TW202012013A - 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 treating respiratory disorders

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

This technique is related to the diagnosis, treatment and improvement of one or more respiratory disorders, and the procedures for avoiding respiratory disorders. Specifically, the technology relates to medical devices and their use to treat respiratory disorders and avoid 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 when they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter the venous blood and expel carbon dioxide from the air. The trachea is divided into right and left main bronchi, and finally divided into terminal bronchioles. The bronchus constitutes a conductive respiratory tract and does not participate in gas exchange. The further branches of the airway lead to the bronchiole, 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 various respiratory 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 normal 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. This often causes excessive daytime sleepiness, and may cause cardiovascular disease and brain damage. Complications are general disorder, especially middle-aged overweight men, although affected people 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 rhythm alternating period of ups and downs, which causes repeated hypoxia and reoxygenation of arterial blood. Chen-Shi breathing may be harmful because of repetitive oxygen deficiency. In some patients, Chen-Shi breathing (CSR) is associated with repeated wakefulness from sleep, which can cause severe sleep disintegration, increased sympathetic nerve activity, and increased afterload. Please refer to US Patent No. 6,532,959 (proposed by Mr. Berthon-Jones).

Obesity Hyperventilation Syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia when awake. There are no other known factors for hypoventilation. Symptoms include difficulty breathing, headache in the morning and excessive sleepiness during the day.

Chronic Obstructive Pulmonary Disease (COPD, Chronic Obstructive Pulmonary Disease) includes any of a number of low airway diseases with common specific characteristics. These include increased resistance to air flow, prolonged breathing and expiratory phases, and loss of normal lung contractility. 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: dyspnea during exercise, chronic cough and sputum production.

Neuromuscular disease (NMD, Neuromuscular Disease) is a broad term, including many diseases and disorders, damage muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle injury leading to decreased mobility (requires wheelchair), difficulty swallowing, respiratory muscle failure, and finally, respiratory failure leading to death. Neuromuscular diseases can be divided into rapid progressive and chronic progressive: (i) rapid progressive disorder: it is characterized by the deterioration of muscle injury for more than a few months, and death within a few years (for example, adolescent amyotrophic lateral sclerosis) (ALS) and Qiu Xin's Muscular Dystrophy (DMD)); (ii) Variable or slow progressive disorder: it is characterized by a deterioration of muscle damage over several years, and only slightly reduces the possibility of average life span (eg, limb (Band type, face shoulder arm type, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea and depression during exercise, fatigue, sleepiness, morning headache, difficulty concentrating, and mood changes.

Thoracic disorders are some chest disabilities that cause inefficient coupling between respiratory muscles and the rib cage. Obstacles are usually characterized by a localized defect and burden the possibility of chronic hypercapnia respiratory failure. Scoliosis and/or posterior scoliosis may cause severe respiratory failure. Symptoms of respiratory failure include: difficulty breathing during exercise, peripheral edema, sit-in breathing, repeated chest infections, morning headache, fatigue, poor sleep quality, and decreased appetite.

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

One known product for the treatment of 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 continuous positive pressure ventilation functions as the same air splint, and the upper airway occlusion can be avoided by pushing the soft palate and tongue forward and backward from the pharyngeal wall.

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

Applying positive air supply to the patient's airway inlet 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 encounter one or more situations that are disgusting, unsatisfactory, unsuitable, difficult 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 components of personal protective equipment) or administered with general anesthetics are quite good for their original application, but are still undesirable or uncomfortable for extended periods of time (eg, 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 seals against the user's face when a force is applied to the patient interface attached to the seal-forming portion of 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 made of an elastomer, such as a rubber. With this type of seal-forming portion, if 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 formation is a flap seal that partially incorporates a thin material and is positioned near the periphery of the nasal mask so that when positive pressure is applied within the nasal mask, it provides a self-sealing effect against the user's face. Similar to the previous style of seal formation, if the fit between the face and the nasal mask is poor, 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 portion may use a cement to create a seal. Some patients may find it inconvenient to often apply and remove facial cement.

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

A seal forming part of a patient interface for positive air pressure treatment will be affected by the corresponding force of air pressure to affect the seal. Such a variety of techniques have been used to position seals to form structures and maintain a sealed relationship with appropriate parts of the face.

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

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

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

ResMed has developed some improved nasal mask vent ports. 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 table of previous mask (ISO 17510-2: 2007, 10cm H ₂ O pressure at 1m (meter))

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

3.4 鼻枕技術 The sound pressure values of various objects are as follows:

3.4 Nose pillow technology

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

ResMed has manufactured the following products that combine 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 (already 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), US Patent Application No. 2009/0044808 (Describe the appearance of ResMed SWIFT LT nose pillow and others); International Patent Application Nos. 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 pillow and others).

The present technology is directed to providing a medical device for diagnosis, improvement, treatment, or prevention of respiratory disorders, which has 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, improve, 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 Holding arms, each holding arm is connected to the patient interface frame at a connection point on a plane, the plane is substantially parallel to the plane of the patient's eye and ear, 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 is vertically offset relative to the upper attachment points and is substantially parallel to the patient's eye and ear plane, 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 can include polycarbonate, and the seal-forming structure can include silicone, (e) the plenum can include at least one plenum retention feature, (f ) The nasal mask frame can have at least one nasal mask frame holding feature, each of which constitutes a detachable attachment of the nasal mask frame to the inflatable chamber by detachably connecting a corresponding one of the at least one inflatable chamber holding feature, (g) The inflation chamber may include four inflation chamber retention features, and the fetal nose mask frame may include four corresponding nose mask frame retention features, (h) The nose mask frame and the inflation chamber may be connected by hard to hard To be detachably attached, (i) the nasal mask frame is detachably connected to the inflation chamber near the periphery of the inflation 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 for detachably attaching a separate lower strap, and each of the pair of upper straps and each of the pair of lower straps may include a ring portion of the ring material, (k ) A hook portion containing hook material can be attached to the distal ends of each of the pair of upper ties and each of the pair of lower ties, (l) each of the pair of upper ties and the pair of lower ties Each of the straps can be adapted to surround 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 loop portion of the strap, (m) Each loop part may be wider than each individual hook part, so that when each hook part is attached to its corresponding loop part, the loop 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 cranial strap to engage the parietal bone of the patient's skull, and/or (p) the positioning and stabilizing structure may include a neck component, use To engage 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 Holding arms, each holding arm is connected to the patient interface frame at a connection point on a plane, the plane is substantially parallel to the plane of the patient's eye and ear, 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 relative to the upper attachment points and substantially parallel to the patient's eye and ear Flat, 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 can include polycarbonate, and the seal-forming structure can include silicone, (e) the plenum can include at least one plenum retention feature, (f ) The nasal mask frame can have at least one nasal mask frame holding feature, each of which constitutes a detachable attachment of the nasal mask frame to the inflatable chamber by detachably connecting a corresponding one of the at least one inflatable chamber holding feature, (g) The inflation chamber may include four inflation chamber retention features, and the fetal nose mask frame may include four corresponding nose mask frame retention features, (h) The nose mask frame and the inflation chamber may be connected by hard to hard To be detachably attached, (i) the nasal mask frame is detachably connected to the inflation chamber near the periphery of the inflation 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 for detachably attaching a separate lower strap, and each of the pair of upper straps and each of the pair of lower straps may include a ring portion of the ring material, (k ) A hook portion containing hook material can be attached to the distal ends of each of the pair of upper ties and each of the pair of lower ties, (l) each of the pair of upper ties and the pair of lower ties Each of the straps can be adapted to surround 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 loop portion of the strap, (m) Each loop part may be wider than each individual hook part, so that when each hook part is attached to its corresponding loop part, the loop 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 cranial strap to engage the parietal bone of the patient's skull, and/or (p) the positioning and stabilizing structure may include a neck component, use To engage 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 includes A pair of holding arms, the attachment points of which are detachably attached to the pair of upper straps, wherein each holding arm is connected to the patient interface frame at a connection point, so that each holding arm can be substantially perpendicular to the patient's eye and ear The plane rotates near one axis, and wherein, when the patient wears, the pair of upper bands are substantially parallel to the plane of the patient's eye and ear.

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 can include polycarbonate, and the seal-forming structure can include silicone, (e) the plenum can include at least one plenum retention feature, (f ) The nasal mask frame can have at least one nasal mask frame holding feature, each of which constitutes a detachable attachment of the nasal mask frame to the inflatable chamber by detachably connecting a corresponding one of the at least one inflatable chamber holding feature, (g) The inflation chamber may include four inflation chamber retention features, and the fetal nose mask frame may include four corresponding nose mask frame retention features, (h) The nose mask frame and the inflation chamber may be connected by hard to hard To be 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, (l) A patient interface system for treating a patient's respiratory disorder may include: the patient interface according to any one of the foregoing examples, and further includes a pair of upper attachment points, each upper attachment point being disposed on the pair of double One of the holding arms; and a pair of lower attachment points, which are provided above the nasal mask frame; and a positioning and stabilizing structure, which includes a back, a pair of upper straps extending from the back, and A pair of lower drawstrings extending from the back, (m) each of the pair of upper drawstrings and each of the pair of lower drawstrings may include a loop part of the loop material, (n) one contains hook material The hooks of the can be attached to the distal ends of each of the pair of upper ties and each of the pair of lower ties, (o) each of the pair of upper ties and each of the pair of lower ties The person can be adjusted around 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 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, (q) the positioning and stabilizing structure may include a head strap, Engage the parietal bone of 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 retaining arm connection feature, wherein the retaining arms connect the patient interface frame at the connection points by direct engagement between the individual frame connection feature and the retention arm connection feature, the connection points are Elastic material seal.

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 can have at least one nasal mask frame holding feature, each of which constitutes a detachable attachment of the nasal mask frame to the inflatable chamber by detachably connecting a corresponding one of the at least one inflatable chamber holding feature, (g) The inflation chamber may include four inflation chamber retention features, and the fetal nose mask frame may include four corresponding nose mask frame retention features, (h) The nose mask frame and the inflation chamber may be connected by hard to hard To be 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, (l) A patient interface system for treating a patient's respiratory disorder may include: the patient interface according to any one of the foregoing examples, and further includes a pair of upper attachment points, each upper attachment point being disposed on the pair of double One of the holding arms; and a pair of lower attachment points, which are provided above the nasal mask frame; and a positioning and stabilizing structure, which includes a back, a pair of upper straps extending from the back, and A pair of lower drawstrings extending from the back, (m) each of the pair of upper drawstrings and each of the pair of lower drawstrings may include a loop part of the loop material, (n) one contains hook material The hooks of the can be attached to the distal ends of each of the pair of upper ties and each of the pair of lower ties, (o) each of the pair of upper ties and each of the pair of lower ties The person can be adjusted around 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 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, (q) the positioning and stabilizing structure may include a head strap, Engage the parietal bone of 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 Relying on the patient's airway, the nasal mask frame includes a pair of holding arms, the pair of holding arms includes a pair of upper attachment points, and each upper attachment point is provided on one of the pair of holding arms, for detachably attaching a separate upper beam Straps, wherein when the patient wears the patient interface system, the retaining 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 attached to the patient's ears Attach one to the top.

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 can include polycarbonate, and the seal-forming structure can include silicone, (e) the plenum can include at least one plenum retention feature, (f ) The nasal mask frame can have at least one nasal mask frame holding feature, each of which constitutes a detachable attachment of the nasal mask frame to the inflatable chamber by detachably connecting a corresponding one of the at least one inflatable chamber holding feature, (g) The inflation chamber may include four inflation chamber retention features, and the fetal nose mask frame may include four corresponding nose mask frame retention features, (h) The nose mask frame and the inflation chamber may be connected by 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 may The loop part including the loop material, (k) a hook part containing a hook material can be attached to the distal end of each of the pair of upper straps and the pair of lower straps, (l) the pair Each of the drawstrings and each of the pair of lower drawstrings can be adjusted to wrap around the pair of upper attachment points and the pair of lower attachment points so that the hook portion of each individual drawstring is detachable The ring parts connecting the harness, (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 effect, (n) the patient interface may include a full face mask, (o) the patient interface may not include a forehead support, (p) the positioning and stabilizing structure may include a head 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 mask has an inflatable chamber and a seal forming structure; a positioning and stabilizing structure; and a connecting point for attaching the positioning and stabilizing Structure to the patient interface.

In an example, (a) the plenum chamber and the seal-forming structure may be an integral piece, for example, permanently connected, integrally molded, and/or common-mode joint, (b) the plenum chamber and the seal-forming structure may be detachable Attachment, for example, by locking, snapping, pressing, and/or friction-fitting, (c) the patient interface system may further include a patient interface frame, wherein the connection points are formed on the patient interface Frame, and wherein the patient interface frame may be detachably connected to the inflation chamber, (d) the connection points may be integrally formed or formed by an integral piece or molded into the inflation chamber, and/or (e) the positioning and stabilization The structure may include upper and lower side straps to join the positioning and stabilizing structure to the patient interface at the connection points, and to detachably fix the patient interface system to the patient's head.

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

Other features of this technology will become clearer from consideration of the information contained in the following "embodiments", "invention summary", "simple drawings" and "scope of 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, which may be changed. It should also be understood that the terminology used herein is for the purpose of describing the specific examples discussed in this specification, not for limitation.

The following description pertains to various examples where one or more common features and/or characteristics may be shared. It should be appreciated that one or more features of any instance may be combined with one or more features of another instance or other instances. Furthermore, any single feature or combination of features may constitute further examples. 1. Treatment system

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

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

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

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

In a specific example of the present technology, mouth breathing is restricted, restricted, or hindered. 3. Patient interface

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

For the purposes of the present invention, the term "patient interface" means a variety of different interface types, such as full face masks, nasal masks, oronasal masks, nasal sprays or nasal pillows, and/or oronasal masks. In other words, in order to supply pressurized breathable gas, any device that facilitates access to the patient's airway entrance can be a "patient interface." It should also be understood that those skilled in the art should also understand that the term "face mask" broadly refers to the aforementioned various forms of patient interface. Thus, for example, a face mask may include a full face mask, nasal mask, oronasal mask, nasal spray or nasal pillow, and/or oronasal mask. 3.1 Full face mask without forehead support

According to an example of the present technology, a patient interface (3000) may be formed without a forehead support. An exemplary patient interface (3000) may also include a full face mask. The patient interface (3000) does not have a forehead support, and because there is no structure extending upward between the forehead and the two eyes, it is not easy for the patient to have visual impairment. Since there is no structure that forms a barrier to the face, this also makes the patient interface (3000) more visually beneficial to the bed partner. In addition, the absence of a forehead support will reduce the need for the patient interface (3000) to contact 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 bring the patient interface (3000) close to the patient's face to ensure an effective pneumatic sealing of the patient's respiratory tract.

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. To retract upward means that the patient interface (3000) moves upwards 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 contraction may occur. Other factors that will be described in more detail below may also cause upward contraction. 3.1.1 Seal formation structure and inflatable chamber

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

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

The seal formation structure (3100) according to the present technology can be constructed using 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 having a thickness of 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 may be disposed 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 may be or may include a similar spring element and function to support the sealing flange to avoid twisting during use. When in use, the sealing flange can quickly respond to the system pressure acting on the inflation chamber (3200) on its lower side, so that it closely engages the face.

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

According to an example of the present technology, the seal-forming structure (3100) may be molded on the inflatable chamber (3200) to form an integral piece. The seal forming structure (3100) and the plenum chamber (3200) may include a patient interface or mask accessory according to an example of the present technology. 3.1.2 Positioning and stable 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 diagram 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 FIG. 3 includes a back (3302). An exemplary back (3302) may include a left headpiece (3306) and a right headpiece (3308), and a neck member (3310). The positioning and stabilizing structure (3300) may also include an overhead strap (3304). Meanwhile, extending from the back (3302) may be an upper left strap (3312) and an upper right strap (3314), and a lower left strap (3316) and a lower right strap (3318). The hook portion (3320) of the hook material may be attached to the distal end of each of the upper strap (3312, 3314) and the lower strap (3316, 3318). The hook (3320) can be used to attach each strap to itself by surrounding the attachment point of the patient interface, as discussed in more detail below. The connecting hook (3320) can be facilitated by a layer of ring material outside some or all 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 engaging the individual hook portions (3320).

According to another example of the present technology, each component of the positioning and stabilizing structure (3300) may also include an outer layer of ring material so that the upper strap (3312, 3314) and the lower strap (3316, 3318) surround itself When returning, the hook (3320) can connect the back part. For example, the head strap (3348), the left head fitting (3306), the right head fitting (3308), and the neck member (3310) may include an outer layer of loop material so that the hook (3320) can be attached to the back (3302) Individual junctions between components and upper straps (3312, 3314) and lower straps (3316, 3318).

At the same time, FIG. 3 shows that the hook portion (3320) is relatively narrower than its individual straps and the components of the back (3302). This advantage is that the straps and the back can protect the user's skin from contacting the hook, 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 Change ratio of positioning and stable structure with different sizes

Figures 4a-4z1, 5a-5l, and 6a-6v show similar positioning and stabilizing structures, and the individual components of the positioning and stabilizing structures. Each continuous drawing shows the positioning and stabilizing structure of different sizes. Thus, Figures 4a-4z1 show an exemplary positioning and stabilizing structure (3340) and its individual components sized to fit a standard or mid-size head. Figures 5a-5l show an exemplary positioning and stabilizing structure (3350) and its individual components sized to accommodate large sized heads. In other words, the head of the patient wearing the positioning and stabilizing structure (3350) shown in these drawings is larger than the head of the patient wearing the positioning and stabilizing structure (3340) shown in FIGS. 4a-4z1. Figures 6a-6v are sized to accommodate an exemplary positioning and stabilizing structure (3360) and its individual components for a small-sized head. 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 FIGS. 4a-4z1. 3.1.2.1.1 Standard size

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). An exemplary back (3340.1) may include a left headpiece (3345) and a right headpiece (3342), and a neck member (3343). The positioning and stabilizing structure (3340) may also include an overhead strap (3348). Meanwhile, extending from the back (3340.1) may be an upper left strap (3346) and an upper right strap (3341), and a lower left strap (3344) and a lower right strap (3344). It should be appreciated that the lower strap of the exemplary positioning and stabilizing structure (3340) may be the same. The hook portion (3349) of the hook material can be attached to the distal end of each of the upper strap (3346, 3341) and the lower strap (3344). The hook (3349) can be used to attach each strap to itself by surrounding the attachment point of the patient interface. The connecting hook (3349) can be facilitated by a layer of ring material on the outside of some or all 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 engaging individual hook portions (3349).

According to another example of the present technology, each component of the positioning and stabilizing structure (3340) may also include an outer layer of ring material so that when the upper strap (3346, 3341) and the lower strap (3344) wrap around themselves , Hook (3349) can connect the back part. For example, the head strap (3348), the left head fitting (3345), the right head fitting (3342), and the neck member (3343) may include an outer layer of loop material so that the hook (3349) can be attached to the back (3340.1) Individual joints between the assembly and the upper strap (3346, 3341) and lower strap (3344).

At the same time, as previously mentioned, the hook (3349) may be relatively narrower than its individual straps, as well as 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) may be welded by ultrasound at the hook joint (3347) to attach an upper or lower strap. At the same time, the upper and lower straps can be joined by ultrasonic welding at the strap joint (3347.1) to join back components. According to a further example, the strap bonding (3347.1) can be formed by two-way ultrasonic welding.

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

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 stretchability to these components, the weft yarns used to weave the components of the component can be oriented in a desired direction. For example, the weft yarn direction (3343.1) of a neck member is shown in the neck member (3343) shown in FIG. 4h. In Fig. 4n, the right head piece (3342) and a right head piece weft direction (3342.1) are shown. In Fig. 4q, the weft yarn direction of the left head piece (3345) and a left head piece (3342.1) are shown. In Figure 4x, the weft yarn direction of the overhead strap (3348) and the overhead strap (3348.1) are shown.

The size of the components of the positioning and stabilizing structure can be changed or kept constant between different sizes of the positioning and stabilizing structure. Figure 4j shows that the right and lower left straps (3344) can have a length L ₁ , which can be approximately 270.0 mm (mm) ±0.5 mm (mm) according to an example. Figures 41 and 4m show the dimensions L ₂ , L ₃ , L ₄ and L _{5 of the} right overhead strap (3342). According to an example, L ₂ can be about 69.6 mm (mm), L ₃ can be about 43.6 mm (mm), L ₄ can be about 20.4 mm (mm), and L ₅ can 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 overhead strap (3345), which can be equal to the dimensions L ₂ , L ₃ , L ₄ , and of the right overhead 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 band (3346), which may be equal to the dimensions L ₁₀ , L ₁₁ , and L _{12 of the} upper right band (3341), respectively. Figure 4w shows the size L ₁₆ of the overhead strap (3348) according to an example, which may be approximately 239.7 mm (mm). 3.1.2.1.2 Large size

5a-5l depict an example of a positioning and stabilizing structure (3350) according to the present technology. The exemplary positioning and stabilizing structure (3350) shown in these figures may include a back (3350.1). An exemplary back (3350.1) may include a left headpiece (3355) and a right headpiece (3352), and a neck member (3353). The positioning and stabilizing structure (3350) may also include an overhead strap (3358). Meanwhile, extending from the back (3350.1) may be an upper left strap (3356) and an upper right strap (3351), and a lower left strap (3354) and a lower right strap (3354). It should be appreciated that the lower strap of the exemplary positioning and stabilizing structure (3350) may be the same. The hook portion (3359) of the hook material can be attached to the distal end of each of the upper strap (3356, 3351) and the lower strap (3354). The hook (3359) can be used to attach each strap to itself by surrounding the attachment point of the patient interface. The connecting hook (3359) can be facilitated by a layer of ring material on the exterior of some or all 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 individual hook portions (3359).

According to another example of the present technology, each component of the positioning and stabilizing structure (3350) may also include an outer layer of ring material so that when the upper strap (3356, 3351) and the lower strap (3354) wrap around themselves , Hook (3359) can be connected to the back part. For example, the head strap (3358), the left head fitting (3355), the right head fitting (3352), and the neck member (3353) may include an outer layer of loop material so that the hook (3359) can be attached to the back (3350.1) Individual junctions between the assembly and the upper strap (3356, 3351) and lower strap (3354).

At the same time, as previously mentioned, the hook (3359) may be relatively narrower than its 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 portion (3359) can be welded at the hook joint (3357) by ultrasonic waves to attach an upper or lower strap. At the same time, the upper and lower straps can be ultrasonically welded at the strap junction (3357.1) to join the back components. According to a further example, the strap joint (3357.1) may be formed by a two-way ultrasonic welding.

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

The size of the components of the positioning and stabilizing structure can be changed or kept constant 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 band (3356), which are equal to the dimensions L ₁₇ , L ₁₈ , and L _{19 of the} upper right band (3351), respectively. Figure 5k shows the size L ₂₃ of the overhead strap (3358) according to an example, which may be about 249.7 mm (mm).

As mentioned previously, certain dimensions of the components of the exemplary large size positioning and stabilizing structure (3350) can be changed compared to the standard size positioning and stabilizing structure (3340), while others remain unchanged. According to an example of the present technology, the large-size positioning and stabilizing structure (3350) may include larger upper right and upper left straps (3351, 3356) than the corresponding components of the standard-size positioning and stabilizing structure (3340). A larger overhead strap (3358). Please refer to the previous detailed description of the differences in the exemplary dimensions. However, some dimensions can remain the same. For example, the large-sized positioning and stabilizing structure (3350) may 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 headpieces (3352, 3355) The size.

According to the typical measurement of the size of the patient's head, it is possible to choose whether to change the specific size of these components with various positioning and stable structural sizes. For example, it may be the case that the head region adapted by the lower strap may not change between the medium and large head sizes, while the head region adapted by the upper strap and the overhead strap may require a longer strap for larger heads. 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 stabilizing structure (3360) shown in these figures may include a back (3360.1). An exemplary back (3360.1) may include a left headpiece (3365) and a right headpiece (3362), and a neck member (3363). The positioning and stabilizing structure (3360) may also include an overhead strap (3368). Meanwhile, extending from the back (3360.1) may be an upper left strap (3366) and an upper right strap (3361), as well as a lower left strap (3364) and a lower right strap (3364). It should be appreciated that the lower straps of the exemplary positioning and stabilizing structure (3360) may be the same. The hook portion (3369) of the hook material can be attached to the distal end of each of the upper strap (3366, 3361) and the lower strap (3364). The hook (3369) can be used to attach each strap to itself by surrounding the attachment point of the patient interface. The connecting hook (3369) can be facilitated by a layer of ring material on the outside of some or all 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 individual hook portions (3369).

According to another example of the present technology, each component of the positioning and stabilizing structure (3360) may also include an outer layer of ring material so that when the upper strap (3366, 3361) and the lower strap (3364) wrap around themselves , Hook (3369) can connect the back part. For example, the headgear strap (3368), left headgear piece (3365), right headgear piece (3362), and neck member (3363) may include an outer layer of loop material so that the hook portion (3369) may be attached to the back (3360.1) Individual joints between the assembly and the upper strap (3366, 3361) and lower strap (3364).

At the same time, as previously mentioned, the hook (3369) may be relatively narrower than its individual straps, as well as the back (3360.1) components. 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 drawing of an exemplary positioning and stabilizing structure (3360), where the positioning and stabilizing structure is flat and the overhead strap (3368) is not connected to the left strap (3366). When the overhead strap (3368) is connected to the left strap (3366), the positioning and stabilizing structure (3360) will assume a larger curved shape, such as shown in FIG.

The size of the components of the positioning and stabilizing structure can be changed or kept constant between different sizes of the positioning and stabilizing structure. Figure 6h shows that the right and left lower straps (3364) can have an L ₂₄ length according to an example, which can 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 overhead strap (3362). According to an example, L ₂₅ can be about 64.6 mm (mm), L ₂₆ can be about 38.6 mm (mm), L ₂₇ can be about 20.9 mm (mm), and L ₂₈ can 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 overhead strap (3365), which are equal to the dimensions L ₂₅ , L ₂₆ , L _27, and L _{28 of the} right overhead strap (3362), respectively . Figures 6p and 6q show the dimensions L ₃₃ , L ₃₄ , and L _{35 of the} upper right band (3361). According to an example, L ₃₃ can be about 130.0 mm (mm), L ₃₄ can be about 145.8 mm (mm), and L ₃₅ can be about 41.9 mm (mm). Figures 6r and 6s show the dimensions L ₃₆ , L ₃₇ , and L _{38 of the} upper left band (3366), which are equal to the dimensions L ₃₃ , L ₃₄ , and L _{35 of the} upper right band (3361), respectively. Figure 6u shows the size L ₃₉ of the overhead strap (3368) according to an example, which may be approximately 227.4 mm (mm).

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

The specific dimensions of these components for choosing whether to change various positioning and stable structural dimensions can be determined based on the typical patient head dimensions. Relative to large and standard positioning and stabilization structures that can share several sizes, it may be the case that as the patient's head size decreases, more components of the positioning and stabilization structure may need to be reduced to accommodate smaller head sizes. 3.2 Evenly distributed sealing force

According to an example of the present technology, the positioning and stabilizing structure (3300) can produce an even distribution of sealing force on 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} shown to be generated by the upper right band (3314), and an lower sealing force vector F _{2 is} shown to be generated by the lower 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 eye and ear, as shown in Figure 2e. By maintaining these sealing force vectors in a substantially parallel direction with respect to the plane of the eye and ear, it can more evenly distribute the sealing force of the seal forming structure (3100) to seal the patient's face. This can improve patient comfort because there is no place in the formation structure (3100) along the seal to use 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

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 stabilizing structure (3300) in patient assembly and wearing. As described above, the seal forming structure (3100) may be a silicone component molded into the plenum (3200), which may be made of nylon (Nylon) to form a gasket fitting. A further example of Nylon 12 in this technology can also be used to form an inflatable chamber (3200). In another example of the technology, polycarbonate can be used to form the plenum chamber (3200). The patient interface frame (3370) facilitates the connection between the cushion fitting and the positioning and stabilizing structure (3300), therefore, it must be connectable to the cushion fitting to transfer the sealing force from the positioning and stabilizing structure. The plenum chamber (3200) and the patient interface frame (3370) may include cooperating features to make these components rub against 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 holding 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 fit. An opposite structure is also conceivable.

As shown in these figures, the patient interface frame (3370) may be formed around the periphery of the inflation chamber (3200). If the inflatable chamber (3200) is made of transparent polycarbonate, this can allow 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) may be characterized as hard-to-hard.

At the same time, by connecting the patient interface frame (3370) to the inflation chamber (3200) at its periphery, it can facilitate a more uniform transfer of the sealing force to the seal-forming structure (3100). According to an example of the present technology, the plenum chamber (3200) may be formed using polycarbonate or another relatively hard material, while the seal forming structure (3100) may be formed using a relatively elastic material, such as silicone. The tension of the positioning and stabilizing structure (3300) is transferred to the inflation chamber (3200) near the periphery of the inflation chamber via the patient interface frame (3370). The seal forming structure (3100) may also be molded into the plenum (3200) near its periphery. Therefore, the even distribution of the sealing force near the periphery of the inflation chamber (3200) can evenly distribute the sealing force to the seal formation structure (3100) because it is also connected to the inflation chamber near its periphery.

It should be understood that another concept of selecting the materials of the plenum chamber (3200) and the seal-forming structure (3100) is that the plenum chamber needs to be slightly deformable, and at the same time there can be some deformation of the seal-forming structure. Therefore, for the plenum chamber (3200), the material should be selected so that the plenum chamber will not deform under the tensile load generated by the belt. On the other hand, the seal-forming structure (3100) may be intended to deform to form a seal around the patient's facial features. Therefore, the seal-forming structure (3100) should be formed using a material that is sufficiently deformed to affect the degree of pneumatic sealing without deforming the inflation chamber (3200) against the face. By selecting materials according to this concept, it can be ensured that an even distribution of sealing force is provided near the periphery of the seal-forming structure (3100), so that the patient has maximum comfort.

19-21 show another example of the present technology in which the seal-forming structure (3100) can be separated from the plenum chamber (3200). FIG. 19 shows a plenum chamber (3200). A first attachment area (3202) of the plenum chamber can extend around the periphery of the plenum chamber (3200) to engage the seal-forming structure (3100). The plenum 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) may be provided on each side of the inflation chamber (3200) to receive the upper patient interface frame retention feature (3370) when attached to the patient interface frame (3370) 3384) Corresponding to the lower patient interface frame retention feature (3382). The Zhizi (3204) can also be disposed in the inflatable chamber (3200) to facilitate the snap-fit connection to the seal-forming structure (3100). A Zhizi (3204) may be provided on each side of the inflatable chamber (3200).

Figure 20 shows a 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 inflation chamber (3200) at the first attachment area. The second attachment area (3102) may be formed around the periphery of the seal formation structure (3100). The first attachment area (3202) and the second attachment area (3102) can be shaped to conform to each other to be pressed, snapped, and/or frictionally fitted. One of the first attachment area (3202) and the second attachment area (3102) may be formed using a material that is more compliant and/or elastic than the other, allowing for a tight fit by providing conformable engagement by deformation. At the same time, the seal forming structure (3100) may have a protruding portion (3104) conforming to the cheeks (3204) of the inflation chamber to form a buckle therewith, and fix the seal forming structure (3100) to the inflation chamber (3200).

FIG. 21 shows this example of the seal formation structure (3100) and the plenum chamber (3200) joined to each other at their individual periphery by joining the first attachment area (3202) and the second attachment area (3102).

It is conceivable that further examples of attachment between a seal-forming structure (3100) and an inflatable chamber (3200) are disclosed in US Patent Nos. 6,491,034, 6,412,487, and 6,823,869, the entire contents of each of which are incorporated herein Enter 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 right strap (3314); and a right holding arm connection feature (3373) for connecting the patient interface frame (3370) The right-hand frame 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 left strap (3312); and a left holding arm connection feature (3383) for connecting the patient interface frame (3370) A left frame of the connection feature (3378). Each retaining arm connection feature (3373, 3383) can connect its individual retaining arm (3371, 3381) to the patient interface frame (3370) by directly connecting and/or engaging a separate frame connection feature (3376, 3378). The holding arm (3371, 3381) can be formed using 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), so that the elastic connection structure can be used as an intermediate connector.

As shown in FIGS. 8a-8c, the holding arm (3371, 3381) can be shaped so that when the patient wears the patient interface (3000) and the positioning and stabilizing structure (3300), the holding arm does not exceed the eyes. The holding arm (3371, 3381) can also be shaped to avoid ears and temples. As shown in FIG. 8c, the right holding arm (3371) is shaped to pass along the cheek of the patient and extends between the eyes and ears, while avoiding the temple, so that the upper right strap (3314) is on the upper right attachment point above the ear ( 3375) Connect the right holding arm.

At the same time, as shown in these figures, the retaining arm (3371, 3381) is relatively wide along its longitudinal axis. By forming the holding arm (3371, 3381), this can allow the targeted bending of the holding arm. In other words, there is a significantly greater limit to bending in the wider cross-sectional direction, while there is a lower limit to bending in the narrower cross-sectional direction. This advantage is that when the positioning and stabilizing structure is under tension, the holding arm (3371, 3381) is allowed to be bent toward the patient's face and cheeks, but bending upwards towards the patient's eyes or downwardly towards the patient's ears will be hindered.

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 plane of the eye and ear 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 arm (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 an exemplary wanted arm path along the side profile of the patient's head in large and small size heads, respectively. The desired arm path is in a rectangular area with a width of 68 mm (mm) and 51 mm (mm), respectively. The measured values indicated in these figures represent the basis for sizing and shaping the holding arm so that it follows the indicated path to provide optimal patient comfort. 3.2.3.1 Attachment points for positioning and stabilizing structures

According to an example of the present technology, the holding arm (3371, 3381) can provide attachment points (3375, 3385) above 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 the respective ends of the holding arms (3371, 3381). The upper straps (3312, 3314) can be connected to the individual upper attachment points (3375, 3385) by surrounding it. The patient interface frame (3370) may also include lower attachment points (3372, 3374) of the lower straps (3316, 3318), which are shown in FIGS. 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 FIGS. 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 previously, when the patient interface (3000) and positioning and stabilizing structure (3300) are removed, forming the lower attachment points (3372, 3374) will allow the patient to keep the hook (3320) connected to the individual lower strap (3316, 3318). When wearing the patient interface (3000) and positioning and stabilizing 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 formed surround. The lower strap (3316, 3318) is then held via the hook (3380).

Fig. 13 shows another example of a holding arm (3371) according to the present technology. The holding arm (3371) shown in this figure may include a holding arm connection feature (3373). This exemplary retaining arm (3371) is also shaped and sized to resemble the retaining arm shown in Figures 7f and 7g. However, the upper attachment point (3375) may 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 separating the hook from the individual upper strap. This is beneficial to the patient, because each time the patient interface (3000) and positioning and stabilizing structure (3300) are worn, the patient does not need to adjust the length of the upper strap. However, the patient only slides the upper band out of the attachment point of the individual holding arms. At the same time, in this example, the opening can be narrowed into the attachment point (3375). This can make it easier to slide the strap into the attachment point, but makes it less easy 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 can be provided, the strap can be surrounded by the clamp, and the clamp can then be attached to the individual attachment points of the holding arm and the patient interface frame (ie, adapter). 3.2.4 Connection between the holding arm and the patient interface frame

According to an example of the present technology, the holding arm (3371, 3381) can adopt a similar articulation method to connect the patient interface frame (3370). The movable joint can be mechanical or movable. A mechanical movable joint can be formed using a patient interface frame (3370) with a guide rod connected and rotating by holding arms (3371, 3381). A movable joint may include an elastic connection, which will be discussed in more detail below. The movable joint according to an example of the technology may include an elastic silicone movable joint. Regardless of the type of movable joint used, the advantage is that the movable joint is formed so that the holding arm (3371, 3381) substantially adopts a single-sided rotation that is substantially parallel to the plane of the eye and ear shown in FIG. 2e. This helps keep the holding arm (3371, 3381) from rotating upward into the patient's field of view or leaning down against the ear.

It should be understood that the patient interface frame (3370) and the holding arm (3371, 3381) can be formed separately, and then be permanently or detachably connected using a mechanical connection. Alternatively, these components may be joined to each other using overmolding. In a further alternative, the patient interface frame (3370) and the holding arm (3371, 3381) may be formed separately, and then a third component is overmolded at the connection 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 mold, and in a further variation, an additional component can be overmolded to join 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 feature (3383) connected with the left holding arm and the feature (3378) connected with the left frame. The elastic connection structure (3377, 3387) can be formed using 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 overmolded on the holding arm (3371, 3381) and the patient interface frame (3370) to facilitate 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) may 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) may be integrally formed with the inflation chamber (3200). The elastic connection structures (3377, 3387) can be directly overlaid and molded in the inflation chamber (3200) at the right frame connection feature (3376) and the left frame connection feature (3378), respectively, to attach the holding arms (3371, 3381). At the same time, the lower attachment points (3372, 3374) can be integrally formed with the inflatable 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) is integrally formed with the inflation chamber (3200). Therefore, the seal-forming structure (3100) may be integrally formed by joining or cooperating with the inflatable chamber (3200). The advantage of this example is that fewer components are required, which can reduce manufacturing costs and provide a simpler patient interface system for the patient. 3.3 Improve the stability of positioning and stabilizing structure

According to an example of the present technology, the positioning and stabilizing structure (3300) can provide improved stability, especially in the apical 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 this technology, the positioning and stabilizing structure (3300) near the top of the head and at the junction between the upper strap (3316, 3318), the top strap (3304), and the top 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 to widen the aforementioned portion of the exemplary positioning and stabilizing structure (3300) to better suppress the upward contraction of the patient interface (3000), which may occur due to the displacement of the positioning and stabilizing 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 may also be formed to better restrain the band bending. Because of the large surface area contacting the head portion, the stability can be improved by widening these components.

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

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

One form of venting 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 vent (3400) can be located in the plenum (3200). Alternatively, the ventilation port (3400) is provided in a decoupling structure (3500), such as a rotating ring. 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 connection of the air channel (4170). 3.7 Anti-asphyxia parts

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

In one form of the 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 direct measurement of gas characteristics, such as pressure, in the plenum (3200). 3.9 Patient interface and positioning and stabilizing structural accessories

11 and 12 show perspective views of an exemplary patient interface (3000) and positioning and stabilizing structure (3300). The two exemplary devices show similar features, including the aforementioned. 4. Vocabulary

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

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

Continuous Positive Airway Pressure (CPAP, Continuous Positive Airway Pressure): CPAP treatment means continuous positive air pressure and preferably about fixed, through the patient's breathing cycle, air or breathable gas is applied to the airway inlet. In some forms, the inlet pressure of the respiratory tract changes in a few centimeters of water in a single breathing cycle, for example 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, it increases with the detection indicating local upper airway obstruction and decreases without indicating local upper airway obstruction. 4.2 The appearance of PAP devices

Air Circuit: Air pipes or tubes are constructed and arranged in use to transfer air or breathable gas supply between a PAP device and a patient interface. Specifically, the air channel may be an outlet fluidly connecting the pneumatic block and the patient interface. The air channel may be referred to as a gas pipe. In some cases, it may be a separate protruding part of the line for inhalation and exhalation. In other cases, a single protruding member may be used.

Automatic Positive Airway Pressure (APAP, Automatic Positive Airway Pressure): automatically adjusts positive airway pressure 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 delivers a flow of pressurized air above ambient pressure.

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

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

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

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

Transducer: A device used to convert one form of energy or signal into another form. A converter may be a sensor or 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, plethysmography With 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 casing increases the area toward the discharge port. 4.3 Respiratory cycle

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

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

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

Breathing Effort: It is best to use breathing effort as a natural breather's attempt 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 limit (Flow Limitation): It is best to limit the flow rate will be the state of the patient's breathing, where the patient exerts more force without causing a relative increase in flow rate. What happens during a flow rate limit to the inspiratory portion of the breathing cycle, this flow rate limit would be the inspiratory flow rate limit. A flow rate limitation occurs during the expiratory portion of the breathing cycle. This flow rate limitation will be the expiratory flow rate limitation.

Inspiratory flow rate limits the type of waveform: (i) The top flat wave: the relatively flat part then rises and then falls. (ii) M-shaped wave: There are two local peaks, one is on the leading edge and the other is on the trailing edge, and a relatively flat portion is between the two peaks. (iii) Rising edge surge: There is a single local peak, which is at the leading edge, which is continued behind a relatively flat portion. (iv) Falling edge surge: There is a relatively flat part that follows the single local peak, which is at the trailing edge.

Shallow breathing (Hypopnea): It is best to use 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 persistence threshold. In one form, for adults, any of the following can be considered 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) Reduce the patient's breathing (but less than 50%) for at least 10 seconds plus at least 3% or a related saturation drop in transient wakefulness.

Shortness of breath (Hyperpnea): The air flow level increases above 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: The degree of opening of the airway, or the range of opening of the airway. The airway is open. The airway patency can be quantified, for example, a value of 1 is unobstructed, and a value of 0 is off.

Positive End-Expiratory Pressure (PEEP, Positive End-Expiratory Pressure): End-expiratory lung pressure exceeds the atmosphere.

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

Respiratory flow, airflow, patient airflow, respiratory airflow (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 breathing flow rate" or "correct breathing""Airflow", which is the correct breathing flow rate experienced by the patient, is usually expressed in liters per minute.

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

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

Eexhalation Time ( Te ): The duration of the expiratory part of the respiratory flow waveform.

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

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

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

Ventilation (Vent): The 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 minutes of ventilation, this amount is often referred to as "minute ventilation". The minute ventilation is sometimes only expressed in terms of ventilation volume, which is the ventilation volume per minute. 4.4 Device parameters of positive airway pressure ventilation (PAP)

Flow Rate: The amount (or mass) of air conducted per unit of time. When the flow rate and the ventilation have the same volume or mass per unit time, the flow rate is measured in a very short time. The flow rate is a nominally positive value for the inspiratory part of the patient's breathing cycle, therefore, it is negative for the expiratory 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 size 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. The vent flow Q v is the flow rate of air leaving the vent to expel exhaled air. The leakage flow Q l is the unintended leakage rate from the patient interface system. The respiratory flow Q r is the flow rate of air into the patient's respiratory organ system.

Leak: Specifically, the term "leak" will be regarded as an air flow environment. Leakage is intended (for example) to allow exhaled 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 unit area. Pressure can be measured using a variety of units, including cmH ₂ O, gf/cm ² , Hectopascal. 1cmH ₂ O is equal to 1 gf/cm ² and is about 0.98 hPa. In this specification, unless specifically stated otherwise, the unit of pressure is cmH ₂ O. For nasal CPAP treatment of OSA, the reference to treatment pressure refers to a 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 indicated using 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 wavefront area. The sound power is measured in decibel SWL, that is, decibel is equivalent to the reference power, usually ^10-12 watts.

Sound Pressure: 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 is equivalent to the reference power, usually 20×10 ^-6 Pascal (Pa), considering the threshold of human audibility. 4.5 Terminology of respirator

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: The parameter of the respirator used to establish the minimum respiration rate that the respirator will deliver to the patient (typically measured in breaths per minute) (if not triggered in other ways).

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

EPAP (or EEP): The reference pressure for pressure changes during breathing will increase to produce the desired nasal mask pressure that the respirator tries 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 breathing.

Pressure Support Ventilation (Pressure Support): indicates the value of the pressure increase during inhalation of the respirator beyond the exhalation of the respirator, 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 to be achieved by the respirator, not the actual respirator.

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

Spontaneous/Timed ( S/T ): Attempts to detect the mode of a respirator or other device that initiates breathing of a spontaneously breathing patient. However, if the device cannot detect breath within a predetermined period of time, the device will automatically begin to deliver breath.

Swing: Synonymous term for pressure-assisted ventilation.

Triggered: When the respirator is to deliver air to the spontaneously breathing patient, it will trigger at the beginning of the breathing part of the breathing cycle where the patient exerts force.

Ventilator: A mechanical device that provides pressure-assisted ventilation to a patient to perform some or all breathing tasks. 4.6 Facial analysis

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

Nose (Alare): the most lateral point above the nostril.

Nose point or the outermost point of the nostril (Alar Curvature or Alar Crest): the last point of the curved baseline of each nostril, a wrinkle formed by the nostril and 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 maxilla, and the nose of the jaw bone.

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

Nose Column (Columella): A segment 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 at the midpoint of the nostril and a line drawn perpendicular to the horizontal plane of the eye and ear when the lower point of the nose is passed.

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 recess of the tragus above the outer ear.

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

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

Greater Alar Cartilage: a small plate of cartilage located under the lateral nasal cartilage, which flexes around the anterior part of the nostril, and its posterior end connects the frontal process of the maxilla through the dura mater, including three or four small alar cartilages .

Nostrils (Nares or Naris): Nearly formed elliptical holes leading to nostrils. The nostrils are separated by the nasal septum.

Naso-labial sulcus or Naso-Labial Sulcus (Naso-Labial Sulcus or Naso-Labial Fold): from each side of the nose to the corners of the skin folds or recesses, separating the cheeks from the upper lip.

Naso-Labial Angle: The angle between the nasal column and the upper lip when passing the lower nose.

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

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

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

Philtrum: From the lower border of the nasal septum to the middle recess of the lip crest in the upper lip area.

Nasal chin point (Pogonion): Located in the soft tissue of the chin, the foremost midpoint.

Nasal Ridge: Nasal ridge is the midline protrusion of the nose, extending from the bridge of the nose to the tip of the nose.

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

Nose bridge (Sellion): the soft tissue, the most concave point, located above the frontal nose suture area.

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

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

Subnasal Point (Subnasal Point): A point located in the soft tissue where the nasal column merges with the upper lip in the median 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 Head analysis

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

Mandible: The jaw forms the lower jaw. Chin bulge is a bony bulge that forms the jaw.

Maxilla: Maxilla forming the upper jaw and located above the jawbone and under the face of the eyes. The mandibular frontal protrusion protrudes upward against the side of the nose and forms the part of its lateral boundary.

Nasal bone: Nasal bones are two small elongated bones, which vary in size and shape in different individuals. They are placed side by side in the center of the face and above, and form the nose "beam" along the joint.

Nasion: The connection between the anterior bone and the two nasal bones, the depression is located between the eyes and is higher than the bridge of the nose.

Occipital Bone: The occipital bone is located at the back and inferior part of the skull, including an oval hole (large occipital hole). Through this oval hole, the cranial cavity can communicate with the spinal canal. The small curved plate behind the large hole of the occipital bone is the occipital scale.

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

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

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

Zygomatic Bone (Zygomatic Bone): The face includes two cheekbones, which are located on the upper and side parts of the face, and form a cheek bump. 4.8 Analysis of respiratory organ system

Diaphragm: A piece of muscle that extends across the bottom of the rib cage. The diaphragm separates the chest 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) with the trachea.

Lung: Human respiratory organ. The guiding section of the lung includes trachea, bronchi, bronchiole, and terminal bronchiole. The respiratory organ section includes the bronchioles of the respiratory organs, pulmonary ducts, and alveoli.

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

Pharynx: Pharynx located directly below (below) the nasal cavity and above the esophagus and larynx. Pharynx practice is divided into three parts: nasopharynx (upper pharynx) (nose of pharynx), oropharynx (middle pharynx) (oropharynx of pharynx), and pharynx (pharynx). 4.9 Materials

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

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

Anti-asphyxia valve (AAV, Anti-asphyxia Valve): A component or sub-assembly of a mask system that reduces the risk of patients breathing excessive CO2 by failing to communicate with the atmosphere.

Elbow: An air duct changes the direction of the air flow axis 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 catheter 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 maintains a tensile load between two or more connection points with a headband. A nasal mask frame can be a non-closed load structure in the mask. However, some nasal mask frames can also be airtight.

Headgear (Headgear): Headgear means the positioning and stable structure form designed for the head. Preferably, the headgear 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 delivery of respiratory therapy. Some headbands are made of soft, elastic, and elastic materials, such as laminated composites of foam and fabric.

Membrane: Membrane means a typical thin element, preferably with substantial resistance to bending, but prevents stretching.

Inflatable chamber (Plenum Chamber): A face mask inflatable chamber means that the part of the patient interface has a wall that encloses the volume of the space. During use, the volumetric pressure of the air containing it exceeds atmospheric pressure. A cover can form the wall of the mask plenum. In one form, the area of the patient's face forms one of the walls of the plenum.

Seal: Seal means that a structure or barrier is an interface that prevents air from flowing through both surfaces; alternatively, seal means preventing air circulation.

Shell: A shell specifically means a buckling structure with bending, elongation, and compression stiffness. For example, a portion of a mask forms the buckling structure wall of the mask. Specifically, it is relatively thin compared to its overall size. In some forms, a cover may be faceted. Specifically, such walls are airtight, but in some forms, the walls may be airtight.

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

Strut: A stress-resistant member means that a structured component is designed to increase the pressure resistance of another component in at least one direction.

Swivel (Swivel): The sub-assembly of the components rotates about a common axis, preferably independently, specifically below low torque. In one form, the swivel ring can be configured to rotate through an angle of at least 360 degrees. In another form, the swivel ring can be configured to rotate through an angle of less than 360 degrees. When used in terms of air delivery tubes, the sub-assembly of the assembly preferably includes matching cylindrical conduits. Specifically, there is no leakage of air flow from the swivel ring during use.

Tie: A set of firmware is a structured component designed for tensile strength.

Vent: A structure that allows air to pass from the inside of the mask or the duct to the ambient air at a deliberately controlled leak rate to exhaust the carbon dioxide (CO ₂ ) and supply oxygen (O ₂ ) of exhaled air. Terminology used in the patient interface

(Surface) 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 manner in two main directions and has a positive curvature. A flat surface has zero curvature.

Floppy: The quality of materials, structures or composites, combined with the following characteristics: -Easy to adapt to finger pressure. -When you want to support its own weight can not maintain its shape. -Not hard. -A slight force can stretch or bend elastically.

Flexible quality 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, such as 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 a sealed relationship between the patient interface and the patient's airway inlet, it is typically not susceptible to deformation due to finger pressure, and/or tension or load.

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

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

Unless this specification clearly indicates and provides various values, it should be understood that each intervening value (up to one tenth of the lower limit unit) between the upper limit value and the lower limit value in the range, and in the stated range Any other specified values or intervening values within are covered in this technology. The upper and lower limit values of these intervening ranges (which may be included in the intervening range alone) are also covered by the present technology (subject to any specifically excluded limits within the stated range). Where the stated range includes one or two limitations, ranges excluding either or both of these included limitations are also included in the 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 the technology, unless otherwise stated, this value may be an approximate value, and this value may be used for any that is permitted or required by an actual technical implementation Appropriate effective figures.

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

When special materials are considered to be best used to form a component, it is clear that alternative materials with similar properties can be used instead. In addition, unless specified to the contrary, any and all components described herein should be understood to be manufacturable, and as such may be manufactured together or individually.

It must be noted that if the use of the patent scope is applied after this specification and the text, unless expressly stated otherwise, the singular forms "a" and "the" include plural equivalents thereof.

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

The subject matter included in the embodiment is for readers' easy reference only, 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 patent application scope or the limitation of patent application scope.

Although the technology is described herein with reference to specific examples, it should be understood that these examples are only illustrative of the principles and applications of the technology. In some instances, the terms and symbols may indicate specific details that are not required to implement the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, it does not mean any order here, but is used to distinguish different components. In addition, although the processing steps in the method may be described or exemplified in an order, it is not necessarily in this order. Those skilled in the art understand that this sequence can be modified and/or its appearance can be performed simultaneously or even synchronously.

Therefore, it should be understood that many modifications can achieve schematic 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 forming structure 3102: Second attachment area 3104: protrusion 3200: Inflatable room 3202: First attachment area 3204: Zhizi 3206: Lower receiving section 3208: Upper receiving department 3300: positioning and stabilizing structure 3302: back 3304: overhead strap 3306: Left head top piece 3308: Right top piece 3310: Neck parts 3312: Upper left belt 3314: upper right strap 3316: Lower left strap 3318: Lower right strap 3320: Hook 3340: Positioning and stabilizing structure 3340.1: back 3341: upper drawstring 3342: Right head top piece 3342.1: Weft yarn direction of head piece 3343: Neck parts 3343.1: Weft direction of neck part 3344: Lower Girdle 3345: Left head top piece 3346: upper left belt 3347: Hook junction 3347.1: Girdle bonding 3348: overhead strap 3348.1: weft direction of overhead strap 3349: Hook 3350: positioning and stabilizing structure 3350.1: back 3351: Upper right strap 3352: Right head top piece 3353: Neck parts 3354: Lower Girdle 3355: Left head top piece 3356: upper left belt 3357: hook junction 3357.1: Girdle junction 3358: overhead strap 3359: Hook 3360: Positioning and stabilizing structure 3360.1: back 3361: upper right strap 3362: Right head top piece 3363: Neck parts 3364: Lower Girdle 3365: Left head top piece 3366: upper left belt 3367: hook junction 3367.1: Girdle junction 3368: overhead strap 3369: Hook 3370: Patient interface frame 3371: Holding arm 3372: Lower attachment point 3373: retaining 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-asphyxia 3900: connection port 4000: PAP device 4170: Air channel 5000: Humidifier

This technology is illustrated by way of example (and not by way of limitation), together with the accompanying drawings, where 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 gas supply from a PAP device (4000). The air from the PAP device (4000) is humidified in a humidifier (5000) and passed along the air channel (4170) to the patient (1000). 2. Treatment 2.1 Respiratory system

Figure 2a shows an overview of the human respiratory organ system, including the nose and mouth, larynx, vocal cords, esophagus, trachea, bronchus, lung, alveolar sac, heart and diaphragm.

Figure 2b shows the pattern of the human upper respiratory tract, including the nasal cavity, nasal bones, nasal cartilage, nasal cartilage, nostrils, upper lip, lower lip, larynx, hard jaw, soft jaw, oropharynx, tongue, epiglottis, vocal cords, esophagus and trachea . 2.2 Facial anatomy

Figure 2c is a front view of the face with some surface anatomical recognition features, including upper lip, upper red lip, lower red lip, lower lip, mouth width, inner canthus, nasolabial fold, nasolabial fold, and corner of mouth.

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

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

Figure 2f shows the subnasal dot plot.

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

Figure 2h shows the subcutaneous structure of the nose, including lateral nasal cartilage, septal cartilage, large alar cartilage, small wing cartilage, and fibrous fatty tissue.

Figure 2i shows the anatomy of the inside of the nose, about a few millimeters from the sagittal plane. In it, it shows the inner foot of the septal cartilage and the large cartilage of the alar wing.

Figure 2j shows a front view of the skull, including the jawbone, temporal bone, nasal bone, and zygomatic bone. It also points out the turbinate bones, such as the maxilla, mandible and chin.

Figure 2k shows a side view of a skull with a head surface profile and some muscles. The following bones are shown: jaw bone, wedge bone, nasal bone, zygomatic bone, maxillary bone, mandible bone, parietal bone, skull and occipital bone. Chin Long convex also pointed out. The following muscles are shown: digastric muscle, masticatory muscle, sternocleidomastoid muscle and trapezius muscle.

Figure 2l shows the anterior lateral 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.

Fig. 4a shows a rear view of a positioning and stabilizing structural component according to one form of the present technology lying flat.

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

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

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

Fig. 4f shows a rear view of the left strap accessory above the positioning and stabilizing structure accessory according to one form of the present technology.

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

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

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

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

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

Figure 41 shows a rear view of the right headpiece of a positioning and stabilizing structural accessory according to one form of the technology.

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

Figure 4n shows a detailed rear view of the right headpiece of a positioning and stabilizing structural accessory according to one form of the technology.

Figure 4o shows a rear view of the left overhead member of a positioning and stabilizing structural accessory according to one form of the technology.

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

Fig. 4q shows a detailed rear view of the left headpiece of a positioning and stabilizing structural accessory according to one form of the technology.

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

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

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

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

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

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

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

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

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

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

Fig. 5a shows a rear view of a positioning and stabilizing structural component according to one form of the present technology lying flat.

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

Fig. 5d shows a rear view of the left strap accessory above the positioning and stabilizing structure accessory according to one form of the present technology.

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

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

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

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

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

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

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

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

Fig. 6a shows a rear view of a positioning and stabilizing structural component according to one form of the present technology lying flat.

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

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

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

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

Fig. 6f shows a rear view of the left strap accessory above the positioning and stabilizing structure accessory according to one form of the present technology.

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

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

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

Figure 6j shows a rear view of the right headpiece of a positioning and stabilizing structural accessory according to one form of the technology.

Figure 6k shows a top view of the right headpiece of a positioning and stabilizing structural accessory according to one form of the technology.

Figure 61 shows a detailed rear view of the right headpiece of a positioning and stabilizing structural accessory according to one form of the technology.

Fig. 6m shows a rear view of the left head part of the positioning and stabilizing structural accessory according to one form of the present technology.

Fig. 6n shows a top view of the left head part of the positioning and stabilizing structural fitting according to one form of the present technology.

Fig. 6o shows a detailed rear view of the left head part of the positioning and stabilizing structural accessory according to one form of the present technology.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

7l shows an internal cross-sectional view of the patient interface frame taken from the line 7l-7l shown in FIG. 7k according to one form of the technology.

7m shows an external cross-sectional view of the patient interface frame taken from the line 71-71 shown in FIG. 7k according to one form of the present technology.

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

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

7p shows a cross-sectional view of a patient interface frame taken from the line 7p-7p shown in FIG. 7k according to one form of the technology.

Figure 8a shows a front view of a patient interface and positioning and stabilizing structure for patient wearing according to one form of the present technology.

Figure 8b shows a detailed side view of a patient interface and positioning and stabilizing structure for patient wearing according to one form of the present technology.

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

FIG. 9 shows a comparison of the positioning and stabilization structure according to the present technology and the prior art positioning and stabilization structure.

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

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

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

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

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

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

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

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

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 patient interface inflation chamber according to an example of the present technology.

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

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

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

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

3000: Patient interface

3100: Seal forming structure

3200: Inflatable room

3300: positioning and stabilizing structure

3304: overhead strap

3306: Left head top piece

3308: Right top piece

3310: Neck parts

3312: Upper girdle

3314: upper girdle

3316: Lower drawstring

3318: Lower Girdle

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-asphyxia

Claims (21)

A patient interface for treating patients with respiratory disorders, the patient interface includes: An inflatable chamber, which is configured to be pressurized to above atmospheric pressure during use; A seal-forming structure connected to the inflation chamber, the seal-forming structure is composed of soft, elastic, and elastic materials, and it is configured to contact and seal the patient's face during use; A positioning and stabilizing structure configured to position and maintain the patient interface in a proper position on the patient's face for respiratory therapy; A patient interface frame configured to connect the inflation chamber and the seal-forming structure to the positioning and stabilizing structure, the patient interface frame including a pair of frame connection features; A pair of holding arms, each of the pair of holding arms having a holding arm connection feature; and A pair of elastic connecting structures, each of the pair of elastic connecting structures is superimposed and molded on the corresponding one of the patient interface frame and the pair of holding arms, so that each of the pair of holding arms is in A connection point is connected to the patient interface frame, Wherein, each of the pair of elastic connection structures seals each of the pair of frame connection features and a corresponding holding arm connection feature, such that each of the pair of frame connection features and the corresponding There is no direct engagement between the retaining arm connection features. The patient interface according to claim 1, wherein each of the pair of elastic connection structures is formed of an elastic material, such that each of the pair of elastic connection structures is opposite to the patient interface frame compared to the pair of holding arms More flexible. The patient interface according to claim 2, wherein the elastic material is silicone rubber or thermoplastic elastomer. The patient interface of claim 1, wherein each of the pair of elastic connection structures is overmolded on each of the pair of frame connection features and the corresponding retaining arm connection feature, To promote permanent connections. The patient interface according to claim 1, wherein the seal forming structure is molded on the inflation chamber to form an integral piece. The patient interface of claim 1, wherein the plenum chamber is made of a harder material than the seal-forming structure. The patient interface of claim 1, wherein the plenum chamber includes polycarbonate and the seal-forming structure includes silicone. The patient interface of claim 1, wherein the inflation chamber includes at least one inflation chamber retention feature. The patient interface of claim 8, wherein the patient interface frame includes at least one patient interface frame retention feature, the at least one patient interface frame retention feature is configured to be capable of being retained by the at least one inflation chamber retention feature Detachable connection, while detachably attaching the patient interface frame to the inflation chamber. The patient interface of claim 9, wherein the inflation chamber includes four inflation chamber retaining features, and the patient interface frame includes four corresponding patient interface frame retaining features. The patient interface of 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 configured to removably connect the inflation chamber around the periphery of the inflation chamber. The patient interface of 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. A patient interface system for treating patient's respiratory disorders, the patient interface system includes: The patient interface according to any one of claims 1 to 14, the patient interface includes a pair of upper attachment points, each of the pair of upper attachment points is located on a corresponding one of the pair of holding arms, and is located A pair of lower attachment points on the patient interface frame; and Wherein, 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. The patient interface system according to claim 15, wherein each of the pair of upper straps and each of the pair of lower straps includes a ring part made of a ring material. The patient interface system of claim 16, wherein a hook portion made of hook material is attached to a distal end of each of the pair of upper straps and each of the pair of lower straps. The patient interface system of claim 17, wherein each of the pair of upper straps and each of the pair of lower straps are adapted to wrap around one of the pair of upper attachment points and the pair of lower attachment points On the corresponding one, the hook portion of each individual strap is detachably attached to the loop portion of the strap. The patient interface system of claim 18, wherein each ring portion is wider than each individual hook portion, such that when each hook portion is attached to its corresponding ring portion, the ring portion protects the patient's skin from Hook influence. The patient interface system of claim 18, wherein the positioning and stabilizing structure may include a cranial strap to engage the parietal bone of the patient's skull. The patient interface system of claim 18, wherein the positioning and stabilizing structure may include a neck member for engaging the occipital bone of the patient's skull.

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