Nasal mask system

Abstract

To provide a patient interface system.SOLUTION: A swivel elbow and connector assembly for a patient interface system includes a ring (128) configured to be sealingly secured in an aperture of the patient interface system and an elbow (125) swivably secured in the ring. The ring includes a first side (128(1)) in an interior of the patient interface system and a second side (128(2)) at an exterior of the patient interface system when the ring is secured in the aperture. The ring comprises a first flange on the first side and a second flange on the second side, the first and second flanges defining a channel (128(3)) that sealingly engages the aperture of the patient interface system. An inner surface (128(4)) of the ring is partially spherical and an outer surface (125(3)) of the elbow is partially spherical and the elbow and the ring form a ball and socket connection.SELECTED DRAWING: Figure 3-120-5

Description

[Technical field]

[0001] 1 CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 61 / 648,807, filed May 18, 2012, which is incorporated by reference in its entirety.

[0002] 2. Technology Background 2.1(1) Technology field The present technology relates to the treatment of respiratory diseases and procedures for preventing respiratory diseases. In particular, the present technology relates to medical devices and the use of the medical devices for treating and preventing respiratory diseases. In particular, the present technology relates to a nasal mask system used for treatment, for example, the treatment of sleep disordered breathing (SDB) using continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV).

[0003] The technology also relates to an apparatus for delivering breathable gas to a patient, the apparatus including a positive airway pressure (PAP) device, an air delivery conduit or tube, and a patient interface that, in use, contacts the patient's face to deliver pressurized breathable gas from the PAP device to the patient. [Background technology]

[0004] 2.2(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.

[0005] The airways consist of a series of branches that become thinner, shorter, and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, which allows oxygen to move from the air into the venous blood and carbon dioxide to move out. The trachea divides into the left and right main bronchi, which eventually divide into the terminal bronchioles. The bronchi form the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles, which eventually lead to the alveoli. The alveolar region of the lungs is where gas exchange takes place and is called the respiratory zone. For more information, see Brünnell, et al., "Public Health and Medical Research," vol. 14, no. 1, pp. 1111-1115.

[0006] There is a range of respiratory diseases.

[0007] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by the obstruction of the upper airway during sleep. It results from an abnormally small upper airway combined with the normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to stop breathing, typically for periods lasting 30-120 seconds, sometimes 200-300 times per night. This often causes excessive daytime somnolence and may lead to cardiovascular disease and brain damage. The syndrome is particularly common in middle-aged and older obese men, but sufferers may not be aware of the problem. See US Pat. No. 5,399,363 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is a disorder of the 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 considered harmful due to recurrent hypoxia. In some patients, CSR is associated with recurrent arousals from sleep, causing severe sleep disruption, increased sympathetic activity, and increased afterload. See US Patent No. 5,399,993 (Berthon-Jones).

[0009] 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.

[0010] Chronic obstructive pulmonary disease (COPD) encompasses any group of lower airway diseases that share certain common features. These features include increased resistance to air movement, expansion of the expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and phlegm production.

[0011] Neuromuscular diseases (NMD) is a broad term that encompasses many diseases and illnesses that reduce muscle function directly through intrinsic muscle pathology or indirectly through nerve pathology. Some NMD patients are characterized by progressive muscle dysfunction resulting in loss of walking ability, wheelchair confinement, swallowing problems, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular diseases are divided into rapidly progressive and slowly progressive: (i) rapidly progressive diseases are 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 are 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 generalized weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and changing moods.

[0012] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the rib cage. The disorders are usually characterized by restrictive disorders and share long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may cause severe respiratory failure. Symptoms of respiratory failure include dyspnea on exertion, peripheral edema, orthopnea, recurrent pulmonary infections, morning headache, fatigue, poor quality of sleep, and loss of appetite.

[0013] Other healthy individuals may also successfully utilize the systems and devices to prevent the onset of respiratory diseases.

[0014] 2.2.1 System One known product used to treat sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited.

[0015] 2.2.2 Treatment Nasal continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA), with the premise that CPAP may act as a pneumatic splint and prevent upper airway obstruction by forcing the soft palate and tongue forward and away from the posterior oropharyngeal wall.

[0016] Non-invasive ventilation (NIV) has been used to treat OHS, COPD, NMD, and chest wall disease.

[0017] 2.2.3 Patient Interface The application of a positive pressure supply of air to the entrance of a patient's airways, for example while the patient is sleeping, is facilitated by the use of a patient interface, such as a nasal mask, a full face mask, or nasal pillows.

[0018] Known patient interface devices suffer from one or more of the following problems: being highly noticeable, aesthetically unpleasing, fitting poorly, being difficult to use, and being uncomfortable, especially when worn for extended periods of time or when the patient is new to the system.

[0019] 2.2.3.1 Seal forming part The patient interface generally includes a seal forming portion.

[0020] A series of patient interface seal forming technologies are disclosed in the following patent applications assigned to ResMed Limited: US Pat. No. 5,399,433; US Pat. No. 5,499,443; and US Pat. No. 5,523,637.

[0021] 2.2.3.2 Positioning and stabilization Seal-forming portions of patient interfaces used for positive air pressure therapy are subject to corresponding air pressure forces that can compromise the seal, and therefore various techniques have been used to position the seal-forming portion and maintain it in sealing relationship with the appropriate portion of the face.

[0022] One technique is the use of adhesives, see for example US Pat.

[0023] Another technique is the use of one or more straps and a stabilizing harness.

[0024] 2.2.3.3 Ventilation technology Some forms of patient interface systems may include a vent to allow the escape of exhaled carbon dioxide.

[0025] ResMed Limited has developed a number of mask ventilation technologies, see U.S. Patent Nos. 5,393, 5,433, 5,596, 6,741, 6,813, 6,925, 7,103, 7,111, 7,122, 7,116, 7,117, 7,122, 7,136, 7,142, 7,152, 7,166, 7,172, 7,196, 7,181, 7,197, 7,198, 7,203, 7,211, 7,222, 7,236, 7,242, 7,252, 7,262, 7,316, 7,322, 7,362, 7,381, 7,412, 7,422, 7,512, 7,522, 7,532, 7,612, 7,712, 7,822, 7,972, 7,982, 7,992, 8,102, 8,116, 8,136, 8,142, 8,152, 8,162, 8,172, 9,183, 9,197, 9,104, 9,106, 9,108, 9,116, 9,122, 9,136, 9,142, 9,152, 9,162, 9,172, 9,183, 9,197, 9,198, 9,199, 10,106, 10,117, 10,117, 10 [Prior art documents] [Patent documents]

[0026] [Patent Document 1] U.S. Pat. No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 [Patent Document 3] International Publication No. 1998 / 004,310 [Patent Document 4] International Publication No. 2006 / 074,513 [Patent Document 5] International Publication No. 2010 / 135,785 [Patent Document 6] US Patent Application Publication No. 2010 / 0000534 [Patent Document 7] International Publication No. 1998 / 034,665 [Patent Document 8] International Publication No. 2000 / 078,381 [Patent Document 9] U.S. Patent No. 6,581,594 [Patent Document 10] US Patent Application Publication No. 2009 / 0050156 [Patent Document 11] US Patent Application Publication No. 2009 / 0044808 [Patent Document 12] International Publication No. 2009 / 052,560 [Patent Document 13] International Publication No. 2010 / 139,014 [Patent Document 14] US Patent Application Publication No. 2013 / 0199537 [Patent Document 15] US Patent Application Publication No. 2010 / 0307502 [Patent Document 16] US Patent Application Publication No. 2009 / 0078259 [Non-patent literature]

[0027] [Non-Patent Document 1] West, Respiratory Physiology- the essentials Summary of the Invention [Problem to be solved by the invention]

[0028] 3. A brief overview of the technology One aspect of the present technology relates to an elbow connector assembly adapted to receive gas from a flow generator and deliver the gas to a patient interface.

[0029] One aspect of the present technology relates to an elbow and connector adapted to vent gases from a patient interface.

[0030] One aspect of the present technology is having multiple functions in one part or component and / or multiple functions made together, for example, the quick release button / member / actuator, baffle, and swivel are all formed together so the patient does not need to disassemble, which can increase the potential for lower overall part costs.

[0031] One aspect of the present technology relates to a multi-axis elbow assembly that allows movement of a connecting tube in two separate planes while substantially decoupling drag forces from the tube.

[0032] Another aspect of the present technology is a method for manufacturing an elbow for a patient interface assembly, comprising the steps of: providing a scaffold, e.g., of a rigid or semi-rigid material adapted to communicate airflow under pressure between an air delivery conduit and a mask; separately molding an anti-asphyxiation valve (AAV) having a pull tab; and assembling the scaffold and the AAV by pulling the pull tab from inside the scaffold through an opening in the scaffold to position, hold and / or seal the AAV relative to the scaffold. The method may include removing at least a portion of the pull tab once pulled through the opening such that an outer flange of the AAV lies flush with the elbow outer surface. The method may further comprise providing a flexible component to secure the AAV in place. The flexible component may form one or more release buttons or actuators on the elbow.

[0033] Another aspect of the present technology relates to an elbow for a patient interface assembly, comprising a skeleton or frame, e.g., of a rigid or semi-rigid material, adapted to communicate airflow under pressure between an air delivery conduit and a mask, and an anti-asphyxiation valve (AAV) having a pull tab, where the pull tab is inserted or guided inside the skeleton to assemble the AAV to the skeleton and pulled through an opening in the skeleton to position, hold and / or seal the AAV relative to the skeleton. At least a portion of an outer flange of the AAV lies flush with an outer surface of the elbow when the pull tab is pulled through the opening. The elbow may include a flexible component to secure the AAV in place and / or form one or more release buttons or actuators on the elbow, which are adapted to remove the elbow from the frame.

[0034] Another aspect of the present technology relates to a swivel elbow connector assembly for a patient interface for delivering pressurized breathable gas from a PAP device to a patient. According to one aspect, the swivel elbow connector assembly is connected to a flexible patient interface structure, e.g., a cushion, through an opening in the patient interface structure. According to another aspect, the swivel elbow connector assembly includes a connector, e.g., a ring, that can be attached to and detached from the patient interface structure at the opening. The connector includes a plurality of slots for venting gas from the interior of the patient interface structure to the exterior of the patient interface structure.

[0035] Yet another aspect of the present technology relates to a swivel elbow that connects to a connector and a slot to allow for gas venting between the ring and the swivel elbow. According to another aspect, the swivel elbow connects to the connector and the slot allows for gas venting between the connector and the patient interface structure, e.g., a cushion, and no venting occurs between the connector and the swivel elbow.

[0036] A further aspect of the present technology relates to a swivel elbow and anti-asphyxiation valve assembly having a diffusion vent. Yet another aspect of the present technology relates to a swivel elbow and anti-asphyxiation valve assembly having a diffusion vent that may be integrally molded. Yet a further aspect of the present technology relates to a swivel elbow and anti-asphyxiation valve assembly having a diffusion vent that may have an engagement point that when depressed allows for disengagement of the swivel elbow and anti-asphyxiation valve assembly from a patient interface, for example a mask.

[0037] In accordance with one example of the present technology, a swivel elbow connector assembly for a patient interface system includes a ring configured to be sealingly secured to an opening in the patient interface system, the ring including a first side that is interior to the patient interface system when the ring is secured to the opening and a second side that is exterior to the patient interface system, the ring including a plurality of vents configured to allow flow of gas from the interior to the exterior of the patient interface system, and the swivel elbow connector assembly includes an elbow pivotally secured to the ring, the ring including a first flange on the first side and a second flange on the second side, the first flange and the second flange defining a channel that sealingly engages the opening in the patient interface system, and the second flange including an angled surface that directs flow of gas from the plurality of vents at an angle relative to a longitudinal axis of the ring.

[0038] In accordance with another example of the present technology, a patient interface system for delivering a flow of breathable gas to a user comprises a patient interface structure configured for sealing engagement with a face of a user, the patient interface structure having an opening, and a swivel elbow connector assembly as disclosed herein.

[0039] In accordance with another example of the present technology, an elbow for delivering gas to a patient interface comprises a first connection, a second connection, and a vent. The first connection is adapted to receive a tube connection, the second connection is adapted to receive a patient interface assembly, and the vent is proximate to the second connection. The vent may be diffused around a circumference of the second connection. The elbow may further comprise a baffle to separate the vent from an airflow entering from the first connection.

[0040] According to yet another example of the present technology, a swivel elbow anti-asphyxiation valve assembly for a patient interface assembly includes: a first component including a first connecting portion configured to be sealingly secured to an opening of a patient interface system, a second connecting portion configured to be connected to a swivel or a delivery conduit, one or more first supports between the first connecting portion and the second connecting portion, a first opening and a second opening provided between the one or more first supports; and a second component including a valve member, an engagement member, and a flexible member; wherein the valve member is between the one or more first supports of the first component and is movable between a first position where the valve member occludes the first opening and a second position where the valve member does not occlude the first opening, the engagement member configured to engage with the one or more first supports when pressed by a user of the patient interface system, and the flexible member is connected to the engagement member and seals the second opening.

[0041] Other aspects of the present technology are directed to providing medical devices for use in the diagnosis, treatment or prevention of respiratory disorders that have improved one or more of comfort, cost, effectiveness, ease of use and manufacturability.

[0042] Another aspect of the present technology relates to devices for use in the diagnosis, treatment, or prevention of respiratory disorders.

[0043] Other aspects of the present technology relate to methods for use in the diagnosis, treatment, or prevention of respiratory disorders.

[0044] One aspect of the present technology is a patient interface that is one or more of comfortable, effective, simple to use, unobtrusive, and has a wide range of compatibility.

[0045] One aspect of one form of the present technology is a patient interface that avoids the squirting action of nasal pillows or nasal cannulas and / or avoids the discomfort of having part of a mask within the patient's nasal passages.

[0046] One aspect of one form of the present technology is a nasal mask that is easy to don and avoids the need for headgear straps to interfere with or cross the ears when in use, and that avoids interference with or crossing the ears while donning or removing the mask.

[0047] Another aspect of one form of the present technology is a method of donning or removing the mask.

[0048] In one form of the present technology, a small, discreet nasal mask is provided.

[0049] In one form of the present technology, a nasal mask is provided that does not form a seal with the patient's lower lip or chin.

[0050] In one form of the present technology, a patient interface is provided that does not exert a posterior force on the mandible, e.g., the patient interface does not push the mandible from front to back.

[0051] In one form of the present technology, a patient interface is provided that does not include a rigid shell or frame.

[0052] In one form of the present technology, a patient interface is provided comprising a plenum chamber constructed from a flexible or semi-rigid material, such as a flexible rubber of suitable thickness (e.g., silicone having a Type A durometer in the range of about 35 to about 45 and a thickness of about 1.5 mm to about 3 mm).

[0053] In one form of the present technology, a nasal mask is provided that does not require engagement or disengagement of clips to don or remove the mask.

[0054] One aspect of one form of the present technology is a patient interface comprising a seal forming portion having a first seal area configured to provide little or no resistance to compression and a second seal area configured to substantially resist compressive forces (e.g., as a result of headgear tension). In one example, in use, the first seal area is positioned to overlie a portion of the nasal cartilage framework and the second seal area is positioned to overlie a portion of a facial bone region. In one example, the facial bone region is a region adjacent the ala of the nose, optionally adjacent the apex of the ala of the nose.

[0055] In accordance with one form of the present technology, a patient interface is provided that includes: (i) a seal-forming portion that, in use, overlaps at least a portion of the upper lip area of ​​the patient's face and a portion of the nasal cartilage framework; and (ii) a seal positioning and stabilizing structure that can be donned and removed without interfering with the patient's ears.

[0056] Another aspect of one form of the present technology is a patient interface having a seal forming portion associated with a two-point connection with a seal positioning and stabilizing structure. In one example, the patient interface does not include a forehead support. In further or alternative examples, the seal positioning and stabilizing structure includes a non-rigid or flex connection element.

[0057] Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured with a clearly defined circumferential shape that is adapted to fit the circumferential shape of the intended wearer in use.

[0058] Another aspect of one form of the present technology is a patient interface that is configured and arranged to avoid or reduce the tendency to restrict nasal airflow through the patient interface while forming a seal with at least a portion of the nasal cartilage framework.

[0059] In accordance with one form of the present technology, a patient interface is provided comprising a first upper sealing portion that, in use, overlies a portion of the nasal cartilage structure and a second lower sealing portion that, in use, overlies a portion of the upper lip, such that, in use, a relatively greater portion of the headgear sealing force is directed towards the upper lip and a portion of the underlying maxilla, teeth or gums than is directed towards the nasal cartilage structure.

[0060] Another aspect of one form of the present technology is a patient interface that is constructed and arranged to avoid or reduce the tendency to exert unnecessary pressure against the nasal septum.

[0061] In accordance with one form of the present technology, there is provided a patient interface that, in use, forms a seal with a portion of a patient's upper lip and includes a plenum chamber having a wall, a first portion of the wall configured to be positioned adjacent the septum in use having a relatively less stiff spring constant than a portion of the wall adjacent the first portion.

[0062] Another aspect of one form of the present technology is a patient interface that provides an effective or improved seal in the area of ​​the nose near the junction between the greater alar cartilage and the lateral cartilage while forming a seal with a portion of the nasal cartilage framework.

[0063] In accordance with one form of the present technology, a patient interface is provided that includes a sealing flange that defines a generally T-shaped or three-lobed orifice. In one example, the sealing flange includes a membrane and sealing flaps that project from an edge of the membrane along an inner periphery of the membrane on either side of the nasal region. The edges of the membrane along its inner periphery cooperate with edges of each sealing flap along its inner periphery to define an orifice into the plenum chamber. In one example, such an orifice includes a generally T-shaped or three-lobed orifice that includes an upper orifice portion (along a vertical axis v as seen in FIG. 3-20) and a lower orifice portion (along a horizontal axis h as seen in FIG. 3-20) that extends generally perpendicular to the upper orifice portion.

[0064] In accordance with one form of the present technology, an inner edge of the sealing flange is spring biased in use, for example against a central portion of the sealing flange and towards the wearer's face.

[0065] Another aspect of one form of the present technology is a nasal mask constructed and arranged to pivot or rotate about the upper lip area upon adjustment of headgear tension.

[0066] Another aspect of one form of the present technology is a method of manufacturing a patient interface.

[0067] Another aspect of one form of the present technology is an apparatus for preventing, treating, or ameliorating one or more of OSA, CSA, OHS, COPD, NMD, and thoracic abnormalities.

[0068] Another aspect of the present technology is a mask system that can accommodate a wide range of different face shapes, including faces with high and low nasal bridge regions and narrow and wide noses. Another aspect of the present technology is a mask system that has a wide range of fits.

[0069] Another aspect of one form of the present technology is a mask system that is small and unobtrusive, yet remains stable on the patient's face while they sleep.

[0070] One aspect of the present technology is a mask that is constructed and positioned such that its upper extent seals with the area of ​​the nose that is generally above or above the nasal tip or tip of the nose.

[0071] One aspect of one form of the present technology is a mask that is constructed and positioned such that its upper extent seals at a location generally below or inferior to the nasal bone.

[0072] In one form of the present technology, a mask is provided that is constructed and arranged to have a seal-forming portion that overlaps the upper lip or a portion of the upper lip and overlaps a portion of the cartilage skeleton of the nose, for example without overlapping the nasal bone.

[0073] In one form of the present technology, a mask is provided that is constructed and arranged to have a first seal-forming portion that overlaps the upper lip or a portion of the upper lip, and a second seal-forming portion that overlaps the cartilage framework of the nose, for example without overlapping the nasal bone.

[0074] In one form of the present technology, there is provided a mask constructed and arranged to have a first seal-forming portion that is generally in compression or exposed to a bending force in use, and a second seal-forming portion that is generally in tension in use.

[0075] In one form of the present technology, there is provided a mask constructed and arranged to have a first seal-forming portion that is relatively stiff prior to use, and a second seal-forming portion that is relatively soft prior to use.

[0076] Another aspect of one form of the present technology is a mask system having an improved sealing cuff. In one example, the mask system includes a face flap comprising a relatively thin member, e.g., formed from a flexible and at least semi-elastic material. In one example, the mask system further comprises a back-up band in at least some regions.

[0077] Another aspect of the present technology is a mask that is formed, shaped, or otherwise configured with a clearly defined perimeter shape that is adapted to fit the perimeter shape of the intended wearer.

[0078] A further aspect of the present technology is a cushion for a mask whose upper extent seals with the nasal area that is generally above or above the nasal tip or tip of the nose and extends across the ala or alar flare of the patient's nose.

[0079] A further aspect of the present technology is a cushion for a mask that seals at its upper extent with the area of ​​the nose that is generally above or above the nasal tip or tip of the nose and extends across the ala or alar flare of the patient's nose, for example, without extending over or across the nasal bone of the patient's nose.

[0080] One aspect of one form of the present technology is a cushion for a mask that seals its upper extent in the nose area, which for a range of people with large noses is typically close to the junction between the bone and cartilage, and avoids affecting the field of vision for people with small noses.

[0081] In one form of the present technology, a mask system is provided that does not require a rigid frame or framework and that seals at its upper extent with the area of ​​the nose that is generally above or above the nasal tip or tip of the nose.

[0082] One aspect of the present technology is a cushion for a mask that includes a sealing membrane and a back-up band or undercushion in at least some areas.

[0083] Another aspect of the present technology is a cushion for a nasal mask that includes an undercushion or back-up band in the upper lip area.

[0084] Another aspect of one form of the present technology is a cushion for a nasal mask that includes an undercushion or back-up band in the upper lip area and does not include an undercushion or back-up band on either side of the nose or at the ridge of the nasal region to avoid relatively high sealing forces at these sides of the nose or at the ridge of the nasal region, which may cause obstruction of the nasal airway.

[0085] Another aspect of the present technology includes a cushion for a nasal mask, the cushion having a seal area, a sidewall area, and an attachment area, the seal area adapted to form a seal with a patient, the sidewall area connecting the seal area and the attachment area, and the attachment area adapted to connect to or be otherwise attached to an air delivery system.

[0086] Another aspect of the present technology includes a cushion for a nasal mask, the cushion having a sealing region and an attachment region, the attachment region comprising a separation element.

[0087] Another aspect of the present technology includes a cushion for a nasal mask, the cushion having a sealing region and an attachment region, the attachment region comprising a separation element, the separation element comprising a relatively thin wall portion, for example, the relatively thin wall portion may be 50-85% thinner.

[0088] Another aspect of the present technology includes a cushion for a nasal mask, the cushion comprising a headgear connector having an integrally formed sidewall, for example, the sidewall constructed from a flexible elastomer or rubber.

[0089] Another aspect of the present technology includes a cushion for a nasal mask, the cushion having a headgear connector configured and arranged to position a portion of the sealing area above or above the nasal apex or tip of the patient's nose.

[0090] Another aspect of the present technology includes a cushion for a nasal mask, the cushion having a nasal ridge region having a depression or curvature, e.g., a localized saddle-like region adapted to conform to or be complimentary to the patient's nasal ridge.

[0091] A further aspect of the present technology includes a cushion for a nasal mask, the cushion having a nasal ridge region having a relatively long membrane length when compared to other regions of the cushion, the relatively long membrane length adapted to engage a larger range of nasal ridge heights of a patient.

[0092] Another aspect of the present technology includes a cushion for a nasal mask, the cushion having sides of a nasal region, the sides of the nasal region having ridges, the ridges having a greater height when compared to the nasal ridge region, the ridges adapted to engage the sides of a patient's nose and ensure engagement with high and flat nasal ridges.

[0093] Another aspect of the present technology includes a cushion for a nasal mask, the cushion having a nasal corner generally corresponding to an area of ​​the face between the nasal nadir and the nasal apex, including the nasal alar nadir and the nasal alar apex, the nasal corner having a greatest height when compared to all other areas of the cushion, the nasal corner securing the cushion in place, the height of the nasal corner may be adapted to ensure a seal at the corner of the nose, as this is a particularly difficult area of ​​the face to seal.

[0094] Another aspect of the present technology includes a cushion for a nasal mask, the cushion having an upper lip region configured to conform to the curvature of the patient's upper lip region. The upper lip region may be generally rounded and extend from a valley or depression to a side of the nasal region. A membrane of the upper lip region may extend across the patient's upper lip to ensure a seal with the patient's upper lip.

[0095] Another aspect of the present technology relates to a nasal mask system including a cushion assembly including a sealing area providing a single orifice adapted to surround both nostrils of a patient's nose, and a headgear assembly including a pair of side straps and a rear strap. The side straps extend along either side of the patient's face between the patient's eyes and ears and are adapted to engage with respective headgear connectors provided on the cushion assembly to provide a two-point connection with the cushion assembly. The rear straps extend between the side straps and are adapted to engage along the back or rear of the patient's head, along the occipital bone, below or below the occipital bone.

[0096] Another aspect of the present technology relates to a nasal mask system that includes a cushion assembly that includes a sealing area having a nasal ridge area adapted to seal around both nostrils of a patient's nose, sides of the nasal area, corners of the nasal area, and an upper lip area. The nasal ridge area is adapted to seal along a nasal cartilage area above or above the nasal tip and below or below the nasal bone area of ​​the patient's nasal bridge. In one form, the sealing area includes a membrane seal that extends around the entire perimeter of the sealing area and an undercushion that is provided only at the corners of the upper lip and nasal area.

[0097] Another aspect of the present technology relates to a nasal mask system including a cushion assembly including a seal region adapted to seal around both nares of a patient's nose, an attachment region adapted to receive an elbow assembly, and a sidewall region extending between the seal region and the attachment region. The seal region has a nasal ridge region, sides of the nasal region, corners of the nasal region, and an upper lip region. The sidewall region includes a region adjacent the upper lip region of the seal region that includes a thickness that is less than the corresponding thickness adjacent the nasal ridge, sides of the nose, and corners of the nasal region of the seal region.

[0098] Another aspect of the present technology relates to a nasal mask system that includes a cushion assembly including a sealing region with a nasal ridge region adapted to seal around both nostrils of a patient's nose, sides of the nose region, corners of the nose region, and an upper lip region, The sides of the nose region include portions adapted to be positioned along and form a seal with an area adjacent the junction between the greater alar cartilage and the lateral cartilage of the patient's nose.

[0099] Another aspect of the present technology relates to a patient interface for applying a positive pressure supply of air to an entrance to a patient's airway. The patient interface includes a nasal mask and a positioning and stabilizing structure. The nasal mask has a seal-forming portion configured and arranged to form a seal with a portion of the patient's upper lip and a portion of the patient's nasal cartilage structure. The nasal mask further includes a plenum chamber that, in use, receives a portion of the patient's nose including the nasal tip. The positioning and stabilizing structure includes a pair of side straps that provide a two-point connection to the nasal mask, the side straps configured and arranged to be donned or removed without the side straps passing under the patient's ears.

[0100] Another aspect of the present technology relates to a method for fitting a patient interface to a patient, the method including positioning a sealing area of ​​the patient interface against the patient's nose so that the sealing area surrounds both nostrils, and engaging headgear straps of the patient interface with the patient's head without passing the straps under the patient's ears.

[0101] Another aspect of the present technology relates to a nasal mask for delivery of a supply of air to an entrance to a patient's airway. The nasal mask includes an upper sealing portion and an inferior sealing portion. The upper sealing portion is positioned over a portion of the nasal cartilage anatomy and configured and arranged to form a seal with said portion of the nasal cartilage anatomy without exerting a sealing force that restricts airflow through the nasal cavity. The inferior sealing portion is positioned partially over a portion of the patient's upper lip and configured and arranged to direct a sealing force against a portion of the patient's maxilla.

[0102] Another aspect of the present technology relates to a nasal mask defining a breathing chamber for delivery of a positive pressure supply of gas to a patient's airway. The nasal mask includes a vent and a cushion. The vent is adapted to vent respiratory gas and is adapted to be sufficiently rigid to avoid collapse. The cushion includes a seal cuff and a headgear connector. The seal cuff comprises a membrane seal and an undercushion. The membrane seal extends around a periphery of the cushion including a nasal ridge region of the cushion and a side of the nasal region of the cushion, and the undercushion is positioned in an upper lip region of the cushion and does not extend into the nasal ridge region of the cushion or the side of the nasal region of the cushion. The headgear connector is formed with a sidewall of the cushion.

[0103] Another aspect of the present technology relates to a patient interface for applying a positive pressure supply of air to an entrance to a patient's airway. The patient interface includes a nasal mask and a positioning and stabilizing structure. The nasal mask has a seal-forming portion constructed and arranged to form a seal with a portion of the patient's upper lip and a portion of the patient's nasal cartilage structure. The nasal mask further includes a plenum chamber that, in use, receives a portion of the patient's nose including the nasal tip. The positioning and stabilizing structure provides a seal vector that is oriented at an angle relative to the Frankfort horizontal. The positioning and stabilizing structure includes a two-point connection to the nasal mask.

[0104] Another aspect of the present technology relates to a patient interface for applying a positive pressure supply of air to an entrance to a patient's airway. The patient interface includes a nasal mask and a positioning and stabilizing structure. The nasal mask has a seal-forming portion constructed and arranged to form a seal with a portion of the patient's upper lip and a portion of the patient's nasal cartilage structure. The nasal mask further includes a plenum chamber that, in use, receives a portion of the patient's nose including the nasal tip. The positioning and stabilizing structure provides a seal vector that is oriented at an angle relative to the Frankfort horizontal. The nasal mask does not include a forehead support.

[0105] Another aspect of the present technology relates to a patient interface for applying a positive pressure supply of air to an entrance to a patient's airway. The patient interface includes a nasal mask and a positioning and stabilizing structure. The nasal mask has a seal-forming portion configured and arranged to form a seal with a portion of the patient's upper lip and a portion of the patient's nasal cartilage structure. The nasal mask further includes a plenum chamber that, in use, receives a portion of the patient's nose including the nasal tip. The positioning and stabilizing structure provides a seal vector that is oriented at an angle relative to the Frankfort horizontal. The positioning and stabilizing structure includes a pair of side straps adapted to extend toward and over the top of the patient's head.

[0106] Of course, some of the aspects may form subaspects of the technology, and subaspects and / or various aspect portions of the aspects may be combined in various ways and also constitute further aspects or subaspects of the technology.

[0107] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims.

[0108] 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 like reference numerals indicate similar elements and in which: [Brief description of the drawings]

[0109] 4.1 Treatment System [Figure 1a] 4 shows a system according to the present technology. A patient 1000 wearing a patient interface 3000 receives a supply of air at positive pressure from a PAP device 4000. Air from the PAP device is humidified in a humidifier 5000 and passes along an air circuit 4170 to the patient 1000. The PAP device 4000, humidifier 5000, and air circuit 4170 may be connected to the patient interface 3000 according to the present technology. 4.2 Treatment 4.2.1 Respiratory System [Figure 2a] A general diagram of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2b] Shown is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilages, alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. 4.2.2 Facial Anatomy [Figure 2c] A front view of a face with several features of the surface anatomy identified including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, eye corners, nose wings, nasolabial folds, and corners of the mouth. [Figure 2d] FIG. 1 is a side view of the head with several features of the surface anatomy identified, including the glabella, root of the nose, tip of the nose, nasal spine, upper lip, lower lip, upper jaw, nasal ridge, superior ear base, and inferior ear base. Also shown are the superior and inferior, and anterior and posterior directions. [Figure 2e] FIGURE 2 is a further lateral view of the head, showing the approximate location of the Frankfort horizontal plane and the nasolabial angle; [Figure 2f] A bottom view of the nose is shown. [Figure 2g] 1 shows a side view of the surface features of a nose. [Figure 2h] The subcutaneous structures of the nose are shown, including the cartilaginous framework with the lateral nasal cartilages, septal cartilage, greater alar cartilage, and lesser alar cartilage, as well as the fibroadipose tissue. [Figure 2i] There is a medial nasal detachment approximately a few millimeters from the sagittal plane, particularly showing the septal cartilage and the medial crus of the greater alar cartilage. [Figure 2j] Shown is a frontal view of the bones of the skull, including the frontal, temporal, nasal, and cheekbones. The nasal turbinates are shown, as well as the maxilla, mandible, and mental protuberance. [Figure 2k] Shown is a lateral view of the skull with the head surface contour and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygoma, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. 4.3 Patient Interface [Figure 3-1]FIG. 13 is a perspective view of a nasal mask system according to an example of the present technology. [Figure 3-2] Figure 13 shows a side view of a nasal mask system according to an example of the present technology, shown over the head to show the approximate relative position of the headgear in use. [Figure 3-3] FIG. 13 is a front view of a nasal mask system according to an example of the present technology. [Diagram 3-4] FIG. 13 is a front perspective view of a cushion of a nasal mask system according to an example of the present technology. [Figure 3-5] FIG. 13 is a rear perspective view of a cushion of a nasal mask system according to an example of the present technology. [Diagram 3-6] FIG. 13B is an underside view of a cushion of a nasal mask system according to an example of the present technology. [Diagram 3-7] FIG. 13B shows a top view of a cushion of a nasal mask system according to an example of the present technology. [Diagram 3-8] FIG. 13 is a front view of a cushion of a nasal mask system according to an example of the present technology. [Diagram 3-9] FIG. 13 is a rear view of a cushion of a nasal mask system according to an example of the present technology. [Figure 3-10] FIG. 10 is a cross-sectional view of the cushion of the nasal mask system of FIG. 3-9. [Figure 3-11] FIG. 13 is a perspective view of an elbow assembly of a nasal mask system according to an example of the present technology. [Figure 3-12] FIG. 13 is a rear view of an elbow assembly of a nasal mask system in accordance with an example of the present technology. [Figure 3-13] FIG. 3-13 is a cross-sectional view of the elbow assembly of the nasal mask system of FIG. [Figure 3-14] FIG. 13 is a rear perspective view of a cushion of a nasal mask system according to another example of the present technology. [Figure 3-15] FIG. 3-15 is a top view of the cushion of FIG. 3-14. [Figure 3-16] FIG. 3-15 is a bottom view of the cushion of FIG. 3-14. [Figure 3-17] FIG. 3-14 is a front view of the cushion. [Figure 3-18] FIG. 3-18 is a cross-sectional view of the cushion of FIG. 3-17. [Figure 3-19] FIG. 3-18 is an enlarged view of a portion of FIG. [Figure 3-20] FIG. 3-14 is a rear view of the cushion. [Figure 3-21] FIG. 3-14 is a side view of the cushion of FIG. [Figure 3-22] FIG. 3-14 is a rear view of the cushion of FIG. 3-14 showing the section lines. [Figure 3-23] This is a cross section through line 3-23-3-23 in Figure 3-22. [Figure 3-24] This is a cross section through line 3-24-3-24 in Figure 3-22. [Figure 3-25] This is a cross section through line 3-25-3-25 in Figure 3-22. [Figure 3-26] This is a cross section through line 3-26-3-26 in Figure 3-22. [Figure 3-27] This is a cross section through line 3-27-3-27 in Figure 3-22. [Figure 3-28] This is a cross section through line 3-28-3-28 in Figure 3-22. [Figure 3-29] This is a cross section through line 3-29-3-29 in Figure 3-22. [Figure 3-30] This is a cross section through line 3-30-3-30 in Figure 3-22. [Figure 3-31] 14A-14C are sequential diagrams illustrating exemplary steps for donning a nasal mask system in accordance with an example of the present technology. [Figure 3-32] 14A-14C are sequential diagrams showing exemplary steps for donning a nasal mask system in accordance with an example of the present technology. [Figure 3-33] 14A-14C are sequential diagrams illustrating exemplary steps for donning a nasal mask system in accordance with an example of the present technology. [Figure 3-34] 14A-14C are sequential diagrams showing exemplary steps for donning a nasal mask system in accordance with an example of the present technology. [Figure 3-35] FIG. 13 shows a cross section of a nasal mask system engaged with a patient's face in accordance with an example of the present technology. [Figure 3-36]FIG. 13 shows a cross section of a nasal mask system engaged with a patient's face in accordance with an example of the present technology. [Figure 3-37] FIG. 3-14 is another perspective view of the cushion of FIG. [Figure 3-38] 13 shows a cushion assembly engaged with a patient's face and under pressure or inflated in use according to an example of the present technology. [Figure 3-39] FIG. 13 is a schematic rear view of a cushion assembly showing a seal that engages with a patient's face in use in accordance with an example of the present technology. [Figure 3-40-1] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-40-2] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-40-3] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-40-4] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-40-5] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-40-6] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-40-7] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-40-8] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-41-1] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-41-2] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-41-3] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Fig. 3-41-4] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Fig. 3-41-5] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Fig. 3-41-6] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-41-7] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Fig. 3-41-8] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Fig. 3-41-9] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-41-10] 14A-14C show various views of a cushion assembly in accordance with another example of the present technology. [Figure 3-42] FIG. 13 is an isometric cross-sectional view of a swivel elbow connector assembly according to an example of the present technology. [Figure 3-43] FIG. 2 is a side cross-sectional view of the swivel elbow connector assembly of FIG. 1. [Figure 3-44] FIG. 3-42 is an exploded isometric view of the swivel elbow connector assembly. [Figure 3-45] FIG. 3-42 is an exploded isometric view of the swivel elbow connector assembly. [Figure 3-46] FIG. 13 is an isometric view of a double swivel elbow connector assembly in a first position or configuration according to another example of the present technology. [Figure 3-47] FIG. 13 is an isometric view of a double swivel elbow connector assembly in a first position or configuration according to another example of the present technology. [Figure 3-48] FIG. 3-46 and FIG. 3-47 are side views of the double swivel elbow connector assembly. [Figure 3-49] FIG. 3-48 is a side view of the double swivel elbow connector assembly in a second position or configuration. [Figure 3-50] FIG. 13 is a side view of the transition of the double swivel elbow connector assembly from a first position to a second position. [Figure 3-51]FIG. 1 is an isometric cross-sectional view of a double swivel elbow connector assembly in a first position. [Figure 3-52] FIG. 13 is an isometric cross-sectional view of a double swivel elbow connector assembly in a second position. [Figure 3-53] FIG. 2 is a side cross-sectional view of a double swivel elbow connector assembly in a first position. [Figure 3-54] FIG. 11 is a side cross-sectional view of the double swivel elbow connector assembly in a third position or configuration. [Figure 3-55] FIG. 13 is a side cross-sectional view of a double swivel elbow connector assembly transitioning from a first position to a second position. [Figure 3-56] FIG. 11 is a side cross-sectional view of the double swivel elbow connector assembly in a fourth position or configuration. [Figure 3-57] FIG. 13 is a side cross-sectional view of a double swivel elbow connector assembly transitioning from a third position to a fourth position. [Figure 3-58] FIG. 13 is an isometric view of a triple swivel elbow connector assembly including a second swivel cuff in a first position or configuration in accordance with yet another example of the present technology. [Figure 3-59] FIG. 13 is an isometric view of a triple swivel elbow connector assembly including a second swivel cuff in a first position or configuration in accordance with yet another example of the present technology. [Figure 3-60] FIG. 3-58 is an isometric view of the triple swivel elbow connector assembly of FIGS. 3-59 in a second position or configuration. [Figure 3-61] FIG. 3-58 and FIG. 3-59 are side views of the triple swivel elbow connector assembly. [Figure 3-62] FIG. 13 is a side view of the transition of the triple swivel elbow connector assembly from a first position to a second position. [Figure 3-63] FIG. 13 is a side view of the triple swivel elbow connector assembly in a second position. [Figure 3-64]FIG. 1 is a side cross-sectional view of a triple swivel elbow connector assembly in a first position. [Figure 3-65] FIG. 11 is a side cross-sectional view of the triple swivel elbow connector assembly in a second position. [Figure 3-66] FIG. 13 is a side view of the transition of the triple swivel elbow connector assembly from a first position to a second position. [Figure 3-67] FIG. 1 is a cross-sectional isometric view of a triple swivel elbow connector assembly in a first position. [Figure 3-68] FIG. 13 is a cross-sectional isometric view of the triple swivel elbow connector assembly in a second position. [Figure 3-69] FIG. 11 is a side cross-sectional view of the triple swivel elbow connector assembly in a third position or configuration. [Figure 3-70] FIG. 11 is a side cross-sectional view of the triple swivel elbow connector assembly in a fourth position or configuration. [Figure 3-71] FIG. 11 is a side cross-sectional view of the swivel elbow connector assembly transitioning from a third position to a fourth position. [Figure 3-72] 1 is a cross-sectional view of a patient interface structure or cushion that can be used with examples of the present technology. [Figure 3-73] FIG. 13 is an isometric view of a swivel elbow connector assembly according to an example of the present technology. [Figure 3-74] FIG. 3-73 is a partial cross-sectional side view of the swivel elbow connector assembly of FIG. [Figure 3-75] FIG. 3-73 is a cross-sectional plan view of the swivel elbow connector assembly of FIG. [Figure 3-76] FIG. 3-73 is an isometric view of a variation of the swivel elbow connector assembly of FIG. [Figure 3-77] FIG. 3-77 is a front view of the swivel elbow connector assembly of FIG. [Figure 3-78] FIG. 3-76 is a cross-sectional view of the swivel elbow connector assembly. [Figure 3-79]FIG. 13 is an isometric view of a first component of a swivel elbow and anti-asphyxiation valve assembly according to an example of the present technology. [Figure 3-80] FIG. 3-79 is a side view of the first component of FIG. 3-79. [Figure 3-81] FIG. 3-81 is a rear view of the first component of FIGS. 3-79 and 3-80. [Figure 3-82] FIG. 3-82 is a cross-sectional side view of the first component of FIGS. 3-79 and 3-81. [Figure 3-83] FIG. 2 is an isometric view of a first component and a second component of a swivel elbow and anti-asphyxiation valve assembly. [Figure 3-84] FIG. 3-83 is a side view of the swivel elbow and anti-asphyxiation valve assembly. [Figure 3-85] FIG. 3-83 is a rear view of the swivel elbow and anti-asphyxiation valve assembly of FIGS. 3-84 and 3-85. [Figure 3-86] FIG. 2-83 is a front view of the swivel elbow and anti-asphyxiation valve assembly of FIG. 3-85. [Figure 3-87] A side cross-sectional view of the swivel elbow and anti-asphyxiation valve assembly of Figures 3-83 to 3-86. [Figure 3-88] FIG. 3-83 is a top view of the swivel elbow and anti-asphyxiation valve assembly of FIG. 3-87. [Figure 3-89] FIG. 13 is an isometric view of a patient interface including a swivel elbow connector assembly in accordance with another example of the present technology. [Figure 3-90] FIG. 13 is an isometric view of a patient interface including a swivel elbow connector assembly in accordance with another example of the present technology. [Figure 3-91] FIG. 3-90 is an isometric view of the elbow of FIG. [Figure 3-92] FIG. 3-90 is a cross-sectional view of the patient interface of FIG. [Figure 3-93] FIG. 11 is a cross section of a patient interface including a swivel elbow connector assembly in accordance with another example of the present technology. [Figure 3-94] FIG. 133 is an isometric view of an elbow in accordance with an example of the present technology. [Figure 3-95] FIG. 3-94 is a cross-sectional view of the elbow of FIG. [Figure 3-96] FIG. 13 is a cross-sectional view of an elbow tube connector assembly in accordance with the present technology. [Figure 3-97] An enlarged view of a portion of Figure 3-96. [Figure 3-98] FIG. 3-96 is an exploded view of the elbow tube connector assembly. [Figure 3-99] FIG. 13 is an exploded view of an elbow tube connector assembly in accordance with another example of the present technology. [Figure 3-100] Figure 3-99 is an assembly drawing of the elbow tube connector assembly. [Figure 3-101] FIG. 3-100 is a cross-sectional view of the elbow tube connector assembly. [Figure 3-102] FIG. 13 is an exploded view of an elbow tube connector assembly in accordance with another example of the present technology. [Fig. 3-103] Figure 3-102 is an assembly drawing of the elbow tube connector assembly. [Fig. 3-104] FIG. 3-103 is a cross-sectional view of the elbow tube connector assembly. [Fig. 3-105] FIG. 3-104 is an isometric view of the connector of the elbow tube connector assembly. [Figure 3-106] FIG. 3-105 is a cross-sectional view of the connector of FIG. [Fig. 3-107] FIG. 13 is a cross section of a tube connector assembly according to an example of the present technology. [Fig. 3-108] FIG. 3-107 is an isometric view of the tube connector assembly of FIG. [Figure 3-109A] 1 shows a multi-step process for manufacturing an elbow with an anti-asphyxiation valve. [Fig. 3-109B] 1 shows a multi-step process for manufacturing an elbow with an anti-asphyxiation valve. [Fig. 3-109C] 1 shows a multi-step process for manufacturing an elbow with an anti-asphyxiation valve. [Fig. 3-109D] 1 shows a multi-step process for manufacturing an elbow with an anti-asphyxiation valve. [Figure 3-110A]FIG. 13 shows a perspective view of a modified elbow. [Fig. 3-110B] 3-1 shows a cross section of the variation shown in FIG. 110A. [Fig. 3-111] AAV (modified) is shown in isolation. [Figure 3-112-1] FIG. 13 shows a top view of a nasal mask system engaged with a patient's face in accordance with an example of the present technology, with the nasal mask system in a static sealing position. [Figure 3-112-2] FIG. 11 is a relevant cross-sectional view showing a nasal mask system engaged with a patient's face in accordance with an example of the present technology, where the nasal mask system is in a static sealing position; [Figure 3-113-1] FIG. 13 is a side view of a nasal mask system engaged with a patient's face in accordance with an example of the present technology, with the nasal mask system in a static sealing position. [Figure 3-113-2] FIG. 11 is a relevant cross-sectional view showing a nasal mask system engaged with a patient's face in accordance with an example of the present technology, where the nasal mask system is in a static sealing position; [Figure 3-114-1] FIG. 13 shows a top view of a nasal mask system engaged with a patient's face according to an example of the present technology, with the nasal mask system in a dynamic sealing position with the nasal mask system pulled laterally. [Figure 3-114-2] 11 is a relevant cross-sectional view showing a nasal mask system engaged with a patient's face according to an example of the present technology, with the nasal mask system in a dynamic sealing position with the nasal mask system pulled laterally; [Figure 3-115-1] FIG. 13 is a side view showing a nasal mask system engaged with a patient's face according to an example of the present technology, with the nasal mask system in a dynamic sealing position with the nasal mask system pulled upwards. [Figure 3-115-2] 11 is a relevant cross-sectional view showing a nasal mask system engaged with a patient's face in accordance with an example of the present technology, with the nasal mask system in a dynamic sealing position with the nasal mask system pulled upwards; [Figure 3-116-1] FIG. 13 is another side view showing the nasal mask system in a dynamic sealing position with the nasal mask system pulled upwards. [Figure 3-116-2]FIG. 11 is another related cross-sectional view showing the nasal mask system in a dynamic sealing position with the nasal mask system pulled upwards. [Figure 3-117-1] FIG. 13 is a side view showing a nasal mask system engaged with a patient's face according to an example of the present technology, with the nasal mask system in a dynamic sealing position with the nasal mask system pulled downwards. [Figure 3-117-2] 11 is a relevant cross-sectional view showing a nasal mask system engaged with a patient's face in accordance with an example of the present technology, with the nasal mask system in a dynamic sealing position with the nasal mask system pulled downwards; [Figure 3-118-1] 13 shows a rotation of an elbow assembly in the X axis in accordance with an example of the present technology. [Figure 3-118-2] 13 shows rotation of an elbow assembly in the Z axis in accordance with an example of the present technology. [Figure 3-118-3] 13 shows rotation of an elbow assembly in the Y axis according to an example of the present technology. [Figure 3-119-1] FIG. 13 is a perspective view of a nasal mask system with a short tube in a retracted position according to an example of the present technology. [Figure 3-119-2] FIG. 13 is a perspective view of a nasal mask system with a short tube in an extended position according to an example of the present technology. [Figure 3-120-1] FIG. 14 shows various views of an elbow, short tube and swivel assembly in accordance with an example of the present technology. [Figure 3-120-2] FIG. 14 shows various views of an elbow, short tube and swivel assembly in accordance with an example of the present technology. [Figure 3-120-3] FIG. 14 shows various views of an elbow, short tube and swivel assembly in accordance with an example of the present technology. [Figure 3-120-4] FIG. 14 shows various views of an elbow, short tube and swivel assembly in accordance with an example of the present technology. [Figure 3-120-5] A cross section through line 3-120-5-3-120-5 in FIG. 3-120-4 is shown. [Figure 3-120-6] 3-120-4 in the cross section through the line 3-120-6-3-120-6. 4.4 PAP Device [Figure 4a] 1 shows a PAP device in accordance with one form of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0110] 5. Detailed Description of Illustrated Embodiments Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific examples of possible variations described herein, and the terminology used in this disclosure is for the purpose of describing only the specific examples discussed herein, and is not intended to be limiting.

[0111] The following description is provided in the context of several examples that may share common characteristics and features. It should be understood that one or more features of any one example may be combinable with one or more features of other examples. Also, any single feature or combination of features in any example may constitute an additional example.

[0112] In this specification, the term "comprising" must be understood in its "open" sense, i.e. in the sense of "including", and therefore not limited to its "closed" sense, i.e. in the sense of "consisting only of". Where the corresponding terms "comprise", "comprised" and "comprises" appear, corresponding meanings must be ascribed to these terms.

[0113] The term "air" is intended to include breathable gases, such as air with supplemental oxygen. Thus, a supply of air may correspond to a supply of gases including air and supplemental oxygen. It is also recognized that the PAP devices or blowers described herein may be adapted to pump fluids other than air.

[0114] Examples of the present technology are directed to nasal mask systems that are easy and quick to fit (e.g., with little or no adjustment), allow for reduced strap tension, can be manufactured in large quantities, are highly appealing to consumers, provide comfort and a seal, provide reliable quality, are unobtrusive, and / or fit the majority of the population.

[0115] The one or more examples may include typical metrics, e.g., dimensions, angles, percentages, etc. Thus, while particular metrics and ranges may be given, it should be understood that these metrics and ranges are merely exemplary and other metrics and ranges may be contemplated depending on the application. For example, metrics / ranges that vary ±10-20% from those provided may be suitable for a particular application.

[0116] The technology provides a structure or assembly between the patient interface and the tube that can be adapted to isolate tube resistance forces, provide freedom of movement for the tube to allow the patient to position the tube in a desired location without compromising the seal, vent exhaled gases, and provide a compact, unobtrusive structure that is aesthetically acceptable to the patient.

[0117] The ventilation configuration may diffuse the exhausted air to prevent air jets onto the patient or the patient's bed companions and to reduce noise.

[0118] The vent arrangement may cooperate with the elbow assembly or connector assembly to further diffuse the exhaled air, for example the elbow may be provided with ridges to deflect the air in a diffusing manner.

[0119] The elbow may be provided with one or more swivel connectors designed to provide a greater degree of movement and to help isolate tube resistance forces.

[0120] The elbow may also be referred to as an adapter, connector, or may be considered as any element that attaches the air delivery tube to the patient interface.

[0121] 5.1.1 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.

[0122] 5.2 Patient Interface 3000 A patient interface 3000 according to one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, and a connection port 3600 for connection to an air circuit 4170 (see, e.g., FIG. 3-2). In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's airways to facilitate the delivery of air at positive pressure to the airways.

[0123] In one example, the plenum chamber 3200 and the seal-forming structure 3100 are integrally molded. In another example, they are formed as two or more separate components.

[0124] A patient interface 3000 in accordance with one form of the present technology is a nasal mask system 100. As shown in Figs. 3-1-3-3, the nasal mask system 100 in accordance with the present technology may include a headgear assembly 110, an elbow assembly 120, an air delivery assembly 130, and a cushion assembly or cushion 150. Figs. 3-4-3-10 show various views of the cushion assembly 150, and Figs. 3-11-3-12 show various views of the elbow assembly 120.

[0125] A plenum chamber 3200 in accordance with one form of the present technology is a cushion assembly 150. The cushion assembly 150 may be adapted to sealingly engage a patient's airway, including the patient's nose. As shown in FIGS. 3-1-3-3, the cushion assembly 150 may receive breathable gas from an air delivery assembly 130 and / or an elbow assembly 120, and may be supported in place by a headgear assembly 110.

[0126] The cushion assembly 150 may include a sealing area or sealing cuff 151, two headgear connectors 156, a sidewall or sidewall area 157, and an attachment area 158. In one example, the cushion assembly 150 may be formed from a flexible elastomer or rubber.

[0127] 3-14-3-30, 3-35, and 3-36-1-3-40-2 show various views of a cushion assembly 250 according to another example of the present technology similar to the cushion assembly 150. The cushion assemblies 150, 250 are generally referred to as compact nasal cushions, in contrast to the embodiment depicted in FIG. 3-74, which is generally referred to as a nasal pillow. As described below, the cushion assembly 250 includes a thin-walled portion adjacent the upper lip region of the sealing region of the cushion assembly 250 (e.g., to avoid excessive pressure acting on the patient's nasal bridge and septum). Also, both sides of the nasal region of the sealing region include alars or sealing flaps adapted to form a seal in the region adjacent the junction between the greater alar cartilage and the lateral nasal cartilage of the patient's nose.

[0128] In the illustrated example of Figures 3-14 to 3-21, D1 is about 85 to 105 mm (e.g., about 97 mm), D2 is about 35 to 55 mm (e.g., about 48 mm), D3 is about 35 to 55 mm (e.g., about 44 mm), D4 is about 30 to 50 mm (e.g., about 41 mm), D5 is about 25 to 45 mm (e.g., about 35 mm), D6 is about 20 to 30 mm (e.g., about 26 mm), D7 is about 40 to 60 mm (e.g., about 50 mm), and D8 is about 20 to 30 mm (e.g., about 23 mm). Although specific dimensions are given, it will be appreciated that these dimensions are merely representative and other dimensions may be envisaged depending on the application. For example, the representative dimensions may vary by more or less than ±10 to 20% depending on the application.

[0129] 5.2.1 Seal-forming structure 3100 In one form of the present technology, the seal-forming structure 3100 provides a seal-forming surface and may further provide a cushioning function.

[0130] In one example, a seal-forming structure 3100 in accordance with the present technology is constructed from a soft, flexible, elastic material such as silicone.

[0131] In one form, the seal-forming structure 3100 comprises a seal flange 3110 and a support flange 3120. In one form of the present technology, the seal flange 3110 comprises the membrane 160 of the sealing area 151, and the support flange 3120 comprises the undercushion or backup band 165 of the sealing area 151 (see, for example, FIG. 3-10). In one example, the seal flange 3110 comprises a relatively thin member having a thickness of less than about 1 mm, for example about 0.25 mm to about 0.45 mm, extending around the periphery 3210 of the plenum chamber 3200. In one example, the support flange 3120 is relatively thicker than the seal flange 3110. The support flange 3120 is disposed between the seal flange 3110 and the periphery 3220 of the plenum chamber 3200, and extends at least a portion of the way around the periphery 3210 of the plenum chamber 3200. The support flange 3120 is a spring-like element which functions to support the sealing flange 3110 against buckling in use. In use, the sealing flange 3110 is readily responsive to system pressure within the plenum chamber 3200 acting on an underside of the sealing flange to urge the sealing flange into tight sealing engagement with the face.

[0132] In one form of the present technology, a seal-forming structure 3100 comprises an upper sealing portion 3102 and a lower sealing portion 3104 (see, e.g., Figs. 3-10 and 3-21). The upper sealing portion 3102 and the lower sealing portion 3104 may, for example, be positioned adjacent to one another and may blend one region into the other.

[0133] 5.2.1.1 Upper seal part 3102 The superior sealing portion 3102 is configured and positioned to form a seal against a portion of the cartilage framework of the nose. In one example, the superior sealing portion 3102 is constructed from a flap, flange, or membrane of a relatively thin material, such as a thermoplastic elastomer or silicone rubber, and is also constructed from a material that is easily bent or folded, for example, in response to light finger pressure when not in use. Depending on the shape of the nose with which the superior sealing portion is intended to be used, a relatively narrow width of the superior sealing portion 3102 may engage and seal with the nasal ridge. A relatively wide portion of the superior sealing portion 3102 may engage and seal with the skin adjacent the lateral nasal cartilage. See, for example, FIG. 3-39.

[0134] The upper sealing portion 3102 is not configured to completely cover the nose.

[0135] In one example, the upper sealing portion 3102 is constructed and arranged to accommodate different heights of the nasal ridge, for example by being thin or flexible, thus increasing the range of faces on which a good seal can be obtained.

[0136] Also, for a given face and nose, the flexibility of the upper sealing portion 3102 means that a seal can be maintained when the plenum chamber 3200 is moved, for example in response to movement of the air circuit 4170.

[0137] The upper seal portion is configured such that it does not obscure the nasal bone when in use, although certain portions of the upper seal portion may obscure some portion of the nasal bone on some faces depending on exactly how the patient interface is used and depending on the size and shape of a particular face.

[0138] In another form, the superior sealing portion is constructed and arranged to form a seal against the nasal bone in use.

[0139] 5.2.1.2 Lower seal part 3104 The inferior sealing portion 3104 is configured and arranged to form a seal against a portion of the patient's upper lip and to direct at least a portion of a sealing force towards the patient's maxilla. In use, a portion of the inferior sealing portion 3104 is positioned proximate the nadir and the apex of the alar.

[0140] In one form, the lower seal is configured to avoid excessive pressure on the upper teeth or gums. In one example, the lower seal does not extend along the bone (e.g., the frontal process of the maxilla) above the apex of the alar, although in other examples it may do so.

[0141] The lower seal portion 3104 may be comprised of a single relatively thick flap, rim, or flange of a material, such as silicone rubber or a thermoplastic elastomer, having a thickness of, for example, about 1 mm to 2 mm. In one form, the lower seal portion 3104 may be comprised of two flaps, rims, or flanges, for example, one relatively thin and the other relatively thick. Alternatively, the lower seal portion 3104 may be comprised of a gel filled bag.

[0142] 5.2.1.3 “W” shaped area 3-40-1 through 3-40-8 show various views of a cushion assembly 350 according to another example of the present technology. In this example, the cushion assembly includes a generally "W" shape in the upper lip region. That is, as best shown in FIG. 3-40-4, the cushion assembly includes a generally "W" shape along the outer (lower) edge 360(o) of the membrane 360 ​​in the upper lip region.

[0143] 3-41-1 through 3-41-8 show various views of a cushion assembly 450 according to another example of the present technology. This example shows a cushion assembly with a generally "W" shape in the upper lip region. In contrast to the example of Fig. 3-40-1 through 3-40-8, the cushion example of Fig. 3-41-1 through 3-41-8 includes a generally "W" shape in the upper lip region along both the inner (upper) edge 460(i) of the membrane 460 and the outer (lower) edge 460(o) of the membrane, as best shown in Fig. 3-41-4.

[0144] In one form, the "W" portion of the upper lip area is constructed and arranged such that, in use, the central portion of the "W" can rest on the nasal spine or columella, thereby leaving a gap (e.g., as shown by c in FIG. 3-41-8 between the inner edge of the undercushion 465 and the inner surface of the plenum chamber) around the lowest point of each left and right alar when the seal-forming portion moves upward (up) in use.

[0145] In one example, as best shown in Figs. 3-41-6, 3-41-7 and 3-41-10, a portion of the seal portion may have a question mark, sickle or c-shaped cross section. The question mark, sickle or c-shaped cross section may provide the seal portion with a greater range of motion or flexibility towards the patient's face in use. In the illustrated example, the question mark, sickle or c-shaped cross section is provided in the lower portion of the undercushion 465 and / or in the sidewall region 457, thereby providing a space adjacent to the sidewall region 457 below the lower portion of the undercushion 465. For example, the lower portion of the undercushion 465 is radially offset outwardly of the sidewall region 457. Of course, such cross sections may be provided around the entire circumference of the cushion or may be provided only in selected areas of the cushion, such as only in the upper lip region. Also, the size and / or shape of such cross sections may vary in the selected areas.

[0146] In the illustrated examples of Figures 3-40-1 to 3-40-8 and 3-41-1 to 3-41-8, D1 is about 90 to 110 mm (e.g., about 105 mm), D2 is about 40 to 60 mm (e.g., about 51 mm), D3 is about 40 to 60 mm (e.g., about 51 mm), D4 is about 35 to 55 mm (e.g., about 44 mm), D5 is about 30 to 50 mm (e.g., about 38 mm), D6 is about 25 to 35 mm (e.g., about 32 mm), D7 is about 45 to 65 mm (e.g., about 58 mm), and D8 is about 20 to 30 mm (e.g., about 26 mm). Although specific dimensions are given, it will be appreciated that these dimensions are merely representative and other dimensions may be envisaged depending on the application. For example, the representative dimensions may vary by more or less than ±10 to 20% depending on the application. For example, the seals and openings may be wider, e.g., D1 is about 100-120 mm (e.g., about 114 mm), D6 is about 40-50 mm (e.g., about 42 mm), D7 is about 55-75 mm (e.g., about 68 mm), and D8 is about 20-30 mm (e.g., about 24 mm). In other examples, the seals and openings may be narrower, e.g., D1 is about 90-110 mm (e.g., about 100 mm), D6 is about 25-35 mm (e.g., about 28 mm), D7 is about 45-65 mm (e.g., about 54 mm), and D8 is about 20-30 mm (e.g., about 24 mm).

[0147] 5.2.1.4 Sealing Area According to another aspect of the present technology, the seal-forming structure 3100 comprises a sealing area 151. The sealing area 151 may be adapted to interface with a patient to form a seal with the patient's airway. The sealing area 151 may include a nasal ridge or nasal ridge area 152, sides of the nasal area 153, corners of the nasal area 154, and an upper lip area 155. The sealing area 151 may comprise a membrane or flap type seal 160. In the example shown in Fig. 3-18 and Fig. 3-19, the inner edge of the membrane 260 may include a bead 260-1, for example to prevent separation and enhance sealing along the edges. The sealing area 151 may further comprise an undercushion or back-up band 165 that extends around a portion or the entire perimeter of the sealing area. A further aspect of the present technology is a cushion for a mask that seals at its upper extent with the nasal area generally above the tip of the nose and extends across the ala or ala flare of the patient's nose.

[0148] In one example, the seal area 151 may be preformed or otherwise pre-shaped to conform to the patient's facial morphology.

[0149] Seal along the nasal ridge One aspect of the present technology relates to sealing of the sealing area in the nasal ridge region. In one example, the sealing area in the nasal ridge region engages along the nasal ridge between the tip and the base of the nose, and below or below the nasal bone along the nasal cartilage region of the nasal ridge. That is, the nasal mask system is configured to have a seal-forming area substantially over at least a portion of the patient's nasal cartilage framework and not over the nasal bone, i.e., to seal along the nasal ridge without contacting the bridge of the nose / skin over the nasal bone.

[0150] For example, sealing area 151 is adapted to be positioned at its upper extent to seal with the area of ​​the nose that is generally above the tip of the nose (i.e., above the tip of the nose) and extends across the ala or ala flare of the patient's nose, but does not extend, for example, over or across the patient's nasal bone.

[0151] In one example, the sealing area 151 is positioned at its upper extent in the area of ​​the nose that is generally adjacent to the junction between the bone and cartilage for a range of people with large noses to avoid affecting the field of view of individuals with small noses.

[0152] Nasal ridge area The nasal ridge region 152 may be adapted to engage the patient's nasal ridge. In one example, the nasal ridge region may be shaped or preformed to receive the patient's nasal ridge, for example, the nasal ridge region may be lower than the sides 153 of the nasal region (i.e., closer to the attachment region 158 than the sides of the nasal region), as best shown in Figs. 3-7. The nasal ridge region 152 may include a membrane 160 for sealing without an undercushion or back-up band. In one example, such a configuration prevents excessive pressure on the delicate nasal ridge region. In one example, the membrane in the nasal ridge region 152 may be relatively longer than the membranes in other areas of the sealing region, such as the upper lip region 155. The membrane in the nasal ridge region 152 may be, for example, about 2-5 mm in length. In one example, the membrane in the nasal ridge region 152 may be about 2-4 mm in length. In one example, the membrane in the nasal ridge region 152 may be about 3 mm in length.

[0153] Side of nose area The sides 153 of the nasal region may be adapted to engage the sides of the patient's nose. In one example, the sides 153 of the nasal region may be preformed to receive the sides of the patient's nose and possibly the patient's cheeks. As best shown in FIG. 3-5, the sides 153 of the nasal region extend from the apex of the cushion in the nasal ridge region 152 to the corners 154 of the nasal region. The sides 153 of the nasal region slope upward from the nasal ridge region 152 to the corners of the nasal region. See, for example, FIG. 3-6. The sides 153 of the nasal region may include a membrane 160 for sealing without an undercushion or back-up band. In one example, such a configuration prevents excessive pressure acting on the sides of the patient's nose or ala or ala flare. Excessive pressure acting on these areas may cause the nasal cartilage to collapse inward toward the septum, thereby obstructing or partially obstructing the patient's airway.

[0154] Corners of the nose area The nasal corner 154 may be adapted to form a seal with the corner of the patient's nose. Figures 3-6 show the nasal corner 154 having an apex or tip generally indicated by H1, which is the maximum height of the sealing area 151. This height is adapted to ensure that the greatest force is applied to the sealing area 151 at the nasal corner 154. This is because this area is a facial bony area and is therefore less susceptible to pressure. This area of ​​the patient's face is also particularly difficult to seal because the facial shape in this area is very complex, so the more force is applied to the seal in this area, the more likely it is that a seal will be formed. Also, because less sealing force is required in the nasal ridge area and at the sides of the nasal area (for comfort and to avoid blockage), the sealing area must be secured at the nasal corner. The nasal corner 154 may include a membrane or membrane seal 160 and an undercushion or back-up band 165. The use of both a membrane and an undercushion can ensure a higher sealing force in this area. In one example, the membrane may have a thickness of about 0.1 to 0.5 mm, such as about 0.3 mm. In one example, the undercushion may have a thickness of about 0.3 to 2 mm.

[0155] upper lip area The upper lip region 155 may be adapted to engage the surface between the patient's upper lip and the base of the nose. In one example, the upper lip region may have a relatively shorter membrane length than the nasal ridge region, such as a length of about 0.5-2.5 mm, such as about 1.5-2.5 mm. In one example, this shorter membrane length may be advantageous because some patients have only a small space between their upper lip and the base of their nose. As best shown in FIG. 3-10, the upper lip region 155 may have a membrane seal 160 and an undercushion or backup band 165. The use of both a membrane and an undercushion can ensure an even higher sealing force in this region. In one example, the membrane may have a thickness of about 0.1-0.5 mm, such as about 0.3 mm. In one example, the undercushion may have a thickness of about 0.3-2 mm, such as about 1.5 mm. In one example, the thickness of the undercushion may vary along the length of the upper lip region, for example from about 0.3 mm at the corners of the nose region to about 1.2 mm at the center of the upper lip region.

[0156] 5.2.1.5 Seals The use of the undercushion and backup band allows the membrane or face flap to be made much thinner than if a single unsupported flap were used, which is highly beneficial in that the thinner flap is more flexible, thereby feeling softer and more comfortable, and more easily conforming to the contours of the face, and it also allows the flap to more easily respond to system pressure in the breathing chamber acting on the underside of the flap to urge it into tight sealing engagement with the face.

[0157] As previously discussed, the nasal mask system is configured to have a seal-forming region that is substantially over the cartilaginous structure of the nose (i.e., not over the nasal bone) and does not occlude the nose. In one example, this may be achieved by providing a compressive seal (e.g., an inferior seal portion) along the patient's upper lip rather than over the patient's nose (e.g., using an undercushion structure). A seal over the patient's nose (e.g., an superior seal portion) may be achieved by membrane tension and / or a pneumatic seal.

[0158] For example, as shown in the cushion example of Figures 3-14-3-30, and as described in the previous examples, the undercushion or backup band 265 is provided only at the upper lip region 255 and corners 254 of the nose region of the cushion. See, e.g., Figures 3-16, 3-18, 3-22, 3-23, 3-29, and 3-30. That is, the sealing area includes only a single layer or membrane 260 structure at the nasal ridge region 252 and sides 253 of the nose region (see, e.g., Figures 3-18 and 3-22-3-28), and the sealing area includes a dual layer or membrane 260 and undercushion 265 structure at the upper lip region 255 and corners 254 of the nose region. The dual layer structure provides a compression seal along the upper lip region and corners of the nose region. On the other hand, the nasal ridge region and sides of the nose region provide a seal using tension of the membrane (tension applied to the membrane causes the edges of the membrane to stretch into sealing engagement) and / or pressure in the breathing chamber acting on the membrane (pneumatic seal).The nasal ridge region and sides of the nose region are also provided with a single layer to provide a softer and more flexible seal that avoids any possibility of blocking the patient's nose, i.e., preventing excessive pressure on the sides or alae or ala flare of the patient's nose that may collapse the cartilage inwards and potentially at least partially obstruct the patient's airway.

[0159] Thus, a cushion assembly according to one example of the present technology provides different sealing mechanisms for different parts of the cushion. For example, the cushion assembly may provide one sealing mechanism (e.g., membrane tension seal and / or pneumatic seal) for the upper part of the cushion and a different sealing mechanism (e.g., compression seal) for the lower part of the cushion. In the illustrated example, the cushion assembly provides a compression seal by a double layer or membrane and undercushion structure. However, it goes without saying that the compression seal may be provided by another structure, for example, a gel-filled or foam-filled pocket, a thicker single wall (e.g., about 0.8-1.2 mm thick silicone).

[0160] FIG. 3-38 shows an example of a cushion assembly 250 engaged with a patient's face, the cushion assembly being under pressure or inflated in use, i.e., a positive air supply is applied to the cushion assembly 250. FIG. 3-39 shows a shaded area along the seal portion of the cushion assembly 250, which indicates the width or contact area 280 of the seal portion that is engaged with the patient's face in use. The width or contact area includes an inner edge 280(i) (e.g., along the edge of the orifice) and an outer edge 280(o). FIG. 3-36 also shows the outer edge 280(o) of the contact area in dashed lines. As shown, depending on the shape of the nose with which the upper seal portion is intended to be used, a relatively narrow width of the upper seal portion 3102 may engage the nasal ridge to form a seal. A relatively wide portion of the upper seal portion 3102 may engage the skin adjacent the lateral nasal cartilage to form a seal. In the inferior sealing portion 3104, substantially the entire width of the inferior sealing portion may engage the skin along the corners of the nose area and the upper lip area to form a seal. Thus, the width or contact area of ​​the sealing portion that engages with the patient's face in use to form a seal may vary around the circumference of the cushion assembly.

[0161] 5.2.1.6 Sealing flaps In one example, as shown in Figures 3-14, 3-16, 3-20, 3-22, 3-26, 3-27, 3-35, and 3-36, each side 253 of the nasal region of the sealing area includes a portion 270, such as an alar or sealing flap, that projects from the edge of the membrane 260 along its inner periphery. As best shown in Figures 3-35 and 3-36, each sealing flap 270 is adapted to form a seal in the area adjacent the junction between the greater alar cartilage and the lateral nasal cartilage of the patient's nose (also referred to as the alar crease). The exact location of the sealing flap on the face in use may vary depending on the size and shape of the nose with which it is intended to be used.

[0162] As shown, each sealing flap 270 is bent or pre-biased outwardly at least partially away from the breathing chamber of the cushion. When the sealing flap is engaged with the patient's nose, it is biased toward the breathing chamber, thereby providing a sealing bias at the junction described above. That is, the shape, flexibility, and pre-bias of the sealing flap allow the flap to accommodate changes in curvature or contour at this junction (e.g., nasal alar or "flare" tends to constantly change during use), thereby maintaining a seal and preventing leakage during use.

[0163] In one example, the sealing flange (including membrane 260 and sealing flap 270) defines a generally T-shaped orifice. An edge of membrane 260 along its inner periphery cooperates with an edge of each sealing flap 270 along its inner periphery to define an orifice 275 into the plenum chamber. In one example, such orifice 275 includes a generally T-shape including an upper orifice portion 275(1) (along a vertical axis v as viewed in FIG. 3-20) and a lower orifice portion 275(2) (along a horizontal axis h as viewed in FIG. 3-20) that extends generally transversely to upper orifice portion 275(1).

[0164] 3-14, the sealing flap 270 varies the curvature and / or angle of the edges that define the orifice 275. That is, the edges of the orifice 275, at least along the sealing flap 270, curve upwardly and outwardly, away from the breathing chamber.

[0165] The curvature of the cushion may vary along the patient-contacting surface of membrane 260 in different areas of the cushion, for example to facilitate sealing on different areas of the patient's face.

[0166] For example, as shown in Fig. 3-14, the nasal ridge region 252 and the upper lip region 255 each include at least a portion that locally forms a saddle-shaped curvature, such as a portion that curves upward in one direction d1 and downward in a different direction d2. Fig. 3-37 is another view of the cushion 250 showing such a saddle-shaped curvature in the nasal ridge region 252 and the upper lip region 255.

[0167] Of course, the curved shapes described above are approximate shapes and should not be limited to a strict mathematical definition of such shapes.

[0168] It should also be understood that regions may include similar curvature shapes, but the magnitude of such curvature may differ, for example, nasal ridge region 252 and upper lip region 255 may both include at least a portion of a saddle shape locally, but the magnitude of curvature of such saddle shape in one and / or both major directions may differ in each region.

[0169] 5.2.2 Aperture In an example where a single mask is to be used to fit about 85% of the female population, the undercushion opening width (e.g., as shown by uw in FIG. 3-41-9) is about 36 mm to about 42 mm or about 38 mm to about 40 mm. In an example where a single mask is to be used to fit about 85% of the male population, the undercushion opening width is about 40 mm to about 46 mm or about 42 mm to about 44 mm. In one form, taking into account the nose width variations of various ethnicities, the undercushion opening width is about 50 mm to about 56 mm or about 52 mm to about 54 mm to fit up to 95% of the average population.

[0170] In an example where a single mask is to be used to fit about 85% of the female population, the membrane opening width (e.g., shown as mw in FIG. 3-41-9) is about 23 mm to about 29 mm or about 25 mm to about 27 mm. In an example where a single mask is to be used to fit about 85% of the male population, the membrane opening width is about 39 mm to about 45 mm or about 41 mm to about 43 mm. In one form, taking into account nose width variations of various ethnicities, the membrane opening width is about 49 mm to about 55 mm or about 51 mm to about 53 mm to fit up to 95% of the average population.

[0171] 5.2.3 Plenum Chamber 3200 The plenum chamber 3200 is defined in part by a sidewall. In one form, the sidewall includes the sidewall region 157 of the sealing region 151. The plenum chamber has a perimeter 3210 that is shaped to generally conform to the surface contours of an average human face (see, e.g., Figs. 3-8 and 3-9). In use, the perimeter 3220 of the plenum chamber 3200 is positioned adjacent to the adjacent surface of the face (see, e.g., Fig. 3-10). Actual contact with the face is provided by the seal-forming structure 3100. In one example, the seal-forming structure 3100 extends around the entire perimeter 3210 of the plenum chamber 3200 in use. In one example, the plenum chamber is adapted to receive a portion of the patient's nose, including the nasal tip. For example, the plenum chamber covers and surrounds a portion of the cartilaginous structure of the nose, including the nasal tip.

[0172] In one example, the walls of the plenum chamber 3200 are flexible or semi-rigid. In one example, the plenum chamber 3200 does not include a rigid frame or shell. In one example, the walls of the plenum chamber 3200 are not rigid, and for example, the walls of the plenum chamber 3200 are not soft. In certain configurations, the flexibility of the walls of the plenum chamber 3200 helps to isolate tube resistance forces so that the seal is not compromised.

[0173] In one form, the walls of the plenum chamber 3200 are molded from silicone rubber. In one example, the walls of the plenum chamber 3200 are constructed from silicone rubber having an A-type indentation hardness of about 35 to about 40 and a thickness in the range of about 2 mm to about 4 mm. In certain forms of the present technology, the plenum chamber 3200 may have different thicknesses in different regions.

[0174] 5.2.3.1 Sidewall area The sidewall region 157 may extend between the sealing region 151 and the attachment region 158. The sidewall region 157 may be generally conical. That is, the sidewall region may have a first diameter adjacent the attachment region 158 and a second diameter adjacent the sealing region 151, where the first diameter is smaller than the second diameter. The sidewall region may have a thickness of about 1.5-5 mm, such as about 1.5-3 mm, such as about 2 mm. Such a thickness may provide some support for the sealing region 151, may prevent the elbow assembly 120 from contacting the patient's nose, and may prevent the cushion from collapsing due to headgear tension in use.

[0175] The sidewall region 157 may connect with or have the headgear connectors 156 formed in it. Such a configuration may replace the need for a rigid frame or framework, as the headgear connectors are located in close proximity to the sealing region 151. The headgear connectors 156 may be located on both sides of the sidewall 157.

[0176] 5.2.3.2 Thin wall sections In one example, as best shown in Figures 3-16, 3-18, 3-23, and 3-30, the sidewall region 257 between the sealing region 251 and the attachment region 258 includes a region 268 adjacent the upper lip region 255 of the sealing region that includes a thickness less than the nasal ridge, the sides of the nose, and the corresponding thickness adjacent the corners of the nasal region of the sealing region. That is, the region 268 includes a thinner walled cross section adjacent the upper lip region 255 of the sealing region. Such a region 268 of thinner cross section reduces the force exerted by the sealing region along this portion of the upper lip region 255. For example, such a region 268 exerts less pressure along the upper lip region 255 than the corners 254 of the nasal region (i.e., is stiffer along the corners of the nasal region than the upper lip region, thereby creating or exerting a relatively greater pressure along the corners of the nasal region (along the corners of the lip adjacent the ala of the nose) to avoid excessive pressure acting on the columella or septum of the patient's nose, which are the more sensitive areas of the patient's nose.

[0177] 3-22-3-30 show exemplary cross-sections through various regions of the cushion assembly 250. For example, FIG. 3-23 is a cross-section through the nasal ridge region 252 and the upper lip region 255, showing the construction of only a single layer or membrane 260 in the nasal ridge region 252 and the construction of a double layer or membrane 260 and undercushion 265 in the upper lip region 255. FIG. 3-23 also shows a thin cross-section region 268 in the side wall region 257 adjacent the upper lip region 255 to avoid excessive pressure, for example, on the bridge of the nose or the septum. FIG. 3-23 also shows the attachment region 258 including a thin wall portion 258(1), for example, to allow for separation of tube resistance forces. FIG. 3-24 and FIG. 3-25 show the construction of only a single layer or membrane 260 on the side 253 of the nose region. 3-26 and 3-27 also show the construction of only a single layer or membrane 260 at the sides 253 of the nose region, as well as at least a portion of the wings or sealing flaps 270 protruding from the edges of the membrane 260. FIGS. 3-27 and 3-28 show at least a portion of the headgear connectors 256. FIGS. 3-29 and 3-30 show the construction of a dual layer or membrane 260 and undercushion 265 at the corners 254 of the nose region and at the upper lip region 255. FIG. 3-30 shows a thin section region 268 in the sidewall region 257 adjacent the upper lip region 255.

[0178] 5.2.4 Positioning and stabilization structure 3300 In one example, the seal-forming portion 3100 of the patient interface 3000 of the present technology is held in a sealing position by a positioning and stabilising structure 3300 during use.

[0179] In one form, the seal-forming portion 3100 of the patient interface 3000 of the present technology is held in a sealing position by a two-point connection to the positioning and stabilising structure 3300.

[0180] In one form, the positioning and stabilising structure 3300 connects to the plenum chamber 3200 via the headgear connector 156.

[0181] In one example, there are only two connectors 156 to the plenum chamber 3200 .

[0182] 5.2.4.1 Headgear Connector The headgear connector 156 may include a protrusion or interface 159 adapted to receive the cushion connector 116 on the headgear 110. A similar arrangement is disclosed in U.S. Patent Application Publication No. 2007 / 0139994, filed October 22, 2008, which is incorporated herein by reference in its entirety.

[0183] The headgear connectors 156 may be positioned at an angle relative to the vertical axis of the sealing area 151. As best shown in FIGS. 3-6 and 3-7, the headgear connectors 156 may be positioned at an angle α relative to the vertical axis of the sealing area 151. In one example, the angle α may be about 90-135°. In one example, the angle α may be about 90-120°. In one example, the angle α may be about 90-100°. The angle α aligns the headgear connectors to ensure sufficient sealing force between the cushion and the patient to provide a seal without causing discomfort or collapsing the cushion, especially at the sides 153 of the nose region of the sealing area 151 (e.g., the closer the angle α is to 180°, the more likely the cushion will collapse inward toward the vertical axis when headgear tension is applied, thus pinching the patient's nose).

[0184] In another example, as best shown in Figures 3-40-1, 3-40-3, 3-40-5, 3-40-6, 3-41-1, 3-41-5, 3-41-6, a hinged or thin-walled portion 356(1), 456(1) may be provided in each headgear connector 356, 456 to increase the flexibility of the headgear connector to allow sufficient bending in use, so that headgear tensions that would collapse the cushion inward are not transmitted, thereby avoiding, for example, pinching of the nose wings under headgear tension. Also, as shown in Figure 3-41-6, one or more wall portions 457(1) of sidewall regions 457 between prongs of the headgear connector may be thickened, for example, to prevent or reduce collapse of the sidewall regions under headgear tension.

[0185] The headgear connectors 156 may be positioned at an angle relative to the horizontal axis of the sealing area 151. As best shown in FIG. 3-9, the headgear connectors 156 may be positioned at an angle β relative to the horizontal axis of the sealing area 151. In one example, the angle β may be about 90-135°. In one example, the angle β may be about 90-120°. In one example, the angle β may be about 90-100°. The angle β aligns the headgear connectors so that the sealing force exerted by the headgear connectors 156 is distributed across the sealing area 151, where more force is exerted at the corners 154 of the upper lip area 155 and nose area, and less force is exerted at the nasal ridge area 152. Such a distribution may be more comfortable and stable.

[0186] As shown in FIG. 3-8, the headgear connector 156 has a first width w1 in a region adjacent to the side wall 157 and a second width w2 at its tip, in which the first width w1 is greater than the second width w2. In one example, the first width w1 may be about 15-50 mm. In one example, the first width w1 may be about 15-30 mm. In one example, the first width w1 may be about 20-25 mm. In one example, the second width w2 may be about 15-30 mm. In one example, the second width w2 may be about 15-25 mm. In one example, the second width w2 may be about 15-20 mm. The first width w1 allows the force applied by the headgear to be spread from the side 153 of the nose region to the corner 154 of the nose region and stabilizes the cushion in a horizontal plane. The second width w2 is set to reduce the apparent size of the headgear connector 156 and to enable connection with the cushion connector 116.

[0187] The headgear connectors 156 are preferably located proximate the sealing area 151. As shown in FIGS. 3-6, the headgear connectors 156 are positioned at a height H1 from the sealing area 151. In one example, the height H1 may be about 10-50 mm. In one example, the height H1 may be about 10-30 mm. In one example, the height H1 may be about 10-20 mm. In one example, the height H1 may be about 20-30 mm. This configuration allows headgear forces to be transferred directly to the seal and also allows the sealing area to cradle or conform to the shape of the patient's nose.

[0188] The location and size of the headgear connectors direct the sealing forces to the seal area in a way that negates or eliminates the need for forehead supports or vertical headgear straps. For example, the width of the headgear connectors adjacent the side walls stabilizes the seal area on the patient's face. The height of the headgear connectors 156 to the seal area 151 allows the headgear forces to be transferred directly to the seal area, thereby eliminating the need for additional stabilization from a forehead support.

[0189] In another form of the present technology, the headgear connectors 156 are formed separately from the plenum chamber.

[0190] 5.2.4.2 Headgear Assembly One form of positioning and stabilizing structure 3300 in accordance with the present technology is a headgear assembly 110. The headgear assembly 110 may be adapted to support, stabilize, and / or position a cushion assembly 150 on a patient's face.

[0191] As shown in Figs. 3-1-3-3, the headgear assembly 110 may include a pair of side straps 115 connected to a rear strap 118. The side straps 115 define a main headgear loop that may be positioned along the side of the patient's face across the patient's cheeks, and that extends between the patient's eyes and ears, e.g., overlying at least a portion of the cheekbone, toward the top of the patient's head where it overlies, e.g., a portion of the parietal bone. The side straps 115 may have a cushion connector 116 adapted to receive a headgear connector 156 of the cushion 150. The side straps 115 may have an adjustment portion 117, where the side straps 115 are linked or otherwise connected to one another and can be adjusted in length relative to one another. The rear straps 118 may extend between the side straps and loop through respective slots 114 provided in the side straps 115. The rear straps 118 define rear headgear loops that may be positioned over the back of the patient's head, for example, engaging along or below the occipital bone. In one example, a portion of the headgear rear straps 118 or rear headgear loops overlap or engage a point on the head below or below the occipital bone. For example, a portion of the straps sits on a portion of the trapezius muscle adjacent to the occipital bone in use. In one example, at least a portion of the rear straps 118 engage below or below the lower edge of the occipital bone, which edge helps to keep the rear straps in place and prevent them from sliding up the patient's head, for example, sliding upward. See FIG. 2i and FIG. 3-2 for the location of the trapezius muscle and an exemplary positioning of the rear straps 118 along a portion of the trapezius muscle. In one example, the headgear straps are sufficiently stretchy or flexible, for example, to enhance comfort and adjustability. For example, the headgear may not require length adjustment to wear.

[0192] In one form, the headgear assembly 110 comprises a silicone main section and a cloth rear section. In another form, the headgear assembly 110 comprises a cloth main section and a cloth rear section. In another form, the headgear assembly 110 comprises a silicone main section and a silicone rear section.

[0193] In one form, headgear assembly 110 is constructed and arranged to be substantially flexible.

[0194] In one form, the headgear assembly 110 includes main structural straps and rear structural straps.

[0195] An exemplary headgear assembly 110 is disclosed in US Pat. No. 6,399,434, filed Oct. 22, 2008, the entirety of which is incorporated herein by reference.

[0196] 5.2.5 Ventilation hole 3400 In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the exit of exhaled carbon dioxide.

[0197] One embodiment of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0198] In one example, the vent 3400 is positioned in the isolation structure 3500, such as a swivel 3510. Alternatively, the vent 3400 is positioned in the plenum chamber 3200.

[0199] One form of vent 3400 according to the present technology is the vent 126. The vent 126 may allow for the exhalation of exhaled gases from the nasal mask system. The vent 126 may comprise a series of holes, a mesh, or other configuration that allows gas to flow. In one example, the vent 126 may be sufficiently rigid to avoid collapse of the air channel that vents the exhaled gases. The vent 126 may be located in the elbow 125 or in other areas such as the air delivery tube assembly 130 or the cushion assembly 150 (including, for example, the sidewall 157).

[0200] In certain forms of the present technology, the vent 3400 may be constructed from a flexible or soft material supported by a frame that is sufficiently rigid to avoid collapse of the air channel through which exhaled gases escape.

[0201] In another form, the patient interface 3000 does not include a vent.

[0202] 5.2.6 Separation structure 3500 In one form, the patient interface 3000 includes at least one decoupling structure 3500, such as a swivel 3510 or a ball-and-socket 3520 (see, e.g., FIGS. 3-13). In one form, the decoupling structure 3500 may be formed, at least in part, by the attachment region 158.

[0203] 5.2.6.1 Mounting Area The attachment region 158 may be adapted to receive the elbow assembly 120. The attachment region 158 may include a wall portion 158(1) that is thinner than the sidewall region 157, for example, the attachment region 158 may have a wall portion of about 0.1-1 mm, such as about 0.2-0.8 mm, such as about 0.5 mm. In one example, the thin wall portion 158(1) is configured to separate tube resistance forces from sealing forces. At the open end or opening of the attachment region 158 is a lip portion 158(2) having a thickness of about 2 mm-3 mm. The lip portion 158(2) also reduces the diameter of the open end from about 26 mm-27 mm of the sidewall region 157 to about 18 mm-19 mm, which is about a 30% diameter reduction. The thickness and reduced diameter of the lip portion 158(2) aids in retention of the connector ring 128 of the elbow 125 by the cushion assembly 250.

[0204] 5.2.7 Connection port 3600 In one form, the connection port 3600 to the air circuit 4170 is formed by the elbow assembly 120 (see, for example, Figures 3-1 and 3-2).

[0205] 5.2.7.1 Elbow Assembly The elbow assembly 120 may be adapted to connect between the cushion assembly 150 and the air delivery assembly 130 or to serve as an interface between the cushion assembly 150 and the air delivery assembly 130. The elbow assembly 120 may be formed with the air delivery assembly 130 or the cushion assembly 150 or may be integral with the air delivery assembly 130 or the cushion assembly 150. The elbow assembly 120 may also be adapted to allow for the exhaustion of exhaled gases.

[0206] As shown in Figures 3-1-3 and 3-11-3-13, elbow assembly 120 may include elbow 125 having an air vent 126, connecting to or otherwise forming connector ring 128 on elbow. Elbow 125 may be formed with a ball joint and connector ring 128, and may be configured and arranged to allow rotation of the ball joint while ensuring a sufficient seal with elbow 125 to prevent air leakage from compromising patient treatment pressure. The ball joint provides a decoupling mechanism, for example, to separate tube resistance forces from sealing forces. In one embodiment, connector ring 128 may be releasably or removably detachable from elbow 125 by pulling connector ring 128 away from elbow 125 to facilitate thorough cleaning of all surfaces of connector ring 128 and elbow 125. The connector ring 128 has two raised edges 128(1), 128(2) extending outwardly from the outer circumferential surface at the distal end of the connector ring 128, a first raised edge or first flange on a first side of the ring adjacent the inner surface of the cushion assembly in use, and a second raised edge or second flange on a second side of the ring adjacent the outer surface of the cushion assembly in use. As shown in Figures 3-11 and 3-13, a channel 128(3) is defined between the two raised edges 128(1), 128(2), such channel 128(3) is adapted to sealingly engage a lip 158(2) defining an open end or opening of the attachment region 158. As shown in Figure 3-13, the elbow 125 has a first opening 125(1) and a second opening 125(2) for directing pressurized air through the elbow 125. Connector ring 128 is retained on elbow 125 at second opening 125(2) in elbow 125 and is free to rotate relative to elbow 125. As shown in FIGS. 3-13 , a partially spherical or curved inner circumferential surface 128(4) of connector ring 128 abuts a partially spherical outer circumferential surface 125(3) of elbow 125, thereby allowing relative tilting movement between connector ring 128 and elbow 125.In one example, the partially spherical surfaces of ring 128 and elbow 125 have approximately equal radii of curvature. As depicted in FIGURES 3-13, when the center of connector ring 128 and the center of second opening 125(2) of elbow 125 are aligned, first edge 128(1) of connector ring 128 is flush with edge 125(2)e of second opening 125(2) of elbow 125. That is, when the longitudinal axes of elbow 125 and ring 128 are collinear, the annular surface provided by edge 125(2)e of elbow 125 is flush with the annular surface provided by first edge 128(1) of ring 128. Although FIG. 3-13 shows the first edge 128(1) having approximately the same diameter as the second edge 128(2), it can be envisioned that the first edge 128(1) may have a larger diameter than the second edge 128(2) (see, for example, FIG. 3-120-5). This can minimize inadvertent removal of the elbow 125 from the cushion assembly 250 when the lip 158(2) of the attachment region 158 is retained within the channel 128(3) of the connector ring 128. When the lip 158(2) is engaged within the channel 128(3), the lips are locked in place and cannot freely rotate relative to one another due to surface friction.

[0207] The elbow 125 may be attached or otherwise connected to a swivel or swivel cuff 129 adapted to receive the air delivery tube assembly 130. The swivel 129 may be positioned such that it forms a seal with the elbow 125 or has low leakage with the elbow 125 while still being able to rotate freely relative to the elbow 125.

[0208] The swivel cuff 129 includes an annular engagement ring 129(1) that is received in an annular groove 125(4) of the elbow to rotatably connect the swivel cuff 129 to the elbow 125. The swivel cuff 129 also has a channel portion 129(2) defined on its outer periphery for matingly receiving a cuff or connector 135 provided on the air delivery tube assembly 130. The swivel cuff 129 and the cuff or connector of the air delivery tube assembly 130 are removably attachable to and detachable from one another.

[0209] 5.2.8 Frontal support In one example, the patient interface 3000 does not include a forehead support, although in one alternative, a forehead support may be included.

[0210] 5.2.9 Choking prevention In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0211] 5.2.10 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the space within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows direct measurement of gas properties within the plenum chamber 3200, such as pressure.

[0212] 5.2.11 Air Circuit 4170 An air circuit 4170 in accordance with one form of the present technology is an air delivery assembly 130. The air delivery assembly 130 may be configured to connect a flow generator to the mask system 100. As shown in FIGS. 3-1 to 3-3, the air delivery system 130 may include a tube 133 and a connector 135. The tube 133 may be relatively flexible. The connector 135 may be adapted to receive the swivel 129 of the elbow assembly 120.

[0213] 5.2.12 Donning and Removal The nasal mask system forms a small, unobtrusive mask system that is easy to don, easy to remove, stable, comfortable, effective, provides a wide range of fit, is unobtrusive, easy to use, and adjustable. The nasal mask system also does not suffer from the problems of blowing and the possible discomfort associated with nasal cannulae or nasal pillows that are intended to at least partially stretch the patient's nose, and comprises a non-nasal cannulae or non-nasal pillows configuration (i.e., the nasal mask system forms a nose-shaped cushion with a single orifice that is intended to surround both nostrils when in use). The nasal mask system is structured such that little or no adjustment is required to fit the nasal mask system to the patient's head. In one example, a forehead support is not provided with the mask system, but a forehead support can be provided if desired.

[0214] In the illustrated example, the nasal mask system 100 has a two-point connection with the cushion, i.e., two side straps 115 of the headgear assembly engage with respective headgear connectors 156 on the sides of the cushion 150 (see, e.g., Figs. 3-1 to 3-3). The headgear assembly has three adjustment points, e.g., an adjustment 117 on the side straps 115 and an adjustment feature on each end of the rear strap 118 using respective slots 114 on the side straps 115. However, it will be appreciated that more or less adjustment points may be provided, e.g., the side straps and rear straps may be of a non-adjustable length.

[0215] In one example, the two-point connection does not require clip engagement or disengagement to don or remove the mask system, i.e., no clips are provided on the mask system, but clips could be provided if desired. Also, as described below, the main headgear loops defined by the side straps 115 extend from a lower, forward position to an upper, rearward position, thereby avoiding any headgear straps extending below the ears (i.e., the straps do not pass under the patient's ears).

[0216] Figures 3-31 to 3-34 provide a series of views to illustrate an exemplary method for fitting a nasal mask system to a patient, for example, prior to the application of air pressure to the plenum chamber. As shown in Figure 3-31, the patient may grasp the nasal mask system such that one hand holds the cushion assembly 150 in a manner that faces the seal area towards the patient's face and the other hand holds the rear strap 118 in a manner that allows the primary headgear loop defined by the side straps 115 to receive the patient's head. The cushion assembly is then engaged with the patient's face and the rear strap is held over the patient's head so that the patient's head passes through the primary headgear loop, as shown in Figure 3-32. The rear strap, together with the side straps attached thereto, may be pulled over the patient's head until the rear strap is positioned along the back of the patient's head as shown in Figure 3-33. That is, the strap is rotated or pivoted around the cushion assembly onto the patient's head until it engages and positions itself with the patient's head. Finally, as shown in FIG. 3-34, the ends of the rear straps 118 and / or the adjustments 117 on the side straps may be adjusted as needed to secure the nasal mask system on the patient's head.

[0217] This arrangement is easy to don and remove as there is no need to pull straps down over the ears to don the mask system or pull straps up over the ears to remove the mask system, i.e. the headgear straps slide easily over the patient's head like a hat, i.e. the mask system includes headgear that can be donned and removed like a hat without interfering with the patient's ears.

[0218] In use, the side straps 115 are arranged to pull the nasal mask system in an upper and rearward direction (e.g., as shown by arrow a1 in FIG. 3-34), which creates little compressive force along the nasal ridge region of the cushion assembly 150. This is beneficial because such region is along the more sensitive area of ​​the patient's nose, i.e., along the nasal cartilage (not the bone) as previously described. Masks with nasal cushions typically include a headgear arrangement arranged to pull the mask along a direction generally parallel to the Frankfort Horizontal (as shown by arrow a2 in FIG. 3-34) to create a compressive sealing force generally perpendicular to the patient's face. To create such force, the headgear arrangement includes straps that extend under the patient's ears to create such force along the Frankfort Horizontal. In a mask system according to one example of the present technology, the headgear assembly is arranged to pull the mask along the upper rear direction, for example like an "under the nose" mask (e.g., a pillow or cradle), which creates little compressive force along the nasal ridge region while maintaining an adequate seal as described above. Thus, the nasal mask system provides an effective seal vector similar to that of an "under the nose" mask (i.e., not parallel to the Frankfort Horizontal Plane), but instead comprises a headgear used for a mask that covers part of the nose. That is, the nasal mask system compromises the seal force strictly along the Frankfort Horizontal Plane for an over-the-ear headgear configuration to facilitate donning.

[0219] 5.2.13 Plenum chamber rotation adjustment FIG. 3-9 shows the vertical distance h3 between the headgear connection point hp, i.e., the line of headgear tension where the headgear connects to the cushion assembly 150, and the pivot point or axis of rotation pp of the cushion assembly 150 on the face, i.e., on the upper lip. This vertical distance h3 allows adjustment of the headgear tension to provide rotational or pivotal adjustment of the plenum chamber / cushion assembly about the pivot point pp. As shown, the headgear connection point hp is above the pivot point pp or the contact point of the cushion assembly with the upper lip. This configuration allows the user to rotate / pivot the cushion assembly by adjusting the headgear tension as well as accommodate different nasal ridge shapes using only a two-point headgear connection. In one example, increasing the vertical distance h3 increases the moment.

[0220] Another example of an elbow assembly 3-42 through 3-111 show an elbow assembly in accordance with another example of the present technology. Of course, such an elbow assembly may be adapted for use with the types of patient interfaces previously described. However, aspects of the present technology may also be adapted for use with other suitable interface types, such as nasal cannulas.

[0221] Swivel Elbow Connector Assembly - Vented Connector or Ring 3-42 to 3-45, a swivel elbow connector assembly 610 according to an example of the present technology includes a vented elbow connector or ring 620 and a swivel elbow 640. A sleeve 630 is provided between the vented elbow ring 620 and the swivel elbow 640. The sleeve 630 is provided between a first end of the swivel elbow 640 and the vented elbow ring 620. A swivel cuff 650 is provided at a second end of the swivel elbow 640 opposite the first end. The swivel cuff 650 includes a swivel cuff annular engagement ring 651 that is received in annular groove 643 of the swivel elbow 640 such that the swivel cuff 650 can rotate or pivot relative to the swivel elbow 640. In one embodiment, the swivel cuff annular engagement ring 651 and the connector ring 620 are formed from nylon and the elbow 640 is formed from polypropylene.

[0222] The connector ring 620 and the swivel cuff annular engagement ring 651 are inserted into an elbow mold. The elbow 640 is then molded with the molded connector ring 620 and the molded swivel cuff annular engagement ring 651 already in the elbow mold. Because the connector ring 620 and the swivel cuff annular engagement ring 651 are formed from nylon, the melting temperature of these rings is higher than the polypropylene molding temperature, and therefore these rings do not undergo plastic deformation when the elbow 640, which is formed from polypropylene, is molded. This process allows for a precise snug fit between these three components 620, 651, 640, thereby addressing the issue of uncontrolled leakage at the connection points that has traditionally been an issue. This process also eliminates at least one post-molding assembly step that is typically required when attaching multiple plastic parts together. That is, the rings 620 and 651 are insert molded into the elbow mold at approximately the same time. The second end of the swivel elbow 640 also includes a tapered flange 644 that is received in an annular groove 652 of the swivel cuff 650 to secure the swivel elbow 640 to the swivel cuff 650. The swivel elbow 640 also includes an end 653 that is configured to be connected to an air delivery hose or conduit configured to deliver a flow of breathable gas generated by a flow generator or blower.

[0223] Referring to FIG. 3-43, the vented elbow ring 620 includes an inner flange 622 and an outer flange 623. A patient interface structure of a patient interface system, such as a cushion 605, may fit within a channel 624 of the vented elbow ring 620 defined by the flanges 622, 623. The cushion 605 may be a nasal cushion, a full face cushion, or a nasal pillow or cannula cushion. The patient interface system may also include, for example, a support structure or frame that supports the cushion 605, a tube, conduit, or hose configured to deliver a flow of breathable gas to the cushion, and / or a patient interface positioning and stabilization system (e.g., headgear). It will also be appreciated that the vented elbow ring 620 may be mounted to, for example, a support structure or frame.

[0224] 3-72, a cushion 650 that can be used with the swivel elbow connector assembly 610 may include a sealing portion 6950 having an upper lip engaging portion 6962 supported by a support portion 6953. The sealing portion 6950 is spaced from the support portion 6953 by a front gap in the region of the nose tip engaging portion 6952. The nose tip engaging portion 6952 is flexible and can extend downward when contacted by the patient's nose, but is limited in the distance it can extend once it reaches the support portion 6953. The nose tip engaging portion 6952 extends in length from an opening 6955 to accommodate different sized nose tips such that different patients' nose tips can engage the nose tip engaging portion at different locations. A stem 6954 supports the support portion 6953 and the sealing portion 6950. The cushion 605 is disclosed, for example, in U.S. Pat. No. 6,399,433, the entire contents of which are incorporated herein by reference. However, it will be appreciated that the swivel elbow connector assembly disclosed herein may be used with other patient interface structures or systems, such as cushions, for example those disclosed in U.S. Patent No. 5,399,623 or U.S. Patent No. 5,399,623, the entire contents of each of which are incorporated herein by reference.

[0225] The stem 6954 may receive the vented elbow ring 620. The vented elbow ring 620 may be inserted into an opening in the cushion 605 such that the stem 6954 is sealingly positioned in the channel 624 between the flanges 622, 623. The seal portion 6950, the stem 6954, and the support portion 6953 may be a flexible material such as a liquid silicone rubber material or other elastomeric material, such as TPE, gel, or foam. The stem 6954 and the support portion 6953 may be formed together, for example, in a mold, or the seal portion 6950 may be formed separately and then joined together, for example, by gluing. Alternatively, the stem 6954 and the support portion 6953 may be formed together, for example, in a mold, and then the seal portion 6950 may be bonded to the support portion 6953 and the stem 6954 in the mold.

[0226] The cushion 605 may include a flexible gusset 6965, which may include a support 6953 and a stem 6954. The support 6953 and the stem 6954 may be formed as a single, integral element. The flexible gusset 6965 may be constructed from silicone having a hardness of about 20-90 Shore A, preferably about 40 Shore A. The flexible gusset 6965 may also be formed from polycarbonate, polypropylene, nylon, thermoplastic elastomers (TPE), Hytrel®, and the like.

[0227] Referring again to Figures 3-42-3-44, the vented elbow ring 620 includes a plurality of vent slots 625 extending through the inner flange 622, across the channel 624, and through the outer flange 623. As shown in Figure 3-43, the sleeve 630 includes a sleeve flange 631 disposed between the flange 641 of the swivel elbow 640 and the flange 623 of the vented elbow ring 620. As shown in Figure 3-42, the connection of the sleeve 630 between the swivel elbow 640 and the vented elbow ring 620 provides a plurality of vent holes 621 for venting of exhaled gases from the interior of the cushion 605 through the vent slots 625 to the exterior of the cushion 605.

[0228] In one example of the present technology, the vent shape may be such that it has a larger cross section (e.g. circular) on or inwards (at the air inlet) compared to a smaller outer cross section (e.g. diameter) where the air exits to the atmosphere, and the exit point or area may be curved, e.g. to diffuse the air non-perpendicularly away from the bedmate / bed fabric.

[0229] To help reduce / ensure lower noise when venting along a swivel effectively increases the overall length of the vent, a smooth transition may be provided in the vent passageway, allowing laminar flow to develop, resulting in less noise.

[0230] A first end of the swivel elbow 640 includes a tapered flange 642 that engages the annular surface 632 of the sleeve 630. A cylindrical portion 633 of the sleeve 630 extends between the sleeve flange 631 and the tapered flange 642 of the swivel elbow 640. Although the tapered flange 642 may permanently assemble the sleeve 630 within the swivel elbow 640 as shown in FIG. 3-43, it will be appreciated that the sleeve 630 may be conformally molded with, co-molded with, or otherwise formed into the sleeve 630 to reduce assembly costs.

[0231] 3-42, the swivel elbow connector assembly 610 may be provided with a plurality of vents 621, for example 20-60 vents, for example 30-50 vents, for example 38 vents, 40 vents, or 42 vents. The cross-sectional area of ​​the vents may vary, for example, from 0.5 mm×0.5 mm, for example 1.0 mm×1.0 mm, or 0.7 mm×0.7 mm.

[0232] The sleeve flange 631 and the flange 641 of the swivel elbow 640 may be angled to provide ventilation of exhaled gases from within the cushion 605 in a direction away from the patient's face 360° around the swivel elbow 640. The sleeve 630 provides good diffusion and also includes a ventilation path that is easily adjustable. The formation of the ventilation hole 621 by the sleeve 630 also reduces ventilation noise from within the cushion 605.

[0233] Although the vented elbow ring 620 is shown as circular in Figs. 3-42 through 3-45, it will be appreciated that the vented elbow ring may also be elliptical in cross section, for example, as shown in Figs. 3-76 and 3-77.

[0234] Swivel Elbow Connector Assembly - Vented Elbow 3-73 to 3-78, another example swivel elbow and connector assembly 6120 includes a swivel elbow 6140 and a connector or ring 6150. A cushion 6130 includes a flexible base 6133 with an opening for sealingly receiving the ring 6150. The flexible base may include a flange or stem 6138 configured to be received within a channel 6154 of the ring 6150 defined between an inner flange 6152 and an outer flange 6153. The cushion 6130 may include a nasal pillow 6131 for sealingly engaging with the patient's or user's nares and a connector 6132 for connecting the cushion 6130 to a patient interface structure positioning and stabilization system (e.g., headgear). The cushion 6130 may be, for example, as disclosed in U.S. Patent Application Publication No. 2009 / 013399, the entire contents of which are incorporated herein by reference. Of course, other cushions or patient interface structures may be used with the assembly 6120, including rigid or semi-rigid patient interface support structures (eg, frames).

[0235] The elbow 6140 includes a first end 6143 configured for connection to, for example, a delivery hose or conduit. The elbow includes a tapered flange 6142 at a second end for securing the elbow 6140 to a ring 6150. The elbow 6140 includes an angled flange 6141 intermediate the first and second ends, the angled flange having a plurality of vent holes 6145 spaced around the circumference of the flange 6141. The flange 6141 is angled relative to the longitudinal axis of the elbow 6140. The number and size of the vent holes may be similar to those previously described. It will also be appreciated that the vent holes 6145 may be uniformly or irregularly distributed around the circumference of the angled flange 6141. It will also be appreciated that the vent holes 6145 may not extend around the entire circumference of the angled flange 6141 of the elbow 6140, for example as shown in FIG. 3-76.

[0236] Surrounding the angled flange 6141 may be a radial flange 6146 that engages with an outer flange 6153 of the ring 6150. The ring 6150 is secured between the tapered flange 6142 and the radial flange 6146. The elbow 6140 may further comprise a baffle 6144 to separate the vent 6147 from the breathable gas entering from the first end 6143, although the baffle may be circular or have other shapes as well.

[0237] 3-76-3-78, the ring 6150 may have an elliptical configuration (e.g., elliptical cross section). A circular radial flange 6155 may be provided on the ring 6150 to form a sealing interface with the radial flange 6146 of the elbow 6140. As also shown in FIG. 3-76, the vent holes 6145 may not be provided around the entire circumference of the elbow, for example, the lower portion 6159 of the angled flange 6141 may include the vent holes 6145 and / or the angled flange 6141 may have reinforcement portions 6157 between the vent holes 6145. As shown in FIG. 3-78, the baffle 6144 of the elbow 6140 also has an elliptical configuration providing a vented portion 6147 and a non-vented portion 6149 for the elbow 6140.

[0238] Double Swivel Elbow Connector Assembly - Vented Connector or Ring 3-46-3-57, an example double swivel elbow connector assembly 660 includes a ball and socket connection, i.e., a ball joint vented elbow ring 670, a ball joint swivel elbow 680 pivotally connected to the ball joint vented elbow ring 670, and a swivel cuff 690 pivotally connected to the ball joint swivel elbow 680. The ball joint vented elbow ring 670 includes a plurality of vent slots 671 extending around the circumference of the elbow ring 670. As shown in FIG. 3-48, the slots 671 extend through an inner flange 673 of the elbow ring 670 and an outer flange 674 of the elbow ring 670. A cushion 605 having an opening may be received in a channel 675 between the inner flange 673 and the outer flange 674. When the elbow ring 670 is positioned within the opening in the cushion 605, a vent hole is formed between the vent slot 671 of the elbow ring 670 and the cushion 605. The cushion 605 is secured to the double swivel elbow connector assembly 660 when the stem 6454 of the cushion is received within the channel 675 of the vented elbow ring 670. As used herein, the term "sealingly secured" means that the flow of breathable gas delivered through the swivel elbow to the patient interface system, e.g., the cushion, does not pass from the interior to the exterior of the patient interface system through the vent hole in the absence of exhalation by the patient or wearer of the patient interface system.

[0239] Referring to FIG. 3-47, the vented elbow ring 670 includes an annular surface 672 that may be flush with or coincide with an annular surface 681 of the ball joint swivel elbow 680 when the double swivel elbow connector assembly 660 is in the position or configuration shown in FIG. 3-46-3-48, i.e., with the elbow facing generally downward. As shown in FIG. 3-51, the ball joint swivel elbow 680 includes an arcuate annular or partially spherical outer surface 682 that is pivotally received by an arcuate annular or partially spherical inner surface 676 of the vented elbow ring 670. Thus, the vented elbow ring 670 and the ball joint swivel elbow 680 serve as a ball joint connection between the vented elbow ring 670 and the swivel elbow 680. The inner surface 676 and the outer surface 682 have approximately equal radii of curvature. The approximately equal radii of curvature may be achieved by molding the vented elbow ring 670 and the swivel elbow 680 together in a mold without the vented elbow ring 670 and the swivel elbow 680 being mechanically or chemically bonded together, for example by sink marks. The inner surface 676 and the outer surface 682 are engaged over substantially the entire contact area between these surfaces such that there is little or no gas flow between the ring 670 and the elbow 680.

[0240] The swivel elbow 680 may pivot from the position shown in FIG. 3-53, where the annular surface 681 is flush with the annular surface 672 of the vented elbow ring 670 and the longitudinal axis of the ring 670 and the longitudinal axis of the elbow 680 are collinear, to the position shown in FIG. 3-54, FIG. 3-56, and FIG. 3-57, where the annular surfaces 672, 681 are not flush and the longitudinal axes are at an angle to one another. As shown in FIG. 3-54, FIG. 3-56, and FIG. 3-57, the annular interface 685 between the arcuate annular outer surface 682 of the swivel elbow 680 and the end of the swivel elbow 680 limits the pivoting of the elbow 680 within the vented elbow ring 670.

[0241] 3-51-3-57, the end of the swivel elbow 680 includes an annular groove 683 that receives a tapered annular engagement ring 691 of the swivel cuff 690. A tapered flange 684 of the swivel elbow 680 engages the tapered annular engagement ring 691 of the swivel cuff 690 to retain the swivel cuff 690 against the swivel elbow 680. As shown in FIGS. 3-53 and 3-54, the swivel cuff 690 includes an angled groove 692 that allows the swivel cuff 690 to rotate from the position shown in FIG. 3-53 to the position shown in FIG. 3-54.

[0242] 3-50 and 3-55, rotation of the swivel cuff 690 allows the longitudinal axis of the double swivel elbow connector assembly 660 to rotate through an angle α of, for example, 40-60°, such as 50°.

[0243] The double swivel elbow connector assembly 660 allows for the pivoting of the connection of the air delivery tube or conduit to the swivel cuff end 693 in two directions. For example, as shown in Figures 3-48 and 3-49, the swivel cuff 690 may be pivoted from the position shown in Figure 3-48 to the position shown in Figure 3-49 while the swivel elbow 680 remains in place such that the annular surface 681 of the swivel elbow is flush with the annular surface 672 of the vented elbow ring 670. The transition from the configuration shown in Figure 3-48 to the configuration shown in Figure 3-49 is shown in Figure 3-50 as the central axis of the swivel cuff 690 rotates through an angle α of, for example, 50°. Pivoting the cuff 690 from the position shown in FIG. 3-48 to the position shown in FIG. 3-49 allows the short air delivery tube or conduit to be straightened, thereby reducing the torque force applied to the vented elbow ring 670 and cushion 605. In other masks without this swivel, if the tube is pulled in a direction perpendicular to the central axis of the elbow, the elbow cannot rotate to align with the tube because the elbow has an L-shaped configuration and does not have a swivel, and therefore the pulling force is applied directly to the mask, which may compromise the seal. The ball joint (or ball and socket connection) structure allows the elbow and swivel to realign in response to the force being exerted by the tube.

[0244] The double swivel elbow connector assembly 660 also allows the swivel elbow 680 to pivot relative to the vented elbow ring 670, for example, from the position shown in FIG. 3-54 to the position shown in FIG. 3-56. The rotation or pivoting of the swivel elbow 680 is limited by an annular joint 685 between the arcuate annular outer surface 682 of the swivel elbow 680 and the end of the swivel elbow 680. The swivel elbow 680 may also pivot from the position shown in FIG. 3-54 to the position shown in FIG. 3-57 while the swivel cuff 690 rotates or pivots relative to the swivel elbow 680.

[0245] Triple Swivel Elbow Connector Assembly - Vented Connector or Ring 3-58-3-71, another example triple swivel elbow connector assembly 660 includes a second swivel cuff 6100 pivotally connected to an end of a swivel cuff 690. The second swivel cuff 6100 includes a tapered annular engagement ring 6101 that is received in an annular groove 695 at an end of the swivel cuff 690. A tapered flange 694 is provided at an end of the swivel cuff 690 to engage and retain the annular engagement ring 6101 of the second swivel cuff 6100. The second swivel cuff 6100 includes an annular groove 6102 that receives the tapered flange 694 of the swivel cuff 690. The second swivel cuff 6100 includes an end 6103 configured to receive an air delivery tube or conduit to receive a flow of breathable gas supplied by a flow generator or blower for delivery to a patient interface including the cushion 605.

[0246] The swivel cuff 690 and swivel elbow 680 of the example shown in Figures 3-58-3-71 can swivel in the same manner as described with respect to the example disclosed in Figures 3-46-3-57. As shown in Figures 3-62 and 3-66, rotation of the swivel cuff 690 can cause the longitudinal axis of the triple swivel elbow connector assembly 660 to rotate through an angle β of, for example, 40-60°, for example, 50°. The second swivel cuff 6100 is shown as including an annular groove 6102 that receives the tapered flange 694 of the swivel cuff 690, although it will be appreciated that the second swivel cuff 6100 may be provided with an angled groove similar to the angled groove 692 of the first swivel cuff 690 to enable the second swivel cuff 6100 to pivot through an angle similar to the manner in which the swivel cuff 690 pivots relative to the swivel elbow 680.

[0247] Swivel Elbow & Anti-Asphyxiation Valve Assembly 3-79-3-88, a swivel elbow and anti-asphyxia valve assembly 6300 according to an example of the present technology may be provided with a diffusion vent. The assembly may include an engagement portion, such as a button or actuator, for engaging and disengaging the assembly 6300 from a patient interface, such as a mask. The assembly 6300 may be formed as a single piece. This configuration is beneficial because it avoids the patient from disassembling components (thereby preventing potential loss or misalignment upon reassembly), reduces component cost, and allows the anti-asphyxia valve to be positioned such that it cannot be tampered with or accidentally removed.

[0248] As shown in Figs. 3-79-3-82, the assembly 6300 may comprise a first elbow component, base molding, collar, or skeleton 6200. The skeleton 6200 may form a base structure of the assembly 6300 to support the assembly in an open or patient position. As shown in Fig. 3-79, the skeleton 6200 may include a vent hole 6230 adapted to allow exhaust gases to escape from the patient interface as in the examples previously described. As shown in Fig. 3-82, the skeleton 6200 may further comprise a baffle 6260 adapted to separate inlet gases from outlet gases within the assembly 6300 as in the examples previously described.

[0249] The skeleton 6200 may also include a first connection region 6245 with an engagement tab 6240, for example, for mating or connecting with a patient interface. The first connection region 6245 may be generally arcuate or define a first arcuate region when viewed from the front. The skeleton 6200 may also include a second connection region 6250, for example, for mating or connecting with a tube or swivel. The skeleton 6200 may further include a stop 6255 for positioning the assembly 6300, for example, with respect to a mask to prevent the assembly 6300 from moving through the connection with the mask or for preventing insertion of the assembly 6300 into the mask.

[0250] The skeleton 6200 may be formed from a relatively hard or rigid material so that the structure can remain open to allow gas flow. A stiffer material can minimize noise of air exiting the vent. The skeleton 6200 may be formed from, for example, polycarbonate, polypropylene, or nylon. A stiff material may also help maintain the assembly 6300 in an open position under certain loads, such as with a patient positioned on the assembly. A stiff material may also make it easier for a user to connect and disconnect the mask, tube, and / or swivel.

[0251] As shown in FIG. 3-80, the skeleton 6200 may further comprise a support, arm or interconnection region 6290 adapted to connect the first connection region 6245 and the second connection region 6250. The support 6290 may form a boundary between the first opening 6210 and the second opening 6220. The support 6290 may be flexible and resilient. That is, the support 6290 may return to their original shape after deformation. The first opening 6210 may be structured and arranged to receive an anti-asphyxiation valve or other valve. The second opening 6220 may be structured and arranged to receive a flexible member or web. As shown in FIG. 3-81, the second opening 6220 may extend to an opening, gap or relief 6280 in the first connection region 6245.

[0252] Referring to FIG. 3-80, the vent holes 6230 may be located on a generally circular or rounded surface 6235 to better diffuse the outflow airflow. The surface 6235 may be tapered to prevent moisture buildup on the elbow. This may result in a vent whistle, i.e., air exiting the vent resulting in a high-pitched whistling noise. The vent holes 6230 may be interspersed around the surface 6235 to diffuse the airflow. Of course, the vent holes 6230 may be evenly spaced around the surface 6235 or may be provided in a manner other than that described herein.

[0253] The skeleton 6200 may further include a second support or stopper 6270 adapted to receive a button or other engagement feature. The second support 6270 may be adapted to transfer forces from an engagement feature or feature, such as a button, to the skeleton 6200. The second support 6270 may also reinforce or form a base for an engagement feature or feature, such as a button, so that when the button is pressed, it does not collapse, but rather the button transfers the force to the skeleton 6200. The second support 6270 may be an alignment feature for aligning the skeleton 6200 in a tool or mold. The second support 6270 may form a surface against which a second component, such as an outer jacket, is abutted or formed.

[0254] The scaffold 6200 may be overmolded or otherwise formed with a second component (referred to as a flexible or deformable portion) 6335, such as an assembly overmolding. For example, the scaffold 6200 may be molded in a first tool and then transferred to a second tool for overmolding with the second component 6335, or all of this can be done in one tool. That is, the second component 6335 may be chemically, mechanically, or otherwise formed to the scaffold 6200. The second component 6335 may be formed from a relatively flexible material, such as a thermoplastic elastomer (TPE), silicone, gel, or other material.

[0255] The second component 6335 may include an engagement portion 6320, a flexible member or web 6330, a lip 6315, and a valve member 6310. The engagement portion 6320 may be, for example, a button, grip, tab, or other configuration adapted to receive a pressing force or other movement from a patient or clinician. The engagement portion 6320 may be supported and / or reinforced by the second support 6270. The engagement portions 6320 may press toward each other when pressed, thereby moving the first support 6290 inward. At this time, the first support 6290 may deform the first connection region 6245 from a first rest position (e.g., circular) to a second pressed position (e.g., egg-shaped or elliptical). The gap or relief 6280 may be adapted to allow bending of the first connection region 6245. This shape change may move the engagement tab 6240 from a first engaged position to a second disengaged position. The gap or relief 6280 may form a second arcuate region such that when combined with the first arcuate region of the first connection region 6245, the two components form a circle, and thus a cylinder.

[0256] The flexible member or web 6330 may be connected to the engagement portion 6320 and may seal the second opening 6220. The flexible member 6330 may be comprised of a membrane or other easily deformable shape such that the flexible member 6330 can buckle or bend when the engagement portion 6320 is pressed.

[0257] The lip 6315 may be formed near and positioned about the periphery of the first opening 6210. The lip 6315 may be adapted to prevent objects from entering the first opening 6210. The lip 6315 may also serve as a blank off for molding the elbow assembly 6300.

[0258] The valve member 6310 may be positioned within the body of the elbow assembly 6300, i.e., between the first supports 6290, as shown in FIG. 3-87. The valve member 6310 may act as an anti-asphyxiation valve. That is, when air is delivered from the second connection area 6250 to the first connection area 6245, the valve member 6310 may move to a first position (not shown) to block the first opening 6210, and when no air is delivered from the second connection area 6250 to the first connection area 6245, the valve member 6310 may move to a second position (FIG. 3-87) not blocking the first opening 6210, thereby allowing the patient to receive air from the atmosphere through the first opening 6210. The valve member 6310 may be a flap. The second component 6335 may be integrally formed with the valve member 6310, for example, by a living hinge attached to a lip. Of course, the valve member 6310 may be formed separately from and attached to the second component 6335. The valve member 6310 may be larger than the first opening 6210 such that it blocks the first opening 6210 when air is delivered from the second connection region 6250 to the first connection region 6245.

[0259] The valve member 6310, lip 6315, engagement portion 6320, and flexible member 6330 may be integrally formed from the same material, or one or more of these components may be formed separately and / or from different materials.

[0260] In further examples of the present technology, as shown, for example, in Figs. 3-109A-3-111, the elbow 6800 may be formed or constructed in a multi-step process, for example a three-step process, to obtain a single component with multiple functions. The elbow 6800 may include a skeleton or frame 6805, for example constructed of a rigid or semi-rigid material and adapted to communicate airflow from an air delivery tube to the mask. The skeleton 6805 may be initially formed or molded within the device. The skeleton 6805 may be constructed of polymers such as polypropylene, polycarbonate, and nylon.

[0261] The elbow 6800 may further comprise an AAV (anti-asphyxiation valve) 6810 having a flap 6812 adapted to provide the patient with access to atmospheric gases in the event that the flow generator is unable to deliver air to the mask. The AAV 6810 may be formed or molded into the scaffold 6805 or may be assembled to the scaffold 6805 after being formed or molded. For example, as shown in Figures 3-109A-3-109D, the AAV 6810 may be pulled through an opening 6815 in the scaffold after being molded. A pull tab 6820 on the AAV may allow the AAV 6810 to be pulled through the opening 6815 to position, hold and / or seal the AAV to the scaffold. The pull tab 6820 may be a sacrificial component that, once utilized (e.g., pulled through an opening), may be cut (so that the outer surface 6810.2 of the outer flange 6810.1 is approximately flush with the elbow surface) as shown in FIG. 3-110A or otherwise removed (e.g., once the inner flange 6825 is pulled and secured against the inner surface of the scaffold, further applied force tears the pull tab away from the AAV, possibly aided by a perforation between the pull tab and the outer flange 6810.1). Alternatively, the AAV 6810 may be molded into an opening 6815 extending through the scaffold 6805 without the need for a pull tab 6820. The AAV 6810 may include an inner flange 6825 to seal the AAV 6810 against the inner wall 6830 of the scaffold 6805.

[0262] The elbow 6800 may include a flexible component 6832 (FIG. 3-110A) adapted to secure the AAV 6810 in place and / or form one or more release buttons 6835 of the elbow 6800. For example, the flexible component 6832 may be silicone or TPE molded over the backbone 6805 to form an outer portion of the release button 6835, thereby allowing the release button 6835 to flex, and may also be molded over the AAV 6810 at the opening 6830 to seal and hold the AAV 6810 in place relative to the backbone 6805.

[0263] The above arrangement may have one or more of the following advantages.

[0264] 1. The AAV is sealed in place and cannot be removed from the elbow, thereby preventing the patient from accidentally disassembling the AAV and therefore compromising the device.

[0265] 2. Flexible components can be molded in one shot. If the flexible components were not all over the AAV, they could be molded into each side of the elbow at each button. Because the flexible components are molded in one shot, it is more efficient and the equipment is less expensive.

[0266] 3. It makes your elbows visually more prominent.

[0267] Swivel elbow connector assembly with cushion Referring to FIG. 3-89, a patient interface system 6400 for delivering a flow of breathable gas to a patient may include a swivel elbow 6410, a swivel or ring or connector 6420, and a cushion 6430 for sealingly engaging the patient's airway. The illustrated cushion 6430 includes a nasal pillow or nasal cannula or puff, although it will be appreciated that other cushions may be provided, such as a nasal cushion or a full face cushion. The swivel 6420 may be removably attached to the cushion 6430 by a bayonet type connection 6440 including a detent 6421 on the swivel 6420 for engaging a tab 6431 on the cushion 6430. An air vent 6411 is provided between the elbow 6410 and the swivel 6420. The air vent 6411 may include a slot provided on the elbow surface to form an air gap between the elbow 6410 and the swivel 6420. Of course, the slots may be provided in the swivel instead of the elbow, or slots may be provided in both the elbow and the swivel.

[0268] 3-90 to 3-92 for another example, a patient interface system 6450 may include a swivel elbow 6460, a swivel or ring or connector 6470, and a cushion 6490. The swivel 6470 may be connected to a ring 6480 that is attached to the cushion 6490 at 6481. The ring 6480 may be permanently or removably attached to the cushion 6490. For example, the cushion 6490 may be overmolded onto the ring 6480, or the cushion 6490 and ring 6480 may be attached by an adhesive. As another example, the cushion 6490 and ring 6480 may be press fit together.

[0269] The elbow 6460 may be removably attached to the swivel 6470, or the elbow may be permanently attached to the swivel 6470. The elbow 6460 may have a flexible button 6462 disposed between grooves 6463 formed in the elbow 6460. The button 6462 may be pressed or bent to connect and disconnect the elbow 6460 from the swivel 6470.

[0270] An air vent 6461 is provided between the elbow 6460 and the swivel 6470. The air vent 6461 may include a slot provided on the elbow surface to provide an air gap between the elbow 6460 and the swivel 6470. Of course, the slot may be provided in the swivel instead of the elbow, or the slot may be provided in both the elbow and the swivel.

[0271] Referring to FIG. 3-93, another example patient interface system 6500 may include a swivel elbow 6510, a swivel or ring or connector 6520, and a cushion 6530. The cushion 6530 may be permanently or removably connected to the swivel 6250 at 6521. The elbow 6510 may be press-fitted into the swivel 6520 and may be releasable by pressing a button 6512 provided between the grooves 6513, as well as the grooves 6463. The grooves 6463 are formed airtight by being a thin area of ​​material or overmolded with a second material (e.g., TPE, silicone). The elbow 6510 may further include a slot 6511 for venting exhaled gases and a baffle 6514 for reducing noise and increasing exhaust gas outflow.

[0272] 3-94 and 3-95, an elbow 6550 according to an example of the present technology may include a slot 6551 for venting exhaled gases and a baffle 6554 for reducing noise and increasing exhaust gas outflow. An opening 6552 may be provided in the elbow 6550 to allow the patient to breathe when the flow of breathing gas is obstructed or stopped. An AAV flap 6555 is provided to close the opening 6552 when the flow of breathing gas is in the elbow 6550 (i.e., the flow of breathing gas urges the flap 6555 to a closed position over the opening 6552). As shown in FIG. 3-94 and 3-95, the AAV flap 6555 is in an open position. To improve airflow noise and prevent the slot 6551 from being blocked, the elbow 6550 may be molded, for example, from a hard material. The AAV flap 6555 can be formed, for example, from a flexible material to allow movement of the AAV flap 6555 from an open position to a closed position under the influence of the flow of breathable gas.

[0273] Elbow Tube Connector Assembly 3-96-3-98, an elbow and tube connector assembly 6560 may include an elbow 6570 and a tube connector 6580 that clips onto an inner surface of the elbow 6570. Clipping the tube connector 6580 into the elbow 6570 may reduce the overall visual bulk of the assembly 6560 and may also provide a tube specific fit such that only specific manufacturer provided or installed tubes 6590 may be used with the elbow 6570.

[0274] The elbow 6570 may include a lip or flexible element 6571 adapted to engage with an outer surface of the tube connector 6580, such as a groove 6581, to ensure a more robust seal. The tube connector 6580 may also include a series of ridges 6582 adapted to engage with an inner surface of the elbow 6570 to provide a seal while avoiding increased friction between the tube connector 6580 and the elbow 6570 to allow rotation of the components relative to one another.

[0275] Straight Swivel for Elbow Tube Connectors 3-99-3-101, the tube-elbow connector assembly 6600 may include a swivel elbow 6610, a tube connector 6630, and a swivel or connector or ring 6620. The assembly 6600 may be used to connect an elbow 6610, such as the elbow disclosed in U.S. Pat. No. 6,399,633, the entire contents of which are incorporated herein by reference, to a short matable tube having a length of, for example, 150 mm, such as that disclosed in U.S. Pat. No. 6,399,633, the entire contents of which are incorporated herein by reference. The assembly 6600 may reduce rotational / torque forces between the tube and the elbow. For example, as disclosed in U.S. Pat. No. 6,399,633, the patient interface system may include a "pillow cushion" that is adhesively affixed to the patient's face. Thus, since the patient interface system does not have head gear, there is little to no resistance to rotational forces applied to the pillow cushion. The patient interface system may include a separation gusset, a ring elbow, and a short telescopic tube attached to the elbow. A longer tube, for example a 2m tube, may be connected to the short telescopic tube by a swivel. When the short telescopic tube is extended, it may rotate approximately one revolution. This may then rotate the elbow and distort the pillow cushion, pulling the cannula or pillow away from the nose. In the patient interface of US Pat. No. 6,233,933, the short telescopic tube assembly is designed to be "semi-permanent" and to minimize leakage through the tube-elbow interface. Thus, the short telescopic tube cannot rotate at the interaction site with the elbow, and the elbow acts as a rigid fixture, increasing the torque on the cushion.

[0276] By changing the location of the swivel within the patient interface system, for example by placing the swivel between the short telescopic tube and the elbow, all rotational forces of both the long tube and the short telescopic tube are rotationally decoupled from the cushion.

[0277] The shape of the outer surface of the elbow and the inner surface of the short tube cuff are copied and offset by e.g. 0.2mm, preferably 0.1mm, respectively, so that there is a gap between both parts. When the tube is stretched and begins to rotate, the surfaces will swivel with minimal resistance. The swivel may be "fused" (i.e., not rotating) on ​​one side and rotate 100% on the other side, or both sides may take on 50% rotation, so that the cushion is only subjected to tension forces.

[0278] 3-102-3-106, another example tube-elbow connector assembly 6650 includes an elbow 6660 connectable to a tube or tube cuff 6690 by swivel components 6670, 6680 formed, for example, by overmolding a first swivel component 6680 over a second swivel component 6670 in a mold assembly to form a smaller footprint, free-spinning swivel, i.e., to minimize the length the elbow extends. The internal shape of the cuff 6690 and the external shape of the elbow 6600 are replicated to ensure a leak-free, tight fit, while the in-mold assembly sink allows for smooth rotation. The swivel components 6670, 6680 form a two-part swivel that is molded together.

[0279] 3-107 and 3-108, the tube cuff-tube cuff connector assembly 6700 may include a swivel configured to couple short tube cuffs 6710, 6730 without increasing torque forces. Instead of one 300 mm tube with 100% clockwise torque forces, a cuff connector 6720 may be provided between two short tubes, e.g., 150 mm in length. The cuff connector 6720 connects two short tubes, and each of the two short tubes may be wound in a different direction (i.e., 50% clockwise, 50% counterclockwise) to offset the torque of the other.

[0280] Static and dynamic seal position 3-112-1 to 3-112-2 and 3-113-1 to 3-113-2 are exemplary diagrams showing a cushion assembly 250 having a membrane 260 engaged with a patient's face in a static sealing position, and FIG. 3-36-2 shows a sealing flap 270 engaged with the junction between the greater alar cartilage and the lateral cartilage of the patient's nose as described above.

[0281] 3-114-1 through 3-117-2 show the cushion assembly 250 in various dynamic sealing positions as the cushion assembly 250 adapts to accommodate external forces applied thereto, such as tube resistance and torque forces applied thereto. As shown, the thin walled portion at the mounting area 158 of the cushion assembly, the ball joint mechanism and swivel at the elbow assembly 120, and the flexibility provided by the membrane 260 and the sealing flap 270 allow lateral, upward, and / or downward forces to be applied by the elbow assembly while still ensuring an adequate seal between the cushion assembly and the patient's face.

[0282] In the illustrated example, the patient interface is provided with a decoupling system having a plurality of decoupling structures to allow for decoupling of tube torque and / or tube resistance forces from the sealing forces applied by the cushion assembly 250 against the patient's face, i.e., the decoupling structures work together to absorb and / or transfer forces applied by the air delivery tubes so that such tube forces do not adversely affect the sealing forces provided by the cushion assembly 250 and the forces provided by headgear tension.

[0283] Separation gusset The thin wall portion 158(1) (e.g., also referred to as a separation gusset or separation wall) in the attachment region 158 of the cushion assembly provides sufficient flexibility and durability to allow the attachment region 158 to tilt, pivot, or move relative to the sidewall region 157. The wall thickness of the separation gusset 158(1) is thinner than the wall of the adjacent cushion assembly 250. For example, sufficient clearance is provided between the separation gusset 158(1) and the connector ring 128 supported by the attachment region 158 to prevent the connector ring 128 and / or the elbow 125 from piercing and penetrating the separation gusset 158(1) when the elbow 125 tilts beyond a predetermined angle. In one embodiment, the attachment region 158 has a width of about 6 mm to 7 mm and the separation gusset 158(1) has a width of about 3 mm to 4 mm. The separation gusset 158(1) functions similarly to a spheroidal joint. This is because the separating gusset allows for relative movement between two components having one common center about an indefinite number of axes.

[0284] Ball and socket joints / spheroidal joints The ball and socket joint provided by the elbow 125 and the ring 128 allows for an extra degree of freedom of movement (i.e., in two planes) to allow rotation of the elbow 125 to form an isolation structure. For example, the ball and socket joint not only allows for a full 360° rotation in the X-axis (see FIG. 3-118-1), but also adds an extra 30-40°, e.g., 35°, of rotational movement / tilt in the Z-axis (see FIG. 3-118-2). As a result, the elbow 125 can pivot, swivel, and / or rotate relative to the ring 128, such that tension forces (e.g., sideways, upward, and downward forces as shown in FIG. 3-114-1 through FIG. 3-117-2) and / or torque forces applied to the elbow 125 are not applied directly to the cushion assembly 250 and do not compromise the seal with the patient.

[0285] The rotation or pivoting of elbow 125 relative to ring 128 is limited by annular joint 127 between partially spherical outer surface 125(3) of elbow 125 and the end of elbow 125 (see, e.g., FIG. 3-13). When elbow 125 reaches this pivot or pivot point (e.g., annular joint 127 engages edge 128(2) (see, e.g., FIG. 3-13) of ring 128), a tensile force is transferred to isolation gusset 158(1), causing the isolation gusset to deform or pivot as previously described, which may allow further rotation to separate the tube resistance. The type of deformation in isolation gusset 158(1) is generally compression on one circumferential side and tension on the opposite circumferential side.

[0286] In one example, as shown in FIG. 3-115-1, the maximum angle a1 accommodated by the separation gusset 158(1) when the elbow 125 is tilted upward relative to the cushion assembly 250 is approximately 9-10°, for example, before deformation of the sidewall region 157 of the cushion assembly 250 begins to occur.

[0287] In one example, as shown in FIG. 3-117-1, the maximum angle a2 accommodated by the separation gusset 158(1) during a downward tilt is approximately 13-15°, for example, before deformation of the sidewall region 157 of the cushion assembly 250 begins to occur.

[0288] Swivel A swivel or cuff swivel 129 is provided at the lower end or base of the elbow 125 and connects to an air delivery tube assembly 130, such as a short tube. As shown, the air delivery tube assembly 130 includes a tube 133 and a connector 135 adapted to receive the swivel 129. As shown in FIG. 3-13, the swivel cuff 129 includes a swivel cuff annular engagement ring 129(1) that is received within annular groove 125(4) of the swivel elbow 125 such that the swivel cuff 129 can rotate or pivot relative to the swivel elbow 125. The swivel cuff 129 allows for a full 360° rotation in the Y axis (see FIG. 3-118-3), thereby providing a breakaway structure for breaking connection with the air delivery tube assembly 130.

[0289] Short tube In one example, as shown in Figs. 3-119-1 and 3-119-2, the air delivery tube assembly 130 may be in the form of a short length of tube disposed to interconnect the patient interface and a tube that communicates with the PAP machine.

[0290] As shown in Figures 3-120-1 to 3-120-6, the short tube includes tube 133, end cuff or connector 135 provided at one end of tube 133 and adapted to receive swivel 129, and end cuff or connector 137 provided at the opposite end of tube 133 and adapted to receive swivel 136. Swivel 136 is adapted to engage with a tube that is connected to PAP device 4000.

[0291] Tube 133 is in the form of a helical tube that generates a torque when the short tube is moved from its neutral or initial retracted position (FIG. 3-119-1) to an extended position (FIG. 3-119-2). Tube 133 has a helical coil made up of a plurality of adjacent coils each spaced apart by a width and has an outer surface that defines a coil diameter. Tube 133 also has a web of material attached to, e.g., integrally joined to, the helical coil and coaxial therewith. The helical coil and web of material may be formed from a thermoplastic material such as TPE or TPU.

[0292] End cuffs 135, 137 are overmolded onto each end of tube 133. End cuffs 135, 137 are permanently connected to tube 133. End cuffs 135, 137 have circular ridges on their inner periphery for matingly receiving and rotating with components such as elbow 125 and cuff connector 6720.

[0293] In the example shown in FIG. 3-120-5, the swivel cuff 129 is in the form of a swivel cuff annular engagement ring that is received within an annular groove or channel 125(4) provided at the end of the elbow 125 for rotatable connection with the elbow 125. The swivel cuff annular engagement ring 129 includes an annular groove or channel 129(2) along its outer circumferential surface for matingly receiving the circular ridge 135(1) of the end cuff 135, e.g., a snap-fit ​​connection. The end cuff 135 is removably attachable and detachable from the swivel cuff annular engagement ring 129.

[0294] As shown in FIG. 3-120-6, the swivel 136 is provided with a tube connector 138 that is structured to connect the swivel 136 to an end cuff 137 of the tube 133. As shown, one end of the tube connector 138 includes an annular groove or channel 138(1) along its outer periphery to matingly receive the circular ridge 137(1) of the end cuff 137, e.g., a snap-fit ​​connection. The end cuff 137 is removably attachable to and detachable from the tube connector 138. The opposite end of the tube connector 138 rotatably supports the swivel 136 to allow the swivel to rotate 360° relative to the tube connector 138. The opposite end may include an outwardly tapered edge 138(2) to retain the swivel 136 relative to the tube connector 138.

[0295] As shown in FIGS. 3-120-1 through 3-120-4, the exterior surface of the tube connector 138 may include finger grips 139 to facilitate manual attachment and removal of the tube connector 138 and its swivel 136 to and from the tube 133 and the tube communicating with the PAP device 4000. As shown, such finger grips 139 may be generally U-shaped protrusions provided on either side of the tube connector 138. In one example, raised indicia and / or raised features may be provided within each U-shaped protrusion to help provide a grip on the tube connector 138.

[0296] The swivel 129 on the elbow 125 and the swivel 136 on the end of the tube 133 can rotate up to 180° or more to absorb or redirect torque so that the torque has little to no effect on the cushion assembly 250. In one example, the swivel 129 can rotate about 30° at a minimum extension of the short tube 133, about 120° at an intermediate extension of the short tube 133, and about 180° or more at a full extension of the short tube. Both ends of the tube 133 can rotate 360° by the proximal swivel 129 and the distal swivel 136. The extension of the tube 133 causes the helical coil of the tube 133 to twist. This twisting tendency is fully absorbed by both swivels 126, 136, and the tube 133 can easily and freely rotate relative to the swivels 129, 136 without significant frictional resistance when the tube 133 is stretched from its neutral state (see directional arrows in FIG. 3-119-1). Thus, as the tube 133 stretches, no tube torque forces are transmitted to components connected downstream of the tube 133, such as the elbow 125, the seal-forming structure 3100, or the plenum chamber 3200. Specifically, as the tube 133 stretches in a direction parallel to the longitudinal axis of the tube 133, there is generally no (preferably little to no) instantaneous rotation of the elbow 125 in a clockwise or counterclockwise direction corresponding to the chirality (left-handed or right-handed) of the helical coil of the tube 133.

[0297] In a typical scenario, the patient may sit up before going to sleep wearing the patient interface 3000. The PAP device 4000 may be positioned on a bedside table next to the bed where the patient is seated. Due to gravity, the tube 133 tends to elongate and the elbow 125 rotates to a downward position so that the first opening 125(1) of the elbow 125 faces the ground. The swivels 129, 136 isolate the rotation of the tube 133 as the elongation occurs. When the patient falls asleep on his back or on his side facing away from the PAP device 4000, the ball and socket joints of the elbow 125 and the swivels 129, 136 isolate the tube resistance force. The angle of the elbow 125 is particularly suitable for a position where the longitudinal axis of the tube 133 is perpendicular to the Frankfort horizontal. For a short period of time, when the patient is lying on his / her side facing the PAP device 4000, the elbow 125 is tilted upwards so that the tube 133 aligns and positions itself in line with the open end of the attachment area 158. Once the elbow 125 exceeds its maximum tilt range, the separation gusset 158(1) deforms to absorb the tube resistance before the tube resistance begins to deform the sidewall area 157 of the cushion assembly 150, compromising stability. A patient interface 3000 having a non-elbow type component with a ball and socket joint (a straight component) is less likely to experience tube resistance when the patient is lying on his / her side facing the PAP device 4000, but may experience tube resistance in all other positions. Thus, for the majority of the time and in the majority of positions in which the patient is receiving treatment, an elbow 125 with a ball and socket joint is preferred over a non-elbow type component with a ball and socket joint.

[0298] The isolation system generally includes a ball-and-socket elbow 125, an isolation gusset 158(1), and a tube 133 with a dual swivel connection. In an embodiment where there is a headgear assembly 110 with a two-point connection providing only two sealing vectors to the cushion assembly 250, the isolation system can minimize the impact of tube resistance forces affecting stability without over-tightening the headgear tension. In other words, any loss of stability caused by the type of headgear used is at least partially compensated for by the isolation system. This broadens the range of headgear that can be used with the patient interface 3000, including low-profile headgear (with very little surface contact with the patient's face), without requiring high, and potentially uncomfortable, levels of headgear tension to maintain a seal.

[0299] PAP device 4000 A PAP device 4000 according to one aspect of the present technology includes mechanical pneumatic components, electrical components, and is programmed to execute one or more algorithms. In one example, the PAP device has an external housing, for example formed in two parts, an upper portion 4012 of the external housing, and a lower portion 4014 of the external housing. In another form, the external housing may include one or more panels 4015. In one example, the PAP device 4000 includes a housing 4016 that supports one or more internal components of the PAP device 4000. In one form, a pneumatic block is supported by or formed as part of the housing 4016. The PAP device 4000 may include a handle 4018.

[0300] In one example, the air pressure path of the PAP device 4000 includes an inlet air filter 4112, an inlet muffler, a controllable source of positive pressure air (e.g., blower 4142), and an outlet muffler. One or more pressure and flow sensors are included in the air pressure path.

[0301] In one example, the pneumatic block comprises a portion of the pneumatic path positioned within the outer housing.

[0302] In one example, the PAP device 4000 includes a power source 4210, one or more input devices 4220, a processor, a pressure device controller, one or more protection circuits, a memory, a transducer, a data communication interface, and one or more output devices. The electrical components may be implemented on a single printed circuit board assembly (PCBA) 4202. In another form, the PAP device 4000 may include multiple PCBAs 4202.

[0303] The processor of the PAP device 4000, in use, is programmed to execute a series of algorithm modules including, for example, a pre-processing transducer signal module, a therapy engine module, a pressure control module, and further modules, for example a fault condition module.

[0304] 5.3 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.

[0305] 5.3.1 Overview Air: Air is to be interpreted as including breathing gas, for example air with supplemental oxygen.

[0306] Positive Airway Pressure (PAP): PAP treatment is taken to mean the application of a supply of air or breathable gas at a positive pressure relative to the atmosphere to the entrance to the airways. In one form, the pressure is continuously positive (CPAP), e.g., approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the entrance to the airways varies by a few cmH2O within a single breathing 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 is a few cm, e.g., about 5-15 cmH2O, higher during inspiration than during expiration, providing ventilatory support. In some forms, the pressure varies between different breathing 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.

[0307] 5.3.2 Facial Anatomy Alar (ala): The outer wall or "wing" (plural: alar) of each nostril.

[0308] Alar: The outermost point of the nostril.

[0309] Alar curvature (or alar tip) point: the posteriormost point on the curvature baseline of each alar, found in the crease formed by the attachment of the alar to the cheek.

[0310] Auricula or pinna: the entire visible outer part of the ear.

[0311] (Nose) skeleton: The nasal skeleton includes, for example, the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0312] (Nasal) Cartilaginous skeleton: The cartilaginous skeleton of the nose includes, for example, the nasal septum, the lateral cartilages, the greater alar cartilage, and the lesser alar cartilage.

[0313] Columella: the piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0314] Columellar angle: the angle between a line drawn through the midpoint of the nostril opening and a line drawn perpendicular to the Frankfort horizontal plane while intersecting the nasal spine.

[0315] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left tragus point.

[0316] Glabellar: the most prominent point in the midsagittal plane of the forehead, located on the soft tissue.

[0317] Lateral nasal cartilage: roughly triangular plate of cartilage, the upper edge of which is attached to the nasal bone and the frontal process of the maxilla, and the lower edge of which is connected to the greater alar cartilage.

[0318] Greater alar cartilage: a plate of cartilage located below the lateral nasal cartilage. The greater alar cartilage is curved around the anterior part of the nostril. Its posterior end is attached to the frontal process of the maxilla by a tough fibrous membrane that contains the three or four smaller cartilages of the alar.

[0319] 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.

[0320] Naso-labial sulcus or naso-labial fold: A fold or groove of skin extending from either side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0321] Nasolabial angle: the angle between the columella and upper lip across the nasal spine.

[0322] Subauricular base: lowest point of attachment of the pinna to the skin of the face.

[0323] Supraaural base: the uppermost point of attachment of the pinna to the skin of the face.

[0324] 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.

[0325] 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.

[0326] Pogonion: The anterior-most midpoint of the chin, located on the soft tissue.

[0327] Nasal Ridge: The nasal ridge is the midline protrusion of the nose that extends from the root to the tip.

[0328] Sagittal plane: the vertical plane passing from front to back dividing the body into right and left halves.

[0329] Nasal root: the most concave point located on the soft tissue, lying in the area of ​​the frontonasal suture.

[0330] Septal cartilage (nasal septum): The nasal septum cartilage forms part of the septum and divides the front of the nasal cavity.

[0331] Nadir of the alar: The lower edge of the alar base where it joins the skin of the upper (top) lip.

[0332] Nasal spine: located on the soft tissue, the point where the columella meets the upper lip in the midsagittal plane.

[0333] Supramentale: The most concave point on the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion. 5.3.3 Skull structure

[0334] Frontal bone: The frontal bone includes the greater vertical portion, the scales frontalis, which correspond to the area known as the forehead.

[0335] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0336] Maxilla: The maxilla forms the upper jaw and is positioned superior to the mandible and inferior to 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.

[0337] 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 their junction forms the "bridge" of the nose.

[0338] Nasion: the junction 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.

[0339] 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 occipital squama.

[0340] Orbit: cavity in the skull to house the eyeball.

[0341] Parietal bone: The parietal bones are the bones that, when joined together, form the roof and sides of the skull.

[0342] 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.

[0343] Cheekbones: The face includes two cheekbones that are located on the top and sides of the face and form the cheek protuberances. 5.3.4 Structure of the respiratory system

[0344] Diaphragm: layer of muscle that extends across the base of the rib cage. It separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, it increases the volume of the thoracic cavity and draws air into the lungs.

[0345] Larynx: The larynx, or voice box, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

[0346] 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.

[0347] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space in the center of the face behind and above the nose. 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 turbinates (conchae) or turbinates. At the front of the cavity is the nose, which merges dorsally into the nasopharynx via the posterior nares.

[0348] Pharynx: the part of the throat located just below (inferior to) the nasal cavity and above the esophagus and larynx. The larynx is usually divided into three parts: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (mesopharynx) (oral part of the pharynx), and the laryngopharynx (lower pharynx). 5.3.5 Materials

[0349] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, reference to silicone is a reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (registered trademark, included in the line of products sold under this trademark) manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise stated to the contrary, typical 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.

[0350] 5.3.6 Patient Interface Aspects Antiasphyxiation 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.

[0351] Elbow: A conduit that directs the axis of flow or air 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 elliptical or rectangular cross section.

[0352] Frame: Frame is taken to mean a mask structure that supports the tension load between two or more connection points with the headgear. The mask frame may be a non-airtight load-bearing structure in the mask. However, it may also be in the form of an airtight mask frame.

[0353] Headgear: Headgear is taken to mean any form of positioning and stabilizing structure adapted for use on the head. In one example, the headgear comprises a collection of one or more posts, straps, and reinforcements configured to position and hold a patient interface in place on a 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.

[0354] Membrane: Membrane is understood to mean, for example in the context of the sealing part and / or the face-contacting part, a generally thin element that is, for example, substantially non-resistant to bending but resistant to stretching.

[0355] Plenum chamber: Mask plenum chamber is taken to mean a portion of a patient interface having walls enclosing a volume of space, said space having air therein that is pressurized above atmospheric pressure in use. The outer shell may form part of the mask plenum chamber walls. In one form, an area of ​​the patient's face forms one of the plenum chamber walls.

[0356] 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.

[0357] Shell: In one example, shell is taken to mean a curved structure having bending, tensile and compressive stiffness, e.g., a portion of a mask that forms a curved structure wall of a mask. In one example, the shell is relatively thin compared to its overall dimensions. In some embodiments, the shell may be chamfered. In one example, such walls are airtight, but in some embodiments, they may not be airtight.

[0358] Reinforcement: Reinforcement is taken to mean a structural component adapted to increase the bending resistance of another component in at least one direction.

[0359] Strut: A strut is understood to be a structural component adapted to increase the compression resistance of another component in at least one direction.

[0360] Swivel: (noun) A subassembly of components configured to rotate, e.g., independently, about a common axis, e.g., 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 conjunction with an air delivery conduit, comprises, for example, a pair of matched cylindrical conduits. Preferably, there is little or no airflow leakage from the swivel during use.

[0361] String: A string is understood to be a structural component that is adapted to resist tension.

[0362] Vent: (noun) A structure or conduit to the outside air that permits a deliberate, controlled rate of leakage of air from the interior of the mask to allow the escape of exhaled carbon dioxide (CO2) and the supply of oxygen (O2).

[0363] 5.3.7 Terminology used in relation to patient interfaces Soft: The quality of a material, structure, or composite that has a combination of the following characteristics: · Easily adapted to acupressure. -It is unable to maintain its shape when forced to support its own weight. - Not rigid.

[0364] The property of being flexible may also be associated with a direction, such 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.

[0365] Elasticity: Capable of almost elastic deformation within a relatively short time, such as one second, and of releasing almost all of the energy when the load is removed.

[0366] Rigid: Does not easily deform in response to finger pressure and / or tensions or loads typically encountered in establishing and maintaining a sealing relationship between the patient interface and the entrance to the patient's airway.

[0367] Semi-rigid: means sufficiently rigid so as not to substantially distort under the mechanical forces typically applied during positive airway pressure therapy.

[0368] 5.4 Other findings A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the reproduction by any person of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.

[0369] Unless the context clearly dictates otherwise, when a range of values ​​is given, it is understood that each value between the upper and lower limits of that range, to the tenth of the unit of the lower limit, and any other stated value or values ​​within that stated range, are included within the technology. The upper and lower limits of these intervening ranges that may be independently included within the intervening ranges are also included within the technology, subject to any specifically excluded limit value in the stated range. When a stated range includes one or both of its limits, ranges excluding either or both of those included limits are also included within the technology.

[0370] Additionally, where one or more values ​​are set forth herein as implemented as part of the present technology, unless otherwise stated, it will be understood that such values ​​may be approximated and such values ​​may be utilized to any suitable significant figures, provided that practical technical implementation permits or requires it.

[0371] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0372] Where a particular material is deemed preferred for use, or is deemed an example for constructing a component, obviously another material having similar properties may be used as a substitute.

[0373] 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.

[0374] All publications mentioned herein are incorporated by reference into this application to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the technology is not entitled to antedate such publications by virtue of prior invention. Also, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0375] Also, 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, suggesting that the referred element, component, or step may be present, utilized, or combined with other elements, components, or steps not expressly mentioned.

[0376] The subject headings used in the detailed description are included solely for ease of reference to the reader and should not be used to limit the subject matter found throughout the disclosure or claims. The subject headings should not be used to construe the scope of one or more claims in a limiting manner.

[0377] Although the technology herein has been described in relation to specific embodiments, it is 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, the terms "first" and "second" may be used, but unless otherwise specified, these terms are not intended to indicate any order and may be utilized to distinguish between separate elements. Also, although 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 be performed simultaneously or even synchronously.

[0378] In addition, it is also preferable that the present invention includes the following examples. [1] A swivel elbow connector assembly for a patient interface system, comprising: a ring configured to be sealingly secured in an opening of the patient interface system, the ring having a first side that is interior to the patient interface system when the ring is secured in the opening and a second side that is exterior to the patient interface system; an elbow pivotally secured to the ring; Equipped with the ring comprises a first flange on the first side and a second flange on the second side, the first flange and the second flange defining a channel for sealingly engaging the opening of the patient interface system; an inner surface of the ring is partially spherical and an outer surface of the elbow is partially spherical, the elbow and the ring forming a ball-and-socket connection; Swivel elbow connector assembly. [2] A swivel elbow connector assembly as described in Example 1, further comprising a swivel cuff annular engagement ring received within an annular groove of the elbow, the swivel cuff annular engagement ring configured to rotatably engage with a conduit for delivering a flow of breathable gas to the patient interface system. [3] A swivel elbow connector assembly as described in Example 2, wherein the swivel cuff annular engagement ring is rotatably connected to the elbow. [4] A swivel elbow connector assembly described in any of Examples 1 to 3, wherein when the longitudinal axis of the elbow and the longitudinal axis of the ring are collinear, the annular surface of the elbow is flush with the annular surface of the ring. [5] A swivel elbow connector assembly as described in Example 4, wherein the elbow has an annular joint configured to limit rotation of the elbow by engaging with a second annular surface of the ring. [6] A swivel elbow connector assembly according to any one of Examples 1 to 5, wherein the partially spherical surfaces of the ring and the elbow have approximately equal radii of curvature. [7] A swivel elbow connector assembly described in any of Examples 1 to 6, further comprising a vent having a plurality of holes configured to allow gas to flow from the inside to the outside of the patient interface system. [8] A swivel elbow connector assembly as described in Example 7, wherein the air vent is located on the elbow. [9] A swivel elbow connector assembly described in any of Examples 2 to 8, wherein the swivel cuff annular engagement ring has a channel portion defined on its outer peripheral surface for receiving a cuff provided on the conduit in a mating state, and the swivel cuff annular engagement ring and the cuff of the conduit can be removably attached to and detached from each other.

[10] A swivel elbow connector assembly described in any of Examples 1 to 9, wherein the ring is removably attachable and detachable from the elbow.

[11] A cushion assembly; A swivel elbow connector assembly according to any one of Examples 1 to 10 provided on the cushion assembly; A patient interface system comprising:

[12] The patient interface system of Example 11, wherein the cushion assembly includes a separation gusset.

[13] A patient interface system as described in Example 11 or Example 12, wherein the opening is formed in the cushion assembly, and the cushion assembly is adapted to form a seal with the patient in close proximity to the nasal septum cartilage, the upper lip, and the area adjacent the junction between the alar cartilage and the lateral nasal cartilage of the patient's nose.

[14] A conduit for delivering a flow of pressurized air or breathing gas through a patient interface system to an entrance of a patient's airway, comprising: a helical coil having a plurality of adjacent coils each spaced apart by a width, the helical coil having an outer surface defining a coil diameter; and a web of material coaxial with the helical coil, the web attached to the helical coil; a first swivel cuff permanently connected to a first end of the conduit, the first swivel cuff for pivotably and releasably connecting to a first component; a second swivel cuff permanently connected to the second end of the conduit, the second swivel cuff for pivotally and releasably connecting to a second component; Equipped with A conduit, wherein when the conduit is stretched, the conduit is free to rotate relative to the first component and the second component, the rotational force being contained between the first swivel cuff and the second swivel cuff.

[15] The conduit described in Example 14, wherein the first swivel cuff and the second swivel cuff are overmolded onto the end of the conduit.

[16] The conduit of Example 14 or Example 15, wherein the first swivel cuff and the second swivel cuff include annular engagement rings formed on the inner surfaces of the swivel cuffs to be received in a mating state by annular grooves of the first component and the second component.

[17] A conduit as described in any of Examples 14 to 16, wherein the first component is a swivel elbow having a swivel cuff annular engagement ring, and the second component is a cuff connector for connection to another conduit.

[18] A method for manufacturing a swivel elbow connector assembly for a patient interface system, comprising: insert molding a ring having a partially spherical inner surface in an elbow mold; insert molding an elbow pivotally secured to said ring in an elbow mold, said elbow having a partially spherical outer surface; Equipped with said elbow and said ring forming a ball-and-socket connection; The method, wherein the ring is formed from a material that does not plastically deform when the elbow is insert molded.

[19] The method described in Example 18, further comprising the step of insert molding a swivel cuff annular engagement ring within the elbow mold at approximately the same time as insert molding the ring, the swivel cuff annular engagement ring being received within an annular groove in the elbow.

[20] A patient interface system for delivering a flow of pressurized air or breathable gas to an entrance of a patient's airway, comprising: A cushion assembly; a decoupling system for decoupling a tube resistance force when an air conduit for delivering pressurized air is expanded and moves relative to the cushion assembly; Equipped with The separation system comprises: a first isolation component for isolating rotational movement of the air conduit when the air conduit is extended; and a second isolation component for isolating movement of the air conduit relative to the cushion assembly; and A patient interface system comprising:

[21] A patient interface system as described in Example 20, wherein the separation system further comprises a third separation component for separating movement of the air conduit relative to the cushion assembly when the second separation component exceeds a predetermined separation range provided by movement of the air conduit relative to the cushion assembly.

[22] A patient interface system as described in Example 20 or Example 21, wherein the first separation component is a pair of swivel cuff connections at the ends of the air conduit.

[23] A patient interface system according to any one of Examples 20 to 22, wherein the second separation component is a spheroidal joint.

[24] The patient interface system of Example 21, wherein the third separation component is a separation gusset formed in a side wall region of the cushion assembly.

[25] A patient interface system as described in any of Examples 20 to 24, wherein the cushion assembly is adapted to form a seal with the patient adjacent to the nasal septum cartilage, the upper lip, and the area adjacent the junction between the alar cartilage and the lateral nasal cartilage of the patient's nose.

[26] A patient interface system for delivering a flow of pressurized air or breathable gas to an entrance of a patient's airway, comprising: A cushion assembly; a decoupling system for decoupling a tube resistance force when an air conduit for delivering pressurized air is moved relative to the cushion assembly; Equipped with The separation system comprises: a first isolation component for isolating movement of the air conduit relative to the cushion assembly; a second isolation component for isolating movement of the air conduit relative to the cushion assembly when the first isolation component exceeds a predetermined isolation range caused by movement of the air conduit relative to the cushion assembly; A patient interface system comprising:

[0379] It is therefore to be understood that numerous modifications may be made to the illustrated embodiments and other configurations may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0380] 100 Mask System 110 Headgear Assembly 114 Each Slot 115 Side Strap 116 Cushion Connector 117 Adjustment section 118 Rear Strap 120 Elbow Assembly 125 Elbow 125(1) First opening 125(2) Second opening 125(2)e Edge 125(3) Partially spherical outer surface 125(4) Annular groove 127 Annular Joint 128 Connector Ring 128(1) First raised edge 128(2) Second raised edge 128(3) channels 128(4) Curved inner surface 129 Swivel Cuff 129(1) Annular engagement ring 129(2) Channel section 130 Air delivery tube assembly 133 Tube 135 Connector 136 Distal Swivel 150 Cushion Assembly 151 Sealing Area 152 Nasal ridge area 153 Lateral part of nose area 154 Corners of the nose area 155 Upper lip area 156 Headgear Connector 157 Sidewall area 158 Mounting Area 158(1) Separation gusset 158(2) Lip part 159 Protrusions or Interfaces 160 membrane 165 Undercushion or backup band 250 Cushion Assembly 251 Seal Area 252 Nasal ridge area 253 Lateral part of nose area 254 Corners of the nose area 255 Upper lip area 256 Headgear Connector 257 Sidewall area 258 mounting area 260 membrane 260-1 Bead 265 Under Cushion 268 Thin section area 270 Seal flap 275 Orifice 275(1) Upper orifice 275(2) Lower orifice 280 Width or contact area 280(i) Common-law marriage 280(o) Outer edge 350 Cushion Assembly 356 Headgear Connector 356(1) Thin wall section 360 membrane 450 Cushion Assembly 456 Headgear Connector 456(1) Thin wall section 457 Sidewall area 457(1) Wall section 460 Membrane 465 Under Cushion 605 Cushion 610 Swivel Elbow Connector Assembly 620 Connector ring 621 Ventilation hole 622 Inner flange 623 Outer flange 624 Channels 625 Ventilation slot 630 Sleeve 631 Sleeve flange 632 Annular Surface 633 Cylindrical part 640 Swivel Elbow 641 Flange 642 Tapered flange 643 Circular groove 644 Tapered flange 650 Swivel Cuffs 651 Swivel cuff annular engagement ring 652 Circular groove 653 End 660 Swivel Elbow Connector Assembly 670 Elbow Ring 671 Ventilation slot 672 Annular Surface 673 Inner flange 674 Outer flange 675 Channels 676 Inside 680 Ball Joint Swivel Elbow 681 Annular Surface 682 Arcuate annular outer surface 683 Circular Groove 684 Tapered Flange 685 Annular Joint 690 Swivel Cuff 691 Tapered annular engagement ring 692 Slant groove 693 Swivel Cuff Ends 694 Tapered flange 695 Circular Groove 1000 patients 3000 Patient Interface 3100 Seal forming structure 3102 Upper seal part 3104 Lower seal part 3110 Seal flange 3120 Support flange 3200 Plenum Chamber 3210 Outer circumference 3220 Periphery 3300 Positioning and stabilization structures 3400 Vent 3500 Separation structure 3510 Swivel 3520 Ball and Socket 3600 Connection Port 4000 PAP devices 4012 Upper 4014 Lower 4016 Case 4018 Handle 4112 Inlet Air Filter 4142 Blower 4170 Air Circuit 4202 PCBA 4210 Power supply 4220 input device 5000 humidifier 5550 Elbow 6100 Secondary Swivel Cuff 6101 Tapered annular engagement ring 6102 Annular groove 6103 End 6120 Swivel Elbow Connector Assembly 6130 Cushion 6132 Connector 6133 Flexible Base 6140 Swivel Elbow 6141 Inclined flange 6142 Tapered flange 6143 First end 6144 Baffle 6145 Ventilation hole 6146 Radial Flange 6147 Ventilation section 6150 Ring 6152 Inner flange 6153 Outer flange 6154 Channel 6155 Circular radial flange 6157 Reinforcement 6159 Lower 6200 Frame 6210 First opening 6220 Second Opening 6230 Ventilation hole 6235 Surface 6240 Engagement tab 6245 First Connection Area 6250 Second Connection Area 6255 Stopper 6260 Baffle 6270 Second Support 6280 Gap or Relief 6290 First Support 6300 Elbow Assembly 6310 Valve members 6315 Lip 6320 Engagement part 6330 Flexible member 6335 Second Component 6400 Patient Interface System 6410 Swivel Elbow 6411 Ventilation hole 6420 Swivel 6421 Detent 6430 Cushion 6431 Tabs 6440 Bayonet Type Connection 6450 Patient Interface System 6454 Stem 6460 Swivel Elbow 6461 Vent 6462 Flexible Button 6463 Groove 6470 Swivel 6480 Ring 6490 Cushion 6500 Patient Interface System 6510 Swivel Elbow 6511 Slot 6512 Button 6513 Groove 6514 Baffle 6520 Swivel 6530 Cushion 6550 Elbow 6551 Slot 6552 Aperture 6554 Baffle 6555 AAV flap 6560 Elbow Tube Connector Assembly 6570 Elbow 6571 Lip or flexible element 6580 Tube Connector 6582 Ridge 6590 Tube 6600 Tube Elbow Connector Assembly 6610 Swivel Elbow 6620 Swivel 6630 Tube Connector 6650 Tube Elbow Connector Assembly 6660 Elbow 6670 Second Swivel Component 6680 First Swivel Component 6690 Cuff 6710 Cuff 6720 Cuff Connector 6730 Cuff 6800 Elbow 6805 Skeleton 6810 AAV 6810.1 Outer flange 6810.2 External surface 6812 Flap 6815 Aperture 6820 Pull Tab 6825 Inner flange 6830 Interior wall 6832 Flexible Component 6835 Release button 6950 Seal Part 6952 Nose top engagement part 6953 Support part 6954 Stem 6955 Aperture 6962 Upper lip engaging part 6965 Flexible Gusset

Claims

1. 1. A patient interface for delivering a flow of air at a positive pressure relative to atmospheric pressure to an entrance to a patient's airways, including at least the entrances to the patient's nares, while the patient is sleeping to ameliorate sleep disordered breathing, the patient interface comprising: a cushion assembly; the cushion assembly comprising a seal-forming structure including a sealing flange configured and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airway; the sealing flange having a first cross-sectional thickness; the seal-forming structure further comprising a support flange constructed and arranged to support the seal flange; and the support flange has a second cross-sectional thickness; the second cross-sectional thickness of the support flange is relatively greater than the first cross-sectional thickness of the seal flange; The cushion assembly is adapted to withstand a pressure of 5 cmH above atmospheric pressure. ２ O to 15cmH ２ a plenum chamber pressurizable to a therapeutic pressure in the range of O; the plenum chamber including an attachment area configured to be in fluid communication with an air delivery tube; the plenum chamber further includes a sidewall region extending between the seal-forming structure and the mounting region; the sidewall region has a third cross-sectional thickness; a third cross-sectional thickness of the sidewall region is relatively greater than the first cross-sectional thickness of the sealing flange; the attachment region comprising a lip constructed and arranged to assist in retention of the air delivery tube; the lip portion has a fourth cross-sectional thickness; a fourth cross-sectional thickness of the lip portion at the attachment region is relatively greater than a third cross-sectional thickness of the sidewall region; the attachment region further comprising a decoupling gusset, the decoupling gusset configured and arranged to allow the attachment region to move relative to the sidewall region to permit decoupling from tube drag forces exerted by the air delivery tube; the decoupling gusset has a fifth cross-sectional thickness; The fifth cross-sectional thickness of the decoupling gusset is relatively smaller than the second cross-sectional thickness of the support flange; the seal-forming structure and the plenum chamber comprise a one-piece molded structure; A patient interface, wherein the seal-forming structure and the plenum chamber comprise an elastomeric material.

2. 2. A patient interface according to claim 1, wherein the fifth cross-sectional thickness of the decoupling gusset is relatively less than the third cross-sectional thickness of the sidewall region.

3. A patient interface according to claim 1 or 2, wherein the sidewall region is generally conical in shape.

4. 4. The patient interface of claim 3, wherein the sidewall region has a first diameter proximate the attachment region and a second diameter proximate the seal-forming structure, the first diameter being smaller than the second diameter.

5. A patient interface according to any one of claims 1 to 4, wherein the sidewall region has different cross-sectional thicknesses in different regions.

6. A patient interface according to any one of claims 1 to 5, wherein the sidewall region includes at least one region having a tapered cross-sectional thickness.

7. A patient interface according to any one of claims 1 to 6, wherein the seal-forming structure and the plenum chamber comprise silicone.

8. 8. A patient interface according to claim 1, wherein the cushion assembly is configured to seal against the patient proximal to the area adjacent the nasal septum cartilage, the upper lip, and the junction between the greater alar cartilage and the lateral cartilage of the patient's nose.

9. A patient interface according to any one of claims 1 to 8, wherein the seal-forming structure includes a bridge of the nose region, sides of the nose region, corners of the nose region, and an upper lip region.

10. 10. A patient interface according to claim 9, wherein the sidewall region includes an area adjacent an upper lip region of the seal-forming structure having a thickness that is less than corresponding thicknesses adjacent bridge regions, sides of the nose region, and corners of the nose region of the seal-forming structure.

11. A patient interface according to claim 9 or 10, wherein the sides of the nasal region slope outwardly from the bridge of the nose region to the corners of the nasal region.

12. A patient interface according to any one of claims 9 to 11, wherein the support flanges are provided only at the corners of the upper lip and nose areas.

13. 13. A patient interface according to any one of claims 9 to 12, wherein each side of the nasal region includes a wing or sealing flap projecting from an edge of the sealing flange, each wing or sealing flap configured to form a seal in the area adjacent the junction between the greater alar cartilage and the lateral nasal cartilage of the patient's nose.

14. A patient interface according to any one of claims 9 to 13, wherein the nose bridge region and upper lip region each include at least a locally saddle-shaped portion of curvature.

15. A patient interface according to any one of claims 1 to 14, wherein the side wall region provides flexibility to assist in decoupling from tube drag forces.

16. 16. A patient interface according to any one of claims 1 to 15, further comprising a vent having a plurality of holes configured to allow gas to flow from the interior to the exterior of the patient interface.

17. 17. A patient interface according to claim 16, wherein the vent is located in an elbow configured to be secured to the attachment region.

18. 18. A patient interface according to any one of claims 1-17, wherein the first cross-sectional thickness of the sealing flange is less than about 1 mm.

19. A patient interface according to any one of claims 1 to 18, wherein the third cross-sectional thickness of the sidewall region is between about 1.5 mm and 5 mm.

20. 20. A patient interface according to claim 19, wherein the third cross-sectional thickness of the sidewall region is about 2 mm.

21. 21. A patient interface according to any one of claims 1 to 20, wherein the fourth cross-sectional thickness of the lip is between about 2 mm and 3 mm.

22. 22. A patient interface according to any one of claims 1 to 21, wherein the fifth cross-sectional thickness of the decoupling gusset is between about 0.1 mm and 1 mm.

Images