TWI751691B - A patient interface system for treatment of respiratory disorders - Google Patents

Abstract

A patient interface system to treat a respiratory disorder of a patient, the patient interface system comprising: a positioning and stabilising structure including a back portion and a pair of upper straps extending from the back portion; and a patient interface including a patient interface frame and a pair of rigidiser arms each connected to the patient interface frame at a connection point located in a plane substantially parallel to the patient’s Frankfort horizontal plane, the pair of rigidiser arms further including a pair of upper attachment points, wherein the pair of upper straps are adapted to be releasably attached to the pair of upper attachment points such that, when donned by the patient, the pair of upper straps are vertically offset relative to the connection points and substantially parallel to the patient’s Frankfort horizontal plane, and wherein the patient interface does not include a forehead support.

Description

Patient interface system for the treatment of breathing disorders

[Cross-reference to related applications] This application claims New Zealand Patent Application Serial No. 626,417, filed June 19, 2014, and US Provisional Patent Application Serial No. 61/953,240, filed March 14, 2014, which are incorporated herein in their entirety. Incorporated herein for reference.

The present technology pertains to one or more of the diagnosis, treatment, and amelioration of respiratory disorders, and procedures related to the avoidance of respiratory disorders. In particular, the present technology relates to medical devices and their use to treat and avoid breathing disorders.

The human respiratory system facilitates gas exchange. The nose and mouth form the patient's airway entry.

The airway is made up of a series of branch tubes that become narrower, shorter and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen from the air to enter the venous blood and expelling carbon dioxide. The trachea divides into right and left main bronchi, and finally into terminal bronchioles. The bronchi constitute the conducting airways and are not involved in gas exchange. Further branches of the respiratory tract lead to the respiratory bronchioles and eventually to the alveoli. The alveolar area of the lungs is the area where gas exchange occurs and is called the respiratory area. See Essentials of Respiratory Physiology by John B. West.

There are various breathing disorders.

Obstructive Sleep Apnoea (OSA) is a form of Sleep Disordered Breathing (SDB) characterized by upper airway obstruction during sleep. This occurs during sleep from a combination of abnormal small upper airway and normal loss of muscle tone in the tongue region, soft palate and posterior pharyngeal wall. This symptom causes affected patients to stop breathing for a typical duration of 30 to 120 seconds each night, sometimes 200 to 300 seconds. This often causes excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. Complications are a general disorder, especially in middle-aged overweight men, although those affected may not notice the problem. See US Patent No. 4,944,310 (Mr. Sullivan).

Cheyne-Stokes Respiration (CSR) refers to the disorder of the patient's respiratory organ regulation system, in which there is an alternating period of rhythm of ups and downs of ventilation, causing repeated hypoxia and reoxygenation of arterial blood. Chen-Shi respiration is potentially harmful because of repetitive oxygen deficiency. In some patients, Chen-Shi respiration (CSR) is associated with repetitive awakenings from sleep, which cause severe sleep disintegration, increased sympathetic nerve activity, and increased afterload. See US Patent No. 6,532,959 (Mr. Berthon-Jones).

Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia while awake, without other known factors of hypoventilation. Symptoms include difficulty breathing, morning headaches, and excessive daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) includes any of a number of low airway diseases that share specific features. These include increased resistance to air flow, prolonged expiratory phases of breathing, and loss of normal lung flexibility. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (the main risk factor), occupational exposure, air pollution and genetic factors. Symptoms include: exercise-induced dyspnea, chronic cough, and production of sputum.

Neuromuscular Disease (NMD) is a broad term encompassing many diseases and disorders that impair muscle function, either directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage leading to reduced mobility (requiring a wheelchair), dysphagia, respiratory muscle failure, and finally, respiratory failure leading to death. Neuromuscular disease can be divided into rapidly progressive and chronic progressive: (i) rapidly progressive disorder: characterized by muscle damage that worsens over several months and results in death within a few years (eg, amyotrophic lateral sclerosis in adolescents) (ALS) and Crouching's Muscular Dystrophy (DMD); (ii) variable or chronically progressive disorder: characterized by worsening muscle damage over several years and only a slight reduction in the likelihood of average lifespan (eg, limb Belt type, Facial-shoulder-brachial type, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea and depression during exercise, fatigue, drowsiness, morning headache, difficulty concentrating, and mood changes.

Thoracic disorders are some chest disabilities that result in inefficient coupling between the muscles of the respiratory organs and the thorax. The disorder is usually characterized by a localized defect and burdens the possibility of long-term hypercapnic respiratory failure. Scoliosis and/or kyphoscoliosis may cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and decreased appetite.

Otherwise, healthy individuals can use systems and devices to avoid breathing disorders. 1. System

One known product for the treatment of disturbed breathing is the S9 sleep therapy system manufactured by ResMed. 2. Treatment

Nasal Continuous Positive Airway Pressure (CPAP) therapy has been used to treat sleep apnea (OSA). It is assumed that CPAP acts like a splint and that upper airway occlusion can be avoided by pushing the soft palate and tongue forward and away from the posterior pharyngeal wall.

Non-invasive ventilation (NIV) has been used to treat Chen-Shi respiration (CSR), obese hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and thoracic obstacle. 3. Patient Interface

Applying a positive air supply to the patient's airway inlet can be accomplished by using a patient interface such as a nasal mask, full face mask, or nasal pillow. A range of patient interface devices are known, but many suffer from one or more of disgusting, aesthetically unsatisfactory, unsuitable, unusable, and uncomfortable conditions, especially when worn for extended periods of time or when The patient is not familiar with the system. Masks designed only for pilots (as part of personal protective equipment) or for administering general anesthesia are quite good for their original use, but still undesirable or uncomfortable for extended periods of time (eg, while sleeping). 3.1 Seal forming part

The patient interface typically includes a seal-forming structure.

One type of seal-forming structure extends near the periphery of the patient interface and seals against the user's face when a force is applied to the patient interface to which the seal-forming portion of the user's face is attached. The seal-forming structure may include an air or liquid filled cushion, or a contoured or formed surface of a resilient sealing element made from an elastomer, such as a rubber. With this type of seal-forming portion, if unsuitable, there will be a gap between the seal-forming structure and the face, and an external force will be required to seal the patient interface against the face.

Another type of seal-forming portion incorporates a flap seal of thin material positioned near the perimeter of the mask to provide a self-sealing action against the user's face when positive pressure is applied within the mask. Similar to previous styles of seal-forming structures, if the fit between the face and the mask is poor, external force may be required to achieve the seal, or the mask may leak. In addition, if the shape of the seal-forming structure does not conform to the shape of the patient, it may crease or deform in use, causing leakage.

Another form of seal-forming portion may use a cement to create the seal. Some patients may find it inconvenient to frequently apply and remove facial cement.

A series of patient interface seal-forming structure techniques are disclosed in the following patent applications, which have been assigned to ResMed Limited: WO1998/004,310; WO2006/074,513; WO2010/135,785. 3.2 Positioning and stabilization

A seal-forming portion of a patient interface used for positive air pressure therapy experiences the corresponding force of the air pressure to affect the seal. Such a variety of techniques have been used to position seal-forming structures and maintain a sealing relationship with appropriate parts of the face.

One technique is to use cement. See, for example, US Patent Application No. US 2010/0000534.

Another technique is to use one or more webbing and stabilizing harnesses. Many of these harnesses suffer from one or more of improper, poorly handled, uncomfortable and awkward use. 3.3 Ventilation port technology

Some forms of patient interface systems may include a vent that allows exhaled carbon dioxide to be expelled. Many of these vents are noisy. Others may clog when in use and do not provide adequate drainage. Certain vents may disrupt sleep of the patient's (1000) bed partner (1100), such as noise or concentrated airflow.

ResMed has developed certain modified nasal mask ventilation technology. See WO 1998/034,665, WO 2000/078,381, US 6,581,594, US Patent Application, US 2009/0050156, US Patent Application No. 2009/0044808.

Previous noise mask table (ISO 17510-2: 2007, in 1m (m) with a pressure of 10cm H ₂ O) mask name mask type A-weighted sound power level dbA (uncertain value) A-weighted sound pressure dbA (uncertain value) Annual (approx.) Glue-on (*) nasal 50.9 42.9 1981 ResCare standard (*) nasal 31.5 23.5 1993 ResMed Mirage (*) nasal 29.5 21.5 1998 ResMed UltraMirage nasal 36(3) 28(3) 2000 ResMed Mirage Activa nasal 32(3) 24 (3) 2002 ResMed Mirage Micro nasal 30 (3) 22(3) 2008 ResMed Mirage SoftGel nasal 29 (3) 22(3) 2008 ResMed Mirage FX nasal 26(3) 18(3) 2010 ResMed Mirage Swift (*) nasal pillow 37 29 2004 ResMed Mirage Swift II nasal pillow 28(3) 20 (3) 2005 ResMed Mirage Swift LT nasal pillow 25(3) 17 (3) 2008

(*Only one sample, measured in CPAP mode at 10cmH2O using the test method specified in ISO3744)

The sound pressure values of various objects are as follows: object A-weighted sound pressure dbA (uncertain value) instruction Vacuum cleaner: Nilfisk Walter Broadly Litter Hog: B+ rating 68 ISO3744 at 1m (meter) distance conversation speech 60 1m (meter) distance general home 50 quiet library 40 quiet bedroom at night 30 TV workplace background 20 3.4 Nasal pillow technology

One form of nasal pillow can be found in the Adam circuit manufactured by the Puritan Bennett Company. Another nasal pillow, or nasal spray, is the subject of US Patent 4,782,832 (Mr. Trimble et al.), which is assigned to Prutton-Benet.

ResMed has manufactured the following products in combination with nasal pillows: SWIFT nasal pillow mask, SWIFT II nasal pillow mask, SWIFT LT nasal pillow mask, SWIFT FX nasal pillow mask and LIBERTY full face mask. The following patent applications (assigned to ResMed Corporation) describe nasal pillow covers: International Patent Application No. WO 2004/073,778 (describing aspects of the ResMed SWIFT nasal pillow and others), US Patent Application No. 2009/0044808 (Describes aspect of ResMed SWIFT LT nasal pillow and others); International Patent Application No. WO 2005/063,328 and WO 2006/130,903 (Describes ResMed LIBERTY full face mask and others); International Patent Application No. WO 2009/052,560 No. (describes the appearance of the ResMed SWIFT FX nasal pillow and others).

The present technology is directed to providing medical devices for diagnosing, ameliorating, treating, or preventing respiratory disorders that have one or more of the advantages of improved comfort, reduced cost, performance, ease of operation, and manufacturability.

A first aspect of the present technology relates to a device for diagnosing, ameliorating, treating or preventing respiratory disorders.

Another aspect of the present technology relates to a patient interface system for treating a breathing disorder in a patient. The patient interface system can include: a positioning and stabilizing structure including a back and a pair of upper straps extending from the back; and a patient interface including a patient interface frame and a pair of upper straps Holding arms, each holding arm is connected to the patient interface frame at a connection point located on a plane, the plane is substantially parallel to the plane of the patient's eyes and ears, the pair of holding arms further includes a pair of upper attachment points, wherein the pair of upper beams The straps are adapted to be removably attached to the pair of upper attachment points such that when worn by the patient, the pair of upper straps are vertically offset relative to the upper attachment points and substantially parallel to the plane of the patient's eye and ear, and wherein the patient The interface does not include a forehead support.

In examples, (a) the patient interface can further comprise a plenum and a seal-forming structure, (b) the plenum and the seal-forming structure can comprise a single piece, (c) the plenum can comprise a rigid material, It is harder than the material of the seal-forming structure, (d) the plenum can include polycarbonate, and the seal-forming structure can include silicone, (e) the plenum can include at least one plenum retention feature, (f) ) the mask frame may be at least one mask frame retention feature, each configured to removably attach the nose mask frame to the plenum by removably connecting a corresponding one of the at least one plenum retention feature, (g) the plenum may include four plenum retention features, and the nose mask frame may include four corresponding nose mask frame retention features, (h) the nose mask frame and the plenum may be hard-to-hard connected Removably attached, (i) the mask frame is removably connected to the plenum near the perimeter of the plenum, (j) the positioning and stabilizing structure may include a pair of lower straps, and the patient interface frame may include a pair of lower attachment points for releasably attaching a respective lower strap, and each of the pair of upper straps and each of the pair of lower straps may include a loop portion of loop material, (k ) a hook portion containing hook material can be attached to the distal end of each of the pair of upper straps and each of the pair of lower straps, (l) each of the pair of upper straps and the pair of lower straps each of the straps can be adapted to wrap around adjacent a respective one of the pair of upper attachment points and the pair of lower attachment points such that the hook portion of each individual strap is removably attached to the loop portion of the strap, (m) each loop portion may be wider than each individual hook portion such that when each hook portion is attached to its corresponding loop portion, the loop portion protects the patient's skin from the hook portion, (n) the The patient interface may include a full face mask, (o) the positioning and stabilizing structure may include a cranial strap for engaging the parietal bones of the patient's skull, and/or (p) the positioning and stabilizing structure may include a neck piece for to engage the occipital bone of the patient's head.

Another aspect of the present technology relates to a patient interface system for treating a breathing disorder in a patient. The patient interface system can include: a positioning and stabilizing structure including a back and a pair of upper straps extending from the back; and a patient interface including a patient interface frame and a pair of upper straps Holding arms, each holding arm is connected to the patient interface frame at a connection point located on a plane, the plane is substantially parallel to the plane of the patient's eyes and ears, the pair of holding arms further includes a pair of upper attachment points, wherein the pair of upper beams The straps are adapted to be removably attached to the pair of upper attachment points such that when worn by the patient, the sealing force vector produced by the pair of upper straps is vertically offset relative to the upper attachment points and substantially parallel to the patient's eyes and ears flat, and wherein the patient interface does not include a forehead support.

In examples, (a) the patient interface can further comprise a plenum and a seal-forming structure, (b) the plenum and the seal-forming structure can comprise a single piece, (c) the plenum can comprise a rigid material, It is harder than the material of the seal-forming structure, (d) the plenum can include polycarbonate, and the seal-forming structure can include silicone, (e) the plenum can include at least one plenum retention feature, (f) ) the mask frame may be at least one mask frame retention feature, each configured to removably attach the nose mask frame to the plenum by removably connecting a corresponding one of the at least one plenum retention feature, (g) the plenum may include four plenum retention features, and the nose mask frame may include four corresponding nose mask frame retention features, (h) the nose mask frame and the plenum may be hard-to-hard connected Removably attached, (i) the mask frame is removably connected to the plenum near the perimeter of the plenum, (j) the positioning and stabilizing structure may include a pair of lower straps, and the patient interface frame may include a pair of lower attachment points for releasably attaching a respective lower strap, and each of the pair of upper straps and each of the pair of lower straps may include a loop portion of loop material, (k ) a hook portion containing hook material can be attached to the distal end of each of the pair of upper straps and each of the pair of lower straps, (l) each of the pair of upper straps and the pair of lower straps each of the straps can be adapted to wrap around adjacent a respective one of the pair of upper attachment points and the pair of lower attachment points such that the hook portion of each individual strap is removably attached to the loop portion of the strap, (m) each loop portion may be wider than each individual hook portion such that when each hook portion is attached to its corresponding loop portion, the loop portion protects the patient's skin from the hook portion, (n) the The patient interface may include a full face mask, (o) the positioning and stabilizing structure may include a cranial strap for engaging the parietal bones of the patient's skull, and/or (p) the positioning and stabilizing structure may include a neck piece for to engage the occipital bone of the patient's head.

Another aspect of the present technology relates to a patient interface system for treating a breathing disorder in a patient. The patient interface system may include: a patient interface; a positioning and stabilizing structure including a pair of upper straps; and a patient interface frame for connecting the patient interface to the positioning and stabilizing structure, the arm patient interface frame including A pair of holding arms to which the upper attachment points are attached and the pair of upper straps are detachably attached, wherein each holding arm is connected to the patient interface frame at a connection point such that each holding arm can be substantially perpendicular to the patient's eyes and ears Rotates about an axis of the plane, and wherein, when worn by the patient, the pair of upper straps are substantially parallel to the plane of the patient's eye and ear.

In examples, (a) the patient interface can further comprise a plenum and a seal-forming structure, (b) the plenum and the seal-forming structure can comprise a single piece, (c) the plenum can comprise a rigid material, It is harder than the material of the seal-forming structure, (d) the plenum can include polycarbonate, and the seal-forming structure can include silicone, (e) the plenum can include at least one plenum retention feature, (f) ) the mask frame may be at least one mask frame retention feature, each configured to removably attach the nose mask frame to the plenum by removably connecting a corresponding one of the at least one plenum retention feature, (g) the plenum may include four plenum retention features, and the nose mask frame may include four corresponding nose mask frame retention features, (h) the nose mask frame and the plenum may be hard-to-hard connected Removably attached, (i) the mask frame is removably connected to the plenum near the perimeter of the plenum, (j) the patient interface may include a full face mask, (k) the patient interface may not include a forehead Support, (1) a patient interface system for treating a patient's breathing disorder may include: a patient interface according to any of the preceding examples, and further comprising a pair of upper attachment points, each upper attachment point disposed on the pair of dual one of the holding arms; and a pair of lower attachment points disposed above the mask frame; and a positioning and stabilizing structure comprising a back, a pair of upper straps extending from the back, and A pair of lower straps extending from the back, (m) each of the pair of upper straps and each of the pair of lower straps may include a loop portion of loop material, (n) a loop portion containing hook material The hook portion of the pair of upper straps can be attached to the distal end of each of the pair of upper straps and each of the pair of lower straps, (o) each of the pair of upper straps and each of the pair of lower straps can be adapted to wrap around the vicinity of a respective one of the pair of upper attachment points and the pair of lower attachment points such that each individual strap hook portion is removably attached to the strap loop portion, (p) each loop portion can be wider than each individual hook portion so that when each hook portion is attached to its corresponding loop portion, the loop portion protects the patient's skin from the hook portion, (q) the positioning and stabilizing structure may include an overhead strap to Engage the parietal bone of the patient's skull, and/or (r) the positioning and stabilizing structure may include a neck member to engage the occipital bone of the patient's skull.

Another aspect of the present technology relates to a patient interface system for treating a breathing disorder in a patient. The patient interface system may include: a patient interface; a patient interface frame for connecting the patient interface to a positioning and stabilizing structure, the patient interface frame including a pair of frame connection features; and a pair of retention arms, each holding The arms have a retention arm connection feature, wherein the retention arms connect the patient interface frame at connection points by direct engagement between the individual frame connection feature and the retention arm connection feature, the connection points being connected by a Elastomeric material seal.

In examples, (a) the patient interface can further comprise a plenum and a seal-forming structure, (b) the plenum and the seal-forming structure can comprise a single piece, (c) the plenum can comprise a rigid material, It is harder than the material of the seal-forming structure, (d) the plenum can include polycarbonate, and the seal-forming structure can include silicone, (e) the plenum can include at least one plenum retention feature, (f) ) the mask frame may be at least one mask frame retention feature, each configured to removably attach the nose mask frame to the plenum by removably connecting a corresponding one of the at least one plenum retention feature, (g) the plenum may include four plenum retention features, and the nose mask frame may include four corresponding nose mask frame retention features, (h) the nose mask frame and the plenum may be hard-to-hard connected Removably attached, (i) the mask frame is removably connected to the plenum near the perimeter of the plenum, (j) the patient interface may include a full face mask, (k) the patient interface may not include a forehead Support, (1) a patient interface system for treating a patient's breathing disorder may include: a patient interface according to any of the preceding examples, and further comprising a pair of upper attachment points, each upper attachment point disposed on the pair of dual one of the holding arms; and a pair of lower attachment points disposed above the mask frame; and a positioning and stabilizing structure comprising a back, a pair of upper straps extending from the back, and A pair of lower straps extending from the back, (m) each of the pair of upper straps and each of the pair of lower straps may include a loop portion of loop material, (n) a loop portion containing hook material The hook portion of the pair of upper straps can be attached to the distal end of each of the pair of upper straps and each of the pair of lower straps, (o) each of the pair of upper straps and each of the pair of lower straps can be adapted to wrap around the vicinity of a respective one of the pair of upper attachment points and the pair of lower attachment points such that each individual strap hook portion is removably attached to the strap loop portion, (p) each loop portion can be wider than each individual hook portion so that when each hook portion is attached to its corresponding loop portion, the loop portion protects the patient's skin from the hook portion, (q) the positioning and stabilizing structure may include an overhead strap to Engage the parietal bone of the patient's skull, and/or (r) the positioning and stabilizing structure may include a neck member to engage the occipital bone of the patient's skull.

Another aspect of the present technology relates to a patient interface system for treating a breathing disorder in a patient. The patient interface system can include: a patient interface; a positioning and stabilizing structure including a back and a pair of upper straps extending from the back; and a nasal mask frame for keeping the patient interface tight Relying on the patient's airway, the nasal mask frame includes a pair of holding arms, the pair of holding arms includes a pair of upper attachment points, and each upper attachment point is set on one of the pair of holding arms for detachably attaching a separate upper beam Straps, wherein the retention arms are shaped and sized to extend from the mask frame along the patient's cheek and between the patient's eyes and ears when the patient wears the patient interface system, so that each upper strap can be attached to the patient's ear The top one is attached to the attachment point.

In examples, (a) the patient interface can further comprise a plenum and a seal-forming structure, (b) the plenum and the seal-forming structure can comprise a single piece, (c) the plenum can comprise a rigid material, It is harder than the material of the seal-forming structure, (d) the plenum can include polycarbonate, and the seal-forming structure can include silicone, (e) the plenum can include at least one plenum retention feature, (f) ) the mask frame may be at least one mask frame retention feature, each configured to removably attach the nose mask frame to the plenum by removably connecting a corresponding one of the at least one plenum retention feature, (g) the plenum may include four plenum retention features, and the nose mask frame may include four corresponding nose mask frame retention features, (h) the nose mask frame and the plenum may be hard-to-hard connected be removably attached, (i) the mask frame is removably attached to the plenum near the perimeter of the plenum, (j) each of the pair of upper straps and each of the pair of lower straps can be a loop portion comprising loop material, (k) a hook portion containing hook material attachable to the distal ends of each of the pair of upper straps and each of the pair of lower straps, (l) the pair of upper straps Each of the straps and each of the pair of lower straps can be adapted to wrap around the vicinity of a respective one of the pair of upper attachment points and the pair of lower attachment points such that the hook portion of each individual strap is detachable The loop portions of the connecting straps, (m) each loop portion may be wider than each individual hook portion so that when each hook portion is attached to its corresponding loop portion, the loop portion protects the patient's skin from Hook impact, (n) the patient interface may include a full face mask, (o) the patient interface may not include a forehead support, (p) the positioning and stabilizing structure may include a cranial strap to engage the parietal bones of the patient's skull , and/or (q) the positioning and stabilizing structure may include a neck member to engage the occiput of the patient's skull.

Another aspect of the present technology relates to a patient interface system comprising: a patient interface having a plenum and a seal-forming structure; a positioning and stabilizing structure; and a connection point for attaching the positioning and stabilizing structure to the patient interface.

In examples, (a) the plenum and the seal-forming structure may be one piece, eg, permanently attached, integrally molded, and/or co-molded, and (b) the plenum and the seal-forming structure may be removable (c) the patient interface system may further include a patient interface frame, wherein the attachment points are formed at the patient interface frame, and wherein the patient interface frame can be removably attached to the plenum, (d) the attachment points can be integrally formed or formed in one piece or molded into the plenum, and/or (e) the positioning and stabilization The structure may include upper and lower side straps for engaging the positioning and stabilizing structure to the patient interface at the attachment points to removably secure the patient interface system to the patient's head.

Of course, portions of examples or aspects may form sub-aspects or sub-examples of the present technology. Also, various ones of the examples, sub-aspects, and/or aspects can be combined in various different ways and at the same time constitute additional examples, sub-instances, aspects, or dependent aspects of the present technology.

Other features of the present technology will become more apparent from a consideration of the information contained in the following "Embodiments", "Summary of Invention", "Simple Drawings" and "Scope of Claims".

Before the present technology is described in greater detail, it is to be understood that the present technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing the particular example discussed in this specification, and not of limitation.

The following description relates to various examples that may share one or more common features and/or characteristics. It will be appreciated that one or more features of any example may be combined with one or more features of another example or other examples. Furthermore, any single feature or combination of these features may constitute a further example. 1. Therapeutic system

In one form, the present technology includes a device for treating breathing disorders. The device may include an air flow generator; or an inflator to supply pressurized breathing gas, such as air, to the patient (1000) via an airway leading to the patient interface (3000). 2. Treatment

In one form, the present technology includes a method for treating a breathing disorder, the method comprising the step of applying positive pressure to an airway inlet of a patient (1000). 2.1 Nasal continuous positive pressure ventilation (CPAP) therapy for obstructive sleep apnea (OSA) symptoms

In one form, the present technology includes a method of applying continuous positive nasal pressure ventilation to a patient to treat symptoms of obstructive sleep apnea in the patient.

In a specific example of the present technology, a positive pressure air supply is provided to the patient's nasal passages via one or both nostrils.

In particular instances of the present technology, mouth breathing is restricted, restricted or hindered. 3. Patient Interface

A non-invasive patient interface (3000) according to an aspect of the present technology includes the following functional aspects: a seal-forming structure (3100); a plenum (3200); a positioning and stabilizing structure (3300); and a connection port (3600) for connecting the air channel (4170). In some forms, one or more physical components may provide a functional aspect. In some forms, a physical component may provide one or more functional aspects. In use, the seal-forming structure (3100) is disposed around the entrance to the airway of the patient to facilitate the supply of positive pressure air to the airway.

For the purposes of the present invention, the term "patient interface" means a variety of different interface types, such as a full face mask, nasal mask, oronasal mask, nasal spray or pillow, and/or oronasal mask. In other words, for supplying pressurized breathable gas, any device that facilitates interfacing with the entrance of the patient's airway can be a "patient interface." It should also be understood, as will be understood by those skilled in the art, that the term "mask" broadly refers to the various forms of patient interface described above. Thus, for example, a mask can include a full face mask, a nasal mask, an oronasal mask, a nasal spray or nasal pillow, and/or an oronasal mask. 3.1 Full face mask without forehead support

According to one example of the present technology, a patient interface (3000) may be formed without a forehead support. An exemplary patient interface (3000) may also include a full face mask. The patient interface (3000) does not have a forehead support, because there is no structure extending upward toward the forehead and between the eyes, so that the patient's visual field is not easily obstructed. This also makes the patient interface (3000) a more visual bonus for the bed partner since there are no structures that obstruct the face. Additionally, the absence of a forehead support will reduce the number of points of contact the patient interface (3000) needs to have on the patient's face. However, it must still be possible to hold the patient interface (3000) against the patient's face with a force of sufficient magnitude and distributed across the seal-forming structure (3100) to ensure an effective pneumatic seal against the patient's airway.

At the same time, a positioning and stabilizing structure (3300) (described in more detail below) must be designed for use with the patient interface (3000) to prevent the patient interface from retracting upwards. Pulling up means that the patient interface (3000) moves upwards so that it moves to a higher position on the patient's face than the initial position of the patient interface. Pull-up may occur if the sealing force vector created by the positioning and stabilizing structure (3300) is produced in a vertical direction. Other factors, which will be described in more detail below, may also cause the upward retraction. 3.1.1 Seal-forming structure and plenum

According to one example of the present technology, the patient interface (3000) may include a seal-forming structure (3100) and a plenum (3200). Examples of patient interface (3000) and related features are depicted in Figures 8a-8c.

In one form of the present technology, a seal-forming structure (3100) provides a seal-forming surface and may additionally provide a gasket function.

The seal-forming structure (3100) in accordance with the present technology may be constructed using soft, elastic, and resilient materials such as silicone.

In one form, the seal-forming structure (3100) includes a sealing flange and a support flange. The sealing flange includes a relatively thin member, having a thickness of less than about 1 mm (mm), eg, about 0.25 mm (mm) to about 0.45 mm (mm), extending around the perimeter of the plenum (3200). The support flange may be relatively thicker than the sealing flange. The support flange may be disposed between the sealing flange and the edge of the plenum (3200) and extend over at least a portion of the circumference of the perimeter. The support flange may be or may include a spring-like element and function to support the sealing flange against twisting during use. In use, the sealing flange quickly responds to system pressure in the plenum (3200) on its underside to make it tightly engage the face.

The perimeter shaping of the plenum (3200) is complementary to the general facial contours in the area where the seal is formed in use. In use, the edges of the plenum (3200) are located on adjacent faces of adjacent faces. Actual contact with the face is provided by the seal-forming structure (3100). In use, the seal-forming structure (3100) may extend around the entire perimeter of the plenum (3200).

According to one example of the present technology, the seal-forming structure (3100) may be molded over the plenum (3200) as a one-piece piece. The seal-forming structure (3100) and the plenum (3200) may include a patient interface or mask fitting according to one example of the present technology. 3.1.2 Positioning and Stabilizing Structures

Figures 3, 4a-4zl, 5a-5l, 6a-6v, 8a-8c, and 9 show various examples of positioning and stabilizing structures (3300) in accordance with the present technology.

3 shows a perspective view of a positioning and stabilizing structure (3300) according to an example of the present technology. This diagram, while not showing the patient interface (3000), does show the positioning and stabilizing structures (3300) as the patient may wear it.

The exemplary positioning and stabilizing structure (3300) shown in Figure 3 includes a back (3302). Exemplary back (3302) may include a left overhead piece (3306) and a right overhead piece (3308), and a neck piece (3310). The positioning and stabilizing structure (3300) may also include an overhead harness (3304). Meanwhile, extending from the back (3302) can be an upper left strap (3312) and an upper right strap (3314), and a lower left strap (3316) and a lower right strap (3318). The hook portion (3320) of the hook material can be attached to the distal end of each of the upper and lower straps (3312, 3314) and the lower straps (3316, 3318). Hooks (3320) can be used to attach each strap to itself by wrapping around the attachment point of the patient interface, as discussed in more detail below. Attachment hooks (3320) may be facilitated by a layer of loop material external to some or all components of the positioning and stabilizing structure (3300). According to one example of the present technology, each of the upper straps (3312, 3314) and the lower straps (3316, 3318) may have an outer layer of hook material for releasably engaging the individual hooks (3320).

According to another example of the present technology, each component of the positioning and stabilizing structure (3300) may also include an outer layer of loop material so that when the upper straps (3312, 3314) and the lower straps (3316, 3318) wrap around themselves When back, the hooks (3320) can be connected to the components of the back. For example, overhead strap (3348), left overhead member (3306), right overhead member (3308), and neck member (3310) may include an outer layer of loop material so that hooks (3320) may be attached to back (3302) Individual junctions between components and upper and lower straps (3312, 3314) and lower straps (3316, 3318).

Meanwhile, Figure 3 shows the extent to which the hooks (3320) are relatively narrower than their individual straps, as well as the components of the back (3302). This has the advantage that the straps and back protect the user's skin from the hooks, thereby reducing pain and discomfort. Additionally, the components of the exemplary positioning and stabilizing structure (3300) can be connected to each other by ultrasonic welding to assemble the positioning and stabilizing structure. These features are equally applicable to the different sized positioning and stabilizing structures discussed below. 3.1.2.1 Variation ratio of positioning and stabilizing structures of different sizes

Figures 4a-4zl, 5a-5l, and 6a-6v show similar positioning and stabilizing structures, as well as individual components of the positioning and stabilizing structures. Each successive graph shows positioning and stabilizing structures of different sizes. Thus, Figures 4a-4z1 show an exemplary positioning and stabilization structure (3340) and its individual components sized to accommodate a standard or midsize head. Figures 5a-5l show an exemplary positioning and stabilizing structure (3350) and its individual components dimensioned to accommodate a large size head. In other words, the head of a patient wearing the positioning and stabilizing structure (3350) shown in these figures is larger than the head of a patient wearing the positioning and stabilizing structure (3340) shown in Figures 4a-4z1. Figures 6a-6v are dimensioned to accommodate an exemplary positioning and stabilization structure (3360) of a small size head and its individual components. In other words, in these figures, the head of a patient wearing the positioning and stabilizing structure (3360) is smaller than the head of a patient wearing the positioning and stabilizing structure (3340) shown in Figures 4a-4zl. 3.1.2.1.1 Standard Dimensions

4a-4z1 show an example of a positioning and stabilizing structure (3340) in accordance with the present technology. The exemplary positioning and stabilizing structure (3340) shown in these figures may include a back (3340.1). Exemplary back (3340.1) may include a left overhead member (3345) and a right overhead member (3342), and a neck member (3343). The positioning and stabilizing structure (3340) may also include an overhead strap (3348). Meanwhile, extending from the back (3340.1) can be an upper left strap (3346) and an upper right strap (3341), and a left lower strap (3344) and a right lower strap (3344). It should be appreciated that the lower straps of the exemplary positioning and stabilizing structure (3340) may be the same. The hook portion (3349) of the hook material can be attached to the distal end of each of the upper straps (3346, 3341) and the lower straps (3344). Hooks (3349) can be used to attach each strap to itself by wrapping around the attachment point of the patient interface. Attachment hooks (3349) may be facilitated by a layer of loop material over the exterior of some or all components of the positioning and stabilizing structure (3340). According to one example of the present technology, each of the upper straps (3346, 3341) and the lower straps (3344) may have an outer layer of hook material for releasably engaging the individual hooks (3349).

According to another example of the present technology, each component of the positioning and stabilizing structure (3340) may also include an outer layer of loop material so that when the upper straps (3346, 3341) and the lower straps (3344) loop back on themselves , the hook (3349) can be connected to the components of the back. For example, the overhead strap (3348), left overhead piece (3345), right overhead piece (3342), and neck piece (3343) may include an outer layer of loop material so that the hooks (3349) can be attached to the back (3340.1) Individual junctions between components and upper straps (3346, 3341) and lower straps (3344).

Also, as previously described, the hooks (3349) may be relatively narrower than their individual straps, as well as the components of the back (3340.1). Additionally, the components of the exemplary positioning and stabilizing structure (3340) can be connected to each other by ultrasonic welding to assemble the positioning and stabilizing structure. For example, each hook (3349) can be ultrasonically welded at the hook junction (3347) to attach an individual upper or lower strap. At the same time, the upper and lower straps can be ultrasonically welded at the strap joint (3347.1) to join the components of the back. According to a further example, the strap joint (3347.1) may be formed by two-way ultrasonic welding.

It will also be appreciated that Figure 4a shows a diagram of an exemplary positioning and stabilizing structure (3340), wherein the positioning and stabilizing structure is lying flat and the overhead strap (3348) is not attached to the left strap (3346). When the overhead strap (3348) is attached to the left strap (3346), the positioning and stabilizing structure (3340) will assume a more curved shape, such as shown in FIG.

The components of the exemplary positioning and stabilizing structure (3340) may be formed using a weaving process. To provide the desired strength and stretch to these components, the weft yarns used to knit the components of the components can be oriented in a desired direction. For example, a neck piece weft direction (3343.1) is shown in the neck piece (3343) shown in Figure 4h. In Figure 4n, the right header (3342) and a right header weft direction (3342.1) are shown. In Figure 4q, the left header (3345) and a left header weft direction (3342.1) are shown. In Figure 4x, the overhead strap (3348) is shown with a overhead strap weft direction (3348.1).

The dimensions of the components of the positioning and stabilizing structure may vary or remain the same between different dimensions of the positioning and stabilizing structure. FIG. 4j show the right and left lower band (3344) may have a length L _1, according to an example thereof may be from about 270.0 mm (mm) ± 0.5 mm (mm). FIG 4l and 4m show the right head band (3342) dimension L _2, L _3, L ₄ and L _5. According to an example, L ₂ may be about 69.6 mm (mm), L ₃ may be about 43.6 mm (mm), L ₄ may be about 20.4 mm (mm), and L ₅ may be about 67.3 mm (mm). FIG 4o and 4p displays the left head band (3345) dimension _{L 6, L 7, L 8} , and L _9, which may be equal to the right top of the head band (3342) dimension _{L 2, L 3, L 4} , and L ₅ . FIG 4r and 4s displayed on the right band (3341) the size of L _10, L _11, and L _12. According to an example, L ₁₀ may be about 140.0 mm (millimeters), L ₁₁ may be about 155.1 mm (millimeters), and L ₁₂ may be about 40.9 mm (millimeters). Figures 4t and 4u show the dimensions L ₁₃ , L ₁₄ , and L _{15 of the} upper left strap (3346), which may be equal to the dimensions L ₁₀ , L ₁₁ , and L _{12 of the} upper right strap ( 3341 ), respectively. FIG 4w display device according to an example of the head band (3348) dimension L _16, which may be approximately 239.7 mm (mm). 3.1.2.1.2 Large size

5a-5l depict an example of a positioning and stabilizing structure (3350) in accordance with the present technology. The exemplary positioning and stabilizing structure (3350) shown in these figures may include a back (3350.1). Exemplary back (3350.1) may include a left overhead piece (3355) and a right overhead piece (3352), and a neck piece (3353). The positioning and stabilizing structure (3350) may also include an overhead strap (3358). Meanwhile, extending from the back (3350.1) can be an upper left strap (3356) and an upper right strap (3351), and a left lower strap (3354) and a right lower strap (3354). It should be appreciated that the lower straps of the exemplary positioning and stabilizing structure (3350) may be the same. The hook portion (3359) of the hook material can be attached to the distal end of each of the upper straps (3356, 3351 ) and the lower straps (3354). Hooks (3359) can be used to attach each strap to itself by wrapping around the point of attachment of the patient interface. Attachment hooks (3359) may be facilitated by a layer of loop material over the exterior of some or all components of the positioning and stabilizing structure (3350). According to one example of the present technology, each of the upper straps (3356, 3351) and the lower straps (3354) may have an outer layer of hook material for releasably engaging the individual hooks (3359).

According to another example of the present technology, each component of the positioning and stabilizing structure (3350) may also include an outer layer of loop material so that when the upper straps (3356, 3351 ) and the lower straps (3354) loop back on themselves , the hook (3359) can be connected to the components of the back. For example, the overhead strap (3358), left overhead piece (3355), right overhead piece (3352), and neck piece (3353) may include an outer layer of loop material so that the hooks (3359) can be attached to the back (3350.1) Individual junctions between components and upper straps (3356, 3351) and lower straps (3354).

Also, as previously described, the hooks (3359) may be relatively narrower than their individual straps, and components of the back (3350.1). Additionally, the components of the exemplary positioning and stabilizing structure (3350) can be connected to each other by ultrasonic welding to assemble the positioning and stabilizing structure. For example, each hook (3359) can be ultrasonically welded at the hook junction (3357) to attach an individual upper or lower strap. At the same time, the upper and lower straps can be ultrasonically welded at the strap joints (3357.1) to join the components of the back. According to a further example, the strap junction (3357.1) may be formed by a two-way ultrasonic welding.

It will also be appreciated that Figure 5a shows a diagram of an exemplary positioning and stabilizing structure (3350), wherein the positioning and stabilizing structure is lying flat and the overhead strap (3358) is not attached to the left strap (3356). When the overhead strap (3358) is attached to the left strap (3356), the positioning and stabilizing structure (3350) will assume a more curved shape, such as shown in FIG.

The component dimensions of the positioning and stabilizing structure may vary or remain the same between different dimensions of the positioning and stabilizing structure. FIG. 5f and 5g show the right upper band (3351) the size of L _17, L _18, and L _19. According to an example, L ₁₇ may be about 180.0 mm (millimeters), L ₁₈ may be about 195.1 mm (millimeters), and L ₁₉ may be about 40.9 mm (millimeters). Figures 5h and 5i show the dimensions L ₂₀ , L ₂₁ , and L _{22 of the} upper left strap (3356), which are equal to the dimensions L ₁₇ , L ₁₈ , and L _{19 of the} upper right strap ( 3351 ), respectively. FIG. 5k display device according to an example of the head band (3358) dimension L _23, which may be approximately 249.7 mm (mm).

As previously described, some dimensions of the components of the exemplary oversized positioning and stabilizing structure (3350) may vary compared to the standard sized positioning and stabilizing structure (3340), while others remain the same. According to one example of the present technology, the large-sized positioning and stabilizing structure (3350) may include larger upper right and upper left straps (3351, 3356) and A larger overhead strap (3358). Please refer to the aforementioned exemplary dimensions for a detailed description of the differences. However, some dimensions can remain the same. For example, the oversized positioning and stabilizing structure (3350) may be the same as the standard positioning and stabilizing structure (3340) for the neck piece (3353), right and left lower straps (3354), and right and left overhead pieces (3352, 3355). size.

Depending on typical patient head dimensions, it is possible to choose whether or not to vary the specific dimensions of these components for the various positioning and stabilizing feature sizes. For example, it may be the case that the head area adapted by the lower strap may not vary between medium and large head sizes, while the head area adapted by the upper and overhead straps may require longer straps for larger heads. 3.1.2.1.3 Small size

Figures 6a-6l show one example of a positioning and stabilizing structure (3360) in accordance with the present technology. The exemplary positioning and stabilizing structure (3360) shown in these figures may include a back (3360.1). Exemplary back (3360.1) may include a left overhead member (3365) and a right overhead member (3362), and a neck member (3363). The positioning and stabilizing structure (3360) may also include an overhead strap (3368). Meanwhile, extending from the back (3360.1) can be an upper left strap (3366) and an upper right strap (3361), and a lower left strap (3364) and a lower right strap (3364). It should be appreciated that the lower straps of the exemplary positioning and stabilizing structure (3360) may be the same. The hook portion (3369) of the hook material can be attached to the distal end of each of the upper straps (3366, 3361 ) and the lower straps (3364). Hooks (3369) can be used to attach each strap to itself by wrapping around the attachment point of the patient interface. Attachment hooks (3369) may be facilitated by a layer of loop material over the exterior of some or all components of the positioning and stabilizing structure (3360). According to one example of the present technology, each of the upper straps (3366, 3361) and the lower straps (3364) may have an outer layer of hook material for releasably engaging the individual hooks (3369).

According to another example of the present technology, each component of the positioning and stabilizing structure (3360) may also include an outer layer of loop material so that when the upper straps (3366, 3361) and the lower straps (3364) loop back on themselves , the hook (3369) can be connected to the components of the back. For example, the overhead strap (3368), left overhead piece (3365), right overhead piece (3362), and neck piece (3363) may include an outer layer of loop material so that the hooks (3369) may be attached to the back (3360.1) Individual junctions between components and upper straps (3366, 3361) and lower straps (3364).

Also, as previously described, the hook (3369) may be relatively narrower than its individual straps, and components of the back (3360.1). Additionally, the components of the exemplary positioning and stabilizing structure (3360) can be connected to each other by ultrasonic welding to assemble the positioning and stabilizing structure. For example, each hook (3369) may be ultrasonically welded at the hook junction (3367) to attach an individual upper or lower strap. At the same time, the upper and lower straps can be ultrasonically welded at the strap junction (3367.1) to join the components of the back. According to a further example, the strap junction (3367.1) may be formed by two-way ultrasonic welding.

It will also be appreciated that Figure 6a shows a diagram of an exemplary positioning and stabilizing structure (3360), wherein the positioning and stabilizing structure is lying flat and the overhead strap (3368) is not attached to the left strap (3366). When the overhead strap ( 3368 ) is attached to the left strap ( 3366 ), the positioning and stabilizing structure ( 3360 ) will assume a more curved shape, such as shown in FIG. 3 .

The component dimensions of the positioning and stabilizing structure may vary or remain the same between different dimensions of the positioning and stabilizing structure. Figure 6h shows that the lower right and left straps (3364) may have a _{length of L 24} , which may be approximately 230.0 mm (mm) ± 0.5 mm (mm), according to an example. FIG. 6j and 6k show a right head band (3362) the size of _{L 25, L 26, L 27} , and L _28. According to an example, L ₂₅ may be about 64.6 mm (millimeters), L ₂₆ may be about 38.6 mm (millimeters), L ₂₇ may be about 20.9 mm (millimeters), and L ₂₈ may be about 63.6 mm (millimeters). FIG 6m and 6n display left head band (3365) the size of _{L 29, L 30, L 31} , and L _32, which are equal to the right top of the head band (3362) the size of L _25, L _26, L ₂₇ and L ₂₈ . FIG 6p and 6q displayed on the right band (3361) the size of L _33, L _34, and L _35. According to an example, L ₃₃ may be about 130.0 mm (millimeters), L ₃₄ may be about 145.8 mm (millimeters), and L ₃₅ may be about 41.9 mm (millimeters). FIG 6r and 6s band left on the display (3366) the size of L _36, L _37, and L _38, which are equal to the right-band (3361) the size of L _33, L _34, and L _35. FIG 6u display device according to an example of the head band (3368) dimension L _39, which may be approximately 227.4 mm (mm).

As previously discussed, certain components of the exemplary smaller-sized positioning and stabilizing structure (3360) may vary in size compared to the standard-sized positioning and stabilizing structure (3340), while others may remain the same. According to one example of the present technology, a small size headgear (3360) may use only a neck piece (3363) of the same size as a standard size positioning and stabilizing structure (3340). The remaining components can be sized according to the previously disclosed dimensions.

The specific dimensions of these components, selected or not to vary the dimensions of the various positioning and stabilizing structures, can be determined from typical patient head dimensions. As opposed to large and standard positioning and stabilizing structures that can share several sizes, it may be the case that as the size of the patient's head decreases, more components of the positioning and stabilizing structure may need to be reduced to accommodate the smaller head size. 3.2 Evenly distributed sealing force

According to one example of the present technology, the positioning and stabilizing structure (3300) can create an even distribution of sealing force at the seal-forming structure to seal against the patient's face. 3.2.1 Sealing force vector and eye-ear plane

In FIG. 8C, an upper sealing force vector F ₁ is displayed (3314) is produced by the band on the right, and sealing force vector F ₂ at the display is generated by the right-band (3318). According to one example the present technology, the two sealing force vector F ₁ and F ₂ (and which is not shown in the other opposing side portion of the patient's head) to be substantially directed parallel to the plane of eye and ear, shown in Figure 2e. By maintaining these sealing force vectors in a substantially parallel direction with respect to the eye-ear plane, it more evenly distributes the sealing force of the seal-forming structure (3100) to seal against the patient's face. This may improve patient comfort since there is no place along the seal-forming structure (3100) to depress the face with more force than another. According to another example of the present technology, the sealing force vectors generated by the upper and lower straps may be substantially parallel to each other. 3.2.2 Connection of patient interface frame and cushion accessories

7a-7e, 7j-7m, 7o, 7p, and 14-18 show various views of a patient interface box according to an example of the present technology. Figures 8a-8c show various views of the patient interface (3000) and positioning and stabilizing structure (3300) assembled and worn on the patient. As mentioned above, the seal-forming structure (3100) may be a silicone component molded into the plenum (3200), which may be made of Nylon to form a cushion fitting. Nylon 12 can also be used to form the plenum (3200) in a further example of the present technology. In another example of technology, polycarbonate may be used to form the plenum (3200). The patient interface frame (3370) facilitates the connection between the cushion fitting and the positioning and stabilizing structure (3300), therefore, it must be connectable to the cushioning fitting to transfer the sealing force from the positioning and stabilizing structure. The plenum (3200) and patient interface frame (3370) may include cooperating features to frictionally fit these components to each other. Exemplary patient interface frame (3370) may include a pair of upper patient interface frame retention features (3384) and a pair of lower patient interface frame retention features (3382). The plenum (3200) may also include a corresponding pair of upper plenum retention features and a corresponding pair of lower plenum retention features (although these figures do not show such). As shown in these figures, when upper and lower patient interface frame retention features (3384, 3382) protrude from patient interface frame (3370), they may form. Thus, the upper and lower plenum retention features of plenum (3200) would be corresponding indentations or adapters to affect the frictional fit. An opposite structure is also envisaged.

As shown in these figures, patient interface frame (3370) may be formed around the perimeter of plenum (3200). If the plenum (3200) is made of polycarbonate, a transparent material, this may allow the bed partner to see more of the patient's facial features, thereby making the patient interface (3000) look more pleasing. Thus, it should be appreciated that the connection between the plenum (3200) and the patient interface frame (3370) may be characterized as hard-to-hard.

At the same time, by connecting the patient interface frame (3370) to the plenum (3200) at its perimeter, a more uniform transfer of sealing force to the seal-forming structure (3100) may be facilitated. According to one example of the present technology, the plenum (3200) may be formed of polycarbonate or another relatively hard material, while the seal-forming structure (3100) may be formed of a relatively elastic material, such as silicone. The tension of the positioning and stabilizing structure (3300) is transferred to the plenum (3200) near the perimeter of the plenum via the patient interface frame (3370). The seal-forming structure (3100) may also mold a plenum (3200) near its perimeter. Thus, an even distribution of the sealing force near the perimeter of the plenum (3200) may result in an even distribution of the sealing force across the seal-forming structure (3100) as it is also connected to the plenum near its perimeter.

It will be appreciated that another concept in the selection of materials for the plenum (3200) and the seal-forming structure (3100) is that the plenum be able to deform slightly, while allowing some deformation to the seal-forming structure. Therefore, for the plenum (3200), the material should be selected so that the plenum does not deform under the tension loads created by the straps. On the other hand, the seal-forming structure (3100) may be intended to deform to form a seal around the patient's facial features. Therefore, the seal-forming structure (3100) should be formed from a material that will deform sufficiently to affect the pneumatic seal without deforming the degree to which the plenum (3200) presses against the face. By selecting materials according to this concept, it is ensured that an even distribution of sealing force is provided around the perimeter of the seal-forming structure (3100) for maximum patient comfort.

19-21 show another example of the present technology in which the seal-forming structure (3100) can be separated from the plenum (3200). Figure 19 shows the plenum (3200) having a first attachment region (3202) that can extend around the perimeter of the plenum (3200) to engage the seal-forming structure (3100). The plenum (3200) may also include: an upper receiver (3208) for receiving an upper patient interface frame retention feature (3384); and a lower receiver (3206) for receiving a lower patient interface frame retention feature (3382) ). Accordingly, an upper receiver (3208) and a lower receiver (3206) may be provided on each side of the plenum (3200) to receive upper patient interface frame retention features (3370) when attached 3384) and the corresponding ones of the lower patient interface frame retention features (3382). Detent (3204) may also be provided in the plenum (3200) to facilitate snap-fit connection of the seal-forming structure (3100). A latch (3204) can be provided on each side of the inflatable chamber (3200).

Figure 20 shows a seal-forming structure (3100) according to this example. The seal-forming structure (3100) may include a second attachment region (3102) for attaching the seal-forming structure (3100) to the plenum (3200) at the first attachment region. A second attachment region (3102) may be formed around the perimeter of the seal-forming structure (3100). The first attachment region (3202) and the second attachment region (3102) can be shaped to conform to each other for press fit, snap fit, and/or friction fit. One of the first attachment region (3202) and the second attachment region (3102) may be formed of a more compliant and/or resilient material than the other, allowing for a secure fit by deforming to provide a conforming engagement. Meanwhile, the seal-forming structure (3100) may have protrusions (3104) that conform to the catches (3204) of the plenum to form a snap fit therewith, and secure the seal-forming structure (3100) to the plenum (3200).

Figure 21 shows this example of the seal-forming structure (3100) and the plenum (3200) joined to each other at their respective peripheries by joining the first (3202) and second (3102) attachment areas to each other.

Further examples of conceivable attachment between a seal-forming structure (3100) and a plenum (3200) are disclosed in US Pat. Nos. 6,491,034, 6,412,487, 6,823,869, the entire contents of each of which are incorporated herein Incorporated herein for reference. 3.2.3 Holding Arm

According to one example of the present technology, the patient interface frame (3370) may include a pair of holding arms (3371, 3381). Figures 7f and 7g show the right retaining arm (3371). The right retention arm (3371) may include: an upper right attachment point (3375) for attaching the upper right strap (3314); and a right retention arm attachment feature (3373) for attachment to the patient interface frame (3370) A right frame join feature of (3376). Figures 7h and 7i show the left holding arm (3381). The left retention arm (3381) may include: an upper left attachment point (3385) for attaching the upper left strap (3312); and a left retention arm attachment feature (3383) for attachment to the patient interface frame (3370) a left frame connection feature (3378). Each retention arm connection feature (3373, 3383) may connect its respective retention arm (3371, 3381) to the patient interface frame (3370) by directly connecting and/or engaging an individual frame connection feature (3376, 3378). The holding arms (3371, 3381) can be formed of polycarbonate and/or nylon. According to another example of the technology, the elastic connection structures (3377, 3387) can connect the retaining arm connection features (3373, 3383) to the individual frame connection features (3376, 3378), so that the elastic connection structure is used as an intermediate connection.

As shown in Figures 8a-8c, the retention arms (3371, 3381) can be shaped so that the retention arms do not extend beyond the eye when the patient wears the patient interface (3000) and positioning and stabilizing structure (3300). The retaining arms (3371, 3381) can also be shaped to avoid ears and temples. As shown in Figure 8c, the right retaining arm (3371) is shaped to pass along and conform to the patient's cheek, and extends between the eye and the ear, while avoiding the temple, so that the upper right strap (3314) is at the upper right attachment point (3314) above the ear. 3375) Attach the right holding arm.

Also, as shown in these figures, the holding arms (3371, 3381) are relatively wide along their longitudinal axis. By forming the holding arms (3371, 3381), this allows for targeted bending of the holding arms. In other words, there is a significantly larger limit bend in the direction of the wider cross-section, while there is a lower limit bend in the direction of the narrower cross-section. This has the advantage of allowing the retaining arms (3371, 3381) to conform to the patient's face and cheeks when the positioning and stabilizing structure is in tension, but would be hindered by bending up towards the patient's eyes or down towards the patient's ears.

8a-8c also show an attachment point plane PA and a connection point plane PC, which are vertically offset by a distance O from each other. It should be understood that the two planes are substantially parallel to the eye-ear plane shown in Figure 2e. At the same time, the attachment point plane PA is set so that the upper attachment points (3375, 3385) of the holding arms (3371, 3381) are set in the attachment point plane. Furthermore, the connection point plane PC is arranged such that the left and right connection points (3391) between the holding arms (3371, 3381) and the patient interface frame (3370) lie in the connection point plane.

Figures 10a and 10b show exemplary intended holding arm paths along the side profile of the patient's head for large and small sized heads, respectively. The desired holding arm paths are within rectangular areas with widths of 68 mm (mm) and 51 mm (mm), respectively. The measurements indicated in these figures represent the basis for sizing and shaping the holding arm so that it follows the indicated path to provide optimum patient comfort. 3.2.3.1 Attachment points for positioning and stabilizing structures

According to one example of the present technology, the retention arms (3371, 3381) may provide attachment points (3375, 3385) on the upper straps (3312, 3314) of the positioning and stabilizing structure (3300), as previously described. According to one example of the present technology, the upper attachment points (3375, 3385) may be slits formed at the respective ends of the retaining arms (3371, 3381). The upper straps (3312, 3314) may connect individual upper attachment points (3375, 3385) by wrapping around them. The patient interface frame (3370) may also include lower attachment points (3372, 3374) for the lower straps (3316, 3318), which are shown in Figures 7a-7c, 7e, 7j, 7k, 7p, and 8a-8c. Each of the lower attachment points (3372, 3374) may include a hook (3380), as shown in Figures 7j-7n. When the hook (3380) wraps around the lower attachment point, it helps retain the individual lower straps (3316, 3318), as shown in Figures 8a-8c. As previously described, forming the lower attachment points (3372, 3374) will allow the patient retention hooks (3320) to connect to the individual lower straps (3316, 3318). When wearing the patient interface (3000) and positioning and stabilizing structure (3300), the patient simply slides over the individual lower attachment points (3372, 3374) by attaching the hooks (3320) to the individual lower straps (3316, 3318) ) formed by the surround. The lower straps (3316, 3318) are then retained via hooks (3380).

Figure 13 shows another example of a holding arm (3371) in accordance with the present technology. The retention arm (3371) shown in this figure may include a retention arm attachment feature (3373). This exemplary retention arm (3371) is also shaped and sized similarly to the retention arm shown in Figures 7f and 7g. However, the upper attachment point (3375) may be different in that it may include an opening (3379) within the slit containing the attachment point. By shaping the attachment points (3375) as described, the patient can pull the encircling upper strap from the upper attachment point without detaching the hooks from the individual upper straps. This is beneficial to the patient because the patient does not need to adjust the length of the upper strap each time the patient interface (3000) and positioning and stabilizing structure (3300) are worn. However, the patient only slides the upper straps out of the attachment points of the individual holding arms. Also, in this example, the opening can be narrowed into the attachment point (3375). This can make it easier to slide the band into the attachment point, but it makes it less easy to remove the band and, therefore, less likely to slip off the band during treatment.

It is also contemplated that other attachment structures may be provided for attaching the straps to the attachment points. For example, a clip can be provided through which the strap can be looped, and the clip can then be attached to the individual attachment points (ie, adapters) of the holding arm and the patient interface frame. 3.2.4 Connection between the holding arm and the patient interface frame

According to one example of the present technology, the holding arms (3371, 3381) can be articulated similarly to the patient interface frame (3370). The movable joint may be mechanical or movable. A mechanically movable joint can be formed using a patient interface frame (3370) with guide rods connected and rotated by the holding arms (3371, 3381). A movable joint may include a resilient connection, which will be discussed in more detail below. The movable joint according to an example of the technology may include an elastic silicone movable joint. Regardless of the type of articulation used, the advantage is that the articulation is formed so that the holding arms (3371, 3381) substantially employ a single plane of rotation that is substantially parallel to the eye-ear plane shown in Figure 2e. This helps keep the holding arms (3371, 3381) from rotating up into the patient's field of view or down against the ear.

It should be understood that the patient interface frame (3370) and the holding arms (3371, 3381) can be formed separately and then permanently or detachably connected using a mechanical connection. Alternatively, these components may be joined to each other using overmolding. In a further alternative, the patient interface frame (3370) and the holding arms (3371, 3381) can be formed separately, and then a third component is overmolded at the connection to achieve the connection, thereby facilitating the connection. In still further alternatives, the patient interface frame (3370) and retention arms (3371, 3381) may be molded in one piece, and in a further variation, an additional component may be overmolded to further control the elasticity of the retention arms .

In order to use the desired degree of elasticity to facilitate the connection between the retention arms (3371, 3381) and the patient interface frame (3370), the elastic connection structure (3377, 3387) can connect the right retention arm connection feature (3373) and the right frame connection Feature (3376), connection with left retainer arm feature (3383) and left frame connection feature (3378). The elastic connecting structures (3377, 3387) may be formed of a material such as silicone or thermoplastic elastomer that is relatively more elastic than the holding arms (3371, 3381) and the patient interface frame (3370). Elastic connection structures (3377, 3387) can also be overmolded on the holding arms (3371, 3381) and the patient interface frame (3370) to facilitate a permanent connection between these components.

According to another example of the present technology, as shown in Figures 22 and 23, the attachment points of the positioning and stabilizing structure (3300) may be formed directly or integrally with the plenum (3200). According to this example, right frame connection feature (3376) and left frame connection feature (3378) may be integrally formed with plenum (3200). Resilient connection structures (3377, 3387) may be overmolded directly in the plenum (3200) at the right frame connection feature (3376) and the left frame connection feature (3378), respectively, to attach the retention arms (3371, 3381). At the same time, the lower attachment points (3372, 3374) may be integrally formed with the plenum (3200). It should be appreciated that in this example, the patient interface frame (3370) may not necessarily be the elastic connection structures (3377, 3387), and the lower attachment points (3372, 3374) are integrally formed with the plenum (3200). Thus, the seal-forming structure (3100) may be integrally formed with or with the plenum (3200). The advantage of this example is that fewer components are required, which can reduce manufacturing costs and provide a simpler patient interface system for the patient. 3.3 Improve the stability of positioning and stabilizing structures

According to one example of the present technology, the positioning and stabilizing structure (3300) may provide improved stability, particularly in the crown region of the head. Improving the stability of the positioning and stabilizing structure (3300) with respect to the previous positioning and stabilizing structure can be achieved by widening the assembly of the positioning and stabilizing structure. 3.3.1 Widened connection

Positioning and stabilizing structure (3300) near the crown of the head and at the connection between the upper straps (3316, 3318), the crown strap (3304), and the crown members (3306, 3308), according to one example of the present technology The connection area can be widened to improve stability. This can be achieved by widening the aforementioned components in the vicinity of this area. Desirably, widening the aforementioned portion of the exemplary positioning and stabilizing structure (3300) preferably inhibits upward retraction of the patient interface (3000), which may occur due to shifting of the positioning and stabilizing structure from where it should be. . Increasing the surface area, these joined areas can increase stiffness so that the back (3302) remains on the back of the head. It is also possible to form a better restraint of strap bending. Stability can be improved by widening these components because of the larger surface area in contact with the head.

Figure 9 shows a standard size positioning and stabilizing structure (3340) designed to fit the same size head lying flat with a prior art positioning and stabilizing structure (3399). This graph shows regions of relatively increased width, which indicates the extent to which these regions are more prone to slip and bend relative to the width of the prior art positioning and stabilizing structure (3399). 3.4 Ventilation port (3400)

In one form, the patient interface (3000) includes a ventilation port (3400) constructed and arranged to allow exhalation of exhaled carbon dioxide.

One form of vent (3400) according to the present technology includes a plurality of orifices, eg, about 20 to about 80 orifices, or about 40 to about 60 orifices, or about 45 to about 55 orifices.

The ventilation port (3400) may be located in the plenum (3200). Alternatively, the ventilation port (3400) is provided in a decoupling structure (3500), such as a swivel. 3.5 Decoupling Structure (3500)

In one form, the patient interface (3000) includes at least a decoupling structure (3500), such as a swivel or a ball and socket. 3.6 Connection port (3600)

Connection port (3600) allows connection of air channel (4170). 3.7 Anti-suffocation parts

In one form, the patient interface (3000) includes an anti-asphyxia valve (3800). 3.8 Connection port (3900)

In one form of the present technology, a patient interface (3000) includes one or more connection ports allowing access to the volume within the plenum (3200). In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows for direct determination of gas properties, such as pressure, within the plenum (3200). 3.9 Patient Interface and Positioning and Stabilizing Structural Accessories

11 and 12 show perspective views of an exemplary patient interface (3000) and positioning and stabilizing structure (3300). The two exemplary devices exhibit similar characteristics, including those previously described. 4. Vocabulary

For the purposes of this technical disclosure, in particular forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may apply. 4.1 General

Air: In certain forms of the present technology, the air supplied to the patient can be atmospheric air, and in other forms of the present technology, atmospheric air can supplement oxygen.

Continuous Positive Airway Pressure (CPAP): Taking CPAP therapy means applying air or breathable gas to the airway inlet through the patient's breathing cycle at continuous positive atmospheric pressure and preferably approximately constant. In some forms, the airway inlet pressure varies by several centimeters of water during a single breath cycle, eg, higher during inhalation and lower during expiration. In some forms, the airway inlet pressure is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure may vary between different breathing cycles of the patient, eg, increasing with detection indicating local upper airway obstruction, and decreasing without indicating local upper airway obstruction. 4.2 Aspects of PAP Devices

Air Circuit: A conduit or tube is constructed and arranged in use to transfer air or a supply of breathable gas between a PAP device and a patient interface. Specifically, the air passage may be an outlet that fluidly connects the pneumatic block and the patient interface. The air passages may be referred to as air ducts. In some cases, there may be separate protrusions for the inhalation and exhalation circuits. In other cases, a single protruding member may be used.

Automatic Positive Airway Pressure (APAP): Automatically adjust the positive airway pressure ventilation. Positive airway pressure can be continuously adjusted between minimum and maximum restrictions, depending on whether an SDB event is indicated.

Blower or Flow Generator: A device that delivers a flow of compressed air above ambient pressure.

Controller: A device or part of a device that can adjust an output based on an input. For example, one form of the controller has a variable under control, one of the control variables, to constitute the input to the device. The output of the device is a function of the current value of the control variable, and a set point of the variable. An assisted ventilator may include a controller having ventilation as an input, target ventilation as a set point, and pressure support levels as an output. Other forms of input may be one or more of oxygen saturation (SaO ₂ ), partial pressure of carbon dioxide (PCO ₂ ), motion, signal from a photovolumetric signal meter, and peak flow. The set point of the controller can be one or more fixed, variable or learned values. For example, a ventilator's set point may be a long-term average of the patient's measured respiration. Another ventilator may have a breathing set point that changes over time. A pressure controller may be configured to control a booster or pump to deliver air at a particular pressure.

Therapy: Therapy in this specification can be one or more of positive pressure therapy, oxygen therapy, carbon dioxide therapy, control of confined spaces, and medication.

Motor: A device used to convert electrical energy into rotational motion of a member. In this specification, a rotary motion is a propeller that rotates near a fixed axis so that the air moving along the axis of rotation increases the pressure.

Positive Airway Pressure (PAP, Positive Airway Pressure) device: A device used to provide positive pressure air supply to the respiratory tract.

Transducer: A device used to convert one form of energy or signal into another. A transducer may be a sensor or detector for converting a mechanical source, such as motion, into an electrical signal. Examples converter comprises a pressure sensor, flow sensor, a carbon dioxide (CO ₂₎ sensor, oxygen (O ₂₎ sensor, a stress sensor, a motion sensor, a noise sensor, plethysmography device and camera.

Volute: The casing of a centrifugal pump to receive air propelled by the impeller, which slows the air flow and increases the pressure. The cross section of the helical housing increases the area towards the discharge port. 4.3 The state of breathing cycle

Apnea: Preferably, an apnea should be, eg, 10 seconds in duration, which occurs when the flow falls below a predetermined threshold. Obstructive apnea should be a condition that occurs when some obstruction of the airway prevents air flow, despite the patient's efforts. Central apnea can be said to occur when apnea is detected (due to reduced or no respiratory effort).

Breathing Rate: The patient's natural breathing rate, usually measured in breaths per minute.

Duty Cycle: The ratio of the inhalation time Ti to the total breathing time Ttot.

Breathing Effort: It is best to use it. Breathing Effort should be the action done by the natural breather trying to breathe.

Expiratory portion of a breathing cycle: The period from the onset of expiratory flow to the onset of inspiratory flow.

Flow Limitation: Preferably, the flow limitation will be a condition of the patient's breathing, where more force by the patient does not cause a relative increase in flow. Where flow is limited during the inspiratory portion of the breathing cycle, this flow limitation will be an inspiratory flow limitation. In the event of a flow restriction that occurs during the expiratory portion of the breathing cycle, this flow restriction may be an expiratory flow restriction.

Types of Inspiratory Flow Limiting Waveforms: (i) Top Flat Wave: A rise followed by a fall in a relatively flat part. (ii) M-shaped wave: There are two local peaks, one at the leading edge and the other at the trailing edge, and a relatively flat portion between the two peaks. (iii) Rising edge spur: There is a single local peak, the local peak is at the leading edge, which follows a relatively flat portion. (iv) Descending edge spur: A relatively flat portion that follows a single local peak that is on the trailing edge.

Shallow breathing (Hypopnea): Best practice, shallow breathing will reduce flow but not stop it. In one form, shallow breathing should occur when the reduced flow rate falls below a persistent threshold. In one form, on the adult side, any of the following may be considered shallow breathing: (i) a 30% decrease in the patient's breathing for at least 10 seconds plus an associated 4% decrease in saturation; or (ii) Reduce the patient's breathing (but less than 50%) for at least 10 seconds plus at least 3% or an associated desaturation of brief arousal.

Hyperpnea: Increased air flow levels above normal.

Inspiratory portion of a breathing cycle: Preferably, the period from the beginning of inspiratory flow to the beginning of expiratory flow will be the inspiratory portion of the breathing cycle.

Patency Airway: The degree to which the airway opens, or the extent to which the airway opens. The open airway is open. Airway patency can be quantified, for example, 1 is clear and 0 is closed.

Positive End-Expiratory Pressure (PEEP): The pressure in the lungs at the end of expiration exceeds that of the atmosphere.

Peak Flow ( Qpeak ): The maximum flow value during the inspiratory portion of the respiratory flow waveform.

Respiratory Flow, Airflow, Patient Airflow, Respiratory Airflow ( Qr ): These synonymous terms can be considered as PAP devices' assessment of respiratory airflow, not "correct respiratory flow" or "correct breathing"Airflow", which is the correct flow rate of breathing experienced by the patient, usually expressed in liters per minute.

Tidal volume ( Vt ): Inspiratory or expiratory volume during normal breathing when no additional effort is applied.

Inhalation Time ( Ti ): The duration of the inspiratory portion of the respiratory flow waveform.

Exhalation Time ( Te ): The duration of the expiratory portion of the respiratory flow waveform.

Total Time ( Ttot ): The total period between the start of the inspiratory portion of one respiratory flow waveform and the beginning of the inspiratory portion of the next respiratory flow waveform.

Typical Recent Ventilation: Ventilation values in which the most recent values tend to be dense over some predetermined period of time, ie, the median amount of recent ventilation values.

Upper Airway Obstruction (UAO, Upper Airway Obstruction): including partial and total upper airway obstruction. This may be related to a state of flow limitation, where the degree of flow increases only slightly, or may even decrease when the pressure difference across the upper airway increases (Starling resistance behavior).

Ventilation (Vent): A measure of the total amount of gas exchanged by a patient's respiratory system, including inspiratory and expiratory flow rates per unit of time. When expressed as air changes per minute, this volume is often referred to as "minute air changes". Minute ventilation is sometimes only expressed in terms of ventilation volume, that is, ventilation per minute. 4.4 Parameters of Positive Airway Pressure (PAP) Device

Flow Rate: The instantaneous amount (or mass) of air conducted per unit of time. The flow rate measured over a very short period of time when the flow rate is the same volume or mass per unit time as the air change. Flow is nominally positive for the inspiratory portion of the patient's breathing cycle and therefore negative for the expiratory portion of the patient's breathing cycle. In some cases, the flow rate reference will be treated as a scalar quantity, that is, a magnitude-only quantity. In other cases, the flow rate reference will be treated as a vector, that is, a quantity that has both magnitude and direction. The flow rate is expressed using symbol consumption Q. The total flow Qt is the flow of air leaving the PAP device. Q v is the ventilation air outlet flow leaving the ventilating port in the discharge flow rate of the exhaled gases. Q l drain flow from a patient interface system is intended to non-leakage rate. Respiratory flow of air into the patient's Q r is the flow rate of respiratory system.

Leak: Specifically, the term "leak" is to be considered an air flow environment. Leakage flow is intended (e.g.) to allow exhaled gases CO _2. Leakage is unintended, eg, therefore, it is an incomplete seal between the mask and the patient's face.

Pressure: The force per unit area. More pressure measurement units can be used, including ^{_{cmH 2 O, gf / cm 2}} , hPa (Hectopascal). 1 cmH ₂ O equals 1 gf/cm ² and is about 0.98 hectopascals. In this specification, unless otherwise stated, the unit of pressure is cmH ₂ O. For nasal CPAP treatment of OSA, a reference treatment pressure means about 4-20cmH ₂ O, or a pressure range from about 4-30cmH ₂ O. The pressure of the patient interface is expressed using the symbol Pm.

Sound Power: The energy per unit time carried by a sound wave. Sound power is proportional to the square of the sound pressure times the wavefront area. Sound power is measured in decibels SWL, that is, decibels are equivalent to reference power, usually ^10-12 watts.

Sound Pressure: Local deviations from the environment at a particular point in time as sound waves travel through the medium. Sound power green is usually expressed in decibel SPL, that is, decibel is equivalent to the reference power, usually 20 × 10 ^-6 Pascal (Pa), considering the critical value of human audibility. 4.5 Terminology of respirator

Adaptive Assisted Respirator: A respirator with variable rather than fixed targeted ventilation. Variable targeted ventilation can be learned from certain characteristics of the patient, such as the patient's breathing characteristics.

Backup Rate: A parameter of the ventilator that establishes the minimum breath rate (typically measured in breaths per minute) that the ventilator will deliver to the patient (if not otherwise triggered).

Cycled: The inspiratory phase of the respirator is terminated. When the ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator cycle stops delivering breaths.

EPAP (or EEP): The baseline pressure for pressure changes in the breath is increased to produce the desired mask pressure that the respirator is trying to achieve at a particular point in time.

IPAP: The desired mask pressure that the respirator will attempt to achieve during the inspiratory portion of the breath.

Pressure Support: Indicates the value of the pressure increase during inspiration of the respirator over the exhalation of the respirator, and usually means the pressure difference between a maximum value during inspiration and a minimum value during expiration (eg PS = IPAP - EPAP ). In some contexts, pressure-assisted ventilation refers to the pressure differential that the ventilator is intended to achieve, rather than what the ventilator actually achieves.

Servo-ventilator: A ventilator that measures patient ventilation has a target ventilation and adjusts the degree of pressure support so that patient ventilation can reach the target ventilation.

Spontaneous/Timed ( S/T ): A mode of a ventilator or other device that attempts to detect the onset of breathing in a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically begin delivering a breath.

Swing: A synonym for pressure-assisted ventilation.

Triggered: When the ventilator is to deliver air breaths to a spontaneously breathing patient, this is triggered at the beginning of the breathing portion of the breathing cycle where the patient exerts force.

Ventilator: A mechanical device that provides pressure-assisted ventilation to a patient for some or all of the work of breathing. 4.6 Facial Anatomy

Alar (Ala or Alar): The outer outer wall or "wing" of each nostril.

Alare: The most lateral point above the alar of the nose.

Alar Point or Alar Crest (Alar Curvature or Alar Crest): The last point of the curved baseline of each alar, the crease formed by the union of the alar and cheek.

Auricle or Auricula (Auricula or Pinna): The entire outer visible part of the ear.

(Nose) Bony Framework: The skeleton of the nose includes the nasal bone, the frontal process of the maxilla, and the nose of the jawbone.

(Nose) Cartilaginous Framework: The cartilaginous framework of the nose includes the septum, sides, and large and small alar cartilages.

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

Columella Angle: The angle between the line drawn through the midpoint of the nostril and the line drawn perpendicular to the eye and ear level when meeting the subnasal point.

Frankfort Horizontal Plane: A line extending from the lowest point of the orbital rim to the point of the left tragus. The tragus point is the deepest point in the notch of the tragus above the outer ear.

Glabella: Soft tissue, most prominent point in the midsagittal plane of the forehead.

Lateral Nasal Cartilage: Usually a small angular plate of cartilage, the upper edge of which connects the nasal bone to the frontal process of the maxilla, and the lower edge connects to the greater alar cartilage.

Greater Alar Cartilage: A small plate of cartilage beneath the lateral nasal cartilage that flexes around the anterior part of the nostril and whose rear end connects to the frontal process of the maxilla through the dura mater, including three or four lesser alar cartilages .

Nostrils (Nares or Naris): Form nearly oval openings leading to the nostrils. The nostrils are separated by the nasal septum.

Naso-Labial Sulcus or Naso-Labial Fold: A fold or depression of skin from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

Naso-Labial Angle: The angle between the columella and the upper lip when meeting the infranasal point.

Otobasion Inferior: Connect the outer ear to the lowest point of the facial skin.

Otobasion Superior: Connect the outer ear to the highest point of the skin of the face.

Pronasale: The most convex point or tip of the nose, identifiable from a profile view of the rest of the head.

Nasolabial sulcus (Philtrum): The middle recess from the lower border of the nasal septum to the roof of the lip in the region of the upper lip.

Pogonion: Located in the soft tissue of the chin, the most anterior midpoint.

Nasal Ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the tip of the nose.

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

Nose Bridge (Sellion): The soft tissue, most concave point, above the frontonasal suture area.

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

Subalare: The lower edge point at the base of the alar where the base of the alar joins the skin of the upper lip.

Subnasal Point: The point in the soft tissue where the columella merges with the upper lip in the midsagittal plane.

Supramentale: The largest concave point on the midline of the lower lip between the midpoint of the lower lip and the soft tissue premental point. 4.7 Anatomy of the head

Frontal Bone: The frontal bone includes a large vertical part (frontal scale) that corresponds to the area known as the forehead.

Mandible: The jaw forms the lower jaw. The chin eminence is the bony eminence that forms the jaw.

Maxilla: The jawbone that forms the upper jaw and is located above the jawbone and below the face of the eyes. The frontal process of the maxilla protrudes upward against the side of the nose and forms part of its lateral border.

Nasal Bone: The nasal bones are two small long bones that vary in size and shape in different individuals. They are arranged side by side in the center and upper parts of the face, and along which they join to form the "bridge" of the nose.

Nasion: The junction of the front bone and the two nasal bones, the concave part is located between the eyes and higher than the bridge of the nose.

Occipital Bone: The occipital bone is located at the back and lower part of the skull and includes an oval foramen (foramen magnum) through which the cranial cavity can communicate with the spinal canal. The curved plate behind the foramen magnum is the occipital scale.

Orbit: The bony cavity in the skull that houses the eyeball.

Parietal bone: The parietal bone is the bone that (when joined together) forms the top and sides of the skull.

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

Zygomatic Bone: The face includes two cheekbones, which are located on the upper and side parts of the face and form the bulge of the cheeks. 4.8 Anatomy of the respiratory system

Diaphragm: A piece of muscle that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, including the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the chest cavity increases and air enters the lungs.

Larynx: The larynx, or larynx, houses the vocal cords and connects the lower part of the laryngopharynx (hypopharynx) to the trachea.

Lung: The human respiratory organ. The leading segment of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. Respiratory organ segments include respiratory organ bronchioles, alveoli, and alveoli.

Nasal Cavity: The nasal cavity (or nasal cavity) is the large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal outgrowths called the nasal passages or turbinates. As for the front of the nasal cavity is the nose, while the back of the nasal cavity is mixed into the nasopharynx through the posterior nasal opening.

Pharynx: The part of the throat located just below (below) the nasal cavity and above the esophagus and larynx. The pharynx is divided into three parts: the nasopharynx (upper pharynx) (the nose of the pharynx), the oropharynx (mesopharynx) (the oral head of the pharynx), and the laryngopharynx (the hypopharynx). 4.9 Materials

Silicone or Silicone Elastomer: A synthetic rubber. In this specification, the reference to silicone is a liquid silicone rubber (LSR) or a compression molding silicone rubber (CMSR). One form of commercial LSR is SILASTIC (including various products sold under this trademark), manufactured by the Dow Corning Company. Another LSR player is Wacker. Unless otherwise stated, a preferred form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

Polycarbonate: A typical transparent thermoplastic polymer (Bisphenol-A Carbonate). 4.10 Appearance of the patient interface

Anti-asphyxia Valve (AAV): A component or subassembly of a mask system that reduces the risk of a patient rebreathing excessive CO2 by opening it to the atmosphere in a failsafe manner.

Elbow: A duct is an air flow axis that changes 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 be of an approximately circular cross-section. In another form, the conduit may be an oval or rectangular cross-sectional view.

Frame: Frame means that a mask structure is held to a tensile load between two or more points of attachment to a headgear. A nasal mask frame can be a non-hermetic load structure in the mask. However, some nasal mask frames may also be airtight.

Headgear: A headgear is intended to refer to a form of positioning and stabilizing structure designed for use on the head. Preferably, the headgear includes all of one or more compression members, fasteners and reinforcements that are configured to position and maintain the patient interface in position on the patient's face for delivering respiratory therapy. Some headbands are formed from soft, elastic, and elastic materials, such as laminated composites of foam and fabric.

Membrane: Membrane means a typically thin element, preferably substantially impervious to bending, but resistant to stretching.

Plenum Chamber: A mask plenum means that part of the patient interface has walls that enclose a volume of space in which the volume of air contained therein exceeds atmospheric pressure when in use. An outer cover may form the walls of the mask plenum. In one form, the area of the patient's face forms one of the walls of the plenum.

Seal: Seal means that a structure or barrier is an interface that prevents the flow of air across two surfaces; alternatively, seal means that the flow of air is prevented.

Shell: A shell specifically means a flexural structure with bending, elongation and compressive stiffness, eg, a portion of a mask forming the flexural structural walls of the mask. Specifically, it is relatively thin compared to its overall size. In some forms, a cover may be faceted. Specifically, such walls are airtight and airtight, although in some forms the walls may be airtight.

Stiffener: A stiffener means a structural component designed to increase the bending resistance of another component in at least one direction.

Strut: A Strut means a structural component designed to increase the pressure resistance of another component in at least one direction.

Swivel: A sub-assembly of components constitutes rotation about a common axis, preferably independently, especially under low torque. In one form, the swivel can be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of air transfer tubes, sub-assemblies of components preferably include mating cylindrical conduits. Specifically, there is no leakage of air flow from the swivel during use.

Tie: A tie is a structured component designed for tensile strength.

Ventilation port (Vent): allows deliberate leak rate controlled air from the inside of the mask, the structure of the ambient air or to the conduit to discharge exhaled carbon dioxide gas (CO ₂₎ and supplied with oxygen (O _2). Terminology used in the patient interface

Curvature (of a surface): A surface area has a saddle shape that is curved in one direction and downward in different directions, and has a negative curvature. A surface area has a dome shape that is curved in the same way in both principal directions and has a positive curvature. A flat surface has zero curvature.

Floppy: The quality of a material, structure or composition that combines the following characteristics: - Easily adapts to finger pressure. - When it wants to support its own weight and cannot keep its shape. - Not rigid. - Elastically stretch or bend with little force.

The quality of flexibility may have a relative direction, so that a particular material, structure or composite may be flexible in a first direction, but rigid or stiff in a second direction, eg, a second direction perpendicular to the first direction.

Resilient: Can be substantially elastically deformed and can release substantially all of the energy in a relatively short period of time, such as 1 second, when there is no load.

Rigid: Typically not easily deformed by finger pressure, and/or tension or load when establishing and maintaining a sealed relationship between the patient interface and the patient's airway inlet.

Semi-rigid: means rigid enough to not substantially distort under the effects of mechanical forces typically applied during positive pressure ventilation therapy. 5. Other supplementary instructions

The disclosed portion of this patent document includes material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction of either the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights.

Unless the specification expressly states and provides various values, it should be understood that each intervening value (to the tenth of the unit of the lower value) between the upper and lower value in a range, and the value in the stated range Any other specified or intervening values within are encompassed within the present technology. The upper and lower limits of such intervening ranges (which may individually be included in the intervening ranges) are also encompassed within the present technology (subject to any specifically excluded limit in the stated range). Where the stated range includes one or both of the limitations, ranges excluding either or both of those included limitations are also included in the technology.

In addition, it should be understood that where a value or numerical value described in this specification is implemented as part of the present technology, unless specifically stated otherwise, the value may be an approximation, and that the value may be used for any actual technology implementation allows or requires. appropriate significant digits.

Unless defined, all technical and scientific terms used herein have the same meanings as commonly understood by those skilled in the art. Although any methods and materials similar or equivalent to those described in this specification can also be used in the practice or testing of the present technology, a limited number of exemplary methods and materials are described in this specification.

When a particular material is considered to be best used to form an assembly, it is obvious that alternative materials with similar properties can be used instead. Furthermore, unless specified herein to the contrary, any and all components described herein are understood to be manufacturable, and as such, may be manufactured together or individually.

It must be noted that, as used in this specification and later in the scope of claims, unless expressly stated otherwise, the singular forms "a", "the" and "the" include their plural equivalents.

All patents mentioned in this specification are incorporated by reference for the methods and/or materials that disclose and describe the subject matter of these patents. The publications discussed in this specification are provided only for disclosure of publications prior to the filing date of this application. This should not be construed as an admission that the technology does not antedate these disclosures by virtue of prior invention. Additionally, dates of publication provided may differ from actual publication dates and may need to be confirmed separately.

The subject matter used in the embodiments is included for ease of reference by the reader only, and should not be used to limit the subject matter used in the disclosure or claims. The subject title should not constitute the scope of the patent application or the scope of the limitation of the patent application scope.

Although the technology is described herein with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, terms and symbols may indicate that specific details are not required to implement the technology. For example, although the terms "first" and "second" may be used, unless specifically stated otherwise, they do not imply any order, but rather are used to distinguish different elements. Additionally, although process steps in a method may be described or illustrated in an order, this order is not necessarily required. Those skilled in the art understand that this sequence can be modified and/or aspects thereof can be performed simultaneously or even simultaneously.

Thus, it should be understood that many modifications can be made to the illustrative examples and other configurations can be devised without departing from the spirit and scope of the present technology.

1000: patients 1100: Bed Companion 3000: Patient Interface 3100: Seal Forming Structure 3102: Second attachment zone 3104: Protrusions 3200: Inflatable Chamber 3202: First attachment zone 3204: Zhizi 3206: Lower Receiving Department 3208: Upper Receiving Department 3300: Positioning and Stabilizing Structures 3302: Back 3304: Overhead Girdle 3306: Left head top piece 3308: Right head top piece 3310: Neck Piece 3312: Upper Left Girdle 3314: Upper Right Girdle 3316: Lower Left Girdle 3318: Lower Right Girdle 3320: Hook 3340: Positioning and Stabilizing Structures 3340.1: Back 3341: Upper Girdle 3342: Right head top piece 3342.1: Weft Direction of Top Piece 3343: Neck Piece 3343.1: Neck Weft Direction 3344: Lower Girdle 3345: Left head top piece 3346: Upper Left Girdle 3347: Hook Joint 3347.1: Strap engagement 3348: Overhead Girdle 3348.1: Weft orientation of overhead straps 3349: Hook 3350: Positioning and Stabilizing Structures 3350.1: Back 3351: Upper Right Girdle 3352: Right head top piece 3353: Neck Piece 3354: Lower Girdle 3355: Left head top piece 3356: Upper Left Girdle 3357: Hook Joint 3357.1: Strap junction 3358: Overhead Girdle 3359: Hook 3360: Positioning and Stabilizing Structures 3360.1: Back 3361: Upper Right Girdle 3362: Right head top piece 3363: Neck Piece 3364: Lower Girdle 3365: Left head top piece 3366: Upper Left Girdle 3367: Hook Joint 3367.1: Strap junction 3368: Overhead Girdle 3369: Hook 3370: Patient Interface Box 3371: Retaining Arm 3372: Lower attachment point 3373: Retainer Arm Attachment Feature 3374: Lower attachment point 3375: Attachment Point 3376: Right frame connection feature 3377: Elastic Connection Structure 3378: Left frame connection feature 3379: Opening 3380: Hook 3381: Left holding arm 3382: Lower Patient Interface Frame Retention Features 3383: Left Retainer Arm Attachment Feature 3384: Upper Patient Interface Frame Retention Feature 3385: Top Left Attachment Point 3387: Elastic connection structure 3391: Right join point 3399: Positioning and Stabilizing Structures 3400: Ventilation port 3500: Decoupling Structure 3600: connection port 3800: Anti-suffocation parts 3900: connection port 4000: PAP device 4170: Air channel 5000: Humidifier

The present technology is illustrated by way of example (and not by way of limitation), in conjunction with the accompanying drawings, wherein like reference numerals refer to similar elements, including: 1. Therapeutic System

Figure 1a shows a system in accordance with the present technique. The patient (1000) wears a patient interface (3000) that receives a positive pressure gas supply from a PAP device (4000). Air from the PAP device (4000) is humidified in a humidifier (5000) and delivered to the patient (1000) along the air passage (4170). 2. Treatment 2.1 Respiratory System

Figure 2a shows an overview of the human respiratory system, including the nose and mouth, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm.

Figure 2b shows a schematic representation of the human upper airway, including nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus and trachea . 2.2 Facial anatomy

Figure 2c is a frontal view of a face with some surface anatomical identifying features, including upper lip, upper vermilion, lower vermilion, lower lip, mouth width, medial canthus, alar, nasolabial fold, and corners of the mouth.

Figure 2d is a side view of the head with some surface anatomical identification features, including the glabella, the bridge of the nose, the nasal prominence, the meeting point of the lip-nasal septum, the upper lip frenulum, the lower lip frenulum, the serpentine, the nose crest, the supra-auricular point diameter and the Diameter below the ear. At the same time, the upper and lower parts and the front and rear parts are marked.

Figure 2e is a further side view of the head, indicating the approximate location of the eye-ear level and the nasolabial angle.

Figure 2f shows a subnasal dot plot.

Figure 2g shows a side view of the surface features of the nose.

Figure 2h shows the subcutaneous structure of the nose, including lateral nasal cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, and fibrofatty tissue.

Figure 2i shows the medial anatomy of the nose, approximately a few millimeters from the sagittal plane, in which the medial crus of the septal cartilage and the greater alar cartilage are shown.

Figure 2j shows an anterior view of the skull, including the jaw, temporal, nasal, and zygomatic bones. Also points out the turbinate bones, such as the upper jaw, lower jaw, and chin eminence.

Figure 2k shows a side view of the skull with the outline of the head surface, and some muscles. The following bones are displayed: jawbone, cuneiform, nasal, zygomatic, upper jaw, lower jaw, parietal, skull and occiput. Chin protrusion is also pointed out. The following muscles are shown: digastric, masticatory, sternocleidomastoid, and trapezius.

Figure 2l shows an anterolateral view of the nose. 3. Patient Interface

3 shows a perspective view of a positioning and stabilizing structure in accordance with one form of the present technology.

Figure 4a shows a rear view of a positioning and stabilizing structural assembly laid flat in accordance with one form of the present technology.

Figure 4b shows a rear view of the bottom strap fitting of the positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 4c shows a top view of the bottom strap fitting of the positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 4d shows a rear view of the right strap fitting over the positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 4e shows a top view of a right strap fitting over a positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 4f shows a rear view of the left strap fitting over the positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 4g shows a top view of the left strap fitting over the positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 4h shows a rear view of a neck piece of a positioning and stabilizing structural accessory according to one form of the present technology.

Figure 4i shows a top view of a neck piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 4j shows a rear view of a strap under a positioning and stabilizing structural assembly in accordance with one form of the present technology.

Figure 4k shows a top view of a strap under a positioning and stabilizing structural accessory according to one form of the present technology.

41 shows a rear view of a right overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 4m shows a top view of a right overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 4n shows a detailed rear view of the right overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 4o shows a rear view of the left overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 4p shows a top view of a left overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 4q shows a detailed rear view of the left overhead piece of a positioning and stabilizing structural accessory according to one form of the present technology.

Figure 4r shows a rear view of a right strap over a positioning and stabilizing structural accessory in accordance with one form of the present technology.

4s shows a top view of a right strap over a positioning and stabilizing structural accessory according to one form of the present technology.

Figure 4t shows a rear view of the left strap over the positioning and stabilizing structural accessory according to one form of the present technology.

Figure 4u shows a top view of the left strap over a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 4v shows a rear view of an overhead harness of a positioning and stabilizing structural accessory according to one form of the present technology.

4w shows a top view of an overhead harness of a positioning and stabilizing structural accessory according to one form of the present technology.

4x shows a detailed rear view of an overhead harness of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 4y shows a rear view of a hook portion of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

4z shows a top view of a hook portion of a positioning and stabilizing structural accessory according to one form of the present technology.

4z1 shows a rear view of a hook portion of a positioning and stabilizing structural accessory according to one form of the present technology.

Figure 5a shows a rear view of a positioning and stabilizing structural assembly laid flat in accordance with one form of the present technology.

Figure 5b shows a rear view of the right strap fitting over the positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 5c shows a top view of a right strap fitting over a positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 5d shows a rear view of the left strap fitting over the positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 5e shows a top view of the left strap fitting over the positioning and stabilising structural fitting in accordance with one form of the present technology.

5f shows a rear view of the right strap over the positioning and stabilizing structural accessory according to one form of the present technology.

Figure 5g shows a top view of the right strap over the positioning and stabilizing structural accessory according to one form of the present technology.

Figure 5h shows a rear view of the left strap over the positioning and stabilizing structural accessory according to one form of the present technology.

Figure 5i shows a top view of the left strap over a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 5j shows a rear view of an overhead harness of a positioning and stabilizing structural accessory according to one form of the present technology.

5k shows a top view of an overhead harness of a positioning and stabilizing structural accessory according to one form of the present technology.

51 shows a detailed rear view of an overhead harness of a positioning and stabilizing structural accessory according to one form of the present technology.

Figure 6a shows a rear view of a positioning and stabilizing structural assembly laid flat in accordance with one form of the present technology.

Figure 6b shows a rear view of a strap assembly under a positioning and stabilizing structural assembly in accordance with one form of the present technology.

Figure 6c shows a top view of the strap fitting under the positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 6d shows a rear view of the right strap fitting over the positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 6e shows a top view of a right strap fitting over a positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 6f shows a rear view of a left strap assembly over a positioning and stabilizing structural assembly in accordance with one form of the present technology.

Figure 6g shows a top view of the left strap fitting over the positioning and stabilising structural fitting in accordance with one form of the present technology.

Figure 6h shows a rear view of a strap under a positioning and stabilizing structural accessory according to one form of the present technology.

Figure 6i shows a top view of a strap under a positioning and stabilizing structural assembly in accordance with one form of the present technology.

Figure 6j shows a rear view of the right overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 6k shows a top view of the right overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

61 shows a detailed rear view of a right overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 6m shows a rear view of the left overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 6n shows a top view of the left overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 6o shows a detailed rear view of the left overhead piece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 6p shows a rear view of the right strap over a positioning and stabilizing structural accessory in accordance with one form of the present technology.

6q shows a top view of a right strap over a positioning and stabilizing structural accessory according to one form of the present technology.

Figure 6r shows a rear view of the left strap over a positioning and stabilizing structural accessory in accordance with one form of the present technology.

6s shows a top view of the left strap over the positioning and stabilizing structural accessory according to one form of the present technology.

6t shows a rear view of an overhead harness of a positioning and stabilizing structural accessory according to one form of the present technology.

Figure 6u shows a top view of an overhead harness of a positioning and stabilizing structural accessory according to one form of the present technology.

Figure 6v shows a detailed rear view of an overhead harness of a positioning and stabilizing structural accessory according to one form of the present technology.

7a shows a bottom perspective view of a patient interface frame in accordance with one form of the present technology.

7b shows a front view of a patient interface frame according to one form of the present technology.

7c shows a bottom view of a patient interface frame in accordance with one form of the present technology.

Figure 7d shows an interior cross-sectional view of the patient interface frame taken from lines 7d-7d shown in Figure 7b, in accordance with one form of the present technology.

Figure 7e shows an external cross-sectional view of the patient interface frame taken from lines 7d-7d shown in Figure 7b in accordance with one form of the present technology.

Figure 7f shows a front view of a left retention arm in accordance with one form of the present technology.

Figure 7g shows a bottom view of the left retention arm in accordance with one form of the present technology.

Figure 7h shows a front view of a right retention arm in accordance with one form of the present technology.

Figure 7i shows a bottom view of a right retaining arm in accordance with one form of the present technology.

7j shows a perspective view of a patient interface frame assembly in accordance with one form of the present technology.

7k shows a front view of a patient interface frame with holding arms in accordance with one form of the present technology.

71 shows an interior cross-sectional view of the patient interface frame taken from lines 71-71 shown in FIG. 7k in accordance with one form of the present technology.

Figure 7m shows an external cross-sectional view of the patient interface frame taken from lines 7l-7l shown in Figure 7k, in accordance with one form of the present technology.

7n shows a detailed view of the hook portion of the attachment point of the patient interface frame according to one form of the present technology.

Figure 7o shows a cross-sectional view of the patient interface frame taken from line 7o-7o shown in Figure 7k in accordance with one form of the present technology.

Figure 7p shows a cross-sectional view of the patient interface frame taken from line 7p-7p shown in Figure 7k, in accordance with one form of the present technique.

8a shows a front view of a patient-worn patient interface and positioning and stabilizing structure in accordance with one form of the present technology.

8b shows a detailed side view of a patient-worn patient interface and positioning and stabilizing structure in accordance with one form of the present technology.

8c shows a side view of a patient-worn patient interface and positioning and stabilizing structure in accordance with one form of the present technology.

Figure 9 shows a comparison of the positioning and stabilizing structure according to the present technology lying flat with the prior art positioning and stabilizing structure also lying flat.

Figure 10a shows a side view of the measurement of the patient's head and face.

Figure 10b shows a side view of the measurement of the patient's head and face.

11 shows a perspective view of a patient interface and positioning and stabilization structure in accordance with one form of the present technology.

12 shows a perspective view of a patient interface and positioning and stabilization structure in accordance with one form of the present technology.

13 shows a perspective view of a retaining arm in accordance with one form of the present technology.

14 shows a perspective view of a patient interface frame and a pair of holding arms according to an example of the present technology.

15 shows a front view of a patient interface frame and a pair of holding arms according to an example of the present technology.

16 shows a rear view of a patient interface frame and a pair of holding arms according to an example of the present technology.

17 shows a top view of a patient interface frame and a pair of holding arms according to an example of the present technology.

18 shows a bottom view of a patient interface frame and a pair of holding arms according to an example of the present technology.

19 shows a side view of a plenum of a patient interface according to an example of the present technology.

20 shows a side view of a seal-forming structure of a patient interface according to an example of the present technology.

21 shows a side view of a patient interface according to an example of the present technology.

22 shows a perspective view of a patient interface and positioning and stabilization structure according to an example of the present technology.

23 shows a front view of a patient interface and positioning and stabilizing structure according to an example of the present technology.

3000: Patient Interface

3100: Seal Forming Structure

3200: Inflatable Chamber

3300: Positioning and Stabilizing Structures

3304: Overhead Girdle

3306: Left head top piece

3308: Right head top piece

3310: Neck Piece

3312: Upper Girdle

3314: Upper Girdle

3316: Lower Girdle

3318: Lower Girdle

3320: Hook

3371: Retaining Arm

3372: Lower attachment point

3377: Elastic Connection Structure

3380: Hook

3381: Retaining Arm

3387: Elastic connection structure

3400: Ventilation port

3500: Decoupling Structure

3600: connection port

3800: Anti-suffocation parts

Claims (18)

A patient interface for treating a breathing disorder in a patient, the patient interface comprising: a plenum configured to be pressurized to above atmospheric pressure in use; a seal-forming structure connected to the plenum, the seal forming the structure is constructed of soft, elastic, and resilient materials and is configured to contact and seal against the patient's face in use; a positioning and stabilizing structure comprising a back; and a pair of upper straps extending from the back ; and a patient interface frame for keeping the patient interface close to the patient's airway, the patient interface frame including a pair of retaining arms, the pair of retaining arms including a pair of upper attachment points, each upper attachment point being disposed on the pair of retaining arms one for removably attaching an individual upper strap; and the patient interface frame further includes a pair of lower attachment points for removably attaching an individual lower strap, the pair of lower attachment points extending from the retaining The arms are individually attached to the patient interface frame; wherein when the patient wears the patient interface, the retaining arms are shaped and sized to extend from the patient interface frame along the patient's cheek and between the patient's eyes and ears such that each upper The straps may be attached to a respective upper attachment point above the patient's ear, with each upper strap being substantially parallel to the patient's eye-ear plane. The patient interface of claim 1, wherein the plenum and the seal-forming structure form a single piece. The patient interface of claim 1, wherein the plenum comprises a hard material that is harder than the seal-forming structure. The patient interface of claim 1, wherein the plenum comprises polycarbonate and the seal-forming structure comprises silicone. The patient interface of claim 1, wherein the plenum includes at least one plenum retention feature. The patient interface of claim 5, wherein the patient interface frame includes at least one patient interface frame retention feature, each of the patient interface frame retention features being configured by contact with the at least one plenum retention feature The patient interface frame is removably attached to the plenum, one for one detachable connection. The patient interface of claim 6, wherein the plenum includes four plenum retention features and the patient interface frame includes four corresponding patient interface frame retention features. The patient interface of claim 1, wherein the patient interface frame and the plenum are removably attached by a hard-to-hard connection. The patient interface of claim 1, wherein the patient interface frame is detachably connected to the plenum near the perimeter of the plenum. The patient interface of claim 1, wherein the positioning and stabilizing structure further comprises a pair of lower straps, and wherein, when the pair of lower straps is attached to the lower attachment point, the lower attachment point is used for the pair of lower straps The straps lie in a plane substantially parallel to the plane of the patient's eyes and ears. The patient interface of claim 10, wherein each of the pair of upper straps and each of the pair of lower straps includes a loop portion of a loop material. The patient interface of claim 11, wherein a hook portion comprising hook material is attached to the distal end of each of the pair of upper straps and each of the pair of lower straps. The patient interface of claim 12, wherein each of the pair of upper straps and each of the pair of lower straps is adapted to wrap around a corresponding one of the pair of upper and lower attachment points In one, the hook portion of each individual strap is removably attached to the loop portion of that strap. The patient interface of claim 13, wherein each loop portion is wider than each individual hook portion such that when each hook portion is attached to its corresponding loop portion, the loop portion protects the patient's skin from the Hook effect. The patient interface of claim 1, wherein the patient interface includes a full face mask. The patient interface of claim 1, wherein the patient interface does not include a forehead support. The patient interface of claim 1, wherein the positioning and stabilizing structure includes a cranial strap for engaging the parietal bones of the patient's skull. The patient interface of claim 1, wherein the positioning and stabilizing structure includes a neck member for engaging the occipital bone of the patient's skull.

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