Nasal mask system

1(A) Nasal Mask System 2(B) Cross-Reference to Related Applications This application claims the benefit of Australian Provisional Patent Application No. 2011904754, filed November 15, 2011, which is incorporated herein by reference in its entirety.

3(C) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable

4(D) Name of organization involved in joint research and development Not applicable

5(E) Sequence Listing Not Applicable

The present technology relates to the treatment of respiratory disorders and procedures for preventing respiratory disorders. In particular, the present technology relates to medical devices and their use in treating and preventing respiratory disorders. More particularly, the present technology relates to nasal mask systems used to treat sleep disordered breathing (SDB), for example, by continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV).

The respiratory system of the body allows for the exchange of gases. The nose and mouth form the entrance to the patient's airways.

The airways consist of a series of branching tubes that become narrower, shorter and more numerous the deeper they go into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from the outside air into the venous blood and carbon dioxide to be carried away. The trachea divides into the right and left main bronchi, which eventually divide further into the terminal bronchioles. The bronchi constitute the conducting airways and are not involved in gas exchange. The airways further divide into respiratory bronchioles, which eventually lead to the alveoli. The alveolar regions of the lungs, where gas exchange takes place, are called the respiratory regions. See, e.g., Circulatory System, vol. 14, no. 1, pp. 1111-1123, 2002.

There are a variety of respiratory diseases.

Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by the obstruction of the upper airway during sleep. It occurs as a result of an abnormal narrowing of the upper airway during sleep combined with a normal loss of muscle tone in the lower, soft palate, and posterior oropharynx. The condition causes affected patients to stop breathing for periods of time, sometimes 200-300 times per night, typically lasting 30-120 seconds. This often results in excessive daytime somnolence, which can lead to cardiovascular disease and brain damage. The syndrome is common, especially in middle-aged and obese men, although affected individuals may not be aware of the problem. See US Pat. No. 5,399,323 (Sullivan).

Cheyne-Stokes respiration (CSR) is a disorder of the patient's respiratory regulation function in which there are rhythmic alternating periods of waxing and waning ventilation, which causes repeated deoxygenation and reoxygenation of arterial blood. CSR is harmful due to repeated hypoxia. In some patients, CSR is associated with repeated arousals from sleep, which causes severe sleep disturbance, increased sympathetic activity, and increased afterload. See US Patent No. 5,399,633 (Berthon-Jones).

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

Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain characteristics. These include increased resistance to air movement, an 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 smoking (the major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

Neuromuscular diseases (NMD) is a broad term that encompasses many diseases and illnesses that impair muscle function, either directly through lesions of intrinsic muscles or indirectly through lesions of nerves. Some NMD patients are characterized by progressive muscle damage that leads to loss of walking, wheelchair confinement, swallowing problems, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be divided into rapidly and slowly progressive diseases, with (i) rapidly progressive diseases characterized by muscle disorders that worsen over months and lead to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) seen in teenagers) and (ii) fluctuating or slowly progressive diseases characterized by muscle disorders that worsen over years and only slightly reduce life expectancy (e.g., limb-girdle muscular dystrophies, facioscapulohumeral muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include generalized weakness, dysphagia, dyspnea on exertion and at rest, fatigue, drowsiness, increased headaches on awakening, and difficulty concentrating and mood changes.

Thoracic anomalies are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the rib cage. They are usually characterized by restrictive disorders and share the potential for long-term hypercapnic respiratory failure. Scoliosis and/or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include dyspnea on exertion, peripheral edema, orthopnea, recurrent pulmonary infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

Other healthy individuals may utilize systems and devices that prevent respiratory illnesses from occurring.

6.2.1 Systems One known product used to treat sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited.

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

Non-invasive ventilation (NIV) is used to treat OHS, COPD, NMD and thoracic abnormalities.

6.2.3 Patient Interfaces Providing an air supply at positive pressure to the entrance of a patient's airways, for example whilst the patient is sleeping, is made possible by the use of a patient interface such as a nasal mask, full face mask or nasal pillows.

Known patient interface devices suffer from one or more of the following problems: being occlusive, being aesthetically unpleasing, not fitting well, being difficult to use, and being uncomfortable, especially when worn for extended periods of time or when the patient is unfamiliar with the system.

6.2.3.1 Seal-Forming Part Patient interfaces typically include a seal-forming part.

Various patient interface seal forming techniques are disclosed in patent applications assigned to ResMed Limited, namely U.S. Patent Nos. 5,393, 5,433, 5,596, 6,741, and 6,823,663.

6.2.3.2 Positioning and Stabilization The seal-forming parts of patient interfaces used in positive air therapy will break a seal when subjected to the force of the corresponding air pressure. Therefore, various techniques are used to position and maintain the seal-forming parts in a sealing relationship with the appropriate part of the face.

One approach is to use adhesives, see for example US Pat.

Another approach is to use one or more straps and a stabilizing harness.

6.2.3.3 Vent Technology Some forms of patient interface systems may include a vent to allow the escape of exhaled carbon dioxide.

ResMed Limited has developed several mask vent technologies, see U.S. Patent Nos. 5,393, 6,433, 6,511, 6,689, 7,713, 7,825, 7,911, 7,925, 7,103, 7,116, 7,117, 7,251, 7,252, 7,253, 7,254, 7,255, 7,256, 7,257, 7,259, 7,260, 7,270, 7,271, 7,272, 7,273, 7,274, 7,275, 7,276, 7,277, 7,278, 7,277, 7,279, 7,280, 7,290, 8,

<p><patcit num="1"><text>U.S. Pat. No. 4,944,310</text></patcit><patcit num="2"><text>U.S. Patent No. 6,532,959</text></patcit><patcit num="3"><text>International Publication No. 1998/004,310 Pamphlet</text></patcit><patcit num="4"><text>International Publication No. 2006/074,513 Brochure</text></patcit><patcit num="5"><text>International Publication No. 2010/135,785 Brochure</text></patcit><patcit num="6"><text>US Patent Application Publication No. 2010/0000534</text></patcit><patcit num="7"><text>International Publication No. 1998/034,665 Pamphlet</text></patcit><patcit num="8"><text>International Publication No. 2000/078,381 Brochure</text></patcit><patcit num="9"><text>U.S. Patent No. 6,581,594</text></patcit><patcit num="10"><text>US Patent Application Publication No. 2009/0050156</text></patcit><patcit num="11"><text>US Patent Application Publication No. 2009/0044808</text></patcit><patcit num="12"><text>PCT/AU2008/001557</text></patcit></p>

<p><nplcit><text>West, Respiratory Physiology- the essentials</text></nplcit></p>

<p>The present technology is directed to providing medical devices used in the diagnosis, treatment or prevention of respiratory disorders that have improved one or more of comfort, cost, effectiveness, ease of use, and manufacturability.</p>

<p>A first aspect of the present technology relates to an apparatus for use in the diagnosis, treatment or prevention of respiratory disease.</p><p>Another aspect of the present technology relates to methods used in the diagnosis, treatment or prevention of respiratory disorders.</p><p>One aspect of the present technology is a patient interface that is one or more of: comfortable, effective, easy to use, non-occlusive, and has a wide range of fit.</p><p>One aspect of one form of the present technology is a patient interface that avoids the jetting effect of nasal pillows or cannulas and/or the discomfort of having portions of a mask located within the patient's nasal passages.</p><p>One aspect of one form of the present technology is a nose mask that is easy to wear, that avoids the need for headgear straps to interfere with or hang over the ears during use, and that avoids interference with or hanging over the ears during donning or doffing.</p><p>Another aspect of one form of the present technology is a method for donning or doffing a mask.</p><p>In one form of the present technology, a miniature non-occlusive nasal mask is provided.</p><p>In one form of the present technology, a nasal mask is provided that does not form a seal on the patient's lower lip or chin.</p><p>In one form of the present technology, a patient interface is provided that does not exert a posterior force on the mandible, eg, the patient interface does not push the mandible from anterior to posterior.</p><p>In one form of the present technology, a patient interface is provided that does not include a rigid shell or frame.</p><p>In one form of the present technology, a patient interface is provided that includes a plenum chamber constructed from a flexible or semi-rigid material of suitable thickness, such as flexible rubber (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).</p><p>In one form of the present technology, a nasal mask is provided that does not require the engagement or disengagement of clips to put on or take off the mask.</p><p>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 have no resistance to compression and a second seal area configured to substantially withstand compression forces (e.g., as a result of tension in headgear). In one embodiment, during use, the first seal area is positioned over a portion of the cartilaginous framework of the nose and the second seal area is positioned over a portion of the facial bone area. In one embodiment, the facial bone area is adjacent the ala of the nose, optionally adjacent the apex of the ala of the nose.</p><p>In accordance with one form of the present technology, there is provided a patient interface comprising: (i) a seal-forming portion that, in use, covers at least a portion of the upper lip area of the patient's face and a portion of the cartilaginous framework of the nose; and (ii) a seal positioning and stabilizing structure that can be attached and removed without interfering with the patient's ears.</p><p>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 embodiment, the patient interface does not include a forehead support. In additional or alternative embodiments, the seal positioning and stabilizing structure includes a non-rigid or flex connection element.</p><p>Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured with a clearly defined perimeter shape that is intended to match the perimeter shape of the intended wearer during use.</p><p>Another aspect of one form of the present technology is a patient interface that is constructed and arranged to form a seal against at least a portion of the nasal cartilaginous framework while avoiding or reducing the tendency for nasal airflow to be restricted therethrough.</p><p>In accordance with one form of the present technology, a patient interface is provided comprising a first, upper sealing portion which, in use, covers a portion of the nasal cartilaginous skeleton and a second, lower sealing portion which, in use, covers a portion of the upper lip, such that, in use, a relatively greater portion of the headgear sealing force is directed against a portion of the upper lip and the overlying maxilla than is directed against the nasal cartilaginous skeleton.</p><p>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 apply unwanted pressure to the nasal septum.</p><p>In accordance with one form of the present technology, there is provided a patient interface that, in use, forms a seal against 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 softer spring constant than a portion of the wall adjacent the first portion.</p><p>Another aspect of one form of the present technology is a patient interface that provides an effective or improved seal against the area of the nose near the junction between the alar cartilage and the lateral cartilage while forming a seal against a portion of the cartilaginous framework of the nose.</p><p>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 trilobular orifice. In one embodiment, the sealing flange includes a membrane and a sealing flap that projects from an end of the membrane along its inner periphery on each side of the nasal region. The ends of the membrane along its inner periphery, together with the ends of each sealing flap along its inner periphery, cooperate to define an orifice to a plenum chamber. In one embodiment, such an orifice includes a generally T-shaped or trilobular 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 transversely to the upper orifice portion.</p><p>In accordance with one form of the present technology, an inner end of the sealing flange is spring biased, during use, against an intermediate portion of the sealing flange, for example, towards the wearer's face.</p><p>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 in response to adjustment of headgear tension.</p><p>Another aspect of one form of the present technology is a method of manufacturing a patient interface.</p><p>Another aspect of one form of the present technology is a device that prevents, treats or ameliorates one or more of OSA, CSA, OHS, COPD, NMD and thoracic abnormalities.</p><p>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 areas, and narrow and wide noses. Another aspect of the present technology is a mask system that has a wide fit range.</p><p>Another aspect of one form of the present technology is a mask system that is small, non-occlusive, and yet remains stable against the patient's face while they are asleep.</p><p>One aspect of the present technology is a mask that is constructed and arranged to seal, at its upper extent, with the area of the nose generally above or superior to the tip of the nose.</p><p>One aspect of one form of the present technology is a mask constructed and arranged to seal, at its upper extent, at a location generally below or inferior to the nasal bone.</p><p>In one form of the present technology, a mask is provided that is constructed and arranged to cover the upper or superior lip and have a seal-forming portion that covers, for example, a portion of the cartilaginous framework of the nose without covering the nasal bone.</p><p>In one form of the present technology, a mask is provided that is constructed and arranged to have a first seal-forming portion over the upper or superior lip and a second seal-forming portion over the cartilaginous framework of the nose, for example, without covering the nasal bone.</p><p>In one form of the present technology, there is provided a mask constructed and arranged to have a first seal-forming portion that is substantially in compression or under a bending force during use, and a second seal-forming portion that is substantially in tension during use.</p><p>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 rigid prior to use and a second seal-forming portion that is relatively flexible prior to use.</p><p>Another aspect of one form of the present technology is a mask system having an improved sealing cuff. In one embodiment, the mask system includes a face flap comprising a relatively thin member formed from a flexible, e.g., at least semi-elastic, material. In one embodiment, the mask system further comprises a backing band in at least some regions.</p><p>Another aspect of the present technology is a mask that is formed, shaped or otherwise constructed with a clearly defined peripheral shape that is intended to conform to the peripheral shape of an intended wearer during use.</p><p>A further aspect of the present technology is a cushion for a mask that, at its upper extent, seals against the nose, generally the tip, or the area superior or above the tip of the nose, and extends across the ala or flare of the patient's nose.</p><p>A further aspect of the present technology is a cushion for a mask that, at its upper extent, seals against the area of the nose generally superior or above the tip, or tip of the nose, and extends across the ala or flare of the patient's nose, e.g., not over or across the nasal bone of the patient's nose.</p><p>One aspect of one form of the present technology is a cushion for a mask that, at its upper extent, seals the area of the nose of various people with larger noses, generally near the junction between the bone and cartilage, to avoid obstructing the view of people with smaller noses.</p><p>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 generally above or superior to the tip of the nose.</p><p>One aspect of the present technology is a cushion for a mask that includes a sealing membrane in at least some areas and a backing band or undercushion.</p><p>Another aspect of the present technology is a cushion for a nasal mask that includes an undercushion or backing band in at least some areas.</p><p>Another aspect of one form of the present technology is a cushion for a nasal mask that includes an undercushion or backing band in the upper lip area and does not include an undercushion or backing band in the side of the nose or nasal ridge area to avoid relatively strong sealing forces against these areas that may cause occlusion of the nasal airway.</p><p>Another aspect of the present technology includes a cushion for a nasal mask, the cushion including a sealing region, a sidewall region, and an attachment region, the sealing region adapted to form a seal with a patient, the sidewall region connecting the sealing region and the attachment region, and the attachment region adapted to connect or otherwise attach to an air delivery system.</p><p>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.</p><p>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 thinner wall section, for example, the relatively thinner wall section may be 50-85% thinner.</p><p>Another aspect of the present technology includes a cushion for a nasal mask, the cushion having a headgear connector integrally formed with a sidewall, for example, the sidewall constructed from a flexible elastomer or rubber.</p><p>Another aspect of the present technology includes a cushion for a nasal mask, the cushion having a headgear connector that is constructed and arranged to position a portion of the sealing area superior or above the tip or tip of the patient's nose.</p><p>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 local saddle, that is adapted to match or be complimentary to the patient's nasal ridge.</p><p>A further aspect of the present technology includes a cushion for a nasal mask, the cushion having a nasal ridge region, the nasal ridge region having a relatively longer membrane length when compared to other regions of the cushion, the relatively longer membrane length adapted to engage a wider fitting range of nasal ridge heights of patients.</p><p>Another aspect of the present technology includes a cushion for a nasal mask, the cushion having a nasal side region, the nasal side region having a raised portion, the raised portion having a greater height when compared to the nasal ridge region, the raised portion adapted to engage the side of a patient's nose and ensure engagement with high and flat nasal ridges.</p><p>Another aspect of the present technology includes a cushion for a nasal mask, the cushion having a nasal corner region generally corresponding to and including the underside of the nose and the apex of the nose, the nasal corner region having a maximum height when compared to all other regions of the cushion, the nasal corner region securing the cushion in place. The height of the nasal corner region may be configured to ensure a seal at the corner of the nose, as this is a particularly difficult area of the face to seal.</p><p>Another aspect of the present technology includes a cushion for a nasal mask, the cushion having an upper lip region configured to match the curvature of the patient's upper lip region. The upper lip region may be generally curved and extend from a groove or recess into the nasal side region. A membrane in the upper lip region may stretch across the patient's upper lip to ensure a seal with the patient's upper lip.</p><p>Another aspect of the present technology relates to a nasal mask system including a cushion assembly including a sealing region providing a single orifice adapted to encircle both nostrils of the patient's nose, and a headgear assembly including a pair of side straps and a rear strap. The side straps are adapted to extend along the sides of the patient's face between the patient's eyes and ears and engage respective headgear connectors provided on the cushion assembly to provide a two-point connection with the cushion assembly. The rear strap extends between the side straps and is adapted to engage along the back or rear of the patient's head, along, under or inferior to the occipital bone.</p><p>Another aspect of the present technology relates to a nasal mask system including a cushion assembly including a sealing region having a nasal ridge region, a nasal side region, a nasal corner region, and an upper lip region adapted to seal around both nostrils of a patient's nose. The nasal ridge region is adapted to be positioned and seal along a nasal cartilage region above or superior to the tip of the nose and below or inferior to the nasal bone region of the bridge of the patient's nose. In one form, the sealing region includes a membrane seal that extends around the entire periphery of the sealing region and an undercushion that is located only within the upper lip and nasal corner regions.</p><p>Another aspect of the present technology relates to a nasal mask system including a cushion assembly including a sealing region adapted to seal around both nares of a patient's nose, an attachment region adapted to receive a flexion assembly, and a sidewall region extending between the sealing region and the attachment region. The sealing region has a nasal ridge region, a nasal side region, a nasal corner region, and an upper lip region. The sidewall region includes a region adjacent the upper lip region of the sealing region that includes a thickness that is less than corresponding thicknesses adjacent the nasal ridge, nasal side, and nasal corner regions of the sealing region.</p><p>Another aspect of the present technology relates to a nasal mask system including a cushion assembly including a sealing region having a nasal ridge region, a nasal side region, a nasal corner region, and an upper lip region adapted to seal around both nostrils of a patient's nose, The nasal side region includes a portion adapted to be positioned and seal along an area adjacent the junction between the greater alar cartilage and the lateral nasal cartilage of the patient's nose.</p><p>Another aspect of the present technology relates to a patient interface for providing a supply of air at positive pressure 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 against a portion of the patient's upper lip and to form a seal against a portion of the patient's nasal cartilaginous framework. The nasal mask further includes a plenum chamber that receives a portion of the patient's nose, including the nasal tip, during use. The positioning and stabilizing structure includes a pair of side straps that provide a two-point connection to the nasal mask, the side straps being constructed and arranged to be donned and removed without passing the side straps below the patient's ears.</p><p>Another aspect of the present technology relates to a method of fitting a patient interface to a patient, the method including the steps of positioning a sealing region of the patient interface such that the sealing region encompasses both nostrils, and engaging headgear straps of the patient interface with the patient's head without passing the straps below the patient's ears.</p><p>Another aspect of the present technology relates to a nasal mask for delivering an air supply to an entrance to a patient's airways. The nasal mask includes an upper sealing portion and an inferior sealing portion. The upper sealing portion is configured and arranged to overlie a portion of the cartilaginous framework of the nose and form a seal therewith without exerting a sealing force that would restrict airflow through the nasal passages. The inferior sealing portion is configured and arranged to overlie a portion of the patient's upper lip and direct a sealing force against a portion of the patient's maxilla.</p><p>Another aspect of the present technology relates to a nasal mask defining a breathing chamber that delivers a gas supply at positive pressure to a patient's airway. The nasal mask includes a vent and a cushion. The vent is adapted to exhaust breathable gas and is adapted to be rigid enough to avoid collapse. The cushion includes a sealing cuff and a headgear connector. The sealing 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 nasal side region of the cushion, and the undercushion is located at an upper lip region of the cushion and does not extend to the nasal ridge region of the cushion or the nasal side region of the cushion. The headgear connector is formed by a sidewall of the cushion.</p><p>Another aspect of the present technology relates to a patient interface for providing an air supply at positive pressure 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 against a portion of the patient's upper lip and to form a seal against a portion of the patient's nasal cartilaginous framework. The nasal mask further includes a plenum chamber that receives a portion of the patient's nose, including the nasal tip, during use. The positioning and stabilizing structure provides a sealing vector oriented at an angle relative to Frankfurt Horizontal. The positioning and stabilizing structure includes a two-point connection to the nasal mask.</p><p>Another aspect of the present technology relates to a patient interface for providing an air supply at positive pressure 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 against a portion of the patient's upper lip and to form a seal against a portion of the patient's nasal cartilaginous framework. The nasal mask further includes a plenum chamber that receives a portion of the patient's nose, including the nasal tip, during use. The positioning and stabilizing structure provides a sealing vector oriented at an angle relative to Frankfurt Horizontal. The nasal mask does not include a forehead support.</p><p>Another aspect of the present technology relates to a patient interface for providing an air supply at positive pressure 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 against a portion of the patient's upper lip and to form a seal against a portion of the patient's nasal cartilaginous framework. The nasal mask further includes a plenum chamber that receives a portion of the patient's nose, including the nasal tip, during use. The positioning and stabilizing structure provides a sealing vector oriented at an angle relative to Frankfurt 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.</p><p>Of course, portions of the aspects may form partial aspects of the present technology, and various partial aspects and/or aspects may be combined in various ways and may form additional aspects or partial aspects of the present technology.</p><p>Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims.</p><p>The techniques of the present invention are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings in which like reference characters refer to similar elements and in which:</p><p>8(H) Brief description of the various views of the drawing</p>

8.1 Treatment Systems<figref num="1a">8.1 Diagram of 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 travels 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 in accordance with the present technology. 8.2 Treatment 8.2.1 Respiratory System</figref><figref num="2a">FIG. 1 shows an overview of the human respiratory system, including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm.</figref><figref num="2b">Diagram of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. 8.2.2 Facial anatomy</figref><figref num="2c">FIG. 1 is a front view of a face with several recognized features of superficial anatomy, including upper lip, upper vermilion, lower vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth.</figref><figref num="2d">FIG. 1 is a side view of a face with several recognized features of the surface anatomy, including the glabella, root of the nose, tip of the nose, nasal spine, upper lip, lower lip, chin area, nasal ridge, superior and inferior ear bases. Also shown are superior and inferior, and anterior and posterior directions.</figref><figref num="2e">FIGURE 2 is a further side view of the head, showing the approximate location of the Frankfurt horizontal angle and the nasolabial angle;</figref><figref num="2f">FIG.</figref><figref num="2g">FIG. 2 is a side view of the surface features of a nose.</figref><figref num="2h">FIG. 1 shows the subcutaneous structures of the nose, including the lateral cartilage, septal cartilage, greater alar cartilage, and lesser alar cartilage, and also shows fibroadipose tissue.</figref><figref num="2i">FIG. 1 is a mid-nasal incision approximately a few millimeters from the sagittal plane showing, inter alia, the septal cartilage and the medial crus of the greater alar cartilage.</figref><figref num="2j">FIG. 1 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.</figref><figref num="2k">A lateral view of the skull with the head surface contour and some muscles. The frontal, sphenoid, nasal, zygoma, maxilla, mandible, parietal, temporal and occipital bones are shown. The mental protuberance is shown. The digastric, masseter, sternocleidomastoid and trapezius muscles are shown. 8.3 Patient Interface</figref><figref num="3-1">FIG. 1 is a perspective view of a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-2">1 is a side view of a nasal mask system in accordance with one embodiment of the present technology, the nasal mask system is shown covering the head to show the approximate relative position of the headgear when in use.</figref><figref num="3-3">FIG. 1 is a front view of a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-4">FIG. 1 is a perspective front view of a cushion of a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-5">FIG. 1 is a perspective rear view of a cushion of a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-6">FIG. 13 is a bottom view of a cushion of a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-7">FIG. 1 is a top view of a cushion of a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-8">FIG. 1 is a front view of a cushion of a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-9">FIG. 13 is a rear view of a cushion of a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-10">FIG. 10 is a cross-sectional view of the cushion of the nasal mask system of FIG. 3-9.</figref><figref num="3-11">FIG. 1 is a perspective view of a flexure assembly of a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-12">FIG. 13 is a rear view of a flexure assembly of a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-13">FIG. 3-13 is a cross-sectional view of a flexure assembly of the nasal mask system of FIG. 3-12.</figref><figref num="3-14">FIG. 13 is a perspective rear view of a cushion of a nasal mask system in accordance with another embodiment of the present technology.</figref><figref num="3-15">FIG. 3-15 is a top view of the cushion of FIG. 3-14.</figref><figref num="3-16">FIG. 3-15 is a bottom view of the cushion of FIG. 3-14.</figref><figref num="3-17">FIG. 3-15 is a front view of the cushion of FIG. 3-14.</figref><figref num="3-18">FIG. 3-18 is a cross-sectional view of the cushion of FIG. 3-17.</figref><figref num="3-19">FIG. 3-18 is an enlarged view of a portion of FIG.</figref><figref num="3-20">FIG. 3-14 is a rear view of the cushion.</figref><figref num="3-21">FIG. 3-14 is a side view of the cushion of FIG.</figref><figref num="3-22">FIG. 3-14 is a rear view of the cushion of FIG. 3-14 showing the section lines.</figref><figref num="3-23">3-23 is a cross-sectional view taken along line 3-23 in FIG. 3-22.</figref><figref num="3-24">3-24 is a cross-sectional view taken along line 3-24 in FIG. 3-22.</figref><figref num="3-25">3-25 is a cross-sectional view taken along line 3-25 in FIG. 3-22.</figref><figref num="3-26">3-26 is a cross-sectional view taken along line 3-26 in FIG. 3-22.</figref><figref num="3-27">3-27 is a cross-sectional view taken along line 3-27 in FIG. 3-22.</figref><figref num="3-28">3-28 is a cross-sectional view taken along line 3-28 in FIG. 3-22.</figref><figref num="3-29">3-29 is a cross-sectional view taken along line 3-29 in FIG. 3-22.</figref><figref num="3-30">3-22 through line 3-30 and a cross-sectional view taken along line 3-30.</figref><figref num="3-31">FIG. 2 is one of a series of diagrams illustrating exemplary steps for donning a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-32">FIG. 2 is one of a series of diagrams illustrating exemplary steps for donning a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-33">FIG. 2 is one of a series of diagrams illustrating exemplary steps for donning a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-34">FIG. 2 is one of a series of diagrams illustrating exemplary steps for donning a nasal mask system in accordance with one embodiment of the present technology.</figref><figref num="3-35">FIG. 1 is a cross-sectional view showing a nasal mask system engaged with a patient's face in accordance with one embodiment of the present technology.</figref><figref num="3-36">FIG. 1 is a cross-sectional view showing a nasal mask system engaged with a patient's face in accordance with one embodiment of the present technology.</figref><figref num="3-37">FIG. 3-14 is another perspective view of the cushion of FIG.</figref><figref num="3-38">1 illustrates a cushion assembly under pressure or inflated during use and engaged with a patient's face in accordance with one embodiment of the present technology.</figref><figref num="3-39">FIG. 2 is a schematic rear view of a cushion assembly showing the sealing portion engaged with a patient's face in use, in accordance with one embodiment of the present technology.</figref><figref num="3-40-1">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-40-2">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-40-3">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-40-4">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-40-5">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-40-6">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-40-7">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-40-8">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-41-1">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-41-2">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-41-3">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-41-4">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-41-5">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-41-6">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-41-7">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-41-8">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-41-9">11A-11D show various views of a cushion assembly in accordance with another embodiment of the present technology.</figref><figref num="3-41-10">8.4 PAP Device</figref><figref num="4a">FIG. 1 shows a PAP device according to one embodiment of the present invention.</figref>

9(I) DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS Before describing the present technology in more detail, it is to be understood that the present technology is not limited to specific embodiments described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of only describing the specific embodiments described herein, and is not intended to be limiting.

The following description is provided in the context of several embodiments that may share common characteristics and features. It should be understood that one or more features of any one embodiment may be combinable with one or more features of other embodiments. In addition, any single feature or combination of features in any embodiment may constitute an additional embodiment.

The word "comprising" as used herein is to be understood in its "open" sense, i.e. in the sense of "including" and therefore not limited to its "closed" sense, which is in the sense of "consisting only of". Where the corresponding words "comprise", "comprised" and "comprises" appear, corresponding meanings abide by these words.

The term "air" is to be interpreted to include breathable gases, for example air with supplemental oxygen. Thus, an air supply may correspond to a supply of gases including air and supplemental oxygen.

Embodiments of the present technology are directed to nasal mask systems that can be easily and quickly fitted (e.g., with little or no adjustment), allow for reduced strap tension, are manufacturable in high volume, have high consumer appeal, provide comfort and a seal, offer reliable quality, are non-occlusive, and/or fit the majority of people.

One or more examples may include example measures, e.g., dimensions, angles, percentages, etc. Thus, while particular measures and ranges may be provided, it should be understood that these measures and ranges are merely exemplary and other measures and ranges are possible depending on the application. For example, measures/ranges that vary ±10-20% from those provided may be suitable for a particular application.

9.1 Treatment System In one form, the present technology includes an apparatus for treating a respiratory disorder. In one embodiment, the apparatus includes a flow generator or blower that supplies pressurized breathing gas, such as air, to a patient 1000 via an air conduit leading to a patient interface 3000 (see, e.g., FIG. 1a). In one form, the apparatus is a CPAP system, and in another form, the apparatus is a ventilator.

9.2 Treatment In one form, the present technology includes a method of treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000 (see, for example, FIG. 1a).

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

9.3 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 that connects 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 the entrance of the patient's airway to facilitate the supply of air at positive pressure to the airway.

In one embodiment, the plenum chamber 3200 and the seal-forming structure 3100 are molded as a single piece. In another embodiment, they are formed as two or more separate components.

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

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 the air delivery assembly 130 and/or the flexure assembly 120, and may be supported in place by the headgear assembly 110.

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

3-14-3-30, 3-35, and 3-36-1-3-40-2 show various views of a cushion assembly 250 according to another embodiment of the present technology, which is similar to cushion assembly 150. As described below, cushion assembly 250 includes a thinner wall section adjacent the upper lip region of the sealing region of the cushion assembly (e.g., to avoid excessive pressure on the patient's nasal bridge and septum), and each nasal side region of the sealing region includes a wing or sealing flap adapted to form a seal against an area adjacent the junction between the greater alar cartilage and the lateral nasal cartilage of the patient's nose.

In the embodiment shown in Figs. 3-14 to 3-21, D₁is about 85 to 105 mm (e.g., about 97 mm), and D₂is about 35 to 55 mm (e.g., about 48 mm), and D₃is about 35 to 55 mm (e.g., about 44 mm), and D₄is about 30 to 50 mm (e.g., about 41 mm), and D₅is about 25 to 45 mm (e.g., about 35 mm), and D₆is about 20 to 30 mm (e.g., about 26 mm), and D₇is about 40 to 60 mm (e.g., about 50 mm), and D₈is about 20-30 mm (e.g., about 23 mm). Although specific dimensions are provided, it should be understood that these dimensions are exemplary only and other dimensions are possible depending on the application. For example, the exemplary dimensions may vary by ±10-20% more or less depending on the application.

9.3.1 Seal-Forming Structure 3100 In one form of the present technology, the seal-forming structure 3100 provides a sealing surface and may additionally provide a cushioning function.

In one embodiment, a seal-forming structure 3100 in accordance with the present technology is constructed from a soft, flexible, resilient material, such as silicone.

In one form, the seal-forming structure 3100 comprises a sealing flange 3110 and a support flange 3120. In one form of the present technology, the sealing flange 3110 comprises the membrane 160 of the sealing region 151, and the support flange 3120 comprises the undercushion or backing band 165 of the sealing region 151 (see, for example, Figs. 3-10). In one embodiment, the sealing 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, that extends around the periphery 3210 of the plenum chamber 3200. In one embodiment, the support flange 3120 is relatively thicker than the sealing flange 3110. The support flange 3120 is disposed between the sealing flange 3110 and the peripheral edge 3220 of the plenum chamber 3200 and extends to at least a portion of the periphery of the periphery 3210 of the plenum chamber 3200. The support flange 3120 is a spring-like element which acts to support the sealing flange 3110 against buckling during use. During use, the sealing flange 3110 is in tight sealing engagement with the face on its underside. The plenum chamber 3200 may be readily responsive to system pressure acting to stimulate sealing engagement.

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 located adjacent to one another, with one area blending into the other.

9.3.1.1 Superior Sealing Portion 3102 The superior sealing portion 3102 is constructed and arranged to form a seal against a portion of the cartilaginous framework of the nose. In one embodiment, the superior sealing portion 3102 is constructed, for example, of a flap, flange or membrane made of a relatively thin material, for example, a thermoplastic elastomer or silicone rubber material, and further, a material that easily flexes or folds in response to, for example, light finger pressure when not in use. Depending on the nose shape being used, the relatively narrow superior sealing portion 3102 can engage and form a seal with the nasal ridge. The relatively wider portion of the superior sealing portion 3102 can engage and form a seal with the skin adjacent the lateral nasal cartilage. See, for example, FIG. 3-39.

The upper sealing portion 3102 is not designed to cover the entire nose.

In one embodiment, the upper sealing portion 3102 is constructed and arranged, for example, by being thin and flexible, so that it can conform to nasal ridges of various heights, thus increasing the range of faces on which a good seal can be obtained.

Furthermore, for a given face and nose, the flexibility of the upper sealing portion 3102 means that a seal can be maintained when, for example, the plenum chamber 3200 may move in response to the air circuit 4170 moving.

The superior sealing portion is configured so as not to cover the nasal bone during use, however, depending on exactly how the patient interface is used and the size and shape of the particular face, certain portions of the superior sealing portion may cover some portion of the nasal bone on some faces.

In an alternative form, the superior sealing portion is constructed and arranged to form a seal against the nasal bone during use.

9.3.1.2 Inferior Sealing Portion 3104 The inferior sealing portion 3104 is constructed and arranged to form a seal against a portion of the patient's upper lip and direct at least a portion of a sealing force against the patient's maxilla. In use, a portion of the inferior sealing portion 3104 is located under the alar and near the apex of the alar.

In one form, the inferior sealing portion is configured to avoid placing excessive pressure on the upper teeth or gums. In one embodiment, the inferior sealing portion does not extend along the bone (e.g., the frontal process of the maxilla) above the apex of the alar, although it should be understood that in other embodiments this may be the case.

The lower sealing portion 3104 may be comprised of a single relatively thick flap, rim or flange, for example made of a silicone rubber or thermoplastic elastomer material having a thickness of, for example, about 1 mm to 2 mm. In one form, the lower sealing portion 3104 may be comprised of dual flaps, rims or flanges, for example one relatively thin and the other relatively thick. Alternatively, the lower sealing portion 3104 may be comprised of a gel-filled bladder.

9.3.1.3 "W" Shaped Region FIGS. 3-40-1 through 3-40-8 show various views of a cushion assembly 350 in accordance with another embodiment of the present technology. In this example, the cushion assembly includes an overall "W" shape in the upper lip region, i.e., an overall "W" shape along the outer (lower) edge 360(o) of the membrane 360 in the upper lip region, as best shown in FIG. 3-40-4.

3-41-1 through 3-41-8 show various views of a cushion assembly 450 in accordance with another embodiment of the present technology. This example shows a cushion assembly having an overall "W" shape in the upper lip region. In contrast to the embodiment of FIG. 3-40-1 through 3-40-8, the cushion embodiment of FIG. 3-41-1 through 3-41-8 includes an overall "W" shape along both the inner (superior) end 460(i) of the membrane 460 in the upper lip region and the outer (inferior) end 460(o) of the membrane, as best shown in FIG. 3-41-4.

In one form, the "W" portion of the upper lip area is constructed and arranged such that when the seal-forming portion shifts upwardly (superiorly) during use, a middle portion of the "W" may rest under the alar or on the bridge of the nose during use, leaving a gap around the respective left and right alar (e.g., between the inner end of the undercushion 465 and the inner surface of the plenum chamber, as shown by c in FIG. 3-41-8).

In one example, as best shown in Figs. 3-41-6, 3-41-7, and 3-41-10, a portion of the sealing portion may have a question mark, sickle, or c-shaped cross-section. The question mark, sickle, or c-shaped cross-section may provide the sealing portion with a greater range of motion or flexibility relative to the patient's face during use. In the illustrated embodiment, 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 below the lower portion of the undercushion 465 and adjacent to the sidewall region 457. For example, the lower portion of the undercushion 465 is radially offset outwardly of the sidewall region 457. It should be understood that such a cross-section may be provided around the entire circumference of the cushion or may be provided only in selected regions of the cushion, for example only in the upper lip region. Additionally, the size and/or configuration of such cross-sections may vary in selected regions.

In the illustrated embodiment of Figs. 3-40-1 to 3-40-8 and Figs. 3-41-1 to 3-41-8, D₁is about 90 to 110 mm (for example, about 105 mm), and D₂is about 40 to 60 mm (e.g., about 51 mm), and D₃is about 40 to 60 mm (e.g., about 51 mm), and D₄is about 35 to 55 mm (e.g., about 44 mm), and D₅is about 30 to 50 mm (e.g., about 38 mm), and D₆is about 25 to 35 mm (e.g., about 32 mm), and D₇is about 45 to 65 mm (e.g., about 58 mm), and D₈is about 20-30 mm (e.g., about 26 mm). Although specific dimensions are provided, it should be understood that these dimensions are exemplary only and other dimensions are possible depending on the application. For example, the exemplary dimensions may vary by ±10-20% more or less depending on the application. For example, the sealing portion and opening may be wider, e.g., D₁is about 100 to 120 mm (for example, about 114 mm), and D₆is about 40 to 50 mm, for example, about 42 mm), and D₇is about 55 to 75 mm (for example, about 68 mm), and D₈D is about 20-30 mm (e.g., about 24 mm). In another embodiment, the sealing portion and the opening may be narrower, e.g., D₁is about 90 to 110 mm (for example, about 100 mm), and D₆is about 25 to 35 mm (e.g., about 28 mm), and D₇is about 45 to 65 mm (e.g., about 54 mm), and D₈is about 20 to 30 mm (for example, about 24 mm).

9.3.1.4 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 and form a seal with the patient's airway. The sealing area 151 may include a nasal ridge or nasal ridge area 152, a nasal side area 153, a nasal corner area 154, and an upper lip area 155. The sealing area 151 may comprise a membrane or flap-type seal 160. In one embodiment, as shown in Figs. 3-18 and 3-19, the inner edge of the membrane 260 may include a bead 260-1 to prevent separation and enhance sealing along the edge, for example. The sealing area 151 may further comprise an undercushion or backing band 165 that extends around a portion or the entire periphery of the sealing area. A further aspect of the present technology is a cushion for a mask that, at its upper extent, seals against the nose, the area generally above the tip of the nose, and extends across the ala or flare of the patient's nose.

In one embodiment, the sealing region 151 may be preformed or otherwise pre-shaped to conform to the patient's facial topology.

9.3.1.4.1 Sealing Along the Nasal Ridge One aspect of the present technology relates to sealing of a sealing area in the nasal ridge region. In one embodiment, the sealing area in the nasal ridge region is adapted to engage along the nasal ridge between the tip and the base of the nose and along the nasal cartilage region of the nasal ridge below or below the nasal bone. That is, the nasal mask system is configured to have a seal-forming area that is substantially over at least a portion of the patient's cartilaginous framework of the nose and not over the nasal bone, i.e., that seals along the nasal ridge without contacting the bridge of the nose/skin over the nasal bone.

For example, sealing region 151 is adapted at its upper extent to be positioned and seal in the area of the nose generally above the tip of the nose (i.e., above the tip of the nose) and extends across the ala or flare of the patient's nose, e.g., does not extend above or across the patient's nasal bone.

In one embodiment, the sealing region 151 is positioned at its upper extent in an area generally near the junction between the bone and cartilage of the nose of people with larger noses to avoid obstructing the view of people with smaller noses.

9.3.1.4.2 Nasal Ridge Region The nasal ridge region 152 may be adapted to engage the patient's nasal ridge. In one embodiment, the nasal ridge region may be shaped or preformed to conform to the patient's nasal ridge, for example, the nasal ridge region may be lower (i.e., closer to the attachment region 158) than the nasal side region 153, as best shown in FIG. 3-7. The nasal ridge region 152 may include a membrane 160 that seals without an undercushion or backing band. In one embodiment, such a configuration prevents excessive pressure from being applied to the sensitive nasal ridge region. In one embodiment, the membrane in the nasal ridge region 152 may be relatively longer than the membrane in other regions of the sealing area, for example, the membrane in the upper lip region 155. The membrane in the nasal ridge region 152 may be, for example, about 2-5 mm long. In one embodiment, the membrane in the nasal ridge region 152 may be about 2-4 mm long. In one embodiment, the membrane in the nasal ridge region 152 may be about 3 mm long.

9.3.1.4.3 Nasal Side Region The nasal side region 153 may be adapted to engage the side of the patient's nose. In one embodiment, the nasal side region 153 may be preformed to conform to the side of the patient's nose and possibly the patient's cheek. As best shown in FIG. 3-5, the nasal side region 153 extends from the apex of the cushion at the nasal ridge region 152 to the nasal corner region 154. The nasal side region 153 slopes downward from the nasal ridge region 152 to the nasal corner region. See, for example, FIG. 3-6. The nasal side region 153 may include a membrane 160 that seals without an undercushion or backing band. In one embodiment, such a configuration prevents excessive pressure from being applied to the side or ala or flares of the patient's nose. Excessive pressure on these regions may cause the nasal cartilage to collapse inward toward the septum, thereby obstructing or partially obstructing the patient's airway.

9.3.1.4.4 Nose Corner Region The nose corner region 154 may be adapted to form a seal with the corner of the patient's nose. FIG. 3-6 illustrates the maximum height of the sealing region 151, generally H₁1 shows the nose corner region 154 with an apex or point indicated by . This height is to ensure that most of the force is applied to the sealing area 151 in the nose corner region 154 since this is a bony area of the face and therefore is less sensitive to pressure. Furthermore, this area of the patient's face is particularly difficult to seal because the shape in this area of the face is very complex and the more force is applied to the seal in this area, the more likely it is that the seal will form. Additionally, the sealing force required in the nasal ridge and nasal side regions is lower (for comfort and to avoid blockage) so the sealing area must be secured to the nose corner region. The nose corner region 154 may comprise a membrane or membrane seal 160 and an undercushion or backing band 165. By using both a membrane and an undercushion, a higher sealing force can be ensured in this region. In one embodiment, the membrane may have a thickness of about 0.1-0.5 mm, for example, about 0.3 mm. In one embodiment, the undercushion may have a thickness of about 0.3-2 mm.

9.3.1.4.5 Upper Lip Region The upper lip region 155 may be adapted to engage a surface between the patient's upper lip and the base of the nose. In one embodiment, the upper lip region may have a relatively shorter membrane length than the nasal ridge region, for example, a length of about 0.5-2.5 mm, for example, about 1.5-2.5 mm. In one embodiment, this shorter membrane length may be advantageous since 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 backing band 165. By using both a membrane and an undercushion, a higher sealing force can be ensured in this region. In one embodiment, the membrane may have a thickness of about 0.1-0.5 mm, for example, about 0.3 mm. In one embodiment, the undercushion may have a thickness of about 0.3-2 mm, for example, about 1.5 mm. In one embodiment, the thickness of the undercushion may vary along the length of the upper lip region, for example, from about 0.3 mm in the nose corner region to about 1.2 mm in the center of the upper lip region.

9.3.1.5 The use of a sealing undercushion or backing band allows the membrane or face flap to be considerably thinner than if a single unsupported flap were used. This is highly advantageous in that a thinner flap will be more flexible, and therefore softer and more comfortable to the touch, and will more easily conform to irregular facial contours. This also allows the flap to more easily respond to system pressures in the breathing chamber which act to urge it into tight sealing engagement with the face on its underside.

As described above, the nasal mask system is configured to have a seal-forming region that is mostly over the cartilaginous framework above the nose (i.e., not over the nasal bone) and does not occlude the nose. In one embodiment, this may be achieved by providing a pressure seal (e.g., using an undercushion structure) along the patient's upper lip (e.g., the lower sealing portion) but not against the patient's nose. The seal against the patient's nose (e.g., the upper sealing portion) may be achieved by tension in the membrane and/or a pneumatic seal.

For example, as shown in the cushion embodiment of Figures 3-14-3-30 and described in the above embodiments, the undercushion or backing band 265 is provided only in the upper lip region 255 and nose corner region 254 of the cushion. See, for example, Figures 3-16, 3-18, 3-22, 3-23, 3-29, and 3-30. That is, the sealing region includes only a single layer or membrane 260 structure in the nasal ridge region 252 and nose side region 253 (see, for example, Figures 3-18 and 3-22-3-28), while the sealing region includes a dual layer or membrane 260 and undercushion 265 structure in the upper lip region 255 and nose corner region 254. The dual layer structure provides a compression seal along the upper lip region and nose corner region. In contrast, the nasal ridge and nasal side regions provide a seal using tension within the membrane (tension on the membrane causing the edges of the membrane to stretch towards a sealing engagement) and/or pressure within the breathing chamber acting on the membrane (pneumatic seal). A single layer is also provided in the nasal ridge and nasal side regions to provide a softer, more flexible seal that avoids any possibility of blocking the patient's nose, i.e., preventing excessive pressure from being applied against the sides or ala or flares of the patient's nose which could potentially cause the cartilage to collapse at least partially inwards into the patient's airway.

Thus, a cushion assembly according to one embodiment of the present technology provides different sealing mechanisms in different portions of the cushion. For example, the cushion assembly may provide one sealing mechanism (e.g., tension and/or pneumatic seal in the membrane) in the upper portion of the cushion and a different sealing mechanism (e.g., compression seal) in the lower portion of the cushion. In the illustrated embodiment, the cushion assembly provides the compression seal via a bi-layer or membrane and undercushion structure. However, it should be understood that the compression seal may be provided by alternative structures, such as gel-filled or foam-filled pockets, thicker single walls (e.g., silicone about 0.8-1.2 mm thick).

FIG. 3-38 illustrates an embodiment of the cushion assembly 250 engaged with a patient's face and under pressure or inflated, i.e., an air supply at positive pressure is provided to the cushion assembly 250. FIG. 3-39 illustrates a shaded area along the sealing portion of the cushion assembly, indicating a width or contact area 280 of the sealing portion engaged with the patient's face, in use. The width or contact area includes an inner end 280(i) (i.e., along the edge of the orifice) and an outer end 280(o). FIG. 3-36 also illustrates the outer end 280(o) of the contact area in dashed lines. As illustrated, a relatively narrow upper sealing portion 3102 can engage the nasal ridge to form a seal, for example, depending on the shape of the nose being used. A relatively wider portion of the upper sealing portion 3102 can engage the skin adjacent the lateral nasal cartilage to form a seal. In the lower sealing portion 3104, substantially the entire width of the lower sealing portion can engage the skin along the nose corner area and upper lip area to form a seal. Thus, the width or contact area of the sealing portion engaged with the patient's face during use to form a seal can vary around the periphery of the cushion assembly.

9.3.1.6 Sealing Flaps In one embodiment, as shown in Figures 3-14, 3-16, 3-20, 3-22, 3-26, 3-27, 3-35, and 3-36, each nasal side region 253 of the sealing area includes a portion 270, e.g., a wing or sealing flap, that projects from the end 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 against the area adjacent the junction between the greater alar cartilage and the lateral nasal cartilage (also referred to as the alar muscle) of the patient's nose. The exact location of the sealing flap on the face during use may vary depending on the size and shape of the nose being used.

As shown, each sealing flap 270 is at least partially angled or pre-biased outwardly from the breathing chamber of the cushion. When engaged with the patient's nose, the sealing flap is biased toward the breathing chamber providing a bias for sealing at the junction. That is, the shape, flexibility and pre-bias of the sealing flap allow the flap to conform to changes in curvature or contour at this junction (e.g., as the nasal ala or "flare" tends to move constantly during use) thereby maintaining a seal and preventing leakage during use.

In one embodiment, the sealing flange (including membrane 260 and sealing flap 270) defines a generally T-shaped orifice. The ends of membrane 260 along its inner periphery, together with the ends of each sealing flap 270 along their inner periphery, cooperate to define an orifice 275 into the plenum chamber. In one embodiment, such orifice 275 includes a generally T-shape including an upper orifice portion 275(1) (along vertical axis v as seen in FIG. 3-20) and a lower orifice portion 275(2) (along horizontal axis h as seen in FIG. 3-20) that extends generally transversely to upper orifice portion 275(1).

As best shown in FIGS. 3-14, the sealing flap 270 varies the curvature and/or angle of the edge that defines the orifice 275, i.e., the edge of the orifice 275 curves upward and outward from the breathing chamber at least along the sealing flap 270.

9.3.1.6.1 Curvature The curvature of the cushion may vary along the patient-contacting surface of membrane 260 in different areas of the cushion to allow sealing in different areas of the patient's face.

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 is locally saddle-shaped curved, e.g., curved up in one direction d1 and curved down in a different direction d2. FIG. 3-37 is another view of the cushion assembly 250 illustrating such saddle-shaped curvature in the nasal ridge region 252 and the upper lip region 255.

It should be understood that the curved shapes described above are approximate shapes and should not be limited to precise mathematical definitions of such shapes.

In addition, it should be understood that while regions may include similar curved shapes, the degree of such curvature may vary. For example, nasal ridge region 252 and upper lip region 255 may both include at least a portion that is locally saddle-shaped, but the predominant direction of one and/or both of such saddle shapes may differ in each region.

9.3.2 Opening In one embodiment, if a single mask is to be used to fit approximately 85% of the female population, the undercushion opening width (e.g., as shown at uw in FIG. 3-41-9) is about 36 mm to about 42 mm, or about 38 mm to about 40 mm. In one embodiment, if a single mask is to be used to fit approximately 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 embodiment, to accommodate the variability in nose widths of various ethnicities, to fit up to 95% of the average population, the undercushion opening width is about 50 mm to about 56 mm, or about 52 mm to about 54 mm.

In one embodiment, if a single mask is to be used to fit about 85% of the female population, the membrane opening width (e.g., as shown in mw in FIG. 3-41-9) is about 23 mm to about 29 mm, or about 25 mm to about 27 mm. In one embodiment, if 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 embodiment, to accommodate the variability in nose widths of various ethnicities, to fit up to 95% of the average population, the membrane opening width is about 49 mm to about 55 mm, or about 51 mm to about 53 mm.

9.3.3 Plenum Chamber 3200 The plenum chamber 3200 is formed 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 periphery 3210 that is generally shaped to match the surface contours of an average human face (see, e.g., Figs. 3-8 and 3-9). In use, the peripheral edge 3220 of the plenum chamber 3200 is positioned in close proximity 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 embodiment, the seal-forming structure 3100 extends around the entire periphery 3210 of the plenum chamber 3200 in use. In one embodiment, the plenum chamber is adapted to receive a portion of the patient's nose, including the tip of the nose, for example, the plenum chamber forms over and surrounds a portion of the cartilaginous framework of the nose, including the tip of the nose.

In one embodiment, the walls of the plenum chamber 3200 are flexible or semi-rigid. In one embodiment, the plenum chamber 3200 does not include a rigid frame or shell. In one embodiment, the walls of the plenum chamber 3200 are not rigid, e.g., the walls of the plenum chamber 3200 are not flexible. In certain configurations, the flexibility of the walls of the plenum chamber 3200 helps to prevent pulling forces on the tube from destroying the seal.

In one form, the walls of the plenum chamber 3200 are molded from silicone rubber. In one embodiment, the walls of the plenum chamber 3200 are constructed from silicone rubber having a Type A indentation durometer 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.

9.3.3.1 Sidewall Region The sidewall region 157 may extend between the sealing region 151 and the attachment region 158. The sidewall region may be generally conical, i.e., having a first diameter near the attachment region 158 and a second diameter near the sealing region 151, the first diameter being smaller than the second diameter. The sidewall region may have a thickness of about 1.5-5 mm, e.g., 1.5-3 mm, e.g., about 2 mm. Such a thickness may provide some support to the sealing region 151, prevent the flexure assembly 120 from contacting the patient's nose, and ensure that the cushion does not collapse from tension in the headgear when in use.

Sidewall region 157 may be connected to or formed by headgear connectors 156. Such a configuration may replace the need for a rigid frame or framework because the headgear connectors are located proximate sealing region 151. Headgear connectors 156 may be located on opposite sides of sidewall 157.

9.3.3.2 Thinner Wall Section In one embodiment, 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 that is less than the corresponding thickness adjacent the nasal ridge, nasal side, and nasal corner regions of the sealing region. That is, region 268 includes a thinner cross-section of the wall adjacent the upper lip region 255 of the sealing region. Such a thinner cross-section region 268 reduces the force exerted by the sealing region on this section of the upper lip region 255. For example, such region 268 may provide less pressure along the upper lip region 255 than along the nasal corner region 254 (i.e., be stiffer along the nasal corner region than along the upper lip region) to avoid exerting excessive pressure on the columella or septum of the patient's nose, which are the more sensitive areas of the patient's nose, thereby generating or achieving a relatively greater pressure along the nasal corner region (along the corner of the lip adjacent the ala of the nose).

3-22-3-30 show exemplary cross-sectional views through various regions of the cushion assembly 250. For example, FIG. 3-23 shows a cross-sectional view 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 a double layer or membrane 260 and undercushion 265 in the upper lip region 255. FIG. 3-23 also shows a thinner region 268 of the cross section in the sidewall region 257 adjacent the upper lip region 255 to avoid excessive pressure on the nasal bridge or septum, for example. In addition, FIG. 3-23 shows the attachment region 258 including a thinner wall section 258(1) that allows for, for example, isolating the traction forces of the tube. FIG. 3-24 and FIG. 3-25 show the construction of only a single layer or membrane 260 in the nasal side region 253. Figures 3-26 and 3-27 also show the construction of only a single layer or membrane 260 in the nose side region 253, and at least a portion of the wings or sealing flaps 270 protruding from the ends of the membrane 260. Figures 3-27 and 3-28 show at least a portion of the headgear connector 256. Figures 3-29 and 3-30 show the construction of a dual layer or membrane 260 and undercushion 265 in the nose corner region 254 and upper lip region 255. Figure 3-30 shows a thinner region 268 of cross section in the sidewall region 257 adjacent the upper lip region 255.

9.3.4 Positioning and Stabilising Structure 3300 In one embodiment of the seal-forming structure 3100 of the patient interface 3000 of the present technology is held in a sealing position during use by a positioning and stabilising structure 3300.

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

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

In one embodiment, there are only two headgear connectors 156 to the plenum chamber 3200 .

9.3.4.1 Headgear Connector The headgear connector 156 may include a lug or interface 159 adapted to receive the cushion connector 116 on the headgear assembly 110. A similar arrangement is disclosed in PCT Application No. PCT/AU2008/001557, filed October 22, 2008, which is incorporated herein by reference in its entirety.

The headgear connectors 156 may be positioned at an angle relative to the vertical axis of the sealing region 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 region 151. In one embodiment, the angle α may be about 90-135°. In one embodiment, the angle α may be about 90-120°. In one embodiment, the angle α may be about 90-100°. The angle α positions the headgear connectors to ensure that the sealing force between the cushion and the patient, particularly at the nasal side region 153 of the sealing region 151, is sufficient to achieve a seal without causing discomfort or allowing the cushion to collapse (e.g., the closer the angle α is to 180°, the greater the likelihood that the cushion will collapse inward toward the vertical axis when tensioned by the headgear, thus pinching the patient's nose).

In alternative embodiments, as best shown in Figures 3-40-1, 3-40-3, 3-40-5, 3-40-6, 3-41-1, 3-41-3, 3-41-5, 3-41-6, each headgear connector 356, 456 may be provided with a hinge or thinner wall section 356(1), 456(1) to increase the flexibility of the headgear connector and allow it to flex sufficiently to transfer headgear tension and not collapse the cushion inwardly during use, e.g., to avoid pinching of the nasal wings under headgear tension. Also, as shown in Figure 3-41-6, one or more wall sections 457(1) of the sidewall regions 457 between the lugs of the headgear connector may be made thicker, e.g., to prevent or reduce collapse of the sidewall region under headgear tension.

The headgear connectors 156 may be positioned at an angle relative to the horizontal axis of the sealing region 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 region 151. In one embodiment, the angle β may be about 90-135°. In one embodiment, the angle β may be about 90-120°. In one embodiment, the angle β may be about 90-100°. The angle β positions the headgear connectors to ensure that the sealing force provided by the headgear connectors 156 is distributed across the sealing region 151 such that more force is provided at the upper lip region 155 and nose corner region 154 and less force is provided at the nasal ridge region 152. Such a distribution may be more comfortable and stable.

As shown in FIG. 3-8, the headgear connectors 156 have a first width w₁and at its tip has a second width w₂and a first width w₁is the second width w₂In one embodiment, the first width w₁In one embodiment, the first width w₁In one embodiment, the first width w₁In one embodiment, the second width w₂In one embodiment, the second width w₂In one embodiment, the second width w₂The first width w may be about 15 to 20 mm.₁The second width w ensures that the forces exerted by the headgear are distributed from the nose side region 153 to the nose corner region 154 and also stabilizes the cushion in the horizontal plane.₂is configured to reduce the visual bulk of the headgear connector 156 and enable connection with the cushion connector 116.

The headgear connectors 156 are advantageously located proximate the sealing region 151. The headgear connectors 156 are spaced apart from the sealing region 151 at a height H, as shown in FIGS.₁In one embodiment, the height H₁In one embodiment, the height H₁In one embodiment, the height H₁In one embodiment, the height H₁may be about 20-30 mm. This configuration ensures that the force of the headgear is transferred directly to the sealing portion, and the sealing area is able to wrap or conform to the shape of the patient's nose.

The location and size of the headgear connectors direct the sealing forces to the sealing area, thereby negating or eliminating the need for forehead supports or vertical headgear straps. For example, the width of the headgear connectors in close proximity to the side walls stabilizes the sealing area against the patient's face. The height of the headgear connectors 156 to the sealing area 151 ensures that the headgear forces are transferred directly to the sealing area, thereby eliminating the need for additional stabilization from a forehead support.

In an alternative form of the present technology, the headgear connectors 156 are formed separately from the plenum chamber.

9.3.4.2 Headgear Assembly One form of a 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 the cushion assembly 150 on the patient's face.

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 sides of the patient's face across the patient's cheeks, for example, between the patient's eyes and ears, covering at least a portion of the cheekbones, and extending toward the top of the patient's head, for example, covering 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 interlock or otherwise connect to one another and are adjustable relative to one another in the length direction. The rear straps 118 extend between the side straps and may be looped through respective slots 114 provided in the side straps 115. The rear straps 118 may be positioned over the back of the patient's head, for example, engaging along or below the occipital region of the patient's head. In one embodiment, the rear straps 118 or rear headgear loops cover or engage a point on the head that is below or inferior to the occipital bone, e.g., a portion of the strap overlies a portion of the trapezius muscle adjacent to the occipital bone during use. In one embodiment, at least a portion of the rear straps 118 engage below or inferior to the lower end of the occipital bone, which helps to keep the rear straps in place and prevent them from riding up against the patient's head, e.g., sliding superiorly. See FIG. 2i and FIG. 3-2 for the location of the trapezius muscle and exemplary positioning of the rear straps 118 along a portion of the trapezius muscle. In one embodiment, the headgear straps are sufficiently stretchy or flexible to improve comfort and adjustability. For example, the headgear may not require length adjustment to be worn.

In one form, the headgear assembly 110 comprises a silicone main section and a fabric rear section. In another form, the headgear assembly 110 comprises a fabric main section and a fabric rear section. In another form, the headgear assembly 110 comprises a silicone main section and a silicone rear section.

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

In one form, the headgear assembly 110 includes a main structural tie and a rear structural tie.

An exemplary headgear assembly 110 is disclosed in US Pat. No. 6,399,432, filed Oct. 22, 2008, which is incorporated herein by reference in its entirety.

9.3.5 Vent 3400 In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the exit of exhaled carbon dioxide.

One embodiment of the vent 3400 in accordance with the present technology includes a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

In one embodiment, the vent 3400 is located in the isolation structure 3500, such as a swivel 3510. Alternatively, the vent 3400 is located in the plenum chamber 3200.

One form of vent 3400 according to the present technology is vent 126. Vent 126 may allow exhaled gas to exit the nasal mask system. Vent 126 may comprise a series of holes, mesh, or other configuration adapted to allow gas to flow. In one embodiment, vent 126 may be sufficiently rigid to avoid collapsing the air flow path that exhausts exhaled gas. Vent 126 may be located in bend 125 or other areas such as air delivery assembly 130 or cushion assembly 150 (including, for example, sidewall 157).

In certain forms of the present technology, the vent 3400 may be constructed from a flexible or pliable material supported by a frame that is sufficiently rigid to avoid collapsing the air flow path through which exhaled gases escape.

In an alternative embodiment, the patient interface 3000 does not include a vent.

9.3.6 Decoupling Structure(s) 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 joint 3520 (see, e.g., FIG. 3-13). In one form, the decoupling structure 3500 may be formed, at least in part, by the attachment region 158.

9.3.6.1 Attachment Region The attachment region 158 may be adapted to receive the flexure assembly 120. The attachment region 158 may include a wall section 158(1) that is thinner than the sidewall region 157, for example, the attachment region 158 may have a wall section of about 0.1-1 mm, such as about 0.2-0.8 mm, for example about 0.5 mm. In one embodiment, the thinner wall section is configured to allow for separation of tube traction forces from sealing forces.

9.3.7 Connection Port 3600 In one form, a connection port 3600 to the air circuit 4170 is created by the flexure assembly 120 (see, eg, Figures 3-1 and 3-2).

9.3.7.1 Flexure Assembly The flexure assembly 120 may be adapted to connect or act as an interface between the cushion assembly 150 and the air delivery assembly 130. The flexure assembly 120 may be formed with or integrally with the air delivery assembly 130, or the cushion assembly 150. The flexure assembly 120 may also be adapted to allow for the exhaust of exhaled gases.

As shown in Figures 3-1-3 and 3-11-3-13, the flexure assembly 120 may include a flexure 125 having an air vent 126, the flexure connected to or otherwise formed with a connector ring 128. The flexure 125 may be formed with a ball and socket joint, and the connector ring 128 may be constructed and arranged to allow rotation of the ball and socket joint while ensuring a sufficient seal with the flexure to ensure that air leakage does not compromise the patient treatment pressure. The ball and socket joint provides a decoupling mechanism, for example, to separate tube traction forces from sealing forces.

Flexure 125 may also be attached or otherwise connected to a swivel 129 that is adapted to receive air delivery assembly 130. Swivel 129 may be configured to form a seal with flexure 125 or to have low leakage with the flexure while still being able to rotate freely relative to flexure 125.

9.3.8 Forehead Support In one embodiment, the patient interface 3000 does not include a forehead support, although in an alternative form, a forehead support may be included.

9.3.9 Anti-Asphyxiation In one form, the patient interface 3000 includes an anti-asphyxiation valve.

9.3.10 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a suitable gas, such as pressure, to be measured directly within the plenum chamber 3200.

9.3.11 Air Circuit 4170 An air circuit 4170 according to 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 nasal mask system 100. As shown in Figures 3-1 to 3-3, the air delivery assembly 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 flexure assembly 120.

9.3.12 The removable nasal mask system provides a compact non-occlusive mask system that is easy to don and remove, stable, comfortable, efficient, provides a wide range of fit, is non-occlusive, easy to use, and adjustable. In addition, the nasal mask system provides a non-cannula or non-pillow configuration without the jetting effect issues and potential discomfort associated with nasal cannulae or pillows that are adapted to at least partially stretch the patient's nose (i.e., the nasal mask system provides a nose-shaped cushion that provides a single orifice that is adapted to enclose both nasal passages during use). The nasal mask system is configured such that little or no adjustment may be required to fit the nasal mask system to the patient's head. In one embodiment, the nasal mask system is not provided with a forehead support, although one may be provided if desired.

In the illustrated example, the nasal mask system 100 provides a two-point connection with the cushion, i.e., two side straps 115 of the headgear assembly engage respective headgear connectors 156 along the sides of the cushion 150 (see, e.g., Figs. 3-1 to 3-3). The headgear assembly provides three connection points, e.g., adjustability at each of the adjustment portions 117 of the side straps 115 and the ends of the rear straps 118 with respective slots 114 of the side straps 115. However, more or fewer adjustment points may be provided, e.g., the side straps and rear straps may provide fixed lengths with no adjustability.

In one embodiment, the two-point connection does not require engaging or disengaging clips to don or remove the mask system, i.e., no clips are provided on the mask system, although one may be provided if desired. Also, the main headgear loops defined by the side straps 115 extend from a lower posterior position to an upper front position, thereby avoiding any headgear straps extending below the ears (i.e., the straps do not pass below the patient's ears), as described below.

3-31-3-34 provide a series of views illustrating an exemplary method for fitting a nasal mask system to a patient, for example, prior to applying air pressure to the plenum chamber. As shown in FIG. 3-31, the patient may grasp the nasal mask system with one hand holding the cushion 150 to orient the sealing area to the patient's face and the other hand holding the rear strap 118 to allow the main headgear loop to be 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 as it passes through the main headgear loop, as shown in FIG. 3-32. The rear strap, together with the side straps attached thereto, may be pulled against the patient's head until the rear strap is positioned along the back of the patient's head as shown in FIG. 3-33, i.e., the strap is rotated or pivoted around the cushion assembly to the patient's head until it engages the patient's head and positions itself relative to the patient's head. Finally, as shown in FIG. 3-34, the ends of the rear straps 118 and/or the adjustment portions 117 of the side straps may be adjusted as needed to secure the nasal mask system against the patient's head.

This arrangement is easy to don and remove as straps do not have to be pulled down over the ears to don the mask system and do not have to be pulled up over the ears to remove the mask system, i.e. the headgear straps simply slide on and off the patient like a hat, i.e. the mask system includes headgear that can be put on and taken off like a hat without interfering with the patient's ears.

In use, the side straps 115 are configured to pull the nasal mask system in a superior-posterior direction (e.g., as shown by arrow a1 in FIG. 3-34), which provides less compressive force along the nasal ridge region of the cushion assembly 150, which is advantageous because, as described above, such region is along the more sensitive region of the patient's nose, i.e., along the nasal cartilage (not the bone). Masks with nose-shaped cushions typically include a headgear arrangement configured to pull the mask along a direction that is substantially parallel to the Frankfurt horizontal (as shown by arrow a2 in FIG. 3-34) to provide a compressive sealing force substantially perpendicular to the patient's face. To provide such force, the headgear arrangement includes straps that extend under the patient's ears to provide such force along the Frankfurt horizontal. In a mask system according to one embodiment of the present technology, the headgear assembly is configured to pull the mask along a superior-posterior direction like a "under the nose" mask (e.g., pillow or cradle), which provides less compressive force along the nasal ridge region while maintaining an adequate seal as described above. Thus, the nasal mask system provides an effective sealing vector similar to an "under the nose" mask (i.e. not parallel to the Frankfurt Horizontal) but instead provides headgear for use with a mask that covers a portion of the nose, i.e. the nasal mask system compromises the sealing force strictly along the Frankfurt Horizontal for an over the ear headgear configuration for ease of wearing.

9.3.13 Plenum Chamber Pivot Adjustment FIG. 3-9 illustrates the vertical distance h between the headgear connection point hp, i.e., the line of tension in the headgear where it 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., upper lip.₃This vertical distance h₃allows for adjustment of the headgear tension to effect rotation or pivot adjustment of the plenum chamber/cushion about the pivot point pp. As shown, the headgear connection point hp is superior to the pivot point pp or the contact point of the cushion assembly with the upper lip. This configuration allows the user to use only a two-point headgear connection to rotate/pivot the cushion assembly via adjusting the headgear tension to accommodate different nasal ridge shapes. In one embodiment, the vertical distance h₃Increasing will result in an increase in the moment.

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

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

In one embodiment, the pneumatic block comprises a portion of the pneumatic path that is located within the outer housing.

In one embodiment, 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 mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative embodiment, the PAP device 4000 may include two or more PCBAs 4202.

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

9.5 Glossary In certain aspects of the present technology, one or more of the following definitions may apply. In certain aspects of the present technology, alternative definitions may apply.

9.5.1 General air: Air is understood to include breathable gases, for example air with supplemental oxygen.

Positive Airway Pressure (PAP): PAP treatment is taken to mean providing a supply of air or breathable gas to the inlet of the airway at a pressure that is positive with respect to atmospheric pressure. 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 inlet of the airway varies by a few centimeters of water within a single breathing cycle, e.g., higher during inspiration and lower during expiration. In some forms, the pressure at the inlet of the airway varies by a few centimeters of water within a single breathing cycle, e.g., higher during inspiration and lower during expiration. In some forms, the pressure is a few centimeters of water higher during inspiration than during expiration, e.g., about 5-15 cm pressure, to provide ventilatory support. In some forms, the pressure will vary during multiple different breathing cycles of the patient, e.g., increased in response to an indication of partial upper airway obstruction being detected and decreased in the absence of an indication of partial upper airway obstruction.

9.5.2 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural alar).

Alar fold: the outermost point of the ala of the nose.

Alar (or alar apex) point: The most posterior point within the curved baseline of each ala, seen in the crease formed where the ala meets the cheek.

Pinna or Auricle: the entire externally visible part of the ear.

(Nasal) skeleton: The nasal skeleton includes, for example, the nasal bones, the frontal process of the maxilla, and the nasal portion of the frontal bone.

Cartilaginous framework (of the nose): The cartilaginous framework of the nose includes, for example, the septal cartilage, the lateral cartilage, the greater cartilage and the lesser cartilage.

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

Columellar angle: the angle between a line drawn through the midpoint of the nostril opening and a line drawn perpendicular to the Frankfurt horizontal while intersecting the underside of the alar.

Frankfurt horizontal plane: a line extending from the lowest point of the orbital rim to the left auricular point.

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

Lateral nasal cartilage: a generally triangular cartilage plate whose upper margin is attached to the nasal bone and the frontal process of the maxilla, and whose lower margin is connected to the greater alar cartilage.

Aerial cartilage: a cartilaginous plate beneath the lateral nasal cartilages, 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 containing three or four alar cartilages.

Nares (Nostrils): The 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.

Nasolabial fold or nasolabial fold: the crease or groove of skin that extends from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

Nasolabial angle: the angle between the bridge of the nose and the upper lip, where it intersects with the underside of the nose.

Lower ear base: the lowest point where the auricle attaches to the facial skin.

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

Nasal tip: the most prominent point or apex of the nose, visible in profile view from the rest of the face.

Philtrum: a median groove extending from the inferior border of the nasal septum to above the lips in the upper lip area.

Mental point: the anterior-most midpoint of the jaw, located on the soft tissue.

(Nasal) ridge: The nasal ridge is the midline protuberance of the nose that extends from the root to the tip.

Sagittal plane: vertical plane running from front to back dividing the body into right and left halves.

Nasal root: the most concave point above the nasal frontal structures, located on the soft tissue.

(Nasal) Septal Cartilage: The nasal septal cartilage forms part of the septum and divides the frontal part of the nasal cavity.

Subala: The point on the lower margin of the base of the alar where it joins the skin of the upper (top) lip.

Nasal spine point: the point located on the soft tissue where the columella is aligned with the upper lip in the midsagittal plane.

Mental area: the most concave point in the midline of the lower lip between the sublabial point and the soft tissue mental point.

9.5.3 Skull Anatomy Frontal bone: The frontal bone contains a large vertical portion, the scales frontalis, which corresponds to the area known as the forehead.

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

Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye socket. The frontal process of the maxilla projects upwards near the side of the nose and forms part of its lateral border.

Nasal bones: The nasal bones are two small rectangular bones, whose size and shape vary from person to person, that lie next to each other in the upper center of the face and, when joined, form the "bridge" of the nose.

Nasal base: the concave area where the frontal bone and the two nasal bones intersect, directly between the eyes and superior to the bridge of the nose.

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

Orbit: bony cavity in the skull that contains the eyeball.

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

Temporal Bone: The temporal bone is located at the base and sides of the skull and supports that part of the face known as the temples.

Cheekbones: The face contains two cheekbones that are located in the upper lateral part of the face and form the cheek ridges.

9.5.4 Respiratory System Anatomy Diaphragm: A 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, the volume of the thoracic cavity increases and air is drawn into the lungs.

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

Lung: respiratory organ in humans. The introductory portion of the lung includes the airways, bronchi, bronchioles, and terminal bronchioles. The respiratory portion includes the respiratory bronchioles, alveolar ducts, and alveoli.

Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space located above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called the nasal conchae (singular "concha") or turbinates. At the front of the nasal cavity is the nose, while at the back it connects via the nasal conchae to the nasopharynx.

Pharynx: That part of the throat that is located just inferior (below) the nasal cavity and superior to the esophagus and larynx. The pharynx is traditionally divided into three compartments: the nasopharynx (nasal part of the pharynx), the oropharynx (mesopharynx) (oral part of the pharynx), and the laryngopharynx (hypopharynx).

9.5.5 Materials Silicone or Silicone Elastomer: Synthetic rubber. When silicone is referenced herein, this refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One example of a commercially available LSR is SILASTIC (included within the range of products sold under this trademark) manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary 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.

9.5.6 Patient Interface Aspects Asphyxiation Valve (AAV): prevents the patient from breathing excessive CO by opening in a failsafe manner against atmospheric pressure.₂A component or subcomponent of a mask system that reduces the risk of rebreathing.

Bend: A conduit that directs the axis of flow or air to change direction through an angle. In one form, the angle may be about 90 degrees. In another form, the angle may be less than 90 degrees. The conduit may have a generally circular cross section. In another form, the conduit may have an oval or rectangular cross section.

Frame: Frame is taken to mean a mask structure that carries the load in tension between two or more connection points with the headgear. The mask frame may be a non-airtight load bearing structure within the mask. However, some forms of mask frames may also be airtight.

Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed for use on the head. In one embodiment, the headgear comprises a collection of one or more posts, ties, and stiffeners configured to position and maintain the patient interface in position on the patient's face to deliver respiratory therapy. Some ties are formed from soft, flexible, elastic materials, such as laminated composites of foam and fabric.

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

Plenum chamber: Mask plenum chamber is taken to mean a portion of a patient interface having walls that enclose a volume of space, the volume having air therein that is pressurized above atmospheric pressure during use. A shell may form part of the mask plenum chamber wall. In one form, an area of the patient's face forms one of the walls of the plenum chamber.

Seal: The noun form ("a 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.

Shell: In one embodiment, shell is taken to mean a curved structure having bending, tensile and compressive stiffness, e.g., a portion of a mask forming the curved structure walls of a mask. In one embodiment, the shell is relatively thin compared to the overall dimensions. In some embodiments, the shell may be faceted. In one embodiment, such walls are airtight, but in some embodiments, they may not be airtight.

Reinforcement: Reinforcement is taken to mean a structural component designed to increase the flexural resistance of another component in at least one direction.

Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

Swivel: (noun) A subassembly of components that are 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 an angle of at least 360 degrees. In another form, the swivel may be configured to rotate an angle of less than 360 degrees. When used in the context of air conduits, for example, the subassembly of components includes a matched pair of cylindrical conduits. Preferably, there is little or no air leakage flow from the swivel during use.

Tie: A tie is understood to be a structural component designed to resist tension.

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

9.5.7 Terms used in relation to patient interfaces Floppy: A quality of a material, structure or composite that is a combination of the following characteristics:

- The feature of easily adapting to finger pressure.

- The inability to maintain its shape when forced to support its own weight.

- Non-rigid features.

The property of being flexible may 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, e.g., the second direction is orthogonal to the first direction.

Elastic: Capable of substantially elastically deforming and of releasing substantially all of its energy upon load release within a relatively short period of time, such as one second.

Rigidity: Not easily deformed under finger pressure and/or tension or loads typically encountered when establishing and maintaining a patient interface in sealing relationship with the entrance to the patient's airway.

Semi-rigid: means sufficiently rigid not to deform significantly under the action of mechanical forces typically applied during positive airway pressure therapy.

9.6 Other Notes A portion of the disclosure of this patent specification contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction of either this patent specification or this patent disclosure as disclosed in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.

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

Furthermore, when one or more values are described herein as being implemented as part of the technology of the present invention, such values may be approximate unless otherwise noted, and it will be understood that such values may be utilized to any suitable significant figures to the extent that the actual technical implementation may permit or require it.

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 the technology of the present invention belongs. Any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the technology of the present invention, but only a limited number of exemplary methods and materials are described herein.

Where a particular material is identified as preferred for use or as one embodiment for constructing a component, obvious alternative materials having similar properties may be substituted.

It must be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly indicates otherwise.

All publications mentioned herein are incorporated by reference to disclose and describe the methods and/or materials to which they are directed. The publications mentioned 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 of the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the publication dates provided may be different from the actual publication dates, which may need to be independently confirmed.

Moreover, in interpreting this disclosure, all terms should be interpreted in the broadest manner reasonable 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, indicating that a referenced element, component, or step may be present in, utilized with, or combined with other elements, components, or steps that are not expressly referenced.

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 entire claim disclosure. The subject headings should not be used to construe the scope of the claims or the limitations of the claims.

Although the technology of the present invention has been described with reference to certain embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology of the present invention. In some instances, terms and symbols may imply specific details that are not necessary to practice the technology of the present invention. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but may be utilized to distinguish between separate elements. Furthermore, although steps in a method may be described or illustrated in a certain order, such order is not required. Those skilled in the art will recognize that such order may be changed and/or aspects thereof may be performed simultaneously or even synchronously.

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

100 Nasal Mask System

110 Headgear Assembly

114 slot

115 Side straps

116 Cushion Connector

117 Adjustment part

118 Rear strap

120 Flexure Assembly

125 Bend

126 Ventilation openings

128 Connector ring

129 Swivel

130 Air Delivery Assembly

133 tube

135 connector

150 Cushion Assembly or Cushion

151 Sealing area or sealing cuff

152 Nasal ridge area

153 Lateral nose area

154 Nose corner area

155 Upper lip area

156 Headgear Connector

157 Sidewall Area or Sidewall

158 Attachment Area

158(1) Thinner walled sections

159 Lag or interface

160 Membrane or flap type seal or membrane seal

165 Undercushion or backing band

250 Cushion Assembly

251 Sealing area or sealing cuff

252 Nasal ridge area

253 Lateral nose area

254 Nose corner area

255 Upper lip area

256 Headgear Connector

257 Sidewall area or sidewall area

258(1) Thinner walled sections

258 Attachment Area

260 film

265 Undercushion or backing band

268 Thinner areas of the cross section

270 Sealing flaps or wings

275 Orifice

275(1) Upper orifice part

275(2) Lower orifice part

280 Contact Area

280(i) Inner end

280(o) Outer end

350 Cushion Assembly

356 Headgear Connector

356(1) Hinged or thinner walled sections

360 film

360(o) Outer edge

450 Cushion Assembly

456 Headgear Connector

456(1) Hinged or thinner walled sections

457 Sidewall Area

457(1) Wall Section

460 film

460(o) Outer end

460(i) Inner end

465 Under cushion

466 Sickle-shaped cross section

1000 patient

1100 Bedmate

3000 Patient Interface

3100 Seal formation structure

3102 Upper sealing part

3104 Lower sealing part

3110 Sealing flange

3120 Support flange

3200 Plenum Chamber

3210 Periphery

3220 Peripheral Edge

3300 Positioning and stabilization structure

3400 Ventilation openings

3500 Separation Structure

3510 Swivel

3520 Ball joint

3600 Connection Ports

4000 PAP Device

4012 Upper part

4014 Lower part

4015 panel

4016 Chassis

4018 Handle

4112 Inlet Air Filter

4142 Blower

4170 Air Circuit

4202 PCBA

4210 Power Source

4220 Input Devices

5000 Humidifier