TW202116370A - 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 respiratory disorders

[Cross-reference of related applications] This application claims the New Zealand patent application No. 626417 filed on June 19, 2014, and the U.S. Provisional Patent Application No. 61/953,240 filed on March 14, 2014, the entirety of which is incorporated herein. Included in this article for reference.

This technology is related to the diagnosis, treatment and improvement of one or more of respiratory disorders, and procedures related to avoiding respiratory disorders. Specifically, the present technology relates to medical devices and their use in treating and avoiding respiratory disorders.

The human respiratory system can facilitate gas exchange. The nose and mouth form the patient's airway entrance.

The respiratory tract is composed of a series of branch tubes, which become narrower, shorter and more as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and expel carbon dioxide. The trachea is divided into right and left main bronchus, and finally into terminal bronchioles. The bronchus constitutes a conductive airway and does not participate in gas exchange. The further branches of the respiratory tract lead to the respiratory bronchioles and eventually reach the alveoli. The alveolar area of the lungs is the area where gas exchange occurs, and is called the breathing area. See "The Essentials of Respiratory Physiology" published by Mr. John B. West.

There are multiple breathing disorders.

Obstructive Sleep Apnoea (OSA) is a form of Sleep Disordered Breathing (SDB), which is characterized by upper airway occlusion during sleep. This is a combination of abnormal small upper airway and normal loss of muscle tone in the tongue area, soft palate and posterior pharyngeal wall during sleep. This symptom causes affected patients to stop breathing typically for 30 to 120 seconds each night, sometimes 200 to 300 seconds. At this time, it often causes excessive daytime sleepiness, and may cause cardiovascular disease and brain damage. Complications are general disorder, especially in middle-aged overweight men, although the affected person may not notice the problem. Please refer to US Patent No. 4,944,310 (proposed by Mr. Sullivan).

Cheyne-Stokes Respiration (CSR, Cheyne-Stokes Respiration) is a disorder of the patient's respiratory organ regulation system. Among them, there is a rhythmic alternating period of ups and downs in ventilation, causing repeated hypoxia and reoxygenation of arterial blood. Chen-Shi's breathing may be harmful because of repetitive oxygen deficiency. In some patients, Chen-Shi's breathing (CSR) is related to repetitive awakening from sleep, which can cause severe sleep breakdown, increase sympathetic nerve activity, and increase afterload. Please refer to US Patent No. 6,532,959 (proposed by Mr. Berthon-Jones).

Obesity Hyperventilation Syndrome (OHS, Obesity Hyperventilation Syndrome) is defined as a 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, Chronic Obstructive Pulmonary Disease) includes any of a number of low airway diseases that share specific characteristics. These include increasing resistance to air flow, prolonging the exhalation phase 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 sputum production.

Neuromuscular disease (NMD, Neuromuscular Disease) is a broad term, including many diseases and disorders, which directly damage muscle function through intrinsic muscle pathology or indirectly through neuropathology. Some patients with NMD are characterized by progressive muscle injury leading to reduced mobility (requiring a wheelchair), difficulty swallowing, respiratory organ muscle failure, and finally, respiratory organ failure leading to death. Neuromuscular diseases can be divided into rapidly progressive and chronic progressive disorders: (i) Rapidly progressive disorders: It is characterized by a deterioration of muscle damage for more than a few months and death within a few years (for example, adolescent amyotrophic lateral sclerosis) (ALS) and Qiuxin’s muscular dystrophy (DMD)); (ii) Variable or slow-progressive disorder: It is characterized by deterioration of muscle damage over several years and only a slight reduction in the likelihood of average life expectancy (for example, limbs Band type, face-shoulder-arm type, and myotonic muscular dystrophy). The symptoms of respiratory failure of NMD include: increasing general weakness, difficulty swallowing, breathing difficulties and depressions during exercise, fatigue, sleepiness, morning headaches, difficulty concentrating, and mood changes.

Thoracic disorders are some chest disabilities that cause inefficient coupling between the muscles of the respiratory organs and the rib cage. The usual feature of the disorder is a localized defect and burdens the possibility of chronic hypercapnic respiratory failure. Scoliosis and/or posterior carina may cause severe respiratory failure. Symptoms of respiratory failure include: difficulty breathing during exercise, peripheral edema, orthopedic breathing, recurrent chest infections, morning headaches, fatigue, poor sleep quality and reduced appetite.

In other respects, healthy individuals can use systems and devices to avoid breathing disorders. 1. System

One known product used to treat impaired 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 the effect of continuous positive pressure ventilation is the same as an air splint, and the upper airway occlusion can be avoided by pushing the soft palate and tongue forward and away from the back pharyngeal wall.

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

Applying positive air pressure to the patient's airway entrance can be achieved by using a patient interface (such as a nasal mask, full face mask or nasal pillow). A series of patient interface devices are known, but many patient interface devices will encounter one or more of disgusting, unsatisfactory aesthetics, unsuitable, uneasy to use, and uncomfortable, especially when worn for a long time or when The patient is not familiar with the system. Masks designed only for pilots (as parts of personal protective equipment) or administered with general anesthetics are quite good for their original applications, but they are still undesirable or uncomfortable for extended periods of time (for example, when 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 when a force is applied to the patient interface attached to the seal forming part of the user's face, it seals against the user's face. The seal forming structure may include a cushion filled with air or liquid, or a molding or forming surface of an elastic sealing element, which is made of an elastic body, such as a rubber. Using this type of seal forming part, if it is not suitable, there will be a gap between the seal forming structure and the face, and external force is required to make the patient interface seal against the face.

Another type of seal forming part incorporates a flap seal of thin material and is positioned near the periphery of the nasal mask so that when positive pressure is applied inside the nasal mask, it can provide a self-sealing effect against the user's face. Similar to the previous style of the seal formation structure, if the fit between the face and the nasal mask is not good, external force may be required to achieve the seal, or the nasal mask may leak. In addition, if the shape of the seal forming structure does not conform to the shape of the patient, there will be creases or deformation during use, causing leakage.

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

A series of patient interface sealing forming structure technologies 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 stability

A seal forming part of the patient interface used for positive air pressure therapy will be affected by the corresponding force of the air pressure to affect the seal. Such a variety of techniques have been used to locate the seal formation structure and maintain the sealing relationship with the proper part of the face.

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

Another technique is to use one or more webbing and stabilizing straps. Many of these straps have one or more of improper, poor handling, uncomfortable and awkward use. 3.3 Vent technology

Some forms of patient interface systems may include a ventilation port that allows the carbon dioxide of the exhaled air to be expelled. Many of these vents are noisy. Others may be blocked during use and cannot provide sufficient discharge capacity. Certain ventilation ports may interrupt the sleep of the bed partner (1100) of the patient (1000), such as noise or concentrated air flow.

ResMed has developed some improved nasal mask vent technologies. Please see WO 1998/034,665, WO 2000/078,381, US 6,581,594, US Patent Application, US 2009/0050156, US Patent Application 2009/0044808.

Noise meter of the previous mask (ISO 17510-2: 2007, 10cm H ₂ O pressure at 1m (meter)) Mask name Mask type A-weighted sound power level dbA (uncertain value) A-weighted sound pressure dbA (uncertain value) Annual (approximate) Glue-on (*) Nose 50.9 42.9 1981 ResCare standard (*) Nose 31.5 23.5 1993 ResMed Mirage (*) Nose 29.5 21.5 1998 ResMed UltraMirage Nose 36(3) 28(3) 2000 ResMed Mirage Activa Nose 32(3) 24 (3) 2002 ResMed Mirage Micro Nose 30 (3) 22(3) 2008 ResMed Mirage SoftGel Nose 29 (3) 22(3) 2008 ResMed Mirage FX Nose 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

(*There is only one sample, using CPAP mode at 10cmH2O, using the test method specified in ISO3744 for measurement)

The sound pressure values of various objects are as follows: object A-weighted sound pressure dbA (uncertain value) Description Vacuum cleaner: Nilfisk Walter Broadly Litter Hog: Class B+ 68 ISO3744 at a distance of 1m (meters) 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 technique

One form of nasal pillow can refer to the Adam circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal spray, is the subject of US Patent 4,782,832 (Mr. Trimble et al.), which has been assigned to Prudence Bennett.

ResMed has manufactured the following products incorporating nasal pillows: SWIFT nasal pillow covers, SWIFT II nasal pillow covers, SWIFT LT nasal pillow covers, SWIFT FX nasal pillow covers and LIBERTY full-face masks. The following patent applications (assigned to ResMed) describe nasal pillow covers: International Patent Application No. WO 2004/073,778 (describes the appearance of ResMed SWIFT nasal pillows and others), U.S. Patent Application No. 2009/0044808 (Describe the appearance of ResMed SWIFT LT nasal pillow and others); International Patent Application No. WO 2005/063,328 and WO 2006/130,903 (Describe ResMed LIBERTY full face mask and others); International Patent Application No. WO 2009/052,560 No. (Describe the appearance of ResMed SWIFT FX nasal pillows and others).

The present technology is aimed at providing medical devices for diagnosing, improving, treating, or preventing respiratory disorders. The medical devices have one or more advantages of improved comfort, cost reduction, efficiency, ease of operation, and manufacturability.

One of the first aspects of this technology relates to devices used to diagnose, ameliorate, treat or prevent respiratory disorders.

Another aspect of the technology relates to a patient interface system for treating patients with respiratory disorders. The patient interface system may 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 being 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 strap is adapted to be detachably attached to the pair of upper attachment points, so that when the patient wears, the pair of upper straps are vertically offset relative to the upper attachment points, and are substantially parallel to the plane of the patient’s eyes and ears, and wherein the patient The interface does not include a forehead support.

In an example, (a) the patient interface may further include an inflatable chamber and a seal forming structure, (b) the inflatable chamber and the seal forming structure may include an integral piece, (c) the inflatable chamber may include a hard material, It is harder than the material of the seal forming structure, (d) the plenum may include polycarbonate, and the seal forming structure may include silicone, (e) the plenum may include at least one plenum retention feature, (f ) The nasal mask frame may have at least one nasal mask frame retaining feature, each of which is configured to detachably attach the nasal mask frame to the inflation chamber by detachably connecting a corresponding one of the at least one inflation chamber retaining feature, (g) The inflation chamber may include four inflation chamber retention features, and the fetal nasal mask frame may include four corresponding nasal mask frame retention features, (h) the nasal mask frame and the inflation chamber may be connected hard-to-hard To be detachably attached, (i) the nasal mask frame is detachably connected to the inflatable chamber near the periphery of the inflatable chamber, (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 are used to detachably attach a separate lower strap, and each of the pair of upper straps and each of the pair of lower straps may include the ring part of the ring 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 surround the vicinity of a respective one of the pair of upper attachment points and the pair of lower attachment points, so that the hook portion of each individual strap can be detachably attached to the ring portion of the strap, (m) Each ring part may be wider than each individual hook part, so that when each hook part is attached to its corresponding ring part, the ring part protects the patient’s skin from the hook part, (n) the The patient interface may include a full face mask, (o) the positioning and stabilizing structure may include a crown strap for engaging the parietal bone of the patient's skull, and/or (p) the positioning and stabilizing structure may include a neck component, with To join the occipital bone of the patient's head.

Another aspect of the technology relates to a patient interface system for treating patients with respiratory disorders. The patient interface system may 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 being 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 strap is adapted to be detachably attached to the pair of upper attachment points, so that when the patient wears, the sealing force vector generated by the pair of upper straps is vertically offset with respect to the upper attachment points and is substantially parallel to the patient’s eyes and ears Plane, and wherein the patient interface does not include a forehead support.

In an example, (a) the patient interface may further include an inflatable chamber and a seal forming structure, (b) the inflatable chamber and the seal forming structure may include an integral piece, (c) the inflatable chamber may include a hard material, It is harder than the material of the seal forming structure, (d) the plenum may include polycarbonate, and the seal forming structure may include silicone, (e) the plenum may include at least one plenum retention feature, (f ) The nasal mask frame may have at least one nasal mask frame retaining feature, each of which is configured to detachably attach the nasal mask frame to the inflation chamber by detachably connecting a corresponding one of the at least one inflation chamber retaining feature, (g) The inflation chamber may include four inflation chamber retention features, and the fetal nasal mask frame may include four corresponding nasal mask frame retention features, (h) the nasal mask frame and the inflation chamber may be connected hard-to-hard To be detachably attached, (i) the nasal mask frame is detachably connected to the inflatable chamber near the periphery of the inflatable chamber, (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 are used to detachably attach a separate lower strap, and each of the pair of upper straps and each of the pair of lower straps may include the ring part of the ring 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 surround the vicinity of a respective one of the pair of upper attachment points and the pair of lower attachment points, so that the hook portion of each individual strap can be detachably attached to the ring portion of the strap, (m) Each ring part may be wider than each individual hook part, so that when each hook part is attached to its corresponding ring part, the ring part protects the patient’s skin from the hook part, (n) the The patient interface may include a full face mask, (o) the positioning and stabilizing structure may include a crown strap for engaging the parietal bone of the patient's skull, and/or (p) the positioning and stabilizing structure may include a neck component, with To join the occipital bone of the patient's head.

Another aspect of the technology relates to a patient interface system for treating patients with respiratory disorders. 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 with attachment points attached to the upper straps in a detachable manner, wherein each holding arm is connected to the patient interface frame at a connecting point, so that each holding arm can be substantially perpendicular to the patient’s eyes and ears The plane rotates near an axis, and when the patient wears the pair of straps, the pair of upper straps is substantially parallel to the plane of the patient's eyes and ears.

In an example, (a) the patient interface may further include an inflatable chamber and a seal forming structure, (b) the inflatable chamber and the seal forming structure may include an integral piece, (c) the inflatable chamber may include a hard material, It is harder than the material of the seal forming structure, (d) the plenum may include polycarbonate, and the seal forming structure may include silicone, (e) the plenum may include at least one plenum retention feature, (f ) The nasal mask frame may have at least one nasal mask frame retaining feature, each of which is configured to detachably attach the nasal mask frame to the inflation chamber by detachably connecting a corresponding one of the at least one inflation chamber retaining feature, (g) The inflation chamber may include four inflation chamber retention features, and the fetal nasal mask frame may include four corresponding nasal mask frame retention features, (h) the nasal mask frame and the inflation chamber may be connected hard-to-hard It is detachably attached, (i) the nasal mask frame is detachably connected to the inflation chamber near the periphery of the inflation chamber, (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 patients with respiratory disorders may include: a patient interface according to any one of the foregoing examples, and further includes a pair of upper attachment points, each of which is set on the pair of upper attachment points. One of the holding arms; and a pair of lower attachment points, which are set on the nasal mask frame; and a positioning and stabilizing structure, the positioning and stabilizing structure includes 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 part of the loop material, (n) a hook material containing The hooks of 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 It can be adapted to surround the vicinity of the respective one of the pair of upper attachment points and the pair of lower attachment points, so that each individual strap hook portion can be detachably attached to the strap ring portion, (p) each ring portion can be Wider than each individual hook, so that when each hook is attached to its corresponding loop, the loop protects the patient’s skin from the hook. (q) The positioning and stabilizing structure may include a crown strap to The parietal bone that engages the patient's skull, and/or (r) the positioning and stabilizing structure may include a neck component to engage the occipital bone of the patient's skull.

Another aspect of the technology relates to a patient interface system for treating patients with respiratory disorders. 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 holding arms, each holding The arm has a holding arm connection feature, wherein the holding arms are connected to the patient interface frame at the connection points by direct engagement between the individual frame connection features and the holding arm connection features, and the connection points are Sealed with elastic material.

In an example, (a) the patient interface may further include an inflatable chamber and a seal forming structure, (b) the inflatable chamber and the seal forming structure may include an integral piece, (c) the inflatable chamber may include a hard material, It is harder than the material of the seal forming structure, (d) the plenum may include polycarbonate, and the seal forming structure may include silicone, (e) the plenum may include at least one plenum retention feature, (f ) The nasal mask frame may have at least one nasal mask frame retaining feature, each of which is configured to detachably attach the nasal mask frame to the inflation chamber by detachably connecting a corresponding one of the at least one inflation chamber retaining feature, (g) The inflation chamber may include four inflation chamber retention features, and the fetal nasal mask frame may include four corresponding nasal mask frame retention features, (h) the nasal mask frame and the inflation chamber may be connected hard-to-hard It is detachably attached, (i) the nasal mask frame is detachably connected to the inflation chamber near the periphery of the inflation chamber, (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 patients with respiratory disorders may include: a patient interface according to any one of the foregoing examples, and further includes a pair of upper attachment points, each of which is set on the pair of upper attachment points. One of the holding arms; and a pair of lower attachment points, which are set on the nasal mask frame; and a positioning and stabilizing structure, the positioning and stabilizing structure includes 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 part of the loop material, (n) a hook material containing The hooks of 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 It can be adapted to surround the vicinity of the respective one of the pair of upper attachment points and the pair of lower attachment points, so that each individual strap hook portion can be detachably attached to the strap ring portion, (p) each ring portion can be It is wider than each individual hook, so that when each hook is attached to its corresponding loop, the loop protects the patient’s skin from the hook. (q) The positioning and stabilizing structure may include a crown strap to The parietal bone that engages the patient's skull, and/or (r) the positioning and stabilizing structure may include a neck component to engage the occipital bone of the patient's skull.

Another aspect of the technology relates to a patient interface system for treating patients with respiratory disorders. The patient interface system may 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 Leaning on the patient’s respiratory tract, 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 When the patient wears the patient interface system, the holding arms are shaped and sized to extend from the nasal mask frame along the patient’s cheeks and between the patient’s eyes and ears, so that each upper strap can be connected to the patient’s ears The upper one is attached to the attachment point.

In an example, (a) the patient interface may further include an inflatable chamber and a seal forming structure, (b) the inflatable chamber and the seal forming structure may include an integral piece, (c) the inflatable chamber may include a hard material, It is harder than the material of the seal forming structure, (d) the plenum may include polycarbonate, and the seal forming structure may include silicone, (e) the plenum may include at least one plenum retention feature, (f ) The nasal mask frame may have at least one nasal mask frame retaining feature, each of which is configured to detachably attach the nasal mask frame to the inflation chamber by detachably connecting a corresponding one of the at least one inflation chamber retaining feature, (g) The inflation chamber may include four inflation chamber retention features, and the fetal nasal mask frame may include four corresponding nasal mask frame retention features, (h) the nasal mask frame and the inflation chamber may be connected hard-to-hard To be detachably attached, (i) the nasal mask frame is detachably connected to the plenum near the periphery of the plenum, (j) each of the pair of upper straps and each of the pair of lower straps can be The ring part including the ring material, (k) a hook part containing hook material can be attached to each of the pair of upper straps and the distal end of each of the pair of lower straps, (l) the pair of upper Each of the straps and each of the pair of lower straps can be adapted to surround each of the pair of upper attachment points and the pair of lower attachment points, so that the hook of each individual strap is detachable The ring parts connecting the straps, (m) Each ring part may be wider than each individual hook part, so that when each hook part is attached to its corresponding ring part, the ring part protects the patient’s skin from Hook influence, (n) the patient interface may include a full face mask, (o) the patient interface may not include a forehead support, (p) the positioning and stabilization structure may include a crown strap to engage the parietal bone of the patient’s skull , And/or (q) The positioning and stabilizing structure may include a neck component to engage the occipital bone of the patient's skull.

Another aspect of the technology relates to a patient interface system, including: a patient interface, the patient interface has an air chamber and a seal forming structure; a positioning and stabilization structure; and a connection point for attaching the positioning and stabilization Structure to the patient interface.

In an example, (a) the inflatable chamber and the seal-forming structure can be an integral piece, for example, permanent connection, integral molding, and/or common mode bonding, (b) the inflatable chamber and the seal-forming structure can be removed Type attachment, for example, by locking mechanism, buckling, pressing, and/or friction sealing, (c) the patient interface system may further include a patient interface frame, wherein the connection points are formed on the patient interface Frame, and the patient interface frame can be detachably connected to the inflatable chamber, (d) the connection points can be integrally formed or formed by one piece or molded in the inflatable chamber, and/or (e) the positioning and stabilization The structure may include upper and lower straps for joining the positioning and stabilizing structure to the patient interface at the connection points to detachably fix the patient interface system on the patient's head.

Of course, parts of the examples or aspects can form sub-aspects or sub-examples of the present technology. At the same time, various different examples, sub-aspects, and/or aspects can be combined in various ways, and at the same time constitute additional examples, sub-examples, aspects, or subsidiary aspects of the present technology.

The other features of this technology will become clearer from the consideration of the information contained in the following "implementations", "abstract of invention", "simple schema" and "patent application".

Before describing the technology in more detail, it should be understood that the technology is not limited to the specific examples described herein, and these specific examples can be changed. It should also be understood that the terms used in this disclosure are only used to describe the specific examples discussed in this specification, rather than limiting.

The following description relates to various different examples that can share one or more common features and/or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, any single feature or combination of these features may constitute further examples. 1. Treatment system

In one form, the technology includes devices for treating respiratory disorders. The device may include an air flow generator; or an inflator for supplying pressurized breathing gas (such as air) to the patient (1000) through an air pipe leading to the patient interface (3000). 2. Treatment

In one form, the present technology includes a method for treating respiratory disorders, the method including the step of applying positive pressure to the airway entrance of the patient (1000). 2.1 Nasal continuous positive pressure ventilation (CPAP) treatment for obstructive sleep apnea (OSA) symptoms

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

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

In certain instances of the present technology, mouth breathing is restricted, constrained, or hindered. 3. Patient interface

The non-invasive patient interface (3000) according to one aspect of the present technology includes the following functional aspects: a seal forming structure (3100); a pneumatic chamber (3200); a positioning and stabilization structure (3300); and a connection port (3600), used to connect the air channel (4170). In some forms, one or more physical components can provide a functional aspect. In some forms, a physical component can provide one or more functional aspects. When in use, the seal forming structure (3100) is arranged around the entrance of the patient's airway to facilitate the supply of positive air pressure to the airway.

For the purpose of the present invention, the term "patient interface" means various types of interfaces, such as full face masks, nasal masks, oronasal masks, nasal sprays or pillows, and/or oronasal masks. In other words, in order to supply pressurized breathable gas, any device that facilitates the interface to the patient's airway entrance can be a "patient interface." It should also be understood that those who are familiar with this technique should also understand that the term "mask" broadly refers to the aforementioned various forms of patient interface. Thus, for example, a face mask may 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 an example of the present technology, a patient interface (3000) can 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, and because there is no structure extending upward toward the forehead and between the two eyes, the patient's visual field is not easily obstructed. Since there is no structure that forms an obstacle to the face, this also makes the patient interface (3000) have a more visual effect on the bed partner. In addition, the absence of a forehead support can reduce the contact points of the patient interface (3000) to the patient's face. However, it must still be possible to use a force of sufficient size and distributed in the seal forming structure (3100) to make the patient interface (3000) close to the patient's face to ensure an effective pneumatic seal to the patient's airway.

At the same time, a positioning and stabilizing structure (3300) (described in more detail below) must be designed to be used with the patient interface (3000) to prevent the patient interface from shrinking upward. Upward shrinking means that the patient interface (3000) moves upward so that it moves to a higher position on the patient's face compared to the initial position of the patient interface. If the sealing force vector formed by the positioning and stabilizing structure (3300) is generated in the vertical direction, then upward shrinkage may occur. Other factors described in more detail below may also cause upward shrinkage. 3.1.1 Sealing forming structure and inflatable chamber

According to an example of the present technology, the patient interface (3000) may include a seal forming structure (3100) and a pneumatic chamber (3200). Examples of the 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 can additionally provide a gasket function.

The seal formation structure (3100) according to the present technology can be made of soft, elastic, and elastic materials (such as silicone).

In one form, the seal forming structure (3100) includes a sealing flange and a supporting flange. The sealing flange includes a relatively thin member whose thickness is less than about 1 mm (mm), for example, about 0.25 mm (mm) to about 0.45 mm (mm), which extends around the periphery of the inflation chamber (3200). The support flange may be relatively thicker than the sealing flange. The supporting flange can be arranged between the sealing flange and the edge of the inflation chamber (3200), and extends at least part of the periphery of the periphery. The supporting flange can be or include a similar spring element and function to support the sealing flange to avoid distortion during use. When in use, the sealing flange can quickly respond to the system pressure in the inflation chamber (3200) on the underside of the sealing flange, so that it can tightly engage the face.

The shape of the periphery of the inflatable chamber (3200) is complementary to the contour of the general face in the area where the seal is formed during use. When in use, the edge of the plenum (3200) is located on the adjacent face of each other's face. The actual face contact is provided by the seal forming structure (3100). When in use, the seal forming structure (3100) can extend around the entire periphery of the inflatable chamber (3200).

According to an example of the present technology, the seal forming structure (3100) can be molded on the inflation chamber (3200) to form an integral piece. The seal forming structure (3100) and the inflation chamber (3200) may include a patient interface or a mask accessory according to an example of the present technology. 3.1.2 Positioning and stabilizing structure

Figures 3, 4a-4z1, 5a-5l, 6a-6v, 8a-8c, and 9 show various examples of positioning and stabilizing structures (3300) according to the present technology.

Figure 3 shows a perspective view of a positioning and stabilizing structure (3300) according to an example of the present technology. Although this drawing does not show the patient interface (3000), it shows the positioning and stabilization structure (3300) when the patient may be worn.

The exemplary positioning and stabilizing structure (3300) shown in Figure 3 includes a back (3302). The exemplary back (3302) may include a left crown piece (3306) and a right crown piece (3308), and a neck piece (3310). The positioning and stabilizing structure (3300) may also include an overhead strap (3304). At the same time, 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 part (3320) of the hook material can be attached to the distal end of each of the upper strap (3312, 3314) and the lower strap (3316, 3318). The hooks (3320) can be used to attach each strap to itself by surrounding the attachment points of the patient interface, as discussed in more detail below. The connecting hooks (3320) can be facilitated by a ring material layer outside some or all of the components of the positioning and stabilizing structure (3300). According to an example of the present technology, each of the upper strap (3312, 3314) and the lower strap (3316, 3318) may have an outer layer of hook material for detachably joining the individual hook parts (3320).

According to another example of the present technology, each component of the positioning and stabilizing structure (3300) can also include an outer layer of ring material, so that the upper strap (3312, 3314) and the lower strap (3316, 3318) surround themselves When returning, the hook (3320) can be connected to the back part. For example, the crown strap (3348), the left crown piece (3306), the right crown piece (3308), and the neck part (3310) may include an outer layer of loop material so that the hook (3320) can be connected to the back (3302) The individual joints between the components and the upper straps (3312, 3314) and the lower straps (3316, 3318).

At the same time, Figure 3 shows how the hook (3320) is relatively narrower than the individual straps and the components of the back (3302). The advantage is that the straps and the back can protect the user's skin from contacting the hooks, thereby reducing pain and discomfort. In addition, 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 can also be applied to positioning and stabilizing structures of different sizes discussed below. 3.1.2.1 The change ratio of different size positioning and stable structure

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

Figures 4a-4z1 show an example of a positioning and stabilizing structure (3340) according to the present technology. The exemplary positioning and stabilizing structure (3340) shown in these figures may include a back (3340.1). The exemplary back (3340.1) may include a left crown piece (3345) and a right crown piece (3342), and a neck piece (3343). The positioning and stabilizing structure (3340) may also include an overhead strap (3348). At the same time, extending from the back (3340.1) can be an upper left strap (3346) and an upper right strap (3341), as well as 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 part (3349) of the hook material can be attached to the distal end of each of the upper strap (3346, 3341) and the lower strap (3344). The hooks (3349) can be used to attach each strap to itself by surrounding the attachment points of the patient interface. The connecting hooks (3349) can be facilitated by a layer of ring material on the exterior of some or all of the components of the positioning and stabilizing structure (3340). According to an example of the present technology, each of the upper strap (3346, 3341) and the lower strap (3344) may have an outer layer of hook material for detachably joining the individual hook parts (3349).

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

At the same time, as mentioned above, the hook (3349) can be relatively narrower than the individual straps and the components of the back (3340.1). In addition, 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 joint (3347) to attach a separate upper or lower strap. At the same time, the upper strap and the lower strap can be ultrasonically welded at the strap joint (3347.1) to join the components on the back. According to a further example, the strap joint (3347.1) can be formed by two-way ultrasonic welding.

It should also be understood that Figure 4a shows a diagram of an exemplary positioning and stabilizing structure (3340), where the positioning and stabilizing structure is laid flat and the overhead strap (3348) is not connected to the upper left strap (3346). When the overhead strap (3348) is connected to the upper left strap (3346), the positioning and stabilizing structure (3340) will assume a larger curved shape, such as shown in FIG. 3.

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

The size of the components of the positioning and stabilizing structure can be changed or kept unchanged between different sizes of the positioning and stabilizing structure. Figure 4j shows that the right and left lower straps (3344) may have a length L ₁ , which according to an example may be about 270.0 mm (mm) ± 0.5 mm (mm). Figures 41 and 4m show the dimensions L ₂ , L ₃ , L ₄ and L _{5 of the} right crown strap (3342). 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). Figures 4o and 4p show the dimensions L ₆ , L ₇ , L ₈ , and L _{9 of the} left top strap (3345), which can be equal to the dimensions L ₂ , L ₃ , L ₄ , and of the right top strap (3342), respectively L ₅ . Figures 4r and 4s show the dimensions L ₁₀ , L ₁₁ , and L _{12 of the} upper right strap (3341). According to an example, L ₁₀ may be about 140.0 mm (mm), L ₁₁ may be about 155.1 mm (mm), and L ₁₂ may be about 40.9 mm (mm). 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. _{Figure 4w shows the size L 16} of the crown strap (3348) according to an example, which may be about 239.7 mm (mm). 3.1.2.1.2 Large size

Figures 5a-5l depict an example of a positioning and stabilizing structure (3350) according to the present technology. The exemplary positioning and stabilization structure (3350) shown in these figures may include a back (3350.1). The exemplary back (3350.1) may include a left crown piece (3355) and a right crown piece (3352), and a neck piece (3353). The positioning and stabilizing structure (3350) may also include an overhead strap (3358). At the same time, extending from the back (3350.1) can be an upper left strap (3356) and an upper right strap (3351), as well as 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 part (3359) of the hook material can be attached to the distal end of each of the upper strap (3356, 3351) and the lower strap (3354). The hook (3359) can be used to attach each strap to itself by surrounding the attachment points of the patient interface. The connecting hook portion (3359) can be facilitated by a layer of ring material on the exterior of some or all of the components of the positioning and stabilizing structure (3350). According to an example of the present technology, each of the upper strap (3356, 3351) and the lower strap (3354) may have an outer layer of hook material for detachably engaging the individual hooks (3359).

According to another example of the present technology, each component of the positioning and stabilizing structure (3350) can also include an outer layer of ring material, so that when the upper strap (3356, 3351) and the lower strap (3354) loop back on itself , The hook (3359) can be connected to the back part. For example, the crown strap (3358), the left crown piece (3355), the right crown piece (3352), and the neck part (3353) may include an outer layer of ring material so that the hook (3359) can be connected to the back (3350.1) The individual joints between the component and the upper strap (3356, 3351) and the lower strap (3354).

At the same time, as mentioned above, the hook (3359) can be relatively narrower than the individual straps and the components of the back (3350.1). In addition, 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 joint (3357) to attach a separate upper or lower strap. At the same time, the upper and lower straps can be ultrasonically welded at the strap joint (3357.1) to join the back components. According to a further example, the strap joint (3357.1) can be formed by a two-way ultrasonic welding.

It should also be understood that Figure 5a shows a diagram of an exemplary positioning and stabilizing structure (3350), where the positioning and stabilizing structure is laid flat and the overhead strap (3358) is not connected to the upper left strap (3356). When the overhead strap (3358) is connected to the upper left strap (3356), the positioning and stabilizing structure (3350) will assume a larger curved shape, such as shown in FIG. 3.

The component size of the positioning and stabilizing structure can be changed or kept unchanged between different sizes of the positioning and stabilizing structure. Figures 5f and 5g show the dimensions L ₁₇ , L ₁₈ , and L _{19 of the} upper right strap (3351). According to an example, L ₁₇ may be about 180.0 mm (mm), L ₁₈ may be about 195.1 mm (mm), and L ₁₉ may be about 40.9 mm (mm). Figures 5h and 5i show the dimensions L ₂₀ , L ₂₁ , and L _{22 of the} upper left strap (3356), which are respectively equal to the dimensions L ₁₇ , L ₁₈ , and L _{19 of the} upper right strap (3351). _{Figure 5k shows the size L 23} of the crown strap (3358) according to an example, which may be about 249.7 mm (mm).

As mentioned above, compared to the standard size positioning and stabilization structure (3340), some dimensions of the components of the exemplary large size positioning and stabilization structure (3350) can be changed while others remain the same. According to an example of the present technology, compared to the corresponding components of the standard size positioning and stabilizing structure (3340), the large size 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 detailed description of the differences in the aforementioned exemplary dimensions. However, some dimensions can remain the same. For example, the large-size positioning and stabilizing structure (3350) can be the same as the standard positioning and stabilizing structure (3340) of the neck part (3353), the right and left lower straps (3354), and the right and left head pieces (3352, 3355)的size.

According to the measurement of typical patient's head size, it is possible to choose whether to change the specific size of these components with various positioning and stabilizing structure sizes. For example, it is possible that the head area adapted by the lower strap may not change between medium and large head sizes, and the head area adapted by the upper strap and the overhead strap may require a longer strap for a larger head. 3.1.2.1.3 Small size

Figures 6a-6l show an example of a positioning and stabilizing structure (3360) according to the present technology. The exemplary positioning and stabilization structure (3360) shown in these figures may include a back (3360.1). The exemplary back (3360.1) may include a left crown piece (3365) and a right crown piece (3362), and a neck piece (3363). The positioning and stabilizing structure (3360) may also include an overhead strap (3368). At the same time, extending from the back (3360.1) can be an upper left strap (3366) and an upper right strap (3361), as well as a left lower strap (3364) and a right lower strap (3364). It should be appreciated that the lower straps of the exemplary positioning and stabilizing structure (3360) may be the same. The hook part (3369) of the hook material can be attached to the distal end of each of the upper strap (3366, 3361) and the lower strap (3364). The hook (3369) can be used to attach each strap to itself by surrounding the attachment points of the patient interface. The connecting hooks (3369) can be facilitated by a layer of ring material on the exterior of some or all of the components of the positioning and stabilizing structure (3360). According to an example of the present technology, each of the upper strap (3366, 3361) and the lower strap (3364) may have an outer layer of hook material for detachably engaging the individual hook parts (3369).

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

At the same time, as mentioned above, the hook (3369) can be relatively narrower than the individual straps and the components of the back (3360.1). In addition, 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) can be ultrasonically welded at the hook joint (3367) to attach an upper or lower strap. At the same time, the upper and lower straps can be ultrasonically welded at the strap joint (3367.1) to join the back components. According to a further example, the strap joint (3367.1) may be formed by two-way ultrasonic welding.

It should also be understood that Figure 6a shows a diagram of an exemplary positioning and stabilizing structure (3360), where the positioning and stabilizing structure is laid flat and the overhead strap (3368) is not connected to the upper left strap (3366). When the overhead strap (3368) is connected to the upper left strap (3366), the positioning and stabilizing structure (3360) will take on a larger curved shape, such as shown in FIG. 3.

The component size of the positioning and stabilizing structure can be changed or kept unchanged between different sizes of the positioning and stabilizing structure. Figure 6h shows that the right and left lower straps (3364) may have a _{length of L 24} according to an example, which may be about 230.0 mm (mm) ± 0.5 mm (mm). Figures 6j and 6k show the dimensions L ₂₅ , L ₂₆ , L ₂₇ , and L _{28 of the} right top strap (3362). According to an example, L ₂₅ may be about 64.6 mm (mm), L ₂₆ may be about 38.6 mm (mm), L ₂₇ may be about 20.9 mm (mm), and L ₂₈ may be about 63.6 mm (mm). Figures 6m and 6n show the dimensions L ₂₉ , L ₃₀ , L ₃₁ , and L _{32 of the} left top strap (3365), which are respectively equal to the dimensions L ₂₅ , L ₂₆ , L ₂₇ and L _{28 of the right top strap (3362)} . Figures 6p and 6q show the dimensions L ₃₃ , L ₃₄ , and L _{35 of the} upper right strap (3361). According to an example, L ₃₃ may be about 130.0 mm (mm), L ₃₄ may be about 145.8 mm (mm), and L ₃₅ may be about 41.9 mm (mm). Figures 6r and 6s show the dimensions L ₃₆ , L ₃₇ , and L _{38 of the} upper left strap (3366), which are respectively equal to the dimensions L ₃₃ , L ₃₄ , and L _{35 of the} upper right strap (3361). _{Fig. 6u shows the size L 39} of the crown strap (3368) according to an example, which may be about 227.4 mm (mm).

As mentioned above, compared to the standard size positioning and stabilization structure (3340), the dimensions of certain components of the exemplary smaller size positioning and stabilization structure (3360) can be changed, but others can remain the same. According to an example of the present technology, the small-size headband (3360) can use only the neck part (3363) of the same size as the standard size positioning and stabilizing structure (3340). The remaining components can be sized according to the previously disclosed dimensions.

The specific size of these components for choosing whether to change various positioning and stabilizing structure sizes can be determined based on the size of a typical patient's head. Compared with large and standard positioning and stabilizing structures that can share several sizes, it may be that when the size of the patient's head is reduced, 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 an example of the present technology, the positioning and stabilizing structure (3300) can generate an even distribution of sealing force in the seal forming structure to seal 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 an example of the present technology, the two sealing force vectors F ₁ and F ₂ (and their opposite parts are not shown on the other side of the patient's head) are substantially directed parallel to the plane of the eyes and ears, as shown in FIG. 2e. By maintaining these sealing force vectors in substantially parallel directions with respect to the plane of the eyes and ears, the sealing force of the sealing formation structure (3100) can be more evenly distributed to seal the patient's face. This can improve patient comfort because there is no place along the seal forming structure (3100) that uses more force than another to press down on the face. 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

Figures 7a-7e, 7j-7m, 7o, 7p, and 14-18 show various diagrams of a patient interface frame according to an example of the present technology. Figures 8a-8c show various diagrams of the patient interface (3000) and positioning and stabilization structure (3300) assembled and worn by the patient. As mentioned above, the seal forming structure (3100) can be a silicone component molded in the inflatable chamber (3200), which can be made of nylon to form a gasket accessory. Nylon 12 can also be used to form a plenum (3200) in a further example of this technology. In another example of the technology, polycarbonate can 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 with the cushion fitting to transfer the sealing force from the positioning and stabilizing structure. The plenum (3200) and the patient interface frame (3370) may include cooperating features to make these components frictionally close to each other. The 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 this type). As shown in these figures, when the upper and lower patient interface frame retention features (3384, 3382) protrude from the patient interface frame (3370), they may be formed. Therefore, the upper and lower plenum retention features of the plenum (3200) will be corresponding indentations or adapters to affect the frictional tightness. An opposite structure is also conceivable.

As shown in these figures, the patient interface frame (3370) can be formed around the periphery of the inflation chamber (3200). If the plenum (3200) is made of polycarbonate, which is a transparent material, this allows the bed partner to see more facial features of the patient, thereby making the patient interface (3000) look more pleasant. Therefore, it should be understood that the connection between the inflation chamber (3200) and the patient interface frame (3370) can be characterized as hard-to-hard.

At the same time, by connecting the patient interface frame (3370) to the inflatable chamber (3200) around the patient interface frame (3370), a more even transfer of the sealing force to the seal forming structure (3100) can be promoted. According to an example of the present technology, the inflatable chamber (3200) may be formed of polycarbonate or another relatively hard material, while the seal formation 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 periphery of the plenum via the patient interface frame (3370). The seal forming structure (3100) can also be molded in the air chamber (3200) near its periphery. Therefore, the even distribution of the sealing force near the periphery of the plenum chamber (3200) allows the sealing force to be evenly distributed in the seal forming structure (3100) because it is also connected to the plenum chamber near its periphery.

It should be understood that another concept for selecting the materials of the plenum chamber (3200) and the seal forming structure (3100) is that the plenum chamber should be able to deform slightly and at the same time, the seal forming structure can have some deformation. Therefore, for the plenum chamber (3200), the material should be selected so that the plenum chamber will not deform under the tension load generated by the strap. On the other hand, the seal forming structure (3100) may be intended to deform to form a seal around the facial features of the patient. Therefore, the seal forming structure (3100) should be formed with materials that deform sufficiently to affect the pneumatic seal without deforming the degree to which the inflatable chamber (3200) presses the face. By selecting materials based on this concept, it can be ensured that an even distribution of the sealing force is provided near the periphery of the seal forming structure (3100), so that the patient has the greatest comfort.

Figures 19-21 show another example of the present technology, in which the seal forming structure (3100) can be separated from the plenum (3200). Fig. 19 shows a plenum (3200). A first attachment area (3202) of the plenum can extend around the periphery of the plenum (3200) to engage the seal forming structure (3100). The inflation chamber (3200) may also include: an upper receiving portion (3208) for receiving the upper patient interface frame holding feature (3384); and a lower receiving portion (3206) for receiving the lower patient interface frame holding feature (3382) ). Therefore, an upper receiving portion (3208) and a lower receiving portion (3206) can be provided on each side of the inflation chamber (3200) to receive the upper patient interface frame holding feature (3370) when the patient interface frame (3370) is attached 3384) corresponds to the lower patient interface frame retention feature (3382). The detent (3204) can also be arranged in the inflatable chamber (3200) to facilitate the snap-fit connection of the seal forming structure (3100). A stopper (3204) can be arranged on each side of the inflatable chamber (3200).

Figure 20 shows the seal formation structure (3100) according to this example. The seal forming structure (3100) may include a second attachment area (3102) for attaching the seal forming structure (3100) to the plenum (3200) in the first attachment area. The second attachment area (3102) may be formed around the periphery of the seal forming structure (3100). The first attachment area (3202) and the second attachment area (3102) can be formed to conform to each other and press-fit, snap-fit, and/or frictionally fit. One of the first attachment area (3202) and the second attachment area (3102) may be formed of a material that is more compliant and/or elastic than the other, allowing the deformation to provide a conformable joint for a tight fit. At the same time, the seal forming structure (3100) may have a protrusion (3104) that conforms to the detent (3204) of the inflatable chamber to form a buckle thereupon, and fix the seal forming structure (3100) to the inflatable chamber (3200).

FIG. 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 attachment area (3202) and the second attachment area (3102).

It is envisaged that further examples of attachment between a seal forming structure (3100) and a plenum (3200) are disclosed in U.S. Patent Nos. 6,491,034, 6,412,487, and 6,823,869, the entire contents of each of which are incorporated herein. Included in this article for reference. 3.2.3 Holding arm

According to an 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 holding arm (3371). The right holding arm (3371) may include: an upper right attachment point (3375) for attaching the upper right strap (3314); and a right holding arm connection feature (3373) for connecting the patient interface frame (3370) A right box connection feature (3376). Figures 7h and 7i show the left holding arm (3381). The left holding arm (3381) may include: an upper left attachment point (3385) for attaching the upper left strap (3312); and a left holding arm connection feature (3383) for connecting to the patient interface frame (3370) A left frame of the connection feature (3378). Each holding arm connection feature (3373, 3383) can connect its individual holding arm (3371, 3381) to the patient interface frame (3370) by directly connecting and/or joining a 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 structure (3377, 3387) can connect the holding arm connection feature (3373, 3383) to the individual frame connection feature (3376, 3378), making the elastic connecting structure used as an intermediate connecting piece.

As shown in Figures 8a-8c, the holding arms (3371, 3381) can be shaped so that when the patient wears the patient interface (3000) and the positioning and stabilization structure (3300), the holding arm does not exceed the eye. The holding arms (3371, 3381) can also be shaped to avoid ears and temples. As shown in Figure 8c, the right holding arm (3371) is shaped along and conforms to the patient's cheeks and extends between the eyes and ears, while avoiding temples, so that the upper right strap (3314) is attached to the upper right attachment point (3314) on the ear 3375) Connect the right holding arm.

At the same time, as shown in these figures, the holding arms (3371, 3381) are relatively wide along their longitudinal axis. By forming the holding arm (3371, 3381), this allows the holding arm to be bent in a targeted manner. In other words, there is a significantly larger restricted bend in the direction of the wider cross-section, and a lower limit bend in the direction of the narrower cross-section. This advantage is that when the positioning and stabilizing structure is under tension, the holding arms (3371, 3381) are allowed to bend to the patient's face and cheeks, but bending upwards to the eyes of the patient or downwards to the ears of the patient will be blocked.

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 FIG. 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. In addition, the connection point plane PC is set so that the left and right connection points (3391) between the holding arm (3371, 3381) and the patient interface frame (3370) are located in the connection point plane.

Figures 10a and 10b show exemplary desired holding arm paths along the side contours of the patient's head for large and small size heads, respectively. The path of the holding arm is intended to be within a rectangular area 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 the best patient comfort. 3.2.3.1 Positioning and stabilizing the attachment point of the structure

According to an example of the present technology, the holding arms (3371, 3381) can provide attachment points (3375, 3385) on the upper straps (3312, 3314) of the positioning and stabilizing structure (3300), as described above. According to an example of the present technology, the upper attachment points (3375, 3385) may be slits formed at individual ends of the holding arms (3371, 3381). The upper straps (3312, 3314) can be connected to individual upper attachment points (3375, 3385) by wrapping around them. The patient interface frame (3370) may also include the lower attachment points (3372, 3374) of 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 to hold the individual lower straps (3316, 3318), as shown in Figures 8a-8c. As mentioned above, when the patient interface (3000) and positioning and stabilization structure (3300) are taken off, the formation of the lower attachment points (3372, 3374) will allow the patient to keep the hooks (3320) connected to the individual lower straps (3316, 3316). 3318). When wearing the patient interface (3000) and positioning and stabilization structure (3300), the patient simply slides on the individual lower attachment points (3372, 3374) by attaching the hook (3320) to the individual lower straps (3316, 3318) ) The surrounding part formed. The lower straps (3316, 3318) are then held via the hooks (3380).

Figure 13 shows another example of a holding arm (3371) according to one of the present technology. The holding arm (3371) shown in this figure may include a holding arm connection feature (3373). This exemplary holding arm (3371) is also shaped and sized to resemble the holding arm shown in Figures 7f and 7g. However, the upper attachment point (3375) can be different in that it may include an opening (3379) containing the attachment point in the slit. By forming the attachment point (3375) as described, the patient can pull the surrounding upper strap from the upper attachment point without detaching the hook from the individual upper strap. This is beneficial to the patient, because the patient does not need to adjust the length of the upper strap every time the patient interface (3000) and the positioning and stabilization structure (3300) are worn. However, the patient only slides the upper strap out of the attachment point of the individual holding arm. At the same time, in this example, the opening can be reduced into the attachment point (3375). This can make it easier to slide the strap into the attachment point, but it makes it more difficult to remove the strap, and therefore, it is impossible to slip off the strap during treatment.

It is also conceivable that other attachment structures may be provided for connecting the strap to the attachment point. For example, a clamp may be provided, the strap may be surrounded by the clamp, and the clamp may 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 an example of the present technology, the holding arms (3371, 3381) can be connected to the patient interface frame (3370) in a manner similar to movable joints. The movable joint can be mechanical or movable. A mechanical movable joint can be formed by using a patient interface frame (3370) with a guide rod connected and rotating with a holding arm (3371, 3381). An active joint may include an elastic connection, which will be discussed in more detail below. According to an example of the technology, the movable joint may include an elastic silicone movable joint. Regardless of the type of movable joint used, the advantage is that the movable joint is formed, so that the holding arm (3371, 3381) essentially adopts a single-sided rotation, which is substantially parallel to the eye-ear plane shown in FIG. 2e. This helps to keep the holding arms (3371, 3381) from rotating up into the patient's field of view or down against the ears.

It should be understood that the patient interface frame (3370) and the holding arms (3371, 3381) can be formed separately, and then mechanically connected for permanent or detachable 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 superimposed and molded at the joint to achieve the connection, thereby facilitating the connection. In still a further alternative, the patient interface frame (3370) and the holding arm (3371, 3381) can be a one-piece plastic mold, and in a further variant, an additional component can be over-molded and joined to further control the elasticity of the holding arm .

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

According to another example of the present technology, as shown in FIGS. 22 and 23, the connection point of the positioning and stabilizing structure (3300) can be directly or integrally formed in the inflation chamber (3200). According to this example, the right frame connection feature (3376) and the left frame connection feature (3378) can be integrally formed with the plenum (3200). The elastic connection structure (3377, 3387) can be directly superimposed and molded on the air chamber (3200) on the right frame connection feature (3376) and the left frame connection feature (3378) to attach the holding arms (3371, 3381). At the same time, the lower attachment points (3372, 3374) can be integrally formed with the inflation chamber (3200). It should be understood that in this example, the patient interface frame (3370) may not necessarily be an elastic connection structure (3377, 3387), and the lower attachment point (3372, 3374) and the inflation chamber (3200) are integrally formed. Therefore, the seal forming structure (3100) can be integrally formed in conjunction with or in cooperation with the plenum chamber (3200). The advantage of this example is that fewer components are required, which can reduce manufacturing costs and provide patients with a simpler patient interface system. 3.3 Improve the stability of positioning and stable structure

According to an example of the present technology, the positioning and stabilizing structure (3300) can provide improved stability, especially in the crown area of the head. Improving the stability of the positioning and stabilizing structure (3300) in the previous positioning and stabilizing structure can be achieved by widening the components of the positioning and stabilizing structure. 3.3.1 Widened connection

According to an example of the present technology, the positioning and stabilizing structure (3300) near the crown of the head and at the connection between the upper strap (3316, 3318), the crown strap (3304), and the crown piece (3306, 3308) The connection area can be widened to improve stability. This can be achieved by widening the aforementioned components near this area. It is desirable that widening the aforementioned part of the exemplary positioning and stabilization structure (3300) can better inhibit the patient interface (3000) from shrinking upward, which may occur due to the displacement of the positioning and stabilization structure from where it should be . Increasing the surface area, these connected areas can increase the stiffness, so that the back (3302) remains on the back of the head. It is also possible to form a better suppression of the bending of the band. Because of the larger surface area of the contact head, the stability can be improved by widening these components.

Figure 9 shows the standard size positioning and stabilizing structure (3340) designed to fit the same size head lying flat with the prior art positioning and stabilizing structure (3399). This figure shows areas of relatively increased width, which indicates that these areas are easier to slip and bend relative to the width of the prior art positioning and stabilization structure (3399). 3.4 Ventilation port (3400)

In one form, the patient interface (3000) includes a ventilation port (3400) that is constructed and configured to allow exhaled carbon dioxide to be discharged.

One form of the ventilation port (3400) according to the present technology includes a plurality of orifices, for example, 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 inflation chamber (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 socket. 3.6 Connection port (3600)

The connection port (3600) allows the air channel (4170) to be connected. 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 in the inflation chamber (3200). In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows the direct determination of gas characteristics, such as pressure, in the plenum chamber (3200). 3.9 Patient interface and positioning and stabilization structure accessories

Figures 11 and 12 show perspective views of an exemplary patient interface (3000) and positioning and stabilization structure (3300). The two exemplary devices show similar characteristics, including the foregoing. 4. Vocabulary

For the purpose of this technical disclosure, in a specific form of the present technology, one or more of the following definitions may be applied. In other forms of this technology, other definitions can be applied. 4.1 General

Air: In a specific form of this technology, the air supplied to the patient can be atmospheric air, and in other forms of this technology, atmospheric air can supplement oxygen.

Continuous Positive Airway Pressure (CPAP, Continuous Positive Airway Pressure): The use of CPAP treatment means continuous positive atmospheric pressure and preferably approximately fixed, through the patient's breathing cycle, applying air or breathable gas to the airway inlet. In some forms, the airway inlet pressure changes by a few centimeters in a single breathing cycle, for example, it is higher during inhalation and lower during exhalation. In some forms, the airway inlet pressure is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will change between different breathing cycles of the patient, for example, as the detection indicates a local upper airway obstruction and decreases when there is no indication of a local upper airway obstruction. 4.2 State of PAP device

Air Circuit (Air Circuit): The pipeline or tube is constructed and arranged in use to transmit air or breathable gas supply between a PAP device and a patient interface. Specifically, the air channel may be an outlet that fluidly connects the pneumatic block and the patient interface. The air channel can be called an air pipe. In some cases, it can be a separate protruding part of the pipeline for inhalation and exhalation. In other cases, a single protruding part can be used.

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

Blower or Flow Generator: A device that transmits pressure air flow above the ambient pressure.

Controller: A device or part of a device that can adjust an output based on input. For example, one form of the controller has one of the control variables under control to form the input of 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 auxiliary respirator may include a controller that has ventilation as an input, target ventilation as a set point, and a pressure support level as an output. Other input forms can be one or more oxygen saturation (SaO ₂ ), carbon dioxide (PCO ₂ ) partial pressure, movement, signal from the light volume description signal meter, and peak flow rate. The set point of the controller can be one or more fixed, variable or learned values. For example, the set point of a ventilator can be a long-term average of the patient's measured breathing. The other respirator may have a breathing set point that changes over time. A pressure controller can be configured to control a booster or pump to deliver air at a particular pressure.

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

Motor: A device used to convert electrical energy into rotational movement of a component. In this specification, the rotary motion is a propeller that can rotate near a fixed shaft, so that the air moving along the rotating shaft increases the pressure.

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

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

Volute: The casing of a centrifugal pump to receive the air propelled by the impeller, which can slow down the air flow rate and increase the pressure. The cross-section of the spiral housing increases the area toward the discharge port. 4.3 The state of the breathing cycle

Apnea: Preferably, the apnea should be, for example, 10 seconds in duration, when the flow rate falls below a predetermined threshold. Harmful respiratory cessation should occur when some obstacles in the respiratory tract cannot make air flow regardless of the patient's efforts. Central respiratory cessation can be said to occur when respiratory cessation (due to reduced breathing force, or no breathing force) is detected.

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

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

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

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

Flow Limitation (Flow Limitation): It is best, the flow limit will be the state of the patient's breathing, in which the patient is harder to cause a relative increase in the flow rate. In the event that the flow rate is limited during the inspiratory portion of the breathing cycle, this flow rate limit will be the inspiratory flow rate limit. In the event that a flow rate limitation occurs during the expiratory portion of the breathing cycle, this flow rate limitation will be the expiratory flow rate limitation.

Types of inspiratory flow rate limiting waveforms: (i) Flat wave at the top: It then rises and then falls on the 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 part is between the two peaks. (iii) Rising edge surge: There is a single local peak, which is at the leading edge and continues behind a relatively flat part. (iv) Falling edge surge: There is a relatively flat part that follows a single local peak, which is at the trailing edge.

Shallow breathing (Hypopnea): It is best to do, shallow breathing will reduce the flow, but will not stop the flow. In one form, shallow breathing should occur when the reduced flow rate is below the critical value of persistence. In one form, for adults, any of the following can be regarded as shallow breathing: (i) The patient's breathing is reduced by 30% for at least 10 seconds plus the associated 4% decrease in saturation; or (ii) Decrease the patient's breathing (but less than 50%) for at least 10 seconds plus at least 3% or associated saturation drop for brief awakening.

Hyperpnea: The air flow level increases higher than the normal flow.

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

Patency Airway (Patency Airway): The degree to which the airway opens, or the extent to which the airway opens. It is open to change the airway. The unobstructed airway can be quantified, for example, 1 value is unobstructed, and 0 value is closed.

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

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

Respiratory Flow, Airflow, Patient Airflow, Respiratory Airflow ( Qr ): These synonymous terms can be regarded as the assessment of respiratory airflow by the PAP device, rather than "correct respiratory flow rate" or "correct breathing""Airflow" is the correct respiratory flow rate experienced by the patient, usually expressed in liters per minute.

Tidal volume ( Vt ): The volume of inhalation or exhalation during normal breathing when no additional force is applied.

Inhalation Time ( Ti ): The duration of the inhalation part of the respiratory flow waveform.

Eexhalation Time ( Te ): The duration of the exhalation portion of the respiratory flow waveform.

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

Typical Recent Ventilation (Typical Recent Ventilation): Ventilation value, in which the recent value tends to be dense in some predetermined time periods, that is, the number of trends in the recent ventilation value.

Upper Airway Obstruction (UAO, Upper Airway Obstruction): Including partial and total upper airway obstruction. This may be related to the state of flow restriction, where the flow rate is only slightly increased, or when the pressure difference across the upper airway increases (Starling resistance behavior), it may even decrease.

Ventilation (Vent): A measurement of the total amount of gas exchanged by the patient's respiratory system, including the inspiratory and expiratory flow rates per unit time. When expressed in terms of the amount of air exchange per minute, this amount is often referred to as "minute air exchange". Minute ventilation is sometimes only expressed in terms of ventilation volume, that is, ventilation volume per minute. 4.4 Device parameters of positive airway pressure (PAP)

Flow Rate: The amount (or mass) of air that is transmitted instantaneously per unit time. When the flow rate and the ventilation have the same volume or mass per unit time, the flow rate measured in a very short time. The flow rate is a nominal positive value for the inhalation part of the patient's breathing cycle, and therefore, is a negative value for the exhalation part of the patient's breathing cycle. In some cases, the flow rate reference will be regarded as a scalar quantity, that is, a quantity of only size. In other cases, the flow rate reference will be regarded as a vector, that is, it has both magnitude and direction. The flow rate is represented by the 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. The leakage flow Q l is the unintended leakage flow rate from the patient interface system. The respiratory flow Q r is the flow rate of air entering the patient's respiratory system.

Leak: Specifically, the term "leak" will be regarded as an air flow environment. The leakage flow is intended (for example) to allow the expiratory gas CO ₂ to be expelled. Leakage is unintended, for example, therefore, it is an incomplete seal between the mask and the patient's face.

Pressure: The force per single area. Pressure can be measured in a variety of units, including cmH ₂ O, gf/cm ² , and Hectopascal. 1 cmH ₂ O is equal to 1 gf/cm ² and approximately 0.98 hectopascals. In this specification, unless otherwise stated, the unit of pressure is cmH ₂ O. For the nasal CPAP treatment of OSA, the reference treatment pressure refers to the pressure in the range of about 4-20 cmH ₂ O, or about 4-30 cmH ₂ O. The pressure on the patient interface is represented by the symbol Pm.

Sound Power: The energy per unit time carried by sound waves. The sound power is proportional to the square of the sound pressure times the area of the wavefront. The sound power uses the decibel SWL as the unit, that is, the decibel is equivalent to the reference power, usually ^10-12 watts.

Sound Pressure: A local deviation from the environment at a specific point in time because sound waves travel through the medium. Acoustic power green is usually expressed in decibels SPL, that is, decibels are equivalent to the reference power, usually 20×10 ^-6 Pascal (Pa), considering the critical value of human audibility. 4.5 Terminology for respirators

Adapted auxiliary 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 to establish the minimum breathing rate that the ventilator will deliver to the patient (typically measured in the number of breaths per minute) (if not touched in other ways).

Cycled: The inhalation phase of the respirator ends. When the respirator delivers breath to the spontaneously breathing patient, the inhalation part of the breathing cycle ends, and the respirator cycle stops delivering breath.

EPAP (or EEP): The baseline pressure for pressure changes during breathing will increase to produce the desired nasal mask pressure that the respirator is trying to achieve at a specific point in time.

IPAP: The desired nasal mask pressure that the respirator will try to achieve during the inhalation part of the breath.

Pressure Support: indicates that the pressure increase during the inhalation of the ventilator during the exhalation of the ventilator is exceeded, and usually means the pressure difference between the maximum value during inhalation and the minimum value during exhalation (For example, PS = IPAP - EPAP ). In some situations, pressure-assisted ventilation means the pressure difference achieved by the respirator, rather than the actual achieved by the respirator.

Servo-ventilator (Servo-ventilator): It is determined that the patient's ventilation device has a target ventilation, and it adjusts the degree of pressure support so that the patient's ventilation can reach the target ventilation.

Spontaneous/Timed ( S/T ): Try to detect the mode of breathing apparatus or other devices in spontaneously breathing patients. However, if the device fails to detect breathing within a predetermined period of time, the device will automatically start to deliver breathing.

Swing: A synonymous term for pressure-assisted ventilation.

Triggered: When the respirator is about to deliver air to a spontaneously breathing patient, it will be triggered at the beginning of the breathing part of the breathing cycle by the patient.

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

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

Alare: The most lateral point above the nose.

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

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

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

(Nose) Cartilaginous Framework: The soft framework of the nose includes the nasal septum, side, and large and small alar cartilage.

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 a line drawn perpendicular to the horizontal plane of the eyes and ears when the subnasal point is handed over.

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 higher than the outer ear.

Glabella: The most prominent point of the soft tissue located in the mid-sagittal plane of the forehead.

Lateral Nasal Cartilage (Lateral Nasal Cartilage): usually a small angle plate of cartilage, the upper edge of which connects the nasal bone and the frontal process of the maxilla, and its lower edge connects the large nasal cartilage.

Greater Alar Cartilage: The small cartilage plate located under the lateral nasal cartilage, which flexes around the front of the nostril, and its rear end is connected to the frontal process of the maxillary through the dura mater, including three or four small alar cartilage .

Nostril (Nares or Naris)): Almost an oval hole leading to the nostril is formed. The nostrils are separated by the nasal septum.

Naso-Labial Sulcus or Naso-Labial Fold (Naso-Labial Sulcus or Naso-Labial Fold): The skin folds or recesses 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 nasal columella and the upper lip when handing over the subnasal point.

Otobasion Inferior: The lowest point connecting the outer ear to the skin of the face.

Otobasion Superior: connects the outer ear to the highest point of the facial skin.

Pronasale: The most convex point or tip of the nose, which can be identified from the side view of other parts of the head.

Philtrum: The middle recess from the lower border of the nasal septum to the top of the lips in the upper lip area.

Pogonion (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, extending from the bridge of the nose to the tip of the nose.

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

Nasal bridge (Sellion): The soft tissue, the most concave point located above the frontal nasal suture area.

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

Subalare: At the lower edge point of the bottom of the nose, where the bottom of the nose joins the skin of the upper lip.

Subnasal Point: A point located in the soft tissue where the columella merges with the upper lip in the mid-sagittal plane.

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

Frontal Bone: The frontal bone includes a large vertical part (frontal scales), corresponding to the area known as the forehead.

Mandible: The jaw forms the lower jaw. Mental protuberance is a bony protuberance that forms the chin and jaw.

Maxilla: The jawbone that forms the upper jaw and is located above the jawbone and below the eye and face. The frontal process of the upper mandible protrudes upwards against the side of the nose and forms the part of its side boundary.

Nasal Bone: The nasal bones are two small long bones. The size and shape of the nasal bones will change in different individuals. They are arranged side by side in the center and the upper part of the face, and join them to form the "bridge" of the nose.

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

Occipital bone (Occipital Bone): The occipital bone is located behind and under the head cover and includes an oval hole (foramen magnum) through which the cranial cavity can be connected to the spinal canal. The small curved plate behind the foramen magnum is the occipital scale.

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

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

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

Zygomatic bone (Zygomatic Bone): The face includes two cheek bones, which are located on the upper and side parts of the face and form the bulge of the cheek. 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 from the abdominal cavity, including the heart, lungs, and ribs. When the diaphragm contracts, the volume of the chest cavity increases and air enters the lungs.

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

Lung: The human respiratory organ. The guiding section of the lung includes the trachea, bronchi, bronchiole, and terminal bronchiole. The respiratory organ segment includes the respiratory organ bronchiole, pulmonary cell duct, and alveoli.

Nasal Cavity: The nasal cavity (or nasal fossa) is a large filled air 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 exophytes called nasal passages or turbinates. As for the front part of the nasal cavity is the nose, while the back part of the nasal cavity is mixed into the nasopharynx through the posterior nasal cavity.

Pharynx: The part of the throat located directly below (under) the nasal cavity and above the esophagus and throat. The pharynx is divided into three parts: nasopharyngeal (upper pharynx) (nose part of pharynx), oropharynx (middle pharynx) (oral part of pharynx), and laryngopharyngeal (lower pharynx). 4.9 Materials

Silicone or Silicone Rubber (Silicone or Silicone Elastomer): A synthetic rubber. In this specification, the silicon referred to is a liquid silicone rubber (LSR) or a compression molded silicone rubber (CMSR). One form of commercial LSR is SILASTIC (including many products sold under this trademark), which is manufactured by Dow Corning. Another LSR player is Wacker. Unless otherwise stated, a preferred LSR form 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 State of the patient interface

Anti-asphyxia Valve (AAV, Anti-asphyxia Valve): A component or subassembly of a mask system that communicates with the atmosphere in a fail-safe manner to reduce the risk of patients breathing over CO2 again.

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 duct may have an approximately circular cross-section. In another form, the catheter may be an elliptical or rectangular cross-sectional view.

Frame: Frame means that a mask structure is held in tension between two or more connection points with a headgear. A nasal mask frame can be a non-closed load structure in the mask. However, some forms of nasal mask frames may also be airtight.

Headgear: The headgear is a positioning and stable structure designed to be used on the head. Preferably, the headband includes all of one or more compression members, fasteners and reinforcements, which constitute the placement and maintenance of the patient interface on the patient's face for delivering respiratory therapy. Some headbands are made of soft, elastic, and elastic materials, such as laminated composite materials of foam and fabric.

Membrane: Membrane refers to a typical thin element, preferably having a substantial inability to withstand bending, but can prevent stretching.

Plenum Chamber: A mask inflatable chamber refers to a wall part of the patient interface that has a volume that encloses the space. When in use, the volumetric pressure of the air in between exceeds the atmospheric pressure. An outer cover can form the wall of the mask air chamber. In one form, the area of the patient's face forms one of the walls of the plenum.

Seal: Sealing means that a structure or barrier is an interface that prevents air from flowing across two surfaces; or, sealing means preventing air from circulating.

Shell: A shell specifically refers to a flexural structure with bending, stretchable and compressible hardness. For example, a part of a mask forms the flexural structure wall of the mask. Specifically, it is relatively thin compared to its overall size. In some forms, an outer cover may be a small plane. In particular, such walls are airtight and airtight, although in some forms they may be airtight.

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

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

Swivel: The sub-assembly of components rotates around a common axis, preferably independently, specifically below 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 can be configured to rotate through an angle of less than 360 degrees. When used in the air transfer tube, the sub-assembly of the component preferably includes a pair of cylindrical ducts. Specifically, no air flow will leak from the swivel during use.

Tie: Tie is a structured component designed for tension resistance.

Vent: A structure that allows air to flow from the inside of the mask or duct to the ambient air at a deliberately controlled leakage rate to discharge carbon dioxide (CO ₂ ) and supply oxygen (O ₂ ) in the exhaled gas. Regarding the terms used in the patient interface

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

Floppy: The quality of a material, structure or composition, combined with the following characteristics: -Easily follow finger pressure. -When it is necessary to support its own weight, it cannot maintain its shape. -Not hard. -It can stretch or bend elastically with a small amount of force.

The quality of flexibility can have a relative direction. Therefore, a particular material, structure, or composite can be flexible in a first direction, but rigid or rigid in a second direction, for example, a second direction perpendicular to the first direction.

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

Rigid: When establishing and maintaining the sealing relationship between the patient interface and the patient's airway entrance, it is typically not easily deformed by finger pressure, and/or tension or load.

Semi-rigid: means hard enough to not be substantially distorted under the effect of the mechanical force typically applied during positive pressure ventilation therapy. 5. Other supplementary instructions

The disclosed part of this patent document includes material subject to copyright protection. The copyright owner has no objection to the fax reproduction of any of the patent documents or patent disclosures, because the patent documents or patent disclosures appear in the patent files or records of the Patent and Trademark Office, but retain all copyrights in other respects.

Unless this specification clearly indicates and provides various values, it should be understood that each intermediate value (to one-tenth of the lower limit unit) between the upper limit and the lower limit in the range is different from that in the stated range. Any other specified values or intermediate values within are covered by this technology. The upper limit value and the lower limit value of these intermediate ranges (which may be individually included in the intermediate range) are also covered by the present technology (subject to any special exclusion limits within the stated range). When the stated range includes one or two limitations, a range excluding any one or both of these including limitations is also included in the present technology.

In addition, it should be understood that in the case where a value or value described in this specification is implemented as part of this technology, unless specifically stated otherwise, this value may be an approximate value, and this value may be used for any actual technical implementation permitted or required. Appropriately valid figures.

Unless defined, all technical and scientific terms used here have the same meaning as those generally understood by those familiar with the technology. Although any methods and materials similar or equivalent to those described in this specification can also be used to implement or test this technology, a limited number of exemplary methods and materials are described in this specification.

When a particular material is deemed best to construct a component, it is obvious that alternative materials with similar properties can be used instead. In addition, unless specified to the contrary herein, any and all components described herein should be understood to be manufacturable, and likewise, may be manufactured together or individually.

It must be noted that if the scope of patent application is used in this specification and later, unless expressly stated otherwise, the singular form "one" and "the" include their plural equivalents.

All patents mentioned in this specification are methods and/or materials incorporated for reference to reveal and describe the subject matter of these patents. The publications discussed in this specification are provided only for the purpose of revealing the publications before the filing date of this application. It should not be construed as an admission that this technology cannot precede these disclosures because it was a previous invention. In addition, the publication date provided may be different from the actual publication date and may need to be confirmed separately.

The topics included in the implementation are only for readers' easy reference, and should not be used to limit the subject matter used in the disclosure or patent application. The subject title should not constitute the scope of the patent application or the scope of the scope of the patent application.

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 specific details that do not require implementation of the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they do not imply any order here, but are used to distinguish different elements. In addition, although the processing steps in the method may be described or exemplified in a sequence, this sequence is not necessarily required. Those familiar with this technique understand that this sequence can be modified and/or its aspect can be executed simultaneously or even simultaneously.

Therefore, it should be understood that many modifications can achieve illustrative examples, and other configurations can be designed without departing from the spirit and scope of the technology.

1000: patient 1100: bed partner 3000: patient interface 3100: Seal formation structure 3102: Second attachment zone 3104: Protruding part 3200: Inflatable room 3202: first attachment zone 3204: Zhizi 3206: Lower receiving part 3208: Upper Receiving Department 3300: Positioning and stabilizing structure 3302: back 3304: Headband 3306: Left head top piece 3308: Right head top piece 3310: neck part 3312: upper left strap 3314: upper right strap 3316: Lower left strap 3318: Lower right strap 3320: hook 3340: Positioning and stabilizing structure 3340.1: back 3341: upper strap 3342: Right head top piece 3342.1: Weft direction of the head piece 3343: neck part 3343.1: Weft direction of neck part 3344: lower strap 3345: Left head top piece 3346: upper left strap 3347: hook joint 3347.1: tie-in 3348: Headband 3348.1: Weft direction of head band 3349: hook 3350: Positioning and stabilizing structure 3350.1: back 3351: upper right strap 3352: Right head top piece 3353: neck part 3354: lower strap 3355: Left head top piece 3356: upper left strap 3357: hook joint 3357.1: Strap junction 3358: Headband 3359: hook 3360: Positioning and stabilizing structure 3360.1: back 3361: upper right strap 3362: Right head top piece 3363: neck part 3364: lower strap 3365: Left head top piece 3366: upper left strap 3367: hook joint 3367.1: tie point 3368: Headband 3369: hook 3370: Patient Interface Frame 3371: Holding Arm 3372: Lower attachment point 3373: Holding arm connection 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 feature 3383: Left holding arm connection feature 3384: Upper patient interface frame retention feature 3385: Upper left attachment point 3387: Elastic connection structure 3391: Right connection point 3399: Positioning and stabilizing structure 3400: Ventilation port 3500: Decoupling structure 3600: connection port 3800: Anti-suffocation parts 3900: connection port 4000: PAP device 4170: Air Channel 5000: Humidifier

This technology is illustrated schematically by way of example (and not by way of limitation) and accompanying drawings, in which the same reference numbers indicate similar elements, including: 1. Therapeutic system

Figure 1a shows a system according to the present technology. The patient (1000) wears a patient interface (3000) and receives a positive pressure gas supply from a PAP device (4000). The air from the PAP device (4000) is humidified in a humidifier (5000) and delivered to the patient (1000) along the air channel (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 the schematic diagram of the human upper respiratory tract, including the nasal cavity, nasal bones, nasal cartilage, alar cartilage, nostril, 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 front view of a face with some surface anatomical recognition features, including upper lip, upper red lip, lower red lip, lower lip, mouth width, inner canthus, nasal wing, nasolabial fold and corner of the mouth.

Figure 2d is a side view of the head with some surface anatomical recognition features, including the eyebrow, the bridge of the nose, the nasal protrusion, the meeting point of the lip-nasal septum, the upper lip frenulum, the lower lip frenulum, the syrup, the nose peak, the diameter of the upper ear point and Tap the diameter under the ear. At the same time, the upper part, the lower part, the front part and the rear part are marked.

Figure 2e is a further side view of the head, indicating the approximate position of the eye and ear horizontal plane and the nasolabial angle.

Figure 2f shows a diagram of the under-nose dots.

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, alar cartilage, pterygoid cartilage and fibrofatty tissue.

Figure 2i shows the internal anatomy of the nose, about a few millimeters from the sagittal plane, in which it shows the inner foot of the septal cartilage and the alar cartilage.

Figure 2j shows the front view of the skull, including the jaw bones, temporal bones, nasal bones, and cheek bones. Also pointed out the turbinate bones, such as the upper jaw bone, the lower jaw bone, and the chin protuberance.

Figure 2k shows a side view of the skull with the outline of the head surface and some muscles. The following bones are shown: jawbone, cuneiform bone, nasal bone, cheekbone, upper jawbone, lower jawbone, parietal bone, skull and occiput. Mental bulge also pointed out. The following muscles are shown: digastric muscles, masticatory muscles, sternocleidomastoid muscles and trapezius muscles.

Figure 21 shows an anterolateral view of the nose. 3. Patient interface

Figure 3 shows a perspective view of a positioning and stabilizing structure according to one form of the present technology.

Figure 4a shows a rear view of the positioning and stabilizing structure fitting according to one form of the present technology lying flat.

Figure 4b shows a rear view of the bottom strap fitting of the positioning and stabilizing structure fitting according to one form of the present technology.

Figure 4c shows a top view of the bottom strap accessory of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 4d shows a rear view of the right strap accessory on top of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 4e shows a top view of the right strap accessory on the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 4f shows a rear view of the left strap fitting on top of the positioning and stabilizing structure fitting according to one form of the present technology.

Figure 4g shows a top view of the left strap accessory on top of the positioning and stabilizing structure accessory according to one form of the present technology.

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

Figure 4i shows a top view of the neck part of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 4j shows a rear view of the strap underneath the positioning and stabilizing structure accessory according to one form of the present technology.

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

Figure 41 shows a rear view of the right top piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 4m shows a top view of the right top piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 4n shows a detailed rear view of the right top piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Fig. 4o shows a rear view of the left top piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Fig. 4p shows a top view of the left top piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Fig. 4q shows a detailed rear view of the left head piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 4r shows a rear view of the right strap on the positioning and stabilizing structure accessory according to one form of the present technology.

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

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

Figure 4u shows a top view of the left strap on the positioning and stabilizing structure accessory according to one form of the present technology.

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

Figure 4w shows a top view of the overhead strap of a positioning and stabilizing structure accessory according to one form of the present technology.

Figure 4x shows a detailed rear view of the overhead strap of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 4y shows a rear view of the hook of the positioning and stabilizing structure accessory according to one form of the present technology.

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

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

Figure 5a shows a rear view of the positioning and stabilizing structure fitting according to one form of the present technology lying flat.

Figure 5b shows a rear view of the right strap accessory on top of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 5c shows a top view of the right strap accessory on top of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 5d shows a rear view of the left strap fitting on top of the positioning and stabilizing structure fitting according to one form of the present technology.

Figure 5e shows a top view of the left strap fitting on top of the positioning and stabilizing structure fitting according to one form of the present technology.

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

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

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

Figure 5i shows a top view of the left strap on the positioning and stabilizing structure accessory according to one form of the present technology.

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

Figure 5k shows a top view of the overhead strap of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 51 shows a detailed rear view of the overhead strap of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 6a shows a rear view of the positioning and stabilizing structure fitting according to one form of the present technology lying flat.

Figure 6b shows a rear view of the strap fitting under the positioning and stabilizing structure fitting according to one form of the present technology.

Figure 6c shows a top view of the strap fitting under the positioning and stabilizing structure fitting according to one form of the present technology.

Figure 6d shows a rear view of the right strap accessory on top of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 6e shows a top view of the right strap accessory on top of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 6f shows a rear view of the left strap fitting on top of the positioning and stabilizing structure fitting according to one form of the present technology.

Fig. 6g shows a top view of the left strap fitting on the positioning and stabilizing structure fitting according to one form of the present technology.

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

Figure 6i shows a top view of the strap underneath the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 6j shows a rear view of the right top piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Fig. 6k shows a top view of the right top piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Fig. 61 shows a detailed rear view of the right top piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 6m shows a rear view of the left head piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Fig. 6n shows a top view of the left head piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Fig. 6o shows a detailed rear view of the left top piece of the positioning and stabilizing structure accessory according to one form of the present technology.

Figure 6p shows a rear view of the right strap on the positioning and stabilizing structure accessory according to one form of the present technology.

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

Figure 6r shows a rear view of the left strap on the positioning and stabilizing structure accessory according to one form of the present technology.

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

Figure 6t shows a rear view of the overhead strap of the positioning and stabilizing structure accessory according to one form of the present technology.

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

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

Fig. 7a shows a bottom perspective view of a patient interface frame according to a form of the present technology.

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

Figure 7c shows a bottom view of a patient interface frame according to one form of the present technology.

Fig. 7d shows an internal cross-sectional view of the patient interface frame taken from the lines 7d-7d shown in Fig. 7b according to a form of the present technology.

Fig. 7e shows an external cross-sectional view of the patient interface frame taken from the lines 7d-7d shown in Fig. 7b according to a form of the present technology.

Fig. 7f shows a front view of a left holding arm according to a form of the present technology.

Fig. 7g shows a bottom view of a left holding arm according to a form of the present technology.

Fig. 7h shows a front view of a right holding arm according to a form of the present technology.

Fig. 7i shows a bottom view of a right holding arm according to a form of the present technology.

Fig. 7j shows a perspective view of a patient interface frame accessory according to a form of the present technology.

Figure 7k shows a front view of a patient interface frame with a holding arm according to one form of the present technology.

Fig. 71 shows an internal cross-sectional view of the patient interface frame taken from the lines 71-7l shown in Fig. 7k according to a form of the present technology.

Fig. 7m shows an external cross-sectional view of the patient interface frame taken from the lines 71-7l shown in Fig. 7k according to a form of the present technology.

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

FIG. 7o shows a cross-sectional view of the patient interface frame taken from the lines 7o-7o shown in FIG. 7k according to a form of the present technology.

Fig. 7p shows a cross-sectional view of the patient interface frame taken from the lines 7p-7p shown in Fig. 7k according to a form of the present technology.

Fig. 8a shows a front view of a patient interface and positioning and stabilization structure worn by a patient according to a form of the present technology.

Figure 8b shows a detailed side view of a patient interface and positioning and stabilization structure worn by a patient according to a form of the present technology.

Fig. 8c shows a side view of a patient interface and positioning and stabilization structure worn by a patient according to a form of the present technology.

Figure 9 shows a comparison of the positioning and stabilizing structure according to the present technology when it is placed flat and the prior art positioning and stabilizing structure also being placed 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.

Figure 11 shows a perspective view of a patient interface and positioning and stabilization structure according to one form of the present technology.

Figure 12 shows a perspective view of a patient interface and positioning and stabilization structure according to one form of the present technology.

Figure 13 shows a perspective view of a holding arm according to a form of the present technology.

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

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

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

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

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

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

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

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

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

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

3000: patient interface

3100: Seal formation structure

3200: Inflatable room

3300: Positioning and stabilizing structure

3304: Headband

3306: Left head top piece

3308: Right head top piece

3310: neck part

3312: upper strap

3314: upper strap

3316: Lower strap

3318: lower strap

3320: hook

3371: Holding Arm

3372: Lower attachment point

3377: Elastic connection structure

3380: hook

3381: Holding 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 patients with respiratory disorders, the patient interface including: A plenum chamber, which is configured to be pressurized to higher than atmospheric pressure during use; A seal-forming structure connected to the inflatable chamber, the seal-forming structure made of soft, elastic, and elastic materials, and configured to contact and seal the patient's face in use; A positioning and stabilizing structure, which includes a back; and a pair of upper straps, which extend from the back; and A patient interface frame for keeping the patient interface close to the patient's airway, the patient interface 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 an upper strap; and the patient interface frame further includes a pair of lower attachment points for detachably attaching a lower strap, the pair of lower attachment points are separate from the holding arm Connect to the patient interface frame; Wherein, when the patient wears the patient interface, the holding arms are shaped and sized to extend from the patient interface frame along the patient’s cheeks and between the patient’s eyes and ears, so that each upper strap can be connected to the patient’s ears. An attachment point is attached so that each upper strap is substantially parallel to the plane of the patient's eyes and ears. The patient interface according to claim 1, wherein the inflatable chamber and the seal forming structure form an integral piece. The patient interface according to claim 1, wherein the inflatable chamber includes a hard material that is harder than the seal forming structure. The patient interface according to claim 1, wherein the inflatable chamber includes polycarbonate, and the seal forming structure includes silicone. The patient interface of claim 1, wherein the plenum includes at least one plenum retention feature. The patient interface according to claim 5, wherein the patient interface frame includes at least one patient interface frame retention feature, and each of the patient interface frame retention features is configured to maintain the feature by connecting to the at least one plenum One to one detachable connection, and the patient interface frame is detachably attached to the inflation chamber. The patient interface according to claim 6, wherein the plenum includes four plenum holding features, and the patient interface frame includes four corresponding patient interface frame holding features. The patient interface according to claim 1, wherein the patient interface frame and the inflation chamber are detachably attached by hard-to-hard connection. The patient interface according to claim 1, wherein the patient interface frame is detachably connected to the inflatable chamber near the periphery of the inflatable chamber. The patient interface according to claim 1, wherein the positioning and stabilizing structure further includes a pair of lower straps, and Wherein, when the pair of lower straps are attached to the lower attachment point, the lower attachment point is used for the pair of lower straps and is located in a plane substantially parallel to the plane of the patient's eyes and ears. The patient interface according to claim 10, wherein each of the pair of upper straps and each of the pair of lower straps includes a ring part of a ring material. The patient interface according to claim 11, wherein a hook portion including a 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 according to claim 12, wherein each of the pair of upper straps and each of the pair of lower straps are adapted to wrap around the corresponding one of the pair of upper attachment points and the pair of lower attachment points For one, the hook part of each individual strap is detachably attached to the loop part of the strap. The patient interface according to claim 13, wherein each ring part is wider than each individual hook part, so that when each hook part is attached to its corresponding ring part, the ring part protects the patient’s skin from the Hook effect. The patient interface according to claim 1, wherein the patient interface includes a full face mask. The patient interface according to claim 1, wherein the patient interface does not include a forehead support. The patient interface according to claim 1, wherein the positioning and stabilizing structure includes a crown strap for joining the parietal bone of the patient's skull. The patient interface according to claim 1, wherein the positioning and stabilizing structure includes a neck part for engaging the occipital bone of the patient's skull.

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