Headgear for patient interface

Abstract

To provide a headgear for a patient interface relating to one or more of screening diagnosis, monitoring, treatment, prevention and improvement of respiratory-related diseases.SOLUTION: A positioning and stabilizing structure comprising at least one gas delivery tube to receive the flow of air from a connection port on top of a patient's head and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, the at least one gas delivery tube comprising a tube wall having an extendable concertina structure comprising a plurality of folds in the tube wall alternatingly forming a plurality of ridges and a plurality of grooves, the at least one gas delivery tube, where the folds able to be at least partially unfolded to increase a separation of the ridges to elongate the extendable concertina structure; and one or more ridge connecting portions provided to the tube wall, each of the one or more ridge connecting portions connecting two or more adjacent ridges of the plurality of ridges and the one or more ridge connecting portions being configured to resist the separation of the ridges.SELECTED DRAWING: Figure 8A

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims the benefit of Australian Provisional Application No. 62 / 764,995, filed on August 20, 2018, the content of which is incorporated herein by reference.

[0002] Part of the disclosure of this patent document contains content that is given copyright protection. The copyright owner has no objection if anyone reproduces this patent document or this patent disclosure by fax, provided that it is as described in the patent files or records of the Patent Office and for the purpose intended, but retains all copyrights for other purposes.

Background Art

[0003] 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

[0004] 2.2 Description of related technologies 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0005] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchioles constitute the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0006] There are a range of respiratory diseases. Certain diseases can be characterized by specific presentations (e.g., apnea, hypopnea, and hyperventilation).

[0007] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disease.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by presentations such as closure or obstruction of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue area, and the normal loss of the soft palate and posterior oropharyngeal wall during sleep. Due to such a condition, the respiratory arrest of affected patients typically lasts for 30 - 120 seconds, and sometimes the breathing stops 200 - 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular diseases and brain damage. This syndrome is a common disease, especially common in middle-aged overweight men, but patients have no awareness of the symptoms. See Patent Document 1 (Sullivan).

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of the patient's respiratory controller, in which alternating periods of increasing and decreasing ventilation, known as the CSR cycle, occur periodically. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to the repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive sleep arousals that cause severe insomnia, increased sympathetic activity, and increased afterload. See Patent Document 2 (Berthon-Jones).

[0010] Respiratory insufficiency is a general term for respiratory disorders and refers to the inability of the lungs to perform sufficient oxygen inhalation or sufficient CO2 exhalation to meet the patient's needs. Respiratory insufficiency may include some or all of the following diseases.

[0011] Patients with respiratory insufficiency (a type of respiratory disorder) may experience abnormal shortness of breath during exercise.

[0012] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during wakefulness in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) includes any of a group of lower airway diseases that have certain common characteristics. These include an increase in resistance to the movement of air, an extended expiratory phase of breathing, and a decrease in normal elasticity in the lungs. Examples of COPD are emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0014] Neuromuscular diseases (NMDs) are a broad term encompassing a number of disorders and diseases that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Among NMD patients, some are characterized by progressive muscle impairment, which ultimately leads to inability to walk, confinement to a wheelchair, dysphagia, reduced respiratory muscle strength, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified into the following two categories: rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle impairment that worsens over several months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders: characterized by muscle impairment that worsens over several years and only slightly reduces the average life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMDs include increased general debility, dysphagia, dyspnea on exertion and at rest, fatigue, drowsiness, headache on waking, and difficulty with concentration and mood changes.

[0015] Chest wall disorders are a group of thoracic deformities that cause ineffectiveness of the connection between the respiratory muscles and the thoracic cage. These disorders are mainly characterized by restrictive disorders and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may develop severe respiratory failure. Symptoms of respiratory failure include dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, headache on waking, fatigue, reduced quality of sleep, and loss of appetite.

[0016] To treat or improve such conditions, a range of treatments are being used. Additionally, in other respects, healthy individuals can also benefit from preventive treatment for respiratory diseases. However, these have several drawbacks.

[0017] 2.2.2 Treatment methods A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are being used for the treatment of one or more of the above respiratory diseases.

[0018] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue to advance or retract towards the posterior oropharyngeal wall, continuous positive pressure ventilation therapy functions as an air sprint, thereby preventing upper airway closure. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following regarding the device used for treatment delivery, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, lack of aesthetic appeal.

[0019] Non-invasive ventilation (NIV) provides ventilation assistance to a patient through the upper airway and performs part or all of the respiratory function to provide respiratory assistance to the patient and / or maintain an appropriate oxygen level in the body. The ventilation assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] Invasive ventilation (IV) provides ventilation assistance to a patient who is no longer able to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0021] 2.2.3 Treatment System These treatments can be provided by a treatment system or device. Such systems and devices can also be used for screening, diagnosis, or monitoring without treating the disease.

[0022] The treatment system can include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0023] Another form of treatment system is a mandibular repositioning device.

[0024] 2.2.3.1 Patient Interface The patient interface can be used to provide an interface to the wearer to the breathing apparatus, for example by providing an air flow to the airway inlet. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can form a seal with, for example, the area of the patient's face, thereby promoting gas delivery at a sufficient distributed pressure together with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the atmospheric pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to promote the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O. In some cases, other specific mask systems may be functionally inappropriate in this field. For example, in the case of a mask for purely decorative purposes, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the ambient pressure.

[0025] Certain other masks may be clinically unfavorable in this technology (e.g., when the mask blocks the air flow through the nose and only allows the air flow through the mouth).

[0026] In some specific masks, it may be unpleasant or impractical in this technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal through the lips.

[0027] In some specific masks, it may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on the pillow).

[0028]

[0029] ​There are several challenges in the design of patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory treatment.

[0030] Due to these challenges, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the reasons such as overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic administration mask can withstand their original uses, but in such cases of masks, they may be unacceptably uncomfortable for long-term (e.g., several hours) wearing. Due to such discomfort, the patient's compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0031] CPAP treatment is extremely effective in the treatment of certain respiratory diseases when the patient agrees to the treatment. If the mask is uncomfortable or difficult to use, the patient may not agree to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's compliance.

[0032] Masks designed for the treatment of sleep apnea may be suitable for other uses in some cases, as masks for other uses (e.g., pilots) may not be suitable for the treatment of sleep apnea.

[0033] For these reasons, patient interfaces for CPAP delivery during sleep define a distinct area. to form.

[0034] 2.2.3.1.1 Seal - forming structure The patient interface may include a seal - forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal - forming structure can directly affect the effectiveness and comfort of the patient interface.

[0035] The patient interface can be partially characterized according to the design intent of where the seal - forming structure engages with the face during use. In one form of the patient interface, the seal - forming structure can include a first sub - portion for forming a seal around the left nostril and a second sub - portion for forming a seal around the right nostril. In one form of the patient interface, the seal - forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed to rest, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal - forming structure can include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal - forming structure can include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces can be known by various names such as nasal masks, full - face masks, nasal pillows, nasal puffs, and oro - nasal masks by their manufacturers.

[0036] A seal - forming structure that may be effective in one area of the patient's face may be inappropriate in another area, for example, due to different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of a swimming goggle placed on the patient's forehead may be inappropriate for use on the patient's nose.

[0037] Certain seal-forming structures can be designed for mass production to fit one design over a wide range of different face shapes and sizes and be comfortable and effective. To form a seal, it is necessary to conform one or both of the patient's face shape and the seal-forming structure of the mass-produced patient interface to the extent of any mismatch between them.

[0038] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when a force is applied to the patient interface with the seal-forming structure engaged against the patient's face. This seal-forming structure can include an air or fluid-filled cushion or can include a molded or formed surface of an elastic sealing element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inappropriate, a gap can occur between the seal-forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0039] Another type of seal-forming structure uses a thin flap seal located around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previously described type of seal-forming portion, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal or leakage may occur from the mask. Further, if the shape of the seal-forming structure does not match the patient's shape, creases or buckling can occur in the seal-forming portion during use, causing leakage.

[0040] Another type of seal-forming structure can include friction fit elements that are inserted into, for example, the nostrils, although there are patients who find these seal-forming portions uncomfortable.

[0041] Another form of seal-forming structure can use an adhesive portion to achieve a seal. Among patients , there are also patients who always feel it inconvenient to stick or remove the adhesive portion to or from their face.

[0042] Regarding the technology of a patient interface seal formation structure within a certain range, there is a disclosure in (the following patent applications assigned to ResMed Limited: Patent Document 3; Patent Document 4; Patent Document 5).

[0043] One form of nasal pillows can be found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of Patent Document 6 (Trimble et al.) assigned to the Puritan - Bennett Corporation.

[0044] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask and MIRAGE LIBERTY® Full Face Mask. In the following patent applications assigned to ResMed Limited, there are descriptions of embodiments of nasal pillow masks: Patent Document 7 (particularly, describing the appearance of ResMed Limited's SWIFT® nasal pillow); Patent Document 8 (particularly, describing the appearance of ResMed Limited's SWIFT® LT nasal pillow); Patent Documents 9 and 10 (particularly, describing the appearance of ResMed Limited's MIRAGE LIBERTY® full face type mask); Patent Document 11 (particularly, describing the appearance of ResMed Limited's SWIFT® FX nasal pillow).

[0045] 2.2.3.1.2 Positioning and Stabilization The seal formation structure of a patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that interfere with sealing. Therefore, various techniques are used to position the seal formation structure and maintain the seal against the appropriate part of the face.

[0046] In one technique, an adhesive portion is used. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, when an adhesive portion is used, there may be discomfort.

[0047] In another technique, one or more straps and / or stabilization harnesses are used. In the case of a number of such harnesses, one or more of the following apply: poor fit, bulky, uncomfortable, and difficult to handle.

[0048] 2.2.3.1.3 Conduit for Pressurized Air In one type of treatment system, the flow of pressurized air is provided to the patient interface through a conduit in an air circuit. This conduit fluidly connects to the patient interface such that when the patient interface is positioned on the patient's face during use, the conduit extends away from the patient's face in a forward direction from the patient interface. This can sometimes also be referred to as an "elephant trunk" type interface.

[0049] Some patients find such an interface obstructive, and as a result, if they stop wearing it, patient compliance decreases. Further, when a conduit is connected to the interface in front of the patient's face, it may be prone to entanglement with bedding.

[0050] 2.2.3.1.4 Conduit for Pressurized Air Used for Positioning / Stabilizing the Seal Formation Structure In a patient interface included in another type of treatment system attempting to address these problems, the tube responsible for delivering pressurized air to the patient airway is the seal of the patient interface. The flange forming portion also functions as part of a headgear for positioning and stably arranging it on an appropriate part of the patient's face. This type of patient interface may also be referred to as using "headgear tubing" or "tubing headgear". When using such a patient interface, a conduit in the air circuit that provides a pressurized air flow from a respiratory pressure therapy device can be provided to the patient interface located at a position other than in front of the patient's face. An example of such a treatment system is disclosed in Patent Document 12. The content of this document is incorporated herein by reference. In this document, the conduit is connected to a tube in the patient interface through a port positioned on top of the patient's head during use.

[0051] The Philips DreamWear® mask includes such headgear tubing. The length of the DreamWear® headgear tube cannot be adjusted. Therefore, the DreamWear® headgear is supplied in three different sizes to accommodate patients with different face sizes. An increase in the number of different sizes can lead to an increase in the complexity and cost of manufacturing the headgear and may lead to an increase in the size of the packaging. Furthermore, when supplying masks of different sizes, the range of patients with different head sizes that can be accommodated may be limited. If a certain number of patients are required to forcibly select an individual size with non-adjustable length, there is a high possibility that the patient may not be able to achieve a fit that the patient himself / herself feels is "perfect".

[0052] When using a patient interface with headgear tubing, several advantages can be obtained (for example, avoiding a conduit that connects to the patient interface in front of the patient's face, which may be obstructive and uncomfortable). However, a patient interface with headgear tubing is desirably comfortable while forming an effective seal with the patient's face when the patient wears it for a long time while sleeping.

[0053] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device A respiratory pressure therapy (RPT) device can be used individually for the delivery of one or more of the above-described therapies or as part of a system, for example, by operating the device to generate an air delivery flow to an interface to the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0054] Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical use have specific requirements that are not satisfied by more general air pressure generators (e.g., reliability requirements, size requirements, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0055] An example of a special requirement for a particular RPT device is acoustic noise.

[0056] Designers of devices can be presented with countless options. Since design criteria often conflict with each other, certain design options may be far from convention or unavoidable. Furthermore, the comfort and effectiveness of certain aspects can also be greatly affected by minor changes in one or more parameters.

[0057] 2.2.3.3 Humidifier If the delivery of the air flow is carried out without humidification, it can lead to drying of the airway. When a humidifier is used with an RPT device and a patient interface, a humidified gas is generated, thus minimizing drying of the nasal mucosa and increasing the comfort of the patient's airway. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface results in higher comfort than in the case of cold air. Higher comfort.

[0058] A range of artificial humidification devices and systems are known, but they do not meet the special requirements of medical humidifiers.

[0059] Medical humidifiers are typically used to increase the humidity and / or temperature of an air flow relative to the ambient air when a patient is asleep or at rest (e.g., in a hospital), if necessary. Medical humidifiers placed at the head of a pillow may be small. A medical humidifier may be configured to only humidify and / or heat the air flow delivered to the patient and not humidify and / or heat the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air taken into the patient's body by breathing, but in the case of these systems, since the entire room is also humidified and / or heated, it can be uncomfortable for the occupants. Furthermore, in the case of medical humidifiers, there may be more stringent safety restrictions than industrial humidifiers.

[0060] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more defects. That is, in the case of such medical humidifiers, some may have inappropriate humidification, while others may be difficult or inconvenient for patients to use.

[0061] 2.2.3.4 Data Management For clinical reasons, it may be necessary to obtain data to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is following one or more "compliance rules" with their RPT device). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient must use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's compliance, a provider of the RPT device (e.g., a healthcare provider) may obtain data describing the patient's treatment with the RPT device manually, calculate the usage rate over a given period, and compare this to the compliance rule. If the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0062] In a patient's treatment, there may be other ways to benefit from communicating treatment data to a third party or an external system.

[0063] In the case of existing processes for communicating and managing such data, one or more of high cost, time consumption, and susceptibility to errors may occur.

[0064] 2.2.3.5 Mandibular Repositioning A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other providers that holds the mandible (lower jaw) in a forward position during sleep. The MRD is a removable device that is inserted into the mouth before the patient goes to sleep and removed after sleep. Therefore, the MRD is not designed for continuous wear applications. The MRD may be custom-made or manufactured in a standard form and includes an occlusal impression site designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension to the pharyngeal wall to reduce airway collapse and reduce palatal vibration.

[0065] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or fit with teeth on the maxilla or maxilla bone, and a lower splint intended to engage or fit with teeth on the maxilla or mandible. The upper splint and the lower splint are laterally connected to each other via a pair of connecting rods. This set of connecting rods is symmetrically fixed on the upper splint and the lower splint.

[0066] In such a design, the length of the connecting rod is selected such that the mandible is held in a forward position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the level of protrusion of the mandible. The dentist can determine the level of protrusion according to the mandible, and as a result, the length of the connecting rod is determined.

[0067] There are also MRDs configured to push the mandible forward relative to the maxilla bone, and there are those designed to hold the mandible in a forward position, such as other MRDs like the ResMed Narval CC (registered trademark) MRD. This device also reduces or minimizes dental side effects and side effects of the temporomandibular joint (TMJ) between the temple and the mandible. Therefore, this device is configured to minimize or avoid any movement of one or more of the teeth.

[0068] 2.2.3.6 Ventilation technology Some forms of treatment systems may include a ventilation section for expelling the exhaled carbon dioxide. This ventilation section may enable a gas flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0069] This ventilation section may include an orifice, and when using a mask, gas can flow through the orifice. In the case of a number of such ventilation sections, the sound is noisy. In other cases, it may be blocked during use, resulting in insufficient extrusion. In the case of some ventilation sections, for example, due to sound or airflow concentration, it may interfere with the sleep of patient 1000 and co-sleeper 1100.

[0070] ResMed Limited has developed a number of improved mask ventilation technologies. See the following: Patent Document 13; Patent Document 14; Patent Document 15; Patent Document 16; Patent Document 17. Table of noises of conventional masks (ISO17510-2:2007, at 1 m under a pressure of 10 cmH2O)

[0071]

Table 1

[0072] (*Measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample) List the sound pressure values of various subjects as follows

[0073]

Table 2

[0074] 2.2.4 Screening, diagnostic system and monitoring system A polysomnogram (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary diseases, and typically requires specialized clinical staff for system application in many cases. In a PSG, typically 15 to 20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram recording (EOG), electromyography (EMG)). For PSG of sleep disordered breathing, patients needed to be observed in a specialized hospital for two nights. That is, the first night was for pure diagnosis, and the second night was necessary for the titration of treatment parameters by a clinician. Therefore, PSG is costly and has low convenience. Screening / diagnosis / monitoring of sleep disordered breathing is particularly unsuitable at home.

[0075] Generally, screening and diagnosis are to identify a disease based on the signs and symptoms of the disease. Usually, screening gives a true / false result indicating whether the patient's SDB warrants further investigation, while diagnosis often provides clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the course of a disease can be continued indefinitely. Some screening / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0076] Clinical experts can appropriately perform patient screening, diagnosis, or monitoring based on visual observation of PSG signals. However, there are situations where there is no clinical expert or payment to a clinical expert is not possible. Opinions of clinical experts may vary regarding the patient's condition. Furthermore, some clinical experts may apply different criteria depending on the time.

Prior Art Documents

Patent Documents

[0077]

Patent Document 1

Patent Document 2

[0078] Brief Description of the Technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, improving, treating or preventing respiratory diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0079] A first aspect of the present technology relates to an apparatus for use in screening, diagnosing, monitoring, improving, treating or preventing respiratory diseases.

[0080] Another aspect of the present technology relates to a method for use in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0081] One aspect of a particular form of the present technology is to provide a method and / or apparatus for improving patient compliance with respect to respiratory therapy.

[0082] One aspect of the present technology includes a patient interface for delivering a supply of pressurized breathable gas to the entrance of a patient airway.

[0083] Another aspect of the present technology relates to a patient interface that may include a plenum chamber, a seal-forming structure, and a positioning and stabilization structure. The patient interface may further include a ventilation structure. The patient may be further configured to be in a mother-like state with the patient's oral cavity exposed, or, when the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may be further configured to allow the patient to breathe from the atmosphere through the patient's oral cavity when there is no pressurized air flow through the plenum chamber inlet port.

[0084] Another aspect of the present technology relates to a patient interface including a plenum chamber, a seal-forming structure, a ventilation structure, and a positioning and stabilization structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. At least one gas delivery tube for receiving an air flow from a connection port and delivering the air flow through the seal-forming structure to an inlet of the patient's airway, the gas delivery tube being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use, the positioning and stabilization structure including at least one gas delivery tube.

[0085] According to one aspect of the present technology, a positioning and stabilization structure is provided that provides a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway for delivering an air flow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilization structure comprising: At least one gas delivery tube for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet of the patient's airway, the gas delivery tube being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use, the gas delivery tube comprising at least one gas delivery tube, the gas delivery tube: A tube wall defining a hollow interior through which air can flow from the interior to the seal-forming structure, the tube wall having an extensible portion configured to extend to vary the length of the gas delivery tube, The extensible portion having a tensile stiffness in the range of 0.2 to 0.35 N / mm, the gas delivery tube including the tube wall.

[0086] ​In any embodiment of any aspect of the foregoing paragraphs: (a) the extension stiffness of the extensible portion is in the range of 0.25 to 0.3 N / mm; (b) the pair of gas delivery tubes includes a combined unstretched length that is in the range of 500 to 535 mm, measured along the centerline of the side of the pair of tubes configured to face the patient during use; (c) the combined unstretched length is in the range of 510 to 525 mm; (d) the combined unstretched length is in the range of 512 to 522 mm; (e) the pair of gas delivery tubes includes a combined unstretched length that is in the range of 460 to 500 mm, measured along the centerline of the side of the pair of tubes configured to face the patient during use; (f) the combined unstretched length is in the range of 470 to 490 mm; (g) the combined unstretched length is in the range of 475 to 485 mm; (h) the gas delivery tube forms a loop around the patient's head together with the cushion module, and the loop has an inextensible length measured along the centerline of the side of the gas delivery tube and a cushion module configured to face the patient within the range of 510 to 610 mm during use; (i) the unstretched length of the loop is in the range of 528 to 548 mm; (j) the unstretched length of the loop is in the range of 535 to 541 mm; (k) the unstretched length of the loop is in the range of 534 to 554 mm; (l) the unstretched length of the loop is in the range of 539 to 549 mm; (m) the unstretched length of the loop is in the range of 541 to 561 mm; (n) the unstretched length of the loop is in the range of 546 to 556 mm; (o) the unstretched length of the loop is in the range of 564 to 584 mm; (p) the unstretched length of the loop is in the range of 571 to 581 mm; (q) the unstretched length of the loop is in the range of 577 to 597 mm; and / or (r) the unstretched length of the loop is in the range of 582 to 592 mm.

[0087] According to one aspect of the present technology, a positioning and stabilization structure is provided that provides a force for holding a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway for delivering an air flow at a treatment pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilization structure comprising: at least one gas delivery tube for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet of the patient's airway, the at least one gas delivery tube being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use, the at least one gas delivery tube comprising: an upper tube portion configured to be placed on an upper region of the patient's head during use, the upper tube portion comprising: a first end configured to be placed on an upper portion of the patient's head in or near the sagittal plane of the patient's head during use; a second end configured to be placed on a side portion of the patient's head during use; and a rigid portion between the first end and the second end, the rigid portion being configured to provide a higher resistance in the front and / or rear direction than in the up and / or down direction against relative movement between the first end and the second end during use and; an upper tube portion including the rigid portion, and a lower tube portion connected between the second end of the upper tube portion and the seal-forming structure, the gas delivery tube including the upper tube portion and the lower tube portion.

[0088] In any embodiment of any aspect of the foregoing paragraphs: (a) each upper tube portion includes two rigid portions; (b) the rigid portions are provided on one or both of the side portions of the upper tube portion configured to come forward during use and the side portions of the upper tube portion configured to come backward during use; (c) the upper tube portion includes an extendable portion; (d) the extendable portion includes an extendable bellows structure formed within the tube wall of the gas delivery tube; (e) the extendable bellows structure includes a plurality of folds within the tube wall, alternately forming a plurality of ridges and a plurality of grooves; (f) the rigid portions include a plurality of connecting portions within the tube wall, and each of the plurality of connecting portions connects a pair of adjacent ridges; and / or, (g) the rigid portions are integrally formed with the upper tube portion.

[0089] According to one aspect of the present technology, a positioning and stabilization structure is provided that provides a force for holding a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway for delivering an air flow at a treatment pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilization structure including: at least one gas delivery tube for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet of the patient's airway, the gas delivery tube being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use, the at least one gas delivery tube including a tube wall having an extendable bellows structure, the extendable bellows structure including: a plurality of folds within the tube wall in which a plurality of ridges and a plurality of grooves are alternately formed, the folds being at least partially deployable to increase the separation of the ridges and elongate the extendable bellows structure; and one or more ridge connection portions provided to the tube wall, each of the one or more ridge connection portions connecting two or more adjacent ridges of the plurality of ridges and being configured to withstand the separation of the ridges, including a gas delivery tube including an extendable bellows structure.

[0090] In any embodiment of any aspect of the foregoing paragraphs: (a) each pair of adjacent ridges is connected by at least one ridge connection part of one or more ridge connection parts; (b) more than one pair of adjacent ridges is connected by two ridge connection parts; (c) each pair of adjacent ridges is connected by two ridge connection parts; (d) one or more of the ridge connection parts are disposed on the side of the gas delivery tube configured to face forward during use; (e) one or more of the ridge connection parts are disposed on the side of the gas delivery tube configured to face backward during use; (f) each ridge connection part is centrally spaced between the side of the gas delivery tube configured to face downward during use and the side of the gas delivery tube configured to face upward during use; (g) each pair of adjacent ridges is connected by one of the ridge connection parts disposed on the side of the gas delivery tube configured to face forward during use; (h) each pair of adjacent ridges is connected by one of the ridge connection parts disposed on the side of the gas delivery tube configured to face backward during use; (i) the gas delivery tube includes a non-extendable portion having an outer surface, and each of the plurality of groove portions is formed as a depression with respect to the outer surface of the non-extendable portion; (j) the gas delivery tube includes a non-extendable portion having an outer surface, and each of the plurality of ridges is raised with respect to the outer surface of the non-extendable portion; (k) each of the plurality of groove portions is disposed between each pair of ridge connection parts, and each ridge connection part of the pair of ridge connection parts is disposed at each end of each groove portion; (l) each of the plurality of groove portions includes a groove depth, and each of the plurality of ridge connection parts includes a height of the ridge connection part, and the groove depth of each respective groove portion is equal to the height of each ridge connection part of each pair of ridge connection parts disposed at the ends of each groove portion; (m) each ridge connection part is an integrally formed part of the tube wall; (n) the plurality of ridges, the plurality of groove portions and the plurality The number of bump connection parts is integrally formed; (o) each of the plurality of bumps includes a curved bump part at the center of each bump; (p) each of the plurality of groove parts includes a curved groove part at the center of each groove part; (q) each of the plurality of bumps includes a pair of linear bump parts provided at opposite ends of each bump; (r) each of the plurality of bump connection parts connects to each adjacent pair of bumps at the linear bump parts of the bumps; (s) the cross-section of the gas delivery tube in the extendable bellows structure has a width and a height, the width is substantially aligned in the forward-backward direction during use, and the width is greater than the height; (t) the width is at least twice the height; and / or (u) the positioning and stabilization structure includes two gas delivery tubes fluidly connected between the connection port and the seal formation structure, each gas delivery tube extends in one of the patient's cheek regions during use, and the two gas delivery tubes are provided on different sides of the patient's head.

[0091] According to one aspect of the present technology, a positioning and stabilization structure is provided that provides a force for holding a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure is constructed and arranged to form a seal with an area of the patient's face surrounding an inlet to the patient's airway in order to deliver an air flow at a treatment pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilization structure includes at least one gas delivery tube for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet of the patient's airway. The gas delivery tube is constructed and arranged to contact at least one area of the patient's head above the superior tragus of the patient's head during use. The at least one gas delivery tube includes a tube wall having a hollow interior and an extensible bellows structure provided along the length of the gas delivery tube. The extensible bellows structure includes a first alternating series of ridges and grooves along the non-patient contact side of the gas delivery tube and a second alternating series of ridges and grooves along the patient contact side of the gas delivery tube. The extensible bellows structure includes a plurality of folds within the tube wall, and the tensile stiffness of the first alternating series of ridges and grooves is lower than that of the second alternating series of ridges and grooves. The gas delivery tube includes an extensible bellows structure including a plurality of folds.

[0092] In an embodiment, (a) due to a plurality of folds, an internal raised portion and an internal groove portion are formed inside the gas delivery tube, forming a first alternating series of raised portions and groove portions and a second alternating series of raised portions and groove portions; (b) the internal groove portions of the first alternating series are each provided across the inside of the gas delivery tube on the opposite side of each one of the internal groove portions of the second alternating series, forming a plurality of pairs of opposing groove portions, and each pair of opposing groove portions includes a first internal groove portion that is a first internal groove portion of the first alternating series and a second internal groove portion that is a second internal groove portion of the second alternating series. The groove depth of the first internal groove portion is greater than that of the second internal groove portion; (c) in the tube wall, the material thickness at the base of the second internal groove portion of each pair of opposing groove portions is greater than the material thickness at the base of the first internal groove portion of each pair of opposing groove portions; (d) the material thickness of the tube wall at the base of each internal groove portion of the second alternating series decreases from a first end close to the connection port to a second end along the length of the gas delivery tube; (e) the material thickness of the tube wall at the base of each internal groove portion of the first alternating series is substantially constant along the length of the gas delivery tube; (f) the groove depths of the internal groove portions of the first and second alternating series of internal raised portions and internal groove portions decrease from a first end adjacent to the connection port to a second end along the length of the gas delivery tube; and / or (g) the first internal groove portion of each pair of opposing groove portions is joined to the second internal groove portion of each pair of opposing groove portions on the side of the gas delivery tube between the non-patient contact side and the patient contact side.

[0093] According to one aspect of the present technology, a positioning and stabilization structure is provided that provides a force for holding a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure surrounding an inlet to the patient's airway for delivering an air flow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. Constructed and arranged to form a seal with the facial region of a patient, the positioning and stabilization structure comprising: a pair of gas delivery tubes for receiving an air flow from a connection port on the patient's head and delivering the air flow through a seal-forming structure to an inlet of the patient's airway, each of the pair of gas delivery tubes being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head in use, each gas delivery tube comprising: a tube wall defining a hollow interior along the length of the gas delivery tube; a tab connected to the tube wall, the tab being configured to be positioned above the upper ear base point of the patient's head in use; and a slit formed in the tab, the slit being positioned rearwardly spaced from the tube wall in use, the slit including an upper end and a lower end, the upper end of the slit being positioned further spaced from the tube wall than the lower end of the slit; and a strap constructed and arranged to contact a region of the patient's head positioned below the occipital bone of the patient's head or positioned on the occipital bone of the patient's head in use, the strap being configured to be connected to and between the slits.

[0094] In any example of any aspect of any of the foregoing paragraphs: (a) each tab is integrally formed with each pipe wall; (b) each tab has an upper edge and a lower edge, and the upper edge is longer than the lower edge; (c) the lower end of the slit is disposed at a distance of at least 5 mm from the pipe wall; (d) the lower end of the slit is disposed at a distance of at least 7 mm from the pipe wall; (e) the lower end of the slit is disposed at a distance of 8 mm or more from the pipe wall; (f) the upper end of the slit is disposed at a distance of at least 8 mm from the pipe wall; (g) the upper end of the slit is disposed at a distance of at least 10 mm from the pipe wall; (h) the upper end of the slit is disposed at a distance of 12 mm or more from the pipe wall; (i) the midpoint along the slit is disposed at a distance in the range of 5 mm to 30 mm from the pipe wall; (j) the distance is in the range of 7 mm to 20 mm; (k) the distance is in the range of 8 mm to 15 mm; (l) the distance is in the range of 9 to 11 mm; (m) each gas delivery tube includes an extendable tube portion disposed above the tab of each gas delivery tube during use and a non-extendable tube portion disposed below the tab of each gas delivery tube during use; and (n) each tab is joined to the pipe wall of each gas delivery tube in the non-extendable tube portion; (o) each slit is arcuate between the upper end and the lower end; (p) each slit is linear between the upper end and the lower end; and / or (q) each slit is oriented perpendicular to the direction from the slit in the strap anchor region where the strap is anchored around the patient's head.

[0095] According to one aspect of the present technology, a positioning and stabilization structure is provided that provides a force for holding a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face surrounding an inlet to the patient's airway for delivering an air flow at a treatment pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilization structure comprising: a pair of gas delivery tubes for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet of the patient's airway, each of the pair of gas delivery tubes being constructed and arranged to contact at least one area of the patient's head above the upper ear base point of the patient's head during use; each gas delivery tube comprising: a tube wall configured to be disposed on the patient's head along a path extending between the patient's eyes and ears from an upper portion of the patient's head to the seal-forming structure during use; a tab connected to the tube wall, the tab being configured to be disposed above the upper ear base point of the patient's head during use; and a slit formed in the tab and disposed rearwardly spaced from an adjacent portion of the slit of the path of the tube wall during use, the slit having a posterior-upper to anterior-lower orientation during use and forming an oblique angle with a tangent to the path of the tube wall at the adjacent portion of the slit; and a strap constructed and arranged to contact an area of the patient's head disposed below the occipital bone of the patient's head or disposed on the occipital bone of the patient's head during use, the strap being configured to be connected to and between the slits.

[0096] In any embodiment of any aspect of the foregoing paragraphs: (a) each tab is integrally formed with each of the tube walls; (b) each tab has an upper edge and a lower edge, and in use, the upper edge is longer than the lower edge; (c) each gas delivery tube includes an extendable tube portion above the tab of each gas delivery tube in use and a non-extendable tube portion below the tab of each gas delivery tube in use; (d) each tab is connected to the tube wall of each gas delivery tube in the non-extendable tube portion; (e) each slit is arcuate between the upper end and the lower end of the slit; (f) each slit is linear between the upper end and the lower end of the slit; (g) the lower end of the slit is disposed at least 5 mm away from the tube wall; (h) the lower end of the slit is disposed at least 7 mm away from the tube wall; (i) the lower end of the slit is disposed at least 8 mm away from the tube wall; (j) the upper end of the slit is disposed at least 8 mm away from the tube wall; (k) the upper end of the slit is disposed at least 10 mm away from the tube wall; (l) the upper end of the slit is disposed at least 12 mm away from the tube wall; (m) the bevel angle is in the range of 10 to 20 degrees; (n) the bevel angle is in the range of 12 to 18 degrees; and / or (o) each slit is oriented perpendicular to the direction from the slit in the strap anchor region where the strap is anchored around the patient's head.

[0097] According to one aspect of the present technology, a positioning and stabilization structure is provided that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face that surrounds an inlet to the patient's airway for delivering an air flow at a treatment pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilization structure comprising: a pair of gas delivery tubes for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet of the patient's airway, each of the pair of gas delivery tubes being constructed and arranged to contact at least one area of the patient's head above the upper ear base point of the patient's head during use; each gas delivery tube comprising: a tube wall configured to extend between the patient's eyes and ears from the upper part of the patient's head over the seal-forming structure and to be placed on the patient's head; a tab connected to the tube wall and arranged above the upper ear base point of the patient's head during use; an air inlet formed in the tab and arranged behind the tube wall during use; and a trough formed in the tab and arranged behind the air inlet; and a strap constructed and arranged to contact an area of the patient's head disposed below the occipital bone of the patient's head or disposed on the occipital bone of the patient's head during use, the strap being configured to connect to and connect between the air inlets of the pair of gas delivery tubes and to be disposed within a trough formed in the tab during use.

[0098] In any embodiment of any aspect of the preceding paragraphs: (a) the trough is formed in the tab between the air inlet and the rear side of the tab; (b) the tab includes an outward-facing surface, and the trough includes a substantially planar surface formed as a depression with respect to the outward-facing surface; (c) the trough is formed by a portion of the tab having a smaller material thickness compared to other parts of the tab; (d) the trough includes a length that is approximately equal to the width of the strap; and / or, (e) the air inlet takes the form of a slit.

[0099] According to one aspect of the present technology, a patient interface is provided that includes the following. A plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, the pl enum chamber; a seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an inlet to the patient's airway, the seal-forming structure having a hole therein such that the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle; a positioning and stabilization structure according to any one of the above aspects; and a ventilation structure that allows the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use; the patient interface is configured to allow the patient to breathe from the atmosphere through their mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

[0100] Another aspect of a particular form of the present technology is a system for the treatment of respiratory diseases. The system includes a patient interface according to any one or more of the other aspects of the present technology, an air circuit, and a source of air at positive pressure.

[0101] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed with a peripheral shape that is complementary to the shape of the intended wearer.

[0102] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured to expose the patient's oral cavity during use.

[0103] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured such that a part of the seal-forming structure does not enter the oral cavity during use.

[0104] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured such that the seal-forming structure does not extend into the interior of the patient's airway.

[0105] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured such that the seal-forming structure does not extend below the alveolar ridge region during use.

[0106] Another aspect of a particular form of the present technology is a patient interface constructed and arranged to expose the patient's eyes during use.

[0107] Another aspect of a particular form of the present technology is a patient interface constructed and arranged to enable the patient to breathe ambient air during a power outage.

[0108] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured to form a seal on the lower side of the patient's nose without contacting the nasal bridge region of the patient's nose.

[0109] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a ventilation portion and a pre-nasal chamber. The patient interface is constructed and arranged such that gas from inside the pre-nasal chamber can move to the surroundings through the ventilation portion.

[0110] Another aspect of a particular form of the present technology is a patient interface. This patient interface is constructed and arranged such that a patient can lie comfortably in a lateral or side-lying sleep position when using the patient interface.

[0111] Another aspect of a particular form of the present technology is a patient interface. This patient interface is constructed and arranged such that a patient can lie comfortably in a supine sleep position when using the patient interface.

[0112] Another aspect of a particular form of the present technology is a patient interface. This patient interface is constructed and arranged such that a patient can lie comfortably in a prone sleep position when using the patient interface.

[0113] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, those who have not received medical training, those who are not very dexterous or lack insight, or those with limited experience in using this type of medical device.

[0114] One aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soap water in a patient's home, and no special cleaning equipment is required.

[0115] Of course, some of the above aspects may form sub-aspects of the present technology. Also, various combinations of various one of the sub-aspects and / or aspects can be made, which may also constitute further aspects or sub-aspects of the present technology.

[0116] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

Brief Description of the Drawings

[0117] 4 Brief Description of the Drawings This technology is illustrated as a non-limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements: 4.1 Treatment System

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Mode for Carrying Out the Invention

[0118] 5 Detailed Description of Embodiments of the Present Technology Before describing the present technology in more detail, it should be understood that the present technology is not limited to the specific embodiments that may be described herein. It should also be understood that the terms used in the present disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0119] The following description is provided in relation to various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment can be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0120] 5.1 Treatment Method In one form as shown in FIG. 1A, the present technology includes a method for treating a respiratory disease. The method includes the step of applying a positive pressure to the entrance of the airway of the patient 1000.

[0121] In a particular embodiment of the present technology, an air supply at positive pressure is provided to the nasal passage of the patient via one or both of the nostrils.

[0122] In certain embodiments of the present technology, mouth breathing is restricted, limited, or prevented.

[0123] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device can include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000. FIGS. 1A, 1B, and 1C show a treatment system using a patient interface 3000 with an RPT device 4000 and a humidifier 5000. 5.3 Patient Interface

[0124] Referring to FIG. 3A, a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional modalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation portion 3400, one form of a connection port 3600 for connection to an air circuit 4170, and a forehead support portion 3700. In some forms, the functional modalities can be provided by one or more physical components. In some forms, one physical component can provide one or more functional modalities. In use, the seal-forming structure 3100 is arranged to surround the inlet of the patient's airway so as to facilitate the supply of air at positive pressure to the airway.

[0125] As shown in FIGS. 8A - 9C, a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation portion 3400, and one form of a connection port 3600 for connection to an air circuit (e.g., the air circuit 4170 shown in FIGS. 1A - 1C). In this example, the seal-forming structure 3100 and the plenum chamber 3200 are provided by a cushion module 3150.

[0126] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0127] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the surroundings.

[0128] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the surroundings.

[0129] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the surroundings.

[0130] 5.3.1 Seal formation structure In one form of the present technology, the seal formation structure 3100 may provide a target seal formation area and further provide a cushioning function. The target seal formation area is an area where sealing can occur in the seal formation structure 3100. The area where sealing actually occurs (i.e., the actual sealing surface) may vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0131] In one form, the target seal formation area is disposed on the outer surface of the seal formation structure 3100.

[0132] In a particular form of the present technology, the seal formation structure 3100 is composed of a biocompatible material (e.g., silicone rubber).

[0133] The seal formation structure 3100 according to the present technology may be composed of a soft, flexible and elastic material (e.g., silicone).

[0134] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate different size and / or shape ranges. For example, the system may include one form of the seal-forming structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head.

[0135] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure 3100 includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can act on its underside in easy response to the positive system pressure within the plenum chamber 3200 to form a tight sealing engagement with the surface. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0136] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., from about 0.25 mm to about 0.45 mm). This member extends around the perimeter length of the plenum chamber 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle in use.

[0137] In one form, the seal-forming structure may include a compression seal or a gasket seal. In use, the compression seal or the gasket seal is constructed and arranged to be in a compressed state, for example, due to the elastic tension in the positioning and stabilizing structure.

[0138] In one form, the seal-forming structure includes a tension portion. In use, the tension portion is held in a taut state, for example, by an adjacent region of the sealing flange.

[0139] In one form, the seal-forming structure includes an adhesive surface or a bonding surface and / or a region having a high coefficient of friction compared to other surfaces.

[0140] In certain forms of the present technology, the seal-forming structure can include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension portion, and a site having an adhesive surface or a bonding surface.

[0141] 5.3.1.2 Nasal bridge or nasal sill region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the nasal bridge region or the nasal sill region of the patient's face during use.

[0142] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the nasal bridge region or the nasal sill region of the patient's face during use.

[0143] 5.3.1.3 Upper lip region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the upper lip region (i.e., the upper lip) of the patient's face during use.

[0144] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face during use.

[0145] 5.3.1.4 Jaw region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the jaw region of the patient's face during use.

[0146] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the jaw region of the patient's face during use.

[0147] 5.3.1.5 Forehead region In one form, the seal-forming structure forms a seal on the forehead region of the patient's face when the seal is in use. In such a form, the plenum chamber can cover the eyes during use.

[0148] 5.3.1.6 Nasal Pillows In one form, the seal-forming structure 3100 of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is configured and arranged to form a seal with each nostril of the patient's nose. FIGS. 12A-12F show a patient interface 3000 having a seal-forming structure 3100 provided by the pillow cushion module 3160. The pillow cushion module 3160 includes a pair of nasal pillows 3165. In this example, the same positioning structure 3300 shown in FIGS. 8A-9C is used to maintain a sealed contact between the pillow cushion module 3160 and the patient's nose. The same concepts and features of the positioning and stabilization structure 3300 described for the cradle cushion module 3150 are applicable to a positioning and stabilization structure 3300 configured to be used with the pillow cushion module 3160 (or another type of cushion module (e.g., a full-face cushion module, an oral-nasal cushion module, an ultra-compact full-face cushion module, a nasal cushion module)).

[0149] A nasal pillow 3165 according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the lower side of the patient's nose, the stem, and a flexible region on the lower side of the frustum of the cone, connecting the frustum of the cone to the stem. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible region can function to facilitate a self-aligning structure. The self-aligning structure corresponds to the mutual movement of both the displacement and the angle of the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone can be displaced axially toward the structure to which the stem is connected.

[0150] 5.3.1.7 Nasal Cradle In one form, for example, as shown in FIGS. 8A - 9C, the seal - forming structure 3100 is configured to form a seal with the lower nose area around the nostrils and optionally the upper lip of the patient 1000 during use. This type of seal - forming structure may also be referred to as a "cradle cushion" or a "sub - nasal mask". The shape of the seal - forming structure may be configured to conform to or closely follow the lower side of the patient's nose (i.e., the profile and angle of the seal - forming structure may be substantially parallel to the patient's nasolabial angle). In one form of the nasal cradle cushion, the seal - forming structure includes a bridge portion that defines two orifices. Each of these two orifices supplies air or breathable gas to a different one of the patient's nostrils during use. The bridge portion may be configured to contact or seal the patient's nasal septum during use. In some forms of the present technology, the seal - forming structure 3100 is configured to form a seal with the lower side of the patient's nose without contacting the nasal bridge region of the patient's nose. In some examples, the patient interface may include a seal - forming structure 3100 in the form of a cradle cushion as described in PCT Application No. PCT / AU2018 / 050289 (filing date: March 29, 2018). The entire content of this reference is incorporated herein by reference.

[0151] 5.3.1.8 Nasal mask cushion In one form, the non - invasive patient interface 3000 includes a seal - forming portion that forms a seal over the upper lip region (i.e., the upper lip), the nasal bridge region, and the cheek regions of the patient's face during use. For example, the patient interface 3000 shown in FIG. 1B is in this case. This seal - forming portion delivers air supply or breathable gas to both nostrils of the patient 1000 via a single orifice. This type of seal - forming structure may also be referred to as a "nasal cushion" or a "nasal mask". In some embodiments of the present technology, the positioning and stabilization structure 3300 shown in FIGS. 8A - 9C may be utilized to hold the nasal cushion in a sealed position on the patient's face.

[0152] 5.3.1.9 Full-face mask cushion In one form, the patient interface 3000 includes a seal-forming portion that forms a seal over the patient's jaw region, nasal bridge region, and cheek regions of the face. For example, the patient interface 3000 shown in FIG. 1C is in this case. This seal-forming portion delivers air supply or breathable gas to both nostrils and the oral cavity of the patient 1000 through a single orifice. This type of seal-forming structure may also be referred to as a "full-face mask". In some embodiments of the present technology, the positioning and stabilization structure 3300 shown in FIGS. 8A-9C may be utilized to hold the full-face cushion in a sealed position on the patient's face.

[0153] 5.3.1.10 Oro-nasal mask cushion In another form, the patient interface 3000 includes a nasal seal-forming structure and an oral seal-forming structure. The nasal seal-forming structure takes the form of a nasal cushion or a nasal cradle cushion, and the oral seal-forming structure is configured to form a seal around the patient's oral cavity during use (this may also be referred to as an "oral cushion" or an "oral mask"). In such a mask, air or breathable gas is supplied to the patient's nostrils and the patient's oral cavity through separate orifices during use. This type of seal-forming structure 3100 may be referred to as an "oro-nasal cushion" or an "ultra-compact full-face cushion". In one form, the nasal seal-forming structure and the oral seal-forming structure are integrally formed as a single component. In some examples, the patient interface may include a seal-forming structure 3100 in the form of a cradle cushion as described in U.S. Patent Application No. 62 / 649,376. The entire content of this document is incorporated herein by reference for all purposes.

[0154] The plenum chamber 3200 has a perimeter shaped to be complementary to the surface profile of an average person's face in the area where a seal is formed during use. In use, the peripheral edge of the plenum chamber 3200 is positioned proximate to the adjacent surface of the face. The actual contact with the face is provided by the seal forming structure 3100. The seal forming structure 3100 can extend around the entire perimeter of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal forming structure 3100 are formed from a single homogeneous piece of material.

[0155] In some forms of the present technology, such as the patient interface 3000 shown in FIGS. 8A - 9C, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized space defined by the plenum chamber. In such forms, treatment compliance can be improved because the pressure is often reduced and / or the wearer's comfort is increased.

[0156] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material can reduce the pressure of the patient interface and can assist in improving treatment compliance. The use of a transparent material can assist the clinician in verifying the placement and function of the patient interface.

[0157] In certain forms of the present technology, the plenum chamber 3200 is composed of a translucent material. By using a translucent material, the pressure of the patient interface can be reduced, and the improvement of treatment compliance can be assisted.

[0158] 5.3.2 Positioning and Stabilization Structure The seal-forming structure 3100 of the patient interface 3000 of the present technology can be held in a sealed position by the positioning and stabilization structure 3300 during use. Since the positioning and stabilization structure 3300 engages the patient's head to hold the patient interface 3000 in the sealed position, it can also be called a "headgear".

[0159] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0160] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the gravitational force on the patient interface 3000.

[0161] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tubing drag or accidental interference with the patient interface).

[0162] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to be worn by the patient during sleep. In one embodiment, the positioning and stabilization structure 3300 has a low-profile outer shape or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strap.

[0163] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky so as not to interfere with the patient when sleeping in a supine sleep position with the patient's head resting on a pillow in the posterior region of the head.

[0164] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to not be overly large or bulky so as to be an impediment when a patient lies in a lateral sleeping position with the patient's head resting on the side region of the patient's head.

[0165] In one form of the present technology, the positioning and stabilization structure 3300 includes a separation site disposed between a front site of the positioning and stabilization structure 3300 and a rear site of the positioning and stabilization structure 3300. This separation site is not resistant to compression and can be, for example, a flexible or flimsy strap. The release portion is constructed and arranged so that when the patient lies with the head on the pillow, the presence of the release portion can avoid a situation where a force to the rear is transmitted along the positioning and stabilization structure 3300 and the seal is obstructed.

[0166] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap 3310 composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous such that moisture (e.g., sweat) can pass through the strap 3310. The strap 3310 can be breathable, enabling the passage of water vapor through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0167] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured to be taut during use and direct a force to bring a seal-forming structure into close contact with a portion of the patient's face, and in some embodiments, can be configured in combination with other straps or other structures. In one embodiment, the strap can be configured as a tie.

[0168] ​The tie can be understood as a structure designed to resist tension. In use, the tie is part of the positioning and stabilization structure 3300 under tension. Some ties add the elasticity resulting from this tension, as described above. The tie can function to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient's head.

[0169] In one form of the technology, the positioning and stabilization structure includes a first tie, which is constructed and arranged such that, in use, at least a portion of its lower edge moves upward past the upper ear base point of the patient's head and covers a part of the parietal bone and / or the frontal bone without covering the occipital bone. The first tie can be provided as part of a patient interface including, for example, a cradle cushion, a nasal pillow, a nasal cushion, a full-face cushion, or an oro-nasal cushion. For example, as shown in FIGS. 8A - 9C, the positioning and stabilization structure 3300 includes a first tie in the form of a tube 3350 placed above the patient's head.

[0170] In one form of the technology suitable for a nasal-only mask or a full-face mask, the positioning and stabilization structure 3300 includes a second tie. The second tie is constructed and arranged such that, in use, at least a portion of its upper edge passes below the lower ear base point on the lower side of the patient's head and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head. The second tie can be provided as part of a patient interface including, for example, a cradle cushion, a nasal pillow, a full-face cushion, a nasal cushion, or an oro-nasal cushion. As shown in FIGS. 8A - 9C, the positioning and stabilization structure 3300 includes a second tie in the form of a strap 3310 arranged opposite the rear surface of the patient's head.

[0171] In one form of the present technology suitable for a nose-only mask, a full-face mask, or an oro-nasal mask, the positioning and stabilization structure 3300 includes a third tie configured to be anchored to the back surface of the patient's neck. Further, in some forms, the positioning and stabilization structure interconnects the second tie and the third tie to reduce the tendency of the second tie and the third tie to move in a divergent direction, and includes a fourth tie constructed and arranged to do so.

[0172] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is bendable and, for example, non-rigid. An advantage of this aspect is that the strap is more comfortable when the patient lies on their side during sleep. As shown in FIGS. 8A-9C, the positioning and stabilization structure 3300 includes a bendable strap 3310. The strap 3310 can be regarded as a backstrap. Since the strap 3310 is sufficiently flexible, it passes around the rear of the patient's head and is comfortably positioned relative to the patient's head (even when under tension during use).

[0173] In a particular form of the present technology, a system is provided that includes more than one positioning and stabilization structure 3300. Each positioning and stabilization structure 3300 is configured to provide a holding force for accommodating different sizes and / or ranges of shapes. For example, the system can include a form of the positioning and stabilization structure 3300 suitable for a large-sized head rather than a small-sized head and suitable for a different small-sized head rather than a large-sized head.

[0174] 5.3.2.1 Headgear Tubing In some forms of the present technology, the positioning and stabilization structure 3300 includes one or more tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 to the patient's airway from the RPT device, for example, through the plenum chamber 3200 and the seal-forming structure 3100. In the forms of the present technology shown in FIGS. 8A - 9C, the positioning and stabilization structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the seal-forming structure 3100. These tubes 3350 are an integral part of the positioning and stabilization structure 3300 of the patient interface 3000 for positioning and stably arranging the seal-forming structure 3100 of the patient interface at an appropriate part of the patient's face (e.g., the nose and / or mouth). As a result, the conduit of the air circuit 4170 that provides the pressurized air flow can be connected to the connection port 3600 of the patient interface at a position other than in front of the patient's face, which may be obtrusive to some people. The pair of tubes 3350 has several advantages (described below), but in some examples, the positioning and stabilization structure 3300 includes only a single tube 3350 configured to be placed only on one side of the patient's head. Providing a strap or other stabilizing component to the other side of the patient's head between the upper end of the single tube 3350 and the seal-forming structure 3100 enables an even balance of forces on the seal-forming structure 3100.

[0175] Since it is possible to accommodate and move air through the headgear tubing 3350 to deliver pressurized air from the air circuit 4170 to the patient's airway, the positioning and stabilization structure 3300 can be described as being inflatable. It is understood that an inflatable positioning and stabilization structure 3300 does not require all components of the positioning and stabilization structure 3300 to be inflatable. For example, in the examples shown in FIGS. 8A - 9C and FIGS. 12A - 12F, the positioning and stabilization structure 3300 includes headgear tubing 3350 that is inflatable and straps 3310 that are not inflatable.

[0176] In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 disposed adjacent to the upper, side, or rear portion of the patient's head. For example, in the forms of the present technology shown in FIGS. 8A-9C, the connection port 3600 is disposed on the patient's head. In this example, the patient interface 3000 includes an elbow 3610 provided with the connection port 3600. The elbow 3610 may be rotatable relative to the positioning and stabilization structure 3300, decoupling the movement of the conduit connected to the connection port 3600 from the positioning and stabilization structure 3300. Additionally or alternatively, the conduit connected to the connection port 3600 may be rotatable relative to the elbow 3610. In the illustrated example, the elbow 3610 includes a swivel-type conduit connector capable of connecting the conduit of the air circuit 4170, whereby the conduit can be rotated about the longitudinal axis relative to the elbow 3610. The connection port 3600 may include a fluid connection opening 3390 as shown, for example, in FIGS. 10A and 10B. In some examples, the air circuit 4170 may be connected to the fluid connection opening 3390. The elbow 3610 may be rotatably connected to the fluid connection opening or to a ring received in the fluid connection opening.

[0177] In the case of a patient interface where the connection port is not disposed in front of the patient's face, there may be patients who find it obstructive and uncomfortable when the conduit is connected to a patient interface in front of the face. This can be advantageous. For example, a conduit connected to a patient interface in front of the face may become entangled with bedding or bed linen, especially when the conduit extends downward from the patient interface during use. According to an aspect of the present technology using a patient interface with a connection port disposed adjacent to and above the patient's head during use, the patient may be more easily or comfortably positioned when lying or sleeping in one or more of the following positions: a lateral or side position, a supine position (i.e., a face-up position), and a prone position (i.e., a face-down position). Further, when the conduit is connected in front of the patient interface, a problem known as tubing drag may be exacerbated. In tubing drag, an undesirable pulling force can occur on the conduit relative to the patient interface, which can result in being pulled down from the face.

[0178] In the aspects of the present technology shown in FIGS. 8A-9C and FIGS. 12A-12F, the positioning and stabilization structure 3300 includes two tubes 3350. Each tube 3350 is disposed on a different side of the patient's head during use and extends from above each ear (above the suprameatal point on the patient's head) through each cheek region to the elbow 3610 at the top of the patient's 1000 head. In this aspect of the technology, when the patient is lying on their side and one of the tubes is compressed and the gas flow along that tube is blocked or partially blocked, the other tube remains open and can supply pressurized gas to the patient, which can be advantageous. In other embodiments of the technology, the patient interface 3000 may include a different number of tubes (e.g., one tube or three or more tubes). In an example where the patient interface has one tube 3350, the single tube 3350 is disposed on one side of the patient's head (e.g., over one cheek region) during use, and the strap is disposed on the other side of the patient's head (e.g., over the other region) during use to form part of the positioning and stabilization structure 3300 and assist in fixing the patient interface 3000 on the patient's head.

[0179] In the embodiments of the present technology shown in FIGS. 8A-9C and FIGS. 12A-12F, these two tubes 3350 are fluidly connected to each other at their upper ends and are fluidly connected to the connection port 3600. In one embodiment, these two tubes are integrally formed. In other embodiments, these tubes are separate components that are interconnected during use and can be disconnected, for example, during cleaning or storage. When separate tubes are used, they can be indirectly connected to each other. For example, they can be connected to a T-shaped conduit having two conduit arms each fluidly connectable to a tube 3350 and a third conduit arm or opening that functions as the connection port 3600 and is connectable to the air circuit 4170 during use. The connection port 3600 can include an elbow 3610 received within the fluid connection opening 3390 at the center of the two integrally formed tubes 3350. The elbow 3610 can be configured to rotate within a ring received within a ring in the fluid connection opening 3390 and is incorporated herein by reference in its entirety. The fluid connection opening 3390 may be regarded as the connection port 3600 itself.

[0180] These tubes 3350 can be formed of a semi-rigid material such as an elastomeric material (e.g., silicone). For example, as shown in FIG. 10A, the tube 3350 from the non-extendable tube portion 3363 on the left side to the non-extendable tube portion 3363 on the right side can be formed (e.g., by molding) from a single homogeneous piece of material (e.g., silicone). These tubes can have a natural pre-formed shape and can bend or move to assume another shape when a force is applied to the tube. For example, these tubes can generally assume an arcuate or curved shape similar to the outer contour of a patient's head between the upper head portion and the nose or mouth region.

[0181] In some examples, the positioning and stabilization structure 3300 can include a sleeve 3364 around the tube 3350. For example, as shown in FIGS. 8A-8D, the sleeve 3364 is provided on the non-extendable tube portion 3363. In some examples, the patient interface 3000 may not include the sleeve 3364, and in other examples, the patient interface The face 3000 may include a sleeve 3364 that covers more or all of the tube 3350. The sleeve 3364 may be formed to fit the curved shape of the tube 3350. In some examples, the sleeve 3364 is formed from a smooth fabric. The sleeve 3364 may be more comfortable for the patient's face as compared to a tube 3350 with no covering at all.

[0182] As described in U.S. Patent No. 6,044,844, which is incorporated herein by reference in its entirety, the tube 3350 can withstand crushing in order to avoid a flow of breathable gas through the tube in the event of crushing during use (e.g., between the patient's face and the pillow). Pressurized gas in the tube can function as a spring to avoid or at least limit crushing of the tube 3350 during use, so a tube that withstands crushing is not necessary in all cases. Using a tube that withstands crushing can be advantageous when only a single tube 3350 is present during use, because if a single tube is blocked during use, the gas flow is restricted and the treatment stops or its effectiveness is reduced.

[0183] In certain forms of the present technology, one or more portions of the tube 3350 can be stiffened by one or more stiffening or reinforcing elements. Examples of stiffening elements include: portions of the tube 3350 that are relatively thicker than other portions, portions of the tube 3350 formed from a material that is relatively more rigid than the material forming other portions, and rigid members attached or embedded inside or outside a part of the tube. When such stiffening elements are used, it aids in controlling the positioning and functional mode of the stabilization structure 3300 during use (for example, when a force is applied to the tube 3350 and the tube 3350 is likely to deform, or when a force is applied to the tube 3350 and the shape of the tube 3350 is likely to be maintained). By selecting where to place such stiffening elements within the tube 3350, it can aid in promoting comfort when the patient interface 3000 is worn and can aid in maintaining a good seal in the seal formation structure 3100 during use. The stiffening or reinforcing elements can be disposed within the positioning and stabilization structure 3300. The positioning and stabilization structure 3300 is configured to support a relatively high-weight seal formation structure (such as a full-face or nose-mouth cushion assembly).

[0184] In the embodiments of the present technology shown in FIGS. 8A-9C and FIGS. 12A-12F, the length of the tube 3350 is 15-30 cm (e.g., 20-27 cm respectively). In one example, the length of each tube is about 26 cm. In another example, the length of each tube is about 23 cm. The length of the tube is selected to suit the dimensions of a typical patient's head (e.g., the distance between the upper region of the head where the upper end of the tube 3350 is located and the region near the opening to the patient's airway where the lower end of the tube 3350 is connected to the cradle cushion module 3150 (or the pillow cushion module 3160) when following a generally arcuate path that extends downward along the side of the head and over the patient's cheek region (e.g., as shown in FIGS. 8A-9C or FIGS. 12A-12F)). As described in more detail below, the patient interface 3000 is configured such that in some embodiments of the present technology, the length of the tube 3350 can be varied and the above length can be applied to tubes in a contracted, extended, or neutral state. It is understood that the length of the tube 3350 depends on the lengths of other components in the patient interface 3000 (e.g., the arm length of the T-shaped conduit to which the upper end of the tube 3350 is connected and / or the size of the plenum chamber 3200).

[0185] 5.3.2.1.1 Positioning of the Headgear Component Each tube 3350 can be configured to receive an airflow from the connection port 3600 on the patient's head and deliver this airflow to the seal-forming structure at the patient's airway inlet. In the examples of FIGS. 8A-9C and FIGS. 12A-12F, at least one tube 3350 extends between the connection port 3600 above the patient's cheek region and above the patient's ear and the seal-forming structure 3100 (i.e., between a portion of the tube 3350 that is connected to the cushion module that covers the upper jaw region of the patient's head during use and a portion of the tube 3350 that covers the region of the patient's head above the upper ear base point on the patient's head). One or more tubes 3350 can each be placed on one or both of the patient's sphenoid bone and / or temporal bone and the patient's frontal bone and parietal bone. The connection port 3600 and the elbow 3610 can be placed on the patient's parietal bone, frontal bone, or the junction between them during use. That is, between a portion of the tube 3350 that is connected to the cushion module that covers the upper jaw region of the patient's head during use and a portion of the tube 3350 that covers the region of the patient's head above the upper ear base point on the patient's head). One or more tubes 3350 can each be placed on one or both of the patient's sphenoid bone and / or temporal bone and the patient's frontal bone and parietal bone. The connection port 3600 and the elbow 3610 can be placed on the patient's parietal bone, frontal bone, or the junction between them during use.

[0186] The exemplary forms of the present technology shown in FIGS. 8A to 9C and FIGS. 12A to 12F have tubes 3350. These tubes 3350 extend curvilinearly from the upper end of the tube 3350 that connects to the elbow 3610 on the upper head of the patient around the upper periphery of the patient's head to the point where the strap 3310 connects to the tube 3350 in a state where the curvature in the sagittal plane is relatively small. Between the point where the rear headgear strap 3310 connects to the tube 3350 and the lower end of the tube 3350 that connects to the cradle cushion module 3150 in front of the airway of the patient below the nose, the tube 3350 extends curvilinearly forward across the cheek region between the patient's ear and eye. The radius of curvature of the curved portion of this part of the tube 3350 can be in the range of 60 to 100 mm (for example, 70 to 90 mm (for example, 80 mm)). The lower end of the tube 3350 and the portion of the tube 3350 to which the rear headgear strap 3310 connects to the tube 3350 can be at an angle in the range of 65 to 90° (for example, 75 to 80°). The actual curvature existing in the portion of the tube 3350 above the strap 3310 and the actual curvature existing in the portion of the tube 3350 below the strap 3310 depend on the patient setup and actually vary according to the shape and size of the patient's head as well as the patient's preference.

[0187] The extent to which the patient interface 3000 can be fitted to an individual patient can be changed by altering the length of the tube 3350, or alternatively or additionally, by altering the position of the patient interface 3000 on the patient's head, or the position of those portions on the patient's head. For example, by moving portions of the positioning and stabilization structure 3300 in a rearward or forward direction on the patient's head, the patient interface 3000 having a particular length of tube 3350 can be adjusted to fit the patient better. For example, moving the junction of the tube 3350 on the patient's head further forward (i.e., in the forward direction) makes it possible to fit the patient interface 3000 having a particular length of tube 3350 to a larger head than when the junction of the tube 3350 is positioned further rearward (i.e., in the rearward direction). In the case of most patients, when the junction of the tube 3350 is positioned forward, the upper portion of the tube 3350 is positioned on a smaller portion of the patient's head than when the junction of the tube 3350 is positioned rearward.

[0188] In a particular form of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be arranged at a range of positions across the upper part of the patient's head, thereby making it possible to position the patient interface 3000 at a position suitable for the comfort or fit of an individual patient. As one way to achieve this such that the seal forming structure 3100 forms an effective seal with the patient's face regardless of the position of the connection port 3600 on the patient's head, there is a method of decoupling the movement of the upper part of the patient interface 3000 from the lower part of the patient interface 3000. Such separation can be achieved, for example, using a mechanism that allows parts of the headgear tube 3350 to move or flex easily relative to other parts of the patient interface 3000. Such a mechanism will be described below.

[0189] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 is generally positioned at the upper point of the patient's head. The connection port 3600 can be positioned within the sagittal plane and can be aligned with the upper ear base point in a plane parallel to the coronal plane. The upper ear base point is shown in FIG. 2D. As described below, in some forms of the present technology, the positioning and The stabilization structure 3300 is configured to be worn at different positions, that is, the connection port 3600 can be positioned adjacent to the upper part of the patient's head within the sagittal plane from 20 mm in front of or up to 20 mm behind the upper ear base point.

[0190] In some examples of the present technology, the connection port 3600 can be positioned within the sagittal plane and aligned with the junction between the frontal bone and the parietal bone. The connection port 3600 can be positioned approximately on the junction of the coronal suture and the sagittal suture. In this configuration, the upper part of the tube 3350 can be placed on and / or along a part of the coronal suture. However, as described above, the patient can move the connection port 3600 forward or backward for adjusting the fit of the patient interface 3000.

[0191] An advantage of placing the tube 3350 on the patient's head slightly in front of the uppermost point (e.g., on or near the coronal suture) is that it can reduce the risk of the tube 3350 riding up backward during use. In many patients, there may be a recess or "dimple" at the position where the coronal suture meets the sagittal suture. If the tube 3350 is placed within this dimple, the positioning and stabilization structure 3300 can be particularly stable. Therefore, in some examples, the tube 3350 is configured with an appropriate curvature and / or ability to be curved and placed on the coronal suture.

[0192] As described above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion. The seal-forming structure 3100 is generally disposed under the nose and seals the area around the lower circumference of the nose. The positioning and stabilization structure 3300 can be structured and arranged to pull the seal-forming structure 3100 into the patient's face under the nose (by a sealing force vector having a posterior and upward direction (e.g., a posterior-superior direction)). The sealing force vector in the posterior-superior direction can facilitate the seal-forming structure 3100 to form a good seal on either side of the patient's nose and upper lip against both the area around the lower circumference of the patient's nose and the anterior surface of the patient's face.

[0193] In some examples, during use, the positioning and stabilization structure 3300 can add a sealing force vector having a posterior-superior direction relative to the Frankfurt horizontal of the patient at an angle of approximately 35°. The upper portion of the tube 3350 (e.g., the portion of the tube 3350 above the strap 3310) can be oriented vertically, and the posterior headgear strap 3310 can extend from the tube 3350 in a posterior-inferior direction at an angle of approximately 35° relative to the Frankfurt horizontal of the patient. In this particular setup, an angle of 125° is formed between the strap 3310 and the upper portion of the tube 3350 (to which the strap 3310 is connected).

[0194] FIG. 8D is a side view of a patient wearing the patient interface 3000. Specific forces acting on points 3308 above each patient's ear are shown in FIG. 8D in the vicinity of the location where the strap 3310 is connected to the tube 3350. From the upper portion of the tube 3350, a force 3301 due to the headgear tension can be added to the point 3308. The force 3301 can have a substantially vertical direction. (For example, between the seal forming structure 3100 and the connection to the rear headgear strap 3310) From the lower portion of the tube 3350, a force 3303 can be added onto this point 3308 (at an angle of approximately 125° in the forward and downward direction with respect to the vertical force 3301 added from the upper portion of the tube 3350). With respect to the sealing force that pulls the seal forming structure 3100 into the patient's face below the nose, the force 3303 can be equal in magnitude and opposite in direction. To balance the forces, a force 3302 from the strap 3310 is added at an angle of approximately 125° in the rearward and downward direction with respect to the vertical force 3301 added from the upper portion of the tube 3350. Therefore, the angle between the forward and downward force 3303 added to the point 3308 along each tube 3350 above the patient's ear and the rearward and downward force 3302 added from the strap 3310 is approximately 110°.

[0195] When using the positioning and stabilization structure 3300 with the cradle cushion, for many patients, a sealing force vector of 35° may be considered optimal. Further, the directions of the forces added from each part of the positioning and stabilization structure 3300 described above can be considered ideal. However, in reality, it is understood that the actual directions of the forces added from each part of the headgear will vary to accommodate the specific anatomical structures and preferences of each patient.

[0196] For example, in many instances, the positioning and stabilization structure 3300 can be configured such that the upper portion of the tube 3350 is positioned over the patient's head slightly forward of the uppermost point. As a result, in some patients, the tube 3350 may be angled slightly forward rather than being aligned vertically (e.g., in the coronal plane) such that it is positioned within a slight recess in or near the coronal suture of the skull. In such instances, the patient can adjust the tension in the strap 3310 to balance the forces and achieve an optimal sealing force vector.

[0197] In some examples, the positioning and stabilization structure 3300 can be configured to apply a force at an angle that bisects the angle formed between the upper lip and the nasal column (e.g., the surface forming the nasolabial angle) in a posterior - upper direction over the seal - forming structure 3100.

[0198] In a particular example of the present technology, the tube 3350 is configured to receive the strap 3310 at a position above and adjacent to the patient's ear. If the strap 3310 is connected to the tube 3350 at a position that is too high relative to the patient's head, the strap 3310 may tend to ride up on the back of the patient's head. Further, the strap 3310 may form an angle that is too large with respect to the upper portion of the headgear tube 3350, which can result in the patient needing to tighten the strap 3310 excessively. In that case, the tension within the positioning and stabilization structure 3300 can become excessive and the strap 3310 is also more likely to ride up on the back of the patient's head. Therefore, it is advantageous to position the connection between the strap 3310 and the tube 3350 as low as possible while maintaining a sufficient spacing from above the patient's ear so that the tube 3350 is not pulled into contact with the patient's ear when the strap 3310 is fastened.

[0199] 5.3.2.1.2 Fluid Connection of the Headgear Tube The two tubes 3350 are fluidly connected to the plenum chamber 3200 at their lower ends. In the examples of FIGS. 8A-9C and FIGS. 12A-12F, the tubes 3350 form a fluid connection with the cradle cushion module 3150 and the seal forming structure 3100. In a particular form of the technology, the connection between the tube 3350 and the cradle cushion module 3150 is achieved by the connection of two rigid components such that the patient can easily connect the two rigid components in a reliable manner. Using tactile feedback such as an audible "click" or similar sound can make it easy for the patient to use and also allow the patient to know that the tube is correctly connected to the cradle cushion module 3150. In one form, the tube 3350 is formed from silicone and each lower end of the silicone tube 3350 is overmolded onto a rigid connector formed from, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector may include a male engagement feature configured to connect to a female engagement feature on the cradle cushion module 3150. Alternatively, the rigid connector may include a female engagement feature configured to connect to a male engagement feature on the cradle cushion module 3150. The manner of connecting the tube 3350 to the cradle cushion module 3150 may also be applicable to the connection between the tube 3350 and the nose cushion module 3150 or another plenum chamber 3200 or seal forming structure 3100.

[0200] In another embodiment, a compression seal is used to connect each tube 3350 to the cradle cushion module 3150. For example, when using an elastic flexible (e.g., silicone) tube 3350 without a rigid connector, it may be necessary to slightly compress the tube 3350 to reduce its diameter so that it can be pushed into a port in the plenum chamber 3200. The inherent elasticity of the silicone presses the tube 3350 outward to seal the tube 3350 airtight in the port. When the engagement between the tube 3350 and the port is a rigid-to-rigid type engagement, a pressure-activated seal such as a peripheral sealing flange may be used. When pressurized gas is supplied through the tube 3350, the sealing flange is advanced against the joint between the tube and the inner peripheral surface of the port of the plenum chamber 3200 to facilitate the seal therebetween. When the port is flexible and a rigid connector is provided to the tube 3350, the pressure-activated seal as described above may also be used to confirm that the connection is airtight. In another example, each tube 3350 is formed from an elastically flexible (e.g., silicone) material and overmolded onto a rigid connector so that this elastically flexible material fits over the rigid connector and this elastically flexible material itself functions as a gasket to seal the connection between the tube 3350 and the cradle cushion module 3150 around the air flow path from the tube 3350 into the plenum chamber 3200 of the cradle cushion module 3150.

[0201] In some forms of the present technology, a similar connection mechanism may be used when fluidly connecting to the tube 3350 by a T-shaped upper member that defines or is connectable to the connection port 3600. In one embodiment, since the swivel elbow connected at the connection port 3600 is rotatable, this rotation drives a port size adjustment mechanism that increases or decreases the size of the port that is the insertion destination of the tube 3350, improving the fit of the tube through increasing or decreasing the compression force and reducing unintentional leakage.

[0202] 5.3.2.1.3 Extendable bellows structure The patient interface 3000 may include one or more extendable tube portions. In some examples, the extendable tube portion includes an extendable bellows structure 3362. The patient interface 3000 may include a positioning and stabilization structure 3300. The positioning and stabilization structure 3300 includes at least one gas delivery tube including a tube wall 3352 having an extendable bellows structure 3362. For example, the patient interface 3000 shown in FIGS. 8A-9C and FIGS. 12A-12F includes a tube 3350, and an extendable tube portion in the form of an extendable bellows structure 3362 is provided above the tube 3350 respectively.

[0203] Each extendable bellows structure 3362 may include a part of the tube 3350 having one or more folds, pleats, corrugations or bellows to form an extendable portion of the tube 3350. In the examples shown in FIGS. 8A-9C, each extendable bellows structure 3362 takes the form of an extendable bellows structure. The extendable bellows structure 3362 is separated by an elbow 3610 and a connection port 3600. The extendable bellows structure 3362 has a variable length. Specifically, each extendable bellows structure 3362 can be extended or contracted to change the length of each tube 3350.

[0204] In some examples, each gas delivery tube 3350 may include a cross-section having a width and a height in the extendable bellows structure 3362. The width is greater than the height and is substantially aligned with the front-rear direction during use. For example, the patient interface 3000 shown in FIGS. 8A-8C includes an extendable bellows structure 3362 each having a cross-sectional width greater than the cross-sectional height. The width is a dimension aligned with the front and rear directions of the illustrated patient 1000. In this example, the width is approximately twice as large as the height. That is, in this example, the width decreases along the height of the extendable bellows structure 3362. At the upper end or the middle end of each extendable bellows structure 3362, the width of the tube wall forming the extendable bellows structure 3362 is relatively large, and a swivel elbow 3610 is received in the tube 3350 inside It is the same size as the ring. At the lower or side edge of each extendable bellows structure 3362, the width of the tube wall is relatively small and is the same size as the width of the non-extendable tube portion 3363. The extendable bellows structure 3362 with a varying width between the larger tube size for connection to the elbow 3610 and the smaller tube size of the non-extendable tube portion 3363 results in a smooth and continuous tube 3350, thereby increasing comfort and / or aesthetics (as a result, patient compliance with treatment can be improved).

[0205] 5.3.2.1.3.1 Flexibility In some examples of the present technology, a part of the positioning and stabilization structure 3300 is configured to withstand bending in several directions or around them or in several axes or around them.

[0206] For example, the upper part of each tube 3350 of the positioning and stabilization structure 3300 shown in FIGS. 8A to 9C can be more bendable in a specific direction than in orthogonal directions. Each gas delivery tube 3350 of the positioning and stabilization structure 3300 can include an upper tube portion 3304 configured to be placed on the upper region of the patient's head during use (as shown in FIGS. 8A to 8C). In the illustrated example, the upper tube portion 3304 includes an extendable bellows structure 3362. In other examples of the present technology, the upper tube portion 3304 can include another extendable tube structure (for example, one of the options disclosed in PCT Patent Publication No. WO2017 / 124155, the entire content of each of which is incorporated herein by reference for reference) or can be non-extendable.

[0207] The upper tube portion 3304 may include a first end 3305 and a second end 3306. In this example, the first end 3305 is configured to be placed or disposed on top of the patient's head, approximately in the sagittal plane of the patient's head (e.g., approximately the upper and central portion of the patient's head). The second end 3306 is configured to be placed on the patient's head in a lateral direction (e.g., closer to the side portion of the patient's head) from the first end 3305. In some examples, if the upper tube portion 3304 is not very long, the second end 3306 may be disposed laterally with respect to the first end 3305, but may not be disposed particularly below the first end 3305. In other examples, if the upper tube portion 3304 is longer, the second end 3306 may be disposed both laterally and downward with respect to the first end 3305. FIG. 13 shows a part of another example of the positioning and stabilization structure 3300. The positioning and stabilization structures of FIGS. 8A - 9C and FIG. 13 are capable of bending around multiple axes. For example, the positioning and stabilization structure 3300 in FIG. 13 can extend downward in a draped shape over the patient's head and can also be curved in the forward and backward directions. As shown in FIG. 13, the upper tube portion 3304 is bent around two axes.

[0208] The upper tube portion 3304 may also include one or more rigid portions between the first end 3305 and the second end 3306. These rigid portion(s) may be configured such that the resistance to relative movement between the first end 3305 and the second end 3306 is higher in the forward and / or backward directions than in the upward and / or downward directions.

[0209] When the patient wears the positioning and stabilization structure 3300, the resistance of the upper tube portion 3304 to flexion in the vertical direction can be relatively low, so that the second end portion 3306 can move downward relative to the first end portion 3305. As a result, it is possible for the upper tube portion 3304 to extend downward "in a drape-like manner" from above the upper part of the patient's head to the side of the patient's head, which is advantageous. The relatively high flexibility and up / down direction can be advantageous in that it is possible to adapt the upper tube portion 3304 to the curvature of the patient's head.

[0210] Furthermore, since the upper tube portion 3304 can have a relatively high resistance to flexion in the horizontal direction, the first end portion 3305 will not unexpectedly move forward and / or backward relative to the second end portion 3306. As a result, it is possible to hold the upper tube portion 3304 in a desired position above the patient's head, which is advantageous. The upper tube portion 3304 and especially the connection port 3600 can have a lower resistance to flexion in the forward and / or backward directions, so that it can be less likely to ride forward or backward along the upper part of the patient's head during use. Such resistance to forward or backward movement of the upper tube portion 3304 is particularly advantageous for the patient interface 3000 when there is a connection from the air circuit 4170 to the top of the patient's head (i.e., the tube resistance can act directly on the upper tube portion 3304).

[0211] In some examples, the upper tube portion 3304 may include a shape that inherently provides favorable resistance to bending. For example, the upper tube portion 3304 may include a rectangular cross-section, with one of the parallel long sides of the cross-section configured to be placed on the surface of the patient's head. The long side of the rectangular cross-section provides a relatively high resistance to bending of the upper tube portion in a direction parallel to the long side (e.g., forward and / or backward during use). However, from the short side of the rectangular / trapezoidal cross-section, such a high resistance to bending of the upper tube portion 3304 and in a direction parallel to the short side (e.g., downward and / or upward during use) cannot be obtained. It is understood that the cross-section of the upper tube portion 3304 may not be a perfect rectangle. For example, the corners and / or short sides can be made curved.

[0212] The rigid portion can be formed by the tube wall of the tube 3350 or by one or more stiffening structures provided to the tube wall of the tube 3350. In the examples shown in FIGS. 8A - 10J, the rigid portion is formed by a plurality of raised portion connectors 3370 configured to withstand the separation of adjacent raised portions formed by folds within the tube wall. Specifically, the rigid portion is formed by a series of raised portion connectors 3370 along both the side portion and the rear side of the upper tube portion 3304. The tube 3350 including the rigid portion on both the front and rear sides of the tube 3350 is advantageous because it can have a higher resistance to bending in both the front and rear directions of the tube 3350. However, in some examples, depending on the rigidity, it may be possible to provide the rigid portion on only one side to be sufficient for the resistance to bending in both directions, so the rigid portion is provided only on the front or rear side of the tube 3350.

[0213] In some examples, the rigid portion of the tube 3350 can be provided to the extensible portion of the upper tube portion 3304. In the examples shown in FIGS. 8A-10J, the extensible portion includes an extensible bellows structure 3362 formed in the tube wall of the tube 3350 and an extensible bellows structure 3362 including a plurality of ridges 3372 and a plurality of grooves 3373, as will be described in further detail below. In this example, the rigid portion includes a plurality of ridge connectors 3370 formed in the tube wall, and each of the plurality of ridge connectors 3370 connects to a pair of adjacent ridges 3372. Hereinafter, the hardening effect of the ridge connector 3370 will be described in further detail.

[0214] In other examples of the present technology, the patient interface 3000 can include a tube 3350 having a rigid portion formed by a structure other than the ridge connector. In some examples, a portion of the tube 3350 (e.g., the front portion and / or the rear portion) can include a rigid portion hardened by one or more stiffening elements. The tube 3350 can be stiffened by one or more stiffening components that are more rigid than the tube 3350 embedded within the tube wall. For example, the tube wall can be overmolded onto an elongated bar or rod formed of a material that is harder than the tube wall portion. In other examples, the rigid portion of the tube wall can be obtained by further features of the geometry of the tube wall. In one example, the tube wall can include a greater material thickness at the front side and / or the rear side of the tube 3350. In another example, the tube wall can include a smaller groove depth (or ridge height) at the rigid portion of the tube 3350.

[0215] 5.3.2.1.3.2 Ridges and Grooves The extensible bellows structure 3362 forming each extensible tube portion includes a plurality of ridges 3372 and a plurality of grooves 3373, as shown in FIGS. 10D-10J. The ridges 3372 and the grooves 3373 are alternately formed within the wall of each tube 3350 to form a bellows structure. The alternating series of ridges and grooves is understood to refer to a series in which the grooves are provided between each pair of ridges and the ridges are provided between each pair of grooves (e.g., ridge, groove, ridge, groove).

[0216] The functions of the engaging ridges 3372 and grooves 3373 can be to fold or unfold individually or to cooperate to extend the bellows structure 3362 that can be extended, and thus to shorten or lengthen each tube 3350, etc. A greater groove depth (or ridge height) can result in a more extensible tube 3350. When tension is applied to the tube 3350, the ridges 3372 and grooves 3373 of the extendable bellows structure 3362 are pulled apart in a separating direction from each other, as a result of which the tube wall becomes straight and the tube 3350 is extended. In this example, the extendable bellows structure 3362 is biased to its original (e.g., non-extended) length. When the tension of the head gear is released, the ridges 3372 and grooves 3373 are biased, and each extendable bellows structure 3362 and tube 3350 returns to its original configuration with its original length.

[0217] The raised portions 3372 and the groove portions 3373 not only facilitate the change in length, but also can facilitate the change in the shape of the extensible bellows structure 3362 of each tube 3350. In some examples of the present technology, the first series of alternating raised portions 3372 and groove portions 3373 are provided on the first side (e.g., the patient contact side) of the tube 3350 within the extensible bellows structure 3362, and the second series of alternating raised portions 3372 and groove portions 3373 are provided on the second opposite side (e.g., the non-patient contact side) of the tube 3350. Since the raised portions 3372 and the groove portions 3373 can move relative to each other to different degrees on different sides of the tube 3350, the extensible bellows structure 3362 can facilitate the bending of the tube 3350. For example, on the first side of the tube 3350, the raised portions 3372 and the groove portions 3373 can come into contact, while on the second side of the tube 3350, the raised portions 3372 and the groove portions 3373 can expand, so that as a result, the tube 3350 bends within the extensible bellows structure 3362. Alternatively, the raised portions 3372 and the groove portions 3373 on both the first side and the second side can expand during use, while the raised portions 3372 and the groove portions 3373 on the first side can only expand slightly, so that the tube 3350 can bend (e.g., become curved) in the direction of the first side, for example, while extending in length, it can conform to or surround the patient's head (e.g., cover it in a drape-like manner).

[0218] In some examples, the first alternating series of ridges 3372 and grooves 3373 can have a lower tensile stiffness than the second alternating series of ridges 3372 and grooves 3373 (e.g., the force required to achieve a change in unit length can be lower). Because the tensile stiffness of the non-patient contact side of the extensible bellows structure 3362 is low, by extending the outboard side of the tube 3350 to cover an arc length longer than the inboard side of the tube 3350 in the extensible bellows structure 3362, it may be possible to advantageously promote bending / curvature in the tube 3350 during use. Although the tensile stiffnesses of both the first and second alternating series of ridges 3372 and grooves 3373 can be different from each other, the respective tensile stiffnesses can be selected to achieve the desired overall tensile stiffness of the extensible bellows structure 3362.

[0219] The ridges 3372 and grooves 3373 can each be formed along a portion of the tube wall around a majority of the longitudinal axis of the tube 3350 (e.g., the entire or most of the side of the tube 3350). As a result, it may be possible to bend the extensible bellows structure 3362 around multiple axes. As shown in FIGS. 10H-10J and 13, with the extensible bellows structure 3362 according to an example of the present technique, it may be possible to obtain the tube 3350 at multiple axes. In FIGS. 10H and 10I, the extensible bellows structure 3362 is shown bending in the upward-downward direction (e.g., so as to drape over the patient's head), and in FIG. 10J, the extensible bellows structure 3362 is shown bending in the forward-backward direction (e.g., so that the tube 3350 can be positioned over the upper part of the patient's head at different positions), and in FIG. 13, the extensible bellows structure 10J is shown bending simultaneously in both the up-down and forward-backward directions. In some examples, the ridges 3372 and grooves 3373 are each substantially linear. In other examples, the ridges 3372 and / or grooves 3373 can include one or more arcuate portions.

[0220]

[0221] As shown in FIG. 10D, each raised portion 3372 includes a central curved raised portion 3374. That is, each raised portion 3372 includes a high-precision portion at its center. However, at the end of each raised portion 3372, a linear raised portion 3375 is provided. Therefore, each raised portion 3372 includes a pair of linear raised portions 3375 provided at opposite ends of the raised portion 3372.

[0222] Similarly, each groove portion 3373 includes a curved groove portion 3376 at the center of each groove portion. Therefore, the center of each groove portion 3373 has high precision. Further, at the end of each groove portion 3373, a linear groove portion 3377 is provided. Each groove portion 3373 includes a pair of linear groove portions 3377 provided at opposite ends of the groove portion 3373. Each curved groove portion 3376 may include a curvature that matches or is defined by the curvature of a pair of adjacent raised portions 3372 (specifically, the curvature of the curved raised portion 3374).

[0223] Each raised portion connection portion 3370 connects to each adjacent pair of raised portions 3372 at the linear raised portions 3375 of the pair of raised portions 3372. Each linear groove portion 3377 may be defined along the length of the pipe 3350 and the raised portion connection portion 3370 above or below the linear groove portion 3377 between adjacent linear raised portions 3375 on either side (depending on whether the linear groove portion 3377 is on the upper or lower side of the pipe 3350, in the same manner as for each linear groove portion 3377).

[0224] The extensible bellows structure 3362 includes the raised portions 3372 and the groove portions 3373 outside the gas delivery tube 3350. On the other hand, the raised portions and the groove portions can also be formed inside the gas delivery tube 3350 by the folds forming the extensible bellows structure 3362 (for example, by the folds forming a wave shape (such as a sinusoidal shape, a square wave or other waveforms) in the tube wall). FIG. 10B shows a specific wave shape formed inside the tube wall. As shown in FIG. 10B, the extensible bellows structure 3362 includes the folds forming the internal raised portions 3382 and the internal groove portions 3383. Specifically, due to the folds in the tube wall, inside the tube 3350, a first alternating series of internal raised portions 3382a and internal groove portions 3383a are formed along the non-patient contact side of the tube 3350. Further, due to these folds, a second alternating series of internal raised portions 3382b and internal groove portions 3383b are formed along the patient contact side of the tube 3350.

[0225] Each internal groove portion 3383a of the first alternating series can be provided across the inside of the tube 3350 on the opposite side of each internal groove portion 3383b of the second alternating series, forming a plurality of pairs of opposing groove portions. That is, each internal groove portion 3383a on the non-patient contact side of the tube 3350 can be paired with the internal groove portion 3383b on the opposite side of the patient contact side. As shown in FIG. 10B, each pair of opposing groove portions includes the first internal groove portion 3383a and the second internal groove portion 3383b. In this example, the groove depth of the first internal groove portion 3383a is greater than that of the second internal groove portion 3383b. By making the groove depth of the first internal groove portion 3383a greater in each pair of opposing groove portions, the tensile stiffness of the first alternating series of raised portions and groove portions is lower than that of the second alternating series. In other examples of the present technology, the first alternating series The relatively low stiffness of the ridges and grooves forming it can be enabled by hardening a second alternating series of ridges and grooves. In one example, a ridge connection 3370 (described separately below) is provided in the tube wall to connect to pairs of adjacent ridges. In another example, the second alternating series of ridges and grooves is formed of a stiffer material than the first alternating series (e.g., a different material with higher stiffness or a region of silicone with a higher durometer in the case of a tube formed of silicone). In a further example, the second alternating series of ridges and grooves can be hardened by stiffening components.

[0226] In the illustrated example, the wall of the tube 3350 has a greater material thickness at the base of the second internal groove 3383b of each pair of opposing grooves than at the base of the first internal groove 3383a of each pair of grooves. The greater the material thickness forming the base of the second internal groove 3383b of each pair of grooves, the smaller the groove depth of the second internal groove 3383b. As the groove depth decreases, the extensibility of the extensible bellows structure 3362 (on the side having the second alternating series of ridges and grooves) decreases.

[0227] As shown in FIG. 10B, the material thickness of the tube wall at the base of each internal groove portion 3383b of the second alternating series decreases from the first end near the connection port 3600 to the second end along the length of the tube 3350. Further, the material thickness of the tube wall at the base of each internal groove portion 3383a of the first alternating series is substantially constant along the length of the tube 3350. The groove depths of the internal groove portions 3383a and 3383b of the first and second alternating series of internal ridges 3382 and internal groove portions 3383 decrease from the first end adjacent to the connection port 3600 to the second end along the length of the gas delivery tube 3350. When the groove depth decreases along the length of the bellows structure 3362 that can be extended on both sides of the tube 3350, the size change of the tube 3350 between the larger connection port 3600 and the smaller non-extendable tube portion 3363 is promoted. Although the groove depth is generally smaller at the second end than at the first end, for each pair of opposing groove portions, the groove depth of the second internal groove portion 3383b on the second patient contact side of the extendable bellows structure 3362 is smaller than the groove depth of the first internal groove portion 3383a on the opposite first non-patient contact side.

[0228] In this example, the first internal groove portion 3383a of each pair of opposing groove portions is joined to the second internal groove portion 3383b of each pair of opposing groove portions at the side of the tube 3350 between the non-patient contact side and the patient contact side. That is, the tube 3350 is grooved all the way to the inner periphery of the tube wall. Therefore, the first internal groove portion 3383a and the second internal groove portion 3383b of each pair of opposing groove portions are continuous. Similarly, each internal ridge 3382a of the first alternating series of internal ridges 3382a and internal groove portions 3383a is continuous with the internal ridge 3382b on the opposite side of the second alternating series of internal ridges 3382b and internal groove portions 3383b.

[0229] 5.3.2.1.3.3 Ridge connection As shown in FIGS. 10D - 10J, the extendable bellows structure 3362 also includes a plurality of bulge connectors 3370 provided on the tube wall of the gas delivery tube 3350. Each bulge connector 3370 connects to a pair of adjacent bulges 3372. Each bulge connector 3370 may include an integrally formed portion of the tube wall. Each bulge connector 3370 may be formed into the tube wall. Each bulge connector 3370 connects to two or more adjacent bulges 3372 and is configured to withstand the separation of the bulges 3372. Although the separation of the bulges 3372 cannot be avoided, the bulge connector 3370 may increase the rigidity of the extendable bellows structure 3362.

[0230] As one function of the bulge connector 3370, it may reduce the elongation ability of the extendable bellows structure 3362. Although the extendable bellows structure 3362 is intended to be extensible and has advantages related to the length - extensible tube 3350, if the extensibility of the length - extensible tube 3350 becomes excessive, it may be difficult for the patient to use it comfortably and reliably. Therefore, the bulge connector 3370 suppresses the length - elongation ability of the extendable bellows structure 3362 but does not prevent the elongation itself. In the illustrated example, the bulge connector 3370, together with the bulges 3372 and the groove 3373, forms the extendable bellows structure 3362. The extendable bellows structure 3362 promotes sufficient elongation up to the length of the tube 3350, improving the ability to fit a range of patient head sizes (without becoming so flexible that sufficient tension and sealing force cannot be achieved).

[0231] Each pair of adjacent ridges 3372 of the extensible bellows structure 3362 can be connected by at least one ridge connection part 3370. Alternatively or additionally, one or more pairs of adjacent ridges 3372 can be connected by two ridge connection parts 3370. As shown in FIGS. 10D to 10J, each pair of adjacent ridges 3372 of the extensible bellows structure 3362 is connected by two ridge connection parts 3370. Each of the ridge connection parts 3370 can be spaced apart centrally between the lower side (e.g., the patient contact side) of the gas delivery tube 3350 and the upper side (e.g., the side facing upward and / or outward) of the gas delivery tube 3350.

[0232] As another function of the ridge connection part 3370, there is a point that enables local hardening of the extensible bellows structure 3362. Locally hardening the extensible bellows structure 3362 can be advantageous for the headgear tube 3350, which is intended to be easily bendable around one axis and have a specific resistance to bending around different axes.

[0233] In some examples, the ridge connection part 3370 is provided between a ridge 3372 and a groove 3373 on one side of the tube 3350 configured not to bend more than the other side of the tube 3350. One or more ridge connection parts 3370 can be arranged on the side facing the front of the gas delivery tube 3350. Alternatively or additionally, one or more ridge connection parts 3370 can be arranged on the side facing the rear of the gas delivery tube 3350.

[0234] In the illustrated example, as shown in FIGS. 10D to 10J, the ridge connection part 3370 is provided to the positioning and stabilizing structure 3300 between the front and rear ridges 3372 of the extensible bellows structure 3362. That is, each pair of adjacent ridges 3372 is connected by a ridge connection part 3370 arranged on the side facing the front of the gas delivery tube 3350. Further, each pair of adjacent ridges 3372 is connected by a ridge connection part 3370 arranged on the side facing the rear of the gas delivery tube 3350.

[0235] In this example, since the raised portion connection part 3370 is provided on the front side and the rear side, a greater resistance is provided from the raised portion connection part 3370 to the extendable bellows structure 3362 that bends in the forward and backward directions (compared to bending in the upward and downward directions). The reason why this is advantageous is that the ability of the extendable bellows structure 3362 to bend and fit onto the upper and side surfaces of the patient's head is maintained. Due to such bending ability, the tube 3350 can extend downward in a draped manner over the patient's head and fit comfortably. On the other hand, if the ability of the extendable bellows structure 3362 to bend in the forward and backward directions decreases, the uppermost part of the positioning and stabilization structure 3300 may tend to move forward or backward or ride up during use, and in that case, the stability of the patient interface 3000 may be compromised.

[0236] As an advantage of providing the raised portion connection part 3370, the extensibility of the extendable bellows structure 3362 is limited (without overly compromising the ability of the extendable bellows structure 3362 to bend around a specific axis where it is advantageous for the extendable tube part to bend).

[0237] In some examples of the present technology, another function provided by the raised portion connection part 3370 is that the resistance to torsion of the extendable bellows structure 3362 increases. Since the connection port 3600 is provided between the extendable bellows structures 3362, in some situations, the tube resistance may act on the tube 3350 in a manner that induces torsion of the extendable bellows structure 3362. Although the tube 3350 has a non - conspicuous shape (for example, a substantially rectangular cross - section) and thus resistance to torsion can be obtained, additional torsional resistance is advantageously obtained from the raised portion connection part 3370. With the raised portion connection part 3370, the front side and the rear side of the extendable bellows structure 3362 can be hardened and function as hardening parts that reduce the possibility of torsion of the tube 3350.

[0238] In some examples of the present technology, the groove portion 3373 of the extensible bellows structure 3362 can be formed as a depression with respect to the outer surface of the gas delivery tube 3350. In other examples, the raised portion 3372 of the extensible bellows structure 3362 can be made to protrude in a raised manner with respect to the surface facing outward of the tube wall, and the groove portion 3373 can be formed by the space between the raised raised portions 3372. As shown in FIGS. 10D to 10J, the groove portion 3373 is formed as a depression with respect to the outer surface of the tube 3350. The outer surface of the tube 3350 that is the starting point of the concave shape of the groove portion 3373 can be continuous with the outer surface of the non-extensible tube portion 3363. An advantage of forming the groove portion 3373 as a depression with respect to the outer surface of the tube 3350 is that the raised portion 3372 does not protrude outward beyond the outer surface of the non-extensible tube portion 3363. When the raised portion protrudes outward, it can be uncomfortable for the patient.

[0239] Also, as shown in FIGS. 10D to 10J, the surface facing outward of the raised portion connection part 3370 does not protrude outward more than the raised portion 3372 with respect to the longitudinal axis of the tube. Further, each of the raised portion connection parts 3370 includes a surface facing outward that is continuous with the surface facing outward of the adjacent raised portion 3372. For example, if the raised portion connection part 3370 is made to protrude outward more than the raised portion 3372 with respect to the longitudinal axis of the tube 3350 for increasing bending and / or torsional resistance, although this is the case in some examples of the present technology, the aesthetics may be slightly impaired.

[0240] Furthermore, as shown in FIGS. 10D to 10J, each of the plurality of groove portions 3373 is disposed between each pair of raised portion connection parts 3370. Each of the respective raised portion connection parts 3370 is disposed at each end of each groove portion 3373. Further, each of the plurality of groove portions 3373 includes a groove depth, and each of the plurality of raised portion connection parts 3370 includes a height of the raised portion connection part. In each set of the raised portion connection part 3370 and the groove portion 3373, the groove depth is equal to the height of the raised portion connection part. That is, the groove depth of each groove portion 3373 is equal to the height of the raised portion connection part of each of the pair of raised portion connection parts 3370 disposed at each end of each groove portion 3373. Therefore, the groove portion 3373 is formed as a depression with respect to the outer surface of the raised portion connection part 3370, the raised portion 3372, and the tube wall of the tube 3350.

[0241] As shown in the illustrated example, the raised portion connecting portion 3370 can be relatively narrow and rib-shaped. Alternatively, the raised portion connecting portion 3370 can be thicker (e.g., so as to occupy a larger portion of the front and rear sides of the extensible portion of the tube 3350).

[0242] In the illustrated example, the raised portion connecting portion 3370 is provided outside the tube 3350. That is, the raised portion connecting portion 3370 connects to the raised portion 3372 on the outer side of the tube wall (rather than on the inner side defining the hollow interior within the tube 3350). In other examples, the raised portion connecting portion 3370 can be provided inside the tube wall of the tube 3350. By the creases in the tube wall forming the extensible bellows structure 3362, a series of alternating raised portions and groove portions opposite to the series of raised portions 3372 and groove portions 3373 formed on the outer side of the tube wall can be formed inside the tube wall. That is, by the creases forming the raised portions 3372 on the outer side of the tube wall, groove portions can be formed around the inner circumference of the tube wall. Similarly, by the creases forming the groove portions 3373 on the outer side of the tube wall, raised portions can be formed inside the tube wall.

[0243] The raised portion connecting portion 3370 connects between adjacent raised portions on the outer or inner side of the tube 3350 and can withstand the separation of the raised portions. In an example of the positioning and stabilizing structure 3300 with the raised portion connecting portion 3370 provided outside the tube 3350, the raised portions 3372 outside the tube are connected. Larger tension is required to separate these raised portions 3372, while the raised portions inside the tube are more freely separable. Similarly, in another example of the positioning and stabilizing structure 3300 connecting the raised portions inside the tube 3350 by the raised portion connecting portion 3370, in the case of the raised portions inside the tube wall, a larger force is required for separation, while the raised portions outside the tube are more freely separable. In some examples, the raised portion connecting portion 3370 connects a combination of inner and outer raised portions.

[0244] In some examples of the present technology, a plurality of raised portions 3372 are connected by a single raised portion connection 3370. In other examples, each raised portion connection 3370 connects only a single pair of adjacent raised portions 3372. In some examples, one or more raised portion connections 3370 may connect non - adjacent raised portions 3372 (e.g., the first and last raised portions, every second raised portion).

[0245] 5.3.2.1.4 Non - extensible headgear tubing The patient interface 3000 may include one or more non - extensible tubing portions 3363. For example, the patient interface 3000 shown in FIGS. 8A - 9C includes a tube 3350. A non - extensible tubing portion 3363 is provided below the tube 3350. The non - extensible tubing portion 3363 may be configured to be placed on the patient's cheek and to contact the patient's face below the patient's cheekbone. Each non - extensible tubing portion 3363 may extend downward from the connection between each headgear tube 3350 on a curve and then extend partially forward and partially in an intermediate direction to the seal - forming structure 3100 so as to avoid the patient's cheekbone.

[0246] The positioning and stabilization structure 3300 of the patient interface 3000 is advantageous because it is not placed on the patient's cheekbone. The area below the cheekbone in the patient's face generally has more flesh, so the patient can tolerate the state where the headgear tubes 3350 are placed on these face areas. Further, since the cheekbone area of the patient's face is relatively immobile or deformable, the non - extensible tubing portion 3363 is firmly placed against the fleshy cheek area. Further, the patient's cheekbone can help avoid the situation where the lower part of the headgear tube 3350 rides up from the cheekbone to the patient's eye. When the non - extensible tubing portion 3363 fits snugly against the patient's cheek below the cheekbone, a barrier can be obtained against the situation where the headgear tube 3350 rides up to the patient's eye (resulting in an impact on stability and / or blocking the patient's field of vision) due to the hardness and protrusion of the patient's cheekbone.

[0247] The cross-sectional shape of the non-extendable tube portion 3363 of the tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, as described, for example, in U.S. Patent No. 6,044,844. The cross-sectional shape showing the flat surface of the tube on the side facing and contacting the patient's face or other part of the head can be worn more comfortably than, for example, a tube having a circular cross-section.

[0248] The cross-sectional width and / or height of the tube 3350 can be 8 to 25 mm (for example, 10 to 20 mm). In some forms where the tube has a D-shaped cross-section, for example, in the longitudinal cross-section of the headgear tubing 3350 shown in FIG. 10C, the width of the tube is 15 to 25 mm (for example, 20 mm) and the height is 8 to 15 mm (for example, 10 mm). The height can be considered as the dimension of the tube extending in the direction away from the patient's face during use (i.e., the distance between the side 3348 in contact with the patient and the outermost part of the side 3349 not in contact with the patient), and the width can be considered as the dimension across the surface of the patient's head. The cross-sectional thickness of the material forming the tube 3350 can be 0.8 to 1.6 mm (for example, 1.0 to 1.5 mm (for example, 1.3 mm)).

[0249] The D-shaped cross-section tube 3350 has a curved edge 3347 located on the side surface of the side 3348 in contact with the patient. The curved edge that contacts the patient's skin or is in the vicinity of the patient's skin helps to increase the comfort during the wearing of the patient interface 3000 and to avoid marks or inflammation on the patient's skin. Making the tube have a D-shaped cross-section profile also makes it more resistant to buckling than in the case of other shaped outer profiles.

[0250] As a further advantage of the D-shaped cross-section of the non-extendable tube portion 3363 of the tube 3350, the non-extendable tube portion 3363, which is placed in front of the patient's face during use, is more resistant to bending in the vertical direction than in the horizontal direction. Since the non-extendable tube portion 3363 has a D-shaped cross-section, the tube portion can better withstand bending parallel to the major axis of the D-shaped shape than bending perpendicular to the major axis of the D-shaped shape. By doing so, while maintaining rigidity in the vertical direction to move the vertical force added from the extendable bellows structure 3362 to the non-extendable tube portion 3363 to the seal forming structure 3100 to provide the necessary sealing force to the seal forming structure 3100, the non-extendable tube portion 3363 can be more easily bent in a curved shape from around the front of the patient's face inward to the seal forming structure 3100, which is advantageous.

[0251] Since it can be bent inward around the front of the patient's face, the non-extendable tube portion 3363 can fit snugly against the patient's cheek under the zygomatic bone of the patient. As described in more detail above, the non-extendable tube portion 3363 placed snugly under the zygomatic bone of the patient can obtain a more stable seal than when the non-extendable tube portion 3363 is placed loosely on the patient's cheek or above the zygomatic bone of the patient.

[0252] In other examples, the non-extendable tube portion 3363 may include a rectangular cross-section. With a rectangular cross-section, advantages similar to those of the D-shaped cross-section can be obtained. Specifically, with a rectangular cross-section, the non-extendable tube portion 3363 can obtain higher resistance to bending in a direction parallel to the short side of the rectangular cross-section. In other examples, since the non-extendable tube portion 3363 may include an elliptical or oval-shaped cross-section, similar advantages can be obtained.

[0253] In some examples of the present technology, the non-extendable tube portion 3363 is connected to the cradle cushion module 3150 at a low angle. As described above, after the headgear 3350 extends downward along the side of the patient's head, it can curve forward and in the middle direction and connect to the cradle cushion module 3150 in front of the patient's face. Before the tube 3350 is connected to the cradle cushion module 3150, in some examples, it can extend to the same vertical position as the connection to the cradle cushion module 3150 or to a position below the connection to the cradle cushion module 3150. That is, the tube 3350 can be connected to the cradle cushion module 3150 after at least partially protruding upward. A part of the tube 3350 can be disposed below the cradle cushion module 3150 and / or the seal forming structure 3100. Since the tube 3350 is disposed downward in front of the patient's face, contact with the patient's face below the zygomatic bone of the patient is promoted.

[0254] 5.3.2.2 Sizing and Rigidity of Headgear The size of the positioning and stabilization structure 3300 can vary between different examples of the present technology. By providing different size options for the patient interface 3000, it may be possible to accommodate more patients. The loop around the patient's head can be formed by a pair of headgear tubes 3350 and a cradle cushion module 3150 (or a pillow cushion module 3160 or other seal forming structure 3100) connected between the lower ends of the tubes 3350. The size of this loop can vary to accommodate different sized patient interfaces 3000.

[0255] In one example, the unstretched length of the loop formed by the tube 3350 and the cradle cushion module 3150 can be measured along the center line on the patient-facing side of the loop and can be in the range of 510 - 610 mm. In some examples, the unstretched length of this loop can be in the range of 525 - 600 mm. In some examples, the length of this loop can be in the range of 535 - 590 mm.

[0256] In some specific examples, the unstretched length of the above-mentioned loop can be in the range of 528 to 548 mm (for example, in the range of 535 to 541 mm (for example, about 538 mm)). In further specific examples, the length of this loop can be in the range of 534 to 554 mm (for example, in the range of 539 to 549 mm (for example, about 544 mm or about 547 mm in the example)). In further specific examples, the unstretched length of this loop can be in the range of 541 to 561 mm (for example, in the range of 546 to 556 mm (for example, about 551 mm)).

[0257] In other specific examples, the unstretched length of the above loop can be in the range of 564 to 584 mm (for example, in the range of 571 to 581 mm (for example, about 574 or about 579 mm)). In further examples, the unstretched length of this loop can be in the range of 577 to 597 mm (for example, 582 to 592 mm (for example, about 583 mm or about 587 mm)).

[0258] Specifically, the length of the gas delivery tube 3350 can be variable to enable the positioning and stabilization structure 3300 to be of different sizes. In some examples, the unstretched length of the tube 3350 measured along the centerline on the patient-facing side of the tube 3350 can be in the range of 500 to 535 mm (for example, 510 to 525 mm (for example, 512 to 522 mm (for example, about 517 mm))). In further examples, the unstretched length of the tube 3350 can be in the range of 460 to 500 mm (for example, in the range of 470 to 490 mm (for example, in the range of 475 to 485 mm (for example, about 481 mm)).

[0259] As further detailed above, in some examples of the present technology, the headgear tube 3350 includes an extendable portion (e.g., an extendable bellows structure 3362). In some examples of the present technology, the extendable portion of the gas delivery tube 3350 (e.g., a single bellows portion on one side of the positioning and stabilizing structure 3300) may have a stiffness (of the extension portion) in the range of 2-3.5 N / 10 mm (e.g., 0.2-0.35 N / mm). In a detailed example, the stiffness of the extendable portion may be in the range of 2.5-3 N / 10 mm (e.g., 0.25-0.3 N / mm). In one example, the stiffness of the extendable portion may be approximately 2.75 N / 10 mm (e.g., 0.275 N / mm). In further examples of the present technology, the tension required to extend the extendable portion of the tube 3350 by 10 mm in length may be between 2.5N and 3N, and the tension required to extend the length by 20 mm may be between 5N and 5.5N. It is understood that in various examples of patient interfaces 3000 in accordance with the present technology, any of these disclosed stiffnesses may be provided to tubes 3350 having any of the sizes (e.g., lengths) described above.

[0260] 5.3.2.3 Headgear straps In certain forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap. These headgear straps function to position and stabilize the seal-forming structure 3100 in a sealed position relative to an entrance to the patient's airway, in addition to the tube 3350. As shown in Figures 8A-9C, the patient interface 3000 includes a strap 3310 that forms part of the positioning and stabilizing structure 3300. The strap 3310 may be known, for example, as a rear strap or a rear headgear strap. In other examples of the present technology, one or more additional straps may be provided. For example, a patient interface according to an embodiment of the present technology having a full face or oral-nasal cushion module may be provided. The patient interface 3000 may have a second, lower strap configured to rest on the back of the patient's neck.

[0261] 5.3.2.3.1 Straps In the examples shown in FIGS. 8A-9C, the strap 3310 of the positioning and stabilization structure 3300 is disposed on each side of the patient's head and passes behind the patient's head (e.g., covering or encompassing the posterior portion of the occipital bone of the patient's head during use) and is connected between two tubes 3350. The strap 3310 connects to each tube above the patient's ear. In other embodiments, for example, as part of a nasal-oral patient interface, the positioning and stabilization structure 3300 includes an upper strap similar to the strap 3310 and at least one additional lower headgear strap. These lower headgear straps connect between tubes and / or cushion modules, pass under the patient's ear, and pass behind the patient's head. Such lower headgear straps can also be connected to the upper strap (e.g., one similar to the strap 3310).

[0262] In certain forms of the technology, the positioning and stabilization structure 3300 includes a mechanism for connecting a headgear strap to the headgear tubes 3350. The headgear strap can be connected directly or indirectly to the headgear tubes 3350. In the case of the patient interface 3000 shown in FIGS. 8A-9C, for example, tabs 3320 configured to connect to the strap 3310 project generally rearwardly outwardly from each headgear tube 3350. These tabs 3320 have holes therein for receiving the ends of the strap 3310.

[0263] In some forms of the present technology, the strap 3310 is adjustable. For example, in the case of the patient interface shown in FIGS. 8A-9C, the strap 3310 is screwed through holes in the form of eyelets in each tab 3320 during use. The length of the strap 3310 between the tabs 3320 can be adjusted by pulling a greater or lesser number of straps 3310 through one or both of the tabs 3320. The rear strap 3310 can be secured to itself by passing the strap 3310 through the eyelet in the tab 3320 using, for example, hook and loop fastening means. Thus, the strap 3310 can be adjusted to fit different head sizes. In some forms of the present technology, the angle of the strap 3310 relative to the headgear tube 3350 or the patient's head can be adjusted to fit around the patient's head at different positions. Such adjustability aids in enabling the positioning and stabilization structure 3300 to accommodate different head shapes and sizes.

[0264] In some forms of the present technology, the strap 3310 applies a force to the headgear tube 3350 to pull the headgear tube 3350 at least partially in a rearward (e.g., posterior) direction at the position of the tab 3320. The strap 3310 can also apply a force to the headgear tube to pull the headgear tube at least partially in an inward (e.g., posterior) direction. The magnitude of this force can be adjusted by changing the length of the strap 3310 between the tabs 3320.

[0265] In some embodiments of the present technology, such as the form shown in FIGS. 8A-9C, the direction of the force applied from the strap 3310 to the headgear tube 3350 may be changed. This direction may be changed by adjusting the angle of the strap 3310 relative to the headgear tube 3350 or the patient's head. In some forms of the present technology, the position at which the force is applied from the strap 3310 to the headgear tube 3350 can be changed by adjusting the position at which the strap 3310 is secured to the headgear tube 3350.

[0266] It may be advantageous that the positioning and stabilization structure 3300 can accommodate a range of head sizes and head shapes by being able to adjust the magnitude and direction of the force applied from the strap 3310 to the headgear tube 3350. The strap 3310 can maintain the balance of forces in the headgear tube 3350, thereby assisting the headgear in maintaining its shape and achieving an effective seal against the patient's face while maintaining comfort.

[0267] In some forms of the technology, upon donning by the patient, the point on the headgear tube 3350 near the tab 3320 generally receives an upward (e.g., upward) force from the upper portion of the headgear tube 3350 due to the tension in the headgear tube 3350 and, in some embodiments, due to a biasing mechanism (described in more detail below) that functions to hold the headgear in a fixed position on the patient's head. Further, the point on the headgear tube 3350 near the tab 3320 can receive a generally forward (e.g., forward) and downward (e.g., downward) force generated from a biasing mechanism that functions to propel the seal-forming structure 3100 upward and into the patient's nose. The direction and magnitude of the forces required for a secure fit and effective seal can vary among patients based on the position of the positioning and stabilization structure 3300 on the head, which can vary, for example, due to differences in head shape and size. In some forms of the technology, since the rear headgear strap 3310 is adjustable, it is possible to balance the forces for a range of head shapes and sizes so as to hold the positioning and stabilization structure 3300 in a comfortable position while maintaining an effective seal.

[0268] For example, in order to increase the force applied to the portion of the headgear tube 3350 near the tab 3320 in the rear (e.g., posterior) direction, the strap 3310 can be adjusted by pulling a larger number of straps 3310 through the slots in the tab 3320. Thereby, the length of the strap 3310 can be shortened, and in particular, when the strap 3310 is elastic, a greater force is applied to the headgear tube 3350 in the rear (e.g., posterior) direction. Similarly, in order to balance both the vertical and horizontal components of the force acting on the portion of the headgear tube 3350 near the tab 3320 for a certain range of head shapes and sizes, the angle of the strap 3310 can be adjusted as needed.

[0269] The strap 3310 can include a rectangular cross-section along part or all of its length. Further, the strap 3310 can have a profile that includes one or more curved edges that provide improved comfort and a reduced risk of marks or inflammation on the patient by the headgear strap. In certain forms of the technology, the positioning and stabilization structure 3300 includes a strap 3310 that is bendable and, for example, non-rigid. An advantage of this aspect is that the strap 3310 is more comfortable when the patient lies on their side during sleep.

[0270] In certain forms of the technology, the positioning and stabilization structure 3300 includes a strap 3310 that includes two or more strap bands separated by a split. For example, as shown in FIGS. 8A - 9C and FIGS. 12A - 12F, the strap 3310 includes a split 3313 configured to be positioned against the rear of the patient's head during use. Depending on the patient interface design, the split strap 3310 can anchor the patient interface 3000 onto the patient's head in a particularly stable manner. The rear of the patient's head can have a complex geometry, and providing the split 3313 in the strap 3310 can potentially assist in better conforming the strap to the rear of the patient's head.

[0271] 5.3.2.3.2 Eyelet As described above, each gas delivery tube can include an eyelet for connection to a strap. In some examples, the eyelet can be circular. In other examples, the eyelet can be elongated. Alternatively, the eyelet can have a curved side and a straight side. The eyelet can be, for example, D-shaped. The eyelets in the exemplary patient interface 3000 shown in FIGS. 8A-9C take the form of slits 3322. In this example, a pair of slits 3322 are obtained from a pair of gas delivery tubes 3350 that allow the strap 3310 to be connected. That is, the strap 3310 can be connected between the eyelets. The strap 3310 can be constructed and arranged to be positioned under the occipital bone of the patient's head or to contact the area of the patient's head that is positioned on the occipital bone of the patient's head during use. In this example, the slits 3322 are formed in tabs 3320 connected to the tube walls of the tubes 3350.

[0272] In some examples of the present technology, the eyelets can be arranged along each tube 3350, each of which is 70 mm to 150 mm, from the center of the pair of tubes 3350 (e.g., connection port 3600) along the tube 3350. In a further example, each eyelet can be arranged along each tube 3350 between about 110 mm and 130 mm from the center of the pair of tubes 3350. In a particular example, the eyelet can be arranged along each tube 3350 between about 120 mm and 125 mm from the connection port 3600. In the case of the illustrated positioning and stabilization structure 3300 having slits 3322, the midpoints of these slits are arranged at about 120-125 mm from the center of the pair of gas delivery tubes 3350.

[0273] The exemplary patient interface 3000 shown in FIGS. 8A - 9C includes a single rear headgear strap 3310. This rear headgear strap 3310 passes between slits 3322 and is often necessary when adding force to tube 3350 in a partially downward and partially rearward direction. In order to add force to the tube 3350 in the required direction, the strap 3310 needs to surround the lower part around the rear of the patient's head. Typically, the rear of the patient's head generally curves downward and covers the occipital bone of the skull in the forward direction (up to the position where the head joins the patient's neck).

[0274] If the strap 3310 is not properly placed below the rear of the patient's head (for example, if it does not come below the lowest point of the patient's head where the back of the patient's head curves forward and partially downward), there is a risk that the strap 3310 will ride up on the rear of the patient's head during use. When the strap 3310 rides up above the lowest point of the patient's head, the strap 3310 can be placed on an area of the patient's head that is partially upward-facing. If such a situation occurs, the tension in the strap 3310 can further pull the strap upward, which can lead to a failure to provide the necessary sealing force vector from the positioning and stabilization structure 3300 to the seal formation structure 3100 (subsequently, the seal against the patient's face may be compromised, and the patient may need to re - don the patient interface 3000).

[0275] As shown in FIGS. 11A - 11C, each gas delivery tube 3350 can include a tube wall 3352 that defines a hollow interior (e.g., forms a conduit) along the length of the tube 3350. Pressurized airflow can be sent from the connection port 3600 through the hollow interior within the tube wall 3352 to the seal formation structure 3100.

[0276] In the examples shown in FIGS. 11A - 11C, the tube 3350 includes the tabs 3320. In this example, the tabs 3320 of the positioning and stabilization structure 3300 are each integrally formed with each tube wall 3352 of the tube 3350. Alternatively, the tabs 3320 can be separate components and assembled with the tube 3350. For example, separate components that may be included in the tabs 3320 can be movably connected to the tube 3350 to enable adjustment of the position and / or angle of the tabs 3320. By integrally forming the tabs 3320 with the tube wall 3352, the necessary assembly work is reduced, and an improvement in the ease of use of the positioning and stabilization structure 3300 can be obtained. Further, the integrally formed tabs 3320 can enable a seamless connection between the tabs 3320 and the tube wall 3352, reducing the possibility of connections that can cause discomfort to the patient.

[0277] In the illustrated examples, each tube 3350 includes an extensible tube portion in the form of an extensible bellows structure 3362. Each tab 3320 is joined to the tube wall 3352 of the gas delivery tube 3350 below the extensible tube portion. Specifically, each tab 3320 is joined to the tube wall 3352 of the gas delivery tube 3350 in the non - extensible tube portion 3363 below the extensible tube portion. In some examples, each tab 3320 can have an upper edge 3331 spaced from the end of the extensible tube portion along the length of the tube 3350. In other examples, the tab 3320 can have an upper edge 3331 that meets the tube wall 3352 at or near the lower end of the extensible tube portion.

[0278] In the examples shown in FIGS. 11A - 11C, the slit 3322 of the tube 3350 is formed in the tab 3320. In other examples, the slit 3322 can be formed directly within the tube wall 3352 or alternatively, within a separate component configured to be connected to another part of the positioning and stabilization structure 3300 or to the positioning and stabilization structure 3300.

[0279] The slits 3322 can each be arranged at a distance rearward from the tube wall of each tube 3350 during use. Specifically, each slit 3322 can be arranged side by side with each slit 3322 at a distance rearward from the slit adjacent part 3355 of the tube wall 3352. The slit adjacent part 3355 of the tube wall 3352 can be the part of the tube wall 3352 to which the tab 3320 is connected. More specifically, the slit adjacent part 3355 of the tube wall 3352 can be the part of the tube wall 3352 that is closest to the slit 3322. In some examples, the slit 3322 can be arranged at a distance rearward with respect to the entire length of the tube wall 3352. The slit 3322 can be arranged above the upper eardrum point of the patient's head during use.

[0280] As shown in FIGS. 8A to 8C, each of the tube walls 3352 is configured to be placed on the patient's head along a path 3353 that passes between the patient's eye and ear. A part of the path 3353 is illustrated in FIGS. 11A and 11B. In some examples, the path 3353 is generally a path on the surface of the patient's head, and the tube wall 3350 is placed along this path on this path. Further, the path 3353 can be a path that guides the gas flowing through the tube 3350 to move from above the patient's head to the seal forming structure 3100. In fact, in some examples, since the path 3353 may not be restricted to a plane, the path 3353 can include a curve in three-dimensional space (for example, a space curve). In the illustrated example, the tube 3350 extends laterally and downwardly on the side of the patient's head and then extends downwardly, forwardly and in an intermediate direction to connect to the cradle cushion module 3150.

[0281] As shown in FIGS. 11A to 11C, each of the slits 3322 includes an upper end 3326 and a lower end 3327. The upper end 3326 and the lower end 3327 can be regarded as a first end and a second end, respectively. In this example, the upper end 3326 is disposed at a greater distance from the slit adjacent portion 3355 of the tube wall 3352 than the lower end 3327. As shown in FIG. 11A, the upper end 3326 of the slit 3322 is disposed at a distance from the tube wall 3352 with an interval indicated by SE in the figure. The lower end 3327 of the slit 3322 is disposed at a distance from the tube wall 3352 by an interval indicated by IE. As shown in the figure, since the interval SE is larger than the interval IE, the upper end 3326 is disposed at a greater distance from the tube wall 3352 than the lower end 3327. When the patient wears the patient interface 3000 including the positioning and stabilization structure 3300, the upper end 3326 is disposed at a distance rearward from the lower end 3327. Unless otherwise specified in the context, when an end of a slit or an eyelet is described as being disposed at a greater distance from the tube wall than another end of the same slit or eyelet, this described distance should be understood as the portion of the tube wall that is generally adjacent or closest to the slit or eyelet (e.g., the portion adjacent to the slit or adjacent to the eyelet).

[0282] As shown in FIG. 11B, the slit 3322 is oriented with an angle at the slit adjacent portion 3355 of the tube wall 3352 with respect to the orientation of the tube 3350. The slit 3322 is also oriented with an angle at the slit adjacent portion 3355 of the tube wall 3352 with respect to the path 3353. In this example, the slit 3322 is arcuate between the upper end 3326 and the lower end 3327. Each of the slits 3322 has a curved elongated shape. In other examples, each slit 3322 can be linear between the upper end 3326 and the lower end 3327. By making the slit 3322 into a curved arcuate shape, advantageously, the strap 3310 can be extended through the slit to the center within the slit 3322, and the slit 3322 can also withstand a certain variation in the angle of the strap 3310 extending through the slit 3322 (without causing a situation where the strap 3310 becomes bundled as it goes towards one end of the slit 3322).

[0283] Illustrated in FIG. 11B is the longitudinal axis 3323 of the slit 3322. In this example, since this slit is elongated, the longitudinal axis 3323 is defined along the general length of the slit 3322. The arcuate slit 3322 (for example, the slit 3322 shown in FIGS. 11A - 11C) is also elongated, and thus can include a longitudinal axis. In the case of the arcuate slit 3322, it is understood that the longitudinal axis 3323 can be defined by the general direction from one end of the slit 3322 to the other end, although it is not parallel to each part of the side of the slit 3322. Alternatively, the longitudinal axis 3323 of the arcuate slit 3322 can be defined by the tangent to the curvature of the slit 3322 at the central portion of the slit 3322.

[0284] The slit 3322 may have a rear-upper to front-lower orientation during use. That is, the length of the slit 3322 (e.g., the length axis 3323) may be aligned parallel to a line extending between the rear-upper direction and the front-lower direction. With this orientation, the upper end 3326 of the slit 3322 is disposed rearwardly spaced from the lower end 3327 of the slit 3322. Illustrated in FIG. 11B is a tangent line 3354 to the path 3353 at the slit adjacent portion 3355 of the tube 3350. As shown, a slit angle 3321 is formed with the tangent line 3354 of the path 3353 together with the length axis 3323 of the slit 3322. In this example, the slit angle 3321 is an oblique angle. The oblique angle may be within the range of 5 to 30 degrees. In some examples, the oblique angle may be within the range of 10 to 20 degrees. For example, the oblique angle may be within the range of 12 to 18 degrees. In a particular example, the oblique angle may be about 13 degrees, 15 degrees or 17 degrees. In some examples, the slit 3322 may be angled along the length of the bellows structure 3362 that is extensible relative to the longitudinal axis. Specifically, the slit 3322 may be oriented at an angle of 15 to 45 degrees with respect to the longitudinal axis of the bellows structure 3362 that is extensible when straightened. For example, this angle may be within the range of 20 to 40 degrees (e.g., within the range of 22 to 35 degrees). In a particular example, this angle may be about 25 degrees to 31 degrees with respect to the longitudinal axis of the bellows structure 3362 that is extensible when straightened.

[0285] Angling the slit 3322 rearwardly with respect to the tube wall 3352 or the path 3353 (e.g., disposing the upper end 3326 further spaced from the tube wall 3352 or the path 3353 than the lower end 3327) may enable and be advantageous for a better fit for the reception of the strap 3310 from a lower position around the rear of the patient's head. In an ideal setup, the strap 3310 extends from the slit 3322 in a direction perpendicular to the length axis 3323 of the slit 3322. Thus, angling the slit 3322 more rearwardly When angled, the slit 3322 is angled to receive the strap 3310 from a smaller angle, so it can better correspond to the strap 3310 placed downward around the rear of the patient's head. In contrast, when the slit 3322 is oriented closer to the vertical orientation, the slit 3322 is angled to receive the strap 3310 from a higher position on the patient's head. Thus, when the slit 3322 is oriented at a larger angle with respect to the adjacent portion of the tube wall 3352 and / or the path 3353, it may be possible to obtain a certain resistance against the strap 3310 that rides on the rear of the patient's head (e.g., slides upward).

[0286] Other methods are available to reduce the tendency of the strap 3310 to ride on the back of the patient's head (e.g., by providing a split in the strap 3310 so that the patient fastens the strap 3310 and / or by providing the slit 3322 at a low position). By providing the slit 3322 at an angle rotated rearward to the tube 3350, it may be possible to obtain additional resistance against the riding up of the strap 3310. In some examples, each slit 3322 may be angled to receive the strap 3310 (from the direction in which the strap 3310 is placed across the region placed on the lower part of the occipital bone of the patient's head). In a further example, the slit 3322 may be angled to receive the strap 3310 from the direction in which the strap 3310 is placed at the center or top of the patient's occipital bone.

[0287] Each slit 3322 can be oriented perpendicular to the direction from the slit in the strap anchor region where the strap is to be anchored around the patient's head. The strap anchor region can be a region placed on the occipital bone of the patient (e.g., the lower part of the occipital bone). In some examples, the strap anchor region can be a region placed below the occipital bone of the patient's neck. In some examples, in some examples, the strap 3310 can be placed on the upper part of the patient's trapezius muscle or on a part of the patient's neck or head below the occipital bone, and the slit 3322 can be angled to receive the strap 3310 from the corresponding direction.

[0288] For example, as shown in FIG. 8C, the slit 3322 is angled sufficiently rearward to receive the strap 3310 from the direction in which the strap 3310 is placed across the rear region of the patient's head below the lowermost part of the patient's head. The strap 3310 can be placed on the rear surface of the patient's head that is at least partially downwardly directed, and the slit 3322 can be angled sufficiently rearward to receive the strap 3310 from this location. An advantage of placing the strap 3310 on the rear surface of the patient's head that is at least partially downwardly directed is that an eyelet is disposed above the rearmost part of the strap 3310. After tension is applied to the strap 3310, the tube 3350 applies an upward force, at least in part, onto the strap 3310. That is, the likelihood that the strap 3310 will ride up (when anchored to the downwardly directed rear surface of the patient's head) can be reduced.

[0289] Referring to FIGS. 11A to 11C, tab 3320 includes an upper edge 3331 and a lower edge 3332. In this example, the upper edge 3331 is longer than the lower edge 3332. By making the upper edge 3331 longer, an asymmetric shape is obtained such that tab 3320 faces more downward than the direction in which tab 3320 would face if the length of the upper edge 3331 were equal to the length of the lower edge 3332. Slit 3322 has a substantially central position between the upper edge 3331 and the lower edge 3332. Thus, due to such an asymmetric-shaped tab 3320, slit 3322 is provided facing more downward. When tab 3320 faces downward, it may be advantageous to reduce the tendency of strap 3310 to ride up on the back of the patient's head.

[0290] In addition to giving slit 3322 an oblique slit angle 3321, slit 3 322 may be arranged at a sufficient distance from the tube wall 3352 to further reduce the tendency of strap 3310 to ride up on the back of the patient's head. By sparing no distance between the slit or other eyelet and the tube wall 3352, it may be possible to reduce the distance between the eyelet and the back of the patient's head, which is advantageous. By making the distance between the eyelet and the back of the patient's head relatively short, it may be possible to shorten the length of strap 3310. Strap 3310 is placed laterally on the sides of the patient's head and extends between slits 3322 and opposes the force of the patient's head rearward. By thus shortening the distance and the strap length, it may be possible to advantageously suppress the rotation of strap 3310 relative to the eyelet, thereby reducing the tendency of strap 3310 to ride up upward or downward during use.

[0291] In some examples, the lower end 3327 of slit 3322 may be arranged at least 5 mm away from the tube wall 3352. In a further example, the lower end 3327 of slit 3322 may be arranged at least 7 mm away from the tube wall 3352. For example, the lower end 3327 of slit 3322 may be arranged at least about 8 mm or more away from the tube wall 3352.

[0292] The upper end 3326 of the slit 3322 can be arranged at least 8 mm apart from the pipe wall 3352. In some examples, the upper end 3326 of the slit 3322 can be arranged at least 10 mm apart from the pipe wall 3352. For example, the upper end 3326 of the slit 3322 can be arranged 12 mm or more apart from the pipe wall 3352.

[0293] In some examples, the midpoint 3322 along the slit can be arranged at an interval within the range of approximately 5 mm to 30 mm from the pipe wall 3352. Although it is advantageous in terms of increasing the stability of the strap 3310 to make the interval between the air vent and the pipe wall 3352 extremely large, problems may arise in terms of manufacturability, weight, comfort, and aesthetics due to the increase in the size of the tab 3320. When the interval is within the range of 5 to 30 mm (for example, within the range of 7 mm to 20 mm), it can lead to the benefit of stability in avoiding the riding up of the rear headgear strap 3310, and the problems caused by the increase in the size of the tab 3320 are avoided or minimized. In further examples, this interval can be within the range of 8 mm to 15 mm (for example, within the range of 9 mm to 13 mm). In some specific examples, the above interval can be about 9 mm to 11 mm (for example, about 9.5 mm or 9.75 mm).

[0294] 5.3.2.3.3 Trough FIG. 11C is an enlarged perspective view of one of the tabs 3320 of the positioning and stabilizing structure 3300. As shown, in some examples, a trough 3324 that may be included in the tab 3320 of the positioning and stabilizing structure 3300 is formed in the tab and is disposed behind the slit 3322. The trough 3324 may be formed in the body of the tab 3320 at a position below the strap 3310. In this example, the trough 3324 is provided between the slit 3322 and the rear side 3329 of the tab 3320. The tab 3320 may include a tab surface 3328 that faces outward (e.g., in the lateral direction) on the side of the tab 3320 that faces away from the patient. The tab surface 3328 may be substantially planar in the vicinity of the slit 3322. The trough 3324 may be formed by a portion of the tab 3320 in the trough 3324 (where the material thickness is thinner than other parts of the tab 3320). Thus, in this example, the trough 3324 is recessed with respect to the tab surface 3328.

[0295] The trough 3324 may have a width that is substantially the same as the length of the slit 3322. That is, the trough 3324 may have an upper end in the vicinity of the upper end 3326 of the slit and a lower end in the vicinity of the lower end 3327 of the slit 3322. In this example, the trough 3324 has a width that is substantially the same as the strap 3310. The trough 3324 is configured to receive the strap 3310 in such a manner. The trough 3324 reduces the total thickness of the strap 3310 and the tab 3320. At the position of the trough 3324, the tab 3320 is sandwiched between two layers of the strap 3310 (this is because the strap passes through the slit and loops back over itself). Due to the bulk and / or thickness of the strap 3310 and the tab 3320 at this position, pressure points or discomfort may occur when the patient lies on their side. The trough 3324 may advantageously reduce the stacked thickness of the components at this position, and as a result, the pressure applied to the patient's head at this position when lying on the side may be reduced.

[0296] Furthermore, in this example, the trough 3324 has a side adjacent to the side of the strap 3310. Therefore, the width of the trough 3324 matches the width of the strap 3310. This can advantageously assist in aligning the strap 3310 within the trough 3324 and maintaining it in a centered position. It may also be possible to provide the user with a visual guide regarding the alignment of the strap 3310.

[0297] 5.3.3 Ventilation section In one form, the patient interface 3000 includes a ventilation section 3400 configured and arranged to allow the expulsion of exhaled gas (e.g., carbon dioxide).

[0298] In a particular form, the ventilation 3400 is configured to allow a continuous ventilation flow from the inside of the plenum chamber 3200 to the atmosphere when the pressure in the plenum chamber is positive with respect to the atmosphere. The ventilation section 3400 is configured such that, during use, while maintaining the therapeutic pressure in the plenum chamber, the magnitude of the ventilation flow is large enough to reduce the rebreathing of exhaled CO2 by the patient. Through the ventilation holes 3400, a continuous ventilation flow from the inside of the plenum chamber 3200 to the atmosphere can be obtained throughout the patient's respiratory cycle.

[0299] One form of the ventilation section 3400 according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0300] The venting portion 3400 can be disposed within the plenum chamber 3200. Alternatively, the venting portion 3400 is disposed within a decoupling structure (such as a swivel like the elbow 3610). In the examples shown in FIGS. 8A-9C, the patient interface 3000 includes a plurality of venting portions 3400. Specifically, the patient interface 3000 includes at least one vent hole 3400 in the plenum chamber 3200 and at least one vent hole in the elbow 3610. More specifically, the plenum chamber 3200 includes two vent holes 3400. Each vent hole 3400 on the plenum chamber 3200 includes an array of holes. The vent holes 3400 on the elbow 3610 also include an array of holes. The vent holes 3400 of the patient interface 3000 are sized and configured to provide sufficient gas wash flow throughout the treatment pressure range.

[0301] A diffuser that may be included in the patient interface 3000 is configured to reduce ventilation noise and reduce the air ejected from the vent by diffusing the air flow passing through the vent hole. This diffuser can be provided on a cover over the vent. In some examples, the vent hole 3400 can include a vent module configured to be removable from the plenum chamber 3200. The vent module can include a diffuser.

[0302] 5.3.4 Decoupling Structure(s) In one form, the patient interface 3000 includes at least one decoupling structure (such as a swivel or ball and socket). For example, the patient interface shown in FIGS. 8A-9C The elbow 3610 is configured to rotate relative to the positioning and stabilization structure 3300. In this example, the elbow 3610 is configured to rotate about an axis concentric with a circular opening in the positioning and stabilization structure 3300. In some examples of the present technology, the elbow 3610 may form part of a ball and socket joint relative to the positioning and stabilization structure 3300. For example, a ring having a partially spherical inner surface may be provided to the positioning and stabilization structure 3300 and configured to receive the elbow 3610. The elbow 3610 may have a partially spherical outer surface complementary to the partially spherical inner surface of the ring, thereby enabling the elbow 3610 to rotate relative to the ring about multiple axes.

[0303] 5.3.5 Connection Port The connection port 3600 enables connection to the air circuit 4170. In the exemplary patient interface 3000 shown in FIGS. 8A-9C, the elbow 3610 forms part of the connection port 3600. The elbow 3610, as a decoupling structure, decouples the movement of the air circuit 4170 from the positioning and stabilization structure 3300 to reduce the tube resistance on the positioning and stabilization structure 3300.

[0304] 5.3.6 Forehead Support In one form, the patient interface 3000 includes a forehead support 3700. In other forms, the patient interface 3000 does not include a forehead support. Advantageously, the exemplary patient interface 3000 shown in FIGS. 8A-9C includes a positioning and stabilization structure 3300 capable of holding the seal forming structure 3100 in the sealing position (without connection to a forehead support or any frame or strap member disposed at eye level in front of the patient's face).

[0305] 5.3.7 Anti-Suffocation Valve In one form, the patient interface 3000 includes an anti-asphyxiation valve. In some examples, the patient interface 3000 includes a plurality of anti-asphyxiation valves. For example, if airflow is provided to the seal-forming structure 3100 via two fluid connections, two anti-asphyxiation valves may be provided to the patient interface 3000, with one provided to each fluid connection to the seal-forming structure 3100.

[0306] 5.3.8 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the volume within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the properties (e.g., pressure) of the gas within the plenum chamber 3200.

[0307] 5.4 RPT Device The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 may be configured to generate an airflow that is delivered to a patient's airway for treatment of one or more of the respiratory conditions described, for example, anywhere in this document.

[0308] In one form, the RPT device 4000 is constructed and arranged to be able to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O or at least 10 cmH2O or at least 20 cmH2O.

[0309] The RPT device may have an external housing 4010. The external housing 4010 is formed by two parts, an upper part 4012 and a lower part 4014. Further, the external housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0310] The pneumatic path of the pneumatic RPT device 4000 may include one or more pneumatic circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124), as well as one or more transducers 4270 (e.g., a pressure sensor and a flow sensor).

[0311] One or more of the pneumatic path items may be arranged within a removable integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be arranged within the external housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 or formed as part of the chassis 4016.

[0312] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller, a treatment device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0313] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integrated unit, including the pneumatic component 4100. In an alternative form, one or more of the following components may be arranged as separate units.

[0314] 5.4.1.1 Air filter(s) The RPT device according to one form of the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0315] In one form, the inlet air filter 4112 is arranged at the beginning of the upstream pneumatic path of the pressure generator 4140.

[0316] In one form, the outlet air filter 4114 (e.g., antibacterial factor) is arranged between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0317] 5.4.1.2 Muffler(s) The RPT device according to one form of the present technology may include a muffler 4120 or a plurality of mufflers 4120.

[0318] In one form of the present technology, the inlet muffler 4122 is arranged above the pressure generator 4140 within the pneumatic path.

[0319] In one form of the present technology, the outlet muffler 4124 is arranged between the pressure generator 4140 and the patient interface 3000 within the pneumatic path.

[0320] 5.4.1.3 Pressure generator In one form of the present technology, a pressure generator 4 that generates the flow or supply of air at positive pressure 140 is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impeller may be disposed within a volute. The blower can deliver air supply at a speed of, for example, up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are hereby incorporated by reference in their entirety: U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479, and PCT Patent Application Publication WO2013 / 020167.

[0321] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0322] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0323] 5.4.1.4 Anti-spillback valve In one form of the technology, an anti-spillback valve 4160 may be disposed between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the motor 4144 of the blower).

[0324] 5.4.2 RPT device algorithm As described above, in some forms of the technology, the central control device may be configured to implement one or more algorithms represented as a computer program recorded in a non-transitory computer-readable recording medium (e.g., a memory). These algorithms are generally grouped into groups called modules.

[0325] 5.5 Air circuit An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that, in use, an air flow moves between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0326] Specifically, the air circuit 4170 can be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0327] In some forms, the air circuit 4170 can include one or more heating elements configured to heat the air in the air circuit (e.g., for maintaining or increasing the air temperature). The heating element can take the form of a heating wire circuit and can include one or more transducers (e.g., a temperature sensor). In one form, the heating wire circuit can be wound helically around the axis of the air circuit 4170. The heating element can communicate with a controller (e.g., a central controller). An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349. The entire disclosure of this document is incorporated herein by reference for all purposes.

[0328] 5.5.1 Oxygen Delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic path (e.g., upstream of the pneumatic block 4020), the air circuit 4170, and / or the patient interface 3000.

[0329] 5.6 Humidifier 5.6.1 Overview of the Humidifier In one form of the present technology, a humidifier 5000 is provided for varying the absolute humidity of the air or gas to be delivered to the patient relative to the ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and the temperature of the air flow before delivery to the patient airway.

[0330] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. In some configurations as shown in FIGS. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0331] 5.6.1.1 Conductive portion In one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to enable efficient heat transfer from the heating element 5240 to a quantity of liquid within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, although other shapes may be suitable. All or a portion of the conductive portion 5120 may be constructed of a thermally conductive material such as aluminum (e.g., having a thickness of approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, suitable thermal conductivity may be achieved by a lower conductivity material of appropriate geometry.

[0332] 5.6.1.2 Humidifier reservoir dock In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0333] 5.6.1.3 Water level indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in FIGS. 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as patient 1000 or a caregiver, regarding the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include notification of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50% or 75% or an amount (e.g., 200 ml, 300 ml or 400 ml)).

[0334] 5.7 Glossary For the purposes of the disclosure of the present technology, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may apply.

[0335] 5.7.1 General Air: In certain forms of the present technology, air may mean the atmosphere, and in other forms of the present technology, air may mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0336] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) outside of the treatment system or patient, and (ii) that which directly surrounds the treatment system or patient.

[0337] For example, the ambient humidity for a humidifier may be the humidity of the air that directly surrounds the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may be different from the humidity outside the room where the patient is sleeping.

[0338] In another example, the ambient pressure may be the pressure directly surrounding or outside of the body.

[0339] In certain forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the room where the patient is located, other than the noise generated, for example, from the RPT device or from the mask or patient interface. The ambient noise can originate from sources outside the room.

[0340] Automatic positive airway pressure (APAP) therapy: A CPAP therapy that can automatically adjust the therapy pressure, for example, between a minimum and a maximum limit during the breathing cycle, depending on the presence or absence of signs of SDB onset.

[0341] Continuous positive airway pressure (CPAP) therapy: A respiratory pressure therapy in which the therapy pressure is substantially constant throughout the patient's breathing cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different breathing cycles of the patient (e.g., increased in response to detection of signs of partial upper airway obstruction and reduced in the absence of notification of partial upper airway obstruction).

[0342] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to the instantaneous amount. In some cases, when referring to the flow rate, it refers to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to the flow rate, it refers to a vector quantity (i.e., a quantity having both magnitude and direction). The flow rate can be assigned the symbol Q. The "flow rate" may be abbreviated as "flow" or "airflow" in some cases.

[0343] In an example of a patient's breathing, the flow rate can be nominally positive pressure with respect to the inhalation portion of the patient's breathing cycle and thus can be negative with respect to the exhalation portion of the patient's breathing cycle. The total flow rate Qt is the flow rate of air exiting the RPT device. The ventilation flow rate Qv is the flow rate of air exiting through the ventilation holes to allow the outflow of the exhaled gas. The leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. The respiratory flow rate Qr is the flow rate of air received in the patient's respiratory system.

[0344] Humidifier: The term "humidifier" is construed to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor into an air stream to improve a patient's medical respiratory condition.

[0345] Leakage: The term "leakage" is taken as an unintended air flow. In one embodiment, leakage can occur due to an incomplete seal between the mask and the patient's face. In another embodiment, leakage can occur at the circumferential elbow to the surroundings.

[0346] Noise Conduction (Acoustic): As used in this document, conductive noise refers to noise conveyed to the patient by a pneumatic path (e.g., an air circuit and a patient interface and the air therein). In one form, conductive noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0347] Noise Radiation (Acoustic): As used in this document, radiated noise refers to noise conveyed to the patient by the ambient air. In one form, radiated noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO3744. Thereof by measuring according to ISO3744.

[0348] Noise Ventilation (Acoustic): As used in this document, ventilation noise refers to noise generated by an air flow through any ventilation (e.g., ventilation holes in a patient interface).

[0349] Patient: A person with or without a respiratory disease.

[0350] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH2O, g-f / cm 2 , and hectopascal). 1 cmH2O is equal to 1 g-f / cm 2 and is approximately 0.98 hectopascal. In this specification, unless otherwise specified, pressure is given in units of cmH2O.

[0351] The symbol Pm is assigned to the pressure in the patient interface, and the symbol Pt is assigned to the treatment pressure representing the target value to be achieved by the mask pressure Pm at the current time.

[0352] Respiratory pressure therapy (RPT): The addition of an air supply to the airway inlet at a treatment pressure that is typically positive pressure with respect to the atmosphere.

[0353] Ventilator: A mechanical device that provides pressure assistance when a patient performs some or all of the breathing movements.

[0354] 5.7.1.1 Materials Silicone or silicone elastomer: A synthetic rubber. As used herein, when referring to silicone, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this registered trademark). Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of the exemplary form of LSR, when measured by ASTM D2240, is from about 35 to about 45.

[0355] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0356] 5.7.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0357] Elastic: Substantially all of the energy is released during unloading. For example, it includes certain silicones and thermoplastic elastomers.

[0358] Hardness: The ability of a material to resist deformation of itself (e.g., as described by the Young's modulus or an indentation hardness scale measured on a standardized sample size). The "soft" material may include silicone or thermoplastic elastomer (TPE), and can be easily deformed, for example, under finger pressure. The "hard" material may include polycarbonate, polypropylene, steel or aluminum, and cannot be easily deformed, for example, under finger pressure.

[0359] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, tension, bending or torsion). A structure or component may provide different resistance in different directions.

[0360] A floppy structure or component: A structure or component that changes (e.g., bends) its shape within a relatively short period (e.g., 1 second) when supported under its own weight.

[0361] A rigid structure or component: A structure or component that shows substantially no shape change when subjected to loads typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a sealed manner against the patient airway inlet under a load of a pressure of approximately 20 - 30 cmH2O.

[0362] As an example, an I-beam may include different bending stiffnesses (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0363] 5.7.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when the flow falls below a predetermined threshold and persists for a duration, for example, of 10 seconds. Obstructive apnea is said to occur when, despite the patient's effort, air flow is not permitted due to some airway obstruction. Central apnea refers to the state in which apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to the state in which a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0364] 5.7.3 Anatomical Structure 5.7.3.1 Facial Anatomical Structure Ala: The outer wall or the "wing" of each nasal cavity (plural: alar)

[0365] Alare: The outermost point on the alar nose.

[0366] Alar curvature (or alar apex) point: The rearmost point on the curved reference line of each ala, seen at the fold formed by the junction of the ala and the cheek.

[0367] Auricle: The entire visible part of the ear.

[0368] (Nasal) Skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0369] (Nasal) Cartilage Skeleton: The nasal cartilage skeleton includes the septal cartilage, the lateral cartilage, the major cartilage, and the minor cartilage.

[0370] Columella: A skin flap that separates the nostrils and extends from the tip of the nose to the upper lip.

[0371] Columella Angle: The angle between a line drawn through the midpoint of the nasal cavity and a line drawn perpendicular to the Frankfurt horizontal while intersecting the subnasal point.

[0372] Frankfurt Horizontal Plane: A line extending from the lowest point of the orbital margin to the left auricular point. The auricular point is the deepest point from the upper notch to the earlobe of the auricle.

[0373] Glabella: Located in the soft tissue, the most prominent point on the mid-sagittal of the frontal region.

[0374] Lateral nasal cartilage: Generally triangular plate of cartilage. Its upper peripheral edge is attached to the nasal bone and the frontal process of the maxilla, and its lower peripheral edge is connected to the major alar cartilage.

[0375] Major alar cartilage: A plate of cartilage, located below the lateral nasal cartilage. It curves around the front part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar minor cartilages.

[0376] Nostril (nasal cavity): Generally an ellipsoidal alar cavity, forming the entrance to the nasal cavity. The singular form of nostril (nares) is naris (nasal cavity). These nostrils are separated by the nasal septum.

[0377] Nasolabial groove or nasolabial fold: A fold or groove in the skin, extending from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0378] Nasolabial angle: The angle between the nasal columella and the upper lip, intersecting with the subnasale point.

[0379] Lower ear attachment point: The lowest point of the attachment of the auricle to the facial skin.

[0380] Upper ear attachment point: The highest point of the attachment of the auricle to the facial skin.

[0381] Tip of nose point: The most prominent point or tip of the nose, which can be identified in the side view of the remaining part of the head portion.

[0382] Philtrum: A midline groove extending from the lower boundary of the nasal septum to the upper part of the lip in the upper lip region.

[0383] Pogonion: The most anterior midpoint on the soft tissue of the jaw.

[0384] (Nasal) sill: The nasal sill is a midline elevation of the nose, extending from the sellion to the tip of the nose point.

[0385] Sagittal plane: A vertical plane that extends from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides into a right and a left half.

[0386] Sellion: The most concave point on the area of the fronto-nasal suture, located on top of the soft tissue.

[0387] Septal cartilage (nose): The septal cartilage is part of the septum and divides the front part of the nasal cavity.

[0388] Lowest alar point: The point at the lower margin of the alar base, where the alar base joins the skin of the upper (superior) lip.

[0389] Subnasale: Located on the soft tissue, the point where the columella joins the upper lip in the median sagittal plane.

[0390] Sulston: The most concave point in the midline of the lower lip, between the midpoint of the lower lip and the soft tissue pogonion.

[0391] 5.7.3.2 Anatomical Structure of the Skull Frontal bone: The frontal bone includes the frontal squama, which is a large vertical part corresponding to the area known as the forehead.

[0392] Mandible: The mandible forms the lower jaw. The gonial eminence is a bony prominence of the jaw and forms the jaw.

[0393] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the eye socket. The frontal process of the maxilla projects upward by the side of the nose and forms part of its outer boundary.

[0394] Nasal bone: The nasal bones are two small rectangular bones, varying in size and shape among individuals. The nasal bones are arranged side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0395] Nasion: The intersection of the frontal bone and the two nasal bones, a concave area directly provided between the eyes and the upper side of the nasal bridge.

[0396] Occipital bone: The occipital bone is located at the back and lower part of the skull. The occipital bone contains the foramen magnum, which is an elliptical hole. Through this hole, the cranial cavity communicates with the spinal canal. The curved plate on the posterior side of the foramen magnum is the occipital squama.

[0397] Orbit: A bony cavity in the skull that contains the eyeball.

[0398] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0399] Temporal bone: The temporal bones are located on the base and sides of the skull and support the part of the face known as the temple.

[0400] Zygomatic bone: The two zygomatic bones contained in the face are located in the upper and outer parts of the face and form the zygomatic prominences.

[0401] 5.7.3.3 Anatomical Structure of the Respiratory System Diaphragm: A sheet-like muscle that extends over the lower part of the thorax. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0402] Larynx: The larynx or voice box that houses the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0403] Lung: The respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0404] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called nasal conchae or turbinate bones. In front of the nasal cavity is the nose, and behind it connects to the nasopharynx through the posterior nares.

[0405] Pharynx: The part of the throat located directly below (inferior) the nasal cavity and above the esophagus and larynx. The pharynx has traditionally been divided into the following three parts: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (midpharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0406] 5.7.4 Patient Interface Anti-asphyxia valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient through opening to the atmosphere in a fail-safe manner.

[0407] Elbow: The elbow is an example of a structure that directs the axis of the air flow moving inside and changes the direction through an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a substantially circular cross-section. In another form, the elbow can have an elliptical or rectangular cross-section. In a particular form, the elbow can be rotatable, for example, about 360 degrees with respect to an engaging component. In a particular form, the elbow can be removable from an engaging component, for example, through a snap connection. In a particular form, the elbow can be assembled to an engaging component through a one-time snap during manufacturing while being non-removable by the patient.

[0408] Frame: The frame is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of the mask frame may be airtight.

[0409] Headgear: The headgear is taken to mean a form of positioning and stabilization structure designed to be used on the head. For example, the headgear can include a collection of one or more struts, ties, and supplementary stiffeners configured to position and hold a patient interface at a predetermined position on a patient's face for delivery of respiratory therapy. Some ties are formed of a soft, flexible elastic material (e.g., a laminated composite of a foam material and fabric).

[0410] Membrane: The membrane is taken to typically mean a thin element, and preferably substantially resists bending and resists stretching and contracting.

[0411] Pleural chamber: The mask pleural chamber is taken to mean a part of a patient interface having a wall that at least partially encloses a volume of space, and the air in the volume is pressurized to exceed atmospheric pressure during use. The shell can form part of the wall of the mask pleural chamber.

[0412] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("seal (off)"), it can refer to its effect. Two elements can be constructed and / or arranged such that they "seal" or obtain a "sealing" effect between them without requiring separate "seal" elements themselves.

[0413] Shell: The shell is taken to mean a curved, relatively thin structure having bending, tensile, and compressive rigidity. For example, the curved structural wall of a mask can be a shell. In some forms, the shell can be faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0414] Supplementary stiffener: The supplementary stiffener is taken to mean a structural component designed to increase the stiffness or softness of another component in at least one direction.

[0415] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0416] Swivel (noun): A sub-assembly of components configured to rotate preferably independently and preferably under low torque about a common axis. In one form, the swivel can be configured to rotate at least 360 degrees. In another form, the swivel can be configured to rotate at an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably includes a pair of cylindrical conduits in combination. In use, there is little leakage of air flow from the swivel.

[0417] Tie (noun): A structure designed to resist tension.

[0418] Vent: (noun) A structure that allows air flow to the ambient air inside a mask or conduit, enabling a clinically effective washout of the exhaled gas. For example, in a clinically effective washout, a flow rate of about 10 liters per minute to about 100 liters per minute can be used depending on the mask design and treatment pressure.

[0419] 5.7.5 Shape of the Structure The product according to the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure can be limited by a two-dimensional surface. These surfaces can be distinguished using labels to describe the direction, position, function, or some other characteristic of the associated surface. For example, the structure can include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another embodiment, the seal-forming structure can include a face contact (e.g., outer) surface and a separate non-face contact (e.g., lower or inner) surface. In another embodiment, the structure can include a first surface and a second surface.

[0420] To facilitate the description of the shape and surface of the three-dimensional structure, first consider the cross-section at point p through the surface of the structure. Refer to FIGS. 3B to 3F. FIGS. 3B to 3F show an example of a cross-section at point p on the surface and an example of the resulting planar curve. FIGS. 3B to 3F also show the outward normal vector at p. The outward normal vector at p extends in the direction away from the surface. In some embodiments, this surface is described from the perspective of a fictional small person standing upright on the surface.

[0421] 5.7.5.1 Curvature in One Dimension The curvature of the planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle tangent to the curve at p).

[0422] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (when this fictional small person leaves point p, they need to walk uphill). Refer to FIG. 3B (relatively large positive curvature compared to FIG. 3C) and FIG. 3C (relatively small positive curvature compared to FIG. 3B). Such curves are often referred to as concave.

[0423] Zero curvature: When the curve at p is a straight line, the curvature is taken as zero (when this fictional small person leaves point p, they can walk on a horizontal plane that is neither uphill nor downhill). Refer to FIG. 3D.

[0424] Negative curvature: When the curve at p bends in the direction away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (when this fictional small person leaves point p, they need to walk downhill). Refer to FIG. 3E (relatively small negative curvature compared to FIG. 3F) and FIG. 3F (relatively large negative curvature compared to FIG. 3E). Such curves are often referred to as convex.

[0425] 5.7.5.2 Curvature of the Two-Dimensional Surface The description of the shape at a given point on a two-dimensional surface according to this technique may include a plurality of vertical cross-sections. The plurality of cross-sections may cut the surface in a plane including the outward normal (the "normal plane"), and each cross-section may be taken in a different direction. As a result of each cross-section, a planar curve with a corresponding curvature is obtained. The different curvatures at that point may have the same sign or different signs. The curvatures at that point each have a magnitude (e.g., relatively small). The planar curves in FIGS. 3B to 3F may be examples of such a plurality of cross-sections at a specific point.

[0426] Principal curvatures and directions: The directions of the normal planes in which the curvature of the curve takes on its maximum and minimum values are called the principal directions. In the examples of FIGS. 3B to 3F, since the maximum curvature occurs in FIG. 3B and the minimum in FIG. 3F, FIGS. 3B and 3F are cross-sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0427] Region of the surface: A set of connected points on the surface. This set of points within the region may have similar characteristics (e.g., curvature or sign).

[0428] Saddle region: A region in which the principal curvatures at each point have opposite signs (i.e., one positive and the other negative) depending on the direction in which an imaginary person walking uphill or downhill would face.

[0429] Dome region: A region in which the principal curvatures at each point have the same sign (both positive ("concave dome") or both negative ("convex dome")).

[0430] Cylindrical region: A region in which one principal curvature is zero (or zero within manufacturing tolerances, for example), and the other principal curvature is non-zero.

[0431] Flat region: A region of the surface in which both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0432] Edge of the surface: The boundary or limit of the surface or region.

[0433] Path: In a particular form of the present technology, "path" is taken to mean a path in the mathematical-topological sense (for example, a continuous space curve from f(0) to f(1) on a surface). In a particular form of the present technology, "path" can be described, for example, as a route or course including a set of points on a surface. (The path of a fictional person is the place to walk on the surface and is similar to a garden path).

[0434] Path length: In a particular form of the present technology, "path length" is taken to refer to the distance from f(0) to f(1) along the surface (i.e., the distance along the path on the surface). There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of a fictional person is the distance walked along the path on the surface).

[0435] Straight-line distance: The straight-line distance is the distance between two points on a surface without considering the surface. On a planar region, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there may not be a path having the same path length as the straight-line distance between two points. (For a fictional person, the straight-line distance corresponds to the "distance a crow flies").

[0436] 5.7.5.3 Space curve Space curve: Unlike a planar curve, a space curve does not necessarily exist within any specific plane. A space curve can be closed, i.e., it has no endpoints. A space curve can be considered as a one-dimensional piece of three-dimensional space. A fictional person walking along the strand of a DNA helix is walking along a space curve. A typical human left ear contains a left-handed helix (see Fig. 3Q). A typical human right ear contains a right-handed helix (see Fig. 3R). Fig. 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or an impeller) can follow a space curve. Generally, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of the way a curve deviates from a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with respect to the tangent vector, normal vector, and binormal vector at that point. at that point.

[0437] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies a direction and a magnitude from that point. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional person is flying along a curve and falls out of their vehicle at a particular point, the direction of the tangent vector is the direction in which the person should be moving.

[0438] Unit normal vector: When a fictional person is moving along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the direction in which the tangent vector is changing is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0439] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (e.g., see Fig. 3P) or, alternatively, the left-hand rule (Fig. 3O).

[0440] Contact plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figs. 3O and 3P.

[0441] Torsion of a space curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation from the osculating plane of the curve. The torsion of a space curve lying in a plane is zero. When the deviation from the osculating plane of a space curve is relatively small, the magnitude of the torsion of that space curve is relatively small (for example, a gently sloping helical path). When the deviation from the osculating plane of a space curve is relatively large, the magnitude of the torsion of that space curve is relatively large (for example, a steeply sloping helical path). Referring to Fig. 3S, since T2 > T1, the magnitude of the torsion in the vicinity of the uppermost coil of the helix in Fig. 3S is greater than the magnitude of the torsion of the lowermost coil of the helix in Fig. 3S.

[0442] Referring to the right - hand rule of Fig. 3P, a space curve that bends in the direction of the right - hand binormal can be regarded as having a positive torsion in the right - hand direction (for example, a right - hand helix as shown in Fig. 3S). A space curve that points in the separating direction from the right - hand binormal direction can be regarded as having a negative torsion of the right - hand (for example, a left - hand helix).

[0443] Similarly, referring to the left - hand rule (see Fig. 3O), a space curve that points in the left - hand binormal direction can be regarded as having a positive torsion of the left - hand (for example, a left - hand helix). Thus, the positive direction of the left - hand corresponds to the negative direction of the right - hand. See Fig. 3T.

[0444] 5.7.5.4 Holes A surface can have one - dimensional holes (for example, holes bounded by a planar curve or a space curve). In the case of a thin - walled structure (for example, a membrane) containing holes, this structure can be described as having one - dimensional holes. For example, refer to the state where the one - dimensional holes in the surface of the structure shown in Fig. 3I are bounded by a planar curve.

[0445] The structure can have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the inner surface of the tire. In another embodiment, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, the cushion of FIG. 3L and the exemplary cross-sections of FIG. 3L in FIGS. 3M and 3N where the inner surface bounding the two-dimensional hole is shown. In yet another embodiment, a conduit can include a one-dimensional hole (e.g., at its inlet or its outlet) and can include a two-dimensional hole bounded by the inner surface of the conduit. Also refer to the two-dimensional hole bounded by a surface as shown through the structure of FIG. 3K and as illustrated. Also refer to the two-dimensional hole bounded by a surface.

[0446] 5.8 Other Considerations Unless otherwise clearly apparent from the context and unless a range of values is provided, it is understood that each intervening value between the lower limit of the unit of 1 / 10, between the upper and lower limits of the range, and any other recited value or intervening value in the recited range of the present technology is encompassed by the present technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limits in the recited range, they are encompassed by the present technology. If the recited range includes one or both of these limits, ranges exceeding either or both of these recited limits are also encompassed by the present technology.

[0447] Furthermore, when a value (singular or plural) is embodied as part of the present technology in this specification, unless otherwise specified, it is understood that such a value can be approximated and such a value can be used to any appropriate significant digits up to the extent permitted or required by the practical technical implementation.

[0448] Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which the present technology belongs. 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, although a limited number of exemplary methods and materials are described in this specification.

[0449] Although a particular material is described as being preferably used in the construction of a component, obvious alternative materials with similar properties are used as substitutes. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and may be manufactured either collectively or individually.

[0450] As used herein and in the appended claims, it should be noted that the singular forms "a", "an", and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0451] All publications described herein are hereby incorporated by reference for the disclosure and description of the methods and / or materials for which they are the subject. The publications described herein are provided only for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology does not antedate such publications by virtue of prior invention. Further, the dates of the publications may be different from the actual publication dates which may require individual verification.

[0452] The terms "comprises" and "comprising" are to be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that the recited elements, components, or steps may be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0453] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the claims. These headings should not be used in the interpretation of the claims or the scope of the claims.

[0454] Although the techniques in this specification have been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are unnecessary for the implementation of the technology. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Further, although the process steps in this method may be described or illustrated in an ordered manner, such an order is not necessary. One skilled in the art will recognize that such an order can be changed and / or that the actions can be performed simultaneously or even more synchronously.

[0455] Therefore, it should be understood that numerous variations are possible in the exemplary embodiments and that other arrangements can be devised without departing from the spirit and scope of the technology.

[0456] [Appended Claim 1] A patient interface comprising: a plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's breathing, the plenum chamber; a seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an inlet to the patient's airway for hermetically delivering an air flow at a treatment pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle during use, the seal-forming structure having holes therein such that the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, the seal-forming structure; A positioning and stabilization structure that provides a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, comprising: At least one gas delivery tube for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to the inlet of the patient's airway, wherein the at least one gas delivery tube is constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use, and the at least one gas delivery tube comprises: An upper tube portion configured to be placed on the upper region of the patient's head during use, and the upper tube portion comprises: A first end configured to be placed on the upper part of the patient's head in or near the sagittal plane of the patient's head during use; A second end configured to be placed on the side of the patient's head during use; A rigid portion between the first end and the second end, the rigid portion being configured to provide a higher resistance in the front and / or rear direction than in the up and / or down direction against the relative movement between the first end and the second end during use, and the upper tube portion comprising the rigid portion; and A lower tube portion connected between the second end of the upper tube portion and the seal-forming structure, Comprising a gas delivery tube, A positioning and stabilization structure, A ventilation structure that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber during use, and the ventilation structure, Including, The patient interface is configured to allow the patient to breathe from the atmosphere through his / her own mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed. [Appendix 2] The patient interface according to appended claim 1, wherein each upper tube portion includes two rigid portions. [Appended claim 3] The patient interface according to appended claim 1 or 2, wherein the rigid portion is provided on one or both of a side portion of the upper tube portion configured to come forward during use and a side portion of the upper tube portion configured to come backward during use. [Appended claim 4] The patient interface according to any one of appended claims 1 to 3, wherein the upper tube portion includes an extendable portion. -face. [Appended claim 5] The patient interface according to appended claim 4, wherein the extendable portion includes an extendable bellows structure formed within the tube wall of the gas delivery tube. [Appended claim 6] The patient interface according to appended claim 5, wherein the extendable bellows structure includes a plurality of folds within the tube wall to alternately form a plurality of ridges and a plurality of grooves. [Appended claim 7] The patient interface according to appended claim 6, wherein the rigid portion includes a plurality of connecting portions within the tube wall, and each of the plurality of connecting portions connects a pair of adjacent ridges. [Appended claim 8] The patient interface according to any one of appended claims 1 to 7, wherein the rigid portion is integrally formed with the upper tube portion. [Appended claim 9] A patient interface comprising: A plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O exceeding the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's breathing, and the plenum chamber; A seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an inlet to the patient's airway for delivering an air flow at a treatment pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle during use, the seal-forming structure having holes therein such that the air flow at the treatment pressure is delivered at least to the inlets to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use; A positioning and stabilization structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head: At least one gas delivery tube for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet of the patient's airway, the gas delivery tube including at least one gas delivery tube constructed and arranged to contact at least one area of the patient's head above the upper ear base point of the patient's head during use, the gas delivery tube: A tube wall defining a hollow interior through which air can flow from the interior to the seal-forming structure, the tube wall having an extendable portion configured to extend to vary the length of the gas delivery tube, The tensile stiffness of the extendable portion being in the range of 0.2 to 0.35 N / mm, including the tube wall, Including the gas delivery tube, The positioning and stabilization structure, A ventilation structure that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, the ventilation structure, Including, The patient interface is configured to allow the patient to breathe from the atmosphere through their own mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed. [Appendix Item 10] The tensile stiffness of the extendable part is within the range of 0.25 to 0.3 N / mm, and the patient interface according to Appendix Item 9. [Appendix Item 11] The combined unextended length, including a pair of gas delivery tubes, is within the range of 500 to 535 mm, measured along the center line on the side of the pair of tubes configured to face the patient during use, and the patient interface according to Appendix Item 9 or 10. [Appendix Item 12] The combined unextended length is within the range of 510 to 525 mm, and the patient interface according to Appendix Item 11. [Appendix Item 13] The combined unextended length is within the range of 512 to 522 mm, and the patient interface according to Appendix Item 11 or 12. [Appendix Item 14] The combined unextended length, including a pair of gas delivery tubes, is within the range of 460 to 500 mm, measured along the center line on the side of the pair of tubes configured to face the patient during use, and the patient interface according to Appendix Item 9 or 10. [Appendix Item 15] The combined unextended length is within the range of 470 to 490 mm, and the patient interface according to Appendix Item 14. [Appendix Item 16] The combined unextended length is within the range of 475 to 485 mm, and the patient interface according to Appendix Item 15. [Appendix Item 17] The gas delivery tube forms a loop around the patient's head together with the cushion module. The loop has an unstretched length measured along the center line of the side of the gas delivery tube and a cushion module configured to face the patient during use. The unstretched length of the loop is within the range of 510 to 610 mm. The patient interface according to appended claim 9. [Appended claim 18] The unstretched length of the loop is within the range of 528 to 548 mm. The patient interface according to appended claim 17. [Appended claim 19] The unstretched length of the loop is within the range of 535 to 541 mm. The patient interface according to appended claim 18. [Appended claim 20] The unstretched length of the loop is within the range of 534 to 554 mm. The patient interface according to appended claim 19. [Appended claim 21] The unstretched length of the loop is within the range of 539 to 549 mm. The patient interface according to appended claim 20. [Appended claim 22] The unstretched length of the loop is within the range of 541 to 561 mm. The patient interface according to appended claim 17. [Appended claim 23] The unstretched length of the loop is within the range of 546 to 556 mm. The patient interface according to appended claim 22. [Appended claim 24] The unstretched length of the loop is within the range of 564 to 584 mm. The patient interface according to appended claim 17. [Appended claim 25] The unstretched length of the loop is within the range of 571 to 581 mm. The patient interface according to appended claim 24. [Appended claim 26] The unstretched length of the loop is within the range of 577 to 597 mm. The patient interface according to appended claim 17. [Appended claim 27] The unstretched length of the loop is within the range of 582 to 592 mm. The patient interface according to appended claim 26. [Supplementary Note 28] A patient interface comprising: A plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, a plenum chamber; A seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an inlet to the patient's airway for hermetically delivering an air flow at a treatment pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, said seal-forming structure having holes therein such that an air flow at said treatment pressure is delivered at least to an inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain said treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure; A positioning and stabilization structure for providing a force to hold said seal-forming structure in a therapeutically effective position on the patient's head, comprising: At least one gas delivery tube for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet to the patient's airway, said gas delivery tube being constructed and arranged to contact at least one area of the patient's head above the upper ear base point of the patient's head during use, said at least one gas delivery tube including a tube wall having an extendable bellows structure, said extendable bellows structure comprising: A plurality of folds within the tube wall in which a plurality of ridges and a plurality of grooves are alternately formed, said folds being at least partially deployable to increase the separation of the ridges and to elongate the extendable bellows structure into an elongated shape, a plurality of folds; One or more ridge connectors provided to the tube wall, each of said one or more ridge connectors connecting two or more adjacent ridges of the plurality of ridges and being configured to withstand the separation of the ridges, one or more ridge connectors, including an extendable bellows structure; Including a gas delivery tube; A positioning and stabilization structure, and A ventilation structure that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings. The ventilation structure is sized and shaped to maintain the treatment pressure in the plenum chamber during use, and the ventilation structure, including The patient interface is configured to allow the patient to breathe from the atmosphere through their mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to keep the patient's mouth exposed. The patient interface. [Appended Claim 29] The patient interface according to appended claim 28, wherein each pair of adjacent raised portions is connected by at least one raised portion connection part of one or more raised portion connection parts. [Appended Claim 30] The patient interface according to appended claim 28 or 29, wherein one or more pairs of adjacent raised portions are connected by two raised portion connection parts. [Appended Claim 31] The patient interface according to appended claim 30, wherein each pair of adjacent raised portions is connected by two raised portion connection parts. described [Appended Claim 32] The patient interface according to any one of appended claims 28 to 31, wherein one or more of the raised portion connection parts are arranged on the side portion of the gas delivery tube configured to face forward during use. [Appended Claim 33] The patient interface according to any one of appended claims 28 to 32, wherein one or more of the raised portion connection parts are arranged on the side portion of the gas delivery tube configured to face backward during use. [Appended Claim 34] The patient interface according to any one of appended claims 28 to 33, wherein each of the raised portion connection parts is arranged at a central interval between the side portion of the gas delivery tube configured to face downward during use and the side portion of the gas delivery tube configured to face upward during use. [Additional item 35] The patient interface according to any one of additional items 28 to 34, wherein each pair of adjacent raised portions is connected by one of the raised portion connectors disposed on the side portion of the gas delivery tube configured to face forward during use. [Additional item 36] The patient interface according to any one of additional items 28 to 35, wherein each pair of adjacent raised portions is connected by one of the raised portion connectors disposed on the side portion of the gas delivery tube configured to face rearward. [Additional item 37] The patient interface according to any one of additional items 28 to 36, wherein the gas delivery tube includes a non-extendable portion having an outer surface, and each of the plurality of groove portions is formed as a depression with respect to the outer surface of the non-extendable portion. [Additional item 38] The patient interface according to any one of additional items 28 to 37, wherein each of the plurality of groove portions is disposed between a pair of raised portion connectors, and each raised portion connector of the pair of raised portion connectors is disposed at each end of each groove portion. [Additional item 39] The patient interface according to additional item 38, wherein each of the plurality of groove portions includes a groove depth, each of the plurality of raised portion connectors includes a height of the raised portion connector, and the groove depth of each groove portion is equal to the height of each raised portion connector of each pair of raised portion connectors disposed at each end of each groove portion. [Additional item 40] The patient interface according to any one of additional items 28 to 39, wherein each raised portion connector is a portion integrally formed with the tube wall. [Additional item 41] The patient interface according to additional item 40, wherein the plurality of raised portions, the plurality of groove portions, and the plurality of raised portion connectors are integrally formed. [Additional item 42] The patient interface according to any one of additional items 28 to 41, wherein each of the plurality of raised portions includes a curved raised portion at the center of each raised portion. [Additional item 43] The patient interface according to appended claim 42, wherein each of the plurality of groove portions includes a curved groove portion at the center of each groove portion. [Appended claim 44] The patient interface according to appended claim 42 or 43, wherein each of the plurality of raised portions includes a pair of linear raised portions provided at opposite ends of each raised portion. [Appended claim 45] The patient interface according to appended claim 44, wherein each of the plurality of raised portion connectors connects to each adjacent pair of raised portions at the linear raised portion of the raised portion. [Appended claim 46] The cross-section of the gas delivery tube in the extendable bellows structure has a width and a height, the width is substantially aligned in the front-rear direction during use, and the width is greater than the height, according to any one of appended claims 28 to 45. The patient interface described. [Appended claim 47] The positioning and stabilization structure includes two gas delivery tubes fluidly connected between a connection port and a seal-forming structure, each gas delivery tube extending in one of the patient's cheek regions during use, and the two gas delivery tubes are provided on different sides of the patient's head. The patient interface according to any one of appended claims 28 to 46. [Appended claim 48] A patient interface comprising: A plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O exceeding the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the treatment pressure for the patient's respiration; A seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an inlet to the patient's airway for delivering an air flow at a treatment pressure of at least 6 cmH2O above ambient air pressure throughout the patient's breathing cycle during use, the seal-forming structure having holes therein such that the air flow at the treatment pressure is delivered at least to the inlet to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use; A positioning and stabilization structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head: Including at least one gas delivery tube for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet of the patient's airway, the gas delivery tube being constructed and arranged to contact at least one area of the patient's head above the upper ear base point of the patient's head during use, the at least one gas delivery tube including a tube wall having a hollow interior and an extensible bellows structure provided along the length of the gas delivery tube, the extensible bellows structure: A plurality of folds within the tube wall in which a first alternating series of ridges and grooves is formed along the non-patient contact side of the gas delivery tube and a second alternating series of ridges and grooves is formed along the patient contact side of the gas delivery tube, The extensible bellows structure including a plurality of folds in which the tensile stiffness of the first alternating series of ridges and grooves is lower than that of the second alternating series of ridges and grooves, Including the gas delivery tube, The positioning and stabilization structure, A ventilation structure that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, Including, The patient interface is configured to allow the patient to breathe from the atmosphere through their own mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed. [Appendix Item 49] The patient interface according to Appendix Item 48, wherein the plurality of folds form internal ridges and internal grooves inside the gas delivery tube, forming a first alternating series of ridges and grooves and a second alternating series of ridges and grooves. [Appendix Item 50] The internal groove of each of the first alternating series is provided across the inside of the gas delivery tube on the opposite side of each one of the internal grooves of the second alternating series, forming a plurality of pairs of opposing grooves, and each pair of opposing grooves includes a first internal groove, which is one of the internal grooves of the first alternating series, a second internal groove, which is one of the internal grooves of the second alternating series, and The patient interface according to Appendix Item 48, wherein the groove depth of the first internal groove is greater than that of the second internal groove. [Appendix Item 51] The patient interface according to Appendix Item 50, wherein the material thickness at the base of the second internal groove of each pair of opposing grooves on the tube wall is greater than the material thickness at the base of the first internal groove of each pair of opposing grooves. [Appendix Item 52] The patient interface according to Appendix Item 51, wherein the material thickness of the tube wall at the base of each internal groove of the second alternating series decreases from a first end close to the connection port to a second end along the length of the gas delivery tube. [Appendix Item 53] The patient interface according to Appendix Item 51 or 52, wherein the material thickness of the tube wall at the base of each internal groove of the first alternating series is substantially constant along the length of the gas delivery tube. [Additional item 54] The groove depth of the internal groove portion of the first and second alternating series of internal ridge portions and internal groove portions decreases from a first end adjacent to the connection port to a second end along the length of the gas delivery tube, for the patient interface according to any one of claims 51 to 53. [Additional item 55] The first internal groove portion of each pair of opposing groove portions is joined to the second internal groove portion of each pair of opposing groove portions at a side portion of the gas delivery tube between the non-patient contact side and the patient contact side, for the patient interface according to any one of claims 50 to 54. [Additional item 56] A patient interface comprising: A plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O exceeding ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, a plenum chamber; A seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway for hermetically delivering an air flow at a treatment pressure of at least 6 cmH2O exceeding ambient air pressure throughout the patient's respiratory cycle during use, the seal-forming structure having holes therein such that the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure; A positioning and stabilization structure for providing a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, comprising: Receives an air flow from a connection port on the patient's head and passes the air flow through the seal-forming structure A pair of gas delivery tubes for delivering the air flow to an inlet of the patient's airway, each of the pair of gas delivery tubes being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use, including a pair of gas delivery tubes, each gas delivery tube: A tube wall that defines a hollow interior along the length of the gas delivery tube; A tab connected to the tube wall, the tab being configured to be positioned above the upper ear base point of the patient's head during use; and A slit formed in the tab, the slit being positioned rearwardly spaced from the tube wall during use, the slit including an upper end and a lower end, The upper end of the slit is disposed further spaced from the tube wall than the lower end of the slit. A gas delivery tube, and A strap constructed and arranged to be positioned under the occipital bone of the patient's head or to contact a region of the patient's head that is positioned on the occipital bone of the patient's head during use, the strap being configured to be connected to and between the slits. A positioning and stabilization structure, and A ventilation structure that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure in the plenum chamber during use. Including, The patient interface is configured to allow the patient to breathe from the atmosphere through his or her mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed. [Claim 57] The patient interface according to claim 56, wherein each tab is integrally formed with each tube wall. [Claim 58] The patient interface according to claim 56 or 57, wherein each tab has an upper edge and a lower edge, and the upper edge is longer than the lower edge. [Claim 59] The patient interface according to any one of claims 56 to 58, wherein the lower end of the slit is disposed at least 5 mm spaced from the tube wall. [Additional Item 60] The patient interface according to appended item 59, wherein the lower end of the slit is arranged at a distance of at least 7 mm from the tube wall. [Additional Item 61] The patient interface according to appended item 60, wherein the lower end of the slit is arranged at a distance of at least 8 mm from the tube wall. [Additional Item 62] The patient interface according to any one of appended items 56 to 61, wherein the upper end of the slit is arranged at a distance of at least 8 mm from the tube wall. [Additional Item 63] The patient interface according to appended item 62, wherein the upper end of the slit is arranged at a distance of at least 10 mm from the tube wall. [Additional Item 64] The patient interface according to appended item 63, wherein the upper end of the slit is arranged at a distance of at least 12 mm from the tube wall. [Additional Item 65] The patient interface according to any one of appended items 56 to 64, wherein the midpoint along the slit is arranged at a distance in the range of 5 mm to 30 mm from the tube wall. [Additional Item 66] The patient interface according to appended item 65, wherein the distance is in the range of 7 to 20 mm. [Additional Item 67] The patient interface according to appended item 66, wherein the distance is in the range of 8 to 15 mm. [Additional Item 68] The patient interface according to appended item 67, wherein the distance is in the range of 9 to 11 mm. [Additional Item 69] The patient interface according to any one of appended items 56 to 68, wherein each gas delivery tube includes an extendable tube portion arranged above the tab of each gas delivery tube during use and a non-extendable tube portion arranged below the tab of each gas delivery tube during use. [Additional Item 70] The patient interface according to claim 69, wherein each of the tabs is joined to the tube wall of each of the gas delivery tubes in the non-extendable tube portion. [Claim 71] The patient interface according to any one of claims 56 to 70, wherein each of the slits is arcuate between an upper end and a lower end. [Claim 72] The patient interface according to any one of claims 56 to 71, wherein each of the slits is oriented perpendicular to a direction from a slit in a strap anchor region where the strap is anchored around the patient's head. [Claim 73] A patient interface comprising: A plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the treatment pressure for the patient's respiration; A seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway for hermetically delivering an air flow at a treatment pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, the seal-forming structure having a hole therein such that the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use; A positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, comprising: A pair of gas delivery tubes for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to an inlet of the patient's airway, each of the pair of gas delivery tubes being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use, each gas delivery tube comprising: A tube wall configured to be disposed on a patient's head along a path extending between the patient's eyes and ears from above the upper part of the patient's head to a seal-forming structure during use; A tab connected to the tube wall, the tab being configured to be disposed above the upper ear base point of the patient's head during use; and A slit formed in the tab and disposed at a distance rearward from the slit adjacent portion of the path of the tube wall during use, The slit having a rear-upper to front-lower orientation during use and forming an oblique angle with the tangent of the path of the tube wall at the slit adjacent portion, the slit being included; A gas delivery tube, and A strap constructed and arranged to be disposed below the occipital bone of the patient's head or to contact a region of the patient's head disposed on the occipital bone of the patient's head during use, the strap being configured to be connected to and between the slits; including A positioning and stabilization structure, and A ventilation structure that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure in the plenum chamber during use; Including, The patient interface is configured to enable the patient to breathe from the atmosphere through his or her mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed. [Appendix 74] The patient interface according to Appendix 73, wherein each tab is integrally formed with each tube wall. [Appendix 75] The patient interface according to Appendix 73 or 74, wherein each tab has an upper edge and a lower edge during use, and the upper edge is longer than the lower edge. [Appendix 76] Each of the gas delivery tubes includes an extendable tube portion above the tab of each gas delivery tube and a non-extendable tube portion below the tab of each gas delivery tube during use, and the patient interface according to any one of appended claims 73 to 75. [Appended claim 77] Each of the tabs is connected to the tube wall of each gas delivery tube in the non-extendable tube portion, and the patient interface according to any one of appended claims 73 to 76. [Appended claim 78] Each of the slits is arcuate between the upper end and the lower end of the slit, and the patient interface according to any one of appended claims 73 to 77. [Appended claim 79] The lower end of the slit is arranged at a distance of at least 5 mm from the tube wall, and the patient interface according to any one of appended claims 73 to 78. [Appended claim 80] The lower end of the slit is arranged at a distance of at least 7 mm from the tube wall, and the patient interface according to appended claim 79. [Appended claim 81] The lower end of the slit is arranged at a distance of at least 8 mm from the tube wall, and the patient interface according to appended claim 80. [Appended claim 82] The upper end of the slit is arranged at a distance of at least 8 mm from the tube wall, and the patient interface according to any one of appended claims 73 to 81. [Appended claim 83] The upper end of the slit is arranged at a distance of at least 10 mm from the tube wall, and the patient interface according to appended claim 82. [Appended claim 84] The upper end of the slit is arranged at a distance of at least 12 mm from the tube wall, and the patient interface according to appended claim 88. [Appended claim 85] The bevel angle is within the range of 10 to 20 degrees, and the patient interface according to any one of appended claims 73 to 84. [Appended claim 86] The bevel angle is within the range of 12 to 18 degrees, the patient interface according to appended claim 85. [Appended claim 87] Each of the slits is oriented perpendicular to the direction from the slit in the strap anchor region where the strap is anchored around the patient's head, the patient interface according to any one of appended claims 73 to 86. [Appended claim 88] A patient interface comprising: A plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O exceeding the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, the plenum chamber; A seal forming structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway for hermetically delivering an air flow at a treatment pressure of at least 6 cmH2O exceeding the ambient air pressure throughout the patient's respiratory cycle during use, the seal forming structure having holes therein such that the air flow at the treatment pressure is delivered at least to the inlet to the patient's nostrils, the seal forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal forming structure; A positioning and stabilization structure for providing a force to hold the seal forming structure in a therapeutically effective position on the patient's head, comprising: A pair of gas delivery tubes for receiving an air flow from a connection port on the patient's head and delivering the air flow to an inlet of the patient's airway through the seal forming structure, each of the pair of gas delivery tubes being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use, each gas delivery tube comprising: A tube wall configured to extend between the patient's eyes and ears from the upper part of the patient's head to the seal forming structure and be placed on the patient's head; A tab connected to the tube wall and positioned above the upper ear base point of the patient's head during use; An air inlet formed in the tab and positioned behind the tube wall during use; and Including a trough formed within the tab and positioned behind the air inlet, A gas delivery tube, A strap constructed and arranged to be positioned below the occipital bone of the patient's head or to contact the area of the patient's head positioned on the occipital bone of the patient's head during use, the strap connecting to the air inlets of the pair of gas delivery tubes and connecting between the air inlets of the pair of gas delivery tubes, and being configured to be positioned within the trough formed in the tab during use; Including, A positioning and stabilization structure, A ventilation structure that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, including a ventilation structure; The patient interface is configured to allow the patient to breathe from the atmosphere through their own mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed. [Appended Claim 89] The trough is formed between the air inlet and the rear side of the tab within the tab The patient interface according to appended claim 88. [Appended Claim 90] The tab includes an outward-facing surface, and the trough includes a substantially planar surface formed as a depression with respect to the outward-facing surface. The patient interface according to appended claim 88 or 89. [Appended Claim 91] The trough is formed by a part of the tab with a smaller material thickness compared to other parts of the tab, the patient interface according to any one of appended claims 88 to 90. [Appended claim 92] The trough include...

Claims

1. A positioning and stabilization structure for holding a seal-forming structure of a patient interface at a therapeutically effective position on a patient's head, wherein the positioning and stabilization structure - at least one gas delivery tube for receiving an air flow from a connection port on the upper part of the patient's head and delivering the air flow through the seal-forming structure to the inlet of the patient's airway, at least one of the gas delivery tubes being constructed and arranged to be positioned in use in close proximity to at least one region of the patient's head above the upper ear base point of the patient's head, at least one of the gas delivery tubes having a hollow interior and a tube wall having an extendable bellows structure provided along at least a portion of the length of the gas delivery tube, wherein the extendable bellows structure * a plurality of folds in the tube wall, forming a first alternating series of ridges and grooves along the non-patient-facing side of the gas delivery tube and a second alternating series of ridges and grooves along the patient-facing side of the gas delivery tube, the patient-facing side being on the opposite side of the gas delivery tube from the non-patient-facing side, the folds being provided, a positioning and stabilization structure in which the grooves of the first alternating series of ridges and grooves are discontinuous with the grooves of the second alternating series of ridges and grooves.

2. The positioning and stabilization structure according to claim 1, wherein the first alternating series of ridges and grooves has a lower extensional rigidity than the second alternating series of ridges and grooves.

3. The positioning and stabilization structure according to claim 2, wherein the plurality of folds form internal ridges and internal grooves inside the gas delivery tube that form the first alternating series of ridges and grooves and the second alternating series of ridges and grooves.

4. The internal grooves in the first alternating series of ridges and grooves are provided on the opposite side of the corresponding one of the internal grooves in the second alternating series of ridges and grooves across the inside of the gas delivery tube, forming a plurality of pairs of opposing grooves, each of the pairs of opposing grooves - a first internal groove that is one of the internal grooves in the first alternating series of ridges and grooves, - a second internal groove that is one of the internal grooves in the second alternating series of ridges and grooves, being provided, The positioning and stabilization structure according to claim 3, wherein the first internal groove has a greater groove depth than the second internal groove.

5. The positioning and stabilization structure according to claim 4, wherein the pipe wall has a greater material thickness at the bottom of each of the second internal groove portions of the opposing groove portions than at the bottom of the first internal groove portions of the corresponding opposing groove portions.

6. The positioning and stabilization structure according to claim 5, wherein the material thickness at the bottom of each of the internal groove portions in the second alternating series of ridges and grooves decreases along the length of the gas delivery pipe from a first end proximate to the connection port to a second end.

7. The positioning and stabilization structure according to claim 5 or 6, wherein the material thickness of the gas delivery pipe at the bottom of each of the internal groove portions in the first alternating series of ridges and grooves is substantially constant along the length of the gas delivery pipe.

8. The positioning and stabilization structure according to any one of claims 5 to 7, wherein the groove depth of the internal groove portions in the first and second alternating series of ridges and the internal groove portions decreases along the length of the gas delivery pipe from a first end proximate to the connection port to a second end.

9. The positioning and stabilization structure according to any one of claims 4 to 8, wherein each of the internal ridges in the first alternating series of ridges and grooves is continuous with the corresponding opposite internal ridge in the second alternating series of ridges and grooves.

10. The positioning and stabilization structure according to any one of claims 1 to 9, comprising a ridge connection portion provided on the pipe wall, connecting a pair of adjacent ridges in the second alternating series of ridges and grooves, and hardening the second alternating series of ridges and grooves with respect to the first alternating series of ridges and grooves.

11. The positioning and stabilization structure according to any one of claims 1 to 10, wherein the second alternating series of ridges and grooves is formed of a material having higher rigidity than the first alternating series of ridges and grooves.

12. The positioning and stabilization structure according to any one of claims 1 to 11, wherein the second alternating series of ridges and grooves is hardened with respect to the first alternating series of ridges and grooves using a rigidity-imparting component.

13. The positioning and stabilization structure comprises two gas delivery pipes that fluidly connect between the connection port and the seal formation structure. Each of the gas delivery tubes extends across one of the buccal regions of the patient during use, The two gas delivery tubes are on different sides of the patient's head, the positioning and stabilization structure according to any one of claims 1 to 12. **Claim 14** Each of the gas delivery tubes - An upper tube portion placed in the upper region of the patient's head during use, * A first end configured to be placed on the upper part of the patient's head in or close to the sagittal plane of the patient's head during use, * A second end configured to be placed on the side of the patient's head during use, Comprising an upper tube portion, - A lower tube portion connected between the second end of the upper tube portion and the seal forming structure, Comprising, The extendable bellows structure is provided on the upper tube portion, the positioning and stabilization structure according to claim 13. **Claim 15** Each of the gas delivery tubes includes a tab connected to the tube wall and is configured to be located above the suprameatal point of the patient's head during use, The positioning and stabilization structure further includes a strap configured to be disposed below or on the occipital bone of the patient's head during use, The strap is configured to connect to and between the tabs, the positioning and stabilization structure according to any one of claims 1 to 14. **Claim 16** ・At least 6 cmH higher than the ambient air pressure ２ A plenum chamber capable of being pressurized to a treatment pressure at least 6 cmH higher than the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the treatment pressure for the patient's respiration, a plenum chamber, and ・During use, at least 6 cmH ２ O higher than the ambient air pressure to deliver at a treatment pressure that is hermetically sealed throughout the patient's respiratory cycle, a seal-forming structure constructed and arranged to form a seal against the area of the patient's face surrounding the inlet to the patient's airway, the seal-forming structure having a hole therein such that the airflow at the treatment pressure is delivered at least to the inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure, - The positioning and stabilization structure according to any one of claims 1 to 15, - A ventilation structure that enables the gas exhaled by the patient to continuously flow from the inside of the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure in the plenum chamber during use, a ventilation structure, Including a patient interface, The patient interface is configured such that the patient can breathe from the atmosphere through his or her mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed, a patient interface. **Claim 17** The seal forming structure is configured to form a seal with the patient's nostrils and with the patient's upper lip during use, the patient interface according to claim 16. **Claim 18** The seal forming structure includes a pair of nasal pillows, The patient interface according to claim 16, wherein each of the nasal pillows is constructed and arranged to form a seal with the nostrils of the nose of the patient. **Claim 19** The patient interface according to claim 16, wherein the seal-forming structure comprises a nasal seal-forming structure and an oral seal-forming structure.

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