Patient Interface

Abstract

TECHNICAL FIELD The present technology relates to medical devices and the use of such devices to treat and prevent respiratory disorders. [Solution] A patient interface (3000) for supplying breathable gas to a patient comprises a plenum chamber assembly comprising a nasal plenum chamber (3200) at least partially defining an upper gas chamber, an oral plenum chamber (3200) at least partially defining a lower gas chamber, and a separation structure at least partially connecting the nasal and oral plenum chambers and at least partially defining a flow path; a top plate (3206) including at least one connection feature configured to releasably hold a first portion of a positioning and stabilising structure (3300); and a face plate (3204) configured to releasably hold a second portion of the positioning and stabilising structure.

Description

[Technical Field]

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

[0002] 2. Technical Background 2.1 Technology field The present technology relates to one or more of the diagnosis, treatment, and amelioration of respiratory disorders, as well as procedures for preventing respiratory disorders. In particular, the present technology relates to medical devices and uses of the medical devices for treating and preventing respiratory disorders. [Background technology]

[0003] 2.2 Description of Related Art The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

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

[0005] There is a range of respiratory diseases.

[0006] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by the obstruction of the upper airway during sleep. OSA results from an abnormally small upper airway combined with the normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall regions during sleep. The condition causes affected individuals to stop breathing, typically for periods lasting 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime somnolence and may lead to cardiovascular disease and brain damage. The syndrome is particularly common among middle-aged and elderly obese men, although sufferers may be unaware of the problem. See U.S. Pat. No. 4,944,310 (Sullivan).

[0007] Cheyne-Stokes respiration (CSR) is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of increased and decreased ventilation, causing repeated deoxygenation and reoxygenation of arterial blood. CSR is thought to be harmful due to recurrent hypoxia. In some patients, CSR is associated with repeated arousals from sleep, causing severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

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

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

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

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

[0012] Otherwise, healthy individuals may successfully utilize 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 Nasal continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The premise is that CPAP can prevent upper airway obstruction by acting as a pneumatic splint and forcing the soft palate and tongue forward and away from the posterior oropharyngeal wall.

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

[0016] 2.2.3 Patient Interface The application of a predetermined amount of positive pressure air to the entrance of a patient's airway is facilitated by the use of a patient interface, such as a nasal mask, full-face mask, or nasal pillows. While a range of patient interface devices are known, many suffer from one or more of the following: being highly visible, aesthetically undesirable, poorly fitting, difficult to use, and uncomfortable, especially when worn for extended periods of time or when the patient is unfamiliar with the system. Masks designed for aviators, as part of personal protective equipment, or solely for the administration of anesthetic agents may be acceptable in their original application, but are nevertheless uncomfortable and undesirable to wear for extended periods of time, such as during sleep.

[0017] A traditional oral-nasal mask can be replaced with a full-face mask or the ResMed LIBERTY full-face mask. These oral-nasal masks, due to their size and volume, are less comfortable and more cumbersome than other masks for physiological reasons, including claustrophobia or claustrophobia. Oral-nasal masks are generally bulky and heavy, and can interfere with patient comfort and may interfere with the wearing of eyeglasses.

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

[0019] One type of seal-forming feature extends around the periphery of the patient interface and is adapted to seal against the user's face when force is applied to the patient interface with the seal-forming feature in abutting engagement with the user's face. The seal-forming feature may consist of an air- or fluid-filled cushion or a molded or shaped surface of a resilient sealing element formed from an elastomer such as rubber. With this type of seal-forming feature, if the fit is not proper, there will be gaps between the seal-forming feature 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 devices incorporate a flap seal of thin material located around the periphery of the mask to self-seal against the user's face when positive pressure is applied within the mask. As with previous styles of seal-forming devices, if the fit between the face and the mask is poor, additional force may be required to create a seal, or the mask may leak. Also, if the shape of the seal-forming device does not match the shape of the patient, the seal-forming device may fold or buckle during use, causing leakage.

[0021] Other forms of seal-forming parts may use adhesives to create a seal, and some patients may find it inconvenient to constantly apply and remove adhesive from their face.

[0022] A range of patient interface seal forming technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; and WO 2010 / 135,785.

[0023] 2.2.3.2 Positioning stabilization

[0024] The seal-forming portions of patient interfaces used for positive air pressure therapy are subjected to the corresponding forces of air pressure that can compromise the seal. Accordingly, various techniques have been used to position the seal-forming portion and maintain it in sealing relationship with the appropriate portion of the face.

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

[0026] Another technique is the use of one or more straps and stabilizing harnesses. Many such harnesses suffer from one or more of the following: being ill-fitting, bulky, uncomfortable, and difficult to use.

[0027] 2.2.3.3 Venting technology Some forms of patient interface systems may include a vent to allow the outflow of exhaled carbon dioxide. Many such vents are noisy. Other vents may become blocked during use, resulting in insufficient outflow. Some vents may disrupt the sleep of the patient's 1000 bed partner 1100, for example, by noise or focused airflow.

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

[0029] [Table 1]

[0030] Sound pressure level values ​​for various targets 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. Another nasal pillow or nasal puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan Bennett Corporation.

[0033] ResMed Limited has manufactured the following products that incorporate nasal pillows: the SWIFT nasal pillows mask, the SWIFT II nasal pillows mask, the SWIFT LT nasal pillows mask, the SWIFT FX nasal pillows mask, and the LIBERTY full face mask. The following patent applications assigned to ResMed Limited are incorporated herein by reference: WO 2004 / 073,778 (which describes, among other things, aspects of the ResMed SWIFT nasal pillows); U.S. Patent Application Publication No. 2009 / 0044808 (which describes, among other things, aspects of the ResMed SWIFT LT nasal pillows); WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of the ResMed LIBERTY full face mask); WO 2009 / 052,560 (which describes, among other things, aspects of the ResMed SWIFT FX nasal pillows); (This section describes the nasal pillow mask.) Summary of the Invention [Problem to be solved by the invention]

[0034] 3. A brief overview of the technology The present technology is directed to providing medical devices used in the diagnosis, improvement, treatment, or prevention of respiratory disorders that have one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability. [Means for solving the problem]

[0035] One aspect of the present technology may be directed to a patient interface for delivering breathable gas to a patient. The patient interface may include a plenum chamber assembly including: a nasal plenum chamber at least partially defining a first gas chamber, the nasal plenum chamber configured to contact the patient's nose below the bridge of the nose and around the lower periphery of the nose; an oral plenum chamber at least partially defining a second gas chamber, the oral plenum chamber configured to seal around the patient's mouth; and a separation structure at least partially connecting the nasal and oral plenum chambers and at least partially defining a flow path between the nasal and oral plenum chambers, the separation structure and a decoupling structure configured to decouple relative movement between the plenum chamber and the oral plenum chamber, wherein the patient interface may comprise a top plate operably connected to the plenum chamber assembly at the nasal plenum chamber, the top plate including at least one connection feature configured to releasably hold a first portion of the positioning and stabilising structure, and the patient interface may comprise a face plate operably connected to the plenum chamber assembly at the oral plenum chamber, the face plate configured to releasably hold a second portion of the positioning and stabilising structure, wherein the top plate and the face plate are stiffer than the plenum chamber assembly.

[0036] In one example, (a) the flow path may pneumatically connect a first gas chamber and a second gas chamber, (b) the top plate and the face plate may be releasably attached to a plenum chamber assembly, (c) the positioning and stabilizing structure may comprise a rigidiser arm assembly having a pair of rigidiser arms, the rigidiser arm assembly may be connected to the top plate, and (d) each of the pair of rigidiser arms may be capable of bending in a plane parallel to a transverse plane of a patient, and the pair of rigidiser arms may be configured to bend in a plane parallel to a transverse plane of a patient. (e) each rigidiser arm may be structured to resist bending, torsion and / or extension in a plane perpendicular to the patient's transverse plane; (e) each rigidiser arm 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 nasal flange may include a recess for receiving the tip of the patient's nose; The plenum chamber may include an oral flange defining an oral opening, and the oral flange may be configured to form a seal with at least the mouth of the patient; (i) the oral flange may be formed around the entire periphery of the oral plenum chamber, or around two opposing sides of the periphery of the oral plenum chamber, or around a majority of the periphery of the oral plenum chamber; (j) the oral plenum chamber may include a pair of oral undercushion portions, one on each side of the oral plenum chamber to support the oral flange; (k) the oral plenum chamber may include oral undercushion portions disposed around the periphery of the oral plenum chamber and extending radially from opposite ends of a separation structure to support the oral flange; (j) the separation structure may connect the nasal flange and the oral flange; (k) the separation structure may include an upper surface, a lower surface, and a connecting surface, the connecting surface having a higher rigidity than the upper and lower surfaces; and (l) the separation structure may be stiffer at a portion opposite the patient's face than at a portion adjacent the patient's face.(m) the separation structure may have a stiffness that increases radially from a portion adjacent the patient's face to a portion opposite the patient's face, (n) a nasal contacting portion of the nasal flange may be stiffer at a portion not in contact with the patient's nose than at a portion of the nasal flange not in contact with the patient's nose, (o) the nasal flange may have an increasing stiffness outward from the nasal opening, (p) the stiffness of the nasal flange may vary at predetermined locations around the nasal opening, (q) a lower portion 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 extending symmetrically around the nasal opening, each protruding end configured to seal against a corresponding ala of the patient's nose, and (s) the nasal plenum chamber may have a pair of nasal undercushion portions, each of the pair of nasal undercushion portions being connected to a pair of protruding ends. (t) each of the nasal undercushion portions may be positioned above the oral plenum chamber; (u) the patient interface may comprise 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) a top plate may be permanently connected to the nasal plenum chamber; (w) the top plate may be removably attached to a flexible connection region of the nasal plenum chamber; (x) the top plate may be removably attached to a rigid connection region of the nasal plenum chamber; and / or (y) the top plate and the rigidiser arm are integral parts, and the rigidiser arm is flexible relative to the top plate in a plane parallel to the patient's transverse plane.

[0037] Another aspect of the present technology may be directed to a patient interface for delivering breathable gas to a patient. The patient interface may include a nasal cushion 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, a separation structure disposed between the nasal cushion and the oral cushion, a pair of upper attachment features configured to releasably attach a pair of upper side straps of a positioning and stabilising structure to a top plate secured to the nasal cushion, and a pair of lower attachment features configured to releasably attach a pair of lower side straps of the positioning and stabilising structure to a face plate secured to the oral cushion.

[0038] In one example, (a) the decoupling structure may be adapted to form a pneumatic connection between the nasal gas chamber and the oral gas chamber; (b) the decoupling structure may have an upper surface, a lower surface, and a connecting surface, the connecting surface having a higher stiffness than the upper and lower surfaces; (c) the decoupling structure may have a radially variable stiffness around its circumference such that a portion distal to the patient's face is stiffer than a portion proximal to the patient's face, and may be configured such that a nasal cushion moves independently of an oral cushion; and (d) (e) the separation structure may be configured to support the nasal cushion against the patient's nose; (f) the nasal cushion may be stiffer at the portion of the nasal cushion not in contact with the patient's nose than at the nasal contact portion; (g) the nasal cushion may include a recess for sealing against the patient's upper lip; and (h) the nasal cushion includes a pair of protruding ends, each protruding end corresponding to a respective ala of the nose and nasolabial fold of the patient's face. (i) the nasal cushion may include a pair of nasal undercushion portions, each of which is disposed under a respective protruding end to support the respective protruding end against the patient's face; (j) the nasal cushion may include wings on either side of the nasal cushion to seal against a respective ala of the patient's nose; (k) the oral cushion may include oral undercushion portions extending radially around the oral cushion from either side of the separation structure to support the oral cushion against the patient's face; (l) the oral cushion may include a pair of oral undercushion portions, each of which is disposed on either side of the oral cushion to support the oral cushion against the patient's face; (m) the nasal cushion may be formed to include a recess configured to receive the tip of the patient's nose; (n) the nasal cushion may be configured to contact the lower periphery of the patient's nose below the bridge of the nose; (o) the nasal cushion, the oral cushion, and the separation structure may be integral parts;(p) the top plate may be permanently connected to the nasal plenum chamber; (q) the top plate may be removably attachable to a flexible connection region of the nasal plenum chamber; (r) the top plate may be removably attachable to a rigid connection region of the nasal plenum chamber; (s) the top plate and the rigidiser arm assembly form an integral part, and a pair of rigidiser arms of the rigidiser arm assembly are flexible relative to the top plate in a plane parallel to the patient's transverse plane; (t) the positioning and stabilising structure may comprise a rigidiser arm assembly releasably attachable to the top plate at upper attachment features; (u) the patient interface may further comprise a frame releasably attachable to the faceplate, and lower attachment features may be disposed on the frame; and (v) each of the lower attachment features may be configured to (w) the patient interface may comprise a top plate buffer for damping the connection between the top plate and the rigidiser arm assembly and a face plate buffer for damping the connection between the face plate and the frame; and / or (x) the frame may be formed to couple around the periphery of the face plate, the frame may comprise a catch, the face plate may comprise a notch, and engagement between the catch and the notch may couple the frame to the face plate.

[0039] Another aspect of the present technology may be directed to a patient interface for delivering breathable gas to a patient, the patient interface comprising: a plenum chamber assembly comprising: a nasal plenum chamber at least partially defining a first gas chamber, the nasal plenum chamber adapted to seal against the patient around a lower perimeter of the patient's nose below the bridge of the nose; and an oral plenum chamber at least partially defining a second gas chamber and operatively connected to the nasal plenum chamber, the patient interface comprising a one-piece plate member having an upper portion releasably attachable to the nasal plenum chamber and a lower portion releasably attachable to the oral plenum chamber, the upper portion of the plate member including at least one connection feature configured to releasably retain a first portion of a positioning and stabilising structure having a pair of rigidiser arms, and the lower portion of the plate member configured to releasably retain a second portion of the positioning and stabilising structure.

[0040] In one example, (a) the plenum chamber assembly may include a separation structure at least partially connecting the nasal plenum chamber and the oral plenum chamber, the separation structure at least partially defining a flow path between the nasal plenum chamber and the oral plenum chamber; and (b) each of the pair of rigidiser arms is bendable in a plane parallel to the patient's cross-section, and each of the pair of rigidiser arms is structured to resist bending, to resist twisting, and / or to resist extension in a plane perpendicular to the patient's cross-section. (c) each of the at least one connection feature may comprise a hinge such that a corresponding one of the pair of rigidiser arms can rotate the top of the unitary side plate member relative to the rigid top plate in a plane parallel to the patient's transverse plane; (d) the first portion of the positioning and stabilising structure may include a hook for pivotally connecting with the connection feature of the top of the unitary plate member; and (e) the nasal plenum chamber may comprise a nasal flange defining a nasal opening, and the nasal flange may form a seal with at least the patient's nose. (e) the nasal flange may include a recess for receiving the tip of the patient's nose; (f) the oral plenum chamber may include an oral flange defining an oral opening and configured to form a seal with at least the patient's mouth; (g) the oral flange may be formed around the entire periphery of the oral plenum chamber, or around two opposite sides of the periphery of the oral plenum chamber, or around a majority of the periphery of the oral plenum chamber; (f) the oral plenum chamber may include a pair of oral undercushion portions, one on each side of the oral plenum chamber to support the oral flange; (g) the oral plenum chamber may include oral undercushion portions disposed around the periphery of the oral plenum chamber and extending radially from opposite ends of a separation structure to support the oral flange; (h) the separation structure may connect the nasal flange and the oral flange; (i) the separation structure may be stiffer at a portion opposite the patient's face than at a portion adjacent the patient's face;(j) the separation structure may have a stiffness that increases radially from a portion adjacent the patient's face to a portion opposite the patient's face; (k) a nose-contacting portion of the nasal flange may be stiffer at a portion of the nasal flange not contacting the patient's nose than at a portion of the nasal flange not contacting the patient's nose; (l) the nasal flange may have an increasing stiffness outward from the nasal opening; (m) the stiffness of the nasal flange may vary at predetermined locations around the nasal opening; (n) a lower portion of the nasal flange near the separation structure may be concave to seal against the patient's upper lip; and (o) The nasal flange may include a pair of protruding ends extending symmetrically around the nasal opening, each protruding end configured to seal against a corresponding ala of the patient's nose; (p) the nasal plenum chamber may include a pair of nasal undercushion portions, each of which corresponds to a respective protruding end for supporting the respective protruding end; (q) each of the nasal undercushion portions may be positioned above the oral plenum chamber; and / or (r) each of the pair of rigidiser arms may have an elliptical curvature between a first end and a second end.

[0041] Another aspect of the present technology may be directed to a cushion assembly for a patient interface for treating sleep disordered breathing in a patient, the cushion assembly including: a nasal cushion coupled to a nasal plenum chamber, the nasal cushion configured to seal around an inferior periphery of the patient's nose; an oral cushion coupled to an oral plenum chamber, the oral cushion configured to seal around the patient's mouth; a decoupling structure connecting the nasal cushion and the nasal plenum chamber to the oral cushion and the oral plenum chamber, the decoupling structure configured to allow the nasal cushion and the nasal plenum chamber to move relative to the oral cushion and the oral plenum chamber; and a pair of side supports, each of the pair of side supports configured to support a respective one of the pair of side supports. the patient interface comprises a pair of side supports located on either side of the nasal cushion and connecting each side of the nasal cushion to the oral cushion; a pair of undercushion support walls provided to support a protruding end portion located on the rear side of the nasal cushion; and a pair of pockets, each located on either side of the nasal cushion, each of the pair of pockets including an upper surface defined by the nasal cushion and the nasal plenum chamber, each of the pair of pockets including a lower surface defined by the oral cushion and the oral plenum chamber, and each of the pair of pockets including a side surface defined by the separation structure and a corresponding one of the pair of side supports, wherein the openings of each of the pair of pockets are located on opposite sides of the patient's face when the patient interface is worn by the patient.

[0042] In one example, (a) each of the pair of side supports may include a notch that provides a pivot point for relative movement between the nasal cushion and the oral cushion, (b) the notch of each of the pair of side supports may open in a direction away from the patient's face when the patient interface is worn by the patient, (c) the nasal cushion may include a pair of reinforcing portions, each of the pair of reinforcing portions may be located on either side of the nasal cushion, and the reinforcing portions may be stiffer than the rest of the nasal cushion, (d) the pair of reinforcing portions may be thicker than the other portions of the nasal cushion, and (e) the pair of reinforcing portions may prevent the outer surface of the nasal cushion from being raised. (f) the nasal cushions may comprise a nasal sling, the nasal sling being formed flush with the nasal cushions and configured to contact the bridge of the patient's nose; (g) the nasal cushions and nasal sling may define a pair of nostril ports, each of the pair of nostril ports being configured to be in pneumatic communication with a corresponding one of the patient's nares; and (h) the nasal sling may be configured 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 cushions and the nasal plenum chamber.

[0043] Another aspect of the present technology is directed to a patient interface system for delivering breathable gas to a patient, the patient interface comprising: a cushion assembly, the cushion assembly may comprise: 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 disposed 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 features configured to releasably attach corresponding ones of the pair of lower side straps of the positioning and stabilizing structure to the cushion assembly, each of the pair of lower attachment features comprising a thermoplastic elastomer, and a first magnet embedded within each of the pair of lower attachment features.

[0044] In one example, (a) the patient interface system further comprises a faceplate secured to the oral cushion and a frame releasably attachable to the faceplate, wherein the pair of lower attachment features are secured to the frame; (b) the frame may comprise a material harder than a thermoplastic elastomer; (c) the pair of lower attachment features may be molded onto the frame; (d) the positioning and stabilising structure may comprise a pair of clips for attaching corresponding lower side straps of the pair of lower side straps to corresponding lower attachment features of the pair of lower attachment features; and (e) each of the pair of clips is a clip of the pair of clips. Each of the pair of clips may include a second magnet for attaching it to a corresponding one of the pair of lower mounting features; (f) each of the pair of clips may include a notch and each of the pair of lower mounting features may include a protrusion, and the protrusion may engage with the notch when each of the pair of clips engages with a corresponding one of the pair of lower mounting features; (g) each of the pair of lower mounting features may include a bending point and each of the pair of lower mounting features may be structured to bend at the bending point; and / or (h) each of the pair of lower mounting features may include a region of reduced thickness at the bending point.

[0045] Another aspect of the present technology is directed to a patient interface system for delivering breathable gas to a patient, the patient interface including: 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; a separation structure disposed between the nasal cushion and the oral cushion; a top plate secured to the nasal cushion; and a rigidiser arm assembly releasably attachable to the top plate, the rigidiser arm assembly and the top plate engaging at least three contact points.

[0046] In one example, (a) the top plate may include a pair of upper mounting features, and the rigidiser arm assembly may include a pair of connection features, each of the pair of connection features configured to engage a corresponding upper mounting feature of the pair of upper mounting features; (b) the rigidiser arm assembly may include a rib for engaging with the top plate when the rigidiser arm assembly engages with the top plate; and (c) the patient interface may include a top plate buffer for damping the engagement between the rigidiser arm assembly and the top plate, and the top plate The top plate buffer may be located on the front side of the top plate to contact the rear side of the rigidiser arm assembly; (d) the top plate buffer and the nasal cushion may be an integral part, with the top plate buffer extending from the nasal cushion through the top plate; (e) the rigidiser arm assembly may comprise a pair of rigidiser arms, each of which may be configured to receive an upper side strap of the positioning and stabilising structure; and / or (f) each of the pair of rigidiser arms may comprise a pad for cushioning the pair of rigidiser arms against the patient's face.

[0047] Another aspect of the present technology is directed to a patient interface for delivering breathable gas to a patient, the patient interface comprising: 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 disposed between the nasal cushion and the oral cushion, the separation structure comprising an upper surface coupling the separation structure to the nasal cushion, a lower surface coupling the separation structure to the oral cushion, and a connecting surface coupling the upper and lower surfaces, the upper and lower surfaces being approximately 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 approximately twice as thick as the upper and lower surfaces, (b) the isolation structure may be structured to be flexible so that the upper and lower surfaces can be positioned at up to 50° relative to each other, and / or (c) the upper and lower surfaces may be approximately 0.5 mm thick and the connecting surface is approximately 1.2 mm thick.

[0049] Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured with a clearly defined perimeter that is adapted to match the perimeter of the intended wearer. The patient interface system can have a reduced number of parts compared to currently available patient interface systems. The patient interface system can allow visibility of the patient's mouth area if the faceplate is translucent or transparent. The patient interface system is an oronasal mask, meaning it covers the nasal airway and mouth. An oronasal mask does not obstruct the patient's line of sight and can be considered physiologically non-threatening, improving patient adoption of the system and compliance with treatment. The patient interface system may flex to accommodate changes in jaw movement and head position throughout the night. The patient interface system may deliver a predetermined amount of pressurized air or breathable gas to the patient's nasal passages and may prevent or reduce mouth leaks by providing an effective seal with both the patient's mouth and the patient's nasal passages.

[0050] Another aspect of one form of the present technology is a patient interface that has a reduced skin contact area and fewer overall contact points with the face compared to known full face masks. This allows for significantly less headgear tension to be applied, which can significantly improve patient comfort. By removing any mass, especially near the eyes, patient comfort can be further improved as the patient is less likely to feel claustrophobic.

[0051] Another aspect of one form of the present technology is a patient interface that can be quickly and easily installed by all customer segments, including patients, home medical equipment dealers, and physicians. This patient interface simplifies mask selection for physicians and dealers due to its superior ease of use (fitting, sealing, size selection, sometimes remotely), and its intuitive assembly and fitting allows for highly successful remote setup in an unassisted environment without instruction. 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 anticipated that the three sizes of the patient interface will fit at least 90% of the general adult population.

[0052] Of course, some of the aspects may form sub-aspects of the technology, and various of the sub-aspects and / or aspects may be combined in various ways and form further aspects or sub-aspects of the technology.

[0053] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims.

[0054] 4. Brief description of some of the figures in the drawing The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings in which: In the drawings, like reference numerals refer to like elements. [Brief explanation of the drawings]

[0055] 4.1 Treatment System [Figure 1a] 1 shows a system in accordance with the present technology. A patient 1000 wearing a patient interface 3000 receives a supply of air at positive pressure from a PAP device 4000. The air from the PAP device is humidified in a humidifier 5000 and passes along an air circuit 4170 towards the patient 1000. A bed partner 1100 is also shown. [Figure 1b] 1 shows a PAP device for use with a patient with a nasal mask. [Figure 1c] The PAP device is shown for use with a patient wearing a full-face mask. 4.2 Treatment 4.2.1 Respiratory system [Figure 2a] 1 shows a general view of the human respiratory system, including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2b] 4.2.2 Facial Anatomy [Figure 2c] FIG. 1 is a front view of a face with several features of the surface anatomy identified, including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner corners of the eyes, alae of the nose, nasolabial folds, and corners of the mouth. [Figure 2d] A side view of the head with several features of the surface anatomy identified, including the glabella, root of the nose, tip of the nose, nasal spine, upper lip, lower lip, maxilla, nasal ridge, superior ear base, and inferior ear base. Also shown are the superior and inferior, and anterior and posterior directions. [Figure 2e] 1 is a further lateral view of the head, showing the approximate location of the Frankfort plane and the nasolabial angle. [Figure 2f] A bottom view of the nose is shown. [Figure 2g] 1 shows a side view of the surface features of the nose. [Figure 2h] Shown are the lateral nasal cartilages, septal cartilage, greater alar cartilage, lesser alar cartilage, and subcutaneous structures of the nose, including fibroadipose tissue. [Figure 2i] There is a medial nasal detachment of approximately a few millimeters from the sagittal plane, particularly showing the septal cartilage and the medial crus of the greater alar cartilage. [Figure 2j] 1 shows a frontal view of the bones of the skull, including the frontal bone, temporal bone, nasal bone, and cheekbone. The nasal turbinates are shown, as well as the maxilla, mandible, and mental protuberance. [Figure 2k]Shows a lateral view of the skull with the surface outline of the head and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2l] An anterior-lateral view of the skull and tissue structures is shown. 4.3 Patient Interface [Figure 3a]

[0033] Fig. 14 shows a perspective view of a patient interface in accordance with an example of the present technology. [Figure 3b]

[0043] Fig. 14 shows a front view of a patient interface in accordance with an example of the present technology. [Figure 3c]

[0047] Fig. 11 shows a rear view of a patient interface in accordance with an example of the present technology. [Figure 3d]

[0033] Fig. 14 shows a top view of a patient interface in accordance with an example of the present technology. [Figure 3e]

[0033] Fig. 14 shows a bottom view of a patient interface in accordance with an example of the present technology. [Figure 3f]

[0033] Fig. 14 shows a side view of a patient interface in accordance with an example of the present technology. [Figure 3g]

[0033] Fig. 14 shows a perspective view of a patient interface including an air circuit in accordance with an example of the present technology. [Figure 3h]

[0043] Fig. 14 shows a rear view of a patient interface including an air circuit in accordance with an example of the present technology. [Figure 3i]

[0033] Fig. 14 shows a front view of a patient interface including an air circuit in accordance with an example of the present technology. [Figure 3j]

[0033] Fig. 14 shows a top view of a patient interface including an air circuit in accordance with an example of the present technology. [Figure 3k]

[0033] Fig. 14 shows a bottom view of a patient interface including an air circuit in accordance with an example of the present technology. [Figure 3l]

[0023] Fig. 14 shows a side of a patient interface including an air circuit in accordance with an example of the present technology. [Figure 3m]

[0033] Fig. 14 shows a perspective view of a patient interface including an air circuit worn by a patient in accordance with an example of the present technology. [Figure 3n]

[0033] Fig. 14 shows a front view of a patient interface including an air circuit worn by a patient in accordance with an example of the present technology. [Figure 3o]

[0033] Fig. 14 shows a side view of a patient interface including an air circuit worn by a patient in accordance with an example of the present technology. [Figure 3p]

[0033] Fig. 14 shows a top view of a patient interface including an air circuit worn by a patient in accordance with an example of the present technology. [Figure 3q]

[0023] Figure 10 shows a side cross-sectional view of a patient interface in accordance with an example of the present technology with the patient interface positioned against the patient's face, with the patient shown with a cross-section of the track [Figure 3r]

[0033] Figure 1 shows a detailed front perspective view of a portion of a patient interface in accordance with an example of the present technology, with the patient interface shown in dashed lines and the patient's nose, mouth, and chin shown in solid lines [Figure 3s]

[0033] Fig. 14 shows an exploded perspective view of a patient interface in accordance with an example of the present technology. [Figure 3t]

[0043] Fig. 14 shows an exploded front view of a patient interface in accordance with an example of the present technology. [Figure 3u]

[0033] Fig. 14 shows an exploded rear view of a patient interface in accordance with an example of the present technology. [Figure 4a]

[110] Fig. 114 shows a top view of a nasal cradle cushion of a patient interface in accordance with an example of the present technology. [Figure 4b] FIG. 4c shows a bottom cross section view taken through line 4c-4c of FIG. 4a of a nasal cradle cushion of a patient interface in accordance with an example of the present technology. [Figure 4c] 4c shows a side cross-sectional view taken through line 4c-4c of FIG. 4a of a nasal cradle cushion of a patient interface in accordance with an example of the present technology, with the patient's nose shown in dashed lines. [Figure 5a]

[0043] Fig. 14 shows a top view of another nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Figure 5b] FIG. 5c shows a bottom cross-sectional view taken through line 5c-5c of FIG. 5a of another nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Figure 5c]

[0033] Figure 5c shows a side cross-sectional view taken through line 5c-5c of Figure 5a of another nasal cradle cushion of a patient interface in accordance with an example of the present technology, with the patient's nose shown in dashed lines. [Figure 6a]

[0043] Fig. 14 shows a top view of another nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Figure 6b] FIG. 6c shows a bottom cross-sectional view taken through line 6c-6c of FIG. 6a of another nasal cradle cushion of a patient interface in accordance with another example of the present technology. [Figure 6c] 6c shows a side cross-sectional view taken through line 6c-6c of FIG. 6a of another nasal cradle cushion of a patient interface in accordance with another example of the present technology, with the patient's nose shown in dashed lines. [Figure 7a]

[0043] Fig. 144 shows a rear perspective view of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 7b]

[0043] Fig. 144 shows a side perspective view of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 7c]

[0043] Fig. 144 shows a front perspective view of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 7d]

[0047] Fig. 144 shows a rear view of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 7e]

[0043] Fig. 14 shows a front view of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 7f]

[0043] Fig. 14 shows a top view of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 7g]

[0043] Fig. 14 shows a bottom view of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 7h]

[0043] Fig. 14 shows a side view of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8a]

[0033] Fig. 11 shows a top view of a plenum chamber assembly of a patient interface in accordance with an example of the present technology, including several lines defining various cross sections. [Figure 8b] FIG. 8b shows a cross-sectional side view taken through line 8b-8b of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8c]FIG. 8c shows a cross-sectional side view taken through line 8c-8c of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8d] FIG. 8d shows a cross-sectional side view taken through line 8d-8d of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8e] FIG. 8e shows a cross-sectional side view taken through line 8e-8e of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8f] FIG. 8f shows a cross-sectional side view taken through line 8f-8f of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8g] FIG. 8g shows a cross-sectional front view taken through line 8g-8g of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8h] FIG. 8h shows a cross-sectional front view taken through line 8h-8h of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8i] FIG. 8i shows a cross-sectional front view taken through line 8i-8i of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8j] FIG. 8j shows a cross-sectional front view taken through line 8j-8j of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8k] FIG. 8k shows a cross-sectional side view taken through line 8k-8k of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 8l] FIG. 8l shows a side cross-sectional view taken through line 8l-8l of FIG. 8a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 9a]

[0033] Fig. 11 shows a top view of a plenum chamber assembly of a patient interface in accordance with an example of the present technology, including several lines defining various cross sections. [Figure 9b] FIG. 9b shows a cross-sectional side view taken through line 9b-9b of FIG. 9a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 9c] FIG. 9c shows a cross-sectional side view taken through line 9c-9c of FIG. 9a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 9d] FIG. 9d shows a cross-sectional side view taken through line 9d-9d of FIG. 9a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 9e] FIG. 9e shows a cross-sectional side view taken through line 9e-9e of FIG. 9a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 9f] FIG. 9f shows a cross-sectional side view taken through line 9f-9f of FIG. 9a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 9g] FIG. 9g shows a cross-sectional side view taken through line 9g-9g of FIG. 9a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 9h] FIG. 9h shows a cross-sectional side view taken through line 9h-9h of FIG. 9a of a plenum chamber assembly of a patient interface in accordance with an example of the present technology. [Figure 9i] FIG. 9i shows a cross-sectional side view taken through line 9i-9i of FIG. 9a of a plenum chamber assembly of a patient interface in accordance with one form of the present technology. [Figure 10a]

[110] Fig. 114 shows a top view of nasal cushions of a patient interface in accordance with an example of the present technology. [Figure 10b]

[0033] Fig. 14 shows a top view of a nasal cushion of a patient interface in accordance with another example of the present technology. [Figure 10c]

[0033] Fig. 14 shows a top view of a nasal cushion of a patient interface in accordance with another example of the present technology. [Figure 10d]

[0033] Fig. 14 shows a top view of a nasal cushion of a patient interface in accordance with another example of the present technology. [Figure 11a] FIG. 4b shows a cross-section view of a nasal cushion taken through line 11a-11a in FIG. 4a according to an example of the present technology. [Figure 11b] FIG. 14 shows a cross section of a nasal cushion taken through lines 11b, 11c in FIG. 13 according to an example of the present technology. [Figure 11c]FIG. 14 shows a cross section of a nasal cushion taken through lines 11b, 11c in FIG. 13 according to an example of the present technology. [Figure 12a] FIG. 13 shows a rear view of a mouth cushion with an undercushion of an exemplary seal-forming structure in accordance with the present technology. [Figure 12b] FIG. 13 shows a rear view of a mouth cushion with an undercushion of another exemplary seal-forming structure according to the present technology. [Figure 12c] FIG. 13 shows a rear view of a mouth cushion with an undercushion of another exemplary seal-forming structure according to the present technology. [Figure 12d] FIG. 13 shows a rear view of a mouth cushion with an undercushion of another exemplary seal-forming structure according to the present technology. [Figure 13]

[110] Fig. 114 shows a top view of a nasal cradle cushion of a patient interface in accordance with an example of the present technology. [Figure 14]

[0033] Fig. 14 shows an exploded rear view of a patient interface in accordance with an example of the present technology. [Figure 15a]

[111] Fig. 111 shows a front view of a seal-forming structure, top plate and rigidiser arm according to an example of the present technology. [Figure 15b]

[0033] Fig. 13 shows a front view of a seal-forming structure, top plate and rigidiser arm according to another example of the present technology. [Figure 15c]

[111] Fig. 111 shows a front view of a seal-forming structure, top plate and rigidiser arm according to an example of the present technology. [Figure 15d]

[111] Fig. 111 shows a front view of a seal-forming structure, top plate and rigidiser arm according to an example of the present technology. [Figure 15e]

[111] Fig. 111 shows a front view of a seal-forming structure, top plate and rigidiser arm according to an example of the present technology. [Figure 16a]

[214] Fig. 11 shows a top perspective view of a seal-forming structure and plenum chamber according to an example of the present technology. [Figure 16b]

[210] Fig. 110 shows a bottom perspective view of a seal-forming structure and plenum chamber according to an example of the present technology. [Figure 16c]

[0033] Fig. 14 shows a further top perspective view of a seal-forming structure and plenum chamber according to an example of the present technology. [Figure 16d]

[210] Fig. 11 shows a front view of a seal-forming structure and plenum chamber according to an example of the present technology. [Figure 16e]

[210] Fig. 11 shows a rear view of a seal-forming structure and plenum chamber according to an example of the present technology. [Figure 16f]

[214] Fig. 11 shows a top view of a seal-forming structure and plenum chamber according to an example of the present technology. [Figure 16g]

[214] Fig. 11 shows a bottom view of a seal-forming structure and plenum chamber according to an example of the present technology. [Figure 16h]

[214] Fig. 11 shows a side view of a seal-forming structure and plenum chamber according to an example of the present technology. [Figure 16i]

[0033] Fig. 16i shows a cross section view of a seal-forming structure and plenum chamber taken through line 16i-16i of Figure 16d according to an example of the present technology. [Figure 16j]

[0033] Fig. 16j shows a cross section of a seal-forming structure and plenum chamber taken through line 16j-16j of Fig. 16f according to an example of the present technology. [Figure 16k]

[0033] Fig. 16k shows a cross section of a seal-forming structure and plenum chamber taken through line 16k-16k of Fig. 16h according to an example of the present technology. [Figure 16l]

[0033] Fig. 16l shows a cross section of a seal-forming structure and plenum chamber taken through line 16l-16l in Fig. 16d according to an example of the present technology. [Figure 16m]

[0033] Fig. 16m shows a cross section view of a seal-forming structure and plenum chamber taken through line 16m-16m of Figure 16g according to an example of the present technology. [Figure 16n]

[214] Fig. 11 shows a detailed front perspective view of a seal-forming structure and plenum chamber according to an example of the present technology. [Figure 16o]

[0033] Fig. 16o shows a cross section of a seal-forming structure and plenum chamber taken through line 16o-16o of Figure 16d according to an example of the present technology. [Figure 17a]

[0033] Fig. 14 shows a perspective view of a patient interface in accordance with an example of the present technology. [Figure 17b]

[0043] Fig. 14 shows a front view of a patient interface in accordance with an example of the present technology. [Figure 17c]

[0047] Fig. 11 shows a rear view of a patient interface in accordance with an example of the present technology. [Figure 17d]

[0033] Fig. 14 shows a top view of a patient interface in accordance with an example of the present technology. [Figure 17e]

[0033] Fig. 14 shows a bottom view of a patient interface in accordance with an example of the present technology. [Figure 17f]

[0033] Fig. 14 shows a side view of a patient interface in accordance with an example of the present technology. [Figure 18a]

[210] Fig. 11 shows a perspective view of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 18b]

[210] Fig. 110 shows a front view of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 18c]

[210] Fig. 110 shows a side view of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 18d]

[210] Fig. 110 shows a top view of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 18e]

[210] Fig. 110 shows a rear view of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 18f] FIG. 18f shows a cross section taken through line 18f-18f of FIG. 18d of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 19a]

[0033] Fig. 14 shows a perspective view of a rigidiser arm assembly according to an example of the present technology. [Figure 19b]

[210] Fig. 11 shows a front view of a rigidiser arm assembly according to an example of the present technology. [Figure 19c]

[210] Fig. 11 shows a side view of a rigidiser arm assembly according to an example of the present technology. [Figure 19d]

[230] Fig. 124 shows a top view of a rigidiser arm assembly according to an example of the present technology. [Figure 19e]

[230] Fig. 134 shows a rear view of a rigidiser arm assembly according to an example of the present technology. [Figure 19f]

[230] Fig. 124 shows a top view of a rigidiser arm assembly according to an example of the present technology. [Figure 19g]

[210] Fig. 114 shows another top view of a rigidiser arm assembly according to an example of the present technology. [Figure 19h]

[230] Fig. 134 shows a rear view of a rigidiser arm assembly according to an example of the present technology. [Figure 20a]

[214] Fig. 11 shows a perspective view of a faceplate frame, lower attachment features, and clips according to an example of the present technology. [Figure 20b]

[214] Fig. 11 shows a front view of a faceplate frame, lower attachment features, and clips according to an example of the present technology. [Figure 20c]

[216] Fig. 11 shows a rear view of a faceplate frame, lower attachment features, and clips according to an example of the present technology. [Figure 20d]

[210] Fig. 110 shows a side view of a faceplate frame, lower attachment features, and clips according to an example of the present technology. [Figure 20e]

[214] Fig. 11 shows a top view of a faceplate frame, lower attachment features, and clips according to an example of the present technology. [Figure 20f]

[216] Fig. 11 shows a partially exploded perspective view of a faceplate frame, lower mounting features, and clips according to an example of the present technology. [Figure 20g]

[0033] Fig. 13 shows another partially exploded perspective view of a faceplate frame, lower mounting features, and clips according to an example of the present technology. [Figure 20h]

[214] Fig. 11 shows an exploded perspective view of a faceplate frame, lower attachment features, and clips according to an example of the present technology. [Figure 20i]

[111] Fig. 11 shows a perspective view of a faceplate frame according to an example of the present technology. [Figure 20j]

[214] Fig. 11 shows a front view of a faceplate frame in accordance with an example of the present technology. [Figure 20k]

[210] Fig. 11 shows a rear view of a faceplate frame in accordance with an example of the present technology. [Figure 20l]

[210] Fig. 11 shows a side view of a faceplate frame in accordance with an example of the present technology. [Figure 20m]

[114] Fig. 11 shows a top view of a faceplate frame in accordance with an example of the present technology. [Figure 20n]

[210] Fig. 11 shows a rear view of a faceplate frame in accordance with an example of the present technology. [Figure 20o]

[0033] Fig. 13 shows another partially exploded perspective view of a faceplate frame, lower mounting features, and clips according to an example of the present technology. [Figure 20p]

[214] Fig. 11 shows an exploded perspective view of a faceplate frame, lower attachment features, and clips according to an example of the present technology. [Figure 20q]

[114] Fig. 11 shows a top view of a faceplate frame in accordance with an example of the present technology. [Figure 20r]

[114] Fig. 11 shows a top view of a faceplate frame in accordance with an example of the present technology. [Figure 20s]

[114] Fig. 11 shows a top view of a faceplate frame in accordance with an example of the present technology. [Figure 21a]

[111] Fig. 11 shows a perspective view of a top plate according to an example of the present technology. [Figure 21b]

[214] Fig. 11 shows a front view of a top plate according to an example of the present technology. [Figure 21c]

[214] Fig. 11 shows a rear view of a top plate in accordance with an example of the present technology. [Figure 21d]

[114] Fig. 11 shows a top view of a top plate in accordance with an example of the present technology. [Figure 21e]

[214] Fig. 11 shows a side view of a top plate according to an example of the present technology. [Figure 22a]

[0033] Fig. 14 shows a perspective view of a faceplate in accordance with an example of the present technology. [Figure 22b]

[114] Fig. 11 shows a front view of a faceplate in accordance with an example of the present technology. [Figure 22c]

[110] Fig. 11 shows a rear view of a faceplate in accordance with an example of the present technology. [Figure 22d]

[111] Fig. 111 shows a side view of a faceplate in accordance with an example of the present technology. [Figure 22e]

[114] Fig. 11 shows a top view of a faceplate in accordance with an example of the present technology. [Figure 23a]

[214] Fig. 11 shows a front perspective view of a lower attachment feature support according to an example of the present technology. [Figure 23b]

[214] Fig. 117 shows another front perspective view of a lower attachment feature support according to an example of the present technology. [Figure 23c]

[210] Fig. 110 shows a rear view of a lower attachment feature support according to an example of the present technology. [Figure 23d]

[210] Fig. 110 shows a top perspective view of a lower attachment feature support according to an example of the present technology. [Figure 23e]

[210] Fig. 110 shows a side perspective view of a lower attachment feature support according to an example of the present technology. [Figure 23f]

[210] Fig. 110 shows another side perspective view of a lower attachment feature support according to an example of the present technology. [Figure 23g]

[214] Fig. 11 shows another perspective view of a lower attachment feature support in accordance with an example of the present technology. [Figure 23h]

[214] Fig. 11 shows another perspective view of a lower attachment feature support in accordance with an example of the present technology. [Figure 23i]

[214] Fig. 11 shows another perspective view of a lower attachment feature support in accordance with an example of the present technology. [Figure 23j]

[214] Fig. 11 shows another perspective view of a lower attachment feature support in accordance with an example of the present technology. [Figure 23k]

[214] Fig. 11 shows another perspective view of a lower attachment feature support in accordance with an example of the present technology. [Figure 23l]

[214] Fig. 11 shows another perspective view of a lower attachment feature support in accordance with an example of the present technology. [Figure 23m]

[214] Fig. 11 shows another perspective view of a lower attachment feature support in accordance with an example of the present technology. [Figure 24a]

[216] Fig. 116 shows a front perspective view of a connector for a lower attachment feature according to an example of the present technology. [Figure 24b]

[0047] Fig. 134 shows another front perspective view of a connector for a lower attachment feature according to an example of the present technology. [Figure 24c]

[210] Fig. 11 shows a rear view of a connector on a lower attachment feature according to an example of the present technology. [Figure 24d]

[114] Fig. 116 shows a top perspective view of a connector for a lower attachment feature according to an example of the present technology. [Figure 24e]

[114] Fig. 116 shows a side perspective view of a connector for a lower attachment feature according to an example of the present technology. [Figure 24f]

[0047] Fig. 134 shows another rear perspective view of a connector of a lower attachment feature according to an example of the present technology. [Figure 25a]

[214] Fig. 11 shows a front perspective view of a clip according to an example of the present technology. [Figure 25b]

[214] Fig. 11 shows another front perspective view of a clip according to an example of the present technology. [Figure 25c]

[210] Fig. 11 shows a rear perspective view of a clip according to an example of the present technology. [Figure 25d]

[214] Fig. 11 shows a top perspective view of a clip according to an example of the present technology. [Figure 25e]

[210] Fig. 11 shows a side perspective view of a clip according to an example of the present technology. [Figure 25f]

[210] Fig. 11 shows another rear perspective view of a clip according to an example of the present technology. [Figure 25g]

[214] Fig. 11 shows a top perspective view of a clip according to an example of the present technology. [Figure 25h]

[214] Fig. 11 shows another front perspective view of a clip according to an example of the present technology. [Figure 25i]

[210] Fig. 11 shows a rear perspective view of a clip according to an example of the present technology. [Figure 25j]

[214] Fig. 11 shows a top perspective view of a clip according to an example of the present technology. [Figure 25k]

[210] Fig. 11 shows a side perspective view of a clip according to an example of the present technology. [Figure 25l]

[210] Fig. 11 shows another rear perspective view of a clip according to an example of the present technology. [Figure 26a]

[0033] Fig. 14 shows a perspective view of a tube separation structure according to an example of the present technology. [Figure 26b]

[214] Fig. 11 shows a front view of a tube separation structure according to an example of the present technology. [Figure 26c]

[210] Fig. 110 shows a rear view of a tube separation structure according to an example of the present technology. [Figure 26d] FIG. 26d shows a cross section of a tube separation structure taken through line 26d-26d in FIG. 26c according to an example of the present technology. [Figure 27a]

[210] Fig. 11 shows a perspective view of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 27b]

[210] Fig. 110 shows a front view of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 27c]

[210] Fig. 110 shows a side view of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 27d]

[210] Fig. 110 shows a top view of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 27e]

[210] Fig. 110 shows a rear perspective view of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 27f] FIG. 27f shows a cross section taken through line 27f-27f of FIG. 27d of a seal-forming structure with a top plate and a face plate according to an example of the present technology. [Figure 28a]

[111] Fig. 11 shows a perspective view of a top plate according to an example of the present technology. [Figure 28b]

[214] Fig. 11 shows a front view of a top plate according to an example of the present technology. [Figure 28c]

[214] Fig. 11 shows a rear view of a top plate in accordance with an example of the present technology. [Figure 28d]

[114] Fig. 11 shows a top view of a top plate in accordance with an example of the present technology. [Figure 28e]

[214] Fig. 11 shows a side view of a top plate according to an example of the present technology. [Figure 29a]

[0033] Fig. 14 shows a perspective view of a patient interface in accordance with an example of the present technology. [Figure 29b]

[0043] Fig. 14 shows a front view of a patient interface in accordance with an example of the present technology. [Figure 29c]

[0047] Fig. 11 shows a rear view of a patient interface in accordance with an example of the present technology. [Figure 29d]

[0033] Fig. 14 shows a top view of a patient interface in accordance with an example of the present technology. [Figure 29e]

[0033] Fig. 14 shows a bottom view of a patient interface in accordance with an example of the present technology. [Figure 29f]

[0033] Fig. 14 shows a side view of a patient interface in accordance with an example of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0056] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific embodiments, which may vary, described herein. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the specific embodiments discussed herein, and is not intended to be limiting.

[0057] The following description is provided in connection with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or embodiments. Also, any single feature or combination of features in any embodiment may constitute an additional embodiment.

[0058] 5.1 Treatment System In one form, the technology comprises an apparatus for treating a respiratory disorder, hi one example, the apparatus 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 form, the present technology comprises a method for treating a respiratory disorder comprising applying positive pressure to an entrance to the airways of a patient 1000.

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

[0061] 5.3 Patient Interface A non-invasive patient interface according to one aspect of the present 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 forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure is positioned to surround an entrance to the patient's airways to facilitate the delivery of air at positive pressure to the airways.

[0062] 3a shows a front perspective view of a patient interface 3000 in accordance with 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 stabilising structure 3300.

[0063] 5.3.1 Plenum chamber and seal-forming structure 3a, the upper portion of the seal-forming structure 3100 may include a nasal cushion or flange 3112 for sealing around the lower portion of the patient's nose, particularly around the ala and tip of the nose. This nasal cushion 3112 may define, at least in part, an upper gas chamber, which will be discussed in more detail below.

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

[0065] The rear view of Figure 3c shows the portion of the seal-forming structure 3100 that may contact the patient's face during use. The nasal cushion 3112 is shown connected to the top of the oral cushion 3110 by a decoupling structure 3106. The decoupling structure 3106 may be understood to be an intermediate structure that joins the nasal cushion 3112 and the oral cushion 3110. The decoupling structure 3106 may allow the nasal cushion 3112 and the oral cushion 3110 to move relative to one another while maintaining an air pressure flow path therebetween. The nasal cushion 3112 may define a nasal gas chamber 3104, and a nasal gas chamber opening 3103 of the nasal cushion 3112 may receive a portion of the patient's nose during treatment. During treatment, breathable gas may be supplied to the patient from the patient interface 3000 through the nasal gas chamber 3104 and toward the nose. The oral cushion 3110 may include an oral gas chamber 3102 and an oral gas chamber opening 3101 for supplying breathable gas to the patient's mouth during treatment. The faceplate 3204 and port 3600 are visible through the oral gas chamber 3102 of the oral cushion 3110. It should be understood that when the patient interface 3000 is worn on a patient, the faceplate 3204, plenum chamber 3200, oral cushion 3110, nasal cushion 3112, and isolation structure 3106, together with the patient's face, at least partially define the nasal gas chamber 3104 and the oral gas chamber 3102 through which breathable gas may be supplied to the patient at positive pressure.

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

[0067] FIG. 3r illustrates how an exemplary patient interface 3000 can seal against a patient, particularly the nose. In this detailed front perspective view, the patient's nose, mouth, and chin are shown in solid lines, and the nasal cushion 3112, shown against the nose, is shown in dashed lines. It should be understood that the nasal cushion 3112 may be concave to cradle the patient's nose. A recess 3116 is shown to receive the tip of the nose, and the protruding end 3114 can be seen to seal in the area of ​​the alar and nasolabial folds. A nasal undercushion support wall 3208 supports the nasal cushion 3112 in the area of ​​the protruding end 3114, helping to maintain a seal in this area and may also function like an undercushion. The nasal plenum chamber 3202 is also shown. For clarity, the oral components of the patient interface 3000 are not shown in this view.

[0068] 3d also shows a recess 3116 that may be included on the nasal cushion 3112. This recess 3116 may comprise an inward molding 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 better seal around and under the tip of the patient's nose during treatment by allowing the shape of the nasal cushion 3112 to better conform to the patient's nose. The recess 3116 is also described in more detail below.

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

[0070] This figure also shows the nasal cushion 3112, which surrounds a portion of the patient's 1000 nose, specifically the tip of the nose. The nasal gas chamber 3104 is thus formed by the nasal cushion 3112 and the patient's face. In this example, breathable 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 isolation structure 3106. Line BB shown in FIG. 3m is intended to indicate the transition between the nasal cartilage and nasal bones, extending from the patient's 1000 nasal anatomy. The nasal cushion 3112 depicted with this exemplary patient interface 3000 is adapted to seal against the nose below line BB and around the patient's nose. In other words, the nasal cushion 3112 may seal below the bridge of the nose.

[0071] The patient interface 3000 according to one example of the present technology has a facial surface area of ​​4896 mm, which is approximately 30% less noticeable than a conventional full-face mask (e.g., the ResMed Quattro FX full-face mask has a facial surface area of ​​7007.89 mm). For some patients, it may also feel less claustrophobic. The specific areas of less occlusion are also important, as these have been found to have a significant beneficial psychological effect on bed partners when looking at the mask, making it appear less medical and more "open" to the face. From the patient's perspective, the typical patient interface 3000 is hidden from, or significantly reduced from, the patient's field of view because the nasal cushions 3112 seal below the bridge of the nose. This allows the patient to wear glasses when reading or watching television before falling asleep after wearing the patient interface 3000. By sealing below the bridge of the nose, irritation can be avoided in an area where the skin is thin and sensitive to pressure and / or where there is a high chance of skin breakdown due to blood flow obstruction. Another advantage may be that anthropometric variations between patients above the bridge of the nose do not need to be considered, and the focus for mask fit range can be directed toward anthropometric variations around the upper lip area. Also, unlike some other full-face masks, the patient interface 3000 may not require forehead support, which is required to provide pressure point relief. This also avoids the issue of forehead support being a source of pressure points and skin breakdown.

[0072] Anatomically, Figures 2h and 2i may be referenced for an indication of the location of the transition region between the nasal bone and cartilage. Thus, a typical nasal cushion 3112 is configured to seal around the periphery of a patient's nose in contact with the softer nasal tissues, such as fatty tissue or cartilage. Forming a seal with the nose through these soft tissues may avoid irritation of the patient's skin that would otherwise occur if a seal were formed around / on harder nasal structures, i.e., bone. In other words, sealing below the bridge of the nose minimizes patient discomfort. Positioning the nasal cushion 3112 seal around this area of ​​the nose may also result in a better seal, since the nasal tissue and the nasal cushion 3112 can conform to each other to form a seal. The nasal cushion 3112 should primarily conform to the nose.

[0073] The aforementioned sealing feature visible in FIG. 3m is the portion of the protruding end 3114 that rests against the face of the 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 ala of the nose. These anatomical features can be seen in FIG. 2c. Depending on the patient's individual facial structure, this area may correspond to the recess 3116. As such, 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 FIG. 3m can preferably perform this function.

[0074] Other sealing features of the depicted exemplary patient interface 3000 can be seen in Figure 3p. The nasal cushion 3112, as previously described, includes a recess 3116 for receiving the tip of the nose of the patient 1000 when worn by the patient. Specifically, the tip of the nose of the patient 1000 can be seen in dashed lines in the area where the recess 3116 is located. This figure also shows how the nasal cushion 3112 may be configured at its underside to seal against the periphery of the nose. In other words, the seal formed by the nasal cushion 3112 against the nose may be characterized as against the lower periphery 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 for receiving the nose as a whole, and that the sealing surface of the nasal cushion may further include a recess 3116 for receiving the tip of the nose.

[0075] FIG. 3q depicts 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 side cross-sectional view. Specifically, the nasal cushion 3112, nasal plenum chamber 3202, oral cushion 3110, and oral plenum chamber 3200 are shown in cross-section. Reference may be made to FIGS. 2b-2f for an explanation of relevant anatomical features. The nasal cushion 3112 is shown sealing against the tip of the patient's nose. The connection region 3106.2 between the oral cushion 3110 and the nasal cushion 3112 is shown sealing against the patient's upper lip. It should be noted that the connection region 3106.2 may be positioned to seal against the patient's upper lip in a region below the nares and above the mouth so as not to obstruct airflow into the airway. The connection region 3106.2 may connect the rear of the oral cushion 3110 and the nasal cushion 3112. The connection region 3106.2 may be structured and positioned to maintain a seal against the patient's upper lip below the nares 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 connection region 3106.2 may also function in cooperation with the separation structure 3106 to facilitate this relative movement.

[0076] The nasal gas chamber 3104 may be considered to be defined, at least in part, by the nasal cushions 3112, the nasal plenum chamber 3202, and the patient's nose to provide a sealed pathway for breathable gases to enter the patient's airways via the nares or nostrils. A gap 3106.1 can also be seen between the oral plenum chamber 3200 and the nasal plenum chamber 3202. While the gap 3106.1 is discussed in more detail below, it should be understood that the gap 3106.1 may facilitate, in part, maintaining a seal against the nose and mouth despite independent movement of the nasal cushions 3112 and the oral cushions 3110. It may be advantageous to maintain the seal of the nasal cushion 3112 against the nose, the seal of the connection region 3106.2 against the upper lip, and the seal of the oral cushion 3110 around the mouth while allowing these components to move independently of one another and accommodate anthropometric variations and a wide range of patients.

[0077] As shown in FIG. 3q, the oral gas chamber 3102 may be considered to be defined at least in part by the oral cushion 3110, the oral plenum chamber 3200, and the patient's mouth to provide a sealed path for breathable gas to enter the patient's airway via the mouth. A 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 the oral undercushion 3120 may further support the thinner oral cushion 3110 against the lower lip when the positioning and stabilising structure 3300 presses the patient interface 3000 against the patient's face. In such a situation, the oral undercushion 3120 is biased into contact with a corresponding portion of the oral cushion 3110.

[0078] In one form of the present technology, the seal-forming structure 3100 provides a seal-forming surface and may also provide a cushioning function.

[0079] In one example, the seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, elastic material such as silicone, hi another example of the present technology, the seal-forming structure 3100, e.g., the oral cushion 3110, the nasal cushion 3112, and / or their respective undercushions, may be formed from foam.

[0080] In one example, the plenum chamber 3200 has a perimeter 3210 that is shaped to be complimentary to the surface contours of an average human face in the area where a seal will occur in use. In use, the periphery of the plenum chamber 3200 sits 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 around the entire perimeter 3210 of the plenum chamber 3200 in use.

[0081] 7a-7h depict several views of the seal-forming structure 3100 and plenum chamber 3200. These views show the seal-forming structure 3100 and plenum chamber 3200 without the top plate 3206 and face plate 3204, and without any associated positioning and stabilising structures 3300.

[0082] 7a shows a rear perspective view of the seal-forming structure 3100 and plenum chamber 3200. The exemplary seal-forming structure 3100 shown in this figure includes an oral cushion 3110 and a nasal cushion 3112. In this view, a connection region 3106.2 can be seen connecting the oral cushion 3110 and the nasal cushion 3112. The location of the separation structure 3106 is also shown between the oral cushion 3110 and the nasal cushion 3112.

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

[0084] Also visible in Figure 7a is the nasal plenum chamber 3202, which together with the nasal cushions 3112 partially define the nasal gas chamber 3104. This exemplary nasal cushion 3112 can also be seen to include protruding ends 3114 on either side. A recess 3116 for receiving the tip of the nose can also be seen. Also shown in this view are nasal undercushion support walls 3208. The nasal undercushion support walls 3208 may be associated with each protruding end 3114 and provide support for the protruding ends 3114 as they seal against the patient's alar and nasolabial folds.

[0085] FIG. 7b shows a side perspective view of an exemplary seal-forming structure 3100 and plenum chamber 3200. FIG. 7b depicts features similar to those shown in FIG. 7a. However, this view also depicts that the connection region 3106.2 may have a concave shape. In other examples, the connection region 3106.2 may have a non-concave shape. Forming the connection region 3106.2 with a concave shape may allow the oral cushion 3110 to better seal around the patient's mouth, and the nasal cushion may better seal around and under the patient's nose. Alternatively, a fully convex cushion may function similarly. A portion of the perimeter 3210 of the oral plenum chamber 3200 is also visible in this view. The location of the isolation structure 3106 is also shown.

[0086] 7b shows the nasal undercushion support wall 3208 associated with each protruding end 3114 of the nasal cushion 3112. The nasal undercushion support wall 3208 extends beyond the periphery of the nasal plenum chamber 3202. Such a configuration may allow the nasal undercushion support wall 3208 to provide sufficient support for the protruding end 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] 7c shows a front perspective view of an exemplary seal-forming structure 3100 and plenum chamber 3200. This view particularly illustrates the front 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 side perspective view of an exemplary seal-forming structure 3100 and plenum chamber 3200. This view shows similar features to those shown in Figure 7a. A portion of each nasal undercushion support wall 3208 can be seen on either side of the nasal cushion 3112. This view also shows how the connection region 3106.2 can connect the oral cushion 3110 to the nasal cushion 3112. The location of the separation structure 3106 is also shown.

[0089] FIG. 7e shows a front view of an exemplary seal-forming structure 3100 and plenum chamber 3200. This view particularly shows the oral cushion 3110 positioned around the perimeter 3210 of the oral plenum chamber 3200. It can also be seen that the oral gas chamber 3102 is defined by the oral cushion 3110 and the oral plenum chamber 3200. This view also shows the front of the separation structure 3106 connecting the nasal cushion 3112 to the oral cushion 3110. Nasal undercushion support walls 3208 can be seen on either side of the nasal cushion 3112. The oral undercushion 3120 is also visible from this view. This view also shows that the oral undercushion 3120 may terminate in tapered regions 3122 near either side of the nasal cushion 3112. Thus, there may be no undercushion present in the connection regions 3106.2 (not shown in this view) between the oral cushion 3110 and the nasal cushion 3112. Advantageously, this may allow for greater flexibility in the connection region 3106.2, which can more easily maintain the seal against the upper lip shown in FIG. 3q despite movement of the mouth and nose cushions 3110, 3112.

[0090] 12a-12d show further exemplary configurations of an oral undercushion 3120 in accordance with the present technology. These figures show the oral cushion 3110 with various configurations of the oral undercushion 3120 shown stippled and the opening 3101 to the oral gas chamber 3102. For simplicity, additional features associated with the seal-forming structure 3100 have been omitted from these figures.

[0091] Figure 12a illustrates an example of an oral cushion 3110 in which the oral undercushion 3120 surrounds the entire periphery of the oral cushion 3110. Figure 12b illustrates an example of an oral cushion 3110 in which there are two portions of the oral undercushion 3120, one on each side of the oral cushion. Figure 12c illustrates an example in which the oral undercushion 3120 surrounds the entire periphery of the oral cushion 3110 except for a portion near the upper region of the oral cushion 3110. Figure 12d illustrates an example similar to Figure 12c, except that the portion of the oral cushion 3110 in which the oral undercushion 3120 is not present is the lower region of the oral cushion 3110.

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

[0093] Figure 7g shows a bottom view of an exemplary seal-forming structure 3100 and plenum chamber 3200. This view shows the oral cushion 3110 attached to the oral plenum chamber 3200. Also visible is the protruding end 3114 of the nasal cushion 3112.

[0094] Figure 8a shows another plan view of an exemplary seal-forming structure 3100 and plenum chamber 3200. This figure also shows many cross-section lines to indicate the cross-sections depicted in subsequent figures, i.e., Figures 8b-8l. This figure is similar to Figure 7f, and therefore similar components are depicted. However, to avoid confusion, the reference numerals and leading lines have been eliminated.

[0095] 8b-8d show cross-sectional views of an exemplary seal-forming structure 3100 and plenum chamber 3200 taken along lines 8b, 8c, and 8d-8b, 8c, and 8d. The nasal cushion 3112 can be seen connected to the oral cushion 3110 by a connection region 3106.2. The oral gases chamber 3102 can be seen defined in part by the oral plenum chamber 3200 and the oral cushion 3110. The nasal gases chamber 3104 can be seen defined in part by the nasal plenum chamber 3202 and the nasal cushion 3112. The protruding end 3114 and recessed portion 3116 of the nasal cushion 3112 are also shown. This figure also illustrates how the connection region 3106.2 in one example of the present technology may not include an undercushion, although the oral cushion 3110 may include a nasal undercushion support wall 3208 (not shown in these figures) to support the oral undercushion 3120 and the protruding end 3114. The oral plenum chamber 3200, the nasal plenum chamber 3202, and the gap 3106.1 formed by the hinge-like configuration of the separation structure 3106 can also be seen. In other examples of the present technology, the oral undercushion 3120 may include two discontinuous sides present on either side of the oral cushion 3110, but there is no oral undercushion portion in the connection region 3106.2 or the lower center of the oral cushion 3110. Alternatively, as shown in FIG. 7e, the oral undercushion 3120 may terminate near the nasal cushion 3112 at tapered regions 3122 on either side.

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

[0097] Figure 8e shows another cross-sectional view of an exemplary seal-forming structure 3100 and plenum chamber 3200 taken along line 8e-8e. Again, it can be seen that the oral cushion 3110 includes an oral undercushion 3120. In accordance with this example of the present technology, the connection region 3106.2 is shown without the undercushion. The oral plenum chamber 3200, the nasal plenum chamber 3202, and the gap 3106.1 formed by the hinge-like configuration of the isolation structure 3106 can also be seen. Also visible are the sides 3106.3 of the isolation structure 3106.

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

[0099] Figure 8g shows another cross-sectional view of the exemplary seal-forming structure 3100 and plenum chamber 3200 taken along line 8g-8g. Figure 8g again shows similar features to Figures 8e and 8f. However, this view 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 the exemplary seal-forming structure 3100 and plenum chamber 3200 taken along line 8h-8h. This view also shows similar features to those depicted in Figure 8g. In this view, each protruding end 3114 is visible with a respective nasal undercushion support wall 3208 positioned underneath it.

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

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

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

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

[0105] Figure 9a shows another front view of an exemplary seal-forming structure 3100 and plenum chamber 3200. This figure also shows many cross-section lines to indicate the cross-sections depicted in subsequent figures, i.e., Figures 9b-9i. This figure is similar to Figure 7e, and therefore similar components are depicted. However, to avoid confusion, the reference numerals and leading lines have been eliminated.

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

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

[0108] 9d shows a cross-sectional view of an exemplary seal-forming structure 3100 and plenum chamber 3200 taken along line 9d-9d. The cross-sectional view shown here is taken at an angle so that a portion of the nasal cushion 3112 is not shown. This view also provides a particularly good depiction of the oral undercushion 3120 of the oral cushion 3110. In the example shown in this figure, the tapered region 3122 of the oral undercushion 3120 can also be seen.

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

[0110] Figure 9f shows a cross-sectional view of an exemplary seal-forming structure 3100 and plenum chamber 3200 taken along line 9f-9f. This view particularly well illustrates the oral cushion 3110 and oral undercushion 3120 and how these two cushions 3110, 3120 may share a similar shape to seal against the patient's face.

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

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

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

[0114] 16a-16o show several views of another seal-forming structure 3100 and plenum chamber 3200 according to an example of the present technology.

[0115] The seal-forming structure 3100 and plenum chamber 3200 according to this example includes pockets 3208.1 on either side of the nasal cushion 3112 near the sides 3106.3 and below the protruding ends 3114. See Figures 16a, 16d, 16i, 16k, and 16m-16o. The pockets 3208.1 may be defined, at least in part, by the isolation structure 3106, the undercushion support wall 3208, the sides 3106.3, the nasal plenum chamber 3202, and the side supports 3207. The pockets 3208.1 may be open at the 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 resistance to compression may help to reduce leakage at the corners of the nose area where the pockets 3208.1 may support the nasal cushion 3112 and / or the protruding ends 3114 when the nasal cushion 3112 is in contact with the patient's nose. According to one example of the present technology, it may be advantageous for the nasal cushion 3112 to deform in areas other than the protruding ends 3114 that may be supported by the pockets 3208.1. The pockets 3208.1 and decoupling structures 3106 may help to resist deformation of the nasal cushion 3112 or may help to allow deformation to occur in targeted areas.

[0116] The side supports 3207 shown in the example depicted by FIGS. 16a-16o may be integrally formed with the seal-forming structure 3100 and the plenum chamber 3200. Thus, in examples where the seal-forming structure 3100 and the plenum chamber 3200 are formed from silicone, the side supports 3207 are similarly formed from silicone. The side supports 3207 may serve a reinforcing purpose to improve the seal between the seal-forming structure and the patient's face. For example, the side supports 3207 may help support the nasal cushion 3112 on both sides against the patient's alae of the nose, and / or the side supports may help support the protruding ends 3114 against the area of ​​the patient's face where the alae join near the nasolabial folds. The side supports 3207 may also control deformation of the nasal cushion 3112 such that certain areas of the nasal cushion deform before other areas. The side supports 3207 may control the degree of deformation in certain areas of the nasal cushion 3112. The side supports 3207 can flex when the side supports 3207 are compressed due to contact with the patient's face, thereby facilitating controlled deformation of the nasal cushion 3112. The side supports 3207 can also stiffen the sides of the nasal cushion 3112 to decouple the compressive forces of the face against the nasal cushion 3112 and prevent the nasal cushion 3112 from collapsing towards the isolation structure 3106.

[0117] The side supports 3207 may each include a cutout 3209. The cutouts 3209 in the side supports 3207 may provide a pivot point between the nasal cushion 3112 and the oral cushion 3110. The pocket 3208.1 may also serve to control the position of the pivot point.

[0118] 3206。 In one example, the silicone of the seal-forming structure 3100 and the plenum chamber 3200 may be formed and / or molded around the top plate 3206. In accordance with one example of the present technology, no mechanical connection may be required between the top plate 3206 and the seal-forming structure 3100 and the plenum chamber 3200. Alternatively, there may be no chemical and / or integral connection, in which case a mechanical connection between the top plate 3206 and the seal-forming structure 3100 and the plenum chamber 3200 is required. The top plate 3206 may at least partially define a pivot point between the nasal cushion 3112 and the oral cushion 3110.

[0119] It may also be desirable to strengthen or reinforce the nasal cushion 3112 to provide localized support to reduce or control deformation in certain areas of the nasal cushion relative to other areas. Examples of reinforcement may include increasing the relative thickness of the nasal cushion 3112 where reinforcement is desired. Alternatively, reinforcing ribs or other reinforcing structures may be formed in the nasal cushion 3112 to provide localized support at a desired level and location.

[0120] FIGS. 16i, 16k-16m, and 16o illustrate that the nasal cushion 3112 may include thicker nasal cushion portions 3124 on the sides. The thicker nasal cushion portions 3124 may be thicker portions of the nasal cushion 3112 that extend inwardly of the nasal cushion, generally toward the nasal gas chamber 3104. These thicker nasal cushion portions 3124 may provide additional support for the nasal cushion 3112 when the nasal cushion is in sealing engagement with the patient's nose and face. The thicker nasal cushion portions 3124 may be located in predetermined positions on either side of the nasal cushion 3112 such that the thicker nasal cushion portions are near the patient's nasolabial folds when the seal-forming structure engages the patient's face. The thicker nasal cushion portions 3124 may aid in sealing around the ala of the patient's nose by preventing collapse of the nasal cushion 3112 due to sealing forces. The thicker nasal cushion portions 3124 may be integrally formed with the nasal cushion 3112. Additionally, the thickened nasal cushion portions 3124 may be positioned on the nasal cushion 3112 such that the thickened nasal cushion portions 3124 can be at least partially pressed against the respective undercushion support walls 3208 when the seal-forming structure engages the patient's nose and face. The thickened nasal cushion portions 3124 may have a constant thickness throughout that is greater than the thickness of the remainder of the nasal cushion 3112. Alternatively, the thickened nasal cushion portions 3124 may have a variable thickness throughout their area.

[0121] In another example of the present technology, the thickened nasal cushion portions 3124 may not be provided, and other structures may be provided to increase stiffness in these areas. For example, in areas where the thickened nasal cushion portions 3124 are expected to function to reinforce the nasal cushion 3112, the nasal cushion 3112 may be provided with ribs or other reinforcing structures in these areas.

[0122] 16k also shows an example of the present technology where the port plenum chamber 3200 includes thicker port plenum chamber portions 3212. These thicker port plenum chamber portions 3212 may provide additional support for the port plenum chamber 3200 to help resist collapse of the port plenum chamber.

[0123] Additionally, Figures 16j and 16k show cross-sectional views through the seal-forming structure 3100 and the plenum chamber 3200. These figures illustrate that the connection region 3106.2 in the examples depicted in these figures may be thicker than the connection region 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. Tube torque from the air circuit 4170 may cause the oral cushion 3110 to pull on the nasal cushion 3112 through the separation structure 3106, extending the connection region 3106.2 in a generally vertical direction. Stretching the connection region 3106.2 may disrupt the seal of the nasal cushion 3112. By thickening the connection region 3106.2 and ensuring a consistent thickness throughout, this stretching of the connection region 3106.2 may be resisted and disruption of the seal at the nasal cushion 3112 may be prevented and / or reduced.

[0124] 16b, 16c, 16e, 16f, 16j, and 16o show views of a nasal cushion 3112 including a nasal sling 3119 that separates the opening 3103 to the nasal gas chamber 3104 into the nostril ports 3105. The nasal sling 3119 may seal along the bridge of the patient's nose (see FIG. 2f) to allow each nostril to be sealed individually. Alternatively, the nasal sling 3119 may form a bridge relief by contacting the bridge of the patient's nose without forming a seal. The nasal sling 3119 may also prevent the tip of the patient's nose from extending through the nasal cushion 3112 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 a compliant region. The compliant region is not shown in these examples. Further example descriptions and depictions of compliant regions are provided in International Patent Application Publication No. PCT / AU2014 / 000026. The compliant region may be relatively soft, flexible, and / or compliant compared to the rest of the seal-forming structure 3100. The relative flexibility of the compliant region may be advantageous in that it may help reduce discomfort to the patient in the area of ​​the tip of the nose and nasal septum. The compliant region may be relatively thin compared to the rest of the seal-forming structure 3100 and may therefore act like a mechanical spring to hug and / or contact the tip of the nose to maintain an effective seal at the tip of the nose. The compliant region may be located on the seal-forming structure 3100 at the top where the seal-forming structure 3100 transitions into the plenum chamber 3200, 3202. The compliant region may be located on the seal-forming structure 3100 above the recessed portion 3116. The compliant region may be integral with the recessed portion 3116. The compliant region may be located horizontally approximately in the center of the seal-forming structure 3100. The seal-forming structure 3100 may have a thickness of approximately 0.35 mm at the compliant region according to one example of the present technology, and the compliant region may be one of the thinnest regions of the seal-forming structure 3100.

[0126] 5.3.1.1 Typical nasal cushion 4a-4c, 5a-5c, and 6a-6c depict various examples of nasal cushions 3112 in accordance with the present technology.

[0127] FIG. 4a shows a plan view of an exemplary nasal cushion 3112. Protruding ends 3114 are visible 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, diamond, or trapezoidal shape that 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 the respective ala of the nose when placed against the patient's nose. Also in this example, one of the pair of long sides, specifically the distal 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 side 3104.3, is proximal to the patient's upper lip. A recess 3116 shaped to receive the tip of the nose is also shown.

[0128] Figure 4b shows a bottom view of an exemplary nasal cushion 3112 taken along line 4c-4c of Figure 4a. This view also shows the nasal gas chamber 3104 and its associated opening 3103.

[0129] FIG. 4c shows a side perspective view of a typical nasal cushion 3112 taken along line 4c-4c in FIG. 4a. This view also shows the nasal gas chamber 3104 and the opening 3103 to the nasal gas chamber. The recessed portion 3116 is also shown. Of particular note in this view is the profile of the nasal cushion 3112 along section line 4c-4c. The nasal cushion 3112 can be seen to curve slightly upward as it approaches the recessed portion 3116 toward the edge 3104.1 distal to the opening 3103 to the nasal gas chamber 3104. Also, as can be seen in this view and in FIG. 4b, the upper front portion of the nasal cushion 3112 near the recessed portion 3116 includes a slight depression or concave area in its center, along line 4c-4c, such that the nasal cushion 3112 is higher on both sides than in the center. This view also shows the outline of a patient's nose in dashed lines to illustrate 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 in front of the nostril. The apex 3118 may be located further back, but may have a gradually larger transition to create a balloon effect. The distal long side 3104.1 may be turned up from the cushion 3112 to enhance the seal at the tip of the nose, as the distal long side makes quicker contact with the nose and cradles the nose, creating both a compressive seal and a pneumatic seal. Also shown is a recess 3116 shaped to receive the tip of the nose.

[0130] Figure 5a shows a top view of an exemplary nasal cushion 3112. 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. Also shown is a recess 3116 shaped to receive the tip of the nose.

[0131] Figure 5b shows a bottom view of an exemplary nasal cushion 3112 taken along line 5c-5c of Figure 5a. This view also shows the nasal gas chamber 3104 and its associated opening 3103.

[0132] FIG. 5c shows a side perspective view of an exemplary nasal cushion 3112 taken along line 5c-5c in FIG. 5a. This view also shows the nasal gas chamber 3104 and the opening 3103 to the nasal gas chamber. The recessed portion 3116 is also shown. Of particular note in this view is the shape of the nasal cushion 3112 along section line 5c-5c. In contrast to the shape of the nasal cushion 3112 in FIG. 4c, in this view, the nasal cushion can be seen to be sloped downward as it approaches the recessed portion 3116 toward the edge 3104.1 distal to the opening 3103 to the nasal gas chamber 3104. It can also be seen that this example of the nasal cushion 3112 lacks the depression in the anterior region near the recessed portion 3116 that is visible in the examples shown in FIGS. 4b and 4c. In other words, this example shows that the nasal cushion 3112 may be more circular / rounded than the example shown in Figure 4c in the region from the recess 3116 to the distal edge 3104.1 of the opening 3103 to the nasal gas chamber 3104. This figure also shows the outline of the patient's nose in dashed lines to show how the patient's nose may be positioned relative to the nasal cushion 3112.

[0133] Figure 6a shows a top view of an exemplary nasal cushion 3112. 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 can also be seen. The shape of the opening 3103 to the nasal gas chamber 3104 can be similar to the shape shown in Figure 4a. In Figures 4a-4c, the shape is more balloon-like and rounded than the example shown in Figures 6a-6c.

[0134] Figure 6b shows a bottom view of an exemplary nasal cushion 3112 taken along line 6c-6c in Figure 6a. This view also shows the nasal gas chamber 3104 and its associated opening 3103. As can also be seen in this view, the nasal cushion 3112 has straight sidewalls 3121, as opposed to the sidewalls that smoothly curve from the top surface of the nasal cushion 3112 shown in Figures 4a-4c and 5a-5c. The straight sidewalls 3121 may have a defined upper edge and are believed to enhance the stability and strength of the nasal cushion 3112.

[0135] FIG. 6c shows a side perspective view of an exemplary nasal cushion 3112 taken along line 6c-6c in FIG. 6a. This view also shows the nasal gas chamber 3104 and the opening 3103 to the nasal gas chamber. The recessed portion 3116 is also shown. Of particular note in this view is the shape of the nasal cushion 3112 along section line 6c-6c. As in FIG. 5c, it can be seen that this example of the nasal cushion 3112 lacks the depression in the anterior region near the recessed portion that can be seen in the examples shown in FIGS. 4b and 4c. The straight sidewall 3121 of this exemplary nasal cushion 3112 is also visible in this view. This view also shows the outline of a patient's nose in dashed lines to illustrate how the patient's nose may be positioned relative to the nasal cushion 3112.

[0136] It should also be understood that the exemplary nasal cushion 3112 depicted in Figures 4a-4c, 5a-5c, and 6a-6c is shown in a substantially undeformed state. Figures 4c, 5c, and 6c may show a small amount of deformation due to conformance with the shape of the nose, as shown in dashed lines. Thus, the nasal cushion 3112 may have the concave shape shown when undeformed.

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

[0138] 10a-10d show further nasal cushions 3112 according to further examples of the present technology. These figures depict further variations in the possible shapes of the opening 3103 to the nasal gas chamber 3104.

[0139] 11a-11c depict various cross-sectional shapes of a nasal cushion 3112 in accordance with examples of the present 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 periphery of the nasal cushion 3112.

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

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

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

[0143] FIG. 13 shows a top view of another exemplary nasal cushion 3112 in accordance with the present technology. The opening 3103 to the nasal gas chamber 3104 and the protruding end 3114 are shown to allow for understanding of the orientation of the nasal cushion 3112. Regions of varying thickness are hatched differently to better show where the stiffness and / or thickness of the nasal cushion 3112 may vary. Region 3113 may be the thinnest to allow for a quick conform to the tip of the nose. Region 3113 may have a thickness of approximately 0.35 mm, according to one example of the present technology. Region 3115 may be thicker to provide greater support for the nasal cushion 3112. Region 3115 may have a thickness of approximately 0.5 mm, according to one example of the present technology. Region 3117 may be thicker than other regions to provide maximum support, resistance to deformation, and ensure an effective seal with the patient's ala. Region 3117 may have a thickness of approximately 1 mm, according to one example of the present technology.

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

[0145] 3c, this feature may allow the nasal cushion 3112 and the oral cushion 3110 to move independently of one another when worn by a patient. The nasal cushion 3112, when worn by a patient in conjunction with the positioning and stabilising structure 3300 (e.g., headgear), as described in more detail below, may be pressed against the patient's face, particularly against the nose, by forces transmitted along the rigidiser arms 3302 and through the top plate 3206 to the nasal cushion 3112. Additionally, the oral cushion 3110 may be pressed against the patient's face, particularly against the mouth, by forces transmitted from the headgear straps 3306 to the faceplate 3204. Because different sets of headgear straps 3306 can press different portions of the patient interface 3000 (e.g., the nasal cushion 3112 and the oral cushion 3110) against different portions of the patient's face (e.g., the nose and mouth, respectively), it may be advantageous to allow the nasal cushion 3112 and the oral cushion 3110 to move independently of each other due to the separation structure 3106.

[0146] A decoupling structure 3106 may be used to connect the oral cushion 3110 and the nasal cushion 3112 to facilitate this independent movement. Allowing the cushions 3110, 3112 to move independently may allow for better sealing against a wider variety of patient facial shapes and may help maintain a seal against the patient's face despite movement of different areas 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 areas of the face, nose, and mouth, two separate openings must be provided to deliver breathable gas to the patient. By allowing the sealing structures (e.g., the oral cushion 3110 and nasal cushion 3112) to move independently, a seal around the nose can be maintained independent of the seal around the mouth, preventing undesired leakage and therefore pressure loss through one or both openings.

[0147] The isolation structure 3106 may form a portion of the walls of the oral plenum chamber 3200 and the nasal plenum chamber 3202 in the forward direction. The isolation structure 3106 may be resiliently flexible to allow relative movement and / or length extension between the structures defining the oral gas chamber 3102 and the nasal gas chamber 3104. Thus, the oral plenum chamber 3200 and the nasal plenum chamber 3202 may be extended away from each other or pressed against each other while a pneumatic connection is maintained between the oral gas chamber 3102 and the nasal gas chamber 3104. The isolation structure 3106 may also allow these structures (e.g., the oral plenum chamber 3200 and the nasal plenum chamber 3202) to be tilted relative to each other while a 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 comprise an upper surface 3106.4, a connecting surface 3106.5, and a lower surface 3106.6. The connecting surface 3106.5 may be relatively stiffer than the upper surface 3106.4 and the lower surface 3106.6. The lower surface 3106.6 may be understood to be a surface separate from the oral cushion 3110. The upper surface 3106.4 may be understood to be a surface separate from the nasal cushion 3112. The greater stiffness of the connecting surface 3106.5 may be created by reinforcing ribs or other reinforcing structures or by making the connecting 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 connecting surface 3106.5 may have a thickness of 1.2 mm. According to further examples of the present technology, the specific values ​​may be varied while maintaining the same thickness ratio between the upper surface 3106.4, the connecting surface 3106.5, and the lower surface 3106.6.

[0149] In accordance with further examples of the present technology, the relative thicknesses of the upper surface 3106.4, connecting surface 3106.5, and lower surface 3106.6 may be selected to allow a desired amount of flexibility for the decoupling structure 3106. In one example, the decoupling structure 3106 may be able to bend such that the upper surface 3106.4 and the lower surface 3106.6 lie at up to about 45° to about 50° relative to one another.

[0150] Additionally, according to further examples of the present technology, the angle between the upper surface 3106.4 and the connecting surface 3106.5 may be between about 80° and about 140°. Additionally, according to yet other examples of the present technology, the angle between the upper surface 3106.4 and the connecting surface 3106.5 may be about 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 separation structure 3106 due to the curved shape of the separation structure. In certain examples, 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 nasal structures and oral structures from one another. In certain examples, 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 nasal structures and oral structures toward one another.

[0151] According to further examples of the present technology, the angle between the lower surface 3106.6 and the connecting surface 3106.5 may be between about 80° and about 140°. According to yet other examples of the present technology, the angle between the lower surface 3106.6 and the connecting surface 3106.5 may be about 90°. In certain examples, if the angle between the lower surface 3106.6 and the connecting surface 3106.5 is greater than 90°, it may be easier to separate the nasal structures and oral structures from one another. In certain examples, if the angle between the lower surface 3106.6 and the connecting surface 3106.5 is less than 90°, it may be easier to press the nasal structures and oral structures toward one another.

[0152] Another advantageous feature of this exemplary patient interface 3000 can also be seen in FIG. 3m. This feature is the ability of the nasal cushion 3112 and the oral cushion 3110 to independently form a seal with respect to the patient's respective anatomical features. As previously discussed, the nasal cushion 3112 is adapted to seal with respect to the patient's nose, and the oral cushion 3110 is adapted to seal with respect to the patient's mouth. The decoupling structure 3106 shown in FIG. 3c, for example, may allow the nasal cushion 3112 and the oral cushion 3110 to independently move and seal with each other. Attaching a pair of upper straps 3310 to the nasal cushion 3112 via the top plate 3206 may cause the nasal cushion 3112 to press against the nose of the patient 1000 when the patient interface 3000 is worn. Additionally, the pair of lower straps 3312, through their connection to the face plate 3204, may cause the oral cushion 3110 to press against the patient's mouth.

[0153] It should be understood that each respective pair of upper straps 3310 and lower straps 3312 represents a separate vector pair, along which tension is directed to hold each portion of the patient interface 3000 against the patient's face. In other words, the upper straps 3310 serve to hold the nasal cushion 3112 against the nose, and the lower straps 3312 serve to hold the oral cushion 3110 against the mouth. The decoupling structure 3106 allows for a pneumatic connection between the two cushions 3110, 3112, but these cushions may move independently of one another. Thus, a variety of different patient head and facial shapes can be accommodated by the patient interface 3000. It should also be understood that the ability to independently form separate seals allows the patient interface 3000 to maintain these seals despite movement by the patient.

[0154] 7h shows a side view of an exemplary seal-forming structure 3100 and plenum chamber 3200. This view shows the nasal cushion 3112 attached to the nasal plenum chamber 3202 and the protruding end 3114 supported by the nasal undercushion support wall 3208 near the side 3106.3 of the decoupling structure 3106. The oral plenum chamber 3200 is shown with the oral cushion 3110 disposed around its periphery 3210. Also seen in this view is the decoupling structure 3106 connecting the oral cushion 3110 to the nasal cushion 3112. This view particularly illustrates the hinge-like configuration that the nasal plenum chamber 3202 and nasal cushion 3112 can assume relative to the oral plenum chamber 3200 and oral cushion 3110 by virtue of their connection via the decoupling structure 3106 and connection region 3106.2 (not shown in this view). It should be appreciated that this hinge-like configuration may allow the nasal plenum chamber 3202 and nasal cushions 3112 to tilt in response to forces exerted by the patient's face when the complete patient interface 3000 is placed on the patient. Thus, the oral plenum chamber 3200 and the nasal plenum chamber 3202 can move closer together within the gap 3106.1.

[0155] As shown in this figure, it is envisioned that providing a gap 3106.1 between the front of the oral plenum chamber 3200 and the nasal plenum chamber 3202 allows the components of the oral plenum chamber 3200 and the nasal plenum chamber 3202 some degree of freedom of movement independent of one another before contacting one another. It should also be appreciated that providing the decoupling structure 3106 with a radially variable thickness or varying stiffness may facilitate the independent movement of the nasal cushion 3112 and the oral cushion 3110 while maintaining an effective seal. Thus, the decoupling structure 3106 may be thinnest or least stiff at the portion that contacts the patient's upper lip, and its thickness / stiffness may increase radially toward the front of the decoupling structure 3106. This configuration may provide sufficient support and structure to the cushions 3110, 3112 while maintaining an effective seal against the upper lip. The decoupling structure 3106 may be thicker at its apex at the closed end of the gap 3106.1 than in the area near the open end of the gap 3106.1. This variation can prevent distortion and improve hinging action because the thicker portion of the decoupling structure 3106 at the closed end of the gap 3106.1 can act as a pivot point.

[0156] 14 shows another example of the present technology in a partially exploded side view. This example may include oral and nasal cushions 3110, 3112 and oral and nasal plenum chambers 3200, 3202 connected by a decoupling structure 3106 in a manner similar to other examples disclosed herein. The upper or top plate 3206 and lower or face plate 3204 can be seen detached from the nasal plenum chamber 3202 and oral plenum chamber 3200, respectively. Also shown is the attachment feature 3252 connected to the connection feature 3304 of the rigidiser arm 3302, which has been partially cut away for clarity. This view also shows a central or connecting portion 3205 that may connect the top plate 3206 and face plate 3204 to form a unitary plate member. The connecting portion 3205 may be shaped and dimensioned to generally follow the shape of the isolation structure 3106 such that the connecting portion 3205 may be generally flush with the isolation structure 3106 when the top plate 3206, face plate 3204, and integral members of the connecting portion 3205 are attached to the nasal plenum chamber 3202 and oral plenum chamber 3200. To allow movement of the oral and nasal plenum chambers 3200, 3202 relative to one another as described elsewhere herein, it may be advantageous to form the connecting portion 3205 from silicone or any suitable soft, flexible, air-impermeable, and biocompatible material.

[0157] In other examples of the present technology, the portion of the isolation structure 3106 near the gap 3106.1 may be eliminated such that only the undercushion support wall 3208 and / or connection region 3106.2 connects the oral and nasal plenum chambers 3200, 3202 and the oral and nasal cushions 3110, 3112. In such examples, the connection portion 3205 may perform a sealing function to provide a pneumatically sealed connection between the oral gases chamber 3102 and the nasal gases chamber 3104. In other words, the connection portion 3205 may effectively replace the eliminated portion of the isolation structure 3106 when the unitary members of the top plate 3206, connection portion 3205, and face plate 3204 are attached to the oral and nasal plenum chambers 3200, 3202. Again, 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 Features, Rigidiser Arms, and Positioning and Stabilizing Structures A rigid top plate 3206 may be attached to the nasal plenum chamber 3202 in front of the nasal cushion 3112, which faces the patient's face in 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 attachment feature 3252. In one example, a pair of upper attachment features 3252 may be located on either side of the top plate 3206 to releasably and rotatably connect the respective rigidiser arms 3302 of the positioning and stabilising structure 3300. UBE America Inc.'s Ubesta® nylon, Hytrel®, TPE, and polypropylene and other flexible polymers and materials available from DuPont™ are possible materials for the rigidiser arms 3302. Other materials that allow the rigidiser arms 3302 to bend but are substantially inextensible may also be used for the rigidiser arms 3302. The rigidiser arm 3302 may be flexible in a direction parallel to the patient's coronal plane (see FIG. 2e), but is substantially inflexible in other directions. The connection of the rigidiser arm 3302 may be hinged such that the rigidiser arm's connection feature 3304 can rotate about the attachment feature 3252 of the top plate 3206. In one example of the present technology, the rigidiser arm 3302 may rotate up to 90° about the hinged upper attachment feature 3252. In one example, the rigidiser arm 3302 may rotate more than 180° about the hinged upper attachment feature 3252. The rotation may be provided by a ball and socket connection, a living hinge, a free gimble, or may be overmolded with silicone, TPE, or TPU. At each opposite end of the rigidiser arm 3302 there may be an opening 3308 to receive a respective headgear strap 3306 of the positioning and stabilising structure 3300 discussed in more detail below. Between each end of the rigidiser arm 3302 there may be a curved portion that is shaped to approximately follow the curvature of the patient's face.

[0159] Figures 3s-3u show a further example of a patient interface 3000 with the rigidiser arm 3302 disassembled to depict an exemplary hinged connection between the respective attachment feature 3252 and the connecting feature 3304. As previously mentioned, it should be understood that the rigidiser 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 coronal plane.

[0160] Opposite the oral cushion 3110, a faceplate or lower plate 3204 may be attached to the oral plenum chamber 3200. The means of attachment may include a soft to hard material being overmolded and pressed in, or may include a cushion clip to rely on hoop stress. The faceplate 3204 may include a port 3600 to facilitate connection to the air circuit 4170 (not depicted in this view). The faceplate 3204 may also include at least one lower attachment feature 3250 for attaching each headgear strap of the positioning and stabilising structure 3300, discussed in more detail below. The lower attachment feature 3250 shown in this example may be a female clip-receiving structure for receiving a male clip attached to the headgear strap 3306. Alternatively, this configuration may include a male structure for receiving a female clip.

[0161] The exemplary patient interface 3000 shown in the front view of FIG. 3b includes a top plate 3206 connected to the nasal cushions 3112 and having at least one upper mounting feature 3252 on each side. Rigidiser arms 3302 are shown connected to their respective upper mounting features 3252 via connection features 3304. Again in this view, the faceplate 3204 can be seen connected to the front side of the oral plenum chamber 3200. The ports 3600 shown on the faceplate 3204 are circular for pneumatic connection to the air circuit 4170 (e.g., via a tube isolation structure 3500, discussed further below). Lower mounting features 3250 can also be seen on each side of the faceplate 3204. The isolation structure 3106 is shown in this view, as can the sides 3106.3 of the isolation structure.

[0162] 3c shows a rear view of an exemplary patient interface 3000. In this view, a pair of rigidiser arms 3302 can be seen extending from and connecting to respective upper attachment features 3252 at respective connection features 3304. At each opposite end of each of the rigidiser arms 3302, openings 3308 can be seen for connecting to headgear straps 3306 of the positioning and stabilising structure 3300. The location of the separation structure 3106 is shown in this view, along with the connection area 3106.2 between the oral cushion 3110 and nasal cushion 3112.

[0163] 3d shows a top view of a patient interface 3000 in accordance with an example of the present technology. From this plan view, the portions of the nasal cushions 3112 that contact the patient's nose can be seen, as well as the opening 3103 into the nasal gas chamber 3104. The plan view also shows the connection features 3304 of the rigidiser arms 3302 that connect to upper attachment features 3252 on either side of the top plate 3206, which are not visible in this particular view. It can also be seen that the oral plenum chamber 3200 is connected to the faceplate 3204 around the perimeter 3210 of the plenum chamber. Lower attachment features 3250 are shown on either side of the faceplate 3204. Ports 3600 can also be seen on the faceplate 3204.

[0164]

[00137] Figure 3e shows a bottom view of an exemplary patient interface 3000 in accordance with the present technology. This view shows the oral plenum chamber 3200 connected around its perimeter 3210 to a faceplate 3204. The faceplate 3204 is visible with a lower attachment feature 3250 extending therefrom. The ports 3600 on the faceplate 3204 are also visible. The oral cushion 3110 and nasal cushion 3112 are shown in this view, along with the protruding end 3114 of the nasal cushion 3112. The rigidiser arm 3302 is also shown, although its connection to the top plate 3206 is not visible in Figure 3e.

[0165]

[0013] Figure 3f shows a side view of an exemplary patient interface 3000 in accordance with the present technology. The rigidiser arms 3302 can be seen extending from a connection feature 3304 that is attached to an upper attachment feature 3252 of the top plate 3206. Figure 3f also depicts the oral plenum chamber 3200, which is connected to the face plate 3204 around its perimeter 3210. The lower attachment feature 3250 and connection port 3600 can be seen on the face plate 3204. The nasal cushions 3112 and oral cushions 3110 can also be seen. This view also depicts the location of the decoupling structure 3106, as well as one of the sides 3106.3 of the decoupling structure. The gap 3106.1 between the nasal plenum chamber 3202 and the oral plenum chamber 3200 is also shown, allowing these components to flex or move towards each other while remaining connected. The gap 3106.1 may be understood to be the distance between the oral plenum chamber 3200 and the nasal plenum chamber 3202, and thus the gap 3106.1 may define the distance these structures can approach one another. The gap 3106.1 may extend laterally between the oral plenum chamber 3200 and the nasal plenum chamber 3202, or the gap 3106.1 may face in a forward direction.

[0166] 3m shows a further front perspective view of an exemplary patient interface 3000. This view depicts similar features to those shown in FIG. 3g and shows the patient interface 3000 donned on the patient 1000. Headgear straps 3306 of the positioning and stabilising structure 3300 are shown releasably securing the patient interface 3000 to the patient 1000. The headgear straps 3306 are shown with at least one upper strap 3310 connected to a corresponding rigidiser arm 3302 at its corresponding opening 3308. In the depicted example, each of the upper straps 3310 loops through a corresponding opening 3308, which in this example is an opening in the rigidiser arm 3302. This example also shows at least one lower strap 3312 connected to the lower attachment feature 3250 by looping through a portion of a clip 3314 that is releasably attached to the corresponding lower attachment feature 3250.

[0167] 3n depicts another front view of an exemplary patient interface 3000 being held by a patient 1000. The patient interface 3000 in this view can be seen being held against the face of the patient 1000 by upper straps 3310 and lower straps 3312. The upper straps 3310 are attached to the rigidiser arms 3302, and the lower straps 3312 are attached to the lower attachment feature 3250 by clips 3314. In this example, the nasal cushion 3112 can be seen to seal against the nose of the patient 1000, and the oral cushion 3110 can be seen to seal against the mouth of the patient 1000. The decoupling structure 3106 is shown in this view, and the side 3106.3 of the decoupling structure 3106 can also be seen.

[0168] 3o depicts another side view of the patient interface 3000. In this view, the patient interface 3000 is held against the face of the patient 1000 by headgear straps 3306. An upper strap 3310 is connected to the rigidiser arm 3302 to press the nasal cushion 3112 against the nose, and a lower strap 3312 is connected to the faceplate 3204 to press the oral cushion 3110 against the mouth of the patient 1000. In this view, the lower strap 3312 can be seen extending below the ears of the patient 1000, and the upper strap 3310 can be seen extending above the ears and below the patient's eyes. As previously mentioned, the rigidiser arm 3302 may be formed from a relatively stiff material, such as nylon. Therefore, the rigidiser arms 3302 may cause irritation to the patient's face if they rub against and / or come into direct contact with the face of the patient 1000. Therefore, Figure 3o also depicts a sheath 3316 that may surround the rigidiser arms 3302 to cushion the rigidiser arms against the face of the patient 1000. This figure also depicts the location of the decoupling structure 3106. Instead of adding a sheath, the rigidiser arms 3302 may incorporate or have the face pads 3305 formed therein.

[0169] 3p shows another top view of an exemplary patient interface 3000. In this view, the patient interface 3000 may be held against the face of the patient 1000 by headgear straps 3306. Upper straps 3310 can be seen connected to respective openings 3308 in the rigidiser arms 3302, and lower straps 3312 can be seen connected to the lower attachment feature 3250 by clips 3314.

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

[0171] In one form of the present technology, the rigidiser arm 3302 as described above may be included as a component of the positioning and stabilising structure 3300. Alternatively, the rigidiser arm 3302 may be included as a component of the patient interface 3000.

[0172] The positioning and stabilising structure 3300 may comprise headgear straps 3306. The headgear may include at least upper side straps 3310, lower side straps 3312, and a rear section. The headgear straps 3306 may comprise a unitary composite of soft, flexible material. One layer of the headgear, for example an outer layer that does not contact the patient's skin when worn, may connect to tabs of material secured to the ends of each of the upper and lower side straps 3310, 3312. This connection may comprise 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 attachment features of the patient interface 3000 to releasably and / or adjustably hold the patient interface to the patient's head via the headgear straps 3306. Other connections may include ladder locks or sliders that are not hook-and-loop.

[0173] The inclusion of rigidiser arms 3302 in the patient interface 3000 and attachment of the rigidiser arms to the nasal plenum chamber 3202 by the top plate 3206 may advantageously position the upper straps 3310 of the positioning and stabilising structure 3300. As previously mentioned, to effectively seal against the patient's nose, it may be desirable to have the nasal cushions 3112 facing generally upward and pressed against the underside of the nose. The rigidiser arms 3302 may allow the tension force vectors created by the upper straps 3310 of the positioning and stabilising structure 3300 to be appropriately directed so that the straps 3310 do not pass across the patient's eyes, while still allowing these straps 3310 to be separated from the nasal plenum chamber 3202. In other words, a sufficiently stiff rigidiser arm 3302 allows the upper strap 3310 of the positioning and stabilising structure 3300 to effectively pull the nasal 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 eyeglasses, and see more easily.

[0174] 15a-15e depict various top plate 3206 and rigidiser arm 3302 connections to a seal-forming structure 3100 in accordance with examples of the present technology.

[0175] 15a shows the seal-forming structure 3100 in stippled form. According to the depicted example, the rigidiser arm 3302 and the top plate 3206 are one piece. It can be seen that the attachment feature 3252 and the connection feature 3304 are not shown. Thus, the connection between the top plate 3206 and the rigidiser arm 3302 may be flexible to allow the rigidiser arm 3302 to flex due to tension from the positioning and stabilising structure 3300. Also according to this example, the top plate 3206 is permanently connected to the seal-forming structure 3100 in this example.

[0176] It should be understood that the top plate 3206 may be coupled to the nasal plenum chamber 3202 and / or the face plate 3204 may be coupled to the oral plenum chamber 3200 by a permanent connection. A permanent connection may be facilitated by molding to form a mechanical interlock, or the components may be joined by a chemical bond. A permanent connection may be understood to mean a connection in which 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 operably reconnected.

[0177] Alternatively, the top plate 3206 may be coupled to the nasal plenum chamber 3202 and / or the face plate 3204 may be coupled to the oral plenum chamber 3200 by a non-permanent connection. A non-permanent connection may comprise a connection that allows components to be detached and reattached to one another in a reversible manner. In other words, separation of the connection does not require, for example, tearing, damaging, or destroying one or more of the components so that they cannot be operably reconnected. With a non-permanent connection, reattaching a detached component returns the device to an operative state.

[0178] Figure 15b shows an example similar to Figure 15a, in which the top plate 3206 may be connectable to the seal-forming structure 3100 by a hard-to-soft connection at the flexible connection region 3130. In other words, the top plate 3206 and the rigidiser arm 3302 are detachable.

[0179] Figure 15c shows another variation of the example shown in Figure 15a. In Figure 15c, this example includes an attachment feature 3252 on the top plate 3206 and a connection feature 3304 on the rigidiser arm 3302. Thus, the top plate 3206 is permanently fixed to the seal-forming structure 3100, but the rigidiser arm 3302 may be rotatable or detachable from the top plate 3206.

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

[0181] 15e shows an example which includes a hard-to-hard connection of the top plate 3206 to the hard connection region 3132. This example also includes an attachment feature 3252 on the top plate 3206 and a connection feature 3304 on the rigidiser arm 3302. Thus, the top plate 3206 is removable from the seal-forming structure 3100, but the rigidiser arm 3302 may be rotatable and may be removable or separate from the top plate 3206.

[0182] Other examples of the present technology may include a lower attachment feature 3250 that is magnetic and provided on a living hinge, such as the example described in International Patent Application Publication No. PCT / AU2014 / 000021. The living hinge allows movement of the lower attachment feature 3250 in one plane (e.g., a plane parallel to the patient's transverse plane), and the direction of movement may be about one axis. Such a configuration may provide a greater degree of control over the attachment of the positioning and stabilising structure 3300 to the lower attachment feature 3250 and may also provide greater stability with respect to the seal of the mouth cushion 3110 against the patient's face.

[0183] 17a-17f and 19a-19h show components of a rigidiser arm assembly 3301 in accordance with another example of the present technology. The rigidiser arm assembly 3301 may be removable from the top plate 3206. The connection features 3304 of the rigidiser arm assembly 3301 in these examples may include holes formed to fit over corresponding ones of the upper mounting features 3252.

[0184] The rigidiser arm assembly 3301 may comprise two components. The rigidiser arm 3302 and top plate cover 3303 may be integrally formed, with the connection feature 3304 and opening 3308 also molded therein. Nylon or Hytrel® may be used to form the rigidiser arm 3302 and top plate cover 3303. Pads 3305 may also be overmolded onto each rigidiser arm 3302. The pads 3305 may be formed from a thermoplastic elastomer. The pads 3305 may cushion the patient's face (e.g., cheeks) against the rigidiser 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 FIG. 19d, the rigidiser arms 3302 may be formed with an elliptical curvature. The rigidiser arms 3302 may also be configured to be flexible only in a direction parallel to the patient's coronal plane (see FIG. 2e), e.g., medially and laterally relative to the patient's face. In other words, the rigidiser arms 3302 may be flexible substantially in a single plane parallel to the patient's transverse plane. This may allow the rigidiser arms 3302 to accommodate various patient facial widths. Furthermore, the rigidiser arms 3302 may resist extension along their respective longitudinal axes. The rigidiser arms 3302 may also resist twisting about their respective longitudinal axes. Additionally, the rigidiser arms 3302 may resist upward or downward bending, e.g., upward or downward, relative to the patient's face. The resistance of the rigidiser arms 3302 to deformation in these directions may be beneficial to the stability of the patient interface 3000 when the patient interface is worn by a patient.

[0186] According to examples of the present technology, it may be advantageous to have the rigidiser arm assembly 3301 secured to the top plate 3206 in a manner that minimizes relative movement between the top plate 3206 and the rigidiser arm assembly 3301 when they are engaged with one another. To ensure that relative movement between the top plate 3206 and the rigidiser arm assembly 3301 is properly controlled, these components may be structured to engage with one another at at least three points. The connection features 3304 may provide two contact points, and other structure located on the rigidiser arm assembly 3301 between the connection features 3304 may provide a third contact point.

[0187] 19d and 19e also show that the rigidiser arm assembly 3301 may include ribs 3307. When the rigidiser arm assembly 3301 is attached to the top plate 3206, the ribs 3307 may help to reduce relative movement between the top plate 3206 and the nasal cushion 3112 when engaged with the rigidiser arm assembly 3301. The ribs 3307 may have a cross-sectional profile that is triangular in shape to guide the rigidiser arm assembly 3301 into engagement with the top plate 3206. The ribs 3307 may also help to reduce bending and / or twisting between the rigidiser arm assembly 3301 and the top plate 3206 when engaged. In this manner, the ribs 3307 and the connection features 3304 may provide three contact points on the rigidiser arm assembly that engage with the top plate 3206.

[0188] According to further examples of the present technology, in addition to the connection features, structures other than the ribs 3307 may be provided for the third contact point. For example, the top plate 3206 and rigidiser arm assembly 3301 may engage at the third contact point where the rod is inserted into the hole.

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

[0190] Figures 29a-29f show views of another example of the present technology. These figures show features similar to those shown in Figures 17a-17f. However, Figures 29a-29f do not depict a decoupling structure 3500. However, it should be understood that a decoupling structure 3500, as described elsewhere herein, may be attached to a connection port 3600.

[0191] 5.3.3.1 Top plate and face plate With respect to the face plate 3204 and top plate 3206 described above, it may be advantageous to select a material that is relatively rigid compared to, for example, the nasal cushions 3112, which may be formed from a flexible material such as silicone. Selecting a relatively rigid material may provide effective anchoring points for the positioning and stabilising structure 3300 (e.g., rigidiser arms 3302) so that the positioning and stabilising structure 3300 can attach to the seal-forming structure 3100 in place. If the positioning and stabilising structure 3300 were to be 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 nasal cushions 3110, 3112 when worn by a patient, and tension may be applied by the positioning and stabilising structure 3300. Tension may be applied particularly in the anterior / posterior direction. Examples of the positioning and stabilising structure 3300 may be formed from Breathe-O-Prene™, Soft Edge™, and / or elastic fabric.

[0192] Additionally, by forming the faceplate 3204 and top plate 3206 from a relatively rigid material, these components can be formed to have approximately the same curvature as the patient's face, thereby further ensuring a good seal by properly supporting the seal-forming structure 3100. This may also ensure an effective seal against the patient's airway when the positioning and stabilising structure 3300 exerts a tensile force vector V that is generally parallel to the Frankfort horizontal plane shown in FIG.

[0193] Forming the face plate 3204 and the top plate 3206 from a relatively rigid material may be beneficial in that such a relatively rigid material may prevent the outer portions of the seal-forming structure 3100 from deforming to the point where the periphery folds inward toward the face. This configuration may help ensure that sealing pressure is applied evenly by the seal-forming structure 3100 across the patient's face. While the headgear straps 3306 of the positioning and stabilizing structure 3300 may create tension vectors to seal the seal-forming structure 3100 against the patient's face, the face plate 3204 and the top plate 3206 may help spread these sealing forces across the oral cushion 3110 and nasal cushion 3112. By spreading these sealing forces over a wider area, pressure and / or deformation are not localized in specific areas of the oral cushion 3110 and nasal cushion 3112, for example, near where the headgear straps 3306 are connected.

[0194] Also, by forming the top plate 3206 from a relatively rigid material, this may prevent unwanted vertical bending of the rigidiser arms 3302 when the patient interface 3000 is worn, but may still allow rotation of the rigidiser arms 3302 in a plane parallel to the patient's coronal plane. It should be understood that a slight amount of vertical bending may be allowed.

[0195] Additionally, forming the faceplate 3204 from a relatively rigid material may make it easier for the patient to attach the lower straps 3312 of the positioning and stabilising structure 3300 as the lower attachment feature 3250 may be held in a relatively fixed position when the patient interface 3000 is worn by the patient.

[0196] Also, disassembly and assembly (e.g. for cleaning purposes) of the patient interface 3000 and the positioning and stabilising structure 3300 may be easier for the patient if the positioning and stabilising structure 3300 is not directly connected to the seal-forming structure 3100.

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

[0198] In examples of the present technology, various headgear configurations may be used with the exemplary patient interface 3000 described herein. One example of the present technology may utilize headgear similar to the headgear disclosed in U.S. Patent Application Publication No. 2012 / 0138061. A further variation may include upper straps 3310 that are shorter than the upper straps disclosed in the aforementioned publication by virtue of their connection to the rigidiser arms 3302.

[0199] In a further example of the present technology, the positioning and stabilising structure 3300 may include features disclosed in International Patent Application Publication No. PCT / AU2013 / 000830 or US Patent Application Publication No. 2014 / 0026890. The positioning and stabilising structure 3300 disclosed therein may be used as the upper straps 3310. The lower straps 3312 may be neoprene CommonLine headgear straps.

[0200] According to a further example of the present technology, one size of top plate 3206 and face plate 3204 may be used for various sizes of 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, according to this example of the present technology, only the seal-forming structure 3100 and plenum chamber 3200 need to be molded in different sizes.

[0201] 18a-18f, 21a-21e, 22a-22e, and 28a-28e show examples of a top plate 3206 and a face plate 3204 in accordance with a further example of the present technology. 18a-18f show a top plate 3206 and a face plate 3204 attached to a nasal plenum chamber 3202 and an oral plenum chamber 3200, respectively. In accordance with an example of the present technology, the top plate 3206 and the face plate 3204 may be formed from a material that is relatively rigid compared to silicone. The top plate 3206 and the face plate 3204 may be coupled 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 onto the top plate 3206 and the face plate 3204. The nasal plenum chamber 3202, nasal cushions 3112, oral plenum chamber 3200, oral cushions 3110, and isolation structure 3106 may be molded as a single piece from silicone.

[0202] 18a, 18b, 18c, and 18f also show a top plate buffer 3214 and a face plate buffer 3215. The top plate buffer 3214 may be integrally formed with the nasal plenum chamber 3202 and may be formed from silicone. When the nasal plenum chamber 3202 is overmolded onto the top plate 3206, silicone may pass through holes 3217 into or through core-outs 3216 in the top plate 3206 to form the top plate buffer 3214, as seen in FIGS. 21a-21e. The holes 3217 and core-outs 3216 may collectively provide a smooth flow path for the silicone as it is overmolded onto the top plate 3206. Alternatively, the core-outs 3216 may not be open to provide a path for silicone flow during overmolding; instead, the core-outs 3216 may comprise a recessed pocket that can be filled with silicone to form a mechanical interlock and provide cushioning. The top plate buffer 3214 may press against the rear side of the top plate cover 3303 when the rigidiser arm assembly 3301 is coupled to the top plate 3206. The top plate buffer 3214, which is formed from a relatively softer material than the top plate 3206 and top plate cover 3303, such as silicone, may damp the hard-to-hard connection to reduce or eliminate rattle noise between these components.

[0203] A top plate buffer 3214 formed integrally with the nasal plenum chamber 3202 and connecting through holes 3217 in the top plate 3206 may provide a retention function to hold the top plate 3206 in place relative to the nasal plenum chamber 3206.

[0204] The ribs 3307 may cooperate with the top plate buffer 3214 to provide damping and / or retention of the engagement between the top plate 3206 and the rigidiser arm assembly 3301. The engagement of the ribs 3307 with the top plate buffer 3215 and the top plate 3206 may provide 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 periphery of the mouth plenum chamber 3200. The faceplate buffer 3215 may be integrally formed with the mouth plenum chamber 3200. The faceplate buffer 3215 may be formed from silicone. The faceplate buffer 3215 may damp the hard-to-hard connection between the faceplate 3204 and the frame 3251 to reduce or eliminate rattles that may result from the connection.

[0206] 21a-21e show the top plate 3206 in isolation, and FIGS. 22a-22e show the face plate 3204 in isolation.

[0207] The upper mounting features 3252 of the top plate 3206 may connect to the rigidiser arm assemblies 3301 at the connection features 3304 as shown in Figures 17a-17f. The upper mounting features 3252 in these examples may include rigid pockets and / or undercuts that engage with the respective connection features 3304 to attach the rigidiser arm assemblies 3301.

[0208] The faceplate 3204 may include cutouts 3213 on both sides for connecting the frame 3251 to the faceplate. Each cutout 3213 may extend laterally from the faceplate 3204. The cutouts 3213 may facilitate a rigid-to-rigid connection between the faceplate 3204 and the frame 3251 (e.g., between two relatively rigid components). The rigid-to-rigid connection may be in the form of a snap fit and may cause an audible click when the frame 3251 is attached to the faceplate 3204. Also, connection ports 3600 can be seen formed in the faceplate 3204. In FIGS. 17a-17f, the frame 3251 can be seen attached around the periphery of the faceplate 3204.

[0209] 28a-28e show another example of a top plate 3206 similar to the views shown in Figs. 21a-21e. However, the example shown in Figs. 28a-28e shows that a recess 3219 may be provided in each core-out 3216 on the rear side of the top plate. The recess 3219 may provide more depth for silicone flow during molding of the seal-forming structure 3100 and plenum chamber 3200 to the top plate 3206. The recess 3219 may be hemispherical and therefore may provide more surface area for adhesion of the silicone to the top plate 3206, which may be a viscous liquid silicone rubber (LSR), according to one example of the present technology.

[0210] 27a-27f show another example of the present technology. In these figures, the seal-forming structure 3100 is shown with a face plate 3204 and a top plate 3206. The example shown in these figures is similar to the example shown in FIGS. 18a-18f in that the seal-forming structure 3100 may be formed from silicone and may be overmolded to the top plate 3206 and face plate 3204 to bond these components. FIGS. 27a-27f show another example in that the top plate 3206 may be almost completely embedded in the seal-forming structure 3100. In other words, when the seal-forming structure 3100 is overmolded onto the top plate 3206, it may completely surround the top plate 3206 such that a minimal amount of the top plate 3206 is exposed. Also, an extension 3218 may be formed extending from the top plate 3206, and this extension may be formed integrally with the seal-forming structure 3100. The extension 3218 may perform a buffering and / or vibration damping function similar to the top plate buffer 3214 when the rigidiser arm assembly 3301 is coupled to the top plate 3206. The extension 3218 may also be formed with a hook shape, and therefore the extension may perform a retention function.

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

[0212] 20a-20s, 23a-23f, 24a-24f, and 25a-25f show several views of the frame 3251 with clips 3314 and lower attachment features 3250, in addition to views of their respective subcomponents.

[0213] The frame 3251 may include catches 3253 on either side for engaging with corresponding ones of the cutouts 3213 to facilitate attachment to the faceplate 3204. The engagement of the catches 3253 with the cutouts 3213 may create a hoop stress in the frame 3251 that holds the frame to the faceplate 3204. Lower attachment features 3250 may be formed on the frame 3251. For example, as shown in FIG. 20f, the lower attachment features 3250 may each include a mating surface 3254 to which a respective clip 3314 is coupled. FIG. 20g shows that each mating surface 3254 may rest on a mating portion 3255 of the lower attachment feature 3252. Each lower attachment feature 3250 may include a wing 3257 to couple the frame 3251 to the respective mating portion 3255.

[0214] The wings 3257 may be coupled to the frame 3251 by overmolding the wings 3257 onto the frame extensions 3259 of the frame such that a mechanical interlock is formed. The frame extensions 3259 may then extend into respective recesses 3258 of the wings 3257. The mating portions 3255 may be coupled to the wings 3257 by simultaneous overmolding such that a mechanical interlock is also formed between the wings 3257 and the mating portions 3255. Thus, the mating portion extensions 3256 may extend into the recesses 3258 of the wings 3257.

[0215] The wings 3257 may be formed from a thermoplastic elastomer. The wings 3257 may be flexible such that the lower attachment feature 3250 acts as a living hinge. In other words, the lower attachment feature 3250 may be able to move in an anterior / posterior direction due to their flexibility such that, when worn, tension in the straps 3306 causes the lower attachment feature to flex and hold the patient interface 3000 against the patient. The mating portion 3255 may also be formed from a thermoplastic elastomer.

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

[0217] A magnetic connection may be provided to couple the clip 3314 to the lower attachment feature 3250. Each clip 3314 may be provided with a clip magnet 3260 in a clip pocket 3317, and each mating portion 3255 of the lower attachment feature 3250 may be provided with a mating magnet 3261 in a mating pocket 3262. The magnetic poles of each clip magnet 3260 and each mating magnet 3261 may be aligned such that a magnetic attraction is generated between the magnets to attract and hold the clip 3314 to the lower attachment feature 3250. Further examples of these attachment configurations are disclosed in International Patent Application Publication No. PCT / AU2014 / 000021, which is incorporated herein by reference in its entirety.

[0218] The mating portions 3255 in these examples may also include guide surfaces 3263 and protrusions 3264 to position the clips 3314 as they are 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 protrusion 3264. When the clips 3314 are attached to their respective mating portions 3255 of the lower attachment feature 3250, the engagement of the notch 3318 with the protrusion 3264 may prevent rotation of the clip 3314 relative to the mating portion 3255 of the lower attachment feature 3250. This may help to ensure that the tension vectors of the lower straps 3312 are properly aligned and keep them aligned when the patient interface 3000 is worn by the patient.

[0219] The guide surface 3263 may have a curved shape. The guide surface 3263 may be shaped to form a protrusion. The receiving surface 3319 may be shaped to correspond to the shape of the guide surface 3263. The shape of the guide surface 3263 may have a guiding and / or retaining function. The curved shape and slope of the guide surface 3263 may allow the receiving surface 3319 to slide along the guide surface 3263 into position so that the protrusion 3264 engages the notch 3318. This may be advantageous as it may be difficult for a patient to align the clip 3314 with the lower attachment feature 3250 when the patient interface 3000 is being worn. Also, the patient may be in a dark environment, may have limited tactile capabilities, and / or may have limited eyesight to align the clip 3314 with the lower attachment feature 3250. Therefore, structuring the guide surface 3263 so that it guides the receiving surface 3315, and thus so that the guide surface 3263 guides the clip 3314 into position, may help to ensure a proper and secure fit of the patient interface 3000.

[0220] 20n shows a rear view of the frame 3251 and the lower attachment features 3250. According to this example, each of the lower attachment features 3250 may comprise a bending point, depicted in this view as a reduced thickness portion 3266. The lower attachment features 3250 may be deformed and bend in a rearward direction at the bending point when subjected to tension by the lower side straps 3312 of the positioning and stabilising structure 3300. The lower attachment features may comprise a thermoplastic elastomer.

[0221] 20q-20s illustrate a further example of the present technology with plan views of the frame 3251 and lower attachment features 3250. FIG. 20q illustrates a notch 3265 at a bending point on the front side of each lower attachment feature 3250. The notch 3265 in FIG. 20q may allow the lower attachment feature 3250 to bend forward through the notch 3265. FIG. 20r illustrates a notch 3265 at a bending point on the rear side of each lower attachment feature 3250. The notch 3265 in FIG. 20r may allow the lower attachment feature 3250 to bend rearward through the notch 3265. It should be understood that according to further examples of the present technology, the notch 3265 may be provided on the rear and front sides of each lower attachment feature 3250.

[0222] 20s shows another top view of the frame 3251 and lower attachment feature 3250 according to an example of the present technology. According to this example, the bending point may comprise a reduced thickness portion 3266 that reduces the thickness of the lower attachment feature 3250 from the back and front to allow the lower attachment feature to bend in both directions.

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

[0224] 20p and 25g-25l also show that the clip 3314 may include a clip magnet receiving portion 3321 and a clip magnet cover 3320 for securing the clip magnet 3260 within the clip 3314. The clip magnet cover 3320 may secure the clip magnet 3260 within the clip magnet receiving portion 3321 with a snap fit.

[0225] 5.3.4 Vents, tube isolation structures, connection ports, and anti-asphyxiation valves In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the exit of exhaled carbon dioxide.

[0226] One form of vent 3400 in accordance with the present technology comprises a plurality of holes, such as 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 contemplated.

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

[0228] In other examples of the present technology, the vents 3400 are located in the top plate 3206 and / or face plate 3204. In such examples, the tube isolation structure 3500 may not include a vent.

[0229] The vent 3400 may be laser cut or formed from a mesh material or linear array. The vent 3400 may also be formed from an intertwined plastic fiber material or fabric. The intertwined plastic fiber material is a thermoplastic polymer including polycarbonate, nylon, polyethylene, and preferably polypropylene. Specifically, the fabric may be SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene material. The fabric may be The fabric is typically provided in the form of a roll or ribbon. The weave of the fabric is preferably a satin weave; however, other weaves are contemplated, including plain weave, reverse plain weave, and twill weave. The voids or holes defined through the fabric by the weave of the fibers do not necessarily have uniform dimensions because of variations in fiber positioning, spacing, and compression in the weave of the fabric. The voids are preferably not straight through the holes, but rather define tortuous air flow paths between adjacent fibers throughout the thickness of the fabric. The tortuous air flow paths significantly diffuse the air flow, thereby reducing noise. If the voids were straight through the holes, the fibers of the fabric may be arranged in the form of a mesh lattice.

[0230] In one example, the airflow rate through the vent section of the fabric is first measured with an airflow meter. A determination is made as to whether there is a difference between the measured airflow rate and the desired airflow rate. If the airflow rate through the vent section exceeds a predetermined range, the porosity of the vent section is selectively reduced. A desirable predetermined range is about 42 to about 59 liters / minute at 20 cmH2O pressure, preferably about 47 to about 53 liters / minute at 20 cmH2O pressure. For example, the airflow rate through the SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene material may be about 37 to about 64 liters / minute at 20 cmH2O pressure, preferably about 42 to about 58 liters / minute at 20 cmH2O pressure. The variation across the length of the SEFAR fabric may be sinusoidal across the length of the fabric ribbon. Different regions of the SEFAR fabric when initially received from the fabric manufacturer exhibit different airflow rates. After the porosity has been reduced, the airflow rate is measured again to verify that it is now within the predetermined range. The average diameter of the void openings is preferably less than 0.1 mm, and preferably provides a total open area of ​​about 1% to 10% of the vent's surface area. For example, the total open area may be 22 mm2 if the vent's surface area is 240 mm2.

[0231] Optionally, if the desired airflow velocity is present in the fabric, the holes in the perimeter region of the desired vent are plugged. The perimeter region of the vent is overmolded to the top plate 3206 and / or face plate 3204. Since the holes in the perimeter region have been plugged, the airflow velocity of the vent should not be different after overmolding.

[0232] In some instances, the air velocity may be measured after the vents are cut from the fabric, or after the vents are overmolded onto the top plate 3206 and / or face plate 3204. This allows the air velocity to be known after each step and it can be determined that the air velocity is within a desired predetermined range. This prevents waste as parts are discarded as soon as they are found not to be within the desired predetermined range.

[0233] The porosity of the vent can be reduced by several methods, including heat staking, plastic deformation by compression, ultrasonic welding, application of a sealant (e.g., a hot melt adhesive), and application of a thin film. Preferably, heat staking with a staking punch is used to reduce porosity due to its high precision, high reliability of closing the holes in the fabric, speed of production, good visual appeal after heat staking, and the lack of need for additional material. When heating thermoplastics, some material shrinkage occurs, resulting from excess material surrounding the specific physical dimensions for the vent shape. The porosity of the vent can be reduced by partially or completely blocking the holes in the vent.

[0234] Any portion or region of the vent may be selected for reduced porosity. Preferably, the porosity is reduced in the continuous perimeter region of the vent. This region provides good visual appeal because it is adjacent to or at the location where the vent is overmolded to the top plate 3206 and / or face plate 3204. Any visual difference between the continuous perimeter region of the vent and the remaining regions may be less noticeable in this location because that location may appear to be the defined edge of the top plate 3206 and / or face plate 3204 for receiving the vent 3400. Alternatively, the region for reduced porosity 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] Sound caused by exhaled carbon dioxide passing through the vent 3400 is minimized due to increased air diffusion as the carbon dioxide passes through the fabric, particularly in the nasal pillows, as the patient exhales through their nose and the carbon dioxide flows out through the vent. The diffusion of exhaled carbon dioxide avoids direct or focused airflow onto the bed partner or patient depending on the vent orientation and sleeping position.

[0236] The vents of the patient interface 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 flush the vents for cleaning. The vents can be hand washed and rinsed without disassembling them from the top plate 3206 and / or face plate 3204. This is because the vents can be permanently connected, e.g., overmolded, to the top plate 3206 and / or face plate 3204. Having fewer removable parts for the patient interface avoids the possibility of losing individual parts and reduces cleaning time by not having to remove and reassemble parts from each other. Because the vents are made from plastic fibers, the durability of the vents is maintained even after repeated cleaning, unlike vents made from other less durable materials, such as woven fabrics.

[0237] The vent is quiet. The acoustic energy generated by the exhaled carbon dioxide is spread evenly. Vibrations caused by the exhaled carbon dioxide contacting the top plate 3206 and / or face plate 3204 result in vibrations of the top plate 3206 and / or face plate 3204. Such vibrations may be damped by the vent.

[0238] In one form, the patient interface 3000 includes at least one tube decoupling structure 3500, such as a swivel or ball and socket. The tube decoupling structure 3500 may include an elbow feature. The tube decoupling structure 3500 may be split 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 the tube may include the tubing features disclosed in International Patent Application Publication No. PCT / AU2013 / 000830. A rotatable adapter may be included to connect the short tube to the long tube.

[0240] In one form, the patient interface 3000 includes an anti-asphyxiation valve 3800 .

[0241] FIG. 3g shows another front perspective view of a patient interface 3000 in accordance with the present technology. This view depicts similar features to those shown in FIG. 3a, but also includes features for connecting the patient interface 3000 to a PAP device 4000. These additional depicted features include at least one vent 3400 radially disposed about a port 3600. In the depicted example, the vent 3400 comprises multiple vent holes about the port 3600. The features of the vent 3400 are described in more detail below. Also shown in this view is a tube decoupling structure 3500 for connecting the air circuit 4170 to the port 3600 on the faceplate 3204 of the patient interface 3000. The tube decoupling structure 3500 may be an elbow or may include a swivel 3510 to allow the tube decoupling structure 3500 and the air circuit 4170 to rotate relative to the patient interface 3000 about the port 3600. The tube isolation structure 3500 in this figure also includes an anti-asphyxiation valve 3800, which is 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 isolation structure 3500.

[0242] Figure 3h depicts features of an exemplary patient interface 3000 in a rear view similar to 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 are also visible. The location of the separation structure 3106 is shown in this view, along with the connection region 3106.2 between the oral cushion 3110 and the nasal cushion 3112.

[0243] Figure 3i shows a front view of an exemplary patient interface 3000 similar to Figure 3b. Also shown in Figure 3i is a tube isolation structure 3500 that connects to a port 3600 on the faceplate 3204 of the patient interface 3000. This view also shows a vent 3400 in the form of a plurality of vent holes arranged radially around the port 3600. An anti-asphyxiation valve 3800 can be seen on the tube isolation structure 3500. A cuff 4172 and an air circuit 4170 can also be seen connected to the tube isolation structure 3500. The isolation structure 3106 is shown in this view, and a side 3106.3 of the isolation structure 3106 can also be seen.

[0244] Figure 3j shows a top view of an exemplary patient interface 3000 with features similar to those shown in Figure 3d, which further depicts a vent 3400 in the form of a plurality of vent holes disposed around a port 3600. Extending from the port 3600 is a tube isolation structure 3500 comprising an anti-asphyxiation valve 3800 disposed therein.

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

[0246] Figure 3l shows a side view of an exemplary patient interface 3000 similar to the view shown in Figure 3f. Accordingly, Figure 3l depicts similar features to those shown in Figure 3f. However, Figure 3l also shows a vent 3400 including multiple vent holes arranged radially around a port 3600. A 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. This view also depicts the location of the isolation structure 3106 and one of its sides 3106.3. Also shown is the gap 3106.1 between the nasal plenum chamber 3202 and the oral plenum chamber 3200, which allows these components to flex or move toward each other.

[0247] According to the examples shown in Figures 17a-17f and 26a-26d, a decoupling 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 decoupling structure 3500. In these examples, the tube decoupling structure 3500 may include a rotatable elbow at its connection with the connection port 3600. The decoupling structure 3500 may include a swivel 3510 for connecting to the air circuit 4170. The decoupling structure 3500 may include a baffle 3520 to separate the flow path of pressurized gas from the PAP device 4000 from the flow path of exhaled gases (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 gases (e.g., CO2). The tube isolation structure 3500 may include a quick release mechanism 3530 that allows a patient to easily attach and remove the tube isolation structure 3500 from the connection port 3600 on the faceplate 3204. The quick 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 include an anti-asphyxiation valve 3800.

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

[0249] 5.4.1 General Provisions Air: Air is understood to include breathing gases, for example air with supplemental oxygen.

[0250] Continuous Positive Airway Pressure (CPAP): CPAP treatment is understood to mean the application of a predetermined volume of air or breathing gas to the entrance to the airways at a pressure that is continuously positive relative to the atmosphere and preferably substantially constant over the patient's respiratory cycle. In some forms, the pressure at the entrance to the airways varies by a few centimeters of water within a single respiratory cycle, e.g., higher during inspiration and lower during expiration. In some forms, the pressure at the entrance to the airways is slightly higher during expiration and slightly lower during inspiration. In some forms, the pressure varies between different respiratory cycles of the patient, e.g., increased in response to detection of an indication of partial upper airway obstruction and decreased in the absence of an indication of partial upper airway obstruction.

[0251] 5.4.2 PAP Device Aspects Air Circuit: A conduit or tube constructed and arranged, in use, to deliver a predetermined volume of air or breathable gas between a PAP device and a patient interface. 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, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0252] APAP: Automatic Positive Airway Pressure.

[0253] Blower or Flow Generator: A device that delivers a flow of air at a pressure above ambient pressure.

[0254] Controller: A device or part of a device that adjusts an output based on an input. For example, one form of controller has a variable under control—a controlled variable—that constitutes the input to the device. The output of the device is a function of the current value of the controlled variable and a setpoint for the variable. A servo-ventilator may include a controller with ventilation as an input, a target ventilation as a setpoint, and a pressure support level as an output. Other forms of input may be one or more of oxygen saturation (SaO2), partial pressure of carbon dioxide (PCO2), motion, a signal from a photoplethysmograph, and peak flow. The controller's setpoint may be one or more of fixed, variable, or learning. For example, the setpoint in a ventilator may be the long-term average of the patient's measured ventilation. Other ventilators may have a ventilation 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: Treatment in this context may be one or more of positive pressure therapy, oxygen therapy, carbon dioxide therapy, dead space control, and administration of medication.

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

[0257] 5.4.3 Facial Anatomy Ala (ala): the outer wall or "wing" of each nostril (plural: alae)

[0258] Alar angle: the angle defined between the alars when viewed from below

[0259] Alar outermost point: The outermost point of the nasal ala.

[0260] Alar curvature (or alar tip) point: The most posterior point on the curvature baseline of each alar, found at the crease formed by the attachment of the alar to the cheek.

[0261] Auricula or pinna: the entire visible outer part of the ear.

[0262] (Nasal) skeleton: The nasal skeleton comprises the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

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

[0264] Columella: the 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 while crossing the nasal spine.

[0266] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left tragus point, which is the deepest point of the notch above the auricle of the pinna.

[0267] Glabellar: The most prominent point in the midsagittal plane of the forehead, located on the soft tissue.

[0268] Lateral nasal cartilage: roughly triangular plate of cartilage, the superior margin of which is attached to the nasal bone and the frontal process of the maxilla, and the inferior margin of which is connected to the greater alar cartilage.

[0269] Lower lip (midpoint): The point where the border between the vermilion and skin of the lower lip is intersected by the midsagittal plane.

[0270] Upper lip (midpoint): A point on the upper lip located in the midsagittal plane on a line drawn across the border between the vermilion and the skin.

[0271] Greater alar cartilage: a plate of cartilage located below the lateral nasal cartilage. The greater alar cartilage curves around the anterior part of the nostril. The posterior end of the greater alar cartilage is attached to the frontal process of the maxilla by a tough fibrous membrane that contains three or four small cartilages of the alar.

[0272] Nostrils (nostrils): roughly oval openings that form the entrance to the nasal cavity. The singular form of nares is 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 and runs from either side of the nose to the corners of the mouth.

[0274] Nasolabial angle: the angle between the columella and upper lip across the nasal spine.

[0275] Lower ear base: lowest point of attachment of the pinna to the skin of the face.

[0276] Superior ear base: the uppermost point of attachment of the pinna to the skin of the face.

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

[0278] Philtrum: a median groove extending from the lower edge of the nasal septum to the upper edge of the lip in the upper lip region.

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

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

[0281] Sagittal plane: vertical plane passing from front to back dividing the body into right and left halves.

[0282] Nasal root: the most concave point located on the soft tissue, lying in the area of ​​the frontonasal suture.

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

[0284] Lowest point of the alar: The lower edge of the base of the alar where it joins the skin of the upper (upper) lip.

[0285] Nasal spine point: the point on the soft tissue where the columella meets the upper lip in the midsagittal plane.

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

[0287] 5.4.4 Skull anatomy Frontal bone: The frontal bone includes the greater vertical part, the scales frontalis, which corresponds to the area known as the forehead.

[0288] Mandible: The mandible forms the lower jaw. The mental protuberance is the 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 projects upwards by the side of the nose and forms part of the lateral border of the nose.

[0290] Nasal bones: The nasal bones are two small, oval bones that vary in size and shape in different individuals; they are positioned side by side in the middle and upper part of the face and, when joined, form the "bridge" of the nose.

[0291] Nasion: the intersection of the frontal bone and the two nasal bones, a concave area just between the eyes and the top of the bridge of the nose.

[0292] Occipital bone: The occipital bone is located at the lower back of the skull. It contains an oval opening, the foramen magnum, through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the squama occipitalis.

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

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

[0295] Cheekbones: The face contains two cheekbones that are located on the top and sides of the face and form the cheek ridges.

[0296] 5.4.5 Respiratory system structure Diaphragm: A layer of muscle that extends across the base 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 voice box, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

[0298] Lung: Human respiratory system. The conducting region of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0299] Nasal cavity (or nasal fossa) is the area in the center of the face above and behind the nose. The nasal cavity is a large air-filled space located in the nasal cavity. 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 nasal conchae (singular "concha") or turbinates. At the front of the nasal cavity is the nose, which merges dorsally into the nasopharynx via the choanae.

[0300] Pharynx: the part of the throat that lies just below (inferior to) the nasal cavities and above the esophagus and larynx. The larynx is usually divided into three parts: the nasopharynx (nasopharynx), the oropharynx (mesopharynx), and the laryngopharynx (hypopharynx).

[0301] 5.4.6 Materials Silicone or Silicone Elastomer: Synthetic rubber. In this specification, references to silicone are references to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (sold under the trademark) manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, preferred forms of LSR have a Shore A (or Type A) indentation 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 Aspects Anti-Asphyxiation Valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by venting to atmosphere in a fail-safe manner.

[0304] Elbow: A conduit that directs the axis of airflow to change direction through a predetermined angle. In one form, the angle may be approximately 90°. In other forms, the angle may be less than 90°. The conduit may have a generally circular cross section. In other forms, the conduit may have an oval or rectangular cross section.

[0305] Frame: Frame is understood to mean the mask structure that supports the tension load between two or more connection points with the headgear. A mask frame may be a non-airtight load-bearing structure in the mask. However, some forms of mask frames 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 collect such that normal gas flow within the breathing circuit cannot effectively flush the exhaled air from the breathing circuit.

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

[0308] Membrane: Membrane is understood to mean a generally thin element that is preferably substantially non-resistant to bending but resistant to elongation.

[0309] Plenum Chamber: Mask plenum chamber is taken to mean a portion of a patient interface having walls enclosing a volume of space, said volume having air therein that is pressurized above atmospheric pressure in use. The outer shell may form part of the mask plenum chamber wall. In one form, an area of ​​the patient's face forms one of the plenum chamber walls.

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

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

[0312] Reinforcement: Reinforcement is taken to mean a structural component adapted to increase the bending resistance of another component in at least one direction.

[0313] Strut: A strut is understood to be a structural component adapted to increase the compressive resistance of another component in at least one direction.

[0314] Swivel: (noun) A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360°. In another form, the swivel may be configured to rotate through an angle less than 360°. The subassembly of components, when used in connection with an air circuit, preferably comprises a matched pair of cylindrical conduits. Preferably, there is little or no airflow leakage from the swivel when in use.

[0315] String: A string is understood to be a structural component adapted to resist tension.

[0316] Vent: (noun) A structure or conduit to the outside air that allows a deliberate, controlled rate of leakage of air from the interior of a mask to allow the escape of exhaled carbon dioxide (CO2) and the supply of oxygen (O2).

[0317] 5.4.8 Terminology used in relation to patient interfaces Curvature (of a surface): A region of a surface that has a saddle shape, curving upward in one direction and downward in a different direction, is interpreted as having negative curvature. A region of a surface that has a dome shape, curving equally in both major 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 has the following combination of characteristics: Easily adapts to acupressure. It cannot maintain its shape when forced to support its own weight. Not rigid Can be stretched or bent elastically with little effort

[0319] The quality of being flexible may have an associated direction, so that a particular material, structure, or composite may be flexible in a first direction, but stiff or rigid in a second direction, for example, a second direction perpendicular to the first direction.

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

[0321] Rigid: Does not easily deform in response to finger pressure and / or tensions or loads typically encountered when placing and maintaining a patient interface in sealing relationship with the entrance to a patient's airway.

[0322] Semi-rigid: means sufficiently rigid so as not to substantially distort under the mechanical forces typically 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 commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of exemplary methods and materials are described herein.

[0324] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0325] Moreover, in interpreting the disclosure, all terms should be interpreted in the broadest reasonable 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 thus as suggesting that a referenced element, component, or step may be present or utilized or may be combined with other elements, components, or steps not expressly mentioned.

[0326] Although the technology herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terminology and symbols may suggest specific details that are not required to practice the technology. For example, while the terms "first" and "second" may be used, unless otherwise specified, these terms are not intended to indicate any order and may be utilized to distinguish between separate elements. Also, while process steps in a methodology may be described or illustrated in a certain order, such ordering is not required. As will be appreciated by those skilled in the art, such ordering may be changed and / or aspects may occur simultaneously or even synchronously.

[0327] It is therefore to be understood that numerous modifications may be made to the illustrated embodiments and other arrangements may be devised without departing from the spirit and scope of the present technology.

[0328] Furthermore, the present invention preferably includes the following examples. [Additional note 1] 1. A patient interface for delivering breathable gas to a patient, the patient interface comprising: 1. A plenum chamber assembly comprising: a nasal plenum chamber at least partially defining a first gas chamber, the nasal plenum chamber configured to contact the patient's nose below the bridge of the nose and around the lower periphery of the nose; an oral plenum chamber at least partially defining a second gas chamber, the oral plenum chamber configured to seal around the patient's mouth; a plenum chamber assembly comprising: an isolation structure at least partially connecting the nasal plenum chamber and the oral plenum chamber and at least partially defining a flow path between the nasal plenum chamber and the oral plenum chamber, the isolation structure being configured to isolate relative movement between the nasal plenum chamber and the oral plenum chamber; a top plate operatively connected to the plenum chamber assembly at the nasal plenum chamber, the top plate including at least one connection feature configured to releasably retain a first portion of a positioning and stabilising structure; a faceplate operably connected to the plenum chamber assembly at the plenum chamber, the faceplate configured to releasably retain a second portion of the positioning and stabilising structure; Equipped with A patient interface, wherein the top plate and the face plate are more rigid than the plenum chamber assembly. [Additional note 2] 10. The patient interface of claim 1, wherein the flow path pneumatically connects the first gas chamber and the second gas chamber. [Additional note 3] 3. The patient interface of claim 1 or 2, wherein the top plate and the face plate are releasably attachable to the plenum chamber assembly. [Additional note 4] 4. A patient interface according to any one of claims 1 to 3, wherein the positioning and stabilising structure comprises a rigidiser arm assembly having a pair of rigidiser arms, the rigidiser arm assembly connected to the top plate. [Additional note 5] each of the pair of rigidiser arms is capable of bending in a plane parallel to the patient's transverse plane; 5. A patient interface as described in claim 4, wherein each of the pair of rigidiser arms is structured to resist bending, torsion, and / or extension in a plane perpendicular to the patient's transverse plane. [Additional note 6] 6. A patient interface according to claim 4 or 5, wherein each of the rigidiser arms has an elliptical shape to fit the curvature of the patient's cheek. [Additional note 7] the nasal plenum chamber includes a nasal flange defining a nasal opening; 7. A 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 nose of the patient. [Additional note 8] 8. A 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 port plenum chamber including a port flange defining a port opening; 9. A patient interface according to claim 7 or 8, wherein the oral flange is configured to form a seal with at least the mouth of a patient. [Additional Note 10] 10. A patient interface as described in claim 9, wherein the oral flanges are formed around the entire circumference of the oral plenum chamber, or around two opposite sides of the outer circumference of the oral plenum chamber, or around a majority of the outer circumference of the oral plenum chamber. [Additional Note 11] 10. A patient interface according to claim 9, wherein the oral plenum chamber comprises a pair of oral undercushion portions, each of the oral undercushion portions being disposed on either side of the oral plenum chamber to support the oral flange. [Additional Note 12] 12. A patient interface as described in claim 10 or 11, wherein the oral plenum chamber comprises oral undercushion portions disposed around the periphery of the oral plenum chamber and extending radially from opposite ends of the separation structure to support the oral flange. [Additional Note 13] 13. A patient interface according to any one of claims 10 to 12, wherein the separation structure connects the nasal flange and the oral flange. [Additional Note 14] 14. A patient interface according to claim 13, wherein the isolation structure comprises an upper surface, a lower surface, and a connecting surface, the connecting surface having a greater stiffness than the upper and lower surfaces. [Additional Note 15] 14. A patient interface according to claim 13, wherein the isolation structure is stiffer at a portion opposite the patient's face than at a portion adjacent the patient's face. [Additional Note 16] 16. A patient interface according to any one of claims 13 to 15, wherein the stiffness of the isolation structure increases in a radial direction from a portion adjacent the patient's face to a portion opposite the patient's face. [Additional Note 17] 17. A patient interface according to any one of claims 8 to 16, wherein the nasal contacting portion of the nasal flange is stiffer at the portion not in contact with the patient's nose than at the portion of the nasal flange that is not in contact with the patient's nose. [Additional Note 18] 18. A patient interface according to any one of claims 8 to 17, wherein the nasal flanges increase in stiffness outwardly from the nasal opening. [Additional Note 19] 19. A patient interface according to any one of claims 8 to 18, wherein the stiffness of the nasal flange varies at predetermined locations around the nasal opening. [Additional Note 20] 20. A patient interface according to any one of claims 8 to 19, wherein a lower portion of the nasal flange near the separation structure is concave to seal against the patient's upper lip. [Additional Note 21] 21. A 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, each protruding end configured to seal against a corresponding ala of the patient's nose. [Additional Note 22] 22. A patient interface according to claim 21, wherein the nasal plenum chamber comprises a pair of nasal undercushion portions, each of the pair of nasal undercushion portions supporting one of the pair of protruding ends. [Additional Note 23] 23. The patient interface of claim 22, wherein each of the nasal undercushion portions is positioned above the oral plenum chamber. [Additional note 24] 24. A patient interface according to any one of claims 1 to 23, comprising headgear for releasably securing the patient interface to a patient, the headgear including a pair of upper straps configured to connect to the nasal plenum chambers and a pair of lower straps configured to connect to the oral plenum chambers. [Additional note 25] 25. A 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] 10. The patient interface of claim 1, wherein the top plate is removably attachable to a flexible connection region of the nasal plenum chamber. [Additional note 27] 10. The patient interface of claim 1, wherein the top plate is removably attachable to a rigid connection region of the nasal plenum chamber. [Additional note 28] 28. A patient interface according to any one of claims 4 to 27, wherein the top plate and the rigidiser arm form an integral part, and the rigidiser arm is more flexible than the top plate in a plane parallel to the patient's transverse plane. [Additional note 29] 1. A patient interface for delivering breathable gas to a patient, comprising: a nasal cushion 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; a separation structure disposed between the nasal cushion and the oral cushion; a top plate secured to the nasal cushion, and a pair of upper attachment features configured to releasably attach a pair of upper side straps of a positioning and stabilising structure to the top plate; a face plate secured to the mouth cushion; and a pair of lower attachment features configured to releasably attach a pair of lower side straps of the positioning and stabilising structure. A patient interface comprising: [Additional note 30] 30. A patient interface according to claim 29, wherein the isolation structure is adapted to form a pneumatic connection between the nasal gas chamber and the oral gas chamber. [Additional Note 31] 30. A patient interface according to claim 29, wherein the isolation structure comprises an upper surface, a lower surface, and a connecting surface, the connecting surface having a greater stiffness than the upper and lower surfaces. [Additional note 32] the stiffness of the isolation structure is radially variable around its circumference such that a portion distal to the patient's face is stiffer than a portion proximal to the patient's face; 32. A patient interface according to any one of claims 29 to 31, wherein the nasal cushion is configured for independent movement from the oral cushion. [Additional note 33] 33. A patient interface according to any one of claims 29 to 32, wherein a nasal contacting portion of the nasal cushion is less stiff than a portion of the nasal cushion that does not contact the patient's nose. [Additional note 34] 34. A patient interface according to any one of claims 29 to 33, wherein the isolation structure is configured to support the nasal cushion against the patient's nose. [Additional note 35] 35. A patient interface according to any one of claims 29 to 34, wherein the nasal cushion is stiffer in portions of the nasal cushion not in contact with the patient's nose than in nasal contacting portions. [Additional note 36] 36. A patient interface according to any one of claims 29 to 35, wherein the nasal cushions include a recess for sealing against the patient's upper lip. [Additional note 37] 37. A patient interface according to any one of claims 29 to 36, wherein the nasal cushion comprises a pair of protruding ends, each of the protruding ends configured to form a seal between a respective ala of the nose and the nasolabial fold on the patient's face. [Additional note 38] 38. A patient interface according to claim 37, wherein the nasal cushion comprises a pair of nasal undercushion portions, each of the nasal undercushion portions being positioned under a respective one of the protruding ends to support the respective one of the protruding ends against the patient's face. [Additional note 39] 39. A patient interface according to any one of claims 29 to 38, wherein the nasal cushions include wings on either side thereof for sealing against the patient's respective nasal wings. [Additional note 40] 40. A patient interface according to any one of claims 29 to 39, wherein the oral cushion comprises oral undercushion portions extending radially around the oral cushion from both side ends of the separation structure to support the oral cushion against the patient's face. [Additional note 41] 41. A patient interface according to any one of claims 29 to 40, wherein the oral cushion comprises a pair of oral undercushion portions, one on each side of the oral cushion to support the oral cushion against the patient's face. [Additional note 42] 42. A patient interface according to any one of claims 29 to 41, wherein the nasal cushion is shaped to include a recess configured to receive the tip of the patient's nose. [Additional note 43] 43. A patient interface according to any one of claims 29 to 42, wherein the nasal cushion is configured to contact the lower periphery of the patient's nose below the bridge of the nose. [Additional note 44] 44. A patient interface according to any one of claims 29 to 43, wherein the nasal cushion, the oral cushion and the separation structure are one piece. [Additional note 45] 45. A 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] 46. ​​A patient interface according to any one of claims 29 to 45, wherein the top plate is removably attachable to a flexible connection region of the nasal plenum chamber. [Additional note 47] 46. ​​A patient interface according to any one of claims 29 to 45, wherein the top plate is removably attachable to a rigid connection region of the nasal plenum chamber. [Additional note 48] 48. A patient interface according to any one of claims 29 to 47, wherein the top plate and rigidiser arm assembly form an integral part, and wherein a pair of rigidiser arms of the rigidiser arm assembly are more flexible than the top plate in a plane parallel to the patient's transverse plane. [Additional note 49] 49. A patient interface according to any one of claims 29 to 48, wherein the positioning and stabilising structure comprises a rigidiser arm assembly releasably attachable to the top plate at the upper mounting feature. [Additional Note 50] a frame releasably attachable to the faceplate; 50. A patient interface according to claim 49, wherein the lower mounting feature is disposed on the frame. [Additional Note 51] each of the lower attachment features comprising a mating portion having a mating magnet for releasably connecting to a corresponding clip of the positioning and stabilising structure; 51. A patient interface as described in claim 50, wherein each of the corresponding clips includes a clip magnet, the clip magnets oriented such that the mating portion is coupled to the corresponding clip when each of the clip magnets is magnetically attracted to the respective mating portion magnet. [Additional note 52] 52. A patient interface as described in claim 50 or 51, further comprising a top plate buffer for damping a connection between the top plate and the rigidiser arm assembly, and a face plate buffer for damping a connection between the face plate and the frame. [Additional note 53] the frame is configured to couple to the faceplate around a periphery; the frame includes a catch, the faceplate includes a notch, 53. A patient interface according to any one of claims 50 to 52, wherein engagement between the catch and the notch couples the frame to the faceplate. [Additional note 54] 1. A patient interface for delivering breathable gas to a patient, the patient interface comprising: 1. A plenum chamber assembly comprising: a nasal plenum chamber at least partially defining a first gas chamber, the nasal plenum chamber adapted to seal against the patient about a lower periphery of the patient's nose below the bridge of the nose; an oral plenum chamber at least partially defining a second gas chamber and operatively connected to said nasal plenum chamber; a plenum chamber assembly comprising: a unitary plate member having an upper portion releasably attachable to the nasal plenum chamber and a lower portion releasably attachable to the oral plenum chamber; 10. A patient interface, wherein the upper portion of the one-piece plate member includes at least one connection feature configured to releasably retain a first portion of a positioning and stabilising structure having a pair of rigidiser arms, and the lower portion of the plate member is configured to releasably retain a second portion of the positioning and stabilising structure. [Additional note 55] 55. A patient interface as described in claim 54, wherein the plenum chamber assembly further comprises a separation structure at least partially connecting the nasal plenum chamber and the oral plenum chamber, the separation structure at least partially defining a flow path between the nasal plenum chamber and the oral plenum chamber. [Additional note 56] each of the pair of rigidiser arms is capable of bending in a plane parallel to the patient's transverse plane; 56. A patient interface as described in claim 55, wherein each of the pair of rigidiser arms is structured to resist bending, to resist torsion, and / or to resist extension in a plane perpendicular to the patient's transverse plane. [Additional note 57] 57. A patient interface as described in claim 56, wherein each of the at least one connection feature comprises a hinge such that a corresponding one of the pair of rigidiser arms can rotate the top of the solid side plate member relative to the rigid top plate in a plane parallel to the patient's transverse plane. [Additional note 58] 58. A patient interface according to any one of claims 54 to 57, wherein the first portion of the positioning and stabilising structure includes a hook for pivotal connection with a connection feature on the top of the unitary plate member. [Additional note 59] the nasal plenum chamber includes a nasal flange defining a nasal opening; 59. A 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 nose of the patient. [Additional note 60] 60. A 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 port plenum chamber including a port flange defining a port opening; 61. A patient interface according to claim 59 or 60, wherein the oral flange is configured to form a seal with at least the mouth of the patient. [Additional note 62] 62. A patient interface as described in claim 61, wherein the oral flanges are formed around the entire circumference of the oral plenum chamber, or around two opposite sides of the outer periphery of the oral plenum chamber, or around a majority of the outer periphery of the oral plenum chamber. [Additional note 63] 62. A patient interface as described in claim 61, wherein the oral plenum chamber comprises a pair of oral undercushion portions, one on each side of the oral plenum chamber to support the oral flange. [Additional note 64] 64. A patient interface as described in claim 62 or 63, wherein the oral plenum chamber comprises an oral undercushion portion disposed around the periphery of the oral plenum chamber and extending radially from opposite ends of the separation structure to support the oral flange. [Additional note 65] 65. A patient interface according to any one of claims 62 to 64, wherein the separation structure connects the nasal flange and the oral flange. [Additional note 66] 66. A patient interface according to claim 65, wherein the isolation structure is stiffer at a portion opposite the patient's face than at a portion adjacent the patient's face. [Additional note 67] 67. A patient interface according to claim 65 or 66, wherein the stiffness of the isolation structure increases in a radial direction from a portion adjacent the patient's face to a portion opposite the patient's face. [Additional note 68] 68. A patient interface according to any one of claims 59 to 67, wherein the nasal contacting portion of the nasal flange is stiffer at the portion of the nasal flange not in contact with the patient's nose than at the portion of the nasal flange not in contact with the patient's nose. [Additional note 69] 69. A patient interface according to any one of claims 59 to 68, wherein the nasal flanges increase in stiffness outwardly from the nasal opening. [Additional note 70] 70. A patient interface according to any one of claims 59 to 69, wherein the stiffness of the nasal flange varies at predetermined locations around the nasal opening. [Additional note 71] 71. A patient interface according to any one of claims 59 to 70, wherein a lower portion of the nasal flange near the separation structure is concave to seal against the patient's upper lip. [Additional note 72] 72. A 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, each protruding end configured to seal against a corresponding ala of the patient's nose. [Additional note 73] 73. A patient interface according to claim 72, wherein the nasal plenum chamber comprises a pair of nasal undercushion portions, one of the nasal undercushion portions corresponding to each of the protruding ends for supporting the respective protruding ends. [Additional note 74] 74. A patient interface according to claim 73, wherein each of the nasal undercushion portions is positioned above the oral plenum chamber. [Additional note 75] 75. A patient interface according to any one of claims 59 to 74, wherein each of the pair of rigidiser arms has an elliptical curvature between the first end and the second end. [Additional note 76] 1. A patient interface for delivering breathable gas to a patient, comprising: a nasal cushion 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; a separation structure disposed between the nasal cushion and the oral cushion; a top plate fixed to the nasal cushion; a rigidiser arm assembly releasably attachable to the top plate; Equipped with A patient interface wherein the rigidiser arm assembly and the top plate engage at least three contact points. [Additional note 77] 77. A patient interface as described in claim 76, wherein the top plate comprises a pair of upper mounting features and the rigidiser arm assembly comprises a pair of connection features, each of the pair of connection features configured to engage a corresponding one of the pair of upper mounting features. [Additional note 78] 78. A patient interface according to claim 76 or 77, wherein the rigidiser arm assembly comprises a rib for engaging with the top plate when the rigidiser arm assembly engages the top plate. [Additional note 79] 79. A patient interface according to any one of claims 76 to 78, further comprising a top plate buffer for damping engagement between the rigidiser arm assembly and the top plate, the top plate buffer being located on a front side of the top plate so as to contact a rear side of the rigidiser arm assembly. [Additional note 80] 80. A patient interface according to claim 79, wherein the top plate buffer and the nasal cushion are one piece, the top plate buffer extending from the nasal cushion through the top plate. [Additional note 81] 81. A patient interface according to any one of claims 76 to 80, wherein the rigidiser arm assembly comprises a pair of rigidiser arms, each of the pair of rigidiser arms configured to receive an upper side strap of the positioning and stabilising structure. [Additional note 82] 82. A patient interface according to claim 81, wherein each of the pair of rigidiser arms comprises a pad for cushioning the pair of rigidiser arms against the patient's face. [Additional note 83] 1. A cushion assembly for a patient interface for treating sleep disordered breathing in a patient, comprising: a nasal cushion coupled to the nasal plenum chamber, the nasal cushion configured to seal around an inferior periphery of the patient's nose; an oral cushion coupled to the oral plenum chamber, the oral cushion configured to seal around the patient's mouth; a decoupling structure connecting the nasal cushion and the nasal plenum chamber to the oral cushion and the oral plenum chamber, the decoupling structure configured to allow the nasal cushion and the nasal plenum chamber to move relative to the oral cushion and the oral plenum chamber; a pair of side supports, each of which is located on either side of the nasal cushion and connects each side of the nasal cushion to the mouth cushion; a pair of undercushion support walls provided to support the protruding end portions located on the rear side of the nasal cushion; a pair of pockets, each located on either side of the nasal cushion, each of the pair of pockets including an upper surface defined by the nasal cushion and the nasal plenum chamber, each of the pair of pockets including a lower surface defined by the oral cushion and the oral plenum chamber, and each of the pair of pockets including a side surface defined by the separation structure and a corresponding one of the pair of side supports; Equipped with a cushion assembly, wherein openings of each of the pair of pockets are positioned on opposite sides of the patient's face when the patient interface is worn by the patient. [Additional note 84] 84. The cushion assembly of claim 83, wherein each of the pair of side supports includes a notch that provides a pivot point for relative movement between the nasal cushion and the oral cushion. [Additional note 85] 85. The cushion assembly of claim 84, wherein the cutout in each of the pair of side supports opens away from the patient's face when the patient interface is worn by the patient. [Additional note 86] the nasal cushion has a pair of reinforcing portions, the pair of reinforcing portions being located on opposite sides of the nasal cushion, respectively; 86. The cushion assembly of any one of claims 83 to 85, wherein the reinforcement portion is stiffer than the remainder of the nasal cushion. [Additional note 87] 87. The cushion assembly of claim 86, wherein the pair of reinforcing portions are thicker than other portions of the nasal cushion. [Additional note 88] 88. The cushion assembly of claim 86 or 87, wherein the pair of reinforcing portions extend inward relative to the nasal cushion and the nasal plenum chamber so that an outer surface of the nasal cushion does not bulge. [Additional note 89] 89. The cushion assembly of any one of claims 83 to 88, wherein the nasal cushion comprises a nasal sling, the nasal sling being formed flush with the nasal cushion and configured to contact the bridge of the patient's nose. [Additional Note 90] 90. The cushion assembly of claim 89, wherein the nasal cushions and the nasal sling define a pair of nostril ports, each of the pair of nostril ports configured to be in pneumatic communication with a corresponding one of the patient's nares. [Additional Note 91] 91. The cushion assembly of claim 89 or 90, wherein the nasal sling is configured to prevent the tip of the patient's nose from extending into the nasal gas chamber, the nasal gas chamber being defined at least in part by the nasal cushion and the nasal plenum chamber. [Additional note 92] 1. A patient interface for delivering breathable gas to a patient, comprising: 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; a separation structure disposed between the nasal cushion and the mouth cushion; Equipped with the separation structure includes an upper surface that connects the separation structure to the nasal cushion, a lower surface that connects the separation structure to the mouth cushion, and a connecting surface that connects the upper surface and the lower surface, the upper surface and the lower surface have approximately equal thickness; A patient interface wherein the connecting surface is thicker than the upper and lower surfaces. [Additional Note 93] 93. A patient interface according to claim 92, wherein the connecting surface is approximately twice as thick as the upper and lower surfaces. [Additional Note 94] 94. A patient interface according to claim 92 or 93, wherein the separation structure is flexible so that the upper and lower surfaces can be positioned at an angle of up to 50° relative to each other. [Additional Note 95] 93. A patient interface according to claim 92, wherein the upper and lower surfaces are approximately 0.5 mm thick and the connecting surface is approximately 1.2 mm thick. [Additional note 96] 1. A patient interface system for delivering breathable gas to a patient, comprising: 1. A cushion assembly comprising: a nasal cushion for at least partially defining a nasal gas chamber; a mouth cushion at least partially defining an oral gas chamber separate from the nasal gas chamber; a separation structure disposed between the nasal cushion and the mouth cushion; a cushion assembly comprising: a positioning and stabilising structure with a pair of lower side straps; a pair of lower attachment features configured to releasably attach corresponding ones of the pair of lower side straps of the positioning and stabilising structure to the cushion assembly; Equipped with A patient interface system wherein each of the pair of lower mounting features comprises a thermoplastic elastomer and wherein a first magnet is embedded within each of the pair of lower mounting features. [Additional note 97] a face plate fixed to the mouth cushion; a frame releasably attachable to the faceplate; Further provided with 97. A patient interface system according to claim 96, wherein the pair of lower mounting features are fixed to the frame. [Additional note 98] 98. A patient interface system according to claim 97, wherein the frame comprises a material that is harder than the thermoplastic elastomer. [Additional note 99] 99. A patient interface system according to claim 97 or 98, wherein the pair of lower mounting features are molded onto the frame. [Additional Note 100] 100. A patient interface system according to any one of claims 97-99, wherein the positioning and stabilising structure further comprises a pair of clips for attaching a corresponding lower one of the pair of lower side straps to a corresponding lower one of the pair of lower attachment features. [Additional Note 101] 101. A patient interface system according to claim 100, wherein each of the pair of clips comprises a second magnet for attaching each of the pair of clips to a corresponding one of the pair of lower attachment features. [Additional Note 102] each of the pair of clips includes a notch and each of the pair of lower attachment features includes a protrusion; 102. A 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 a corresponding one of the pair of lower attachment features. [Additional Note 103] 103. A patient interface system according to any one of claims 97 to 102, wherein each of the pair of lower attachment features comprises a flex point, and wherein each of the pair of lower attachment features is configured to flex at the flex point. [Additional Note 104] 104. A patient interface system according to claim 103, wherein each of the pair of lower attachment features includes a region of reduced thickness at the inflection point. [Explanation of symbols]

[0329] 1000 patients 1100 Bed Partner 3000 Patient Interface 3100 Seal forming structure 3101 Nasal opening 3102 Nasal gas chamber 3103 Nasal opening 3104 Nasal gas chamber 3104.1 Distal long side 3104.2 Short side 3104.3 Long side of proximal end 3105 Nostril Port 3106 Separate structure 3106.1 Gap 3106.2 Connection Area 3106.3 Sides 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 Nasal Sling 3120 Mouth Under Cushion 3121 Straight sidewall 3122 Tapered area 3124 Thick nose cushion 3130 Flexible Connection Area 3132 Hard connection area 3200 outlet plenum chamber 3202 Nasal Plenum Chamber 3204 Faceplate 3205 Connection 3206 Top Plate 3207 Side support 3208 Nasal under-cushion support wall 3208.1 Pocket 3209 Notch 3210 Outer perimeter 3212 Plenum chamber part 3213 Cutout 3214 Top Plate Buffer 3215 Faceplate Buffer 3216 Recess 3217 holes 3218 Extension 3219 depression 3250 Lower Mounting Feature 3251 frames 3252 Upper mounting feature 3253 Catch 3254 mating surface 3255 Fitting part 3256 Extension of fitting part 3257 Wings 3258 recess 3259 Frame extension 3260 Clip Magnet 3261 Engagement magnet 3262 Fitting pocket 3263 Guideway 3264 Protrusion 3265 Cutout 3266 Thickness reduction part 3267 Fitting part Magnet receiving part 3300 Positioning and Stabilizing Structure 3301 Rigidiser Arm Assembly 3302 Rigidiser Arm 3303 Top Plate Cover 3304 Connection function unit 3305 Pad 3306 Headgear Strap 3308 Aperture 3309 Nails 3310 Upper strap 3312 Lower strap 3314 clips 3315 Bar 3316 Sheath 3317 Clip Pocket 3318 Notch 3319 Reception area 3320 Clip magnetic cover 3321 Clip magnet receiving part 3400 Vent 3500 Tube separation structure 3510 Swivel 3520 Baffle 3530 Rapid release mechanism 3600 connection port 3800 Anti-asphyxiation valve 4000 PAP devices 4170 Air Circuit 4172 Cuff 5000 humidifier

Claims

1. 1. A patient interface for delivering breathable gas to a patient, comprising: a nasal cushion having a concave shape for receiving and sealing around the lower part of the patient's nose, the nasal cushion including nasal openings configured to direct breathing gas to the patient's nares during use; a mouth cushion configured to seal around the patient's mouth against the patient's face, the mouth cushion including a mouth opening configured, in use, to direct breathable gas to the patient's mouth; a nasal plenum chamber and an oral plenum chamber, the nasal plenum chamber, the oral plenum chamber, the nasal cushion, and the oral cushion at least partially forming an oral gas chamber; a cushion assembly comprising: an anti-asphyxiation valve; a positioning and stabilising structure including a pair of upper side straps, a pair of lower side straps, and a rear portion, the pair of upper side straps and the pair of lower side straps extending from the rear portion; a unitary plate member removably connected to the cushion assembly, the unitary plate member including a connection port connected to an air delivery tube, the connection port configured to receive breathable gas from the air delivery tube and direct breathable gas to the cushion assembly for breathing by a patient in use, the unitary plate member including an upper portion and a lower portion, the upper portion of the unitary plate member contacting the nasal plenum chamber to support the nasal cushion against the patient's face in use; 1. A patient interface comprising: A patient interface, wherein a top portion of the unitary plate member is attached to the nasal plenum chamber when the unitary plate member is removably connected to the cushion assembly.

2. 10. A patient interface according to claim 1, wherein the nasal cushion includes a recess configured to receive the tip of the patient's nose in use, the nasal cushion including a pair of peaks, each peak positioned laterally outward of a recess and configured to extend upwardly relative to the patient in use, the recess being recessed below the peak.

3. 3. A patient interface according to claim 1 or 2, wherein the oral plenum chamber further comprises a vent configured to allow washout of exhaled carbon dioxide, the vent having a plurality of holes.

4. 4. A patient interface according to any one of claims 1 to 3, wherein the nasal cushion further comprises a pair of protruding ends, each of the protruding ends being disposed on a corresponding side of the nasal cushion and configured to contact and seal against the patient's face between a respective ala of the nose and a respective nasolabial fold of the patient.

5. A patient interface according to any preceding claim, wherein the nasal openings increase in lateral width from their leading edge to their trailing edge with respect to the patient in use.

6. A patient interface according to any preceding claim, wherein the nasal cushions increase in thickness in a direction laterally outward from the nasal openings.

7. A patient interface according to any preceding claim, wherein the lower portion of the nasal cushion is concave to seal against the patient's upper lip in use.

8. the positioning and stabilising structure includes a pair of clips; a lower portion of the integral plate member including a pair of lower attachment mechanisms, each of the lower side straps being removably connected to a corresponding one of the clips, each of the lower attachment mechanisms including a clip receptacle, each of the clips being removably connected to a corresponding one of the lower attachment mechanisms; 8. A patient interface according to any one of claims 1 to 7, wherein each of the lower side straps includes hook and loop material for releasably connecting to a corresponding one of the clips.

9. 9. A patient interface according to any one of claims 1 to 8, wherein an upper portion of the integral plate member includes a pair of outer portions that, in use, extend further upwardly relative to the patient than a middle portion located between the pair of outer portions.

10. further comprising a rigidiser arm assembly removably connected to an upper portion of the integral plate member; the rigidiser arm assembly is integrally formed and extends across an upper portion of the unitary plate member; each upper side strap is removably connected to said rigidiser arm assembly; A patient interface according to any one of claims 1 to 9, wherein the one-piece plate member is constructed from a material that is more rigid than the nasal and oral cushions.

11. 11. A patient interface according to any preceding claim, wherein the nasal opening is a single opening configured to direct breathable gas to both nostrils of the patient in use.

12. The nasal cushion a first region disposed proximal to the opening on each lateral side of the opening, the first region configured to contact the patient's nose; a second region disposed adjacent to and laterally outward from the first region, the second region being thicker than the first region; a third region disposed laterally outwardly of and adjacent to the second region, the third region having a different thickness relative to the second region; A patient interface according to any one of claims 1 to 11, comprising:

13. 13. The patient interface of claim 12, wherein the nasal cushion has a curved shape from the first region through the second region to the third region, with an apex of the curved shape located in the second region.

14. the third region is thicker than the second region; or the third region is thinner than the second region and thicker than the first region; or 13. A patient interface according to claim 12, wherein the third region is thinner than the first and second regions.

15. the nasal cushion includes a recess configured to receive the tip of the patient's nose in use; the nasal cushion includes a pair of peaks, each of the peaks being positioned laterally outward of the recess and configured to extend upwardly relative to a patient in use; the recess is recessed below the peak; the nasal openings increasing in width from leading edge to trailing edge for a patient in use; a lower portion of the nasal cushion being concave to seal against the patient's upper lip during use; the positioning and stabilising structure includes a pair of clips; a lower portion of the integral plate member including a pair of lower attachment mechanisms, each of the lower side straps being removably connected to a corresponding one of the clips, each of the lower attachment mechanisms including a clip receptacle, each of the clips being removably connected to a corresponding one of the lower attachment mechanisms; each of the lower side straps includes hook and loop material for releasably connecting to a corresponding one of the clips; an upper portion of the integral plate member including a pair of outer portions that extend further upward relative to a patient in use than an intermediate portion disposed between the pair of outer portions; 10. A patient interface according to claim 1, wherein the nasal opening is a single opening configured to direct breathable gas to both nostrils of a patient in use.

16. 1. A patient interface for delivering breathable gas to a patient, comprising: a nasal plenum chamber portion including a nasal cushion having a concave shape for receiving and sealing around the lower part of the patient's nose, the nasal cushion including nasal openings configured to direct breathing gas to the patient's nares during use; a mouth plenum chamber portion including a mouth cushion configured to seal around the patient's mouth against the patient's face, the mouth cushion including a mouth opening configured, in use, to direct breathable gas to the patient's mouth; a cushion assembly comprising: an anti-asphyxiation valve; a positioning and stabilising structure including upper side straps, lower side straps and a rear portion, the upper side straps and the lower side straps extending from the rear portion; a faceplate having a connection port configured to connect to an air delivery tube, the faceplate having a connection port configured to receive breathable gas from the air delivery tube and direct the breathable gas to the cushion assembly for breathing by a patient in use; The top plate and a connecting portion that joins the top plate and the face plate to form an integral structure and that removably connects to the cushion assembly; 1. A patient interface comprising: the top plate contacts the nasal plenum chamber portion for supporting the nasal cushion against a patient's face in use; A patient interface, wherein the top plate is attached to the nasal plenum chamber portion when the unitary structure is removably connected to the cushion assembly.

17. 17. A patient interface according to claim 16, wherein the nasal cushion includes a recess configured to receive the tip of the patient's nose in use, the nasal cushion including a pair of peaks, each peak positioned laterally outward of a recess and configured to extend upwardly relative to the patient in use, the recesses being recessed below the peaks.

18. 18. A patient interface according to claim 16 or 17, wherein the oral plenum chamber portion further comprises a vent configured to allow washout of exhaled carbon dioxide, the vent having a plurality of holes.

19. 19. A patient interface according to any one of claims 16 to 18, wherein the nasal cushion further includes a pair of protruding ends, each of the protruding ends being located on a corresponding side of the nasal cushion and configured to contact and seal against the patient's face between a respective ala of the nose and a respective nasolabial fold of the patient.

20. A patient interface according to any one of claims 16 to 19, wherein the nasal openings increase in lateral width from their leading edge to their trailing edge with respect to the patient in use.

21. A patient interface according to any one of claims 16 to 20, wherein the nasal cushions increase in thickness in a direction laterally outward from the nasal openings.

22. A patient interface according to any one of claims 16 to 21, wherein a lower portion of the nasal cushion is concave to seal against the patient's upper lip in use.

23. the positioning and stabilising structure comprises a clip; the faceplate includes a lower attachment mechanism, each of the lower straps being removably connected to a corresponding one of the clips, each of the lower attachment mechanisms including a clip receptacle, each of the clips being removably connected to a corresponding one of the lower attachment mechanisms; A patient interface according to any one of claims 16 to 22, wherein the lower strap includes hook and loop material for releasably connecting to a corresponding one of the clips.

24. 24. A patient interface according to any one of claims 16 to 23, wherein the top plate includes a pair of outer portions that, in use, extend further upwardly relative to the patient than a middle portion located between the pair of outer portions.

25. further comprising a rigidiser arm assembly removably connected to the top plate of the unitary structure; the rigidiser arm assembly is integrally formed and extends across the top plate; each upper strap is removably connected to said rigidiser arm assembly; A patient interface according to any one of claims 16 to 24, wherein the unitary structure is constructed from a stiffer material than the nasal and oral cushions.

26. 26. A patient interface according to any one of claims 16 to 25, wherein the nasal opening is a single opening configured to direct breathable gas to both nostrils of the patient in use.

27. The nasal cushion a first region disposed proximal to the opening on each lateral side of the opening, the first region configured to contact the patient's nose; a second region disposed adjacent to and laterally outward from the first region, the second region being thicker than the first region; a third region disposed laterally outwardly of and adjacent to the second region, the third region having a different thickness relative to the second region; A patient interface according to any one of claims 16 to 26, comprising:

28. 28. A patient interface according to claim 27, wherein the nasal cushion has a curved shape from the first region through the second region to the third region, with an apex of the curved shape located in the second region.

29. the third region is thicker than the second region; or the third region is thinner than the second region and thicker than the first region; or 28. A patient interface according to claim 27, wherein the third region is thinner than the first and second regions.

30. the nasal cushion includes a recess configured to receive the tip of the patient's nose in use; the nasal cushion includes a pair of peaks, each of the peaks being positioned laterally outward of the recess and configured to extend upwardly relative to a patient in use; the recess is recessed below the peak; the nasal openings increasing in width from leading edge to trailing edge for a patient in use; a lower portion of the nasal cushion being concave to seal against the patient's upper lip during use; the positioning and stabilising structure includes a pair of clips; a lower portion of the unitary structure including a pair of lower attachment mechanisms, each of the lower side straps being removably connected to a corresponding one of the clips, each of the lower attachment mechanisms including a clip receptacle, each of the clips being removably connected to a corresponding one of the lower attachment mechanisms; each of the lower side straps includes hook and loop material for releasably connecting to a corresponding one of the clips; the top plate of the one-piece structure includes a pair of outer portions that extend further upward relative to a patient in use than an intermediate portion disposed between the pair of outer portions; 17. A patient interface according to claim 16, wherein the nasal opening is a single opening configured to direct breathable gas to both nostrils of a patient in use.

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