publication 2014 / 0026890. The positioning stabilization structure 3300 disclosed in this document may be used as an upper strap 3310. The lower strap 3312 may be a neoprene CommonLine headgear strap.

[0200] In a further example of this technology, one size of the top plate 3206 and faceplate 3204 may be used for various sizes of the seal-forming structure 3100 and plenum chamber 3200. This can be advantageous in reducing the number of parts that need to be formed to manufacture the patient interface 3000 to accommodate various patient head / face sizes. Thus, in this example of this technology, only the seal-forming structure 3100 and plenum chamber 3200 need to be molded in different sizes.

[0201] Figures 18a-18f, 21a-21e, 22a-22e, and 28a-28e show examples of a top plate 3206 and a faceplate 3204 relating to further examples of the present technology. Figures 18a-18f show a top plate 3206 and a faceplate 3204 attached to a nasal plenum chamber 3202 and an oral plenum chamber 3200, respectively. According to one example of the present technology, the top plate 3206 and the faceplate 3204 may be formed from a material that is relatively harder than silicone. The top plate 3206 and the faceplate 3204 may be bonded to the nasal plenum chamber 3202 and the oral plenum chamber 3200, respectively, by overmolding the nasal plenum chamber 3202 and the oral plenum chamber 3200 over the top plate 3206 and the faceplate 3204. The nasal plenum chamber 3202, nasal cushion 3112, oral plenum chamber 3200, oral cushion 3110, and separation structure 3106 may be molded as a single component from silicone.

[0202] Figures 18a, 18b, 18c, and 18f also show the top plate buffer 3214 and the face plate buffer 3215. The top plate buffer 3214 may be formed integrally with the nasal plenum chamber 3202 or it may be formed from silicone. When the nasal plenum chamber 3202 is overmolded onto the top plate 3206, as can be seen in Figures 21a to 21e, silicone may pass through the hole 3217 into or through the core out 3216 of the top plate 3206 to form the top plate buffer 3214. The hole 3217 and the core out 3216 together may provide a smooth flow path for the silicone as it is overmolded onto the top plate 3206. Alternatively, the core out 3216 does not have to be open to provide a passage for silicone flow during overmolding; instead, the core out 3216 may have a recessed pocket into which silicone can be filled to form a mechanical connection and provide a buffering effect. The top plate buffer 3214 may be pressed against the rear side of the top plate cover 3303 when the rigidizer arm assembly 3301 is coupled to the top plate 3206. The top plate buffer 3214, formed from a material that is relatively more flexible than the top plate 3206 and the top plate cover 3303, such as silicon, may dampen vibrations at the rigid-to-rigid connection to reduce or eliminate rattle noises from these components.

[0203] A top plate buffer 3214, which is integrally formed with the nasal plenum chamber 3202 and connected through a hole 3217 in the top plate 3206, may provide a retaining function for holding the top plate 3206 in a predetermined position relative to the nasal plenum chamber 3206.

[0204] Rib 3307 may cooperate with top plate buffer 3214 to dampen and / or retain the engagement between top plate 3206 and rigidizer arm assembly 3301. The engagement between rib 3307 and top plate buffer 3215 and top plate 3206 may also result in damping and / or retention, and the relative dimensions of these components may be selected to ensure a desired level of damping and / or retention.

[0205] The faceplate buffer 3215 may extend forward from the outer circumference of the plenum chamber 3200. The faceplate buffer 3215 may be formed integrally with the plenum chamber 3200. The faceplate buffer 3215 may be formed from silicon. The faceplate buffer 3215 may dampen the rigid-to-rigid connection between the faceplate 3204 and the frame 3251 to reduce or eliminate rattle noise that may be caused by the connection.

[0206] Figures 21a to 21e show the top plate 3206 in an isolated state, and Figures 22a to 22e show the faceplate 3204 in an isolated state.

[0207] The upper mounting section 3252 of the top plate 3206 may be connected to the rigidizer arm assembly 3301 by a connecting section 3304, as shown in Figures 17a to 17f. In these examples, the upper mounting section 3252 may have rigid pockets and / or undercuts that engage with the respective connecting sections 3304 for mounting the rigidizer arm assembly 3301.

[0208] The faceplate 3204 may include notches 3213 on both sides for connecting the frame 3251 to the faceplate. Each notch 3213 may extend laterally from the faceplate 3204. The notches 3213 may facilitate a rigid-to-rigid connection between the faceplate 3204 and the frame 3251 (for example, between two relatively rigid components). The rigid-to-rigid connection may take the form of a snap fit and may produce an audible click when the frame 3251 is attached to the faceplate 3204. It can also be seen that a connection port 3600 is formed in the faceplate 3204. In Figures 17a to 17f, it can be seen that the frame 3251 is attached around the faceplate 3204.

[0209] Figures 28a to 28e show other examples of the top plate 3206 similar to those shown in Figures 21a to 21e. However, the examples shown in Figures 28a to 28e show that recesses 3219 may be provided in each core out 3216 on the rear side of the top plate. The recesses 3219 may provide greater depth for silicon flow during the molding of the seal forming structure 3100 and plenum chamber 3200 to the top plate 3206. The recesses 3219 may be hemispherical and therefore may provide a larger surface area for silicon adhesion to the top plate 3206, and the silicon may be tacky liquid silicone rubber (LSR) according to an example of this art.

[0210] Figures 27a to 27f show other examples of the present technology. In these figures, the seal-forming structure 3100 is shown with a faceplate 3204 and a topplate 3206. The examples shown in these figures are similar to the examples shown in Figures 18a to 18f in that the seal-forming structure 3100 may be formed from silicon and may be overmolded to bond these components to the topplate 3206 and faceplate 3204. Figures 27a to 27f show another example in which the topplate 3206 may be almost completely embedded in the seal-forming structure 3100. In other words, the seal-forming structure 3100 may completely surround the topplate 3206 so that a minimum amount of the topplate 3206 is exposed when overmolded to the topplate 3206. Alternatively, an extension 3218 may be formed to extend from the topplate 3206, and this extension may be formed integrally with the seal-forming structure 3100. The extension portion 3218 may perform a cushioning and / or vibration damping function similar to that of the top plate buffer 3214 when the rigidizer arm assembly 3301 is coupled to the top plate 3206. Furthermore, the extension portion 3218 may have a hook shape, and therefore, the extension portion may perform a holding function.

[0211] In yet another example, the extension 3218 may be formed integrally with the top plate 3206. In this example, the hook shape of the extension 3218 may serve a holding function, but may not serve a cushioning and / or vibration damping function due to being formed from the same relatively hard material as the top plate 3206. Thus, the overmolded silicon of the seal-forming structure 3100 substantially surrounding the top plate 3206 may serve a cushioning and / or vibration damping function.

[0212] Figures 20a to 20s, 23a to 23f, 24a to 24f, and 25a to 25f show several diagrams of the frame 3251 with the clip 3314 and the lower mounting function part 3250, in addition to diagrams of their respective dependent parts.

[0213] The frame 3251 may include catches 3253 on both sides to engage with corresponding notches among the notches 3213 to facilitate attachment to the faceplate 3204. The engagement of the catches 3253 with the notches 3213 may create hoop stress in the frame 3251 that holds the frame to the faceplate 3204. Lower mounting functions 3250 may be formed on the frame 3251. For example, as shown in Figure 20f, each lower mounting function 3250 may include a mating surface 3254 to which each clip 3314 is coupled. Figure 20g shows that each mating surface 3254 may be on a mating surface 3255 of a lower mounting function 3252. Each lower mounting function 3250 may include a wing portion 3257 to connect the frame 3251 to each mating surface 3255.

[0214] The wing portion 3257 may be joined to the frame 3251 by overmolding the wing portion 3257 onto the frame extension portion 3259 of the frame so that a mechanical connection is formed. In this case, the frame extension portion 3259 may extend into the respective recesses 3258 of the wing portion 3257. The fitting portion 3255 may be joined to the wing portion 3257 by simultaneous overmolding so that a mechanical connection is also formed between the wing portion 3257 and the fitting portion 3255. Therefore, the fitting portion extension portion 3256 may extend into the recesses 3258 of the wing portion 3257.

[0215] The wing portion 3257 may be formed from a thermoplastic elastomer. The wing portion 3257 may be flexible so that the lower attachment portion 3250 functions as a living hinge. In other words, the lower attachment portion 3250 may be able to move forward / backward due to their flexibility so that when worn, the tension of the strap 3306 causes the lower attachment portion to bend and hold the patient interface 3000 to the patient. The fitting portion 3255 may also be formed from a thermoplastic elastomer.

[0216] The clip 3314 may include a bar 3315, and the strap 3312 is looped around the bar 3315 in order to attach the clip 3314 to the lower strap 3312.

[0217] A magnetic connection may be provided to connect the clip 3314 to the lower mounting function 3250. Each clip 3314 may be provided with a clip magnet 3260 in a clip pocket 3317, and each fitting portion 3255 of the lower mounting function 3250 may be provided with a fitting portion magnet 3261 in a fitting portion pocket 3262. The magnetic poles of each clip magnet 3260 and each fitting portion magnet 3261 may be aligned such that a magnetic attractive force is generated between these magnets to attract and hold the clip 3314 to the lower mounting function 3250. Further examples of these mounting configurations are disclosed in International Patent Application Publication PCT / AU2014 / 000021, which is incorporated in whole by reference herein.

[0218] Furthermore, the mating portions 3255 in these examples may include a guide surface 3263 and a projection 3264 to position the clip 3314 as it is attached. Each clip 3314 may also include a receiving surface 3319 for engaging with the respective guide surface 3263 and a notch 3318 for engaging with the respective projection 3264. When the clip 3314 is attached to the respective mating portions 3255 of the lower mounting function 3250, the engagement of the notch 3318 and the projection 3264 may prevent the clip 3314 from rotating relative to the mating portion 3255 of the lower mounting function 3250. This may help to ensure that the tension vector of the lower strap 3312 is properly aligned and holds the patient interface 3000 in place when it is worn by the patient.

[0219] The guide surface 3263 may have a curved shape. The guide surface 3263 may be molded to form a protrusion. The receiving surface 3319 may be molded to correspond to the shape of the guide surface 3263. The shape of the guide surface 3263 may have a guiding function and / or a holding function. Due to the curved shape and inclination of the guide surface 3263, the receiving surface 3319 may slide along the guide surface 3263 to a predetermined position so that the projection 3264 engages with the notch 3318. This may be advantageous because when the patient interface 3000 is worn, it may be difficult for the patient to align the clip 3314 with the lower mounting function 3250. Also, the patient may be in a dark environment, may have limited tactile ability, and / or may have limited visual acuity to align the clip 3314 with the lower mounting function 3250. Therefore, structuring the guide surface 3263 so that it guides the receiving surface 3315, and consequently the clip 3314 to a predetermined position, may help ensure proper and secure mating of the patient interface 3000.

[0220] Figure 20n shows a rear view of the frame 3251 and the lower mounting function section 3250. In this example, each of the lower mounting function sections 3250 may have a bending point, which is depicted in this figure as a thickness reduction portion 3266. When the lower mounting function section 3250 is subjected to tension from the lower side straps 3312 of the positioning stabilization structure 3300, it may deform and bend backward at the bending point. The lower mounting function section may be made of a thermoplastic elastomer.

[0221] Figures 20q to 20s provide further examples of the art by showing plan views of the frame 3251 and the lower mounting function 3250. Figure 20q shows a notch 3265 at a bending point on the front side of each lower mounting function 3250. The notch 3265 in Figure 20q may allow the lower mounting function 3250 to bend forward through the notch 3265. Figure 20r shows a notch 3265 at a bending point on the rear side of each lower mounting function 3250. The notch 3265 in Figure 20r may allow the lower mounting function 3250 to bend rearward through the notch 3265. It should be understood from further examples of the art that notches 3265 may be provided on the rear and front sides of each lower mounting function 3250.

[0222] Figure 20s shows another plan view of the frame 3251 and the lower mounting function 3250 according to an example of the present technology. In this example, the bending point may include a thickness reduction portion 3266 that reduces the thickness of the lower mounting function 3250 from the rear and front sides so that the lower mounting function can bend in both directions.

[0223] Figures 20o and 20p show exploded views depicting similar features to those in Figures 20g and 20h. However, Figures 20o and 20p also show the mating magnet receiving portions 3267. Each mating magnet receiving portion 3267 may be structured to receive the corresponding mating magnet 3261. Figures 23g to 23m also depict the mating magnet receiving portions 3267.

[0224] Figures 20p and 25g to 25l also show that the clip 3314 may include a clip magnet receiving portion 3321 and a clip magnet cover 3320 for fixing the clip magnet 3260 inside the clip 3314. The clip magnet cover 3320 may be used to fix the clip magnet 3260 inside the clip magnet receiving portion 3321 by snap fitting.

[0225] 5.3.4 Vents, tube separation structures, connection ports, and suffocation prevention valves In one configuration, the patient interface 3000 includes a vent 3400 configured and positioned to allow the outflow of exhaled carbon dioxide.

[0226] One form of the vent 3400 relating to this technology comprises multiple holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes. More than 80 holes are also conceivable.

[0227] In one example, the vent 3400 is located in the plenum chamber 3200. Alternatively, the vent 3400 is located in the tube separation structure 3500, for example, the swivel 3510.

[0228] In other examples of this technology, the vent 3400 is located on the top plate 3206 and / or the face plate 3204. In such examples, the tube separation structure 3500 may not include the vent.

[0229] The vent 3400 may be laser-cut or formed from a mesh material or a linear arrangement. Alternatively, the vent 3400 may be formed from entangled plastic fiber material or fabric. The entangled plastic fiber material is a thermoplastic polymer containing polycarbonate, nylon, polyethylene, and preferably polypropylene. Specifically, the fabric may be SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene material. Generally, they are provided in the form of rolls or ribbons. The weave of the fabric is preferably satin. However, other weaves are possible, including plain weave, reverse plain weave, and twill weave. The gaps or holes defined through the fabric by the weave of the fibers do not necessarily have uniform dimensions. This is because there are some variations in the positioning, spacing, and compression of the fibers in the weave of the fabric. Preferably, the gaps define winding air passages between adjacent fibers across the thickness of the fabric, rather than being straight through the holes. The winding air passages diffuse the airflow considerably, thereby reducing noise. If the gaps were straight through the holes, the fibers of the fabric may be arranged in the form of a mesh grid.

[0230] In one example, the airflow velocity at the vent of the fabric is first measured by an airflow meter. A decision is made regarding whether there is a difference between the measured airflow velocity and the desired airflow velocity. If the airflow velocity through the vent exceeds a predetermined range, the porosity of the vent is selectively reduced. The desired predetermined range is about 42 to about 59 liters / min at a 20 cmH2O pressure, preferably about 47 to about 53 liters / min at a 20 cmH2O pressure. For example, the airflow velocity through the SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene material may be about 37 to about 64 liters at a 20 cmH2O pressure, preferably about 42 to about 58 liters at a 20 cmH2O pressure. The variation over the length of the SEFAR fabric may be sinusoidal over the length of the fabric ribbon. Different areas of the SEFAR fabric when first received from the fabric manufacturer will exhibit different airflow velocities. After the porosity has decreased, the airflow velocity is measured again to verify that it is now within a predetermined range. The average diameter of the void openings is preferably less than 0.1 mm, and preferably gives a total opening area of ​​about 1% to 10% of the vent surface area. For example, the total opening area may be 22 mm² if the vent surface area is 240 mm².

[0231] If a desirable airflow velocity exists in the fabric, the holes in the outer peripheral region of the desired vent are optionally closed. The outer peripheral region of the vent is overmolded onto the top plate 3206 and / or faceplate 3204. Since the holes that existed in the outer peripheral region are closed, the airflow velocity of the vent should not change after overmolding.

[0232] In some cases, the airflow velocity may be measured after the vent section has been cut from the fabric, or after the vent has been overmolded onto the top plate 3206 and / or faceplate 3204. This allows the airflow velocity to be known after each step and to determine if it is within a desired range. This prevents waste, such as discarding a part as soon as it is found not to be within a desired range.

[0233] The porosity of the vent area can be reduced by several methods, including thermal scribing, plastic deformation by compression, ultrasonic welding, application of a sealant (e.g., hot melt adhesive), and application of a thin film. Preferably, thermal scribing with a scribing punch is used to reduce porosity due to its high precision, high certainty of hole closure in the fabric, manufacturing speed, good visual appeal after thermal scribing, and the fact that no additional materials are required. When heating thermoplastic materials, some material shrinkage occurs, resulting from excess material surrounding specific physical dimensions for the shape of the vent. The porosity of the vent area can be reduced by partially or completely sealing the holes in the vent area.

[0234] Any part or region of the vent may be selected to reduce porosity. Preferably, the porosity of the continuous outer edge region of the vent is reduced. This region provides good visual appeal because it is adjacent to or located where the vent is overmolded to the top plate 3206 and / or face plate 3204. Any visual difference between the continuous outer edge region of the vent and the rest of the region may not attract much attention in this location, because it may appear as a defined edge of the top plate 3206 and / or face plate 3204 for receiving the vent 3400. Alternatively, the area for porosity reduction may take the form of a character / letter or logo in the central region of the vent to enhance visual impact and improve brand recognition.

[0235] The noise caused by exhaled carbon dioxide passing through the vent 3400 is minimized due to air diffusion, which increases as the carbon dioxide passes through the fabric in the nasal pillow when the patient exhales through their nose and the carbon dioxide escapes through the vent. The diffusion of exhaled carbon dioxide avoids direct or concentrated airflow to the bed partner or patient, depending on the vent direction and sleeping position.

[0236] The patient interface vents are easy to clean. A mild cleaning solution or soapy water can be used to clean the vents. Hot water can also be used to run through the vents for cleaning. The vents can be hand-washed and rinsed without disassembling them from the top plate 3206 and / or faceplate 3204. This is because the vents can be permanently connected to the top plate 3206 and / or faceplate 3204, for example, by overmolding. Fewer removable parts for the patient interface avoid the possibility of losing individual parts and reduces cleaning time by eliminating the need to remove and reassemble each part from the others. Because the vents are formed from plastic fibers, the durability of the vents is maintained even after repeated washing, unlike vents formed from other less durable materials, such as woven fabrics.

[0237] The vent is quiet. The acoustic energy generated by the expelled carbon dioxide is spread uniformly. Vibrations caused by the expelled carbon dioxide in contact with the top plate 3206 and / or faceplate 3204 result in vibrations of the top plate 3206 and / or faceplate 3204. Such vibrations may be damped by the vent.

[0238] In one embodiment, the patient interface 3000 includes at least one tube separation structure 3500, such as a swivel or a ball and socket. The tube separation structure 3500 may include an elbow function. The tube separation structure 3500 may be divided between the hose and the mouth.

[0239] The connection port 3600 may allow connection to an air circuit 4170. The air circuit 4170 may include a short tube connected to a long tube. Examples of tubes may include the tube features disclosed in International Patent Application Publication PCT / AU2013 / 000830. A rotatable adapter may be included to connect the short tube and the long tube.

[0240] In one configuration, the patient interface 3000 includes an asphyxiation prevention valve 3800.

[0241] Figure 3g shows another front perspective view of the patient interface 3000 according to the present technology. This figure depicts features similar to those shown in Figure 3a, but also includes features for connecting the patient interface 3000 to the PAP device 4000. These additionally depicted features include at least one vent 3400 arranged radially around the port 3600. In the example depicted, the vent 3400 comprises multiple vent holes around the port 3600. The features of the vent 3400 are described in more detail below. This figure also shows a tube separation structure 3500 for connecting the air circuit 4170 to the port 3600 on the faceplate 3204 of the patient interface 3000. The tube separation structure 3500 may be an elbow, and the tube separation structure may include a swivel 3510 to allow the tube separation structure 3500 and the air circuit 4170 to rotate relative to the patient interface 3000 around the port 3600. The tube separation structure 3500 in this figure also includes an asphyxiation prevention valve 3800, which will be described in more detail below. Figure 3g also shows that the air circuit 4170 may include a cuff 4172 for attaching the air circuit to the separation structure 3500.

[0242] Figure 3h depicts a rear view of a typical patient interface 3000 similar to that in Figure 3c. However, Figure 3h also shows that the patient interface 3000 may include a vent 3400 in the form of multiple vent holes arranged radially around the port 3600. The cuff 4172 and air circuit 4170 can also be seen. In this figure, the location of the separation structure 3106 is shown along with the connection region 3106.2 between the mouth cushion 3110 and the nose cushion 3112.

[0243] Figure 3i shows a front view of a typical patient interface 3000 similar to that in Figure 3b. Figure 3i also shows a tube isolation structure 3500 connected to a port 3600 on the faceplate 3204 of the patient interface 3000. The figure also shows a vent 3400, which consists of multiple vent holes arranged radially around the port 3600. An asphyxiation prevention valve 3800 is visible on the tube isolation structure 3500. The cuff 4172 and air circuit 4170 are also visible connected to the tube isolation structure 3500. The figure also shows an isolation structure 3106, and a side view 3106.3 of the isolation structure 3106 can also be seen.

[0244] Figure 3j shows a plan view of a typical patient interface 3000 with features similar to those shown in Figure 3d. Figure 3d further depicts a vent 3400, which consists of multiple vent holes arranged around a port 3600. Extending from the port 3600 is a tube separation structure 3500, which houses an asphyxiation prevention valve 3800.

[0245] Figure 3k shows a bottom view of a typical patient interface 3000. This figure is similar to Figure 3e and therefore depicts similar features. This figure also depicts a vent 3400 with multiple vent holes arranged radially around the port 3600. A tube isolation structure 3500 is shown extending from the port 3600. A cuff 4172 and an air circuit 4170 can also be seen.

[0246] Figure 3l shows a side view of a typical patient interface 3000 similar to the one shown in Figure 3f. Thus, Figure 3l depicts features similar to those shown in Figure 3f. However, Figure 3l also shows a vent 3400 including multiple vent holes radially arranged around the port 3600. The tube isolation structure 3500 is shown with one end connected to the port 3600 and the other end connected to the air circuit 4170 via a cuff 4172. The figure also depicts the position of the isolation structure 3106 and one of the sides 3106.3 of the isolation structure. The gap 3106.1 between the nasal plenum chamber 3202 and the oral plenum chamber 3200 is also shown, which allows these components to bend or move toward each other.

[0247] In the examples shown in Figures 17a-17f and 26a-26d, the separation structure 3500 may be coupled to the faceplate 3204 and the connection port 3600. In these examples, a vent 3400 may be formed in the tube separation structure 3500. In these examples, the tube separation structure 3500 may have a rotatable elbow at the connection to the connection port 3600. The separation structure 3500 may include a swivel 3510 for connection to the air circuit 4170. The separation structure 3500 may include a baffle 3520 for separating the flow path of pressurized gas from the PAP device 4000 from the flow path of exhaled gas (e.g., CO2) from the patient exiting through the vent 3400. By separating these flow paths, the baffle 3520 can improve the outflow of exhaled gas (e.g., CO2). The tube isolation structure 3500 may include a rapid release mechanism 3530 that allows the patient to easily attach the tube isolation structure 3500 to and detach it from the connection port 3600 on the faceplate 3204. The rapid release mechanism 3530 may also be configured to provide a snap-fit ​​connection between the connection port 3600 and the tube isolation structure 3500, and the engagement may provide an audible click to assure the patient that the connection has been made. The tube isolation structure 3500 may also include an asphyxiation prevention valve 3800.

[0248] 5.4 Glossary In certain forms of this technology, one or more of the following definitions may apply. In other forms of this technology, different definitions may apply.

[0249] 5.4.1 General Provisions Air: Air is interpreted to include breathing gases, such as air with oxygen supplementation.

[0250] Continuous Positive Airway Pressure (CPAP): CPAP treatment is interpreted as applying a predetermined volume of air or breathing gas to the airway inlet at a pressure that is continuously positive to the atmosphere and preferably substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet changes by the amount of a few centimeters of water within a single respiratory cycle, for example, higher during inspiration and lower during expiration. In some forms, the pressure at the airway inlet is slightly higher during expiration and slightly lower during inspiration. In some forms, the pressure changes between different respiratory cycles of the patient, for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing when there are no signs of partial upper airway obstruction.

[0251] 5.4.2 Appearance of PAP device Air circuit: A conduit or tube configured to deliver a predetermined amount of air or respiratory gas between the PAP device and the patient interface during use. In particular, the air circuit may be fluidly connected to the outlet of the pneumatic block and the patient interface. The air circuit may also be referred to as an air delivery tube. In some cases, separate limbs for inspiration and expiration may be present. In other cases, a single limb is used.

[0252] APAP: Automatic Positive Airway Pressure.

[0253] Blower or flow generator: A device that delivers an airflow at a pressure exceeding the ambient pressure.

[0254] Controller: A device or part of a device that adjusts the output based on the input. For example, one form of controller has a controlled variable—a control variable—that constitutes the input to the device. The output of the device is a function of the current value of the control variable and a setpoint for the variable. A servo ventilation device may include a controller having ventilation as the input, a target tidal volume as the setpoint, and a pressure support level as the output. Other forms of input may be one or more of oxygen saturation (SaO2), partial pressure of carbon dioxide (PCO2), operation, a signal from a photoplethysmograph, and peak flow rate. The setpoint of the controller may be one or more of fixed, variable, or learned. For example, the setpoint in a ventilation device may be a long-term average of the patient's measured tidal volume. Other ventilation devices may have a tidal volume setpoint that changes over time. A pressure controller may be configured to control a blower or pump to deliver air at a specific pressure.

[0255] Treatment: In this context, treatment may consist of one or more of the following: positive pressure therapy, oxygen therapy, carbon dioxide therapy, dead space control, and drug administration.

[0256] Positive airway pressure (PAP) device: A device for supplying a predetermined amount of air at positive pressure to the airway.

[0257] 5.4.3 Biological structure of the face Nasal ala: The outer wall or "wing" of each nostril (plural: alaye)

[0258] Nasal wing angle: The angle defined between the nostrils when viewed from below.

[0259] Alare: The outermost point of the nasal ala (the outermost part of the nasal wing).

[0260] Alar curvature (or ala apex) point: The posteriormost point on the baseline of the curvature of each ala, found at the fold formed by the connection of the ala to the cheek.

[0261] Auricle (or pinna): The visible outer part of the ear.

[0262] (Nasal) skeleton: The nasal skeleton consists of the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0263] (Nasal) cartilaginous skeleton: The cartilaginous skeleton of the nose consists of the nasal septum, lateral nasal cartilages, greater alar cartilages, and lesser alar cartilages.

[0264] Columella: A piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0265] Columella angle: The angle between a line drawn through the midpoint of the nostril opening and a line drawn perpendicular to the Frankfort horizontal plane, crossing the nasal spine.

[0266] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the notch above the ear hairs of the auricle.

[0267] Glabella: The highest point of elevation in the sagittal midline of the forehead, located on soft tissue.

[0268] Lateral nasal cartilage: A roughly triangular plate of cartilage. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the greater alar cartilage.

[0269] Lower lip (midpoint of the lower lip): The point where the boundary between the lip color and the skin of the lower lip is intersected by the median sagittal plane.

[0270] Upper lip (midpoint of the upper lip): A point on the upper lip located within the median sagittal plane on a line drawn across the boundary between the lip color and the skin.

[0271] Greater alar cartilage: A plate of cartilage located beneath the lateral nasal cartilage. The greater alar cartilage is curved around the anterior part of the nostril. The posterior end of the greater alar cartilage is connected to the frontal process of the maxilla by a sturdy fibrous membrane containing three or four small cartilages of the nasal ala.

[0272] Nostrils: The roughly oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nostrils (naris (nostril)). The nostrils are separated by the nasal septum.

[0273] Naso-labial sulcus or naso-labial fold: A fold or groove of skin that separates the cheek from the upper lip, extending from both sides of the nose to the corners of the mouth.

[0274] Nasolabial angle: The angle between the columella and the upper lip when crossing the nasal spine.

[0275] Inferior ear base: The lowest point where the auricle attaches to the skin of the face.

[0276] Superior base of the ear: The highest point where the auricle attaches to the skin of the face.

[0277] Nasal tip: The most prominent point or apex of the nose, which can be identified in a lateral view of the rest of the head.

[0278] Philtrum: The midline groove extending from the lower edge of the nasal septum to the upper edge of the upper lip.

[0279] Pogonion: The anterior midpoint of the jaw, located on soft tissue.

[0280] Nasal ridge (nasal ridge): The nasal ridge is the midline process of the nose that extends from the root to the tip.

[0281] Sagittal plane: The vertical plane that passes through from the front (front) to the back (back) of the body, dividing it into right and left halves.

[0282] Nasal root: The most concave point located on soft tissue, lying within the region of the frontonasal suture.

[0283] Septal cartilage (nasal septal cartilage): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0284] Lowermost point of the ala: The point at the lower edge of the ala base where the ala base connects to the skin of the upper lip.

[0285] Nasal spine point: Located in soft tissue, this is the point where the columella merges with the upper lip in the sagittal midline.

[0286] Supramentare: The most concave point on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue pogonion.

[0287] 5.4.4 Biological structure of the skull Frontal bone: The frontal bone includes the greater vertical portion, or frontal squama, which corresponds to the area known as the forehead.

[0288] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance of the jaw that forms the chin.

[0289] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbit. The frontal process of the maxilla protrudes upward along the side of the nose and forms part of the lateral boundary of the nose.

[0290] Nasal bones: The nasal bones are two small, oval-shaped bones that vary in size and shape from individual to individual. They are located side-by-side in the central and upper parts of the face and, by joining together, form the "ridge" of the nose.

[0291] Nasion: The point where the frontal bone meets the two nasal bones, a recessed area located exactly between the eye and the upper part of the nasal bridge.

[0292] Occipital bone: The occipital bone is located in the posterior lower part of the skull. The occipital bone contains an elliptical opening, or foramen magnum, through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squama.

[0293] Parietal bone: The parietal bones are the bones that, when joined together, form the top and sides of the skull.

[0294] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temple.

[0295] Zygomatic bones: The face includes two zygomatic bones located on the upper and lateral parts of the face, forming the cheekbones.

[0296] 5.4.5 Structure of the Respiratory System Diaphragm: A muscular layer extending across the bottom of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases, drawing air into the lungs.

[0297] Larynx: The larynx, or vocal organ, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0298] Lungs: The human respiratory system. The conduction region of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0299] Nasal cavity: The nasal cavity (or nasal fossa) is located in the center of the face, above and behind the nose. It is a large air-filled space located there. The nasal cavity is divided into two by a vertical fin called the nasal septum. On either side of the nasal cavity are three horizontal extensions called conchae (singular "concha") or turbinates. In front of the nasal cavity is the nose, whose dorsal portion merges with the nasopharynx via the posterior nostrils.

[0300] The pharynx is a part of the throat located directly below the nasal cavity and above the esophagus and larynx. The larynx is usually divided into three parts: the nasopharynx (upper pharynx), the oropharynx (mesopharynx), and the pharyngolarynx (lower pharynx).

[0301] 5.4.6 Materials Silicone or silicone elastomer: synthetic rubber. In this specification, reference to silicone is to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (marketed under this trademark) manufactured by Dow Corning. It is included in a series of products. Another manufacturer of LSR is Wacker. Unless otherwise specified, the preferred form of LSR has a Shore A (or Type A) press-fit hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0302] Polycarbonate: A generally transparent thermoplastic polymer of bisphenol A carbonate.

[0303] 5.4.7 Patient Interface Configuration Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to the atmosphere in a fail-safe manner.

[0304] Elbow: A conduit that directs the axis of airflow to change direction over a predetermined angle. In one embodiment, the angle may be approximately 90°. In other embodiments, the angle may be less than 90°. The conduit may have a substantially circular cross-section. In other embodiments, the conduit may have an elliptical or rectangular cross-section.

[0305] Frame: The term "frame" is interpreted to mean the mask structure that supports the tensile load between two or more connection points with the headgear. The mask frame may be a non-airtight load-supporting structure in the mask. However, some forms of the mask frame may be airtight.

[0306] Functional dead space: A functional dead space is at least one area within a breathing circuit where a patient's exhaled air can accumulate in such a way that normal gas flow within the breathing circuit cannot effectively flush out the exhaled air from the breathing circuit.

[0307] Headgear: Headgear is interpreted to mean a form of positioning and stabilizing structure intended for use on the head. Preferably, the headgear comprises an assembly of one or more struts, straps, and reinforcing members configured to position and hold a patient interface in place on the patient's face in order to provide respiratory therapy. Some of the straps are formed from a flexible, pliable, and elastic material, such as a laminated composite of foam and fabric.

[0308] Membrane: The term "membrane" is interpreted to mean a generally thin element that preferably has substantially no bending resistance but possesses stretch resistance.

[0309] Plenum Chamber: The term "mask plenum chamber" is interpreted to mean the portion of the patient interface having walls surrounding a space of a predetermined volume, the volume containing air that is pressurized above atmospheric pressure when in use. The outer shell may form part of the walls of the mask plenum chamber. In one embodiment, a region of the patient's face forms one of the walls of the plenum chamber.

[0310] Seal: The noun form ("seal") is interpreted as meaning a structure or barrier that intentionally resists the flow of air through the interface of two surfaces. The verb form ("to seal") is interpreted as meaning to resist the flow of air.

[0311] Outer shell: Preferably, the outer shell is interpreted to mean a portion of a mask that forms a curved structure having bending stiffness, tensile stiffness, and compressive stiffness, such as the curved structural wall of a mask. Preferably, the outer shell is relatively thin compared to its overall dimensions. In some embodiments, the outer shell may be chamfered. Preferably, such walls are airtight, but in some embodiments, they may not be airtight.

[0312] Reinforcement: Reinforcement is interpreted to mean a structural component that increases the bending resistance of other components in at least one direction.

[0313] Supports: Supports are interpreted as structural components that increase the compressive resistance of other components in at least one direction.

[0314] Swivel: (noun) A subassembly of components configured to rotate, preferably independently, under low torque, around a common axis. In one embodiment, the swivel may be configured to rotate over an angle of at least 360°. In other embodiments, the swivel may be configured to rotate over an angle of less than 360°. When used in conjunction with an air circuit, the subassembly of components preferably comprises a fitted pair of cylindrical conduits. Preferably, there is little to no airflow leakage from the swivel during use.

[0315] A string is interpreted as a structural component designed to resist tension.

[0316] Vent: (noun) A structure or conduit to the outside air that allows a deliberately controlled percentage of air to leak from inside a mask in order to allow the outflow of exhaled carbon dioxide (CO2) and the supply of oxygen (O2).

[0317] 5.4.8 Terminology used in relation to the patient interface (Surface) Curvature: A region of a surface with a saddle shape, curving upward in one direction and downward in the other, is interpreted as having negative curvature. A region of a surface with a dome shape, curving similarly in two principal directions, is interpreted as having positive curvature. A flat surface is interpreted as having zero curvature.

[0318] Soft: The quality of a material, structure, or composite that is a combination of the following characteristics. It adapts easily to acupressure. It cannot maintain its shape when it is forced to support its own weight. Not hard It can be stretched or bent elastically with minimal effort.

[0319] The quality of being flexible may have a related direction; therefore, a particular material, structure, or composite may be flexible in a first direction, but rigid or hard in a second direction, for example, a second direction perpendicular to the first direction.

[0320] Elasticity: It can deform almost elastically within a relatively short time, such as one second, and can release almost all of its energy when the load is removed.

[0321] Rigid: Does not easily deform in response to acupressure and / or the tension or load generally faced when setting and maintaining a seal relationship with the entrance to the patient's airway.

[0322] Semi-rigid: This means that it is sufficiently rigid so as not to deform substantially under the action of the mechanical forces commonly applied during positive airway pressure therapy.

[0323] 5.5 Other findings Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art in which this art belongs. Any methods and materials similar to or equivalent to those described herein may be used in the implementation or testing of this art, however, only a limited number of typical methods and materials are described herein.

[0324] It should be noted that the singular forms “a,” “an,” and “the” used herein and in the appended claims include their plural equivalents unless the context otherwise explicitly indicates.

[0325] Furthermore, when interpreting the disclosure, all terms should be interpreted in the broadest and most appropriate manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, and therefore suggesting that the referred elements, components, or steps may exist or be used, or may be combined with other elements, components, or steps not explicitly mentioned.

[0326] While the techniques described herein have been explained in relation to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the techniques. In some cases, technical terms and symbols may indicate specific details that are not necessary for carrying out the techniques. For example, the terms “first” and “second” may be used, but unless otherwise specified, these terms are not intended to indicate any order and may be used to distinguish between distinct elements. Similarly, process steps in methodologies may be described or illustrated in a predetermined order, but such ordering is not required. As those skilled in the art will see, such ordering may be changed, and / or the embodiments may occur simultaneously or even synchronously.

[0327] Therefore, it should be understood that numerous modifications may be made to the exemplified embodiments, and other configurations may be devised, without deviating from the concept and scope of this technology.

[0328] Furthermore, the present invention may also preferably include the following examples. [Additional note 1] A patient interface for supplying respiratory gas to a patient, wherein the patient interface is A plenum chamber assembly, A nasal plenum chamber that at least partially defines a first gas chamber, wherein the nasal plenum chamber is structured to contact the patient's nose below the nasal bridge and over the lower outer circumference of the nose, An oral plenum chamber that at least partially defines a second gas chamber, wherein the oral plenum chamber is structured to seal around the mouth of a patient, A plenum chamber assembly comprising a separation structure that at least partially connects the nasal plenum chamber and the oral plenum chamber and at least partially defines a flow path between the nasal plenum chamber and the oral plenum chamber, wherein the separation structure is configured to separate the relative motion between the nasal plenum chamber and the oral plenum chamber, A top plate operably connected to the plenum chamber assembly in the nasal plenum chamber, the top plate includes at least one connecting functional portion configured to releasably hold a first portion of a positioning and stabilizing structure, A faceplate operably connected to the plenum chamber assembly in the mouth plenum chamber, and configured to releasably hold a second portion of the positioning stabilization structure. Equipped with, A patient interface in which the top plate and the faceplate are more rigid than the plenum chamber assembly. [Additional note 2] The patient interface according to claim 1, wherein the flow path connects the first gas chamber and the second gas chamber by air pressure. [Additional note 3] The patient interface according to claim 1 or 2, wherein the top plate and the face plate are removably attached to the plenum chamber assembly. [Additional note 4] The patient interface according to any one of claims 1 to 3, wherein the positioning stabilization structure comprises a rigidizer arm assembly having a pair of rigidizer arms, and the rigidizer arm assembly is connected to the top plate. [Additional note 5] Each of the pair of rigidizer arms is capable of bending in a plane parallel to the patient's cross-section. The patient interface according to claim 4, wherein each of the pair of rigidizer arms is constructed to resist bending, torsion, and / or extension in a plane perpendicular to the patient's cross-section. [Additional note 6] The patient interface according to claim 4 or 5, wherein each of the rigidizer arms has an elliptical shape to conform to the curvature of the patient's cheek. [Additional note 7] The nasal plenum chamber comprises a nasal flange that defines the nasal opening, The patient interface according to any one of claims 1 to 6, wherein the nasal flange is configured to form a seal with at least the patient's nose. [Additional note 8] The patient interface according to claim 7, wherein the nasal flange includes a recess for receiving the tip of the patient's nose. [Additional note 9] The mouth plenum chamber comprises a mouth flange that defines the mouth opening, The patient interface according to claim 7 or 8, wherein the mouth flange is configured to form a seal with at least the mouth of the patient. [Additional Note 10] The patient interface according to claim 9, wherein the mouth flange is formed around the entire circumference of the mouth plenum chamber, or near two opposing sides of the outer circumference of the mouth plenum chamber, or over a large portion of the outer circumference of the mouth plenum chamber. [Additional Note 11] The patient interface according to claim 9, wherein the oral plenum chamber comprises a pair of oral undercushion portions, each of which is positioned on each side of the oral plenum chamber to support the oral flange. [Additional Note 12] The patient interface according to claim 10 or 11, wherein the oral plenum chamber comprises an oral undercushion portion that is arranged around the oral plenum chamber and extends radially from both ends of the separation structure to support the oral flange. [Additional Note 13] The patient interface according to any one of claims 10 to 12, wherein the separation structure connects the nasal flange and the mouth flange. [Additional Note 14] The patient interface according to claim 13, wherein the separation structure comprises an upper surface, a lower surface, and a connecting surface, the connecting surface having higher rigidity than the upper surface and the lower surface. [Additional Note 15] The patient interface according to claim 13, wherein the separation structure has greater rigidity in the portion opposite to the patient's face than in the portion adjacent to the patient's face. [Additional Note 16] The patient interface according to any one of claims 13 to 15, wherein the rigidity of the separation structure increases radially from the portion adjacent to the patient's face to the portion opposite to the patient's face. [Additional Note 17] The patient interface according to any one of claims 8 to 16, wherein the nasal contact portion of the nasal flange has higher rigidity in the portion that does not contact the patient's nose than in the portion of the nasal flange that does not contact the patient's nose. [Additional Note 18] The nasal flange has increasing rigidity outward from the nasal opening, according to any one of claims 8 to 17. [Additional Note 19] The patient interface according to any one of claims 8 to 18, wherein the rigidity of the nasal flange varies at a predetermined position around the nasal opening. [Additional Note 20] The patient interface according to any one of claims 8 to 19, wherein the lower part of the nasal flange near the separation structure is concave to seal against the patient's upper lip. [Additional Note 21] The patient interface according to any one of claims 8 to 20, wherein the nasal flange comprises a pair of protruding ends extending symmetrically around the nasal opening, and each protruding end is configured to seal to the ala of the patient's nose corresponding thereto. [Additional note 22] The patient interface according to claim 21, wherein the nasal plenum chamber comprises a pair of nasal undercushion portions, and each of the pair of nasal undercushion portions supports one of the pair of protruding ends. [Additional Note 23] The patient interface according to claim 22, wherein each of the nasal undercushion portions is positioned on the upper part of the oral plenum chamber. [Additional note 24] A patient interface according to any one of claims 1 to 23, comprising a headgear for releasably securing the patient interface to the patient, wherein the headgear includes a pair of upper straps configured to connect to the nasal plenum chamber and a pair of lower straps configured to connect to the oral plenum chamber. [Additional note 25] The patient interface according to any one of claims 1 to 24, wherein the top plate is permanently connected to the nasal plenum chamber. [Additional note 26] The patient interface according to claim 1, wherein the top plate is detachably attached to the flexible connection area of ​​the nasal plenum chamber. [Additional note 27] The patient interface according to claim 1, wherein the top plate is removablely attached to the rigid connection area of ​​the nasal plenum chamber. [Additional note 28] The patient interface according to any one of claims 4 to 27, wherein the top plate and the rigidizer arm form an integrated component, and the rigidizer arm is more flexible than the top plate in a plane parallel to the patient's cross-section. [Additional note 29] A patient interface for supplying respiratory gas to a patient, A nasal cushion that at least partially defines the nasal gas chamber, A mouth cushion for at least partially defining an oral gas chamber separate from the nasal gas chamber, A separating structure is disposed between the nose cushion and the mouth cushion, A top plate fixed to the nose cushion, and a pair of upper mounting functional parts configured to releasably attach a pair of upper side straps of the positioning and stabilizing structure to the top plate, A face plate fixed to the mouth cushion, and a pair of lower mounting functional parts configured to releasably attach a pair of lower side straps of the positioning stabilization structure. A patient interface equipped with a [Additional note 30] The patient interface according to claim 29, wherein the separation structure is configured to form a pneumatic connection between the nasal gas chamber and the oral gas chamber. [Additional Note 31] The patient interface according to claim 29, wherein the separation structure comprises an upper surface, a lower surface, and a connecting surface, the connecting surface having higher rigidity than the upper surface and the lower surface. [Additional note 32] The rigidity of the separation structure is variable radially along its outer circumference such that the portion distal to the patient's face is more rigid than the portion proximal to the patient's face. The patient interface according to any one of claims 29 to 31, wherein the nose cushion is structured to move independently of the mouth cushion. [Additional note 33] The patient interface according to any one of claims 29 to 32, wherein the nasal contact portion of the nasal cushion has lower rigidity than the portion of the nasal cushion that does not come into contact with the patient's nose. [Additional note 34] The patient interface according to any one of claims 29 to 33, wherein the separation structure is structured to support the nasal cushion with respect to the patient's nose. [Additional note 35] The patient interface according to any one of claims 29 to 34, wherein the portion of the nose cushion that does not come into contact with the patient's nose has higher rigidity than the portion that comes into contact with the nose. [Additional note 36] The patient interface according to any one of claims 29 to 35, wherein the nasal cushion comprises a recess for sealing against the patient's upper lip. [Additional note 37] The patient interface according to any one of claims 29 to 36, wherein the nasal cushion comprises a pair of protruding ends, each of which is configured to form a seal between the respective nasal wings and nasolabial folds of the patient's face. [Additional note 38] The patient interface according to claim 37, wherein the nose cushion comprises a pair of under-nose cushion portions, each of which is positioned below the respective protruding end to support the respective protruding end against the patient's face. [Additional note 39] The patient interface according to any one of claims 29 to 38, wherein the nasal cushion comprises wings on both sides of the nasal cushion for sealing to each of the patient's nostrils. [Additional note 40] The patient interface according to any one of claims 29 to 39, wherein the mouth cushion comprises mouth under cushion portions extending radially around the mouth cushion from both ends of the separation structure to support the mouth cushion against the patient's face. [Additional note 41] The patient interface according to any one of claims 29 to 40, wherein the mouth cushion comprises a pair of mouth under cushion portions, each of which is positioned on each side of the mouth cushion to support the mouth cushion against the patient's face. [Additional note 42] The patient interface according to any one of claims 29 to 41, wherein the nose cushion has a shape that includes a recess configured to receive the tip of the patient's nose. [Additional note 43] The patient interface according to any one of claims 29 to 42, wherein the nasal cushion is configured to contact the lower outer circumference of the patient's nose below the nasal bridge. [Additional note 44] The patient interface according to any one of claims 29 to 43, wherein the nose cushion, the mouth cushion, and the separation structure form an integrated component. [Additional note 45] The patient interface according to any one of claims 29 to 44, wherein the top plate is permanently connected to the nasal plenum chamber. [Additional note 46] The patient interface according to any one of claims 29 to 45, wherein the top plate is removablely attachable to a flexible connection area of ​​the nasal plenum chamber. [Additional note 47] The patient interface according to any one of claims 29 to 45, wherein the top plate is removablely attachable to a rigid connection area of ​​the nasal plenum chamber. [Additional note 48] The patient interface according to any one of claims 29 to 47, wherein the top plate and the rigidizer arm assembly form a single integrated component, and the pair of rigidizer arms of the rigidizer arm assembly are more flexible than the top plate in a plane parallel to the patient's cross-section. [Additional note 49] The patient interface according to any one of claims 29 to 48, wherein the positioning stabilization structure comprises a rigidizer arm assembly that can be releasably attached to the top plate in the upper mounting functional section. [Additional Note 50] The frame further comprises a frame that can be removably attached to the faceplate, The patient interface according to claim 49, wherein the lower mounting function is arranged on the frame. [Additional note 51] Each of the lower mounting functional parts is provided with a fitting portion having a fitting portion magnet for releasably connecting to the corresponding clip of the positioning stabilization structure, The patient interface according to claim 50, wherein each of the corresponding clips includes a clip magnet, and the clip magnets are oriented such that the fitting portion is coupled to the corresponding clip when each of the clip magnets is magnetically attracted to the respective fitting portion magnet. [Additional note 52] The patient interface according to claim 50 or 51, further comprising a top plate buffer for damping vibrations at the connection between the top plate and the rigidizer arm assembly, and a face plate buffer for damping vibrations at the connection between the face plate and the frame. [Additional note 53] The frame is shaped such that it is joined to the outer circumference of the faceplate. The frame is provided with a catch, and the faceplate is provided with a notch. The patient interface according to any one of claims 50 to 52, wherein the frame is coupled to the faceplate by engagement between the catch and the notch. [Additional note 54] A patient interface for supplying respiratory gas to a patient, wherein the patient interface is A plenum chamber assembly, A nasal plenum chamber that at least partially defines a first gas chamber, wherein the nasal plenum chamber seals to the patient below the nasal bridge and over the lower outer circumference of the patient's nose, A second gas chamber is defined at least partially by an oral plenum chamber operably connected to the nasal plenum chamber. A plenum chamber assembly comprising, The integral plate member comprises an upper part that can be releasably attached to the nasal plenum chamber and a lower part that can be releasably attached to the oral plenum chamber, A patient interface wherein the upper part of the integrated plate member includes at least one connecting function configured to releasably hold a first portion of a positioning and stabilizing structure having a pair of rigidizer arms, and the lower part of the plate member is configured to releasably hold a second portion of the positioning and stabilizing structure. [Additional note 55] The patient interface according to claim 54, wherein the plenum chamber assembly further comprises a separation structure that at least partially connects the nasal plenum chamber and the oral plenum chamber, the separation structure at least partially defines a flow path between the nasal plenum chamber and the oral plenum chamber. [Additional note 56] Each of the pair of rigidizer arms is capable of bending in a plane parallel to the patient's cross-section. The patient interface according to claim 55, wherein each of the pair of rigidizer arms is constructed to resist bending in a plane perpendicular to the patient's cross-section, to resist twisting, and / or to resist stretching. [Additional note 57] The patient interface according to claim 56, wherein each of the at least one connecting function portion is hinged such that a corresponding rigidizer arm of the pair of rigidizer arms can rotate the upper part of the integral side plate member relative to the rigid top plate in a plane parallel to the patient's cross-section. [Additional note 58] The patient interface according to any one of claims 54 to 57, wherein the first portion of the positioning stabilization structure includes a hook for rotatably connecting to the upper connecting function portion of the integrated plate member. [Additional note 59] The nasal plenum chamber comprises a nasal flange that defines the nasal opening, The patient interface according to any one of claims 54 to 58, wherein the nasal flange is configured to form a seal with at least the patient's nose. [Additional note 60] The patient interface according to claim 59, wherein the nasal flange includes a recess for receiving the tip of the patient's nose. [Additional note 61] The mouth plenum chamber comprises a mouth flange that defines the mouth opening, The patient interface according to claim 59 or 60, wherein the mouth flange is configured to form a seal with at least the mouth of a patient. [Additional note 62] The patient interface according to claim 61, wherein the mouth flange is formed around the entire circumference of the mouth plenum chamber, or near two opposing sides of the outer circumference of the mouth plenum chamber, or over a large portion of the outer circumference of the mouth plenum chamber. [Additional note 63] The patient interface according to claim 61, wherein the oral plenum chamber comprises a pair of oral undercushion portions, each of which is positioned on each side of the oral plenum chamber to support the oral flange. [Additional note 64] The patient interface according to claim 62 or 63, wherein the oral plenum chamber comprises an oral undercushion portion that is arranged around the oral plenum chamber and extends radially from both ends of the separation structure to support the oral flange. [Additional note 65] The patient interface according to any one of claims 62 to 64, wherein the separation structure connects the nasal flange and the mouth flange. [Additional note 66] The patient interface according to claim 65, wherein the separation structure has greater rigidity in the portion opposite to the patient's face than in the portion adjacent to the patient's face. [Additional note 67] The patient interface according to claim 65 or 66, wherein the rigidity of the separation structure increases radially from the portion adjacent to the patient's face toward the portion opposite to the patient's face. [Additional note 68] The patient interface according to any one of claims 59 to 67, wherein the nasal contact portion of the nasal flange has higher rigidity in the portion that does not contact the patient's nose than in the portion of the nasal flange that does not contact the patient's nose. [Additional note 69] The nasal flange has increasing rigidity outward from the nasal opening, according to any one of claims 59 to 68. [Additional note 70] The patient interface according to any one of claims 59 to 69, wherein the rigidity of the nasal flange varies at a predetermined position around the nasal opening. [Additional note 71] The patient interface according to any one of claims 59 to 70, wherein the lower part of the nasal flange near the separation structure is concave to seal against the patient's upper lip. [Additional note 72] The patient interface according to any one of claims 59 to 71, wherein the nasal flange comprises a pair of protruding ends extending symmetrically around the nasal opening, and each protruding end is configured to seal to the ala of the patient's nose corresponding thereto. [Additional note 73] The patient interface according to claim 72, wherein the nasal plenum chamber comprises a pair of nasal undercushion portions, each of which corresponds to each of the protruding ends in order to support each of the protruding ends. [Additional note 74] The patient interface according to claim 73, wherein each of the nasal undercushion portions is positioned on the upper part of the oral plenum chamber. [Additional note 75] The patient interface according to any one of claims 59 to 74, wherein each of the pair of rigidizer arms has an elliptical curvature between a first end and a second end. [Additional note 76] A patient interface for supplying respiratory gas to a patient, A nasal cushion that at least partially defines the nasal gas chamber, A mouth cushion for at least partially defining an oral gas chamber separate from the nasal gas chamber, A separating structure is disposed between the nose cushion and the mouth cushion, The top plate fixed to the aforementioned nose cushion, A rigidizer arm assembly that can be releasably attached to the top plate and Equipped with, A patient interface in which the rigidizer arm assembly and the top plate engage at at least three contact points. [Additional note 77] The patient interface according to claim 76, wherein the top plate comprises a pair of upper mounting functional parts, the rigidizer arm assembly comprises a pair of connecting functional parts, and each of the pair of connecting functional parts is structured to engage with a corresponding upper mounting functional part of the pair of upper mounting functional parts. [Additional note 78] The patient interface according to claim 76 or 77, wherein the rigidizer arm assembly comprises ribs for engaging with the top plate when the rigidizer arm assembly engages with the top plate. [Additional note 79] The patient interface according to any one of claims 76 to 78, further comprising a top plate buffer for damping vibrations in the engagement portion between the rigidizer arm assembly and the top plate, wherein the top plate buffer is positioned on the front side of the top plate so as to contact the rear side of the rigidizer arm assembly. [Additional note 80] The patient interface according to claim 79, wherein the top plate buffer and the nasal cushion form an integrated component, and the top plate buffer extends from the nasal cushion through the top plate. [Additional note 81] The patient interface according to any one of claims 76 to 80, wherein the rigidizer arm assembly comprises a pair of rigidizer arms, each of which is configured to receive an upper side strap of a positioning and stabilizing structure. [Additional note 82] The patient interface according to claim 81, wherein each of the pair of rigidizer arms is provided with a pad for cushioning the pair of rigidizer arms against the patient's face. [Additional note 83] A cushion assembly for a patient interface for the treatment of sleep-disordered breathing in patients, A nasal cushion connected to a nasal plenum chamber, wherein the nasal cushion is structured to seal around the lower outer circumference of the patient's nose, An oral cushion connected to an oral plenum chamber, wherein the oral cushion is structured to seal around the patient's mouth, A separation structure connecting the nasal cushion and the nasal plenum chamber to the oral cushion and the oral plenum chamber, wherein the separation structure is configured such that the nasal cushion and the nasal plenum chamber are movable relative to the oral cushion and the oral plenum chamber. A pair of lateral supports, each of which is located on both sides of the nose cushion, and which connects each side of the nose cushion to the mouth cushion, A pair of under cushion support walls are provided to support the protruding end located on the rear side of the nose cushion, A pair of pockets, each of which is located on either side of the nose cushion, and each of the pair of pockets includes an upper surface defined by the nose cushion and the nasal plenum chamber, each of the pair of pockets includes a lower surface defined by the mouth cushion and the mouth plenum chamber, and each of the pair of pockets includes a side surface defined by the separation structure and the corresponding side support of the pair of side supports. Equipped with, A cushion assembly in which, when the patient interface is worn by the patient, the openings of each of the pair of pockets are positioned on the opposite side of the patient's face. [Additional note 84] The cushion assembly according to claim 83, wherein each of the pair of side supports includes a notch that provides a point of rotation for relative movement between the nose cushion and the mouth cushion. [Additional note 85] The cushion assembly according to claim 84, wherein each of the pair of side supports has a notch that opens away from the patient's face when the patient interface is worn by the patient. [Additional note 86] The nose cushion comprises a pair of reinforcing portions, each of which is located on both sides of the nose cushion. The cushion assembly according to any one of claims 83 to 85, wherein the reinforcing portion is more rigid than the rest of the nose cushion. [Additional note 87] The cushion assembly according to claim 86, wherein the pair of reinforcing portions are thicker than the other portions of the nose cushion. [Additional note 88] The cushion assembly according to claim 86 or 87, wherein the pair of reinforcing portions extend inward relative to the nasal cushion and the nasal plenum chamber so as not to cause the outer surface of the nasal cushion to bulge. [Additional note 89] The cushion assembly according to any one of claims 83 to 88, wherein the nose cushion comprises a nose sling, the nose sling is formed in the same plane as the nose cushion, and the nose sling is structured to contact the patient's nasal bridge. [Additional Note 90] The cushion assembly according to claim 89, wherein the nasal cushion and the nasal sling define a pair of nasal ports, and each of the pair of nasal ports is structured to communicate pneumatically with a corresponding nostril of the patient. [Additional Note 91] The cushion assembly according to claim 89 or 90, wherein the nasal sling is constructed such as to prevent the tip of the patient's nose from extending into the nasal gas chamber, and the nasal gas chamber is at least partially defined by the nasal cushion and the nasal plenum chamber. [Additional note 92] A patient interface for supplying respiratory gas to a patient, A nasal cushion for at least partially defining the nasal gas chamber, A mouth cushion for at least partially defining an oral gas chamber separate from the nasal gas chamber, A separating structure is disposed between the nose cushion and the mouth cushion. Equipped with, The separation structure comprises an upper surface for connecting the separation structure to the nose cushion, a lower surface for connecting the separation structure to the mouth cushion, and a connecting surface for connecting the upper surface and the lower surface. The upper surface and the lower surface have approximately equal thickness. The aforementioned connection surface is thicker than the aforementioned top surface and bottom surface, forming a patient interface. [Additional Note 93] The patient interface according to claim 92, wherein the thickness of the connecting surface is approximately twice that of the upper surface and the lower surface. [Additional note 94] The patient interface according to claim 92 or 93, wherein the separation structure has a flexible structure so that the upper surface and the lower surface can be positioned at a maximum angle of 50° relative to each other. [Additional note 95] The patient interface according to claim 92, wherein the upper surface and the lower surface are approximately 0.5 mm thick, and the connecting surface is approximately 1.2 mm thick. [Additional Note 96] A patient interface system for supplying respiratory gas to a patient, A cushion assembly, A nasal cushion for at least partially defining the nasal gas chamber, A mouth cushion that at least partially defines an oral gas chamber separate from the nasal gas chamber, A separating structure is disposed between the nose cushion and the mouth cushion. A cushion assembly comprising, A positioning and stabilizing structure with a pair of lower side straps, A pair of lower mounting functional parts configured to releasably attach the corresponding lower side strap of the pair of lower side straps of the positioning stabilization structure to the cushion assembly, Equipped with, A patient interface system in which each of the pair of lower mounting functional parts is made of thermoplastic elastomer, and a first magnet is embedded in each of the pair of lower mounting functional parts. [Additional Note 97] The faceplate fixed to the mouth cushion, A frame that can be removably attached to the faceplate and Furthermore, The patient interface system according to claim 96, wherein the pair of lower mounting functional units are fixed to the frame. [Additional note 98] The patient interface system according to claim 97, wherein the frame is made of a material harder than the thermoplastic elastomer. [Additional Note 99] The patient interface system according to claim 97 or 98, wherein the pair of lower mounting functional parts are molded onto the frame. [Additional Note 100] The patient interface system according to any one of claims 97 to 99, further comprising a pair of clips for attaching a corresponding lower side strap of the pair of lower side straps to a corresponding lower mounting function of the pair of lower mounting functions. [Additional Note 101] The patient interface system according to claim 100, wherein each of the pair of clips is provided with a second magnet for attaching each of the pair of clips to the corresponding lower mounting function of the pair of lower mounting functions. [Additional Note 102] Each of the pair of clips is provided with a notch, and each of the pair of lower mounting functional parts is provided with a protrusion, The patient interface system according to claim 100 or 101, wherein the protrusion engages with the notch when each of the pair of clips engages with the corresponding lower mounting function of the pair of lower mounting functions. [Additional Note 103] The patient interface system according to any one of claims 97 to 102, wherein each of the pair of lower mounting functional parts has a bending point, and each of the pair of lower mounting functional parts is structured to bend at the bending point. [Additional Note 104] The patient interface system according to claim 103, wherein each of the pair of lower mounting functional parts includes a thickness reduction region at the bending point. [Explanation of Symbols]

[0329] 1000 patients 1100 Bed Partner 3000 Patient Interfaces 3100 Seal-forming structure 3101 Nasal opening 3102 Nasal gas chamber 3103 Nasal opening 3104 Nasal gas chamber 3104.1 Long side of the distal end 3104.2 Short side 3104.3 Longer side of the proximal end 3105 Nasal port 3106 Separate structure 3106.1 Gap 3106.2 Connection Area 3106.3 Side 3106.4 Top surface 3106.5 Connection surface 3106.6 Bottom side 3110 Mouth cushion 3112 Nose cushion 3112.1 Area 3112.2 Area 3112.3 Area 3113 area 3114 Projecting end 3115 area 3116 recess 3117 area 3118 Peak 3119 Nose Sling 3120 Under Cushion 3121 Straight side wall 3122 Tapered region 3124 Thick nose cushion portion 3130 Flexible connectivity area 3132 Rigid connection area 3200 plenum chamber 3202 Nasal plenum chamber 3204 Faceplate 3205 Connection part 3206 Top Plate 3207 Side support 3208 Nasal undercushion support wall 3208.1 Pocket 3209 Notch 3210 Outer circumference 3212 Oral plenum chamber section 3213 Notch 3214 Top Plate Buffer 3215 Faceplate Buffer 3216 recess 3217 Hole 3218 Extension 3219 Indentation 3250 Lower mounting function section 3251 Frame 3252 Upper mounting function section 3253 Catch 3254 Mating surface 3255 Fitting section 3256 Extending part of the fitting section 3257 Wings 3258 recess 3259 Frame extension 3260 Clip Magnet 3261 Mating part magnet 3262 Fitting pocket 3263 Guide surface 3264 Protrusion 3265 Notch 3266 Thickness reduction portion 3267 Fitting part, magnet receiving part 3300 Positioning Stabilization Structure 3301 Rigidizer Arm Assembly 3302 Rigidizer Arm 3303 Top Plate Cover 3304 Connection Function Unit 3305 Pad 3306 Headgear Strap 3308 Aperture 3309 Nail 3310 Upper strap 3312 Lower strap 3314 clips 3315 Bar 3316 Sheath 3317 Clip Pocket 3318 Notch 3319 Acceptance surface 3320 Clip Magnetic Cover 3321 Clip magnet receiving part 3400 vents 3500 Tube Separation Structure 3510 Swivel 3520 Baffle 3530 Rapid release mechanism 3600 connection ports 3800 Suffocation prevention valve 4000 PAP devices 4170 Air Circuit 4172 Cuff 5000 humidifier

Claims

[Claim 1] The patient interface described in the specification and drawings of this application.

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