TWI811865B - 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 New Zealand Patent Application No. 626417 filed on June 19, 2014, and U.S. Provisional Patent Application No. 61/953,240 filed on March 14, 2014, the entirety of which are hereby incorporated by reference. Incorporated into this article for reference.

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

The human respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's respiratory tract.

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

A variety of breathing disorders exist.

Obstructive Sleep Apnoea (OSA) is a form of sleep disordered breathing (SDB), which is characterized by upper airway obstruction during sleep. This occurs during sleep from a combination of an abnormally small upper airway and normal loss of muscle tone in the tongue area, soft palate, and posterior pharyngeal wall. The symptoms cause affected patients to stop breathing each night, typically for a duration of 30 to 120 seconds, and sometimes for 200 to 300 seconds. This often causes excessive daytime drowsiness and may cause cardiovascular disease and brain damage. Complicated symptoms are general disorder, especially in middle-aged overweight men, although those affected may not notice the problem. Please see U.S. Patent No. 4,944,310 (by Mr. Sullivan).

Cheyne-Stokes Respiration (CSR) is a disorder of the patient's respiratory organ regulatory system, in which there are alternating rhythmic periods of ups and downs of ventilation, causing repeated hypoxia and reoxygenation of arterial blood. Chen-Shi breathing is potentially harmful because of repetitive oxygen deprivation. In some patients, CSR is associated with repetitive arousals from sleep, which can cause severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (by Mr. Berthon-Jones).

Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia in the absence of other known causes of hypoventilation. Symptoms include difficulty breathing, morning headaches, and excessive daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) includes any of a number of low airway diseases that share specific characteristics. These include increased resistive air flow, prolonged expiratory phase of breathing, 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 exertional dyspnea, chronic cough, and phlegm production.

Neuromuscular Disease (NMD) is a broad term that includes many diseases and disorders that damage muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some patients with NMD are characterized by progressive muscle damage leading to reduced mobility (needing a wheelchair), difficulty swallowing, respiratory muscle failure, and ultimately, respiratory failure leading to death. Neuromuscular disorders can be divided into rapidly progressive and chronically progressive disorders: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over months and results in death within a few years (e.g., amyotrophic lateral sclerosis in adolescents (ALS) and DMD); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly reduces the likelihood of life expectancy (e.g., limb girdle type, facioshoulder-brachial type, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing and concavity during exercise, fatigue, sleepiness, morning headaches, difficulty concentrating, and mood changes.

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

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

1. System

One known product for treating dyspnea 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 hypothesized that continuous positive pressure ventilation acts like an air splint and prevents upper airway occlusion by pushing the soft palate and tongue forward and away from the posterior pharyngeal wall.

Non-invasive ventilation (NIV) has been used to treat Chernobic Respiratory Syndrome (CSR), obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and thoracic disease. obstacles.

3.Patient interface

Applying a positive pressure air supply to the patient's airway inlet may be accomplished through the use of a patient interface such as a nasal mask, full face mask, or nasal pillow. A range of patient interface devices are known, however many patient interface devices suffer from one or more conditions that are objectionable, aesthetically unsatisfactory, unsuitable, difficult to use and uncomfortable, particularly when worn for extended periods of time or when worn. The patient is unfamiliar with the system. Masks designed only for pilots (as part of personal protective equipment) or for administering general anesthesia are fine for their original use, but are still undesirable or uncomfortable for extended periods of time (for example, while sleeping).

3.1 Seal forming part

The patient interface typically includes a seal-forming structure.

One type of seal-forming structure extends near the perimeter of the patient interface and seals against the user's face when force is exerted on the patient interface that adheres to the seal-forming portion of the user's face. The seal-forming structure may include an air- or liquid-filled cushion, or the molded or formed surface of a resilient sealing element made from an elastomer, such as a rubber. Use this type of seal If the component is not suitable, there will be a gap between the seal-forming structure and the face, and external force will be required to make the patient interface form a seal against the face.

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

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

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

3.2 Positioning and stabilization

The seal-forming portion of a patient interface used for positive air pressure therapy is subject to a corresponding force of air pressure that affects the seal. Such a variety of techniques have been used to position seal-forming structures and maintain sealing relationships 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 straps with a stabilizing harness. Many of these carriers suffer from one or more of improper handling, discomfort, and clumsy use.

3.3 Ventilation port technology

Some forms of patient interface systems may include a ventilation port that allows carbon dioxide from exhaled air to be vented. Many of these vents are noisy. Others may become clogged during use and fail to provide adequate drainage. Certain vents may disrupt the patient's (1000) bed partner's (1100) sleep, such as through noise or concentrated air flow.

ResMed has developed certain improved nasal mask vent technologies. Please refer to WO 1998/034,665, WO 2000/078,381, US 6,581,594, US Patent Application No. US 2009/0050156, and US Patent Application No. 2009/0044808.

Noise table for previous masks (ISO 17510-2:2007, 10cm H ₂ O pressure at 1m (meters))

(*Only one sample, measured in CPAP mode at 10cmH ₂ O, using the test method specified in ISO3744)

The sound pressure values of various objects are as follows:

3.4 Nasal pillow technology

One form of nasal pillow is the Adam circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal spray, is the subject of U.S. Patent 4,782,832 (Trimble et al.), which has been assigned to the Prudential-Bennett Company.

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 (assigned to ResMed, Inc.) describe nasal pillow covers: International Patent Application No. WO 2004/073,778 (describing aspects of the ResMed SWIFT nasal pillow, among other things), U.S. Patent Application No. 2009/0044808 ( Describing the appearance of the ResMed SWIFT LT nasal pillow and others); International Patent Application No. WO 2005/063,328 and WO 2006/130,903 (describing the ResMed LIBERTY full face mask and others); International Patent Application No. WO 2009/052,560 (Describe the appearance of ResMed SWIFT FX nasal pillow and others).

This technology is directed to providing medical devices for diagnosing, improving, treating, or preventing respiratory disorders, which medical devices have one or more advantages of improved comfort, cost reduction, efficiency, ease of operation, and manufacturability.

A first aspect of the technology relates to devices for diagnosing, improving, treating or preventing respiratory disorders.

Another aspect of the technology relates to a patient interface system for treating respiratory disorders in patients. 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 located on a plane that is substantially parallel to the patient's eye and ear plane, and the pair of holding arms further includes a pair of upper attachment points, wherein the pair of upper beams The straps are adapted to be detachably attached to the pair of upper attachment points such that when worn by the patient, the pair of upper straps are vertically offset relative to the upper attachment points and substantially parallel to the plane of the patient's eyes and ears, and wherein the patient The interface does not include a forehead support.

In examples, (a) the patient interface may further include a plenum and a seal-forming structure, (b) the plenum and the seal-forming structure may include an integral piece, (c) the plenum 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 may have at least one nasal mask frame retention feature, each configured to releasably attach the nasal mask frame to the plenum by removably connecting a corresponding one of the at least one plenum retention feature, (g) The plenum can include four plenum retaining features, and the nose frame can include four corresponding nose frame retaining features, (h) the nose frame and the plenum can be connected by hard-to-hard connection be detachably attached, (i) the nasal mask frame is detachably connected to the inflatable chamber adjacent the perimeter of the plenum, (j) the positioning and stabilizing structure may include a pair of lower straps, and the patient interface frame may include a pair of lower attachment points for releasable attachment of an individual lower strap, and the Each of the pair of upper straps and each of the pair of lower straps may include a loop portion of loop material, and (k) a hook portion containing hook material may be attached to each of the pair of upper straps. and the distal end of each of the pair of lower straps, (1) each of the pair of upper straps and each of the pair of lower straps may be adapted to surround the pair of upper attachment points and the pair of lower straps near each of the attachment points so that the hook portion of each individual strap is removably attached to the loop portion of the strap, (m) each loop portion can be wider than each individual hook portion so that when When each hook portion is attached to its corresponding loop portion, the loop portion protects the patient's skin from the hook portion, (n) the patient interface may include a full face mask, (o) the positioning and stabilizing structure may include a crown a strap for engaging the parietal bones of the patient's skull, and/or (p) the positioning and stabilizing structure may include a neck member for engaging the occipital bones of the patient's skull.

Another aspect of the technology relates to a patient interface system for treating respiratory disorders in patients. 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 located on a plane that is substantially parallel to the patient's eye and ear plane, and the pair of holding arms further includes a pair of upper attachment points, wherein the pair of upper beams The straps are adapted to be detachably attached to the pair of upper attachment points such that when worn by the patient, 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 eyes and ears plane, and wherein the patient interface does not include a forehead support.

In examples, (a) the patient interface may further include a plenum and a seal-forming structure, (b) the plenum and the seal-forming structure may include an integral piece, (c) the plenum 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 be one or less nasal mask frame retention features, each configured to releasably attach the nasal mask frame to the plenum by removably connecting a corresponding one of the at least one plenum chamber retention feature, (g) the plenum Four plenum retaining features may be included, and the nose frame may include four corresponding nose frame retaining features, (h) the nose frame and the plenum may be removably attached by a hard-to-hard connection, (i) the nasal mask frame is removably connected to the plenum adjacent the periphery of the plenum, (j) the positioning and stabilizing structure may include a pair of lower straps, and the patient interface frame may include a pair of lower attachment points, for releasably attaching an individual lower strap, and each of the pair of upper straps and each of the pair of lower straps may include a loop portion of loop material, (k) a loop portion containing hook material The hook is attachable to a distal end of each of the pair of upper straps and each of the pair of lower straps, (1) each of the pair of upper straps and each of the pair of lower straps may be adapted to surround each of the pair of upper attachment points and the pair of lower attachment points such that the hook portion of each individual strap is releasably attached to the loop portion of the strap, (m) each loop The member portion may be wider than each individual hook portion such that when each hook portion is attached to its corresponding loop portion, the loop portion protects the patient's skin from the hook portions, (n) the patient interface may include a full surface mask, (o) the positioning and stabilizing structure may include a vertex strap for engaging the parietal bones of the patient's skull, and/or (p) the positioning and stabilizing structure may include a neck member for engaging the occipital bones of the patient's skull .

Another aspect of the technology relates to a patient interface system for treating respiratory disorders in patients. The patient interface system may include: a patient interface; a positioning and stabilizing structure including a pair of upper straps; and a patient interface frame for connecting the patient interface to the positioning and stabilizing structure, the arm patient interface frame including A pair of holding arms, the upper attachment points of which are removably 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 eyes and ears The upper straps are rotated about an axis of the plane, and when worn by the patient, the pair of upper straps are substantially parallel to the plane of the patient's eyes and ears.

In examples, (a) the patient interface may further include a plenum and a seal-forming structure, (b) the plenum and the seal-forming structure may include an integral piece, (c) the plenum 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 may have at least one nasal mask frame retention feature, each configured to releasably attach the nasal mask frame to the plenum by removably connecting a corresponding one of the at least one plenum retention feature, (g) The plenum can include four plenum retaining features, and the nose frame can include four corresponding nose frame retaining features, (h) the nose frame and the plenum can be connected by hard-to-hard connection be removably attached, (i) the nasal mask frame is removably connected to the plenum adjacent the periphery of the plenum, (j) the patient interface may include a full face mask, (k) the patient interface may not include a forehead Support member, (1) A patient interface system for treating a patient's respiratory disorder may include: a patient interface according to any of the foregoing examples, and further include a pair of upper attachment points, each upper attachment point being disposed on the pair of One of the holding arms; and a pair of lower attachment points, which are provided on the nasal mask frame; and a positioning and stabilizing structure, the positioning and stabilizing structure includes a back, a pair of upper straps extending from the back, and a pair of lower straps extending from the back, (m) each of the pair of upper straps and each of the pair of lower straps may include a loop portion of loop material, (n) a loop portion containing hook material The hook portion may be attached to the distal end of each of the pair of upper straps and each of the pair of lower straps, (o) each of the pair of upper straps and each of the pair of lower straps (p) each loop portion may be removably attached to the strap loop portion; Wider than each individual hook so that when each hook is attached to its corresponding loop, the loop protects the patient's skin from the hook, (q) the positioning and stabilizing structure may include an overhead strap to engaging the parietal bones of the patient's skull, and/or (r) the positioning and stabilizing structure may include a neck member to engage the occipital bones of the patient's skull.

Another aspect of the technology relates to a patient interface system for treating respiratory disorders in patients. The patient interface system may include: a patient interface; a patient interface frame for connecting the patient interface Faced with a positioning and stabilizing structure, the patient interface frame includes a pair of frame connection features; and a pair of retention arms, each retention arm having a retention arm connection feature, wherein the retention arms are connected via respective frame connection features The patient interface frame is connected to the patient interface frame at connection points by direct engagement between the member and the retaining arm connection feature, and the connection points are sealed by an elastomeric material.

In examples, (a) the patient interface may further include a plenum and a seal-forming structure, (b) the plenum and the seal-forming structure may include an integral piece, (c) the plenum 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 may have at least one nasal mask frame retention feature, each configured to releasably attach the nasal mask frame to the plenum by removably connecting a corresponding one of the at least one plenum retention feature, (g) The plenum can include four plenum retaining features, and the nose frame can include four corresponding nose frame retaining features, (h) the nose frame and the plenum can be connected by hard-to-hard connection be removably attached, (i) the nasal mask frame is removably connected to the plenum adjacent the periphery of the plenum, (j) the patient interface may include a full face mask, (k) the patient interface may not include a forehead Support member, (1) A patient interface system for treating a patient's respiratory disorder may include: a patient interface according to any of the foregoing examples, and further include a pair of upper attachment points, each upper attachment point being disposed on the pair of One of the holding arms; and a pair of lower attachment points, which are provided on the nasal mask frame; and a positioning and stabilizing structure, the positioning and stabilizing structure includes a back, a pair of upper straps extending from the back, and a pair of lower straps extending from the back, (m) each of the pair of upper straps and each of the pair of lower straps may include a loop portion of loop material, (n) a loop portion containing hook material The hook portion may be attached to the distal end of each of the pair of upper straps and each of the pair of lower straps, (o) each of the pair of upper straps and each of the pair of lower straps (p) each loop portion may be removably attached to the strap loop portion; Wider than each individual hook so that when each hook is attached to its corresponding loop, the loop protects the patient's skin from the hook, (q) positioning and stabilizing the knot (r) the positioning and stabilizing structure may include a neck member to engage the occipital bones of the patient's skull.

Another aspect of the technology relates to a patient interface system for treating respiratory disorders in patients. 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 respiratory tract, the nasal mask frame includes a pair of holding arms. The pair of holding arms includes a pair of upper attachment points. Each upper attachment point is provided on one of the pair of holding arms for detachable attachment of an individual upper bundle. Straps, wherein the retaining arms are shaped and sized to extend from the nasal mask frame along the patient's cheek and between the patient's eyes and ears such that each upper strap can be attached to the patient's ear when the patient wears the patient interface system. One of the upper pins has an attachment point.

In examples, (a) the patient interface may further include a plenum and a seal-forming structure, (b) the plenum and the seal-forming structure may include an integral piece, (c) the plenum 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 may have at least one nasal mask frame retention feature, each configured to releasably attach the nasal mask frame to the plenum by removably connecting a corresponding one of the at least one plenum retention feature, (g) The plenum can include four plenum retaining features, and the nose frame can include four corresponding nose frame retaining features, (h) the nose frame and the plenum can be connected by hard-to-hard connection be removably attached, (i) the nasal mask frame is removably connected to the plenum adjacent the periphery of the plenum, (j) each of the pair of upper straps and each of the pair of lower straps may a loop portion including loop material, (k) a hook portion containing hook material attachable to the distal ends of each of the pair of upper straps and each of the pair of lower straps, (l) the pair of upper straps; Each of the straps and each of the pair of lower straps are adjustable to wrap around a respective one of the pair of upper attachment points and the pair of lower attachment points such that the hook portion of each individual strap is removable The loop portions of the connecting strap, (m) each loop portion can be wider than each individual hook portion, so that when each hook portion (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 vertex strap to engage the parietal bones of the patient's skull, and/or (q) the positioning and stabilizing structure may include a neck member to engage the occipital bones of the patient's skull.

Another aspect of the present technology relates to a patient interface system including: a patient interface having an inflatable chamber and a seal-forming structure; a positioning and stabilizing structure; and a connection point for attaching the positioning and stabilizing structure. Structure to this patient interface.

In examples, (a) the plenum and the seal-forming structure may be a single piece, e.g., permanently connected, integrally molded, and/or co-molded, and (b) the plenum and the seal-forming structure may be removable. (c) the patient interface system may further include a patient interface frame, wherein the connection points are formed on the patient interface frame, and wherein the patient interface frame may be removably connected to the plenum, (d) the connection points may be integrally formed or integrally formed or molded into the plenum, and/or (e) the positioning and stabilization The structure may include upper and lower straps for joining the positioning and stabilizing structure to the patient interface at the attachment points to releasably secure the patient interface system to the patient's head.

Of course, portions of an example or aspect may form sub-aspects or sub-examples of the technology. At the same time, various embodiments, sub-aspects and/or aspects can be combined in various ways and simultaneously constitute additional instances, sub-instances, aspects or subsidiary aspects of the present technology.

Other characteristics of the present technology will become clearer from consideration of the information contained in the following "Embodiments," "Abstract of the Invention," "Simple Drawings," and "Patentable Scope."

1000:Patients

1100: Bedmate

3000:Patient Interface

3100: Seal forming structure

3102:Second attachment zone

3104:Protrusion

3200:Inflatable chamber

3202: First attachment area

3204:Beloved Son

3206: Lower receiving department

3208: Upper receiving department

3300: Positioning and Stabilizing Structures

3302:Back

3304:Headband

3306:Left head piece

3308: Right head piece

3310: Neck piece

3312: Upper left drawstring

3314: Upper right drawstring

3316:Lower left drawstring

3318: Lower right strap

3320:Hook

3340: Positioning and Stabilizing Structures

3340.1:Back

3341: Upper drawstring

3342: Right head piece

3342.1: Head piece weft direction

3343: Neck piece

3343.1: Neck piece weft direction

3344:Lower strap

3345:Left head piece

3346: Upper left drawstring

3347:Hook joint point

3347.1: Strap joint

3348:Headband

3348.1: Headband weft direction

3349:Hook

3350: Positioning and Stabilizing Structures

3350.1:Back

3351: Upper right drawstring

3352: Right head piece

3353: Neck piece

3354:Lower strap

3355:Left head piece

3356: Upper left drawstring

3357:Hook joint point

3357.1: Strap joint

3358:Headband

3359:Hook

3360: Positioning and Stabilizing Structures

3360.1:Back

3361: Upper right drawstring

3362: Right head piece

3363: Neck piece

3364:Lower strap

3365:Left head piece

3366: Upper left drawstring

3367:Hook joint point

3367.1: Strap joint

3368:Headband

3369:Hook

3370:Patient interface box

3371: Holding arm

3372:Lower attachment point

3373: Retaining arm connection features

3374:Lower attachment point

3375:Attachment point

3376: Right frame connection feature

3377: Elastic connection structure

3378: Left frame connection feature

3379:Open your mouth

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 Structures

3400: Ventilation port

3500: Decoupling structure

3600: connection port

3800: Anti-suffocation parts

3900:Connection port

4000:PAP device

4170:Air channel

5000:humidifier

The present technology is schematically illustrated by way of example (and not by way of limitation) along with the accompanying drawings, in which like reference numbers refer to similar elements, including:

1. Treatment system

Figure 1a shows a system according to the present technology. The patient (1000) wears a patient interface (3000) and receives a supply of positive pressure gas from a PAP device (4000). Air from the PAP device (4000) is humidified in a humidifier (5000) and delivered to the patient (1000) along the air channel (4170).

2. Treatment

2.1 Respiratory system

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

Figure 2b shows a diagram of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilage, greater nasal alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus and trachea .

2.2 Facial anatomy

Figure 2c is a front view of the face with some surface anatomical identification features, including the upper lip, upper vermilion, lower vermilion, lower lip, oral width, medial canthus, nose alar, nasolabial groove and mouth corners.

Figure 2d is a side view of the head with some surface anatomical identification features, including the glabella, nasal bridge, nasal prominence, lip-nasal septum meeting point, upper lip frenulum, lower lip frenulum, cheekbones, nasal peak, supraauricular diameter and Diameter below the ear. At the same time, mark the upper, lower, front, and rear parts.

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

Figure 2f shows the subnasal point diagram.

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

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

Figure 2i shows the medial anatomy of the nose, approximately a few millimeters from the sagittal plane, showing the medial crura of the septal cartilage and the greater alar cartilage.

Figure 2j shows the front view of the skull, including the jawbone, temporal bones, nasal bones, and zygomatic bones. Also pointed out are the turbinate bones, such as the maxilla, mandible, and mental protuberance.

Figure 2k shows a side view of the skull with the outline of the head surface and some muscles. The following bones are shown: jaw, cuneiform, nasal, zygomatic, maxillary, mandibular, parietal, cranial, and occipital bones. The chin protuberance is also pointed out. The following muscles are shown: digastric, masticatory, sternocleidomastoid, and trapezius muscles.

Figure 2l shows the anterolateral view of the nose.

3.Patient interface

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

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

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

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

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

Figure 4e shows a top view of a right strap assembly on top of a positioning and stabilizing structural assembly in accordance with one form of the present technology.

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

Figure 4g shows a top view of a left strap assembly on top of a positioning and stabilizing structural assembly in accordance with one form of the present technology.

Figure 4h shows a rear view of a neck member of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

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

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

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

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

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

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

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

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

Figure 4q shows a detailed rear view of the left headpiece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

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

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

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

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

Figure 4v shows a rear view of an overhead harness for positioning and stabilizing structural accessories in accordance with one form of the present technology.

Figure 4w shows a top view of an overhead harness as a positioning and stabilizing structural accessory in accordance with one form of the present technology.

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

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

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

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

Figure 5a shows a rear view of a positioning and stabilizing structural accessory laid flat according to one form of the present technology.

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

Figure 5c shows a top view of a right strap assembly on top of a positioning and stabilizing structural assembly in accordance with one form of the present technology.

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

Figure 5e shows a top view of a left strap assembly on top of a positioning and stabilizing structural assembly in accordance with one form of the present technology.

Figure 5f shows a rear view of the right strap over a positioning and stabilizing structural accessory in accordance with one form of the present technology.

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

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

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

Figure 5j shows a rear view of an overhead harness as a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 5k shows a top view of an overhead harness as a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 5l shows a detailed rear view of an overhead harness for positioning and stabilizing structural accessories in accordance with one form of the present technology.

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

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

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

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

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

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

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

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

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

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

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

Figure 6l shows a detailed rear view of a right headpiece of a positioning and stabilizing structural accessory in accordance with one form of the present technology.

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

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

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

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

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

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

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

Figure 6t shows a rear view of an overhead harness as a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 6u shows a top view of an overhead harness as a positioning and stabilizing structural accessory in accordance with one form of the present technology.

Figure 6v shows a detailed rear view of an overhead restraint that is a positioning and stabilizing structural accessory in accordance with one form of the present technology.

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

Figure 7b shows a front view of a patient interface frame in accordance with one form of the present technology.

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

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

Figure 7e shows an exterior cross-sectional view of the patient interface frame taken along line 7d-7d shown in Figure 7b, in accordance with one form of the present technology.

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

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

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

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

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

Figure 7k shows a front view of a patient interface frame with a retaining arm in accordance with one form of the present technology.

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

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

Figure 7n shows a detailed view of a hook portion of an attachment point for a patient interface frame in accordance with one form of the present technology.

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

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

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

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

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

Figure 10a shows a side view of a patient's head and face being measured.

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

Figure 11 shows a perspective view of a patient interface and positioning and stabilizing structures in accordance with one form of the present technology.

Figure 12 shows a perspective view of a patient interface and positioning and stabilizing structures in accordance with one form of the present technology.

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

Figure 14 shows a perspective view of a patient interface frame and a pair of retention arms according to one example of the present technology.

Figure 15 shows a front view of a patient interface frame and a pair of retention arms according to one example of the present technology.

Figure 16 shows a rear view of a patient interface frame and a pair of retention arms according to one example of the present technology.

Figure 17 shows a top view of a patient interface frame and a pair of retention arms according to one example of the present technology.

Figure 18 shows a bottom view of a patient interface frame and a pair of retention arms according to one example of the present technology.

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

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

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

Figure 22 shows a perspective view of a patient interface and positioning and stabilizing structures in accordance with one example of the present technology.

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

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

The following describes various examples that may share one or more common features and/or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. Furthermore, any single feature or combination of these features may constitute further examples.

1. Treatment system

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

2. Treatment

In one form, the present technology includes a method for treating a breathing disorder that includes the step of applying positive pressure to the airway inlet of a patient (1000).

2.1 Nasal continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) symptoms

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

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

In certain examples of this technology, mouth breathing is restricted, restricted, or impeded.

3.Patient interface

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

For the purposes of this invention, the term "patient interface" means various interface types, such as full face mask, nasal mask, oronasal mask, nasal spray or pillow, and/or oronasal mask. In other words, any device that facilitates access to the patient's airway inlet for the purpose of supplying pressurized breathable gas may be a "patient interface." It should also be understood, and those skilled in the art should also understand, that the term "mask" broadly refers to the various forms of patient interface described above. Thus, for example, a mask may include a full face mask, a nasal mask, an oronasal mask, a nasal spray or pillow, and/or an oronasal mask.

3.1 Full face mask without forehead support

According to one example of the present technology, a patient interface (3000) may be formed without a forehead support. An exemplary patient interface (3000) may also include a full face mask. When the patient interface (3000) does not have a forehead support, since there is no structure extending upward toward the forehead and between the eyes, it is less likely to cause visual impairment of the patient. Since there is no structure that obstructs the face, this also makes the patient interface (3000) more visually beneficial to the bed partner. Additionally, the absence of a forehead support will reduce the number of contact points the patient interface (3000) needs to have on the patient's face. However, it must still be possible to use force of sufficient magnitude and distribution across the seal-forming structure (3100) to hold the patient interface (3000) against the patient's face to ensure an effective pneumatic seal against the patient's airway.

At the same time, a positioning and stabilizing structure (3300) (described in more detail below) must be designed for use with the patient interface (3000) to prevent the patient interface from shrinking upward. Shrinking upward means that the patient interface (3000) is facing The upward movement causes the patient interface to move to a higher position on the patient's face than its initial position. If the sealing force vector formed by the positioning and stabilizing structure (3300) is generated in the vertical direction, upward retraction may occur. Other factors, described in more detail below, may also cause upward drawdown.

3.1.1 Seal forming structure and plenum chamber

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

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

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

In one form, the seal-forming structure (3100) includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm (millimeters), such as about 0.25 mm (millimeters) to about 0.45 mm (millimeters), which extends around the perimeter of the plenum (3200). The support flange may be relatively thicker than the sealing flange. The support flange may be disposed between the sealing flange and an edge of the plenum (3200) and extend around at least part of the perimeter. The support flange may be or may include a spring-like element and function to support the sealing flange to prevent distortion during use. When in use, the sealing flange can quickly respond to the system pressure acting in the inflatable chamber (3200) on its lower side to tightly engage the face.

The perimeter of the plenum (3200) is shaped to complement the general contours of the human face in the area where the seal is formed in use. When in use, the edges of the inflatable chamber (3200) are located on adjacent surfaces of adjacent faces. actual contact The face is provided by a seal-forming structure (3100). In use, the seal-forming structure (3100) may extend about the entire perimeter of the plenum (3200).

According to one example of the present technology, the seal-forming structure (3100) may be molded onto the plenum (3200) to form an integral piece. The seal-forming structure (3100) and plenum (3200) may include a patient interface or mask accessory according to one example of the present technology.

3.1.2 Positioning and stabilizing structures

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

Figure 3 shows a perspective view of a positioning and stabilizing structure (3300) according to one example of the present technology. Although this diagram does not show the patient interface (3000), it does show the positioning and stabilizing structure (3300) that the patient may wear.

The exemplary positioning and stabilizing structure (3300) shown in Figure 3 includes a back portion (3302). An exemplary back (3302) may include a left head piece (3306) and a right head piece (3308), as well as a neck piece (3310). The positioning and stabilizing structure (3300) may also include an overhead harness (3304). At the same time, extending from the back (3302) may be an upper left strap (3312) and an upper right strap (3314), as well as a lower left strap (3316) and a lower right strap (3318). The hook portion (3320) of the hook material can be attached to the distal end of each of the upper and lower straps (3312, 3314) and lower straps (3316, 3318). Hooks (3320) can be used to attach each strap to itself by wrapping around the attachment point of the patient interface, as discussed in more detail below. The connecting hook (3320) may be facilitated by a layer of loop material on the exterior of some or all components of the positioning and stabilizing structure (3300). According to one example of the present technology, each of the upper straps (3312, 3314) and lower straps (3316, 3318) may have an outer layer of hook material for releasable engagement of 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 loop material such that when the upper straps (3312, 3314) and lower straps (3316, 3318) wrap around themselves When returning, the hook (3320) can connect the parts on the back. For example, the overhead strap (3348), left overhead piece (3306), right overhead piece (3308), and neck piece (3310) may include an outer layer of loop material so that the hook portion (3320) can be attached to the back (3302) Individual joints between the assembly and upper straps (3312, 3314) and lower straps (3316, 3318).

At the same time, Figure 3 shows the extent to which the hook (3320) is relatively narrower than its individual straps, and the components of the back (3302). The advantage is that the straps and back protect the user's skin from contact with the hooks, thereby reducing pain and discomfort. Additionally, the components of the exemplary positioning and stabilizing structure (3300) may be connected to each other by ultrasonic welding to assemble the positioning and stabilizing structure. These features can be applied equally to the different sized positioning and stabilizing structures discussed below.

3.1.2.1 Change ratios of positioning and stable structures of different sizes

Figures 4a-4z1, 5a-5l, and 6a-6v show similar positioning and stabilizing structures, as well as individual components of the positioning and stabilizing structures. Each successive diagram shows different dimensions of positioning and stabilizing structures. Accordingly, Figures 4a-4z1 show an exemplary positioning and stabilizing structure (3340) and its individual components sized to accommodate a standard or medium-sized head. Figures 5a-5l show an exemplary positioning and stabilizing structure (3350) and its individual components sized to accommodate large head sizes. In other words, the head of the patient wearing the positioning and stabilizing structure (3350) shown in these figures is larger than the head of the patient wearing the positioning and stabilizing structure (3340) shown in Figures 4a-4z1. Figures 6a-6v illustrate an exemplary positioning and stabilizing structure (3360) and its individual components sized to accommodate small head sizes. 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) shown in Figures 4a-4z1.

3.1.2.1.1 Standard dimensions

Figures 4a-4z1 show an example of a positioning and stabilizing structure (3340) in accordance with the present technology. The figures show that the exemplary positioning and stabilizing structure (3340) may include a back portion (3340.1). An exemplary back (3340.1) may include a left head piece (3345) and a right head piece (3342), as well as a neck piece (3343). The positioning and stabilizing structure (3340) may also include an overhead harness (3348). At the same time, extending from the back (3340.1) may be an upper left strap (3346) and an upper right strap (3341), as well as a lower left strap (3344) and a lower right strap (3344). It should be appreciated that the lower straps of the exemplary positioning and stabilizing structure (3340) may be the same. The hook portion (3349) of the hook material can be attached to the distal end of each of the upper and lower straps (3346, 3341) and lower strap (3344). Hooks (3349) may be used to attach each strap to itself by wrapping around the attachment points of the patient interface. The connecting hook (3349) may be facilitated by a layer of loop material on the exterior of some or all components of the positioning and stabilizing structure (3340). According to one example of the present technology, each of the upper straps (3346, 3341) and the lower strap (3344) may have an outer layer of hook material for releasable engagement of 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 loop material such that when the upper straps (3346, 3341) and lower straps (3344) wrap back on themselves , the hook (3349) can connect the parts on the back. For example, the overhead strap (3348), left overhead piece (3345), right overhead piece (3342), and neck piece (3343) may include an outer layer of loop material so that the hook portion (3349) can be attached to the back (3340.1) Individual joint points between the assembly and the upper straps (3346, 3341) and lower straps (3344).

Also, as mentioned previously, the hook portion (3349) can be relatively narrower than its individual straps, as well as the components of the back (3340.1). Additionally, the components of the exemplary positioning and stabilizing structure (3340) may be connected to each other by ultrasonic welding to assemble the positioning and stabilizing structure. For example, each hook portion (3349) can be attached with an individual upper or lower strap via ultrasonic welding at the hook engagement point (3347). At the same time, the upper and lower straps can be joined to the back components by ultrasonic welding at the strap junction (3347.1). According to a further example, the strap joint (3347.1) may be formed by bidirectional ultrasonic welding.

It should also be appreciated that Figure 4a shows a diagram of an exemplary positioning and stabilizing structure (3340) lying flat with the overhead strap (3348) 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 more curved shape, such as shown in Figure 3.

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

The dimensions of components of the positioning and stabilizing structure may vary or remain constant between different dimensions of the positioning and stabilizing structure. Figure 4j shows that the right and left lower straps (3344) may have a length _L1 , which according to one example may be approximately 270.0 mm (millimeters) ± 0.5 mm (millimeters). Figures 4l and 4m show the dimensions _L2 , _L3 , _L4 and _L5 of the right overhead strap (3342). According to an example, L ₂ may be approximately 69.6 mm (millimeters), L ₃ may be approximately 43.6 mm (millimeters), L ₄ may be approximately 20.4 mm (millimeters), and L ₅ may be approximately 67.3 mm (millimeters). Figures 4o and 4p show dimensions L ₆ , L ₇ , L ₈ , and L ₉ of the left overhead strap (3345), which may be equal to the dimensions L ₂ , L ₃ , L _{4 , and L 4} of the right overhead strap (3342), respectively. _L5 . 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 approximately 140.0 mm (millimeters), L ₁₁ may be approximately 155.1 mm (millimeters), and L ₁₂ may be approximately 40.9 mm (millimeters). Figures 4t and 4u show dimensions _L13 , _L14 , and _L15 of the upper left strap (3346), which may be equal to dimensions _L10 , _L11 , and _L12 of the upper right strap (3341), respectively. Figure 4w shows the dimension _L16 of the overhead strap (3348) according to one example, which may be approximately 239.7 mm.

3.1.2.1.2 Large size

Figures 5a-5l depict an example of a positioning and stabilizing structure (3350) in accordance with the present technology. The figures show that the exemplary positioning and stabilizing structure (3350) may include a back portion (3350.1). An exemplary back (3350.1) may include a left head piece (3355) and a right head piece (3352), as well as a neck piece (3353). The positioning and stabilizing structure (3350) may also include an overhead harness (3358). At the same time, extending from the back (3350.1) may be an upper left strap (3356) and an upper right strap (3351), as well as a lower left strap (3354) and a lower right strap (3354). It should be appreciated that the lower straps of the exemplary positioning and stabilizing structure (3350) may be the same. The hook portion (3359) of the hook material can be attached to the distal end of each of the upper and lower straps (3356, 3351) and lower strap (3354). Hooks (3359) may be used to attach each strap to itself by wrapping around the attachment point of the patient interface. The connecting hook (3359) may be facilitated by a layer of loop material on the exterior of some or all components of the positioning and stabilizing structure (3350). According to one example of the present technology, each of the upper straps (3356, 3351) and the lower strap (3354) may have an outer layer of hook material for releasable engagement of 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 loop material such that when the upper straps (3356, 3351) and lower straps (3354) wrap back on themselves , the hook (3359) can connect the parts on the back. For example, the overhead strap (3358), left overhead piece (3355), right overhead piece (3352), and neck piece (3353) may include an outer layer of loop material so that the hook portion (3359) can be attached to the back (3350.1) Individual joint points between the assembly and the upper straps (3356, 3351) and lower straps (3354).

Also, as mentioned previously, hook portion (3359) can be relatively narrower than its individual straps, as well as the components of back (3350.1). Additionally, the components of the exemplary positioning and stabilizing structure (3350) may be connected to each other by ultrasonic welding to assemble the positioning and stabilizing structure. For example, each hook portion (3359) may be ultrasonically welded to attach an individual upper or lower strap at the hook engagement point (3357). At the same time, the upper and lower straps can be The junction (3357.1) is ultrasonic welded to join the components on the back. According to a further example, the strap joint (3357.1) may be formed by bi-directional ultrasonic welding.

It should also be understood that Figure 5a shows a diagram of an exemplary positioning and stabilizing structure (3350) lying flat with the overhead strap (3358) 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 more curved shape, such as shown in Figure 3.

The dimensions of the components of the positioning and stabilizing structure may vary or remain constant between different dimensions of the positioning and stabilizing structure. Figures 5f and 5g show the dimensions _L17 , _L18 , and _L19 of the upper right strap (3351). According to one example, L ₁₇ may be approximately 180.0 mm (millimeters), L ₁₈ may be approximately 195.1 mm (millimeters), and L ₁₉ may be approximately 40.9 mm (millimeters). Figures 5h and 5i show the dimensions _L20 , _L21 , and _L22 of the upper left strap (3356), which are equal to the dimensions _L17 , _L18 , and _L19 of the upper right strap (3351), respectively. Figure 5k shows the dimension _L23 of the overhead strap (3358) according to one example, which may be approximately 249.7 mm.

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

Depending on typical patient head dimensions, one may choose whether to vary the specific dimensions of these components for various positioning and stabilizing structure sizes. For example, it is possible that the lower strap is adapted to The head area may not change between medium and large head sizes, while the upper and overhead straps accommodate the head area which may require longer straps for larger heads.

3.1.2.1.3 Small size

Figures 6a-6l show an example of a positioning and stabilizing structure (3360) in accordance with the present technology. The figures show that the exemplary positioning and stabilizing structure (3360) may include a back portion (3360.1). An exemplary back (3360.1) may include a left head piece (3365) and a right head piece (3362), as well as a neck piece (3363). The positioning and stabilizing structure (3360) may also include an overhead harness (3368). Meanwhile, extending from the back (3360.1) are 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 and lower straps (3366, 3361) and lower strap (3364). Hooks (3369) can be used to attach each strap to itself by wrapping around the attachment point of the patient interface. The connecting hook (3369) may be facilitated by a layer of loop material on the exterior of some or all components of the positioning and stabilizing structure (3360). According to one example of the present technology, each of the upper straps (3366, 3361) and the lower strap (3364) may have an outer layer of hook material for releasable engagement of 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 loop material such that when the upper straps (3366, 3361) and lower straps (3364) wrap back on themselves , the hook (3369) can connect the parts on the back. For example, the overhead strap (3368), left overhead piece (3365), right overhead piece (3362), and neck piece (3363) may include an outer layer of loop material so that the hook portion (3369) can be attached to the back (3360.1) Individual joint points between the assembly and the upper straps (3366, 3361) and lower straps (3364).

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

It should also be understood that Figure 6a shows a diagram of an exemplary positioning and stabilizing structure (3360) lying flat with the overhead strap (3368) 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 more curved shape, such as shown in Figure 3.

The dimensions of the components of the positioning and stabilizing structure may vary or remain constant between different dimensions of the positioning and stabilizing structure. Figure 6h shows that according to one example the right and left lower straps (3364) may have a length of L ₂₄ , which may be approximately 230.0mm (millimeters) ± 0.5mm (millimeters). 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 may be approximately 64.6 mm (millimeters), L ₂₆ may be approximately 38.6 mm (millimeters), L ₂₇ may be approximately 20.9 mm (millimeters), and L ₂₈ may be approximately 63.6 mm (millimeters). 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 , respectively, of the right overhead strap (3362). . Figures 6p and 6q show the dimensions _L33 , _L34 , and _L35 of the upper right strap (3361). According to one example, L ₃₃ may be approximately 130.0 mm (millimeters), L ₃₄ may be approximately 145.8 mm (millimeters), and L ₃₅ may be approximately 41.9 mm (millimeters). Figures 6r and 6s show the dimensions _L36 , _L37 , and _L38 of the upper left strap (3366), which are equal to the dimensions _L33 , _L34 , and _L35 of the upper right strap (3361), respectively. Figure 6u shows the dimension L ₃₉ of the overhead strap (3368) according to one example, which may be approximately 227.4 mm.

As mentioned previously, certain component dimensions of the exemplary smaller sized positioning and stabilizing structure (3360) may be changed compared to the standard sized positioning and stabilizing structure (3340), although others may remain the same. According to this skill As an example of this technique, a small size headgear (3360) may use only the same size neck piece (3363) as a standard size positioning and stabilization structure (3340). The remaining components can be sized according to the previously disclosed dimensions.

The specific dimensions of these components may be chosen based on typical patient head dimensions as to whether or not to vary the dimensions of the various positioning and stabilizing structures. Rather than having large and standard positioning and stabilizing structures that can share several sizes, it may be the case that as a patient's head size decreases, more components of the positioning and stabilizing structure may need to be reduced to accommodate the smaller head size.

3.2 Evenly distributed sealing force

According to one example of the present technology, the positioning and stabilizing structure (3300) can 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 Figure 8c, an upper sealing force vector _F1 is shown to be generated by the upper right strap (3314), and a lower sealing force vector _F2 is shown to be generated by the lower right strap (3318). According to one 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 eye-ear plane, as shown in Figure 2e. By maintaining these sealing force vectors in a substantially parallel direction relative to the eye-ear plane, it can more evenly distribute the sealing force of the seal-forming structure (3100) to seal the patient's face. This may improve patient comfort because there is no place along the seal-forming structure (3100) that is depressing the face with more force than another place. 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 pad accessories

Figures 7a-7e, 7j-7m, 7o, 7p, and 14-18 show various diagrams of a patient interface frame in accordance with one example of the present technology. Figures 8a-8c show various views of the patient interface (3000) and positioning and stabilizing structure (3300) during patient assembly and donning. As mentioned above, the seal-forming structure (3100) can be a silicone component molded into the plenum (3200), which can be made of Nylon to form a gasket component. Nylon 12 may also be used to form the plenum (3200) in a further example of this technology. In another example of the technology, polycarbonate may be used to form the plenum (3200). The patient interface frame (3370) facilitates the connection between the cushion fitting and the positioning and stabilizing structure (3300), and therefore, it must be able to connect the cushion fitting to transfer the sealing force from the positioning and stabilizing structure. The plenum (3200) and patient interface frame (3370) may include cooperating features to frictionally seal these components with each other. An 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 are not shown in these figures). As shown in these figures, the upper and lower patient interface frame retention features (3384, 3382) may be formed when they protrude from the patient interface frame (3370). Therefore, the upper and lower plenum retention features of plenum (3200) will be corresponding indentations or adapters to effect a frictional fit. An opposite structure is also conceivable.

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

At the same time, by connecting the patient interface frame (3370) to the plenum (3200) at its perimeter, a more even transfer of sealing force to the seal-forming structure (3100) can be facilitated. According to one example of the present technology, the plenum (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. Positioning and stabilizing structure (3300) tension via patient interface frame (3370) is transferred to the plenum (3200) near the periphery of the plenum. The seal-forming structure (3100) may also mold a plenum (3200) around its perimeter. Therefore, an even distribution of sealing force near the periphery of the plenum (3200) results in an even distribution of sealing force across the seal-forming structure (3100) since it is also connected to the plenum near its periphery.

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

Figures 19-21 show another example of the present technology in which the seal-forming structure (3100) is detachable from the plenum (3200). Figure 19 shows a plenum (3200) with a first attachment zone (3202) extending around the perimeter of the plenum (3200) to engage the seal-forming structure (3100). The plenum (3200) may also include an upper receiving portion (3208) for receiving the upper patient interface frame retention feature (3384); and a lower receiving portion (3206) for receiving the lower patient interface frame retention feature (3382). ). Accordingly, an upper receiving portion (3208) and a lower receiving portion (3206) may be provided on each side of the plenum (3200) to receive the upper patient interface frame retention feature (3370) when the patient interface frame (3370) is attached. 3384) and corresponding ones of the lower patient interface frame retention feature (3382). A latch (3204) may also be provided in the plenum (3200) to facilitate a snap connection to the seal-forming structure (3100). A catch (3204) can be provided on each side of the plenum (3200).

Figure 20 shows a seal forming 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 first attachment area. Pneumatic chamber (3200). A second attachment zone (3102) may be formed around the perimeter of the seal-forming structure (3100). The first attachment area (3202) and the second attachment area (3102) can be shaped to conform to each other for press fit, snap fit, and/or frictional fit. One of the first attachment area (3202) and the second attachment area (3102) may be formed from a more compliant and/or elastic material than the other, allowing for a secure fit through deformation to provide a conforming joint. At the same time, the seal-forming structure (3100) may have a protrusion (3104) that conforms to the latch (3204) of the plenum to thereby form a snap and secure the seal-forming structure (3100) to the plenum (3200).

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

Further examples of conceivable attachments between a seal-forming structure (3100) and a plenum (3200) are disclosed in U.S. Patent Nos. 6,491,034, 6,412,487, and 6,823,869, the entire contents of each of which are hereby incorporated by reference. Incorporated into this article for reference.

3.2.3 Holding arm

According to one example of the present technology, the patient interface frame (3370) may include a pair of retention arms (3371, 3381). Figures 7f and 7g show the right retaining arm (3371). The right retaining arm (3371) may include: an upper right attachment point (3375) for attaching the upper right strap (3314); and a right retaining arm connection feature (3373) for connecting the patient interface frame (3370) A right box connection feature (3376). Figures 7h and 7i show the left retaining arm (3381). The left retaining arm (3381) may include: an upper left attachment point (3385) for attaching the upper left strap (3312); and a left retaining arm connection feature (3383) for connecting the patient interface frame (3370) A left frame connection feature (3378). Each retainer arm connection feature (3373, 3383) may connect its individual retainer arm (3371, 3381) to the patient interface frame (3370) by directly connecting and/or engaging an individual frame connection feature (3376, 3378). The holding arms (3371, 3381) can be formed using polycarbonate and/or nylon. According to another example of technology, bomb Flexible connection structures (3377, 3387) Where these connection features are not directly connected and/or engaged, the retaining arm connection features (3373, 3383) can be connected to the individual frame connection features (3376, 3378) such that the resilient connection features Used as an intermediate connector.

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

Also, as shown in these figures, the retaining arms (3371, 3381) are relatively wide along their longitudinal axis. By forming the retaining arms (3371, 3381), this may allow targeted bending of the retaining arms. In other words, there is significantly greater restricted bending in the wider cross-sectional direction, while there is lower restricted bending in the narrower cross-sectional direction. This has the advantage that when the positioning and stabilizing structure is in tension, it allows the holding arms (3371, 3381) to bend toward the patient's face and cheeks, but is blocked when bending upward toward the patient's eyes or downward toward the patient's ears.

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

Figures 10a and 10b show exemplary desired retention arm paths along the side contours of a patient's head for large and small head sizes, respectively. The desired holding arm paths are within rectangular areas with widths of 68mm (millimeters) and 51mm (millimeters) respectively. The measured values indicated in these figures represent the basis for sizing and forming the holding arm. base so that it follows the path indicated to provide optimal patient comfort.

3.2.3.1 Attachment points for positioning and stabilizing structures

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

Figure 13 shows another example of a retaining arm (3371) in accordance with one of the present techniques. The retaining arm (3371) shown in this figure may include a retaining arm connection feature (3373). This exemplary retaining arm (3371) is also shaped and sized similar to 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) within the slit containing the attachment point. By shaping the attachment points (3375) as described, the patient can pull the circumferential upper band from the upper attachment point without detaching the hooks from the individual upper bands. This is beneficial to the patient because the patient does not need to adjust the length of the upper strap each time the patient interface (3000) and positioning and stabilizing structure (3300) are worn. However, the patient only slides the upper strap out of the attachment points of the individual retention arms. At the same time, in this In this example, the opening can be narrowed into the attachment point (3375). This makes it easier to slide the band into the attachment point, but makes it harder to remove the band, and therefore, impossible to slip the band off during treatment.

It is also contemplated that other attachment structures may be provided for connecting the strap to the attachment point. For example, a clamp may be provided through which the strap may be looped, and the clamp may then be attached to the individual attachment points (ie, adapters) of the retention arm and patient interface frame.

3.2.4 Connection of holding arm and patient interface frame

According to an example of this technology, the holding arms (3371, 3381) can be connected to the patient interface frame (3370) in a similar movable joint manner. The movable joint can be mechanical or movable. A mechanically movable joint may be formed using a patient interface frame (3370) having guide rods connected to and rotated by retaining arms (3371, 3381). A movable joint may include an elastic connection, which is discussed in more detail below. According to an example of the technology, the movable joint may include an elastic silicone movable joint. Regardless of the type of movable joint used, the advantage is that the movable joint is formed so that the holding arms (3371, 3381) essentially adopt a single plane of rotation that is essentially parallel to the eye-ear plane shown in Figure 2e. This helps keep the retention arms (3371, 3381) from rotating upward into the patient's field of view or downward against the ear.

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

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

According to another example of the present technology, as shown in Figures 22 and 23, the connection points of the positioning and stabilizing structure (3300) can be directly or integrally formed in the plenum (3200). According to this example, right frame connection feature (3376) and left frame connection feature (3378) may be integrally formed with plenum (3200). The elastic connection structures (3377, 3387) can be directly stacked and molded on the inflatable chamber (3200) on 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) may be integrally formed with the plenum (3200). It should be understood that in this example, the patient interface frame (3370) may not necessarily be the elastic connection structure (3377, 3387), and the lower attachment points (3372, 3374) are integrally formed with the plenum (3200). Accordingly, the seal-forming structure (3100) may engage or be integrally formed with the plenum (3200). The advantage of this example is that fewer components are required, which reduces manufacturing costs and provides a simpler patient interface system for the patient.

3.3 Improve the stability of positioning and stabilizing structures

According to one example of the present technology, a positioning and stabilizing structure (3300) may provide improved stability, particularly in the crown region of the head. Improving the stability of the positioning and stabilizing structure (3300) in terms of 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 one example of the present technology, a positioning and stabilizing structure (3300) near the top of the head and at the connection between the upper strap (3316, 3318), the overhead strap (3304), and the head piece (3306, 3308) The connection area can be widened to improve stability. This can be achieved by widening the aforementioned components near this area. Desirably, widening the aforementioned portions of the exemplary positioning and stabilizing structure (3300) will better inhibit the patient interface (3000) from collapsing upward, which may occur due to the positioning and stabilizing structure being displaced from its intended position. . By increasing the surface area, these connected areas increase stiffness so that the back (3302) remains on the back of the head. It may also form a better restrained strap from bending. Stability can be improved by widening these components due to the larger surface area contacting the head portion.

Figure 9 shows a standard sized positioning and stabilizing structure (3340) designed to fit the same size head laid flat against a prior art positioning and stabilizing structure (3399). This figure shows areas of relatively increased width, which indicates the extent to which these areas are more susceptible to slipping and bending relative to the width of prior art positioning and stabilizing structures (3399).

3.4 Ventilation port (3400)

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

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

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

3.5 Decoupling structure (3500)

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

3.6 Connection port (3600)

The connection port (3600) allows connection of the air channel (4170).

3.7 Anti-suffocation parts

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

3.8 Connection port (3900)

In one form of the technology, a patient interface (3000) includes one or more connection ports that allow access to the volume within the plenum (3200). In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows direct determination of gas properties, such as pressure, within the plenum (3200).

3.9 Patient interface and positioning and stabilizing structural accessories

Figures 11 and 12 show perspective views of an exemplary patient interface (3000) and positioning and stabilizing structure (3300). Both exemplary devices exhibit similar characteristics, including those described above.

4. Vocabulary

For purposes of this disclosure, one or more of the following definitions may apply in a particular form of the technology. In other forms of the technology, other definitions may apply.

4.1 General

Air: In certain forms 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 applying air or breathable gas to the respiratory inlet through the patient's breathing cycle at continuous positive atmospheric pressure, preferably approximately fixed. In some forms, airway inlet pressure varies by a few centimeters of water during a single breathing cycle, such as being 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 may vary from patient to respiratory cycle, for example, increasing with a test indicating local upper airway obstruction versus decreasing if a test does not indicate local upper airway obstruction.

4.2 Appearances of PAP devices

Air Circuit: Pipes or tubes are used to construct and dispose air or breathable gas supplies between a PAP device and a patient interface. Specifically, the air channel may be an outlet fluidly connecting the pneumatic module to the patient interface. The air passage may be called an air duct. In some cases, there may be separate protruding parts for the inhalation and exhalation circuits. In other cases, a single projecting member may be used.

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

Blower or Flow Generator: A device that delivers a pressure air flow exceeding the ambient pressure.

Controller: A device or part of a device that adjusts an output based on input. For example, one form of a controller has one variable under control, one of the control variables, to form the input to the device. The output of the device is a function of the current value of the control variable, and a set point of the variable. An assisted breathing apparatus may include a controller that has ventilation as an input, target ventilation as a set point, and pressure support level as an output. Other input forms may be one or more of oxygen saturation (SaO ₂ ), partial pressure of carbon dioxide (PCO ₂ ), motion, signals from photovolume descriptors, and peak flow. A controller's set point can be one or more fixed, variable, or learned values. For example, a respirator set point could be a long-term average of measured breathing for the patient. Another respirator 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 specific pressure.

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

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

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

Transducer: A device used to convert one form of energy or signal into another form. A transducer may be a sensor or detector that converts a mechanical source (such as motion) into an electrical signal. Examples of transducers include pressure sensors, flow sensors, carbon dioxide (CO ₂ ) sensors, oxygen (O ₂ ) sensors, stress sensors, motion sensors, noise sensors, plethysmography devices and cameras.

Spiral casing (Volute): The casing of a centrifugal pump is used to receive the air propelled by the impeller, which can slow down the air flow rate and increase the pressure. The cross section of the spiral housing increases the area towards the discharge port.

4.3 The appearance of respiratory cycle

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

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

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

Breathing Effort: The best method is Breathing Effort. Breathing Effort should be the action completed by a natural breather trying to breathe.

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

Flow Limitation: Preferably, flow limitation will be a condition of the patient's breathing in which the patient exerts more force without causing a relative increase in flow rate. This flow limit is the inspiratory flow limit when it occurs during the inspiratory portion of the breathing cycle that the flow rate is limited. In the event that flow limitation occurs during the expiratory portion of the breathing cycle, this flow limitation will be the expiratory flow limitation.

Types of inspiratory flow rate limiting waveforms:

(i) Top flat wave: then rises in the relatively flat part, and then falls.

(ii) M-shaped wave: There are two local peaks, one at the leading edge and the other at the trailing edge, and a relatively flat part is between the two peaks.

(iii) Rising edge surge: There is a single local peak, which is at the leading edge and continues behind a relatively flat part.

(iv) Falling edge surge: There is a relatively flat part that follows a single local peak, and the local peak is at the trailing edge.

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

Hyperpnea: Increased air flow levels above normal.

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

Patency Airway: The degree to which the respiratory tract is open, or the extent to which the respiratory tract is open. Changing the airway is open. The airway is open and can be quantified, for example, a value of 1 means it is open and a value of 0 means it is closed.

Positive End-Expiratory Pressure (PEEP, Positive End-Expiratory Pressure): The pressure in the lungs at the end of expiration 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 ( Qr ): These synonymous terms can be regarded as the PAP device's assessment of respiratory airflow, rather than "correct respiratory flow" or "correct breathing""Airflow" is the correct respiratory flow rate experienced by the patient, usually expressed in liters per minute.

Tidal volume ( Vt ): The volume of inspiration or expiration during normal breathing without exerting additional force.

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

Exhalation Time ( Te ): The duration of the expiration part of the respiratory flow waveform.

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

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

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

Ventilation ( Vent ): Measurement of the total amount of gas exchanged in the patient's respiratory system, including inspiratory and expiratory flow rates per unit time. When expressed in terms of air changes per minute, this amount is often referred to as "minute air change." Minute ventilation is sometimes expressed only in terms of air change volume, which is the air change volume per minute.

4.4 Positive airway pressure (PAP) device parameters

Flow Rate: The instantaneous amount (or mass) of air conducted per unit time. A flow rate measured over a very short period of time when the flow rate and air exchange have the same volume or mass per unit time. The flow rate is nominally positive for the inspiratory portion of the patient's breathing cycle and, therefore, negative for the expiratory portion of the patient's breathing cycle. In some cases, the flow rate reference will be treated as a scalar quantity, that is, a quantity with only magnitude. In other cases, the flow rate reference will be treated as a vector, that is, a quantity with both magnitude and direction. The flow rate is represented by the consumption Q. The total flow rate Qt is the flow rate of air leaving the PAP device. Ventilation flow Q v is the flow rate of air leaving the vent to expel exhaled air. Leak flow rate Ql is the rate of unintended leakage flow from the patient interface system. Respiratory flow rate Q r is the flow rate of air into the patient's respiratory organ system.

Leak: Specifically, the term "leak" will be considered an air flow environment. Leakage flow is intended, for example, to allow expulsion of exhaled _CO2 . Leakage is unintended, for example, because it is an incomplete seal between the mask and the patient's face.

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

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

Sound Pressure: Local deviation from the environment at a specific point in time as sound waves travel through the medium. Sound power green is usually expressed in decibels SPL, that is, decibels are equivalent to the reference power, usually 20×10 ^-6 Pascal (Pa), taking into account the critical value of human audibility.

4.5 Respirator terminology

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

Backup Rate: A respirator parameter used to establish the minimum respiratory rate (typically measured in breaths per minute) that the respirator will deliver to the patient if not otherwise activated.

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

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

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

Pressure Support: Indicates the pressure increase during inhalation of a respirator over that during 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 refers to the pressure difference that the respirator aims to achieve, rather than what the respirator actually achieves.

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

Spontaneous/Timed ( S/T ): A mode of respirator or other device that attempts to detect the onset of breathing in a spontaneously breathing patient. However, if the device is unable to detect breaths within a predetermined period of time, the device will automatically begin delivering breaths.

Swing: A synonym for pressure-assisted ventilation.

Triggered: When the respirator is to deliver air to a spontaneously breathing patient, it is triggered at the beginning of the breathing portion of the breathing cycle when the patient exerts force.

Ventilator: A mechanical device that provides pressure-assisted ventilation to patients for some or all breathing tasks.

4.6 Facial Analysis

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

Alare: the most lateral point above the nose.

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

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

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

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

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

Columella Angle: When meeting the inferior point of the nose, the angle between the line drawn through the midpoint of the nostril and a line drawn perpendicular to the level of the eye and ear.

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

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

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

Greater Alar Cartilage: A small cartilage plate located under the lateral nasal cartilage. It flexes around the front of the nostril, and its rear end is connected to the frontal process of the maxilla through the dura mater. It includes three or four small alar cartilages. .

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

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

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

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

Otobasion Superior: The highest point connecting the outer ear to the facial skin.

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

Internasolabial longitudinal groove (Philtrum): The middle recess from the lower border of the nasal septum to the top of the lip in the upper lip area.

Pogonion: The soft tissue located in the chin, the most anterior midpoint.

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

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

Sellion: The soft tissue and the most concave point located above the frontonasal suture area.

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

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

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

Supramentale: The largest concave point in the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue.

4.7 Cranial Anatomy

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

Mandible: The jaw forms the lower jaw. The mental protuberance is the bony protuberance that forms the jaw.

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

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

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

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

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

Parietal bone: The parietal bones are the bones that (when joined together) form the top and sides of the skull.

Temporal Bone: The Temporal Bone is located at the base and sides of the skull and supports the area of the face known as the temples.

Zygomatic Bone: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the protuberance of the cheek.

4.8 Anatomy of respiratory system

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

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

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

Nasal Cavity: The nasal cavity (or nasal fossa) is the large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal exophuses called meatus or turbinates. As for the front part of the nasal cavity, it is the nose, while the back part of the nasal cavity mixes into the nasopharynx through the choanal aperture.

Pharynx: The part of the throat just below (below) the nasal cavity and above the esophagus and larynx. The pharynx is commonly divided into three parts: the nasopharynx (upper pharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the hypopharynx (hypopharynx).

4.9 Materials

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

Polycarbonate: a typical transparent thermoplastic polymer (Bisphenol-A Carbonate).

4.10 What the patient interface looks like

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

Elbow: A duct in which the air flow axis changes direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be less than 90 degrees. The conduit may be of approximately circular cross-section. In another form, the conduit may have an oval or rectangular cross-section.

Frame: Frame means that a mask structure is held in tension between two or more connection points to the headband. A nasal mask frame can be a non-sealed load-bearing structure in the mask. However, some nasal mask frames may also be airtight.

Headgear: Headgear refers to a positioning and stable structural form designed for use on the head. Preferably, the headband includes one or more compression-resistant members, fasteners and reinforcements, the structure of which is Place and maintain the patient interface in position on the patient's face for delivery of respiratory therapy. Some headbands are made from soft, stretchy, and elastic materials, such as laminated composites of foam and fabric.

Membrane: Membrane refers to a typical thin component that is essentially unable to withstand bending but can prevent stretching.

Plenum Chamber: A mask plenum means the portion of the patient interface with walls that encloses a volume of space in which the pressure of the volume of air contained therein exceeds atmospheric pressure during use. An outer cover may 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 a structure or barrier that prevents air from flowing through the interface between two surfaces; alternatively, seal means preventing air from flowing through.

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

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

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

Swivel: A subassembly of components configured to rotate about a common axis, preferably independently, specifically under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of air delivery ducts, the subassembly of the assembly preferably includes mating cylindrical ducts. Specifically, there is no leakage of air flow from the swivel when in use.

Tie: A tie is a structural component designed to withstand tension.

Vent: A structure that allows air to flow from the interior of the mask or duct to the ambient air at a deliberately controlled leak rate to exhaust carbon dioxide (CO ₂ ) of exhaled gas and supply oxygen (O ₂ ).

About the terminology used in the patient interface

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

Floppy: The quality of a material, structure, or composite that combines the following characteristics:

- Easily conforms to finger pressure.

- Unable to maintain its shape when trying to support its own weight.

- Not hard.

- It can be elastically stretched or bent with a small amount of force.

Flexible qualities can have an associated direction, so that a particular material, structure or composite can be flexible in a first direction but rigid or stiff in a second direction, for example a second direction perpendicular to the first direction.

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

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

Semi-rigid: means stiff enough to not substantially distort under the effects of the mechanical forces typically exerted during positive pressure ventilation therapy.

5. Other supplementary instructions

The disclosure of this patent document contains material subject to copyright protection. The copyright owner has no objection to the facsimile reproduction of any of the patent documents or patent disclosure portions, as they appear in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright rights whatsoever.

Unless this specification expressly indicates and provides various values, it will be understood that each intervening value between the upper and lower limits of the range (to one-tenth of the unit of the lower limit) is the same as the value within the stated range. Any other specified values within or intermediate values are covered by this technology. The upper and lower limits of these intervening ranges (which may be individually included in the intervening ranges) are also encompassed by the technology (subject to any specific exclusions within the stated ranges). Where the stated range includes one or both 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 numerical value described in this specification is implemented as part of the present technology, unless otherwise stated, the value may be an approximate value, and the value may be used for any purpose permitted or required by an actual technical implementation. Appropriate significant figures.

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

When a particular material is deemed best for use in constructing a component, it is obvious that alternative materials with similar properties may be used instead. Furthermore, unless specified to the contrary herein, it is understood that any and all components described herein may be manufactured, either together or individually.

It must be noted that when used in this specification and the following claims, the singular forms "a", "the" and "the" include plural equivalents unless expressly stated otherwise.

All patents mentioned in this specification are incorporated by reference for the purpose of disclosing and describing the methods and/or materials that are the subject matter of such patents. The publications discussed in this specification are provided solely for the purpose of disclosing publications prior to the filing date of this application. It is not to be construed as an admission that the present technology does not antedate these disclosures by reason of prior invention. In addition, the publication date provided may differ from the actual publication date and may require separate confirmation.

The subject matter included in the embodiments is provided for ease of reference by the reader and is not intended to limit the subject matter disclosed or claimed. The subject title should not constitute the scope of the patent application or limit the scope of the patent application.

Although the technology is described herein with reference to specific examples, it should be understood that these examples are only illustrative of the principles and applications of the technology. In some instances, terms and symbols may refer to specific details that are not required to implement the technology. For example, although the terms "first" and "second" may be used, these do not imply any order unless otherwise specified, but are instead used to distinguish between different elements. Furthermore, although the processing steps in a method may be described or exemplified in an order, they are not necessarily required to be in this order. Those skilled in the art will understand that this sequence may be modified and/or aspects thereof may be executed concurrently or even simultaneously.

Accordingly, it is to be understood that many modifications may be made to the illustrative examples and other configurations may be devised without departing from the spirit and scope of the technology.

3000:Patient Interface

3100: Seal forming structure

3200:Inflatable chamber

3300: Positioning and Stabilizing Structures

3304:Headband

3306:Left head piece

3308: Right head piece

3310: Neck piece

3312: Upper drawstring

3314: Upper drawstring

3316:Lower strap

3318:Lower strap

3320:Hook

3371: Holding arm

3372:Lower attachment point

3377: Elastic connection structure

3380:Hook

3381: Holding arm

3387: Elastic connection structure

3400: Ventilation port

3500: Decoupling structure

3600: connection port

3800: Anti-suffocation parts

Claims (19)

A patient interface system for treating respiratory disorders in patients, the patient interface system includes: a patient interface; a positioning and stabilizing structure including a pair of upper straps; and A patient interface frame connects the patient interface to the positioning and stabilizing structure, the patient interface frame includes a pair of retaining arms with a plurality of attachment points for removably attaching the pair of upper straps, and the patient interface frame further including a pair of lower attachment points for removably attaching a respective lower strap, the lower attachment points being connected to the patient interface frame from the pair of retaining arms; Wherein, each holding arm is connected to the patient interface frame at a connection point such that each holding arm rotates around an axis substantially perpendicular to the patient's eye-ear level (Frankfort Horizontal Plane); and Wherein, when the patient wears the patient interface, the pair of upper straps are substantially parallel to the patient's eye-ear plane. The patient interface system of claim 1, wherein the patient interface further includes an air chamber and a seal-forming structure. The patient interface system of claim 2, wherein the inflatable chamber and the seal-forming structure are formed into one piece. The patient interface system of claim 2, wherein the plenum includes a hard material that is harder than the seal-forming structure. The patient interface system of claim 2, wherein the plenum includes polycarbonate and the seal-forming structure includes silicone. The patient interface system of claim 2, wherein the plenum includes at least one plenum retention feature. The patient interface system of claim 6, wherein the patient interface frame includes at least one patient interface frame retention feature, each patient interface frame retention feature configured to engage with the at least one plenum retention feature A corresponding one is detachably connected, and the patient interface frame is detachably attached to the plenum. The patient interface system of claim 7, wherein the plenum includes four plenum retention features and the patient interface frame includes four corresponding patient interface frame retention features. The patient interface system of claim 2, wherein the patient interface frame and the inflatable chamber are detachably attached by a hard-to-hard connection. The patient interface system of claim 2, wherein the patient interface frame is detachably connected to the plenum around the periphery of the plenum. The patient interface system of claim 2, wherein the positioning and stabilizing structure further includes a pair of lower straps, and when the pair of lower straps are attached to the lower attachment points, the lower attachment points are used for the pair of lower straps. The band is located in a plane substantially parallel to the patient's eye and ear level. The patient interface system of claim 11, wherein each of the pair of upper straps and each of the pair of lower straps include a loop portion of loop material and a hook portion of hook material for attachment At the distal end of each of the pair of upper straps and each of the pair of lower straps. The patient interface system of claim 12, 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. Correspondingly, the hook portion of each individual strap is removably attached to the loop portion of the strap. The patient interface system of claim 13, wherein each of the loop portions is wider than each of the hook portions such that when each of the hook portions is attached to its corresponding loop portion, the loop portion protects the patient The skin is not affected by this hook. The patient interface system of claim 1, wherein the patient interface includes a full face mask. The patient interface system of claim 1, wherein the patient interface does not include a forehead support. The patient interface system of claim 1, wherein the positioning and stabilizing structure includes a cranial strap for engaging the parietal bones of the patient's skull. The patient interface system of claim 1, wherein the positioning and stabilizing structure includes a neck member for engaging the occipital bone of the patient's head. The patient interface system of claim 1, wherein the holding arms are more elastic in a plane substantially parallel to the patient's eye and ear level than in a plane substantially perpendicular to the patient's eye and ear level.