Adjustable headgear tubing for patient interface

Abstract

To provide a positioning and stabilising structure for holding a seal-forming structure in a therapeutically effective position on a patient's head.SOLUTION: A positioning and stabilising structure 3300 may include at least one gas delivery tube 3350 for delivering a flow of air to an entrance to a patient's airways via a seal-forming structure. The at least one gas delivery tube may be constructed and arranged to contact, in use, at least a region of the patient's head superior to the otobasion superior of the patient's head. The positioning and stabilising structure may include an adjustment mechanism 3360 for adjustment of a length of the at least one gas delivery tube to enable the positioning and stabilising structure to be fitted to heads of different sizes. The positioning and stabilising structure may include a biasing mechanism. The biasing mechanism imparts a biasing force along at least a part of the length of the at least one gas delivery tube to urge the seal-forming structure towards the entrance to the patient's airways in use.SELECTED DRAWING: Figure 3A

Description

Technical Field

[0001] 1 Cross - References to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 281,322 and U.S. Provisional Application No. 62 / 330,371. The entire disclosures of these documents are incorporated herein by reference in their entireties.

[0002] 2 Statement Regarding Federally Sponsored Research or Development Not applicable

[0003] 3 Name of Organization for Joint Research and Development Not applicable

[0004] 4 Sequence Listing Not applicable

[0005] 5 Background of the Technology 5.1 Field of the Technology This technology relates to one or more of the detection, diagnosis, treatment, prevention, and amelioration of respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

[0006] A particular form of this technology relates to patient interfaces used in respiratory therapy, prevention, and amelioration of respiratory - related diseases.

[0007] 5.2 Description of Related Technology 5.2.1 The Human Respiratory System and Its Diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0008] These airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they extend deeper into the lungs. The primary function of the lungs is gas exchange, which involves taking oxygen from the air into the venous blood and removing carbon dioxide. The trachea divides into the right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. Further division of the airways results in respiratory bronchioles, which eventually become alveoli. Gas exchange takes place in the alveolar region of the lungs, and this region is called the respiratory region. See Non-Patent Literature 1.

[0009] A range of respiratory diseases exist. Certain diseases can be characterized by specific onsets (e.g., apnea, respiratory depression, and hyperventilation).

[0010] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by the onset of closure or obstruction of the upper airway during sleep. This results from a combination of an abnormally small upper airway, normal loss of muscle tone in the tongue region, and normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result of this condition, respiratory cessation in affected patients typically lasts 30 to 120 seconds, sometimes as many as 200 to 300 times a night. Consequently, excessive daytime sleepiness occurs, which can lead to cardiovascular disease and brain injury. This condition is common, particularly prevalent in overweight middle-aged men, although patients often have no subjective symptoms. See Patent Document 1.

[0011] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, characterized by alternating, cyclical increases and decreases in ventilation known as the CSR cycle. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CCR is accompanied by recurrent sleep-wake cycles, which cause severe insomnia, increased sympathetic activity, and increased afterload. See Patent Document 2.

[0012] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to adequately inhale oxygen or exhale CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following conditions:

[0013] Patients with respiratory failure (a type of respiratory failure) may experience abnormal shortness of breath during exercise.

[0014] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

[0015] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to air movement, prolonged expiratory phase of respiration, and reduced normal elasticity in the lungs. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational radiation exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0016] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage, which can lead to inability to walk, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified into rapidly progressive and slowly progressive types: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over several months and leads to death within several years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: characterized by muscle damage that worsens over several years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increased general weakness, dysphagia, dyspnea at exertion and rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0017] Chest wall disorders are a group of thoracic deformities that cause dysfunction in the connection between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0018] A range of treatments are used to treat or improve such conditions. Furthermore, otherwise healthy individuals can also take advantage of preventive treatments for respiratory diseases. However, these have several drawbacks.

[0019] 5.2.2 Treatment Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves the continuous positive airway pressure acting as an air splint, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing upper airway obstruction. Since CPAP treatment for OSA can be voluntary, patients may choose not to adhere to treatment if they notice one or more of the following regarding the device used to deliver the treatment: discomfort, difficulty of use, high cost, or lack of aesthetic appeal.

[0020] Non-invasive ventilation (NIV) provides ventilatory support to the patient through the upper airway to assist with breathing and / or maintain adequate oxygen levels throughout the body by performing some or all of the respiratory function. Ventilation support is provided through a non-invasive patient interface. NIV is used to treat forms of respiratory failure and pulmonary stenosis, such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0021] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0022] 5.2.3 Treatment System These treatments may be provided by treatment systems or devices. Such systems and devices may also be used to diagnose symptoms without treating them.

[0023] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, and a patient interface.

[0024] 5.2.3.1 Patient Interface A patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an airflow to an airway inlet. The airflow 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, for example, form a seal with the area of the patient's face, thereby promoting gas delivery at a sufficient distributed pressure along 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 delivery of gas supply to the airway at a positive pressure of about 10 cmH2O.

[0025] Certain other mask systems may be functionally inadequate in the art. 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 surroundings.

[0026] Certain masks may be clinically unfavorable in the art (e.g., when the mask blocks airflow through the nose and only allows airflow through the mouth).

[0027] In certain masks, it may be uncomfortable or impractical in the art when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal through the lips.

[0028] Certain masks may be impractical for use during sleep (e.g., when sleeping on a bed on the side with the head on a pillow).

[0029] There are several challenges in designing 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. Because the head contains bone, cartilage, and soft tissue, different areas of the face respond differently 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 period.

[0030] Due to these challenges, some masks, especially when worn for extended periods or when the patient is unfamiliar with the system, may be intrusive, aesthetically undesirable, expensive, poorly fitting, difficult to use, and uncomfortable for one or more reasons. Using an incorrectly sized mask can lead to decreased compliance, reduced comfort, and a poorer patient outcome. While pilot-specific masks, personal protective equipment (e.g., filter masks), masks designed as part of a SCUBA mask, or masks used for anesthesia may be tolerable for their original purpose, they can be undesirable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient compliance with treatment, especially if the mask needs to be worn during sleep.

[0031] CPAP therapy is highly effective in treating certain respiratory conditions, provided the patient consents to the treatment. Patients may refuse treatment if the mask is uncomfortable or difficult to use. Since patients are often advised to wash their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean the mask, which can affect patient compliance.

[0032] Masks designed for other purposes (e.g., pilot use) may be unsuitable for treating sleep-disordered breathing, while masks designed for treating sleep-disordered breathing may be suitable for other purposes.

[0033] For these reasons, the patient interface for CPAP delivery during sleep forms a distinct field.

[0034] 5.2.3.1.1 Seal formation portion The patient interface may include a seal-forming portion. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming portion can directly affect the effectiveness and comfort of the patient interface.

[0035] Patient interfaces can be partially characterized according to the design intent of where the seal-forming portion engages with the face during use. In one form of patient interface, the seal-forming portion may include two sub-parts that engage with each nostril, the left and the right. In one form of patient interface, the seal-forming portion may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and the nasal bridge region of the face. In one form of patient interface, the seal-forming portion may include an element that surrounds the mouth region by forming a seal, for example, on the lower lip region of the face during use. In one form of patient interface, the seal-forming portion may include a single element that surrounds both nostrils and the oral cavity region during use. These different types of patient interfaces may be known by various names by their manufacturers, such as nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nasal masks. Mouth-nasal masks may include compact full-face masks without forehead support. Alternatively, a mouth-nose mask may include a full-face mask that seals around the nose and mouth openings, and a nasal seal may include a cradle that seals below the lateral nasal cartilages.

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

[0037] Specific seal-forming portions can be designed for mass production so that a single design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. To form a seal, one or both the patient's face shape and the seal-forming portion of the mass-produced patient interface must be adapted to a certain extent, even if there is some mismatch.

[0038] One type of sealing portion extends around the periphery of the patient interface and is intended to seal the patient's face when force is applied to the patient interface while the sealing portion is engaged with the patient's face. This sealing portion may include an air or fluid-filled cushion, or it may include a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. With this type of sealing portion, if the fit is improper, a gap will form between the sealing portion and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0039] Another type of sealing mechanism uses a thin flap seal positioned around the perimeter of the mask to provide a self-airtight seal against the patient's face when positive pressure is applied inside the mask. Similar to the previously mentioned type of sealing mechanism, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the sealing mechanism does not conform to the patient's shape, creases or buckling may occur in the sealing mechanism during use, leading to leakage.

[0040] Other types of seal-forming components may include, for example, friction-fitting elements inserted into the nostrils, but some patients may find these seal-forming components uncomfortable.

[0041] Another form of seal-forming portion may use an adhesive portion to achieve a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive portion from their face.

[0042] The technology for forming a patient interface seal within a certain range is disclosed in the following patent applications (assigned to ResMed Limited: Patent Document 3, Patent Document 4, Patent Document 5).

[0043] One form of nasal pillow is found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of Patent Document 6, which was transferred to 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 MIRAGELIBERTY® full face mask. The following patent applications, assigned to ResMed Limited, describe examples of nasal pillow masks: Patent Document 7 (in particular describing the appearance of ResMed Limited's SWIFT® nasal pillow), Patent Document 8 (in particular describing the appearance of ResMed Limited's SWIFT® LT nasal pillow); Patent Documents 9 and 10 (in particular describing the appearance of ResMed Limited's MIRAGE LIBERTY® full face mask); and Patent Document 11 (in particular describing the appearance of ResMed Limited's SWIFT® FX nasal pillow).

[0045] 5.2.3.1.2 Positioning and Stabilization The seal-forming portion of the patient interface used in positive pressure air therapy is subjected to corresponding forces from the air pressure that interfere with the seal. Therefore, various techniques are used to position the seal-forming portion and maintain a seal over the appropriate part of the face.

[0046] In one technology, adhesive joints are used. For example, see U.S. Patent Application Publication US2010 / 0000534. However, the use of adhesive joints can sometimes cause discomfort.

[0047] In other technologies, one or more straps and / or stabilizing harnesses are used. Many such harnesses suffer from one or more of the following drawbacks: poor fit, bulkiness, discomfort, and difficulty of handling. When designed to be worn on a patient's head, such harnesses may be called headgear.

[0048] 5.2.3.1.3 Conduits for pressurized air In one type of treatment system, a flow of pressurized air is supplied to the patient interface through conduits in an air circuit. These conduits fluidly connect to the patient interface such that when the patient interface is positioned over the patient's face during use, the conduits extend forward from the patient interface and away from the patient's face. This is sometimes referred to as an "elephant trunk" type interface.

[0049] Some patients may find such interfaces visually bothersome, and if they discontinue wearing them as a result, patient compliance decreases. Furthermore, if the conduit is connected to the interface in front of the patient's face, it may easily become entangled with bedding.

[0050] 5.2.3.1.4 Pressurized air conduit used for positioning / stabilizing seal-forming structures In patient interfaces included in another type of therapeutic system that attempts to address these problems, the tube responsible for delivering pressurized air to the patient's airway also functions as part of a headgear to position and stabilize the sealing portion of the patient interface in the appropriate part of the patient's face. This type of patient interface may also be called one using “headgear tubing” or “conduit headgear.” Using such a patient interface, a conduit in an air circuit that provides pressurized airflow from a respiratory pressure therapy device can be provided to a patient interface located at a position other than in front of the patient's face. An example of such a therapeutic system is disclosed in Patent Document 12, which is incorporated herein by reference. In that document, the conduit is connected to the tube in the patient interface through a port positioned above the patient's head during use.

[0051] Philips' DreamWear® nasal masks include headgear tubing. One problem with this mask is that the length of the headgear tubing cannot be adjusted. Therefore, DreamWear® masks are supplied in different sizes to accommodate patients with different face sizes. However, this increases complexity and cost in the manufacture of DreamWear® masks, as well as increases packaging size. Furthermore, supplying masks in different sizes limits the range of patients with different head sizes that can be accommodated (for example, whether a patient's head size falls between the mask sizes offered).

[0052] Using a patient interface with headgear tubing offers several advantages (for example, avoiding conduits connecting to the patient interface in front of the patient's face, which can be visually distracting and uncomfortable). However, a patient interface with headgear tubing should be comfortable while forming an effective seal with the patient's face, especially when worn for extended periods while the patient is sleeping.

[0053] 5.2.3.2 Respiratory Pressure Therapy (RPT) Devices Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that cannot be met by more general pneumatic generators (e.g., reliability, size, 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.

[0054] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another embodiment of an RPT device is the ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide assistance for invasive and non-invasive independent breathing for a range of patients for the treatment of multiple conditions (e.g., NMD, OHS, and COPD).

[0055] 5.2.3.3 Humidifier Delivering airflow without humidification can lead to airway dryness. Using a humidifier with the RPT device and patient interface generates humidifying gas, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, adding warm air to the facial area around the patient interface generally provides greater comfort than cool air. [Prior art documents] [Patent Documents]

[0056] [Patent Document 1] U.S. Patent No. 4944310 [Patent Document 2] U.S. Patent No. 6532959 [Patent Document 3] International Publication No. 1998 / 004310 [Patent Document 4] International Publication No. 2006 / 074513 [Patent Document 5] International Publication No. 2010 / 135785 [Patent Document 6] U.S. Patent No. 4782832 [Patent Document 7] International Publication No. 2004 / 073778 [Patent Document 8] U.S. Patent Application Publication No. 2009 / 0044808 [Patent Document 9] International Publication No. 2005 / 063328 [Patent Document 10] International Publication No. 2006 / 130903 [Patent Document 11] International Publication No. 2009 / 052560 [Patent Document 12] U.S. Patent Application Publication No. 2007 / 0246043 [Patent Document 13] U.S. Patent No. 6044844 [Patent Document 14] U.S. Patent No. 7866944 [Patent Document 15] U.S. Patent No. 8638014 [Patent Document 16] U.S. Patent No. 8636479 [Patent Document 17] International Publication No. 2013 / 020167 [Patent Document 18] U.S. Patent No. 8733349 [Non-patent literature]

[0057] [Non-Patent Document 1] “Respiratory Physiology”, by John B. West, Lippincott Williams & Wilkins, 9th edition published 2011 [Overview of the project] [Problems that the invention aims to solve]

[0058] 6. Brief explanation of the technology This technology relates to the provision of medical devices used in the diagnosis, improvement, treatment, or prevention of respiratory diseases, which have one or more of the following advantages: improved comfort, cost, effectiveness, ease of use, and manufacturability. [Means for solving the problem]

[0059] A first aspect of this technology relates to a device used for the diagnosis, improvement, treatment, or prevention of respiratory diseases.

[0060] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0061] One form of this technology includes a patient interface for delivering a supply of pressurized, breathable gas to the entrance of the patient's airway.

[0062] Another aspect of one embodiment of this technology includes a positioning and stabilization structure for holding a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure may be constructed and positioned to form a seal with a region of the patient's face surrounding the entrance to the patient's airway in order to seally deliver airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure over the entire respiratory cycle of the patient during use. The positioning and stabilization structure may include at least one gas delivery tube for delivering airflow through the seal-forming structure to the entrance of the patient's airway. The at least one gas delivery tube may be constructed and positioned to contact at least one region of the patient's head above the point of aural base on the patient's head during use. The positioning and stabilization structure may include an adjustment mechanism for adjusting the length of at least one gas delivery tube to allow the positioning and stabilization structure to fit heads of different sizes. The positioning and stabilization structure may include a biasing mechanism that provides a biasing force along at least a portion of the length of at least one gas delivery tube to propel the seal-forming structure towards the entrance of the patient's airway during use.

[0063] Another aspect of one embodiment of this technology includes a patient interface comprising a plenum chamber pressurized to a therapeutic pressure of at least 4 cmH2O, exceeding ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and constructed to receive an airflow at a therapeutic pressure for the patient's breathing. The patient interface may include a seal-forming structure constructed and positioned to form a seal against the area of ​​the patient's face surrounding the entrance to the patient's airway, thereby delivering the airflow at the therapeutic pressure to at least the entrance to the patient's nostrils. The seal-forming structure may be constructed and positioned to maintain the therapeutic pressure within the plenum chamber for the entire respiratory cycle of the patient during use. The patient interface may include a connection port for fluid connection to an air circuit connected to the airflow during use. The connection port may be located near the top, side, or rear of the patient's head during use. The patient interface may include a positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include at least one gas delivery tube for delivering the airflow through the seal-forming structure to the entrance to the patient's airway. At least one gas delivery tube may be constructed and positioned to contact at least one area of ​​the patient's head above the point of auricular base during use. The positioning and stabilizing structure may include an adjustment mechanism for adjusting the length of at least one gas delivery tube to allow the positioning and stabilizing structure to fit heads of different sizes. The positioning and stabilizing structure may include a biasing mechanism that imparts a biasing force along at least a portion of the length of at least one gas delivery tube to propel the seal-forming structure toward the entrance of the patient's airway during use.

[0064] Another aspect of one embodiment of this technology includes a positioning and stabilization structure for holding a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure may be constructed and positioned to form a seal with a region of the patient's face surrounding the entrance to the patient's airway in order to deliver airflow in a sealed manner at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's entire respiratory cycle during use. The positioning and stabilization structure may include at least one tie. At least one tie may be configured to contact the patient's head during use. At least one tie may include at least one gas delivery tube for delivering airflow through the seal-forming structure to the entrance to the patient's airway. At least one gas delivery tube may be constructed and positioned to cover at least one region of the patient's head above the point of aortic base during use. The positioning and stabilization structure may include an adjustment mechanism for adjusting at least one tie to allow the positioning and stabilization structure to fit different head sizes. The positioning and stabilization structure may be configured to position the adjustment mechanism so that it does not contact the patient's face during use.

[0065] Another aspect of one embodiment of this technology includes a patient interface comprising a plenum chamber pressurized to a therapeutic pressure of at least 4 cmH2O, exceeding ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's breathing. The patient interface may include a seal-forming structure constructed and positioned to form a seal against the area of ​​the patient's face surrounding the entrance to the patient's airway, thereby delivering airflow at the therapeutic pressure to at least the entrance to the patient's nostrils. The seal-forming structure may be constructed and positioned to maintain the therapeutic pressure within the plenum chamber for the entire respiratory cycle of the patient during use. The patient interface may include a connection port for fluid connection to an air circuit connected to the airflow during use. The connection port may be located near the top, side, or rear of the patient's head during use. The patient interface may include a positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include at least one tie. At least one tie may be configured to contact the patient's head during use. At least one tie may include at least one gas delivery tube for delivering airflow through a seal-forming structure to the entrance of the patient's airway. The at least one gas delivery tube may be constructed and positioned to cover at least one area of ​​the patient's head above the point of aural base when in use. The positioning and stabilization structure may include an adjustment mechanism for adjusting at least one tie to allow the positioning and stabilization structure to fit different head sizes. The positioning and stabilization structure may be configured so that the adjustment mechanism does not come into contact with the patient's face when in use.

[0066] Another aspect of one embodiment of the present technology includes a patient interface comprising a plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, exceeding ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's breathing. The patient interface may include a seal-forming structure constructed and positioned to form a seal against a region of the patient's face surrounding the entrance to the patient's airway, thereby delivering airflow at the therapeutic pressure to at least the entrance to the patient's nostrils. The seal-forming structure may be constructed and positioned to maintain the therapeutic pressure within the plenum chamber for the entire respiratory cycle of the patient during use. The patient interface may include a positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include a first tubular portion constructed and positioned to cover a region of the patient's head above the point of auricular base during use. The positioning and stabilizing structure may include a tie portion that rests on or covers the posterior occipital bone of the patient's head during use. The patient interface may include a ventilation structure to allow the gas exhaled by the patient to flow continuously from inside the plenum chamber to the surroundings. The ventilation structure is sized and shaped to maintain the therapeutic pressure inside the plenum chamber during use. A first tube may be configured to conduct at least a portion of the airflow inhaled by the patient. The first tube may be configured to be taut during use. The first tube may include a longitudinal adjustment mechanism.

[0067] Another aspect of one embodiment of this technology includes a positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure may be constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway in order to seally deliver the airflow at a therapeutic pressure of at least 4 cmH2O relative to the ambient air pressure throughout the patient's entire respiratory cycle during use. The positioning and stabilizing structure may include a first conduit section constructed and positioned to cover an area of ​​the patient's head above the point of auricular base during use. The positioning and stabilizing structure may include a tie section that rests on or covers the posterior part of the occipital bone of the patient's head during use. The first conduit section may be configured to conduct at least a portion of the airflow inhaled by the patient. The first conduit section may be configured to be taut during use. The first conduit section may include a longitudinal adjustment mechanism.

[0068] Another aspect of one embodiment of the present technology includes a patient interface comprising a plenum chamber pressurized to a therapeutic pressure of at least 4 cmH2O, exceeding ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and constructed to receive an airflow at the therapeutic pressure for the patient's breathing. The patient interface may include a seal-forming structure constructed and positioned to form a seal against a region of the patient's face surrounding the entrance to the patient's airway, thereby delivering the airflow at the therapeutic pressure to at least the entrance to the patient's nostrils. The seal-forming structure may be constructed and positioned to maintain the therapeutic pressure within the plenum chamber for the entire respiratory cycle of the patient during use. The patient interface may include a positioning and stabilizing structure that provides elasticity to hold the seal-forming structure in a therapeutically effective position on the patient's head in order to deliver the therapeutic pressure in an airflow. The positioning and stabilizing structure may include a tie. The tie may be constructed and positioned such that at least a portion of the tie covers a region of the patient's head above the point of auricular base on the patient's head during use. The Thai may include a length-adjustable gas delivery tube for delivering airflow through a seal-forming structure to the entrance of the patient's airway. The gas delivery tube may be configured to contact a portion of the patient's head during use. The positioning and stabilization structure may include a biasing mechanism. This biasing mechanism applies a biasing force to the length-adjustable gas delivery tube to propel the seal-forming structure towards the entrance of the patient's airway during use.

[0069] Another aspect of one embodiment of this technology includes a positioning and stabilization structure for holding a seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure may be constructed and positioned to form a seal with a region of the patient's face surrounding the entrance to the patient's airway in order to deliver airflow in a sealed manner at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's entire respiratory cycle during use. The positioning and stabilization structure may include a tie. The tie may be constructed and positioned such that at least a portion of the tie covers a region of the patient's head above the point of aortic base on the patient's head during use. The tie may include a length-adjustable gas delivery tube for delivering airflow through the seal-forming structure to the entrance to the patient's airway. The gas delivery tube may be configured to contact a portion of the patient's head during use. The positioning and stabilization structure may include a biasing mechanism. This biasing mechanism applies a biasing force to the length-adjustable gas delivery tube to propel the seal-forming structure towards the entrance to the patient's airway during use.

[0070] Another aspect of one embodiment of this technology includes an inflatable positioning and stabilizing structure for delivering airflow in a sealed manner to an inlet into the patient's airway formed by a seal-forming structure of a patient interface, at a continuously positive pressure relative to the ambient air pressure, and configured to maintain a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, higher than the ambient air pressure, throughout the patient's respiratory cycle during sleep, thereby improving sleep-disordered breathing. The positioning and stabilizing structure may include at least one gas delivery tube for delivering airflow through the seal-forming structure to the inlet of the patient's airway. The positioning and stabilizing structure may also include an adjustment mechanism that allows for dimensional adjustment of the positioning and stabilizing structure. The positioning and stabilizing structure may also include a biasing mechanism that provides a biasing force to move the adjustment mechanism and the propulsion seal-forming structure toward the inlet of the patient's airway.

[0071] Another aspect of one embodiment of this technology includes a patient interface for delivering a supply of pressurized air to the entrance of a patient's airway at a continuously positive pressure relative to the ambient air pressure. The patient interface is configured to maintain a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, higher than the ambient air pressure, throughout the patient's respiratory cycle during sleep, thereby improving sleep-disordered breathing. The patient interface may include a connection port for fluid connection to an air circuit connected to the supply of pressurized air during use. The connection port is located near the top, side, or back of the patient's head during use. The patient interface may also include a seal-forming structure that seals an area surrounding the entrance to the patient's airway. The patient interface may also include an inflatable positioning and stabilizing structure for maintaining the seal formed by the seal-forming structure. The positioning and stabilizing structure may include at least one gas delivery tube for delivering airflow through the seal-forming structure to the entrance of the patient's airway.

[0072] Another aspect of the relevant form of this technology includes a patient interface. This patient interface includes a positioning and stabilization structure that includes an adjustment mechanism for enabling dimensional adjustment of the positioning and stabilization structure.

[0073] Another aspect of the related forms of this technology includes a patient interface. This patient interface includes a biasing mechanism for applying a biasing force to an adjustment mechanism and propelling a seal-forming structure toward the entrance of the patient's airway.

[0074] Another aspect of one embodiment of this technology includes an inflatable positioning and stabilizing structure for delivering airflow in a sealed manner to an inlet into the patient's airway formed by a seal-forming structure of a patient interface, at a continuously positive pressure relative to the ambient air pressure, and configured to maintain a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, higher than the ambient air pressure, throughout the patient's respiratory cycle during sleep, thereby improving sleep-disordered breathing. The positioning and stabilizing structure may include at least one gas delivery tube for delivering airflow to the inlet of the patient's airway via the seal-forming structure. The positioning and stabilizing structure may also include an adjustment mechanism that allows for dimensional adjustment of the positioning and stabilizing structure. The positioning and stabilizing structure may be configured to be positioned so that the adjustment mechanism does not come into contact with the patient's cheek area during use.

[0075] Another aspect of one embodiment of this technology includes a patient interface for delivering a supply of pressurized air to the inlet of a patient's airway at a continuously positive pressure relative to the ambient air pressure. The patient interface is configured to maintain a therapeutic pressure in the range of approximately 4 cmH2O to approximately 30 cmH2O, higher than the ambient air pressure, throughout the patient's respiratory cycle during sleep, thereby improving sleep-disordered breathing. The patient interface may include a positioning and stabilization structure. The positioning and stabilization structure may include at least one gas delivery tube for delivering airflow to the inlet of the patient's airway via a seal-forming structure. The positioning and stabilization structure may also include an adjustment mechanism that allows for dimensional adjustment of the positioning and stabilization structure. The positioning and stabilization structure may be configured to be positioned so that the adjustment mechanism does not come into contact with the patient's cheek area during use.

[0076] Another aspect of a particular form of this technology is a system for the treatment of respiratory diseases. The system includes a patient interface according to one or more other aspects of this technology, an air circuit, and an air source in positive pressure.

[0077] Another aspect of one form of this technology is a patient interface molded or otherwise constructed together with a peripheral shape that is complementary to the shape of the intended wearer.

[0078] Another aspect of a particular form of this technology is a patient interface. This patient interface includes a seal-forming structure configured to expose the patient's oral cavity during use.

[0079] Another aspect of a particular form of this technology is a patient interface. This patient interface includes a seal-forming structure configured such that no part of the seal-forming structure enters the oral cavity during use.

[0080] Another aspect of a particular form of this 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 patient's airway.

[0081] Another aspect of a particular form of this technology is a patient interface. This patient interface includes a seal-forming structure configured so that the seal-forming structure does not extend below the chin prominence region during use.

[0082] Another aspect of a particular form of this technology is a patient interface constructed and positioned to expose the patient's eyes during use.

[0083] Another aspect of a particular form of this technology is a patient interface constructed and positioned to allow a patient to breathe ambient air during a power outage.

[0084] Another aspect of a particular form of this technology is a patient interface. This patient interface includes a seal-forming structure configured to form a seal on the underside of the patient's nose without contacting the nasal bridge region of the patient's nose.

[0085] Another aspect of a particular form of this technology is a patient interface. This patient interface includes a vent and a plenum chamber. The patient interface is constructed and arranged so that gas from inside the plenum chamber can move to the surroundings through the vent.

[0086] Another aspect of a particular form of this technology is a patient interface. This patient interface is constructed and positioned so that the patient can lie comfortably in a lateral or lateral sleeping position when using the patient interface.

[0087] Another aspect of a particular form of this technology is a patient interface. This patient interface is constructed and positioned so that the patient can lie comfortably in a supine sleeping position when using the patient interface.

[0088] Another aspect of a particular form of this technology is a patient interface. This patient interface is constructed and positioned so that the patient can lie comfortably in a prone sleeping position when using the patient interface.

[0089] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has limited experience using this type of medical device.

[0090] One embodiment of this technology is a patient interface that can be cleaned at the patient's home with, for example, soapy water, and does not require any special cleaning equipment. Another embodiment of this technology is a humidifier tank that can be cleaned at the patient's home with, for example, soapy water, and does not require any special cleaning equipment.

[0091] Of course, some of the above-described embodiments may form sub-embodied embodiments of this technology. Furthermore, various combinations of sub-embodied embodiments and / or embodiments may be formed to constitute even further embodiments or sub-embodied embodiments of this technology.

[0092] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0093] 7. Brief Description of the Drawings This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals include the following similar elements: [Brief explanation of the drawing]

[0094] [Figure 1A] This diagram shows a system including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal pillow and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. A roommate 1100 is also shown. [Figure 1B] This diagram shows a system including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. [Figure 1C] This diagram shows a system including a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full-face mask and receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. [Figure 2A] This diagram outlines the human respiratory system, including the nasal and oral cavities, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] Figure 2B is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of the face including several features of surface anatomical structures, including the upper lip, upper lip robe, lower lip robe, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and corners of the mouth. The superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, therion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, ala apex, auricle supraspinatus, and auricle subspinatus. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankforth horizontal and nasolabial angles are indicated. The coronal plane is also shown. [Figure 2F] This is a basal view of the nose, including several features such as the nasolabial folds, lower lip, upper lip red, nostrils, subnasal point, columella, nasal tip, main axis of the nostrils, and sagittal plane. [Figure 3A] This figure shows a patient interface 3000 including a positioning and stabilization structure 3300 in a specific form of this technology. [Figure 3B] This figure shows a patient interface 3000 including a positioning and stabilization structure 3300 in a specific form of this technology. [Figure 3C] This figure shows a patient interface 3000 including a positioning and stabilization structure 3300 in a specific form of this technology. [Figure 3D] This figure shows a patient interface 3000 including a positioning and stabilization structure 3300 in a specific form of this technology. [Figure 3E] This figure shows a patient interface 3000 including a positioning and stabilization structure 3300 in a specific form of this technology. [Figure 3F] Figures 3C, 3D, and 3E are plan views of the patient interface 3000. [Figure 3G] Figure 3F is a cross-sectional view of a portion of the patient interface 3000. [Figure 3H]This figure shows a longitudinal section of the headgear tube 3350 of the patient interface 3000. [Figure 3I] This graph shows an exemplary force extension characteristic plot of the headgear tube 3350 of the patient interface 3000. [Figure 3J] Figures 3C, 3D, and 3E are side views showing the patient interface being worn by a patient, with the connection port 3600 located at the center (dandent line), anterior position, and posterior position. [Figure 3K] Figures 3C, 3D, and 3E are side views showing the patient interface being fitted by a patient with one head size and by a patient with a larger head size (dandent line). [Figure 3L] Figures 3C, 3D, and 3E are side views showing the patient interface being worn by a patient, with the adjustment mechanism 3360 positioned centrally and positioned forward and backward (dandent lines). [Figure 4A] This figure shows a cushion assembly 3150 of a patient interface 3000 according to a specific form of this technology. [Figure 4B] This figure shows a cushion assembly 3150 of a patient interface 3000 according to a specific form of this technology. [Figure 4C] This figure shows a cushion assembly 3150 of a patient interface 3000 according to a specific form of this technology. [Figure 4D] This figure shows a cushion assembly 3150 of a patient interface 3000 according to a specific form of this technology. [Figure 4E] This figure shows a cushion assembly 3150 of a patient interface 3000 according to a specific form of this technology. [Figure 5] This figure shows a patient interface 3000, which includes a positioning and stabilizing structure 3300 having a folding section 3364 and a strap 3390 according to one embodiment of this technology. [Figure 5A]Figure 5 is a cross-sectional view of the folding section 3364 of the patient interface 3000, where the rotating folding section 3366 folds to a different level onto the adjacent tubular section 3368. [Figure 5B] Figure 5 is a cross-sectional view of the folding section 3364 of the patient interface 3000, where the rotating folding section 3366 folds to a different level onto the adjacent tubular section 3368. [Figure 6] This figure shows a patient interface 3000, which includes a positioning and stabilizing structure 3300 including a flexible tube 3350 according to one embodiment of this technology. [Figure 7A] This figure shows a patient interface 3000 including a positioning and stabilizing structure 3300 having a first tube section 3370 and a second tube section 3372 according to a specific embodiment of the present technology. [Figure 7B] This figure shows a patient interface 3000 including a positioning and stabilizing structure 3300 having a first tube section 3370 and a second tube section 3372 according to a specific embodiment of the present technology. [Figure 7C] This figure shows a patient interface 3000 including a positioning and stabilizing structure 3300 having a first tube section 3370 and a second tube section 3372 according to a specific embodiment of the present technology. [Figure 8] This figure shows a portion of the patient interface 3000, which includes a positioning and stabilizing structure 3300 having separately adjustable first tube section 3370 and second tube section 3372 according to one embodiment of the present technology. [Figure 9] This figure shows a portion of the patient interface, including a positioning and stabilizing structure 3300 having a first tubular section 3370 and a second tubular section 3372 according to one embodiment of this technology. [Figure 10A] This figure shows a patient interface 3000, which includes a positioning and stabilization structure 3300 having an adjustment mechanism 3360 according to one embodiment of this technology. [Figure 10B] This figure shows a patient interface 3000, which includes a positioning and stabilizing structure 3300 having threaded tube sections 3380 and 3382 according to one embodiment of this technology. [Figure 11] This figure shows a patient interface 3000, which includes a positioning and stabilizing structure 3300 having replaceable tubular sections 3385 and 3386 according to one embodiment of the present technology. [Figure 12] This figure shows a patient interface 3000, which includes a positioning and stabilizing structure 3300 having an insertable tube portion 3387 according to one embodiment of the present technology. [Figure 13] This figure shows a portion of tube 3350 for a patient interface, including an extendable tube portion 3355 according to one embodiment of the present technology. [Figure 14] This figure shows a patient interface 3000, which includes a positioning and stabilizing structure 3300 having a band 3395 according to one embodiment of the present technology. [Figure 15] This figure shows a portion of the patient interface, including replaceable loop insertion members 3410 and 3411 according to one embodiment of this technology. [Figure 16] This figure shows a part of the patient interface, including an expandable loop insertion member 3420 according to one embodiment of this technology. [Figure 17] This figure shows a patient interface 3000, which includes a positioning and stabilizing structure 3300 having a bellows tube section 3362 and an elastic sleeve 3340 according to one embodiment of this technology. [Figure 18] This figure shows an RPT device based on one embodiment of this technology. [Figure 19A] This is an isometric view of a humidifier based on one embodiment of this technology. [Figure 19B] This is an isometric view of a humidifier according to one embodiment of this technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Modes for carrying out the invention]

[0095] 8. Detailed Description of Examples of the Technology Before describing the technology in further detail, it should be understood that the technology is not limited to the specific embodiments which may differ as described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0096] The following description is provided in relation to a variety of embodiments that may share one or more common properties and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or any other embodiment. In addition, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0097] 8.1 Treatment In one embodiment, as shown in Figure 1A, the technology includes a method for treating respiratory diseases. The method includes the step of applying positive pressure to the airway entrance of patient 1000.

[0098] 8.2 Treatment System In one embodiment, the technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000. The treatment systems shown in Figures 1A, 1B, and 1C use different forms of the patient interface 3000.

[0099] 8.3 Patient Interface Referring to Figure 3A, a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional modes: a cushion assembly 3150, a positioning and stabilization structure 3300, and a connection port 3600 for connection to an air circuit 4170. In some embodiments, the functional modes may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes.

[0100] The cushion assembly 3150 includes a seal-forming structure 3100 and a plenum chamber 3200. During use, the plenum chamber 3200 receives a positive pressure air supply from the air circuit 4170, and the seal-forming structure 3100 is positioned to seal the area around the entrance to the patient's airway in order to facilitate a positive pressure air supply to the airway.

[0101] 8.3.1 Seal-forming structure In one embodiment of this technology, the seal-forming structure 3100 provides a seal-forming surface and can further provide a cushioning function.

[0102] The seal-forming structure 3100 according to this technology may be made of a soft, flexible, and elastic material (for example, silicone).

[0103] The seal-forming structure 3100 may be non-invasive (i.e., it does not extend into the patient's airway). In some embodiments of this technology, no part of the seal-forming structure 3100 enters the patient's mouth during use. In some embodiments of this technology, the seal-forming structure 3100 is configured to leave the patient's mouth exposed during use. In some embodiments of this technology, the seal-forming structure 3100 does not cover the patient's eyes during use.

[0104] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm). This member extends around the perimeter length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is positioned between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the perimeter length. The support flange is or includes a spring-like element and functions to support the sealing flange so as not to buckle during use. During use, the sealing flange may readily respond to the system pressure in the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface.

[0105] In one embodiment shown in Figure 1A, the seal-forming portion 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 positioned to form a seal with each nostril of the patient's nose. The nasal pillow patient interface 3000 is also shown in Figure 3A.

[0106] A nasal pillow according to one aspect of this technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the underside of the patient's nose, on the stalk, and on a flexible region on the underside of the frustum of the cone, connecting the frustum of the cone to the stalk. In addition, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the stalk. The flexible region may function to facilitate a flexible connection structure. The flexible connection structure accommodates both the displacement and angle of the frustum of the cone and the mutual movement between the nasal pillow and the structure to which it is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stalk is connected.

[0107] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming portion that forms a seal over the upper lip region (i.e., upper lip), nasal bridge region, and cheek region of the patient's face when in use. For example, the patient interface 3000 shown in Figure 1B is an example of this. This seal-forming portion delivers air or breathable gas to both nostrils of the patient 1000 through a single orifice. This type of seal-forming structure may also be called a “nasal cushion” or “nasal mask.”

[0108] In another embodiment, the seal-forming structure is configured to form a seal with the subnasal area around the nostrils and optionally with the upper lip during use. This type of seal-forming structure may also be called a “nasal cradle cushion” or “sub-nasal mask.” The shape of the seal-forming structure may be configured to conform to or closely follow the subnasal area of ​​the patient (i.e., the profile and angles of the seal-forming structure may be substantially parallel to the patient’s nasolabial angle). In one embodiment of the nasal cradle cushion, the seal-forming structure includes a septal member defining two orifices. Each of these two orifices supplies air or a breathable gas to one of the patient’s nostrils during use. The septal member may be configured to contact or seal the patient’s columella during use. In some embodiments of the art, the seal-forming structure 3100 is configured to form a seal with the subnasal area of ​​the patient’s nose without contacting the nasal bridge region of the patient’s nose.

[0109] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming portion that forms a seal over the jaw region, nasal bridge region, and cheek region of the patient's face. For example, the patient interface 3000 shown in Figure 1C is an example of this. This seal-forming portion delivers air or breathable gas to both nostrils and oral cavity of the patient 1000 through a single orifice. This type of seal-forming structure may also be called a "full-face mask."

[0110] In another embodiment, the non-invasive patient interface 3000 includes a nasal seal-forming structure 3170 and an oral seal-forming structure 3180. The nasal seal-forming structure 3170 takes the form of a nasal cushion or nasal cradle cushion, and the oral seal-forming structure 3180 is configured to form a seal around the patient's oral cavity when in use (this may also be called an "oral cushion" or "oral mask"). In such a mask, air or breathable material is supplied to the patient's nostrils and oral cavity through separate orifices when in use. This type of seal-forming structure 3100 may be called an "oral-nasal mask". In one embodiment, the nasal seal-forming structure 3170 and the oral seal-forming structure 3180 are formed as a single component. This is the case, for example, with the cushion assembly 3150 shown in Figures 4A, 4B, and 4C. Alternatively, the nasal seal-forming structure 3170 and the oral seal-forming structure 3180 may be formed separately and configured to be attached together directly or indirectly, for example, by interconnecting frames attached to each cushion. For example, the nasal seal forming structure 3170 and the oral seal forming structure 3180 may be configured to be modularly detachable and then reattached. This makes it possible to functionally convert the patient interface from an oral-nasal mask to a nasal mask or sub-nasal mask, or vice versa, as desired by the patient and / or physician. This is the case, for example, with the cushion assembly 3150 shown in Figures 4D and 4E.

[0111] In some embodiments of this technology, the seal-forming structure 3100 is configured so that it does not extend below the chin prominence region of the patient's head during use.

[0112] Unless otherwise specified, embodiments of the patient interface according to this technology may include any of the seal-forming structures of the types described above.

[0113] In certain embodiments of this technology, the seal-forming structure 3100 is configured to accommodate the head and / or shape of a face of a specific size. For example, one embodiment of the seal-forming structure 3100 is suitable for a large head rather than a small head. In another embodiment, one embodiment of the seal-forming structure 3100 is suitable for a small head rather than a large head.

[0114] 8.3.2 Plenum Chamber The plenum chamber 3200, in use, receives a pressurized breathable gas and is pressurized to a pressure exceeding the ambient pressure. In some embodiments of the art, the plenum chamber 3200 has a rim 3210 whose shape is complementary to the surface contour of an average human face in the area where a seal is formed in use. In use, the peripheral rim of the plenum chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by a seal-forming structure 3100, which may extend around the entire rim of the plenum chamber 3200 in use.

[0115] The plenum chamber 3200 can receive pressurized breathable gas through a plenum chamber inlet port that is sized and constructed to receive gas from another part of the patient interface 3000.

[0116] 8.3.3 Positioning and stabilization structure The seal-forming structure 3100 of the patient interface 3000 of this technology can be held in a sealed position by the positioning and stabilizing structure 3300 during use. The positioning and stabilizing structure 3300 can also be called a "headgear" because it engages with the patient's head to hold the patient interface 3000 in a sealed position.

[0117] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured to be worn by a patient while they are sleeping. In one embodiment, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device.

[0118] The positioning and stabilization structure 3300 may include at least one tie. The tie can be understood as a structure designed to resist tension. In use, the tie is the part of the positioning and stabilization structure 3300 that is under tension. Some ties, as described above, add the elasticity resulting from this tension. The ties may function to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient's head. In certain embodiments of the art, the positioning and stabilization structure 3300 may include ties in the form of headgear tubes 3350 and / or headgear straps, as described below.

[0119] 8.3.3.1 Headgear Tubing In the embodiment of the technology shown in Figure 3A, the positioning and stabilizing structure 3300 includes at least one tube 3350 that delivers pressurized air received from conduits forming a portion of the air circuit 4170 from the RPT device to the patient's airway, for example, through a plenum chamber 3200 and a seal-forming structure 3100. These tubes 3350 are an integral part of the headgear 3300 of the patient interface 3000 for positioning and stabilizing the seal-forming structure 3100 of the patient interface to an appropriate portion of the patient's face (e.g., nose and / or oral cavity). As a result, the conduits of the air circuit 4170 that provide the pressurized airflow can be connected to the connection port 3600 of the patient interface at a location other than in front of the patient's face, which may be visually obstructive to some people.

[0120] Since it is possible to contain and move air through the tube 3350 to deliver pressurized air from the air circuit 4170 to the patient's airway, the positioning and stabilizing structure 3300 can be described as inflatable. It is understood that an inflatable positioning and stabilizing structure 3300 does not require all components of the positioning and stabilizing structure 3300 to be inflatable.

[0121] In certain embodiments of this technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or back of the patient's head. For example, in the embodiment of this technology shown in Figure 3A, the connection port 3600 is located above the patient's head. A patient interface in which the connection port is not located in front of the patient's face may be advantageous because some patients may find it visually irritating and uncomfortable when the conduit is connected to a patient interface in front of their face. For example, a conduit connecting to a patient interface in front of the face may be prone to entanglement with bedding or bed linens, especially if the conduit extends downward from the patient interface during use. Embodiments of this technology using a patient interface in which the connection port is located near the top of the patient's head during use may be easier or more comfortable when the patient is lying or sleeping in one or more of the following positions: lateral or transverse position, supine position (i.e., face up), and prone position (i.e., face down). Furthermore, connecting the conduit in front of the patient interface can cause a problem known as tube drag. In tube drag, an undesirable pulling force can be generated from the conduit towards the patient interface, resulting in the patient being pulled downwards face-first.

[0122] In the example shown in Figure 3A, at least one tube 3350 extends from the connection port 3600 over the patient's cheek region and above the patient's ear to the cushion assembly 3150 (i.e., between a portion of the tube 3350 that connects to the cushion assembly 3150 that covers the maxillary region of the patient's head when in use, and a portion of the tube 3350 that covers the region of the patient's head above the point of auricular base on the patient's head).

[0123] In the embodiment of the technology shown in Figure 3A, the positioning and stabilizing structure 3300 includes two tubes 3350. Each tube is positioned on a different side of the patient's head during use and extends from above each ear (above the point of auricular base on the patient's head) through each cheek region to a connection port 3600 at the top of the patient's head. This embodiment may be advantageous because, if the patient is lying on their side and one of the tubes is compressed, blocking or partially blocking the gas flow along that tube, the other tube remains open, allowing pressurized gas to be supplied to the patient. In other embodiments of the technology, the patient interface may include a different number of tubes (e.g., one tube or three or more tubes). In one example where the patient interface has a single tube 3350, the single tube 3350 is positioned on one side of the patient's head (e.g., on one cheek area) during use, and the strap is positioned on the other side of the patient's head (e.g., on the other area) during use to form part of the positioning and stabilizing structure 3300 and to help secure the patient interface 3000 on the patient's head.

[0124] In the embodiment of the technology shown in Figure 3A, the two tubes 3350 are fluidly connected to each other at their upper ends and to a connection port 3600. In one embodiment, the two tubes are integrally formed, and in other embodiments, the 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 may be indirectly connected to each other, for example, to a T-shaped conduit having two conduit arms to which each tube 3350 can be fluidly connected, and a third conduit arm or opening that functions as a connection port 3600 and can be connected to an air circuit 4170 during use.

[0125] These tubes 3350 may be formed from a semi-rigid material such as an elastomer (e.g., silicone). These tubes may have a naturally pre-formed shape and may bend or move to take on a different shape when force is applied to them. For example, these tubes may generally take on an arc-shaped or curved shape that resembles the outline of the patient's head between the top of the head and the nasal or mouth area.

[0126] An exemplary embodiment of the technology shown in Figure 3A has a tube 3350. These tubes 3350 extend curved around the upper part of the patient's head, from the upper end of the tube 3350 that connects to the upper head connection port 3600, to the point where the posterior headgear strap 3310 connects to the tube 3350 with no sagittal curvature. Between the point where the posterior headgear strap 3310 connects to the tube 3350 and the lower end of the tube 3350 that connects to the cushion assembly 3150 anterior to the patient's airway below the nose, the tube 3350 extends curved forward across the cheek region between the patient's ear and eye. The radius of this curved portion of the tube 3350 may be in the range of 60 to 100 mm (e.g., 70 to 90 mm (e.g., 80 mm)). The lower end of the tube 3350 and the part where the rear headgear strap 3310 connects to the tube 3350 are at an angle in the range of 65 to 90° (for example, 75 to 80°).

[0127] In certain embodiments of this technology, one or more portions of the tube 3350 may be hardened by one or more hardening or reinforcing elements. Examples of hardening 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 the other portions; and reinforcing members attached to or embedded inside or outside portions of the tube. When such hardening elements are used, control of the functional mode of the positioning and stabilization structure 3300 during use is supported (for example, where the tube 3350 is likely to deform when a force is applied to it, or where the shape of the tube 3350 is likely to be maintained when a force is applied to it). By selecting where to place such hardening elements within the tube 3350, it may be possible to enhance comfort when the patient interface 3000 is worn and to support good seal maintenance in the seal-forming structure during use. The hardening or reinforcing elements may be placed within the positioning and stabilization structure 3300. The positioning and stabilizing structure 3300 is configured to support relatively heavy seal-forming structures (e.g., full-face or mouth-nose cushion assemblies).

[0128] In the embodiment of the art shown in Figure 3A, the length of the tube 3350 is 15–30 cm (e.g., 20–27 cm). In one embodiment, the length of the tube is 25 cm. The length of the tube is selected to suit the dimensions of a typical patient's head (e.g., the distance between neighboring areas of the upper part of the head, where the upper end of the tube 3350 is located in a neighboring area of ​​the opening to the patient's airway, where the lower end of the tube 3350 connects to the cushion assembly 3150, as it follows a generally arc-shaped path extending downward along the side of the head and over the patient's cheek area, as shown, for example, in Figure 3A). As will be described in more detail below, the patient interface 3000 is configured such that the length of the tube 3350 can be varied in some embodiments of the art, and the above length can be applied to a contracted, extended, or neutral tube. 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).

[0129] The degree to which the patient interface 3000 fits an individual patient can be changed by changing the length of the tube 3350, and alternatively or additionally, by changing the position of the patient interface 3000 on the patient's head. For example, by moving the positioning and stabilizing structure 3300 backward or forward on the patient's head, the patient interface 3000 with a tube 3350 of a particular length can be adjusted to fit the patient better. Positioning the connection port 3600 further forward (i.e., in the forward direction) makes it possible to fit the patient interface 3000 with a tube 3350 of a particular length to a larger head than when the connection port 3600 is positioned further backward (i.e., in the backward direction).

[0130] In a specific embodiment of this technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned in a certain range over the upper part of the patient's head, thereby allowing the patient interface 3000 to be positioned in a location suitable for the comfort or fit of an individual patient. One way to achieve this, so that the cushion assembly 3150 forms an effective seal with the patient's face regardless of the position of the connection port 3600 on the patient's head, is to disengage 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, by 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.

[0131] In certain embodiments of this technology, the patient interface 3000 is configured such that the connection port 3600 is positioned approximately at the top of the patient's head. The connection port 3600 may be positioned in the sagittal plane and may be aligned with the top of the ear basin in a plane parallel to the coronal plane. The top of the ear basin is shown in Figure 2D. As described below, in some embodiments of this technology, the headgear 3300 is configured to be worn at different positions, namely, the connection port 3600 may be positioned near the top of the patient's head in the sagittal plane, within 20 mm anterior or 20 mm posterior to the top of the ear basin.

[0132] The cross-sectional shape of the tube 3350 may be circular, elliptical, egg-shaped, D-shaped, or rounded rectangle, as described in Patent Document 13, for example. This document is incorporated herein by reference. A cross-sectional shape showing a flat surface on the side of the tube that faces and contacts other parts of the patient's face or head may be more comfortable to wear than, for example, a tube with a circular cross-section.

[0133] The cross-sectional width and / or height of the tube 3350 may be 8 to 25 mm (e.g., 10 to 20 mm). In some forms in which the tube has a D-shaped cross-section, for example in the longitudinal cross-section of the headgear tubing 3350 shown in Figure 3H, the width of the tube is 15 to 25 mm (e.g., 20 mm) and the height is 8 to 15 mm (e.g., 10 mm). The height may be considered as the dimension of the tube in the direction away from the patient's face (i.e., the distance between the outermost side 3348 that contacts the patient and the outermost side 3349 that does not contact the patient), and the width may be considered as the dimension across the surface of the patient's head. The cross-sectional thickness of the material forming the tube 3350 may be 0.8 to 1.6 mm (e.g., 1.0 to 1.5 mm (e.g., 1.3 mm)).

[0134] The D-shaped cross-sectional tube 3350 shown in Figure 3H has a curved edge 3347 located on the side 3348 that comes into contact with the patient. The curved edge, which is in contact with or near the patient's skin, helps to increase the comfort of the patient interface 3000 when worn and helps to avoid scarring or inflammation on the patient's skin. The D-shaped cross-sectional profile of the tube also makes it more resistant to buckling than other external shapes.

[0135] As described in Patent Document 13, the tube 3350 is also resistant to crushing in order to avoid the flow of breathable gas through the tube in the event of crushing during use (for example, crushing between the patient's face and the pillow). Crush-resistant tubes are not always necessary, as the pressurized gas in the tube can act as a splint to avoid or at least limit the crushing of the tube 3350 during use. Using a crush-resistant tube may be advantageous when only a single tube 3350 is present, because if the single tube is blocked during use, the gas flow is restricted, and treatment may be stopped or its effectiveness reduced.

[0136] Two tubes 3350 are fluidly connected to a cushion assembly 3150 at their lower ends. In certain embodiments of this technology, the connection between the tubes 3350 and the cushion assembly 3150 is achieved by connecting two rigid components in such a way that the patient can easily and reliably connect the two rigid components. Using tactile feedback such as a "verifiable click" or similar sound may make it easier for the patient to use and also allow the patient to know that the tubes are correctly connected to the cushion assembly 3150. In one embodiment, the tubes 3350 are formed from silicone, and the lower ends of the silicone tubes 3350 are overmolded into a rigid connector formed, for example, from polypropylene. The rigid connector may include a male interlocking feature configured to connect to a female interlocking feature on the cushion assembly 3150, although the male / female features may be arranged in other ways.

[0137] In another embodiment, a compression seal is used to connect the tube 3350 to the cushion assembly 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 the port in the plenum chamber 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward, creating an airtight seal within the port. If the engagement between the tube 3350 and the port is a rigid-to-rigid engagement, a pressure-activated seal, such as a periphery sealing flange, may be used. When pressurized gas is supplied through the tube 3350, the sealing flange is propelled against the joint between the tube and the inner surface of the port in the plenum chamber 3200, promoting a seal between them. If the port is flexible and a rigid connector is provided to the tube 3350, the pressure-activated seal described above may also be used to ensure that the connection is airtight.

[0138] In some embodiments of this technology, a similar connection mechanism may be used to fluidly connect the pipe 3350 by defining the connection port 3600 or by a T-shaped upper member connectable to the connection port 3600. In one embodiment, the swivel elbow connected at the connection port 3600 is rotatable, and this rotation drives a port size adjustment mechanism that increases or decreases the size of the port into which the pipe 3350 is inserted, thereby improving the pipe fit through increasing or decreasing the compressive force and reducing unintended leakage.

[0139] 8.3.3.2 Headgear Straps In a particular embodiment of this technology, the positioning and stabilizing structure 3300 includes at least one headgear strap. These headgear straps, in addition to the tube 3350, function to position and stabilize the seal-forming structure 3100 relative to the entrance to the patient's airway.

[0140] 8.3.3.2.1 Position of the headgear strap In one example, as shown in Figure 3A, for instance, the positioning and stabilizing structure 3300 includes a rear headgear strap 3310. The rear strap 3310 is connected between two tubes 3350 positioned on each side of the patient's head and passing behind the patient's head (for example, covering or covering the posterior part of the occipital bone of the patient's head when in use). The rear strap 3310 connects to each tube above the patient's ears. In another embodiment, for example, in the case of an oral-nasal mask, the positioning and stabilizing structure 3300 further includes one or more lower headgear straps. These lower headgear straps connect the tubes, pass below the patient's ears, and pass behind the patient's head.

[0141] In one embodiment of this technology, the positioning and stabilization structure 3300 includes a chin strap 3320. The chin strap 3320 extends under the patient's chin when in use, for example, as shown in Figures 10A and 10B. The chin strap 3320 may be connected to a headgear tube 3350, or, in another embodiment, to a cushion assembly 3150 or a frame assembly operably connected to the cushion assembly.

[0142] A particular form of this technology may include multiple headgear straps for increased stability, as described above (e.g., a rear strap, lateral headgear straps, and a chin strap).

[0143] In a particular embodiment of this technology, the positioning and stabilization structure 3300 includes a mechanism for connecting the headgear strap to the seal-forming structure 3100. The headgear strap may be connected directly or indirectly to the seal-forming structure 3100. In the patient interface 3000 shown in Figure 3A, for example, tabs 3345 configured to connect to the rear strap 3310 protrude outward generally rearward from each headgear tube 3350. These tabs 3345 have holes inside for receiving the ends of the rear strap 3310.

[0144] In some embodiments of this technology, the rear strap 3310 is adjustable. For example, in the patient interface shown in Figure 3C, the rear strap 3310 is screwed in through the holes in each tab 3345 when in use. The length of the rear strap 3310 between the tabs 3345 can be adjusted by pulling more or fewer rear straps 3310 through one or both of the tabs 3345. The rear strap 3310 can be secured to itself by passing it through the holes in the tabs 3345, for example, using hook-and-loop fastening means. Thus, the rear strap 3310 can be adjusted to fit different head sizes. In some embodiments of this technology, the angle of the rear 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 helps the headgear 3300 to accommodate different head shapes and sizes.

[0145] In some embodiments of this technology, the rear strap 3345 applies a force to the headgear tube 3350 to pull it at least partially rearward (e.g., backward) at the position of the tab 3345. The rear strap 3310 may also apply a force to the headgear tube 3350 to pull it at least partially inward (e.g., backward). The magnitude of this force can be adjusted by changing the length of the rear strap 3310 between the tabs 3345.

[0146] In some embodiments of this technology, such as the configuration shown in Figure 3C, the direction of the force applied from the rear strap 3310 to the headgear tube 3350 may be changed. This direction may be changed by adjusting the angle of the rear strap 3310 relative to the headgear tube 3350 or the patient's head. In some embodiments of this technology, the position where the force is applied from the rear strap 3310 to the headgear tube 3350 can be changed by adjusting the position where the rear strap 3310 is fixed to the headgear tube 3350.

[0147] The ability to adjust the magnitude and direction of the force applied from the rear strap 3310 to the headgear tube 3350 may be advantageous, as it would allow the headgear 3300 to accommodate a certain range of head sizes and shapes. The rear strap 3310 can help maintain a balance of forces within the headgear tube 3350, thereby helping the headgear maintain its shape and achieve an effective seal against the patient's face while maintaining comfort.

[0148] In some embodiments of this technology, when the headgear is worn by the patient, a point on the headgear tube 3350 near the tab 3345 receives an generally upward force from the top of the headgear tube 3350 due to a biasing mechanism (described in further detail below) that has the function of maintaining the headgear fixed to the patient's head. Furthermore, a point on the headgear tube 3350 near the tab 3345 may receive a generally forward and downward force generated by a biasing mechanism that has the function of propelling the seal-forming structure 3150 upward and moving it into the patient's nose. The direction and magnitude of the force required for a secure fit and effective seal may vary from patient to patient based on the position of the positioning and stabilizing structure 3300 on the head, which may differ due to differences in head shape and size, for example. In some embodiments of this technology, the rear strap 3310 is adjustable so that the force can be balanced for a certain range of head shapes and sizes to hold the headgear 3300 in a comfortable position while maintaining an effective sole.

[0149] For example, to balance a large force acting on the portion of the headgear tube 3350 near the tab 3345 in the forward direction, the rear strap 3310 can be adjusted by pulling more of the rear strap 3310 through the slots in the tab 3345, thereby shortening the length of the rear strap 3310, and if the rear strap 3310 is elastic, a greater force will be applied to the headgear tube 3350 in the rear direction. Similarly, the angle of the rear strap 3310 can be adjusted as needed to balance both the vertical and horizontal components of the force acting on the portion of the headgear tube 3350 near the tab 3345 for a certain range of head shapes and sizes.

[0150] 8.3.3.2.2 Headgear Strap Configuration In one embodiment, the positioning and stabilizing structure 3300 includes at least one strap 3310 having a rectangular cross-section. In another embodiment, the positioning and stabilizing structure 3300 includes at least one flat strap. In yet another embodiment, the positioning and stabilizing structure 3300 includes at least one strap 3310. The profiles of these straps 3310 include one or more curved edges for improved comfort and to reduce the risk of patient marks or inflammation from the headgear straps.

[0151] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap 3310 composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam is porous so that moisture (e.g., sweat) can pass through the strap 3310. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion. The hook material portion may be located distal to the strap 3310.

[0152] In certain embodiments of this technology, the positioning and stabilization structure 3300 includes a stretchable (e.g., stretchable with elasticity) strap 3310. For example, the strap 3310 may be configured to be taut when in use, directing the force that brings the seal-forming structure 3100 into contact with a portion of the patient's face. In one embodiment, the strap may be configured as a tie. In other embodiments of this technology, the positioning and stabilization structure 3300 includes a strap 3310 that is adjustable to change the length of the strap. For example, the strap 3310 can be connected to the tube 3350 by a strap adjustment mechanism (e.g., a hook-and-loop fastener). The adjustable strap 3310 can provide further adjustability to other adjustment features of the patient interface 3000, improving patient comfort and fit. In some embodiments of this technology, the level of adjustability provided by other parts of the positioning and stabilization structure means that the patient interface 3000 is sufficiently adjustable even without the strap 3310.

[0153] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap 3310. An advantage of this embodiment is that the strap 3310 is more comfortable when the patient is lying down during sleep.

[0154] In a particular embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap 3310 comprising two or more strap bands separated by a split. Depending on the patient interface design, the split strap 3310 may allow the patient interface 3000 to be anchored to the patient's head in a particularly stable manner.

[0155] In certain embodiments of this technology, the positioning and stabilizing structure 3300 provides a holding force configured to accommodate heads of a specific size and / or face shape. For example, one embodiment of the positioning and stabilizing structure 3300 provides a holding force suitable for larger heads rather than smaller heads. In another embodiment, one embodiment of the positioning and stabilizing structure 3300 provides a holding force suitable for smaller heads rather than larger heads.

[0156] 8.3.3.3 Headgear Tubing Adjustment Mechanism In certain embodiments of this technology, the positioning and stabilization structure 3300 includes an adjustment mechanism 3360. The adjustment mechanism 3360 is configured to allow the positioning and stabilization structure 3300 to be dimensionally adjusted. In at least one embodiment, the adjustment mechanism 3360 may allow for length adjustment of the positioning and stabilization structure 3300, particularly between the connection port 3600 and the seal-forming structure 3100 (e.g., length adjustment of the tie (e.g., headgear tubing 3350)). Additionally or alternatively, the adjustment mechanism 3360 may be configured to allow the positioning and stabilization structure 3300 to be flexibly adjusted (e.g., bending of the headgear tubing 3350). The adjustment mechanism 3360 makes it possible to adjust the patient interface 3000 to improve its fit to the patient's head, thereby making it possible to fit the patient interface 3000 to heads of different sizes. A patient interface that fits the patient comfortably can also increase stability, reduce the possibility of seal failure, and maintain a sealed structure to the entrance of the patient's airway with a comfortable level of headgear tension. These elements improve patient compliance with treatment and improve treatment outcomes. It is understood that the adjustment mechanism may include multiple mechanisms for adjustment. For example, the combination of adjustment mechanisms described below may be provided on the headgear in some forms of this technology.

[0157] For example, the adjustment mechanism 3360 may allow for adjustment of the size and / or shape of the patient interface 3000. In one embodiment of this technology, the length of the tube 3350 between the connection port 3600 and the seal-forming structure 3100 may be adjustable.

[0158] In some embodiments of this technology, the adjustment mechanism 3360 may allow the size of the patient interface 3000 to be adjusted up to 100 mm so that it fits a wide range of patients. For example, the adjustment mechanism 3360 may allow the total length of the tubes 3350 to be adjusted up to 100 mm. In one embodiment of this technology, the total length of the tubes 3350 can be adjusted up to 80 mm. For example, the length of the tubes 3350 positioned on each side of the patient's face during use may be adjusted up to 40 mm.

[0159] The patient interface 3000 may be configured and constructed such that, when the positioning and stabilizing structure 3300 applies force to the patient's face to maintain a sealed relationship between the cushion assembly 3150 and the patient's face in response to the force applied from the positive pressure gas in the plenum chamber 3200, the force is approximately constant or within a predetermined limit over a certain range of size that the patient interface 3000 can accommodate. This will be explained in more detail below.

[0160] Different forms of the adjustment mechanism 3360 are described below. In some forms, the adjustment mechanism 3360 is included as part of the headgear tubing 3350, and in other forms, the adjustment mechanism 3360 is located separately from the headgear tubing 3350. A particular form of this technology may include multiple adjustment mechanisms 3360 as described below.

[0161] In some forms of this technology, the adjustment mechanism 3360 is configured to be manually adjusted so that the patient interface 3000 can be fitted to the patient in a way that provides comfort and therapeutic effectiveness (i.e., adjusted by the patient or another person). In other forms, the adjustment mechanism 3360 is configured to be automatically adjusted to fit the patient. Using an automatic adjustment mechanism may be advantageous because it reduces the likelihood of the patient interface 3000 being incorrectly or uncomfortably fitted to the patient. On the other hand, some patients may prefer to be able to adjust the fit of the patient interface themselves.

[0162] In some embodiments of this technology, the patient interface 3000 is configured to allow interchangeable connection of different forms of the seal-forming structure 3100 with the positioning and stabilization structure 3300. Different forms of the seal-forming structure 3100 may include seal-forming structures of different sizes and weights. For example, the mouth-nasal cushion may be heavier than the nasal cushion. In such embodiments of this technology, the use of a manual adjustment mechanism offers the advantage of being able to initially configure the mechanism to suit the type of seal-forming structure being used. For example, if a relatively heavy seal-forming structure is used to reduce the tendency of the positioning and stabilization structure 3100 to be pulled downward by the relatively heavy seal-forming structure, the manual adjustment mechanism may be configured to provide a tighter fit. Similar considerations may apply to seal-forming structures exposed to the patient's oral movements (e.g., wide-open mouth movements).

[0163] 8.3.3.3.1 Folding / bellows head gear tube In a particular embodiment of this technology, the adjustment mechanism 3360 includes a tube 3350 having one or more folding sections, pleats, wave patterns, or bellows. That is, the folding section pleats, wave patterns, or bellows include the adjustment mechanism 3360. When each folding section is first in a first folded configuration, the length of each tube 3350 is different from the length when the folding section is in a second unfolded configuration.

[0164] The patient interface 3000 shown in Figure 3A includes a tube 3350 with a bellows section 3362. The bellows section 3362 is provided along the length of the tube 3350 without the bellows. The bellows section 3362 includes a plurality of folds or bellows. These folds or bellows can be folded or unfolded individually or cooperate to shorten or lengthen the bellows section 3362 and thus each tube 3350. The folds in the bellows section 3362 can be expanded (stretched) or contracted by changing the degree on different sides of the tube 3350. For example, contracting the bellows folds on the side of the tube 3350 closest to the patient's head to a greater degree than the bellows folds furthest from the patient's head increases the curvature of the tube 3350. As a result, the shape and length of the tube 3350 can be changed, which also helps to adjust the patient interface to fit the patient's specific head size and shape.

[0165] In certain embodiments of this technology, the bellows section 3362 allows for continuous adjustment of the length of the tube 3350 of the patient interface 3000 through a range of different lengths. In some embodiments, the length of each bellows section may be continuously adjustable. Adjustment mechanisms such as bellows sections that provide continuous adjustment can comfortably fit a wide range of head sizes. In contrast, adjustment mechanisms that provide adjustment between individual lengths may result in a less comfortable fit for patients who require a length between two of the individual length options to achieve an optimal fit.

[0166] In some embodiments of this technology, the tube 3350 includes a plurality of bellows sections 3362 at predetermined positions. Each of these bellows sections 3362 is separated by the length of the tube 3350 without bellows.

[0167] In some embodiments of this technology, the bellows section 3350 is located within a relatively straight portion of the tube 3350. This avoids the tendency for the bellows section 3350 to straighten as pressurized gas passes through the tube 3350. If the bellows section 3350 straightens, the position of the patient interface above the patient's head may change, potentially adversely affecting seal stability and / or flow impedance.

[0168] In the embodiment of the technology shown in Figure 3B, the patient interface 3000 includes a tube 3350 with a bellows section 3362. The bellows section 3362 is longer than the bellows section 3362 shown in Figure 3A. In the embodiment of the technology shown in Figure 3B, the bellows section 3362 extends over most of the length of each tube 3350 between the point where the headgear strap 3310 connects to the tube 3350 and the point where the upper end of the tube 3350 connects to the connection port 3600. For example, the bellows section 3362 may have its lower end directly above the point where the headgear strap 3310 connects to the tube 3350, and its upper end at the point where the tube 3350 connects to the connection port 3600. A longer bellows section may increase the extensibility of the tube 3350. Alternatively, extensibility may be increased by increasing the number of bellows folds in the bellows section 3362. Increased extensibility can be advantageous because it allows the patient interface 3000 to accommodate a wide range of patients across a broad head size range while providing the desired level of retention force to the patient's face to ensure a good seal across this range of head sizes.

[0169] In the embodiments of the present technology shown in Figures 3C, 3D, and 3E, the patient interface 3000 is the same as the patient interface 3000 shown in Figure 3B. One difference is the configuration of the bellows section 3362. In the embodiments of the present technology shown in Figures 3C, 3D, and 3E, the width and diameter of the bellows section 3362 vary along the length of each bellows section 3362. More specifically, the bellows section 3362 is tapered such that the width and diameter of the tube at one end of each bellows section 3362 are smaller than the width and diameter of the tube at the other end of each bellows section 3362. More specifically, the width and diameter of the upper end of each bellows section 3362 (where the bellows section 3362 is connected to the connection port 3600) are greater than the width and diameter of the lower end of each bellows section 3362 (where the bellows section 3362 is connected to a portion of the tube 3350 without bellows), and the width and diameter of the bellows section 3362 gradually increase between the upper and lower ends and are generally linear. The tapered shape of the bellows section 3362 is also shown in Figure 3F. Figure 3F is a plan view of the patient interface 3000 shown in Figures 3C, 3D, 3E, and 3G. Figure 3G shows the patient interface 3000 of Figure 3F in a cross-section along line 3G to 3G. By making the bellows section 3362 tapered, the connection port 3600 is fluidly connected to the lower length of the pipe 3350 that does not include the bellows, thereby reducing the discontinuity in the cross-sectional profile of the air path. This allows for a smooth transition that reduces the increase in impedance and promotes fluid flow along the pipe 3350.

[0170] One advantage of the bellows section 3362 for the adjustment mechanism 3360 is that, compared to other adjustment mechanisms, the bellows section can be curved or bent and extended more easily in the longitudinal direction. Figure 3J shows the headgear 3300 fitted in three different positions on the patient's head, with the reference numerals “a”, “b”, and “c” at the end of the reference numerals. As shown in Figure 3J, the bellows sections 3362a, 3362b, and 3362c are curved to different levels, with the bellows section 3362a being curved forward on the patient's head, the bellows section 3362b being less curved in the posterior / forward direction, and the bellows section 3362c being substantially uncurved on the patient's head.

[0171] In some embodiments of this technology, the bellows section 3362 can extend to different amounts on the anterior and posterior (e.g., anterior and posterior) sides of the headgear tube 3350. That is, the wall portion forming the bellows section 3362 may contract relatively more (e.g., fold more) on one side of the tube and extend relatively more (e.g., fold less) on the other side of the tube, thereby promoting a bend or curved shape within the tube. This effect is shown in Figure 3L. As shown, the wall portion of the bellows section 3362 extends less (e.g., buckles more) anteriorly than posteriorly in the case of the bellows section 3362a (i.e., when the headgear is fitted on the patient's head anterior to the coronal surface). Because the bellows section 3362 can be curved in the forward direction, it is possible to attach the headgear 3300 in a forward position without having to rotate the cushion assembly 3150 forward to remove it from airtight contact with the patient's face (as would be the case if the headgear tube were rigid). Because the headgear tube 3350 can be curved in the forward or backward direction, it is possible to disconnect the connection port 3600 from the cushion assembly 3150. The difference in the amount of extension of the bellows section 3362c between the front and rear sides (i.e., when the headgear 3300 is attached in a rear position on the patient's head) is smaller than the difference in the amount of extension of the bellows section 3362a between the front and rear sides (i.e., when the headgear 3300 is attached in a forward position on the patient's head). Such bellows can reduce the degree to which the headgear tube 3350 is straight (or curved) when attached in a rearward position.

[0172] In one configuration, the bellows sections 3362 on each side of the patient interface 3000 are approximately 40 mm longer in the fully extended configuration than in the fully retracted configuration.

[0173] In other embodiments of this technology, the bellows section 3362 may be positioned at different points along the length of the tube 3350. One advantage of the patient interface 3000 shown in Figures 3A and 3B, in which the bellows section 3362 is positioned along the length of the tube 3350 so as to contact the upper and / or upper side of the patient's head (i.e., the area of ​​the patient's head above the base of the ear), is that the bellows section 3362 does not come into contact with the patient's cheek area. As a result, discomfort that may occur if the bellows section comes into contact with the patient's cheek area during use is avoided.

[0174] The bellows section 3362 is prone to buckling, especially when greatly stretched. This can lead to blockage of the tube 3350 due to the bellows section 3362, potentially limiting or preventing the delivery of breathable gas to the patient. In some embodiments of this technology, the patient interface 3000 includes one or more structures configured to avoid or at least characterize buckling of the bellows section 3362. In one embodiment, the patient interface 3000 includes one or more rigid or semi-rigid rings. These rings are provided on the bellows section 3362 and are circumferentially positioned around the tube 3350. For example, these rings may be positioned inside the bellows section 3362 or molded (e.g., co-molded or overmolded) with the bellows section 3362. In another embodiment, helical elements for buckling suppression are provided along the bellows section 3362. In such embodiments, elasticity can be imparted to the tube by material portions between the pitches of each helical winding, known as tapes. The tape may be formed from an elastic material, or it may be constructed to provide an appropriate level of elasticity that is sufficient to impart sufficient tension to the tube for contraction. In other embodiments, the bellows tube sub-parts formed together with the bellows tube section 3362 are thicker or made of a more rigid material than the other bellows tube sub-parts to suppress buckling.

[0175] In another embodiment of this technology, the patient interface includes an adjustment mechanism 3360 including a tube 3350. The tube 3350 has one or more circumferential folds for folding adjacent portions of the tube 3350 longitudinally. When the circumferential folds are in the folded configuration, the length of the tube covers the adjacent length of the tube. The stiffness of the material from which the tube is formed may be configured such that the tube tends to remain in the folded configuration unless pulled apart by a substantial force (e.g., greater than the force applied to the tube during typical use of the patient interface). Alternatively, the patient interface may include means (e.g., clips) for maintaining the tube in the folded configuration. In another embodiment, when the tube is folded to maintain the tube in the folded configuration, magnets are embedded in the tube to align the overlapping folded portions (unless the magnets are pulled apart).

[0176] The patient interface 3000 shown in Figure 5 includes an adjustment mechanism 3360 which includes a folding section 3364. The folding section 3364 includes a first tube wall portion 3366. The first tube wall portion 3366 can be folded at different levels onto adjacent tube portions 3368 by rotating onto adjacent tube portions. Figures 5A and 5B are cross-sectional views of the folding section 3364 of the patient interface 3000 shown in Figure 5. In Figure 5A, the rotating folding section 3366 folds onto the adjacent tube portion 3368 at a higher level than the level it is folded at in Figure 5B. Therefore, the length of the tube 3350 when the folding section 3364 is in the configuration shown in Figure 5B is longer than the length of the tube 3350 when the folding section 3364 is in the configuration shown in Figure 5A. As can be seen from Figures 5A and 5B, at the location of the folding section 3364, the three layers of the tube 3350 overlap with each other, but the length of the overlapping tube section differs between the configuration in Figure 5A and the configuration in Figure 5B. The rotating folding section 3366 may include a local portion of the tube wall that is thinner than the rest of the tube 3350.

[0177] Another form of the folding adjustment mechanism 3360 of the positioning and stabilization structure 3300 of the patient interface 3000 is shown in Figure 6. In this embodiment of the technology, the tube 3350 extends from the connection port 3600 to the tube end 3352. The tube end 3352 is configured to connect to the cushion assembly 3150 of the patient interface 3000. The tube 3350 has a generally wavy shape along its length and includes at least one curved portion (e.g., curved portions 3353A, 3353B). The tube 3350 is formed of a material that is flexible enough so that the curved portion increases or decreases the curvature so that each tube can fit into a smaller or larger head, respectively. For example, these tubes may be formed of metasilicon having a hardness of 40 durometers on a Shore hardness scale.

[0178] In the embodiment of this technology shown in Figure 6, the tube 3350 above one side of the patient's head extends generally forward-rear away from the connection port 3600 at its upper end and generally downward on the patient's head side near the point where the headgear strap 3310 is attached to the tube 3350, with the positional edge of the upper curved portion 3353A substantially covering the upper part of the patient's head, and the front side of the rear curved portion and the outer part of the inner upper curved portion being provided. Below the point where the headgear strap 3310 is attached to the tube 3350, the tube 3350 extends generally downward and becomes slightly forward curved. The lower curved portion 3353B is positioned generally above the patient's cheek area when in use. The lower end of the tube 3350 extends generally horizontally above the patient's cheek in the forward direction to the tube end 3352 which connects to the cushion assembly 3150. The lower end of tube 3350 may be oriented slightly downward (i.e., slightly extending downward when fitted by some patients). The lower curved portion 3353B, generally positioned over the patient's cheek area, has its outer surface posterior and its inner surface anterior.

[0179] The lower part of tube 3350 in Figure 6 is constructed and configured such that, when in use, tube 3350 is generally positioned away from the patient's eye, thereby ensuring that tube 3350 is not in the patient's field of vision, or at least minimally in it. This can be achieved by constructing the lower part of tube 3350 such that the apex or point of maximum curvature of the lower curved portion 3353B is positioned over the posterior region of the patient's cheek area when in use.

[0180] Although not shown in Figure 6, tube 3350 located on the left side of the patient's face is constructed symmetrically to tube 3350 on the upper right side of the patient's face. In other configurations, tube 3350 may have different structures on each side of the patient's face.

[0181] 8.3.3.3.2 Telescopic headgear tube In a particular embodiment of this technology, the adjustment mechanism 3360 includes a tube 3350 having a first tube section 3370. The first tube section 3370 is telescopically movable relative to a second tube section 3372.

[0182] The patient interface 3000 shown in Figure 7A includes an adjustment mechanism 3360 comprising a first tube section 3370 and a second tube section 3372. The first tube section 3370 and the second tube section 3372 slide telescopically relative to each other. In the embodiment of Figure 7A, the first tube section 3370 is connected to a connection port 3600 and is therefore positioned higher above the patient's head than the first tube section when the patient interface is fitted. The second tube section 3372 has a smaller diameter than the first tube section 3370 (i.e., fits inward) and is fixedly connected to a portion of the tube 3350 located below the patient's head when the patient interface is fitted. The first tube section 3370 can be described as covering the second tube section 3372 through telescopic movement between the first tube section 3370 and the second tube section 3372.

[0183] In certain embodiments of this technology, the patient interface includes a tube fixing mechanism. The tube fixing mechanism fixes a first tube section 3370 and a second tube section 3372 to each other at a plurality of separate positions. For example, in the embodiment of this technology shown in Figure 7A, the second tube section 3372 includes a plurality of raised ribs 3374 on its outer surface, and the first tube section 3370 includes one or more projections or stoppers (not shown). These projections or stoppers work in conjunction with the ribs 3374 to hold the first tube section 3370 and the second tube section 3372 at a plurality of relative longitudinal positions, allowing for adjustment of the length of the tube 3350. In other embodiments of this technology, these tube sections may be fixed to a plurality of separate positions using other interlocking mechanisms (e.g., one or more grooves or holes working in conjunction with one or more projections or stoppers). These grooves may be provided on the surface of the first or second pipe section, and it is understood that a projection may be provided on the surface of the other of the first or second pipe section in a position that interlocks with the grooves during use.

[0184] In one embodiment, the patient interface 3000 of Figure 7B includes a first tube section 3370 and a second tube section 3372, and includes an adjustment mechanism 3360. The first tube section 3370 and the second tube section 3372 slide telescopically relative to each other. The first tube section 3370 may slide on the outer surface of the second tube section 3372. The second tube section 3372 is positioned lower and above the patient's head than the first tube section 3370 when the patient interface 3000 is fitted (i.e., the second tube section 3372 is located downstream of the first tube section 3370). The patient interface 3000 has two similar adjustment mechanisms 3360, one of which is positioned on each side of the patient's head when in use.

[0185] The patient interface 3000 includes an upper tube member 3351. The upper tube member 3351 is positioned above the patient's head when in use. The first tube sections 3370 on each side of the patient's head are integrally formed as part of the upper tube member 3351. Connection ports 3600 are provided on the upper tube member 3351, for example, the upper tube member 3351 has an opening in the upper middle of its central position.

[0186] The first tube section 3370 on each side of the patient's head may include a first or upper tab 3371, and the second tube section 3372 may include a second or lower tab 3373. The second tab 3373 can be pressed against the first tab 3371. For example, a user may place their thumb on the second tab 3373 and their index finger on the first tab 3371 and pinch the two tabs so that the second tab 3373 moves towards the first tab 3371. When the second tab 3373 is moved towards the first tab 3371, the first tube section 3370 and the second tube section 3372 slide telescopically, shortening the headgear tube 3350. When the second tab 3373 is moved away from the first tab 3371, the first pipe section 3370 and the second pipe section 3372 slide telescopically, lengthening the headgear pipe 3350.

[0187] When the second tab 3373 is slid toward the peripheral edge of the first pipe 3370, it functions as a stopper to prevent further shortening of the pipe 3350 when the second tab 3373 comes into contact with the peripheral edge.

[0188] The second tubular portion 3372 of the patient interface 3000 shown in Figure 7B is integrally formed with the length of the tube 3350, which is positioned to contact the side of the patient's head and the patient's cheek area during use. To ensure that the patient interface 3000 can be comfortably worn and conform to a certain range of patient head shapes, the lower part of the tube 3350 (in which the second tubular portion 3370 is integral) may be formed from a semi-rigid material such as an elastomer (e.g., silicone). In contrast, the upper tubular member 3351 (and consequently the first tubular portion 3370) may be formed from a relatively rigid material.

[0189] One possible consequence of telescopically moving a patient interface, where the tube section is formed from a relatively flexible material, to a tube section formed from a relatively rigid material, is that when the inner tube section is pressed against the outer tube section, the tube section made of the relatively flexible material may buckle. This can affect the ease with which the length of the tube 3350 can be adjusted. The patient interface 3000 shown in Figure 7B includes a hardening member 3379 to address this problem. The hardening member 3379 functions to increase the rigidity of the portion of the second tube section 3372 that moves in and out of the first tube section 3370 during use. In the illustrated embodiment, the hardening member 3379 is the length of the relatively rigid material provided above each of the second tube sections 3372. The hardening member 3379 may be attached to the outside of the second tube section 3372, or it may be molded (e.g., co-molded or overmolded) as part of the second tube section 3372. In a particular embodiment of this technology, each hardening member 3379 may be integrally formed with the upper tab 3373 on each second tubular portion 3372.

[0190] The patient interface in Figure 7B includes a padded member 3330 on the patient-contacting side of the upper tube member 3351 to improve comfort when the patient interface 3000 is fitted. One or more padded members 3330 may be provided on any part of any of the positioning and stabilizing structures 3300 of any form of the patient interface 3000 described herein, unless otherwise specified. For example, the padded member 3330 may be provided as part of the tube 3350 to make the fitting of the patient interface more comfortable. The padded member 3330 may be permanently attached to a part of the tube 3350, for example by molding (e.g., co-molding or overmolding) or bonding. Alternatively, the padded member 3330 may be removably attached to the tube 3350, for example using hook-and-loop fasteners or fasteners. Since the padded member 3330 comes into contact with the patient's head during use, it may become soiled. It may be advantageous if the padded member 3330 can be removed for cleaning and / or replacement.

[0191] Another embodiment of this technology is shown in Figure 7C. In this embodiment, the patient interface 3000 includes a second tube 3372. The second tube 3372 slides telescopically on the outer surface of the first tube 3370. That is, the tube that telescopically fits inside the other tube is positioned higher than the other tube on the patient's head when in use.

[0192] In the embodiment shown in Figure 7C, the first tube section 3370 is relatively rigid. The second tube section 3372 includes a relatively rigid ring member 3384 at its upper end. The ring member 3384 surrounds the opening within the upper end of the second tube section 3372. The second tab 3373 may be provided on the ring member 3384 (for example, integrally formed with the ring member 3384). Since both the first tube section 3370 and the second tube section 3372 are formed from relatively rigid materials, they can move telescopically relative to each other without buckling. Thus, the patient interface 3000 shown in Figure 7C can avoid the need for a rigidifying member, as described in relation to Figure 7B, while allowing the tube 3350 to be extended by the same length.

[0193] Another configuration of the telescopic adjustment of the tube 3350 is shown in Figure 8. In this embodiment, the second tube section 3372 of the tube 3350 slides telescopically relative to the first tube section 3370 together with a ratchet mechanism 3376. The ratchet mechanism prevents or suppresses the telescopic movement of the first and second tube sections in one or both directions, unless the ratchet mechanism is released, for example, by pressing a button 3378. Each button 3378 is operably connected to a locking member (not shown). This locking member (not shown) is engaged with a groove or projection (e.g., a rib 3374) on the second tube section 3372, unless the button 3378 is pressed.

[0194] Another embodiment of the ratchet mechanism 3376 is shown in the embodiment of the present technology shown in Figure 7C. In this embodiment, the ratchet mechanism 3376 includes tongs 3397 provided on the head contact side of the second tube 3372. The tongs 3397 are connected to the second tube 3372 at their lower ends and extend generally along the length of the second tube 3372. The tongs 3397 are free at their upper ends and have projections on their upper sides. The first tube 3370 includes a plurality of grooves 3398 on its head contact side. The projections on the ends of the tongs 3397 are configured to selectively engage with each of the grooves 3398 in order to hold the first tube 3370 and the second tube 3372 in relative positions. The tube 3350 may generally have a D-shaped cross-section, with the flat portion of the "D" in contact with the patient. The ratchet mechanism 3376 can be advantageously positioned on the head contact side of the patient interface 3000 (for example, as in Figure 7C). This is because the tongs and groove ratchet mechanism 3376 may be more effective when positioned on a relatively flat area of ​​the tube 3350, as it provides a larger contact area than when there are larger curved surfaces engaging within the ratchet mechanism.

[0195] In another embodiment of this technology, the button 3378 includes tabs positioned on the side of the tube 3350. These tabs tighten inward to release the interlocking mechanism, allowing the telescopic tube sections to move relative to each other. These tabs may include a gap or window in the first tube section 3370 that surrounds the second tube section 3372, thereby allowing the patient or clinician to tighten a portion of the second tube section 3372 and release the interlocking mechanism. Alternatively, the gap may be covered by one or more overmolded buttons. Pressing these buttons tightens the second tube section 3372 and releases the interlocking mechanism. Covering the gap with overmolded buttons or eliminating the gap in the adjustment mechanism 3360 reduces the possibility of patient hair becoming entangled in the adjustment mechanism 3360, which could impair comfort. In one exemplary embodiment, the adjustment mechanism 3360 is configured such that when the side of the ring member 3384 at the upper end of the second tube 3372 is pressed inward, the interlocking feature between the second tube 3372 and the first tube 3370 is released, allowing telescopic movement between the tubes. For example, the ring member 3384 may include a rigid plastic pinch button of silicone overmolding and one or more projections on its inner upper surface, so as to enable interlocking with a groove on the upper surface of the first tube 3370, the projections and groove are pushed out of interlocking engagement when the ring member 3384 is tightened inward at its side.

[0196] The patient interface in Figure 8 includes a padded member 3330 on the side of the positioning and stabilizing structure 3300 that comes into contact with the patient, thereby improving comfort when the patient interface 3000 is worn.

[0197] Another configuration of the telescopic adjustment of the tube 3350 is shown in Figure 9. In this embodiment, the tube 3350 includes a plurality of nested concentric tube sections 3375a, 3375b, and 3375c that slide relative to each other. Each nested concentric tube section 3375 can be fully exposed or fully covered by telescopically extending or retracting adjacent nested concentric tube sections 3375 relative to each other. These nested concentric tube sections interlock with each other (e.g., via a snap-fit ​​mechanism) to maintain their positions in the fully extended or retracted position. In some embodiments, the nested concentric tube sections 3375 can be held in an intermediate position (i.e., not fully extended or retracted).

[0198] In the embodiment shown in Figure 9, each nested concentric tube section is marked with a visual indicator 3377 indicating the length of the tube 3350. When the tube section is exposed, for example, "S" indicates small 3377a, "M" indicates medium 3377b, and "L" indicates large 3377c. Other forms of indicators may be used (e.g., numerical indicators or colored indicators). Physical indicators such as embossing may also be used, which may be advantageous when the patient is sleeping in a dimly lit room. The nested concentric tube sections 3375a to 3375c may be configured to extend or retract in a predetermined order.

[0199] Other embodiments of this technology include a tube 3350 formed from a plurality of telescopic tube sections connected to each other in other ways. For example, each tube 3350 may include a central inner tube section with two outer tube sections on either side. The central inner tube section slides telescopically inside and outside each of these two outer tube sections during use. Alternatively, the central tube section may be located outside the two outer tube sections.

[0200] In other forms of telescopically adjustable headgear tubes, other forms of size indicators may be provided. In certain forms, the first tube section 3370 of the tube 3350 surrounding the second tube section 3372 during telescopic movement between these two tube sections may include a window or gap. Through this window or gap, a visual indicator 3377 on the second tube section 3372 indicating the size of the thus provided tube 3350 can be viewed.

[0201] Another telescopic adjustment mechanism 3360 for the headgear tube 3350 is shown in Figure 10A. In this embodiment, the length of the headgear tube 3350 can be adjusted by the adjustment mechanism 3360, which includes a tooth or pinion 3383. When the tooth or pinion 3383 is rotated, the ribbed or rack-type portions of adjacent first tube sections 3370 and second tube sections 3372 of the tube 3350 move telescopically, thereby changing the length of the tube 3350. The connection of the first tube section 3370 to the cushion assembly 3150 may be integral, permanent, or removable. In the embodiment shown in Figure 10A, the adjustment mechanism 3360 is located at the lower end of the headgear tube 3350. For example, the adjustment mechanism 3360 may be located adjacent to the cushion assembly 3150. In the embodiment shown in Figure 10A, when the tooth or pinion 3383 is rotated, the lower end of the tube 3350 moves telescopically relative to the cushion assembly 3150.

[0202] In another embodiment of this technology, the adjustment mechanism 3360 is located at the connection port 3600, and a swivel elbow is provided on the teeth or pinion, so that when the elbow rotates, the headgear tubes move relative to each other or relative to the T-shaped connection port member. If a desired configuration is achieved, a lock may be provided to avoid or limit the rotation of the elbow.

[0203] When a separate number of relative positions of the first and second tube sections are provided by a telescopic adjustment mechanism, it is understood that a greater number of positions allows for a greater number of adjustment positions, which promotes improved fit to the patient. In some embodiments, three, four, five, six or more adjustment positions are provided.

[0204] In certain embodiments of this technology, the telescopic tube section is configured to move relative to and be continuously adjustable (i.e., the relative positions of the tube sections are not limited to separate positions). As a result, the length of the tube 3350 can be more freely customized.

[0205] An example of a tube 3350 having a continuously adjustable length is shown in Figure 10B. In Figure 10B, tube section 3372 includes a first threaded section 3382 on the first tube section 3370. The first threaded section 3382 is screw-engaged with a second threaded section 3380 on the second tube section 3372. Rotating one of the threaded sections relative to the other adjusts the length of the tube 3350 by converting the rotational movement into the relative longitudinal movement of the associated tube sections. One or both of the threaded sections are connected to the rotational engagement of each tube section to the other, so that the remaining part of the tube 3350 does not rotate even when the threaded section rotates. A first threaded portion 3372 of a surrounding or smaller diameter may be provided on the lower end of the tube 3350 (i.e., the portion of the tube 3350 connected to the cushion assembly 3150 or to the upper end of the tube 3350 (i.e., the portion of the tube 3350 connected to the connection port 3600) as shown in Figure 10B). A support or thread limiting member (not shown) may be provided on one end of the threaded portion to prevent the threaded portion from being unscrewed and removed during use.

[0206] In one embodiment of this technology, a screw mechanism is provided as a fine adjustment mechanism in addition to a coarser adjustment mechanism, and this fine adjustment mechanism may be, for example, one of the other adjustment mechanisms described herein. Generally, one of the adjustment mechanisms described herein may be used in combination with a first adjustment mechanism that allows for finer adjustment than the second adjustment mechanism.

[0207] In another embodiment of this technology, the telescopic sliding portion of the tube 3350 is held in frictional contact through ribs on the sliding surfaces of one or both sliding portions. Alternatively, one or more O-rings may be provided between the telescopic sliding tube portions. These ribs or O-rings hold the tube portions with sufficient frictional force to hold them in the desired position during normal use of the patient interface, but allow for adjustment of their relative positions when sufficient longitudinal adjustment force is applied.

[0208] In another embodiment of this technology, the telescopic tube section may be fixed in place using other fastening mechanisms. In one example, the length of a strap is attached to one of the telescopic tube sections, along with a portion of a hook-and-loop fastening material provided on the strap. This strap may be fixed to a complementary portion of a hook-and-loop fastening material (for fixing a portion at a desired position) provided on another telescopic tube section, thereby allowing adjustment of the length of the tube 3350.

[0209] In the above embodiment of the technology in which one or more tube sections are telescopically movable relative to other tube sections, it is understood that the amount of leakage of breathable gas from the patient interface is reduced because these tube sections are telescopically engaged in a substantially sealed manner. The manner in which this is achieved varies depending on the nature of the telescopic engagement, but one or more O-rings or other sealing members may typically be provided.

[0210] In the patient interface 3000 shown in Figure 7B, for example, an O-ring is provided on the inner surface of the lower end of the first tube portion 3370. For example, the O-ring may be provided in a slot on the inner surface of the lower end of the first tube portion 3370. The O-ring is in airtight contact with the outer surface of the upper end of the second tube portion 3372. In other embodiments of the art, the O-ring may be provided on the outer surface of the upper end of the second tube portion 3372. In one example, the O-ring may be provided on the hardening member 3379 or may be integrally formed with the hardening member 3379.

[0211] The configuration and structure of the sealed contact between the telescopically moving first and second tube sections can be selected to obtain an appropriate friction level to achieve a balance between the quality of the seal and the ease of adjusting the first and second tube sections. In some embodiments of this technology (e.g., the patient interface 3000 shown in Figure 7B), it has been found that the minimum holding force between the first tube section 3370 and the second tube section 3372 can be approximately 10 N, and the maximum holding force can be approximately 20 N. If the holding force is less than a predetermined minimum, the first and second tube sections may move too easily in the separation direction, for example, when shaken by the patient, or due to the patient bending, or as a result of positive pressure gas flowing through the tube 3350, and the length of the tube 3350 may be accidentally adjusted during normal use of the patient interface 3000. If the holding force exceeds a predetermined maximum, it may become excessively difficult for the patient to adjust the length of the tube 3350 by moving the first and second tube sections.

[0212] In another embodiment of this technology, the inner or outer surface of the first tube 3370 or the second tube section 3372 may include one or more movable flap seals, lip seals, or compressible gasket seals. In another embodiment, leakage between the first tube section 3370 and the second tube section 3372 may be controlled so that interference and respiratory pressure therapy do not interfere with each other. In one embodiment, the controlled leakage may function as an additional flush vent.

[0213] In the above embodiment of the technology in which one or more tube sections are telescopically movable relative to other tube sections, the patient interface 3000 may include one or more end stops to prevent the first tube section 3370 and the second tube section 3372 from separating. In one embodiment, the inner tube section includes a flange at its end, and the outer tube section includes an end stop on the inner surface adjacent to the flange at the maximum extension of the tube section.

[0214] While we have discussed swivel elbows, a ball-fossa elbow, which allows for 6 degrees of freedom, may be used instead to increase the release of the tube dragging force.

[0215] 8.3.3.3.3 Modular tubing section In the patient interface 3000 shown in Figure 11, the adjustment mechanism 3360 takes the form of a replaceable tubing 3385. The replaceable tubing 3385 can be removed from the patient interface 3000 and replaced with a replacement tubing 3386 having a different length from the first tubing or module 3385. The replaceable and replacement tubing 3385 and 3386 may be described as tubing modules.

[0216] In the example shown in Figure 11, the replaceable tubing 3385 includes a T-shaped tubing member. This T-shaped tubing member has three ports so that the replaceable tubing 3385 can be fluidly connected to the tubing 3350 and the air circuit 4170, respectively, during use. For example, the upper central port of the replaceable tubing 3385 is configured to connect to or include the connection port 3600. For example, the replaceable tubing 3385 may be positioned above the patient's head during use.

[0217] The tubular section 3385 can be separated from the rest of the patient interface 3000 and replaced with replacement tubular sections 3386a and 3386b. The tubular sections of the replacement tubular sections 3386a and 3386b extend outward from the connection port 3600 by varying amounts relative to the replaceable tubular section 3385. Any number of replacement tubular sections may be provided, but in the embodiment shown in Figure 11, the patient interface 3000 includes "small," "medium," and "large" replaceable sections.

[0218] In the embodiment of the present technology shown in Figure 12, the patient interface 3000 includes one or more tube insertion members 3387a and 3387b. These tube insertion members 3387a and 3387b are configured to be selectively fluid-connected to the tube 3350 to vary the length of the tube. For example, the tube insertion members 3387a and 3387b are configured to be fluid-connected between the tube 3350 and the cushion assembly 3150 to vary the effective length of the tube 3350. In another embodiment, the tube insertion members may be connected to other parts of the patient interface, for example, at the upper end of the tube 3350 between the tube 3350 and the connection port 3600. Each tube insertion member 3387 may be marked with a size indication (e.g., "M" represents "medium" and "L" represents "large"). A patient interface of one size can be achieved without inserting any tube insertion members.

[0219] 8.3.3.3.4 Cuttable pipes In another embodiment of the technology, the tube 3350 may be cut to a desired length. To assist the patient or clinician in deciding where to cut the tube 3350, these tubes may include one or more indicators that show where to cut the tube to fit the patient interface to heads of different sizes. For example, lines or punched holes indicating where to cut may be provided around the diameter of the tube 3350. Each line or punched hole may be marked with a size, for example, "small," "medium," or "large." The cutting marks on the tube 3350 may be provided on the lower end of the tube configured to connect to the cushion assembly 3150 or on the upper end of the tube configured to connect to the connection port 3600.

[0220] In one embodiment, a cutting tool configured to cut the tube 3350 is supplied to the patient interface.

[0221] One disadvantage of cutting the 3350 tube to fit the size of the patient interface is that if the tube is accidentally cut too short, it may be difficult to replace the cut portion.

[0222] 8.3.3.3.5 Extendable tubes In certain embodiments of this technology, the adjustment mechanism includes one or more stretchable portions 3355 of a headgear tube 3350 formed of a stretchable material. The stretchable portions allow the length of the tube 3350 to be continuously adjusted to suit different patient head sizes. It is understood that portions of the tube may be stretchable by the material constituting the tube (for example, if it is made of a stretchable material), by its configuration (for example, the bellows portion 3362 shown in Figure 3A is stretchable by its configuration), or both.

[0223] The relatively stretchable portion of the tube 3355 of the headgear tube 3350 shown in Figure 13 is connected to one or more non-stretchable or less stretchable portions of the tube 3354. Once the desired length is achieved, a fixing mechanism 3356 may be provided to hold the tube 3350 in place. The fixing mechanism 3356 may include a first fixing member 3357 mounted on a certain length of tube 3350 on one side of the stretchable portion 3355, and a second fixing member 3358 mounted on a certain length of tube 3350 on the other side of the stretchable portion 3355. The first fixing member 3357 and the second fixing member 3358 are configured to be connected together by any suitable mechanism (e.g., interlocking clips, magnetic connections, hook-and-loop fasteners). Since one of the fixing members 3358 may include multiple parts to which the other fixing members 3357 can be connected, it becomes possible to fix the pipe 3350 to a desired length.

[0224] In another embodiment, no fixing mechanism is provided, and a tube 3350 of a certain length is automatically achieved by the elastic contraction of the extendable portion 3355.

[0225] The stretchable portion of the tube 3355 may include a portion that is thinner than the less stretchable portion 3354. Alternatively or additionally, the stretchable portion of the tube 3355 may include a portion formed from a material that is more flexible than the less stretchable portion 3354 and / or has a lower durometer value than the less stretchable portion 3354.

[0226] In one embodiment, the stretchable portion of the tube 3355 has a cross-sectional thickness that decreases along its length. For example, the cross-sectional thickness may decrease in a stepped longitudinal section. Alternatively, the cross-sectional thickness of the tube portion 3355 may alternate between thicker and thinner longitudinal sections. Surface transitions between portions with different cross-sectional thicknesses may be smooth or abrupt. Regions with different cross-sectional thicknesses may have different stiffness and / or durometer values. Regions with different cross-sectional thicknesses may be formed from the same material or from different materials. By selecting different materials and different cross-sectional thicknesses for the structure of the stretchable portion of the tube 3355, certain portions of the tube 3350 can be designed to be more flexible than other portions. As a result, the patient interface can be adapted to different patients by making portions of the tube 3350 that are placed over anatomical structures of patients with particularly large interpersonal size differences more flexible than other portions during use. Additionally or alternatively, the extendable portion of tube 3355 may be designed to substantially maintain a predetermined minimum aperture area during use, so that the impedance of the patient interface to the breathable gas flow can be configured to match the respiratory therapy system (e.g., desired gas flow rate).

[0227] 8.3.3.3.6 Different pipe connection locations In certain embodiments of this technology, the pipe 3350 can be connected in a plurality of ways that allow for an effective length of the fluid path between the connection port 3600 and the seal-forming structure 3100 to be adjusted.

[0228] In a particular embodiment, each pipe 3350 includes two or more separate pipe members that can be fluid-connected at multiple locations to vary the length of the fluid path formed by the pipe members. In one embodiment, the first pipe member includes multiple ports along one side, and the second pipe member includes one or more pipes that protrude from one side of the second pipe member and engage with selected ports in the first pipe member to fluid-connect the first pipe member and the second pipe member. The length of the pipe 3350 formed by the first and second pipe members can be adjusted by selecting which ports the protruding pipes on the second pipe member are connected to. The ends of the first and second pipe members adjacent to the connection ports and protruding pipes are sealed so that breathable gas passes only through each pipe member and does not leak intentionally. Alternatively, the ports on one side of the first pipe member may be provided with automatic shut-off valves, in which case gas leakage is avoided if these ports are not connected to the second pipe member.

[0229] In some embodiments of this technology, multiple tube connections are provided on the connection port and / or cushion assembly 3150. For example, the plenum chamber 3200 may include two or more ports on each side to which a tube 3350 can be selectively fluidized. These ports may be positioned such that the size of the patient to which the patient interface fits changes depending on which port the tube is connected. For example, one port may be positioned closer to the patient's face than another port when in use. Connecting to the tube 3350 closer to the patient's face allows for accommodating a larger patient head than connecting the tube 3350 to a port located further away from the patient's face.

[0230] 8.3.3.3.7 Changes to the patient interface loop In a patient interface 3000 included in a particular embodiment of the present technology, a positioning and stabilization structure 3300 defines a loop configured to surround a portion of the patient's head when in use. In some embodiments of the present technology, the loop surrounding the portion of the patient's head may be defined, for example, by one or more ties. For example, in the embodiment shown in Figure 3A, the loop is defined by a tube 3350 and a cushion assembly 3150. The patient's head is positioned within the loop generated by these components when the patient interface 3000 is fitted.

[0231] In some embodiments of this technology, the positioning and stabilization structure between the connection port 3600 and the seal-forming structure 3100 of the cushion assembly 3150 is adjusted by adjusting the size of this loop. By adjusting this loop, the patient interface can be individually adjusted to suit patients of different sizes. In the above embodiment, a method of changing the loop size by changing the length of the tube 3350 was shown. Embodiments using other mechanisms for adjusting the loop size will be described below.

[0232] 8.3.3.3.8 Loop adjustment mechanism In a particular form of this technology, the patient interface 3000 includes a loop adjustment mechanism. This loop adjustment mechanism can operate to adjust the position that holds together two regions of the positioning and stabilizing structure 3300 in order to adjust the loop size.

[0233] In Figure 5, the patient interface 3000 includes a strap 3390 connected between the tubes 3350. The strap 3390 is positioned toward the upper end of the patient interface 3000 below the connection port 3600 so as to pass over or near the patient's head when in use. The strap 3390 may be formed in an upward curve to accommodate the upper part of the patient's head. The strap 3390 may be made of a flexible material, a rigid material, or a semi-rigid material.

[0234] In this embodiment, the loop of the patient interface 3000 that surrounds the patient's head when the patient interface 3000 is fitted is defined by a strap 3390, a cushion assembly 3150, and a portion of a tube 3350 connected between the strap 3390 and the cushion assembly 3150. The size of this loop can be adjusted by adjusting the strap. The patient interface includes a strap adjustment mechanism 3391. The strap adjustment mechanism 3391 allows adjustment of the length of the strap 3390. The strap adjustment mechanism 3391 may include an adjustable fastening attachment between two portions of the strap 3390. For example, one portion of the strap 3390 may pass through a loop. This loop is attached to the end of the other portion of the strap 3390 and attached to the strap 3390 using hook-and-loop material. Alternatively, these two strap portions may be connected together using a popper or interlocking member that can be connected at multiple different positions. In another embodiment, each of the two portions of the strap 3390 includes a rack portion that engages with a pinion or teeth. The length of the strap 3390 can be adjusted by rotating this tooth. In another embodiment, these two parts of the strap 3390 are telescopically slidable relative to each other and can be fixed in place via an interlocking mechanism, magnets, or frictional engagements.

[0235] In yet another embodiment, one or both ends of the strap 3390 may be connected to the tube 3350 by an adjustable strap connection mechanism, so as to change the position to which the strap 3390 is connected to one or both tubes 3350.

[0236] Another form of the present technology is shown in FIG. 14. In this form, the patient interface 3000 includes a band 3395. The band 3395 is disposed around the upper end of the tube 3350 (i.e., the tube end closest to the connection port 3600). The band 3395 holds the tube 3350 at its upper end, and the position of the tube 3350 determines the size of a loop that is partially defined by the tube 3350 that surrounds a portion of the patient's head when the patient interface 3000 is worn. In use, the band 3395 can be moved along the tube 3395 to change the position where the tubes 3350 are held together, so that the size of the loop defined by the patient interface 3000 can be changed. When the band 3395 is moved along the tube 3350 towards the connection port 3600, the size of the loop increases so that the patient interface can fit a larger head.

[0237] Due to an increase in the friction level between the band and the tube, the band 3395 can be tightly fixed around the tube 3350 so that the tube 3350 does not easily move and loosen during use. For example, the band 3395 can be formed from rubber or other high-friction materials. Alternatively, the patient interface can include a mechanism for fixing the band in position. For example, a plurality of ridges and / or protrusions can be provided on the outer edge of the tube 3350, and one or more detents (for interlocking with the ridges / protrusions of the tube 3350 and fixing the band in a predetermined position) can be provided on the inner surface of the band 3395. These detents can be disengaged from the ridges / protrusions by a suitable mechanism that allows the band to be moved along the tube 3350 when desired.

[0238] In another embodiment, the upper portions of these two tubes 3350 are fixed together by a clasp lock or a zipper. For example, a row of teeth of the clasp lock can be attached onto one tube 3350, and another row of teeth of the clasp lock can be attached onto the other tube 3350. Since the slider is movable between these rows of teeth, the position for holding these two tubes 3350 together can be adjusted, thereby changing the loop size formed by the patient interface 3000, and thus corresponding to patients with different head sizes.

[0239] 8.3.3.3.9 Loop Insert In a particular form of this technology, the positioning and stabilization structure 3300 includes one or more loop insertion members. These loop insertion members are configured to be fixed to another part of the patient interface 3000 (for example, directly or indirectly fixed to the tube 3350). The loop insertion member(s) is configured to be fixed so as to at least partially define a loop that surrounds a part of the patient's head during use. By adjusting the size of the loop insertion member or replacing the loop insertion member with loop insertion members of different sizes, the loop size can be adjusted to accommodate patients with different head sizes.

[0240] One form of this technology is shown in FIG. 15. In this form, the patient interface 3000 includes a loop insertion member 3410. The loop insertion member 3410 is connected to the lower side of the tube 3350 and the connection port 3600, and is arranged between the patient's head and the tube 3350 and the connection port 3600 during use. The loop insertion member 3410 functions to change the size of the loop that surrounds a part of the patient's head as compared to the size of the loop formed by the tube 3350 when the loop insertion member is not present.

[0241] The loop insertion member 3410 is removably attached to the tube 3350. Therefore, the loop insertion member 3410 can be removed and replaced with one or more interchangeable loop insertion members 3411a, 3411b, or 3411c. The interchangeable loop insertion members 3411a, 3411b, or 3411c differ in size from the loop insertion member 3410, and by selecting the appropriate loop insertion member, the size of the loop surrounding a portion of the patient's head can be adjusted, resulting in a more comfortable and secure fit of the patient interface. The ability to remove the loop insertion members 3410 and 3411 is also advantageous in that they can be easily cleaned.

[0242] The loop insertion member can be formed from a rigid or semi-rigid material that allows the tube to be positioned at a distance from the patient's head during use, thereby allowing the shape of the loop surrounding the patient's head to be altered. Using a material with a certain degree of elasticity and flexibility can increase comfort during wear (e.g., a foamy substance or gel material). Since the loop insertion member comes into contact with the patient's hair or skin during wear, it is preferable that the loop insertion member be formed from a material that can be easily cleaned.

[0243] The loop insertion members 3410 and 3411 shown in Figure 15 are generally U-shaped, with the apex of the "U" positioned above the patient's head below the connection port 3600 during use. This helps to conform the patient interface to the shape of the upper part of the patient's head. In other embodiments, insertion members of different shapes are used. For example, the insertion member may include a short, straight pad configured to contact a small area of ​​the patient's head. Interchangeable insertion members 3411 of different sizes may have different thicknesses, different lengths, and / or different curvature levels. The patient contact surface of each insertion member may be identical or similar to that which conforms to the shape of the patient's head, regardless of the insertion member used.

[0244] The loop insertion members 3410 and 3411 are attached to the pipe 3350 by a fastening mechanism. In one embodiment, the fastening mechanism includes a hook-and-loop material, which is attached to the underside of the pipe 3350 and to the upper sides of the loop insertion members 3410 and 3411. In other embodiments, a popper, hemispherical shape, clasp blocker, or magnet is used to connect the loop insertion members 3410 and 3411 to the pipe 3350.

[0245] In the embodiment shown in Figure 15, the patient interface 3000 includes a single loop insertion member 3410, and the replacement loop insertion member 3411 is a single component or a monolithic component. In other embodiments, multiple loop insertion members may be attached to the tube 3350 at any time. For example, by attaching multiple loop insertion members along the length of the tube 3350, they can function as multiple spacers to position different parts of the patient's head at intervals from the tube 3350. In another embodiment, multiple loop insertion members 3410 and replacement loop insertion members 3411 may be attached to the tube 3350 at any time. For example, loop insertion members of different sizes can be arranged in a nested manner. To achieve this, the loop insertion members 3410 and 3411 can be connected to each other, for example, using one of the loop insertion member connection mechanisms described above.

[0246] In the embodiment of the technology shown in Figure 16, the patient interface 3000 includes an inflatable loop insertion member 3420. The inflatable loop insertion member 3420 may include a bladder provided on the inner surface of the tube 3350. The bladder has a sealable opening. By allowing air to enter and exit the opening, the size of the bladder can be changed, thereby adjusting the size of the loop defined by the patient interface 3000 that surrounds the portion of the patient's head during use. In one embodiment, the patient interface includes a pump button. Repeated pressing of this pump button introduces air into the bladder through a valve.

[0247] In the embodiment shown in Figure 16, the patient interface includes a single U-shaped bladder 3420. This U-shaped bladder 3420 is connected to each tube 3350 located on either side of the patient's head. The thickness of the bladder 3420 may be maximized at the top of the patient's head to accommodate the symmetrical movement of the tube 3350 away from the surface of the patient's head when the bladder is inflated. In other embodiments, multiple inflatable bladders are mounted on the tube 3350. These inflatable bladders can be inflated collectively or individually. Individually inflatable bladders allow the patient to change the fit of the patient interface as desired, for example, by inflating one bladder more than the other on one side of the head.

[0248] 8.3.3.3.10 Size adjustment of headgear tubing dimensions As described above, the positioning and stabilization structure 3300 may be configured to be worn together with the upper part of the headgear tubing 3350, which is positioned in different locations to suit the patient. For example, the position of the connection port 3600 on the patient's head during use may vary within a certain range of forward / backward positions in the sagittal plane. The headgear tubing 3350, which fits to surround the circumference of the patient's head, may become smaller when the upper part of the headgear tubing 3350 is mounted further forward compared to when the headgear tubing 3350 is mounted further back. In some forms, the positioning and stabilization structure 3300 allows patients with larger head sizes to mount the upper part of the headgear on their head in a more forward (e.g., forward) position, thereby reducing the magnitude of length adjustment required for the adjustment mechanism 3360 to accommodate larger head sizes.

[0249] Figure 3J shows three illustrations of patient interfaces 3000a, 3000b, and 3000c according to one embodiment of the present technology. Each illustration of patient interface 3000 is shown at different positions on the patient's head for comparison. Patient interface 3000b is shown with a solid line at the center position, while patient interfaces 3000a and 3000c are shown with dashed lines and are mounted anteriorly and posteriorly, respectively. In each illustration in Figure 3J, the adjustment mechanism 3360 has substantially the same length. That is, the adjustment mechanism 3360 does not extend or contract between the illustrations labeled "a," "b," and "c." With no change in the length of the adjustment mechanism 3360, patient interface 3000a (anterior position) can fit a larger head (shown with dashed lines) because it is mounted anteriorly. Similarly, patient interface 3000c (posterior position) can be properly fitted to a smaller head (shown with dashed lines) with an adjustment mechanism 3360 of the same length.

[0250] In one of the illustrations in Figure 3J, the patient is wearing the headgear in a central position, as indicated by the reference numeral "b". In this central position, the adjustment mechanism 3360b and the connection port 3600b are generally aligned vertically. The connection port 3600b is centrally located on the anterior-posterior axis; that is, the connection port 3600b is centrally located rather than generally anterior (e.g., anterior) or generally posterior (e.g., posterior) position. The connection port 3600b is located at the top of the patient's head. The connection port 3600b may be located in the sagittal plane and aligned with the top of the ear base in a plane parallel to the coronal plane. The top of the ear base is shown in Figure 2D.

[0251] In another illustration in Figure 3J, as indicated by the reference numeral "a", the patient is wearing the headgear tubing 3350a in a relatively forward (e.g., anterior) position compared to the position of the headgear tubing 3350b. In this configuration, the connection port 3600a is located generally anterior to the adjustment mechanism 3360a. In this position, the connection port 3600a is anterior to the supraauricular base. In another illustration in Figure J, as indicated by the reference numeral "c", the patient is wearing the headgear tubing 3350c in a relatively posterior (e.g., posterior) position compared to the position of the headgear tubing 3350b. In this configuration, the connection port 3600c is located generally posterior to the adjustment mechanism 3360c. In this configuration, the connection port 3600c is posterior to the supraauricular base.

[0252] When fitted in the position indicated by headgear 3300a in Figure 3J, the headgear tubing 3350a generally fits around the smaller circumference of the patient's head, allowing the positioning and stabilization structure 3300 to be fitted in a relatively forward position, accommodating patients with larger heads (shown by dashed lines). Similarly, when fitted in the position indicated by positioning and stabilization structure 3300c in Figure 3J, the headgear tubing 3350c generally fits around the larger circumference of the patient's head, allowing the positioning and stabilization structure 3300 to be fitted in a relatively backward position, accommodating patients with smaller heads (shown by dashed lines). The positioning and stabilization structure 3300 can be fitted in a continuous range of positions between the generally forward and generally backward positions, depending on factors such as patient head size, head shape, and personal preference. In some embodiments of the technology, the positioning and stabilization structure 3300 is configured to be mounted such that the connection port 3600 is positioned approximately 20 mm forward (e.g., forward) and approximately 20 mm backward (e.g., backward) from the center position at the top of the head when in use. In some embodiments of the technology, the upper part of the headgear tube 3350 (e.g., the portion above the rear strap 3310) is configured to flex, bend, or move forward or backward (with substantially no corresponding movement in the lower or non-adjustable tube portion 3363 (e.g., the portion below the rear strap 3310)). In other embodiments of the technology, the upper and lower parts may move together (though not necessarily to the same degree). The rear strap 3310 may be configured to avoid or resist movement of the non-adjustable tube portion 3363. For example, by moving the upper part of the headgear tube 3350 forward over the patient's head (without loosening the rear strap 3310), it may be necessary to move the upper part of the headgear tube 3350 more than the non-adjustable tube portion 3363.

[0253] Apart from the fact that the positioning and stabilization structure 3300 can be mounted separately in different forward / rear positions, in some embodiments of this technology, the headgear tubing adjustment mechanism 3360 makes it possible to fit the positioning and stabilization structure 3300 to heads of different sizes. The headgear tubing adjustment mechanism 3360 may be configured to allow a predetermined amount of length adjustment of the headgear tubing 3350. The amount of length adjustment of the headgear tubing 3350 may be determined at least in part on a certain range of head sizes configured to correspond to the positioning and stabilization structure 3300. In some embodiments of this technology, the adjustment mechanism 3360 may make it possible to increase the length of the headgear tube 3350 on either side of the positioning and stabilization structure 3300 by an amount between approximately 10 mm and 50 mm. In some embodiments of this technology, the length increase may be made by an amount between 20 mm and 40 mm on either side. In some forms of this technology, the length increase performed is substantially one of 25 mm, 30 mm, 35 mm, or 40 mm, and is performed on either side.

[0254] The patient interface 3000 shown in Figure 3K includes a positioning and stabilization structure 3300. The positioning and stabilization structure 3300 has a headgear tube 3350 and a headgear tube adjustment mechanism in a first configuration indicated by reference numeral 3360. The adjustment mechanism 3360 is also shown by dashed lines and indicated by reference numeral 3360' in a second configuration. In the first configuration of the adjustment mechanism 3360, the headgear 3300 fits around a patient with one head size, and in the second configuration of the adjustment mechanism 3360', the headgear 3300 fits around a patient with a larger head. In this embodiment of the art, the adjustment mechanism 3360' makes it possible to extend the length of the headgear tube 3350 to fit around a larger head circumference. As shown in Figure 3K, the adjustment mechanism 3360 / 3360' allows the headgear to be adjusted (or be adjusted) to accommodate different head sizes, while the headgear is mounted in a central position (for example, the connection port 3600 / 3600' is centrally located on the top of the head, rather than forward or backward).

[0255] In some embodiments of this technology, the adjustment mechanism 3360 also allows for length adjustment of the headgear tube 3350 when the headgear 3300 is fitted in the forward, center, and / or rear positions. The patient interface 3000 shown in Figure 3L includes the headgear 3300. The headgear 3300 is fitted in three positions on the patient's head, as indicated by the reference numerals “a”, “b”, and “c”. Positioning and stabilizing structure 3300a is fitted in the forward position, positioning and stabilizing structure 3300b is fitted in the center position, and positioning and stabilizing structure 3300c is fitted in the rear position. That is, connection port 3600a is in the forward position on the patient's head, connection port 3600b is in the center position, and connection port 3600c is in the rear position. In the forward position, the headgear tube 3350a fits around a smaller circumference of the patient's head compared to the circumference around which the headgear tube 3350b fits around the center position. To accommodate this smaller circumference, the length of the headgear tube 3350 can be reduced (or its extension reduced) by positioning the adjustment mechanism 3360a forward. At the rearward position, the circumference of the patient's head to which the headgear tube 3350c fits is larger than the circumference at the center position. To accommodate this larger circumference, the adjustment mechanism 3360c can be made to increase the length of the headgear tube 3350 compared to its length at the center position.

[0256] The combination of different positions to which the positioning and stabilizing structure 3300 can be attached, and different amounts of length adjustment made possible by the adjustment mechanism 3360, expands the variety of adjustment options for the patient. This variety allows the positioning and stabilizing structure 3300 to accommodate a wide range of head shapes and sizes (without excessive discomfort) while enabling sufficient sealing of the seal-forming structure 3150 to the patient's face. In some embodiments, the adjustment mechanism 3360 can reduce the magnitude of length adjustment, because patients with larger head sizes can wear the top of the headgear tubing 3350 in a forward position, rather than relying solely on the adjustment mechanism 3360 to accommodate their larger head size. In other embodiments, the adjustment mechanism 3360 can increase the magnitude of length adjustment, allowing patients with larger head sizes to wear the top of the headgear tubing 3350 even further forward, thus enabling the patient interface 3000 to fit a wider range of head sizes.

[0257] 8.3.3.4 Position of the headgear tubing adjustment mechanism It is generally desirable to avoid patient interface features that cause patient discomfort. Therefore, patient interfaces may be designed with several components that come into contact with the patient's skin, and these components may be flexible and / or smooth. The cheek area is known to be a source of patient discomfort when wearing a patient interface.

[0258] A mechanism that enables adjustment of the positioning and stabilization structure as described above may include features that cause discomfort to the patient when contacting the patient's face or head (particularly, the cheek region). Therefore, the positioning and stabilization structure included in a particular form of this technology is configured such that, when the patient interface is worn, the adjustment mechanism or a part thereof is arranged so as not to contact the patient's skin or hair region (for example, arranged so as not to contact the patient's face or the patient's cheek region). In some forms of this technology, the adjustment mechanism is arranged above the patient's ear (i.e., above the otobasion superius of the patient's head or in the vicinity of the upper part of the patient's head). In these forms of this technology, the headgear tube includes a non-adjustable headgear tube portion. This non-adjustable headgear tube portion is arranged at a position adjacent to the patient's face during use (i.e., arranged at a position where the non-adjustable headgear tube portion can contact the patient's face during use of the patient interface). For example, in some forms, the non-adjustable headgear tube portion is arranged adjacent to the patient's cheek region when worn. In some forms of this technology, only the non-adjustable headgear tube portion is adjacent to the patient's cheek region, comes below the otobasion superius of the patient's head, or covers the maxillary region of the patient's head.

[0259] It is understood that the non-adjustable headgear tube section is a part specifically configured to be dimensionally adjustable during use (i.e., the adjustment mechanism does not form part of the non-adjustable headgear tube section). This does not preclude the possibility of dimensionally adjusting the non-adjustable headgear tube section, for example, when excessive force is applied. However, the position of the non-adjustable headgear tube section may be adjustable during use. In some embodiments of this technology, the axial length of the non-adjustable headgear tube section may be substantially non-adjustable, but it may also be adjustable by other means such as bending, curving, or straightening. For example, as shown in Figure 3L, the non-adjustable headgear tube sections 3363a, 3363b, and 3363c are configured to bend or curve to different ranges so as to facilitate different positions in which the positioning and stabilizing structure 3300 is mounted on the head by different amounts of extension made possible by the adjustment mechanisms 3360a, 3360b, and 3360c.

[0260] Placing the adjustment mechanism outside the patient's field of vision may also be useful in avoiding claustrophobia or the feeling of having their vision obstructed.

[0261] In the configuration of the patient interface 3000 shown in Figures 3A, 3B, 3C, 3D, 3E, and 3F, for example, the bellows portion 3362 is positioned on either side of the patient's head, between the height of both or one ear and the top of the head or crown of the level head and the non-adjustable headgear tube portion 3363. The level head and the non-adjustable headgear tube portion 3363 form the lower end of the headgear tube (i.e., the lower end when worn by the patient) and are positioned adjacent to (or covering) the patient's cheek area when worn. Other examples of the non-adjustable headgear tube portion 3363 are shown in Figures 5, 7A, 7B, 7C, and 17.

[0262] In certain embodiments of this technology, the non-adjustable headgear tube 3363 is configured to help maintain a proper seal between the cushion assembly 3150 and the patient's face when the patient interface 3000 is in use. To this end, it may be necessary to allow selection of the flexibility (or rigidity) of the non-adjustable headgear tube 3363 so that it has sufficient flexibility to accommodate certain movements during use and certain variations in the position in which individual patients wear the patient interface 3000, while also having sufficient rigidity so that the non-adjustable headgear tube 3363 does not easily deform during use.

[0263] While the use of the rear headgear strap 3310 stabilizes the headgear tube 3350 over the patient's head, the lower end of the headgear tube 3350 becomes more prone to movement, particularly at points relatively far from where the rear headgear strap 3310 contacts the headgear tube 3350. If the flexibility of the lower end of the headgear tube 3350 is excessively high, the cushion assembly 3150 tends to rotate forward away from the patient's face, thus interfering with the sealing performance. The effects of such forward rotation can be mitigated by increasing the rigidity of the lower end of the headgear tube 3350 (i.e., the non-adjustable headgear tube portion 3363 in the embodiments of this technology shown in Figures 3A, 3B, 3C, 3D, 3E, 3F, 5, 7A, 7B, 7C, and 17). For the purposes of this discussion, the lower end of the headgear tube 3350 is considered to be the portion of the headgear tube 3350 located below the point where the rear headgear strap 3310 connects to each headgear tube 3350 (i.e., below the patient interface 300 when the patient is fitted). This is because this point is stable on the patient's head and can therefore function as a pivot point for any movement of the headgear tube 3350 below this point. It will be understood that the location of the effective pivot point will also differ when using other configurations of the headgear straps.

[0264] For similar reasons, in some embodiments of this technology, it may be advantageous to free the lower end of the headgear tube 3350 from any adjustment mechanism. If the bellows portion is provided, for example, on the headgear tube 3350 where the rear headgear strap 3310 connects to the headgear tube 3350, the bellows portion tends to buckle and bend when movement occurs, acting as a natural pivot, which may cause the cushion assembly to move and thus interfere with the seal with the patient's face.

[0265] Furthermore, if an adjustment mechanism 3360 is provided on the upper part of the headgear tube 3350 (which, for the purposes of this discussion, is considered to be the portion of the headgear tube 3350 located above the point where the rear headgear strap 3310 connects to each headgear tube 3350), it is possible to disengage the upper and lower parts of the headgear tube 3350, so that even if the upper part moves (due to use or changes in the position of the patient interface 3000 over the patient's head), excessive force that could cause interference with the seal with the patient's face is not applied to the cushion assembly 3150. In detail, using an adjustment mechanism 3360 that allows the length of the headgear tube 3350 helps to avoid a situation where the non-adjustable headgear tube portion 3363 becomes straight at the lower end of the headgear tube 3350. This is because using this type of adjustment mechanism 3360 allows the lower end of the patient interface 3000 to be moved up and down (i.e., downward and upward) relative to the patient's head. Furthermore, if the non-adjustable headgear tube 3363 becomes excessively straight and / or extended, the cushion assembly 3150 may rotate forward, which could interfere with the seal with the patient's face.

[0266] In some embodiments of this technology, the curvature radius of the non-adjustable headgear tube section 3363 (or the lower end of the headgear tube 3350) also affects the level of movement of the upper end of the headgear tube 3350. A larger curvature radius results in a greater separation effect between the upper and lower ends of the headgear tube 3350, making it possible to move the upper end of the headgear tube 3350 without causing significant forward rotation of the cushion assembly 3150 and the resulting loss of sealing performance.

[0267] In some forms of this technology, by positioning the adjustment mechanism 3360 above the headgear tube 3350 near the connection port 3600, the connection can be separated through the extension and bending brought about by the adjustment mechanism, thereby helping to reduce tube drag on the head.

[0268] In some embodiments of this technology, if the adjustment mechanism 3360 is located on the upper part of the headgear tube 3350, spaced apart from the cushion assembly 3150, the influence on the cushion assembly 3150 due to differences in the extension of the headgear tube 3350 may be reduced. For example, it may be possible to mitigate the effects of imbalances in the extension of the adjustment mechanism 3360 on either side of the patient's head and / or any force applied from the adjustment mechanism 3360 to either side of the patient's head. Such effects may result in compromises in the seal formed on the patient's face by the cushion assembly 3150.

[0269] In other embodiments of this technology, the adjustment mechanism may be located near the cushion assembly 3150 of the patient interface and may be positioned at a distance from the patient's face due to the size of the plenum chamber and the position of the port (and thus the adjustment mechanism) connecting the tube 3350 to the plenum chamber, which is positioned away from the patient's skin from the lower end of the tube 3350. The embodiment of this technology shown in Figure 10B is one such example of a patient interface 3000 in which the adjustment mechanism is positioned at a distance from the patient's face when in use. 8.3.3.5 Headgear Tubing Biasing Mechanism

[0270] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a biasing mechanism. This biasing mechanism functions to propel the seal-forming structure 3100 toward the patient's face (i.e., toward the area surrounding the entrance to the patient's airway (where the seal-forming structure 3100 is sealed)) during use. Thus, the biasing mechanism functions to help the seal-forming structure 3100 provide a good seal with the patient's face during use of the patient interface 3000 and to facilitate the retention of the seal when the patient interface delivers positive pressure gas to the patient. In some embodiments of this technology, the biasing mechanism acts on the adjustment mechanism 3360 (i.e., imparts a biasing force). When the plenum chamber 3200 is pressurized, a tendency occurs for the cushion assembly 3150 of the patient interface 3000 to move away from the patient's face. A biasing mechanism, which has the function of biasing or propelling the cushion assembly 3150 toward the patient's face, neutralizes this tendency in order to maintain the seal.

[0271] In some embodiments of this technology, the biasing mechanism has the function of applying a biasing force along at least a portion of the length of the headgear tube 3350 to propel the seal-forming structure toward the entrance of the patient's airway during use. In such embodiments, the headgear tube 3350 or a portion thereof becomes taut during use. In some embodiments, the biasing mechanism is included as part of the headgear tubing 3350, and in other embodiments, the biasing mechanism is separate from the headgear tubing 3350.

[0272] The biasing mechanism may also assist in automatically adjusting the patient interface to fit a specific patient's head.

[0273] 8.3.3.5.1 Magnitude of force applied by the biasing mechanism The biasing mechanism is preferably configured to apply sufficient inward force (i.e., towards the patient's airway opening) to maintain a good seal during use while avoiding the application of excessive force. If excessive force is applied, the seal-forming structure 3100 may be compressed, and its geometry may change, causing part of the structure to move away from the patient's face, which could lead to gas leakage from the seal-forming structure. Furthermore, avoiding excessive force from the patient interface onto the patient's face promotes comfort and prevents redness, chafing, or sweating on the patient's face.

[0274] In some embodiments of this technology, the acceptable force provided by the biasing mechanism may be 0.5 to 4 N on each side of the positioning and stabilizing structure 3300. In some embodiments, the acceptable force may be 1 to 3.5 N. A force of about 2 N may be considered acceptable. In some embodiments of this technology, the positioning and stabilizing structure 3300 is configured to support a seal-forming structure 3100 in the form of a full-face or mouth-nasal cushion assembly (e.g., the seal-forming structures 3100 shown in Figures 4A to 4E). In some embodiments of this technology, the full-face or mouth-nasal seal-forming structure 3100 is heavier than other forms of seal-forming structures (e.g., nasal cradles or nasal pillows) due to its larger size. The positioning and stabilizing structure 3300 is configured to provide a sufficiently high biasing force to absorb its weight or neutralize the traction of the heavier seal-forming structure 3100, while biasing the cushion assembly 3150 over the patient's face with a force high enough to maintain an effective seal without causing excessive discomfort. Furthermore, if the patient relaxes or moves their jaw (known as "opening their mouth wide"), the full-face or mouth-nose seal forming structure 3100 may be subjected to downward (e.g., downward) forces. The positioning and stabilizing structure 3100 may also be configured to account for the effects of opening the mouth wide by counteracting the downward forces it receives when the mouth is opened wide.

[0275] In some embodiments of this technology, the positioning and stabilizing structure 3300 is configured to interchangeably accommodate seal-forming structures of different sizes (e.g., relatively small or lightweight seal-forming structures (e.g., nasal cradle cushion assemblies) and relatively large or heavy seal-forming structures (e.g., mouth-nasal cushion assemblies)). The biasing mechanism that the positioning and stabilizing structure may include is configured to support both types of seal-forming structures by providing a sufficiently strong biasing force (but not excessively strong enough to cause discomfort) to either type of seal-forming structure.

[0276] In some forms of this technology, the positioning and stabilizing structure 3300 is configured to provide a range of forces in multiple adjustment configurations that are large enough to maintain an effective seal (but not excessively so as to cause discomfort) to the nose cradle or full face mask.

[0277] In some embodiments of this technology, the biasing mechanism is configured to apply a force to the headgear tube 3350 or a portion thereof that propels the headgear tubing to fit around the patient's head. This biasing mechanism may be configured to provide a force within a predetermined range. Such a predetermined range may be limited to a size that allows the headgear 3300 to be comfortable and maintain a sufficient seal between the seal-forming structure 3100 and the patient's face. The biasing mechanism may be configured to propel the seal-forming structure 3100 with a force less than the minimum force required for sufficient force to create a tight seal with the patient's face. That is, this force may be greater than or equal to the minimum sealing force. The biasing mechanism may be configured to propel the headgear tubing 3350 to fit around the patient's head with a force not exceeding the maximum force considered comfortable by the patient. That is, this force may be less than or equal to the maximum comfortable force.

[0278] In some forms of this technology, each headgear tube 3350 includes force extension characteristics resulting from the relationship between the extension of the headgear tube 3350 and the force applied to the headgear tube 3350 from the biasing mechanism. Alternatively or additionally, force extension characteristics may result from the relationship between the force applied to the headgear tube 3350 from the biasing mechanism and the extension of the headgear tube 3350. The term "extension" is understood to refer to the change in the overall length of the headgear tube and not to any physical structure of any adjustment mechanism that causes a change in the overall length of the headgear tube 3350.

[0279] In certain embodiments of this technology, the biasing mechanism may provide a biasing force on the headgear tube 3350 that tends to return the headgear tube 3350 or a portion thereof to a predetermined length (e.g., the length before adjustment by the adjustment mechanism). In some embodiments of this technology, the biasing mechanism provides a restorative force on the headgear tube 3350.

[0280] As described above, the adjustment mechanism 3360 of the patient interface 3000 in some forms of this technology allows for length adjustment of the headgear tube 3350. In some embodiments, if a relationship exists between the biasing force and the extension of the headgear tube 3350, when the headgear tube 3350 is extended to a first extension amount (e.g., to a first extended length), the force applied by the biasing mechanism will be greater than or equal to the minimum sealing force. Furthermore, when the headgear tube 3350 is extended to a second extension amount (e.g., to a second extended length), the force applied by the biasing mechanism will be less than or equal to the maximum comfort level. Furthermore, if there is an extension amount between the first and second extension amounts, the force applied by the biasing mechanism may be between the minimum sealing force and the maximum comfort level.

[0281] In some embodiments of this technology, the headgear tube 3350 may include force extension characteristics. In these force extension characteristics, when the headgear tube 3350 is adjusted to a first extension amount (e.g., to an extension amount that provides at least minimum sealing force from the biasing mechanism), the positioning and stabilizing structure 3300 can accommodate a predetermined minimum head size. Similarly, when the headgear tube 3350 is adjusted to a second extension amount (e.g., to an extension amount that no further maximum comfort can be obtained from the biasing mechanism), the positioning and stabilizing structure 3300 can accommodate a predetermined maximum head size. In the case of extension between the first and second extension amounts, the positioning and stabilizing structure 3300 can accommodate head sizes between a minimum head size and a predetermined maximum head size. The predetermined minimum head size may be, for example, the 5th percentile head size for a particular category of people, and the predetermined maximum head size may be, for example, the 95th percentile head size for a particular category of people. It is understood that other measurements / ranges may be used to determine the minimum and maximum head sizes that the positioning and stabilization structure 3300 can accommodate.

[0282] The force extension plot 6000 shown in Figure 3I illustrates the force extension characteristics 6300 of the headgear tube 3350 of the patient interface 3000 according to one embodiment of this technology. The horizontal extension axis 6100 and vertical force axis 6200 shown in the force extension plot 6000 illustrate the relationship between the length of the headgear tube 3350 and the resulting force applied by the biasing mechanism.

[0283] Three extensions of the headgear tube 3350 are shown on the extension axis 6100: namely, zero extension 6105, a first extension 6110 corresponding to the extension required to accommodate the 5th percentile head size (e.g., a given minimum head size), and a second extension 6120 corresponding to the extension required to accommodate the 95th percentile head size (e.g., a given maximum head size). The magnitudes of two forces are shown on the force axis 6200: namely, minimum sealing force 6210 and maximum comfort 6220.

[0284] In this exemplary embodiment of the technology, in the force extension characteristics 6300 included in the headgear tube 3350, the force applied by the biasing means is greater than the minimum sealing force 6210 and less than the maximum comfort 6220 over the entire extension within the range between the first extension amount 6110 and the second extension amount 6120. That is, a sufficient seal can be maintained over the entire range of accommodating head sizes without causing discomfort due to excessive biasing force.

[0285] In some forms of this technology, it is understood that the relationship between elongation and biasing force may not be directly proportional. For example, in some forms of this technology, the force may increase relatively significantly in the initial elongation stage, but there is little variation in the force within the elongation range required to accommodate the minimum and maximum predetermined head sizes. Regardless of how the force changes within the limits, if the magnitude of the force is kept between the minimum sealing force and the maximum comfort level throughout the entire elongation range between the minimum and maximum head sizes, an effective seal can be achieved without discomfort.

[0286] 8.3.3.5.2 Location of the biasing mechanism In some embodiments of this technology, a biasing mechanism functions between the seal-forming structure 3100 and the connection port 3600. For example, the biasing mechanism includes a component of the patient interface connected between the seal-forming structure 3100 and the connection port 3600, which can propel the seal-forming structure 3100 generally in the direction of the connection port 3600 and / or longitudinally along the length of the tube 3350.

[0287] 8.3.3.5.3 Morphology of the biasing mechanism The biasing mechanism can take multiple forms. In some embodiments of this technology, the biasing mechanism is a separate mechanism from the adjustment mechanism, enabling adjustment of the positioning and stabilizing structure as described above. In such embodiments, the adjustment mechanism allows the patient interface to be adjusted to fit the patient's head, while the biasing mechanism provides the function of propelling the sheet against the patient's face. In other embodiments, the biasing mechanism and adjustment mechanism are provided at least partially by the same features as the patient interface, and the adjustment and biasing described above are different functions performed by these same features.

[0288] In some embodiments of this technology, the biasing mechanism includes an elastic or elastic member or assembly. In some embodiments, the elastic or elastic member or assembly is connected between the seal-forming structure 3100 and the connection port 3600. For example, the elastic or elastic member or assembly is included as part of the pipe 3350 or connection assembly between the pipe 3350 and the plenum chamber 3200 and / or the connection assembly between the pipe 3350 and the connection port 3600, or is connected to the pipe 3350 or connection assembly between the pipe 3350 and the plenum chamber 3200 and / or the connection assembly between the pipe 3350 and the connection port 3600.

[0289] For example, in the embodiments of this technology shown in Figures 3A, 3B, 3C, 3D, and 3E, the biasing mechanism includes a bellows tube section 3362. The bellows tube section 3362 is configured to be biased to a compressed position. As a result, the bellows tube section 3362 functions to pull the seal-forming structure 3100 towards the patient's face during use.

[0290] In some forms of this technology, there is a relationship between the extension of the bellows tube 3362 and the restoring force applied to the headgear tube 3350. This restoring force may be tension within the bellows tube 3362. The bellows tube 3362 may have force extension characteristics similar to those described in relation to Figure 3I.

[0291] The bellows section 3362 may be designed to extend to a first extension amount that allows the positioning and stabilizing structure 3300 to accommodate a predetermined minimum head size (e.g., the 5th percentile head size), and may be designed to extend to a second extension amount that allows the positioning and stabilizing structure 3300 to accommodate a predetermined maximum head size (e.g., the 95th percentile head size). The bellows section 3362 may be designed such that, at the first extension amount, the tension exceeds the minimum force required to produce a proper seal of the seal-forming structure 3100 against the patient's face. At the second extension amount, the bellows section 3362 may be designed so that the tension does not exceed the maximum force considered comfortable for the patient. In this way, the positioning and stabilizing structure 3300 can accommodate a certain range of head sizes, thereby producing a sufficient seal across the entire range without causing discomfort due to force.

[0292] In certain embodiments of this technology, the bellows section 3362 may include a bellows profile that provides the force-extension characteristics of the bellows section 3362 as described above. As shown in Figure 3G, the bellows section 3362 may include a wall. This wall has a bellows profile having a wave-like repeating pattern in which the inner valleys are curved and the outer peaks are flat. The outer flat peaks provide a smooth, flat surface that can be comfortably positioned against the patient's head. The bellows section 3362 may include a plurality of ribs formed within the wall of the headgear tube 3350 to form a bellows. These ribs may extend inward as shown in Figure 3G. Alternatively or additionally, the bellows section 3362 may include a plurality of grooves.

[0293] The profile of the bellows section 3362 can be modified to achieve desired force extension characteristics. For example, the rib pitch (e.g., the crests / troughs of the bellows wave) can be reduced to obtain a more extensible bellows section 3362 (e.g., generally greater extension at a given force). Furthermore, the rib height (e.g., the amplitude of the bellows wave) may be increased to obtain a more extensible bellows section 3362. Alternatively, a less extensible bellows section 3362 may be provided by increasing the rib pitch or decreasing the rib height.

[0294] Additionally or alternatively, longer bellows sections 3362 may be provided to improve extensibility. This can be achieved, for example, by increasing the number of ribs formed in the walls of the bellows sections 3362.

[0295] Additionally or alternatively, a more expandable bellows tube 3362 may be obtained by reducing the wall thickness of the bellows tube 3362, or a highly rigid bellows tube 3362 may be obtained by increasing the wall thickness of the bellows tube 3362.

[0296] Additionally or alternatively, the material forming the bellows section 3362 may be selected to help provide a predetermined force-extensional properties. In one embodiment of this technology, the material is 50-durometer silicone. Other materials and / or durometer values ​​may also be selected (e.g., 40-durometer silicone).

[0297] Additionally or alternatively, different bellows profile shapes may be used for the bellows tube 3362 to achieve different extension amounts. For example, a more extendable bellows tube 3362 may be obtained if a bellows tube 3362 is used in which the walls defining the profile are generally more folded.

[0298] The configuration of the bellows section 3362 may vary along its length. For example, in some embodiments of this technology, as shown in Figure 3G, the rib height decreases along the length of the bellows section 3362 in the direction away from the connection port 3600 (e.g., towards the non-adjustable headgear section 3363). The rib height may vary within ranges such as 0-6 mm, 0-5 mm, 0-4 mm, 1-5 mm, etc. Alternatively, the rib height may be kept constant at a value such as 2 mm, 3 mm, or 4 mm. The wall thickness may be substantially constant along the length of the bellows section 3362 or may vary. In some embodiments of this technology, the wall thickness may be in the range of 0.5 mm to 1.2 mm (e.g., 0.6 mm to 1 mm or 0.8 mm). The rib pitch may be in the range of 3.5 mm to 5 mm (e.g., 3.8 mm to 4.5 mm or 4.2 mm).

[0299] In other embodiments of this technology, the shape and configuration of the bellows section 3362 differ from the parameters exemplified above.

[0300] In the embodiment of this technology shown in Figure 13, the relatively stretchable portion of the tube 3355 is deformable stretchably or elastically and tends to return to a non-stretchable state. Therefore, during use, the relatively stretchable portion of the tube 3355 has the function of pulling the seal-forming structure 3100 into the patient's face. Alternatively, the tube 3350 may be entirely formed from an elastic material that tends to return to a non-stretchable state when stretched.

[0301] Another embodiment of this technology is shown in Figure 17. In this embodiment, the patient interface 3000 includes one or more elastic sleeves 3340 covering the tube 3350. The elastic sleeves 3340 may partially cover the tube 3350, and it is understood that holes may be provided in the sleeves 3340, for example, as described below. Alternatively, the headgear tube may be considered to include both an elastic sleeve and an inner gas delivery conduit with an elastic sleeve covering the inner gas delivery conduit. The elastic sleeves 3340 may be formed from any stretchable, elastic, or stretchable material (for example, elastic fabrics such as elastane tend to return to their original size and shape when stretched).

[0302] The elastic sleeve 3340 covers the tube 3350, each containing a bellows section 3362. The bellows sections 3362 may or may not be biased to a compressed position. The presence of the bellows sections 3362 allows the patient interface 3000 to adjust the length of the tube 3350 to fit individual patients, while the elastic sleeve 3340 functions to pull the seal-forming structure 3100 of the cushion assembly 3150 to improve the seal over the patient's face.

[0303] The elastic sleeve 3340 may comprise a single sheet of elastic material, or it may be formed from multiple sheets of elastic material that are connected together (e.g., sewn or glued). Alternatively, the patient interface 3000 may comprise multiple separate elastic sleeves, for example, one sleeve covering each tube 3350.

[0304] The elastic sleeve 3340 may include openings that allow portions of the patient interface to pass through the sleeve. For example, the elastic sleeve may include a rear or lateral opening 3342. Through these openings 3342, the rear headgear strap 3310 is connected to the tube 3350. Additionally or alternatively, the sleeve may include an upper opening 3343. Through the upper opening 3343, the air circuit 4170 is connected to a connection port 3600, or the connection port 3600 may protrude. The headgear tube 3350 may come into contact with the patient's head through the opening 3342.

[0305] The bellows portion 3362 of the tube 3350 may cause discomfort if it comes into contact with the patient's skin or hair during use. Even if the bellows are not actually causing increased discomfort, the patient may find the bellows portion visually unappealing or develop an aversion to future use, which is undesirable. These problems can be avoided by covering the bellows portion 3362 with an elastic sleeve 3340. In some embodiments, a non-elastic sleeve may be used to provide the advantage of comfort. This sleeve has the advantage of being made of a flexible material that is not uncomfortable when in contact with the patient.

[0306] The elastic sleeve 3340 is prone to contamination with the patient's natural oils because it may come into contact with the patient's hair or skin during use. Therefore, it may be advantageous for the elastic sleeve 3340 to be formed from a material such as a cloth that is easily washable. To facilitate cleaning of the elastic sleeve 3340 by the patient, it may be possible to remove the elastic sleeve 3340 from the rest of the patient interface 3000. For example, the sleeve may include a mechanism for securing the sleeve to the tube 3350, which can be disengaged when the sleeve is removed. For example, the elastic sleeve 3340 may surround the tube 3350 and connect to itself by clips, poppers, hook-and-loop materials or other suitable fasteners.

[0307] In some forms of this technology, the elastic sleeve 3340 is formed from a material or fabric that helps to release moisture from the patient's face. As a result, it may be possible to help maintain comfort when the patient sweats while wearing the patient interface.

[0308] In other embodiments of this technology, the elastic sleeve may include a tube or other part of a positioning and stabilization mechanism, including other adjustment mechanisms as described above. The sleeve may be advantageous in that it covers a mechanism or component that may be undesirable to wear as a patient interface due to its complex or medical appearance.

[0309] In other embodiments of this technology, the telescopically adjustable headgear tube may include a biasing mechanism that functions to contract a telescopically movable headgear tube section (e.g., a spring).

[0310] An advantage of providing a biasing force through a manually adjustable adjustment mechanism (for example, the adjustment mechanism 3360 shown in Figure 7C) is that it allows for the modular design to support both relatively heavy and relatively light seal-forming structures (i.e., in a manner that allows for the exchange of different types of seal-forming structures). For example, when replacing the cushion assembly 3150 in the embodiment shown in Figure 7C with a heavier or nasal cushion assembly, the patient can manually adjust the length of the headgear tube 3350 to a shorter configuration so that the weight of the or nasal cushion is offset and the cushion hangs downward or is pressed downward by the movement of the patient's mandible.

[0311] 8.3.4 Ventilation In one embodiment, a vent included in the patient interface 3000 is constructed and positioned to reduce the risk of the patient rebreathing such gases by allowing for the continuous flow or flushing of exhaled gases (e.g., carbon dioxide (CO2) from inside the plenum chamber to the surroundings). That is, the vent allows the patient's exhaled CO2 to flow out of the patient interface. This vent is sized and shaped to maintain the therapeutic pressure within the plenum chamber.

[0312] One form of ventilation using this technology includes a plurality of holes (for example, about 20 to 80 holes, or about 40 to 60 holes, or about 45 to 55 holes).

[0313] The ventilation section may be located within the plenum chamber 3200. Alternatively, the ventilation section may be located within another part of the patient interface (for example, the tube 3350 that fluidly connects the plenum chamber 3200 and the connection port 3600).

[0314] 8.3.5 Decoupled Structures (Single or Multiple) In one embodiment, the patient interface 3000 includes at least one disconnection structure (e.g., a swivel or bulbous fossa). This disconnection structure may be located at or near the connection port 3600 so as to allow the conduit of the air circuit 4170 to move relative to the patient interface 3000 and to reduce the risk of destabilization of the seal between the seal-forming structure 3100 and the patient's face.

[0315] 8.3.6 Connection Ports The connection port 3600 enables connection to the air circuit 4170. In embodiments of the present technology shown in Figures 3 and 5-17, for example, the connection port is located on the patient's head when the patient interface 3000 is fitted. In other embodiments, the connection port is configured to be located near the top, side, or back of the patient's head during use. Patient interfaces in which the connection port is not located in front of the patient's face may be advantageous because some patients may find it visually distracting and uncomfortable if the conduit connects to a patient interface in front of their face. For example, a conduit connecting to a patient interface in front of the face may be prone to entanglement with bedding, especially if the conduit extends downward from the patient interface during use.

[0316] 8.3.7 Forehead support In one embodiment, the patient interface 3000 includes a forehead support. This forehead support contacts the patient's forehead area during use to support the patient interface on the patient's head and helps maintain a sealed contact with the patient's face.

[0317] 8.3.8 Suffocation prevention valve In some embodiments of this technology, the patient interface 3000 is constructed and configured to allow the patient to breathe ambient air during a power outage. In one embodiment, the patient interface 3000 includes an asphyxiation prevention valve.

[0318] 8.3.9 Ports In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this enables a clinician to supply supplemental oxygen. In one embodiment, this enables direct measurement of the gas (e.g., pressure) within the plenum chamber 3200.

[0319] 8.4 RPT Devices An RPT device 4000 according to one aspect of this technology (as shown in Figure 4A) includes mechanical and pneumatic components 4100, electrical components 4200, and is configured to execute one or more algorithms 4300. 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. Furthermore, 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.

[0320] The pneumatic path of the pneumatic RPT device 4000 may include one or more air 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) and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0321] One or more of the air passage items may be housed within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be housed within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0322] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative configuration, the RPT device 4000 may include more than one PCBA 4202.

[0323] 8.4.1 RPT Devices: Mechanical and Pneumatic Components An RPT device may include one or more of the following components in a single unit. In one alternative configuration, one or more of the following components may be arranged as separate units.

[0324] 8.4.1.1 Air Filter An RPT device according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110.

[0325] In one embodiment, the inlet air filter 4112 is positioned at the beginning of the upstream air pressure path of the pressure generator 4140.

[0326] In one embodiment, the outlet air filter 4114 (e.g., antimicrobial factor) is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0327] 8.4.1.2 Pressure Generator In one embodiment of this technology, the pressure generator 4140 that generates an airflow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers housed in a volute. The blower can deliver the air supply at a speed of, for example, up to about 120 liters / minute at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are incorporated herein by reference: Patent Document 14, Patent Document 15, Patent Document 16, and Patent Document 17.

[0328] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0329] 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.

[0330] 8.4.1.3 Air Circuit An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and positioned so that airflow moves between two components (e.g., an RPT device 4000 and a patient interface 3000) during use.

[0331] In detail, the air circuit 4170 may be fluidly connected to the outlet of the RPT device 4000 and the patient interface 3000. The air circuit may be called an air delivery tube or conduit. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0332] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (for example, to maintain or raise the air temperature). The heating elements may take the form of a heating wire circuit and may include one or more transducers (e.g., temperature sensors). In one embodiment, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may communicate with a controller (e.g., a central controller 4230). One embodiment of the air circuit 4170 including a heating wire circuit is described in Patent Document 18, which is incorporated herein by reference.

[0333] 8.5 Humidifier 8.5.1 Overview of Humidifiers In one embodiment of this technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air (for example, as shown in Figure 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and temperature of the airflow before it is delivered to the patient's airway.

[0334] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some embodiments, such as those shown in Figures 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.

[0335] 8.6 Glossary For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. Other definitions may also apply in other forms of this technology.

[0336] 8.6.1 General Air: In certain forms of this technology, air may mean the atmosphere, and in other forms of this technology, air may mean a combination of other breathable gases (e.g., an oxygen-rich atmosphere).

[0337] Atmosphere: In certain forms of this technology, the term “atmosphere” should be understood to mean (i) the area outside the treatment system or patient, and (ii) the area directly surrounding the treatment system or patient.

[0338] For example, ambient humidity for a humidifier can be the humidity of the air directly surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). This ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0339] In another embodiment, the ambient pressure may be the pressure directly surrounding or outside the body.

[0340] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the patient's room, excluding noise originating from, for example, RPT devices or masks or patient interfaces. Ambient noise may originate from sources outside the room.

[0341] Automatic positive airway pressure (APAP) therapy: CPAP therapy that can automatically adjust the therapeutic pressure between minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset.

[0342] Continuous positive airway pressure (CPAP) therapy: Respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (e.g., increased in response to the detection of signs of partial upper airway obstruction and decreased in the absence of such indications).

[0343] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when flow rate is mentioned, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be denoted by the sign Q. Sometimes, "flow rate" is simply referred to as "flow."

[0344] In the patient's respiratory embodiment, the flow rate can be negative relative to the expiratory portion of the patient's respiratory cycle, as it can be nominally positive relative to the inspiratory portion of the patient's respiratory cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Vent flow rate Qv is the flow rate of air exiting the vent to allow the exhaled gas to escape. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

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

[0346] Conducted Noise (Acoustics): In this document, conducted noise refers to noise transmitted to a patient via pneumatic pathways (e.g., air circuits and patient interfaces and the air within them). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0347] Noise Radiation (Acoustic): In this document, radiated noise refers to noise transmitted to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO 3744.

[0348] Noise from ventilation (acoustics): In this document, ventilation noise refers to noise generated by airflow through any ventilation (e.g., ventilation holes in a patient interface).

[0349] Patient: A person who has or does not have a respiratory illness.

[0350] Pressure: Force per unit area. Pressure can be expressed and measured in various units (e.g., cmH2O, gf / cm²). 2 , and hectopascals). 1 cmH2O is 1 g-f / cm³ 2 This is equal to approximately 0.98 hectopascals. In this specification, unless otherwise specified, pressure is given in units of cmH2O.

[0351] The pressure within the patient interface is denoted by the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should currently achieve, is denoted by the symbol Pt.

[0352] Respiratory pressure therapy (RPT): Addition of air supply to the airway inlet at therapeutic pressure, which is typically positive pressure relative to the atmosphere.

[0353] Ventilator: A mechanical device that provides pressure assistance to help a patient perform some or all of the breathing motion.

[0354] 8.6.1.1 Materials Silicone or silicone elastomer: synthetic rubber. In this specification, when silicone is referred to, it refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the product line sold under this registered trademark), manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of exemplary forms of LSR, as measured by ASTM D2240, is approximately 35 to approximately 45.

[0355] Polycarbonate: Typically, it is a transparent thermoplastic polymer of bisphenol A carbonate.

[0356] 8.6.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading. • "Elastic": Releases virtually all energy upon unloading. This includes, for example, certain silicones and thermoplastic elastomers.

[0357] Hardness: The ability of a material to resist deformation (described, for example, by Young's modulus or indentation hardness scale measured on a standardized sample size). • "Flexible" materials may include silicone or thermoplastic elastomer (TPE) and can be easily deformed, for example, under finger pressure. "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0358] 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, extension, bending, or torsion). A structure or component may provide different resistance in different directions. • "Floppy" structure or component: A structure or component that changes shape (e.g., bends) within a relatively short period of time (e.g., 1 second) when subjected to its own weight. • "Rigid" structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered during use. An example of such an application is a patient interface, for example, approximately 20-30 cmH 2 It may be possible to set up and maintain a sealed state at the entrance to the patient's airway under pressure load of O.

[0359] In one embodiment, an I-beam may have different bending stiffnesses (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another embodiment, a structure or component may be floppy in the first direction and rigid in the second direction.

[0360] 8.6.2 Respiratory Cycle Apnea: According to some definitions, apnea is said to occur when airflow falls below a certain threshold for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's exertion. Central apnea is said to refer to a condition in which apnea is detected due to decreased or absent respiratory effort, even though the airway is open. Mixed apnea is said to refer to a condition in which decreased or absent respiratory effort occurs simultaneously with airway obstruction.

[0361] Respiratory rate: This is the patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0362] Load cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0363] Exercise (breathing): Breathing effort is said to refer to the movements performed by a person's spontaneous breathing.

[0364] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0365] Flow limitation: Flow limitation is interpreted as a situation in a patient's respiration where increased exertion by the patient does not result in a corresponding increase in flow rate. If flow limitation occurs during the inspiratory portion of the respiratory cycle, it may be called inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, it may be called expiratory flow limitation.

[0366] Types of flow-restricted intake waveforms: (i) Flattening: A period of rising followed by a relatively flat section, after which a descent occurs. (ii) M-shaped: It has two local peaks, one at the rise and one at the fall, with a relatively flat area between these two peaks. (iii) Chair-shaped: Has a single localized peak, which rises from the beginning and is followed by a relatively flat area. (iv) Inverted chair shape: A relatively flat area is followed by a single localized peak, which occurs in a sloping section.

[0367] Respiratory depression: According to some definitions, respiratory depression refers to a decrease in flow, rather than an interruption of flow. In one morphology, respiratory depression is said to have occurred if a decrease in flow below a threshold velocity persists for a period of time. If respiratory depression is detected due to a decrease in respiratory effort, it is said to have occurred. In one morphology of an adult, respiratory depression may be considered if any of the following occurs: (i) A 30% decrease in patient respiration lasting at least 10 seconds + associated 4% desaturation, or (ii) The patient's respiration decreases by less than 50% for at least 10 seconds, and associated desaturation is at least 3% or awakening occurs.

[0368] Hyperventilation: A condition in which blood flow increases to a level higher than normal.

[0369] The inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0370] Airway patency: The degree to which the airway is open or the extent to which the airway is open. Airway patency is defined as opening. Airway patency can be quantified, for example, using a value of (1) indicating patency and a value of (0) indicating closure (obstruction).

[0371] Positive end-expiratory pressure (PEEP): This is the pressure in the lungs that exceeds the amount of air present, and it exists at the end of exhalation.

[0372] Peak flow rate (Qpeak): The maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0373] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): These terms may be understood to refer to the estimation of respiratory airflow by an RPT device and are used in contrast to "true respiratory flow" or "true respiratory airflow," which is the patient's actual respiratory flow, usually expressed in liters / minute.

[0374] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort.

[0375] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0376] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0377] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0378] Typical recent ventilation: Ventilation values ​​where recent ventilation values ​​tend to cluster together over a given time scale (i.e., the degree of clustering of recent ventilation values).

[0379] Upper airway obstruction (UAO): Includes both partial and total upper airway obstruction. It may be associated with a flow-limiting condition in which flow may slightly increase or decrease with increasing pressure differences over the upper airway (Stirling register behavior).

[0380] Ventilation: A measurement of the rate of gas exchange performed by a patient's respiratory system. Ventilation measurements may include either or both inspiratory and expiratory airflow per unit time. When expressed as volume per minute, this volume is often called "minute ventilation." Minute ventilation may also simply be given as volume and understood as volume per minute.

[0381] 8.6.3 Ventilation Adaptive servo ventilators (ASVs): Servo ventilators that have a variable target ventilation rather than a fixed target ventilation. The variable target ventilation can be learned from some patient characteristic (e.g., the patient's respiratory characteristics).

[0382] Backup rate: A ventilator parameter that establishes the minimum respiratory rate (typically respiratory rate per minute) delivered from the ventilator to the patient (when not triggered by spontaneous respiratory effort).

[0383] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers air to a patient who is breathing spontaneously, it is said that the ventilator cycles to stop delivering air at the end of the inspiratory portion of the respiratory cycle.

[0384] Positive expiratory airway pressure (EPAP): The base pressure to which varying pressures within respiration are added in order for a ventilator to generate the desired mask pressure that it attempts to achieve at a given time.

[0385] End-of-Expiratory Pressure (EEP): The desired mask pressure that the ventilator aims to achieve at the end of the expiratory portion of respiration. When the pressure waveform template Π(Φ) is zero at the end of exhalation (i.e., Π(Φ)=0 when Φ=1), EEP is equal to EPAP.

[0386] Positive Inspiratory Airway Pressure (IPAP): The maximum desired mask pressure that a ventilator attempts to achieve during the inspiratory portion of breathing.

[0387] Pressure assist: A number indicating the pressure increase during exhalation of a ventilator during inhalation, primarily representing the pressure difference between the maximum inhalational pressure and the baseline pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure assist refers to the difference the ventilator aims to achieve (not the difference the ventilator actually achieves).

[0388] Servo ventilator: A ventilator that has both patient ventilation and target ventilation, and adjusts the pressure support level to bring patient ventilation closer to the target ventilation.

[0389] Spontaneous / Timing (S / T): A mode of a ventilator or other device that attempts to detect the start of breathing in a patient who is breathing spontaneously. However, if the device fails to detect breathing within a predetermined period, the device automatically initiates respiratory delivery.

[0390] Swing: A term equivalent to pressure assistance.

[0391] Trigger: When a ventilator delivers air to a patient who is breathing spontaneously, the ventilator is said to be triggered to deliver air when the patient initiates the respiratory portion of the respiratory cycle.

[0392] Typical Recent Ventilation: Typical recent ventilation (Vtyp) is a range of values ​​over a given time scale in which recent ventilation measurements tend to cluster. For example, measuring the central trend of ventilation measurements over recent history may be a good value for typical recent ventilation.

[0393] 8.6.4 Anatomy 8.6.4.1 Anatomical structure of the face Wing (Ala): The "wing" of the outer wall or each nostril (plural: alar)

[0394] Alare: The outermost point on the nasal ala.

[0395] Wing curvature (or nostril apex) point: The furthest point on the curved reference line of each wing, found at the fold formed by the joining of the wing and cheek.

[0396] Auricle: The entire visible part of the ear.

[0397] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0398] (Nasal) cartilage: The cartilage of the nose includes the septal cartilage, lateral cartilage, macrocartilage, and microcartilage.

[0399] Columella: A piece of skin that separates the nostrils, extending from the tip of the nose to the upper lip.

[0400] Columella angle: The angle between a line drawn through the midpoint of the nostrils and a line drawn perpendicular to the Frankfurt horizontal while intersecting the subnasal point.

[0401] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left auricle. The auricle is the deepest point from the upper side of the notch to the tragus of the auricle.

[0402] Glabella: Located in soft tissue, it is the most prominent point in the midline sagittal direction of the forehead.

[0403] Lateral nasal cartilage: A generally triangular plate of cartilage. Its upper margin is attached to the nasal bone and the frontal process of the maxilla, and its lower margin is connected to the greater alar cartilage.

[0404] Lip, lower side (lower lip: labrale inferius):

[0405] Lip, upper side (upper lip: labrale superius):

[0406] Greater alar cartilage: A plate of cartilage located beneath the lateral nasal cartilage. It curves around the anterior portion of the nostril. Its posterior end connects to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0407] Nostrils: Generally, ellipsoidal pterygoides form the entrance to the nasal cavity. The singular form of nostril (nares) is nostril (naris). These nostrils are separated by the nasal septum.

[0408] Nasolabial fold or groove: A fold or groove of skin that extends from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0409] Nasolabial angle: The angle between the columella and the upper lip, which intersects with the subnasal point.

[0410] Subbase of the ear: The lowest point where the auricle attaches to the skin of the face.

[0411] Ear base point: The highest point where the auricle attaches to the skin of the face.

[0412] Nasal tip: The most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head.

[0413] Philtrum: The midline groove extending from the lower boundary of the nasal septum to the upper part of the lip in the upper lip region.

[0414] Pogonion: The anterior midpoint of the jaw, located on soft tissue.

[0415] Nasal ridge: The nasal ridge is the midline elevation of the nose, extending from the therion to the nasal tip.

[0416] Sagittal plane: A vertical plane that extends from the front (front) to the back (back), dividing the main body into a right half and a left half.

[0417] Serion: The most concave point located on soft tissue within the region of the frontonasal suture.

[0418] Septal cartilage (nose): The nasal septum cartilage is part of the septum and divides the anterior part of the nasal cavity.

[0419] The lowest point of the nasal ala: This is a point on the lower periphery of the wing base, where the wing base joins the skin of the upper lip.

[0420] Subnasal point: Located on soft tissue, this is the point where the columella merges with the upper lip in the midline sagittal direction.

[0421] Supramentare: The most concave point on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue pogonion.

[0422] 8.6.4.2 Anatomical structure of the skull Frontal bone: The frontal bone includes the frontal squama, a large vertical portion that corresponds to the area known as the forehead.

[0423] Mandible: The mandible forms the lower jaw region. The mental protuberance is a bony protuberance in the jaw region and forms the jaw.

[0424] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose, forming its lateral boundary.

[0425] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from person to person. The nasal bones are located side by side in the middle and upper parts of the face, and their joint forms the "bridge" of the nose.

[0426] Nasal root point: The intersection of the frontal bone and the two nasal bones, a concave area directly located between the upper part of the bridge between the eye and the nose.

[0427] Occipital bone: The occipital bone is located in the posterior and inferior part of the skull. The occipital bone contains the foramen magnum, an oval opening through which the intracranial cavity is connected to the vertebral canals. The curved plate on the posterior side of the foramen magnum is the occipital squama.

[0428] Orbit: A bony cavity within the skull that contains the eyeball.

[0429] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0430] Temporal bone: The temporal bone is located on the base and sides of the skull and supports the part of the face known as the temple.

[0431] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face, forming the cheekbones.

[0432] 8.6.4.3 Anatomical Structure of the Respiratory System The diaphragm is a sheet of muscle that extends over the lower part of the rib cage. It 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, drawing air into the lungs.

[0433] Larynx: The larynx or vocal organ that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0434] Lungs: The respiratory organ in humans. The conductive zone of the lungs includes the trachea, bronchi, terminal bronchioles. The respiratory region includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0435] Nasal cavity: The nasal cavity (or nasal fossa) is a large, air-filled space located in the center of the face, above and behind the nose. 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 the nasal conchae or nasal bones. The nose is located anterior to the nasal cavity, and posteriorly it connects to the nasopharynx via the posterior nostrils.

[0436] Pharynx: The part of the throat located directly below the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into the following three parts: nasopharynx (upper pharynx) (the nasal part of the pharynx), oropharynx (oropharynx) (the oral part of the pharynx), and pharynx (lower pharynx).

[0437] 8.6.5 Patient Interface Anti-choking valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to the atmosphere in a fail-safe manner.

[0438] Elbow: An elbow is an embodiment of a structure that directs the axis of airflow moving within, changing its direction through an angle. In one embodiment, the angle may be approximately 90 degrees. In another embodiment, the angle may be greater than or less than 90 degrees. An elbow may have a substantially circular cross-section. In another embodiment, an elbow may have an elliptical or rectangular cross-section. In certain embodiments, an elbow may be rotatable, for example, about 360 degrees relative to a mating component. In certain embodiments, an elbow may be detachable from a mating component, for example, via a snap connection. In certain embodiments, an elbow may be assembled to a mating component via a one-time snap during manufacturing, but cannot be detached by the patient.

[0439] Frame: The term "frame" is taken to mean a mask structure that supports tensile loads between two or more points connecting the headgear. The mask frame can be an airtight load-supporting structure within the mask. However, some forms of mask frames may be airtight.

[0440] Headgear: Headgear is taken to mean a form of positioning and stabilization structure designed for use on the head. For example, headgear may include a collection of one or more struts, ties, and stiffeners configured to position and hold a patient interface in place on the patient's face for the delivery of respiratory therapy. Some ties may be formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0441] Membrane: The term "membrane" is typically used to mean a thin-walled element, preferably one that offers little resistance to bending and little resistance to stretching.

[0442] Plenum Chamber: The term "mask plenum chamber" is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of space, where the air in the volume is pressurized to exceed atmospheric pressure when in use. A shell may form part of the wall of the mask plenum chamber.

[0443] Seal: When used as a noun ("seal"), it can refer to a structure; when used as a verb ("to seal"), it can refer to the effect of sealing. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without requiring a separate "seal" element itself.

[0444] Shell: The term "shell" is used to mean a curved, relatively thin-walled structure with bending, tensile, and compressive rigidity. For example, the curved structural walls of a mask can be a shell. In some forms, a shell can be faceted. In some forms, a shell can be airtight. In some forms, a shell may not be airtight.

[0445] Stiffener: The term "stiffener" is understood to mean a structural component designed to increase the rigidity of another component in at least one direction.

[0446] Support: The term "support" is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0447] Swivel (noun): A subassembly of components configured to rotate preferably independently and preferably under low torque around a common axis. In one embodiment, the swivel may be configured to rotate at an angle of at least 360 degrees. In another embodiment, the swivel may be configured to rotate at an angle of less than 360 degrees. When used in the context of air delivery conduits, the subassembly of components preferably includes a pair of cylindrical conduits. There is little to no air leakage from the swivel during use.

[0448] Thai (noun): A structure designed to resist tension.

[0449] Ventilation (noun): A structure that allows airflow into the surrounding air inside a mask or conduit, enabling clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve flow rates of approximately 10 liters / minute to 100 liters / minute, depending on the mask design and treatment pressure.

[0450] 8.7 Other Notes Some of the disclosures in this patent document include content that is protected by copyright. The copyright holder retains all copyrights to any other purpose, except that any reproduction of this patent document or this patent disclosure by fax by any person is permitted if it is included in the patent files or records of the Japan Patent Office.

[0451] Unless otherwise clearly indicated by the context or provided for a range of values, it is understood that 1 / 10 of the lower limit, the interval between the upper and lower limits of the range, and each intervention value for any other stated values ​​or intervention values ​​within the stated range are included in this technique. Even if the upper and lower limits of these intervention ranges, independently included within the intervention range, specifically exceed the limits within the stated range, they are also included in this technique. If the stated range includes one or both of these limits, the range exceeding either or both of these stated limits is also included in this technique.

[0452] Furthermore, where values ​​(one or more) are embodied in this specification as part of the Art, unless otherwise specified, it is understood that such values ​​may be approximated and used to any appropriate number of significant figures as permitted or required by the practical technical implementation.

[0453] Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as those commonly understood by those skilled in the art. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this art, but only a limited number of exemplary methods and materials are described herein.

[0454] While certain materials are described as suitably used in constructing components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are understood to be manufacturable and therefore can be manufactured collectively or individually.

[0455] Note that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0456] All published documents cited herein are used for disclosure and description of methods and / or materials that are the subject of those documents, and are incorporated for reference only. The published documents cited herein are provided solely for the purposes of their disclosure prior to the filing date of this application. Nothing in this specification should be construed as acknowledging or acknowledging that the present technology is not prior to such published documents for the purpose of prior patents. Furthermore, the dates of the published documents cited herein may differ from the actual dates of the published documents and may require individual verification.

[0457] The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the elements, components, or steps described may exist, be used, or be combined with other elements, components, or steps not explicitly stated.

[0458] The headings used in the detailed descriptions are for the convenience of the reader and should not be used to limit the content found in this disclosure or the claims as a whole. These headings should not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0459] While the techniques described herein have been referred to with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may indicate specific details that are not necessary for carrying out the techniques. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any arbitrary order and are used to distinguish separate elements. Furthermore, while the process steps in the methods may be described or illustrated in order, such order is not necessary. Those skilled in the art will recognize that such order is changeable and / or that such actions can be performed simultaneously or even synchronously.

[0460] Therefore, it should be understood that numerous modifications are possible in the exemplary embodiments, and other configurations may be devised, without deviating from the intent and scope of this technology.

[0461] Furthermore, the present invention may also preferably include the following examples. [Section 1] A positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on the patient's head, wherein the seal-forming structure is constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway in order to deliver airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's entire respiratory cycle during use, and the positioning and stabilizing structure is: A gas delivery tube for delivering the airflow through the seal-forming structure to the entrance of the patient's airway, wherein the at least one gas delivery tube is constructed and positioned to contact at least one area of ​​the patient's head above the base of the ears when in use; An adjustment mechanism for adjusting the at least one gas delivery tube to enable the positioning and stabilizing structure to fit heads of different sizes; A biasing mechanism that applies a biasing force along at least a portion of the length of the at least one gas delivery tube to propel the seal-forming structure toward the entrance of the patient's airway during use, A positioning and stabilization structure, including a positioning and stabilization structure. [Section 2] The positioning and stabilization structure according to item 1, wherein the at least one gas delivery tube includes the adjustment mechanism. [Section 3] The positioning and stabilization structure according to claim 1 or 2, wherein the at least one gas delivery tube includes the biasing mechanism. [Section 4] The positioning and stabilizing structure according to any one of claims 1 to 3, further comprising a connection port for fluid connection to an air circuit connected to a supply of pressurized air during use, wherein the connection port is located near the top, side, or rear of the patient's head during use. [Section 5] The positioning and stabilization structure according to item 4, wherein the biasing mechanism includes an elastic member provided between the seal forming structure and the connection port. [Section 6] The positioning and stabilizing structure according to item 5, wherein the elastic member includes an elastic sleeve, the gas delivery tube includes the elastic sleeve and an inner gas delivery conduit, and the elastic sleeve covers the inner gas delivery conduit. [Section 7] The positioning and stabilization structure according to item 5, wherein the elastic member includes a portion of the gas delivery tube formed from an elastic material. [Section 8] The positioning and stabilizing structure according to item 5, wherein the elastic member includes a portion of the gas delivery tube having a bellows structure. [Section 9] The adjustment mechanism is the positioning and stabilizing structure according to item 8, including the bellows structure. [Section 10] The positioning and stabilizing structure according to paragraph 8 or 9, wherein a portion of the gas delivery tube having the bellows structure is positioned in contact with a region of the patient's head above the base of the ear of the patient's head during use. [Section 11] The expandable positioning and stabilizing structure according to any one of claims 1 to 10, wherein the adjustment mechanism makes it possible to adjust the length of the at least one gas delivery tube over a continuous length range. [Section 12] The positioning and stabilization structure according to any one of claims 1 to 11, wherein the gas delivery tube includes a first tube section and a second tube section, the first tube section being telescopically movable relative to the second tube section to adjust the length of the tube. [Section 13] The positioning and stabilization structure according to item 12, wherein the patient interface includes one or more tabs that facilitate relative telescopic movement between a first tube and a second tube. [Section 14] The positioning and stabilization structure according to claim 12 or 13, wherein the patient interface includes a tube fixing mechanism for fixing the first and second tubes in a plurality of separate relative positions. [Section 15] The positioning and stabilization structure according to any one of claims 1 to 14, wherein the gas delivery tube includes a folding portion such that the length of the gas delivery tube when the folding portion is in a folded configuration is different from the length of the gas delivery tube when the folding portion is not in a folded configuration. [Section 16] The positioning and stabilizing structure according to item 15, wherein the gas delivery tube includes a plurality of folding portions in a part of the gas delivery tube having a bellows structure. [Section 17] The adjustment mechanism includes an extendable portion of the gas delivery tube, the positioning and stabilization structure according to any one of claims 1 to 16. [Section 18] The positioning and stabilization structure according to any one of claims 1 to 17, wherein the adjustment mechanism includes a first tube, the first tube being removable and interchangeable with a second tube having a different length from the first tube. [Section 19] The positioning and stabilization structure according to any one of claims 1 to 18, wherein the adjustment mechanism includes one or more tube insertion members, the one or more tube insertion members being configured to be selectively fluid-connected to the gas delivery pipe so as to change the length of the gas delivery pipe. [Section 20] The positioning and stabilization structure according to any one of items 1 to 19, wherein the gas delivery tube includes a plurality of indicators indicating where the gas delivery tube should be cut to fit a patient's head of a different size. [Section 21] The positioning and stabilizing structure according to any one of claims 1 to 19, wherein the adjustment mechanism is configured to allow the at least one gas delivery tube to be bendable in order to fit the positioning and stabilizing structure to a head of a different size. [Section 22] The positioning and stabilization structure according to any one of claims 1 to 21, wherein the positioning and stabilization structure is configured to be positioned so that the adjustment mechanism does not come into contact with the patient's face during use. [Section 23] The positioning and stabilizing structure according to paragraph 22, wherein the positioning and stabilizing structure is configured such that the adjustment mechanism does not come into contact with the patient's cheek area during use. [Section 24] The adjustment mechanism is positioned above the point above the base of the ear on the patient's head during use, as described in paragraph 23. [Section 25] The positioning and stabilizing structure is a positioning and stabilizing structure according to any one of items 1 to 24, which extends over the cheek area of ​​the patient when in use. [Section 26] The positioning and stabilizing structure according to any one of claims 1 to 25, wherein the positioning and stabilizing structure does not include any mechanism that allows for length adjustment of the at least one gas delivery tube below the upper point of the base of the ear on the patient's head. [Section 27] The positioning and stabilizing structure according to claim 26, wherein the positioning and stabilizing structure does not include any mechanism that allows for length adjustment of the at least one gas delivery tube that extends over the patient's cheek area during use. [Section 28] The positioning and stabilizing structure according to any one of claims 25 to 27, comprising two gas delivery tubes fluidly connected between the connection port and the seal-forming structure, each gas delivery tube extending over one of the patient's cheek regions during use, and the two gas delivery tubes being located on different sides of the patient's head. [Section 29] The connection port is a positioning and stabilizing structure according to any one of items 4 to 28, as it is subject to item 4, provided on the upper part of the patient's head when in use. [Section 30] The positioning and stabilizing structure according to paragraph 29, wherein the positioning and stabilizing structure extends between the patient's eye and the patient's ear when in use. [Section 31] The positioning and stabilizing structure according to paragraph 29, comprising a rear strap connected between the two gas delivery tubes and configured to pass behind the patient's head when in use. [Section 32] The positioning and stabilization structure according to paragraph 31, wherein the length of the rear strap between the two gas delivery tubes is adjustable. [Section 33] The positioning and stabilization structure according to claim 31 or claim 32, wherein the angle of the rear strap relative to each gas delivery tube is adjustable. [Section 34] The positioning and stabilizing structure according to any one of claims 31 to 33, wherein the positioning and stabilizing structure includes an adjustment mechanism positioned above the point at which the rear strap is connected to one of the gas delivery tubes during use, and the positioning and stabilizing structure does not include any mechanism that allows length adjustment of the at least one gas delivery tube positioned below the point at which the rear strap is connected to one of the gas delivery tubes during use. [Section 35] It is a patient interface: A plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, exceeding the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's respiration; A seal-forming structure constructed and positioned to form a seal over the patient's facial region surrounding the entrance to the patient's airway, thereby ensuring that airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use; A connection port that provides fluid connection to an air circuit connected to the airflow during use, wherein the connection port is located near the top, side, or rear of the patient's head during use; A positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on the patient's head, wherein the positioning and stabilizing structure is: At least one gas delivery tube for delivering airflow through the seal-forming structure to the entrance of the patient's airway, wherein the at least one gas delivery tube is constructed and positioned to contact at least one area of ​​the patient's head above the base of the ears when in use; An adjustment mechanism for adjusting the at least one gas delivery tube to enable the positioning and stabilizing structure to fit heads of different sizes; and A positioning and stabilizing structure, including a biasing mechanism that applies a biasing force along at least a portion of the length of the at least one gas delivery tube to propel the seal-forming structure toward the entrance of the patient's airway during use, A patient interface, including... [Section 36] A system for the treatment of respiratory diseases, wherein the system is: The patient interface described in item 35; Air circuits; and An air source with positive pressure relative to the ambient air pressure. A system that includes this. [Section 37] A positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on the patient's head, wherein the seal-forming structure is constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway in order to deliver airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's entire respiratory cycle during use, and the positioning and stabilizing structure is: At least one tie, the at least one tie is configured to come into contact with the patient's head when in use, and the at least one tie is: A gas delivery tube for delivering the airflow through the seal-forming structure to the entrance of the patient's airway, the at least one gas delivery tube comprising at least one tie and positioned to cover at least one area of ​​the patient's head above the upper point of the base of the ears when in use; Includes an adjustment mechanism for adjusting the at least one tie to enable the positioning and stabilizing structure to fit heads of different sizes, The positioning and stabilization structure is configured such that the adjustment mechanism does not come into contact with the patient's face during use. [Section 38] The positioning and stabilization structure according to item 37, comprising the adjustment mechanism for at least one gas delivery tube. [Section 39] The positioning and stabilization structure according to claim 37 or 38, wherein the at least one gas delivery tube includes the biasing mechanism. [Section 40] A positioning and stabilizing structure according to any one of claims 37 to 39, further comprising a connection port for fluid connection to an air circuit connected to a supply of pressurized air during use, wherein the connection port is located near the top, side, or rear of the patient's head during use. [Section 41] The positioning and stabilizing structure according to any one of claims 37 to 40, wherein the positioning and stabilizing structure is configured such that the adjustment mechanism does not come into contact with the patient's cheek area during use. [Section 42] The positioning and stabilizing structure according to any one of items 37 to 41, wherein the adjustment mechanism is positioned above the point of the upper base of the ear on the patient's head when in use. [Section 43] The positioning and stabilizing structure according to any one of claims 37 to 42, wherein the positioning and stabilizing structure includes a biasing mechanism that provides a biasing force along at least a portion of the length of the at least one gas delivery tube to propel the seal-forming structure to the area surrounding the entrance of the patient's airway when in use. [Section 44] The positioning and stabilization structure according to item 43, wherein the biasing mechanism includes an elastic member provided between the seal-forming structure and the connection port. [Section 45] The positioning and stabilizing structure according to item 44, wherein the elastic member includes an elastic sleeve, the gas delivery tube includes the elastic sleeve and an inner gas delivery conduit, and the elastic sleeve covers the inner gas delivery conduit. [Section 46] The positioning and stabilization structure according to item 44, wherein the elastic member includes a portion of the gas delivery tube formed from an elastic material. [Section 47] The positioning and stabilizing structure according to item 44, wherein the elastic member includes a portion of the gas delivery tube having a bellows structure. [Section 48] The adjustment mechanism is the positioning and stabilizing structure according to item 47, including the bellows structure. [Section 49] The positioning and stabilizing structure according to paragraph 47 or 48, wherein a portion of the gas delivery tube having the bellows structure is positioned in contact with a region of the patient's head above the base of the ear of the patient's head when in use. [Section 50] The positioning and stabilizing structure according to any one of claims 37 to 49, wherein the at least one gas delivery tube has a wavy shape along its length. [Section 51] The positioning and stabilization structure according to any one of claims 37 to 49, wherein the adjustment mechanism allows for adjustment of the length of at least one tie. [Section 52] The positioning and stabilization structure according to paragraph 51, wherein the adjustment mechanism allows the length of at least one tie to be adjusted over a continuous length range. [Section 53] The positioning and stabilization structure according to any one of claims 37 to 52, wherein the adjustment mechanism allows for adjustment of the length of at least one gas delivery tube. [Section 54] The positioning and stabilization structure according to claim 52 or 53, wherein the gas delivery tube includes a first tube section and a second tube section, the first tube section being telescopically movable relative to the second tube section to adjust the length of the gas delivery tube. [Section 55] The positioning and stabilization structure according to paragraph 54, wherein the patient interface includes one or more tabs for facilitating relative telescopic movement between a first tube and a second tube. [Section 56] The positioning and stabilization structure according to claim 54 or 55, wherein the patient interface includes a tube fixing mechanism for fixing the first and second tubes to each other at separate positions. [Section 57] The positioning and stabilization structure according to any one of claims 37 to 56, wherein the gas delivery tube includes a folding portion such that the length of the gas delivery tube when the folding portion is in a folded configuration is different from the length of the gas delivery tube when the folding portion is not in a folded configuration. [Section 58] The positioning and stabilizing structure according to item 57, wherein the gas delivery tube includes a plurality of folding portions in a portion of the gas delivery tube having a bellows structure. [Section 59] The adjustment mechanism includes an extendable portion of the gas delivery tube, the positioning and stabilization structure according to any one of claims 37 to 58. [Section 60] The positioning and stabilizing structure according to any one of claims 37 to 59, wherein the adjustment mechanism includes a first tube, the first tube being removable and replaceable with a second tube having a different length from the first tube. [Section 61] The positioning and stabilization structure according to any one of claims 37 to 60, wherein the adjustment mechanism includes one or more tube insertion members configured to be selectively fluid-connected to the gas delivery tube in such a way as to change the length of the gas delivery tube. [Section 62] The positioning and stabilization structure according to any one of paragraphs 37 to 61, wherein the gas delivery tube includes a plurality of indicators indicating where the gas delivery tube should be cut to fit a patient's head of a different size. [Section 63] The positioning and stabilizing structure according to any one of claims 37 to 62, wherein the adjustment mechanism is configured to bend the at least one gas delivery tube so that the positioning and stabilizing structure fits the head of a different size. [Section 64] The positioning and stabilizing structure according to any one of claims 37 to 63, wherein the at least one tie defines a loop configured to surround a portion of the patient's head when in use, the at least one gas delivery tube defines at least a portion of the loop, and the positioning and stabilizing structure includes a loop adjustment mechanism that is operable to adjust the position in which two regions of the at least one tie are held together to adjust the size of the loop. [Section 65] The positioning and stabilizing structure according to any one of claims 37 to 62, wherein the at least one tie defines a loop configured to surround a portion of the patient's head when in use, the at least one gas delivery tube defines at least a portion of the loop, and the positioning and stabilizing structure includes a loop insertion member configured to be fixed directly or indirectly to the at least one gas delivery tube when in use, the loop insertion member defining at least a portion of the loop. [Section 66] The positioning and stabilizing structure according to item 65, wherein the loop insertion member is expandable. [Section 67] The positioning and stabilization structure according to claim 65 or 66, wherein the loop insertion member is configured to be interchangeable with interchangeable loop insertion members of different sizes for adjusting the size of the loop. [Section 68] The adjustment mechanism is a positioning and stabilizing structure according to any one of items 37 to 67, which is positioned above the point of the upper base of the ear on the patient's head when in use. [Section 69] The positioning and stabilizing structure is a positioning and stabilizing structure according to any one of items 37 to 68, which extends over the cheek area of ​​the patient when in use. [Section 70] The positioning and stabilizing structure according to any one of claims 37 to 69, wherein the positioning and stabilizing structure does not include any mechanism for allowing length adjustment of the at least one tie below the upper point of the base of the ear on the patient's head. [Section 71] The positioning and stabilizing structure according to paragraph 70, wherein the positioning and stabilizing structure does not include any mechanism that allows for length adjustment of the at least one tie that extends over the cheek area of ​​the patient when in use. [Section 72] The positioning and stabilizing structure according to any one of claims 69 to 71, comprising two gas delivery tubes fluidly connected between the connection port and the seal-forming structure, each gas delivery tube extending over one of the patient's cheek regions during use, and the two gas delivery tubes located on different sides of the patient's head. [Section 73] The connection port is positioned above the patient's head when in use, and is a positioning and stabilizing structure according to any one of items 40 to 72, as is dependent on item 40. [Section 74] The positioning and stabilizing structure according to paragraph 73, wherein the positioning and stabilizing structure extends between the patient's eye and the patient's ear when in use. [Section 75] The positioning and stabilizing structure according to paragraph 72, wherein the at least one tie includes a rear strap connected between the two gas delivery tubes and configured to pass around the rear of the patient's head when in use. [Section 76] The positioning and stabilization structure according to paragraph 75, wherein the length of the rear strap between the two gas delivery tubes is adjustable. [Section 77] The angle of the rear strap relative to each gas delivery tube is adjustable, positioning and stabilizing structure according to claim 75 or claim 76. [Section 78] The positioning and stabilizing structure according to any one of claims 75 to 77, wherein the positioning and stabilizing structure includes an adjustment mechanism positioned above the point at which the rear strap is connected to one of the gas delivery tubes during use, and the positioning and stabilizing structure does not include any mechanism that allows adjustment of the at least one tie positioned below the point at which the rear strap is connected to one of the gas delivery tubes during use. [Section 79] It is a patient interface: A plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, exceeding the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's respiration; A seal-forming structure constructed and positioned to form a seal over the patient's facial region surrounding the entrance to the patient's airway, thereby ensuring that airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use; A connection port that provides fluid connection to an air circuit connected to the airflow during use, wherein the connection port is located near the top, side, or rear of the patient's head during use; A positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on the patient's head, wherein the positioning and stabilizing structure is: At least one tie, the at least one tie is configured to come into contact with the patient's head when in use, and the at least one tie is: A gas delivery tube for delivering the airflow through the seal-forming structure to the entrance of the patient's airway, the at least one gas delivery tube comprising at least one tie and positioned to cover at least one area of ​​the patient's head above the upper point of the base of the ears when in use; An adjustment mechanism for adjusting the at least one tie to enable the positioning and stabilizing structure to fit heads of different sizes, Includes, The positioning and stabilization structure is configured such that the adjustment mechanism does not come into contact with the patient's face during use. A patient interface, including... [Section 80] A system for the treatment of respiratory diseases, wherein the system is: The patient interface described in item 79; Air circuits; and An air source with positive pressure relative to the ambient air pressure. A system that includes this. [Section 81] It is a patient interface: A plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, exceeding the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's respiration; A seal-forming structure constructed and positioned to form a seal over the patient's facial region surrounding the entrance to the patient's airway, thereby ensuring that airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use; A positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on the patient's head, A first tube section constructed and positioned to cover the area of ​​the patient's head above the base of the ear when in use; and A positioning and stabilizing structure including a tie portion that is placed on the posterior part of the occipital bone of the patient's head or covers the posterior part of the occipital bone of the patient's head when in use. A positioning structure including, A ventilation structure that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surroundings, wherein the ventilation structure is sized and shaped to maintain the therapeutic pressure inside the plenum chamber during use. Includes, The first tube is configured to conduct at least a portion of the airflow respiration by the patient, The first tubular section is configured to be taut when in use. The first tubular section includes a lengthwise adjustment mechanism and is a patient interface. [Section 82] The patient interface according to paragraph 81, wherein the positioning and stabilizing structure includes a second tube, the second tube being configured to cover the maxillary region of the patient's head when in use and to connect to the plenum chamber when in use. [Section 83] The patient interface according to claim 81 or 82, further comprising a connection port configured to receive an air supply and to deliver the air supply to the first tubing. [Section 84] The patient interface according to paragraph 83, wherein the connection port is constructed and positioned to be located above the patient's head when in use. [Section 85] The patient interface according to any one of claims 81 to 84, wherein the positioning and stabilizing structure includes a third tubular portion configured to connect to the connection port and to cover a region of the patient's head above the upper point of the base of the ears of the patient's head when in use. [Section 86] The patient interface according to any one of claims 81 to 85, wherein the positioning and stabilizing structure includes a fourth tubular section configured to cover the maxillary region of the patient's head during use and to connect to the plenum chamber during use. [Section 87] The patient interface according to any one of claims 81 to 86, wherein the seal-forming structure is configured to expose the patient's oral cavity when in use. [Section 88] The patient interface according to any one of paragraphs 81 to 87, wherein the seal-forming structure is configured so that no part of the seal-forming structure enters the oral cavity during use. [Section 89] The patient interface according to any one of paragraphs 81 to 88, wherein the seal-forming structure is configured such that it does not extend into the airway of the patient. [Section 90] The patient interface according to any one of items 81 to 89, wherein the seal-forming structure is configured so that it does not extend below the chin prominence region during use. [Section 91] The patient interface according to any one of paragraphs 81 to 90, wherein the patient interface is constructed and positioned so that the plenum chamber does not cover the eye when in use. [Section 92] A positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on the patient's head, wherein the seal-forming structure is constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway in order to deliver airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's entire respiratory cycle during use, and the positioning and stabilizing structure is: A first conduit section constructed and positioned to cover the area of ​​the patient's head above the base of the ear when in use; and A tie that is placed on the posterior part of the occipital bone of the patient's head or covers the posterior part of the occipital bone of the patient's head when in use. Includes, The first conduit is configured to conduct at least a portion of the airflow respiration by the patient, The first conduit section is configured to be taut when in use. The first conduit section includes a positioning and stabilizing structure with a longitudinal adjustment mechanism. [Section 93] It is a patient interface: A plenum chamber capable of pressurizing to a therapeutic pressure of at least 4 cmH2O, exceeding the ambient air pressure, wherein the plenum chamber includes a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's respiration; A seal-forming structure constructed and positioned to form a seal over the patient's facial region surrounding the entrance to the patient's airway, thereby ensuring that airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use; A positioning and stabilizing structure that provides elasticity to hold a seal-forming structure in a therapeutically effective position on the patient's head in order to deliver the aforementioned therapeutic pressure in a sealed airflow, wherein the positioning and stabilizing structure is: A tie, wherein at least a portion of the tie is constructed and positioned to cover a region of the patient's head above the base of the ears of the patient's head when in use, and the tie includes a length-adjustable gas delivery tube for delivering the airflow through the seal-forming structure to the entrance of the patient's airway, the gas delivery tube being configured to contact a portion of the patient's head when in use; and A biasing mechanism that applies biasing force to the length-adjustable gas delivery tube in order to propel the seal-forming structure towards the entrance of the patient's airway during use. A positioning and stabilization structure, A patient interface, including... [Section 94] The patient interface according to paragraph 93, wherein the gas delivery tube, whose length is adjustable, includes an extendable portion. [Section 95] The patient interface according to paragraph 94, wherein the extendable portion is configured to avoid contact with the patient's face during use. [Section 96] The patient interface according to paragraph 95, wherein the extendable portion is configured to be positioned above the point of the base of the ear on the patient's head when in use. [Section 97] The stretchable portion includes a bellows structure, as described in any one of paragraphs 94 to 96. [Section 98] The patient interface according to paragraph 97, wherein the bellows structure includes one or more elastic portions, the one or more elastic portions being configured to expand or contract to allow adjustment of the length of the gas delivery tube during use. [Section 99] The patient interface according to paragraph 97 or 98, wherein the bellows structure includes one or more elastic portions, the one or more elastic portions being configured to retract to impart the biasing force onto the length-adjustable gas delivery tube. [Section 100] The patient interface according to any one of claims 93 to 99, wherein the length-adjustable gas delivery tube further includes a flexible portion for allowing the position of the length-adjustable gas delivery tube on the patient's head during use. [Section 101] The patient interface according to paragraph 100, wherein the flexible portion is configured such that it is positioned above the base of the ear on the patient's head when in use. [Section 102] The patient interface according to paragraph 101, wherein the flexible portion is configured to release the position adjustment of the length-adjustable gas delivery tube from the movement of the seal-forming structure away from the patient's face during use. [Section 103] The patient interface according to any one of paragraphs 100 to 102, wherein the flexible portion includes one or more elastic portions. [Section 104] A positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on the patient's head, wherein the seal-forming structure is constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway in order to deliver airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's entire respiratory cycle during use, and the positioning and stabilizing structure is: A tie, wherein at least a portion of the tie is constructed and positioned to cover a region of the patient's head above the base of the ears of the patient's head when in use, and the tie includes a length-adjustable gas delivery tube for delivering the airflow through the seal-forming structure to the entrance of the patient's airway, the gas delivery tube being configured to contact a portion of the patient's head when in use; and A biasing mechanism that applies biasing force to the length-adjustable gas delivery tube in order to propel the seal-forming structure towards the entrance of the patient's airway during use. A positioning and stabilization structure, including a positioning and stabilization structure. [Explanation of Symbols]

[0462] 1000 patients 1100 Bedmate 3000 Patient Interfaces 3100 Sealing or seal-forming structure 3150 Cushion Assembly 3170 Nasal seal forming structure 3180 Mouth seal forming structure 3200 Plenum Chamber 3210 Plenum chamber edge 3300 Positioning and stabilization structure / headgear 3310 Headgear Strap 3320 Chin Strap 3330 Padded component 3340 Elastic Sleeve 3342 Side opening 3343 Upper opening 3345 tabs 3347 Curved Edge 3348 The side that comes into contact with the patient 3349 The side that does not come into contact with the patient 3350 Headgear Tube 3351 Upper pipe member 3352 Tube end 3353A Upper curved part 3353B Lower curved part 3354 Pipe section that cannot be stretched very much 3355 Extendable tubular section 3356 Fixing mechanism 3357 First fixing member 3358 Second fixing member 3360 Adjustment Mechanism 3362 Bellows tube section 3363 Non-adjustable headgear tube 3364 Folding part 3366 Pipe wall folding / rotating folding section 3368 Adjacent pipe section 3370 First pipe section 3371 First tab 3372 Second pipe section 3373 Second tab 3374 Rib 3375 Nested concentric tube section 3376 Ratchet Mechanism 3377 Visual Indicator 3378 buttons 3379 Hardening material 3380 First screw-type part 3382 Second screw-type part 3383 Pinion 3384 Ring component 3385 Replaceable tubing 3386 Replacement tube 3387 Pipe insertion member 3390 Strap 3391 Strap adjustment mechanism 3395 band 3397 Tongs 3398 Groove 3410 Loop insertion member 3411 Replacement loop insertion member 3420 Expandable loop insertion member 3600 connection ports 3744 ISO 4000 RPT devices 4010 External Housing 4012 Upper part 4014 parts 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4100 Pneumatic Components 4110 Air Filter 4112 Inlet air filter 4114 Outlet air filter 4122 Entrance muffler 4124 Exhaust muffler 4140 Pressure Generator 4142 Controllable Blower 4144 Air Circuit 4200 Electrical components 4202 Printed Circuit Board Assembly (PCBA) 4210 Power supply 4220 Input Devices 4230 Central Controller 4240 Therapeutic Device Controller 4250 protection circuit 4260 memory 4270 Converter 4272 Pressure Sensor 4274 Flow Sensor 4280 Data communication interface 4290 Output Device 4300 Algorithms 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Humidifier Reservoir 5130 Humidifier Reservoir Dock 5240 heating element 6000 Force Extension Plot 6100 Extension axis 6105 Zero Extension 6110 First elongation 6120 Second amount of elongation 6200 force axis 6210 Minimum sealing force 6220 Maximum Comfort 6300 Force extension characteristics

Claims

1. A positioning and stabilizing structure configured to hold a patient interface cushion assembly in a therapeutically effective position on the patient's head in order to seal and deliver airflow at a therapeutic pressure of at least 4 cmH₂O relative to ambient air pressure throughout the patient's entire respiratory cycle during use, Two gas delivery tubes, each of which is connected at a first end to a corresponding inlet port of the cushion assembly to deliver the airflow to the inlet of the patient's airway via the cushion assembly, each of which is configured to be positioned on a corresponding side of the patient's head when in use, each of which is constructed and positioned to be in contact with at least one area of ​​the patient's head above the base of the ears when in use, each of which has a tab that protrudes substantially backward relative to the patient's head when in use, the tab having a hole, A connection port configured to fluidly connect the two gas delivery tubes to an air circuit when in use in order to deliver the airflow to the patient's airway, wherein the connection port is configured to be positioned above the patient's head when in use, A sleeve made of an elastic material that at least partially covers each of the two gas delivery tubes, the sleeve having a pair of side holes, and each tab of the gas delivery tube extending through the corresponding side hole, A positioning and stabilization structure comprising:

2. The positioning and stabilization structure according to claim 1, characterized in that the elastic material is an elastic fabric.

3. The elbow further comprises a first end rotatably connected to the positioning and stabilizing structure at the connection port and a second end having a swivel configured to be connected to the air circuit, The positioning and stabilization structure according to claim 1 or 2, characterized in that the elbow is rotatable 360 ​​degrees around the connection port, the swivel is rotatable 360 ​​degrees around the second end of the elbow, and the elbow is configured to direct the airflow from the air circuit through the connection port to the gas delivery pipe.

4. The positioning and stabilizing structure according to claim 3, wherein the sleeve has a central hole, and the connection port is exposed through the central hole so that the first end of the elbow can be rotatably connected to the positioning and stabilizing structure at the connection port.

5. The positioning and stabilization structure according to any one of claims 1 to 4, characterized in that each of the two gas delivery tubes is configured to extend over the corresponding cheek area of ​​the patient when in use.

6. The positioning and stabilization structure according to any one of claims 1 to 5, characterized in that each of the two gas delivery tubes is configured to extend between the corresponding eye and ear of the patient when in use.

7. The positioning and stabilizing structure according to any one of claims 1 to 6, wherein each of the gas delivery tubes is provided with a bellows section, and the bellows section has greater flexibility than the adjacent portion of the gas delivery tube.

8. The positioning and stabilization structure according to claim 7, characterized in that each of the two gas delivery tubes is varied in width and diameter along the length of each bellows section.

9. The positioning and stabilization structure according to claim 7 or 8, characterized in that each of the two gas delivery tubes is tapered along the length of each bellows such that the width and diameter of each of the two gas delivery tubes at one end of the bellows are smaller than the width and diameter of each of the two gas delivery tubes at the other end of the bellows.

10. The positioning and stabilization structure according to any one of claims 7 to 9, characterized in that each bellows section is located between the corresponding tab of the gas delivery tube and the connection port.

11. The positioning and stabilizing structure according to any one of claims 7 to 10, characterized in that the sleeve covers each bellows section.

12. The positioning and stabilizing structure according to any one of claims 7 to 11, characterized in that each bellows section is positioned on the corresponding side of the gas delivery tube so as to be separated from the patient's face during use.

13. The positioning and stabilizing structure according to any one of claims 7 to 12, characterized in that each bellows section is positioned toward the corresponding side of the gas delivery tube so as to be separated from the corresponding cheek of the patient during use.

14. The positioning and stabilization structure according to any one of claims 1 to 13, characterized in that each of the two gas delivery tubes is made of a relatively flexible material.

15. The positioning and stabilizing structure according to claim 14, characterized in that the relatively flexible material is silicone.

16. The positioning and stabilization structure according to any one of claims 1 to 15, characterized in that the sleeve is made of a single sheet of elastic material.

17. The positioning and stabilization structure according to any one of claims 1 to 16, characterized in that the sleeve is composed of a plurality of elastic material sheets connected together.

18. The positioning and stabilization structure according to any one of claims 1 to 17, further comprising an adjustable rear strap, the end of which is configured to pass through the hole of the tab so as to removably connect the adjustable rear strap to the gas delivery tube, and which is configured to pass around the posterior portion of the patient's head when in use.

19. The positioning and stabilizing structure according to claim 18, characterized in that the length-adjustable rear strap is configured to rest on the posterior part of the occipital bone of the patient's head or to cover the posterior part of the occipital bone of the patient's head when in use.

20. The positioning and stabilizing structure according to claim 19, further comprising a length-adjustable lower strap configured to pass behind the patient's head and below the patient's ears so as to be indirectly connected to the cushion assembly.

21. The positioning and stabilization structure according to claim 20, characterized in that the length-adjustable lower strap is not connected to the two gas delivery tubes.

22. The positioning and stabilizing structure according to any one of claims 18 to 21, wherein the length-adjustable rear strap comprises a loop material and a hook material portion, the loop material and the hook material portion are configured to removably connect the length-adjustable rear strap to the tab.

23. A patient interface for sealing and delivering airflow at a therapeutic pressure of at least 4 cmH₂O relative to ambient air pressure throughout the patient's entire respiratory cycle during use, wherein the patient interface comprises: A cushion assembly, A plenum chamber pressurized to the aforementioned therapeutic pressure, comprising a pair of plenum chamber inlet ports, each of which is sized and configured to receive the airflow of the therapeutic pressure for the patient to breathe, A nasal seal forming structure configured to contact and form a seal with the patient's face and around the patient's nose during use, having a nasal opening configured to deliver the airflow of the therapeutic pressure to the patient's nostrils during use, and being joined to the plenum chamber, A cushion assembly comprising, A positioning and stabilization structure according to any one of claims 1 to 22, A patient interface equipped with this feature.

24. The patient interface according to claim 23, wherein the plenum chamber comprises a plurality of vents having a size and shape such that the therapeutic pressure is maintained within the plenum chamber, and the vents are configured to allow the discharge of exhaled gas from within the plenum chamber to the surroundings.

25. The patient interface according to claim 23, wherein the cushion assembly comprises a plurality of vents sized and shaped to maintain the therapeutic pressure within the plenum chamber, and configured to allow the discharge of exhaled gas from within the plenum chamber to the surroundings.

26. The patient interface according to any one of claims 23 to 25, characterized in that the nasal seal forming structure is made of silicone.

27. ​​The patient interface according to any one of claims 23 to 26, characterized in that the plenum chamber comprises a shell.

28. The patient interface according to any one of claims 23 to 27, wherein the cushion assembly is a mouth seal forming structure configured to seal around the patient's mouth when in use, and further comprises a mouth seal forming structure having a mouth opening configured to deliver the airflow of the therapeutic pressure to the patient's mouth when in use, the mouth seal forming structure being joined to the plenum chamber.

29. The patient interface according to claim 28, characterized in that the mouth seal forming structure is made of silicone.

30. The patient interface according to claim 28 or 29, characterized in that the nasal seal forming structure and the mouth seal forming structure are formed integrally.

31. The patient interface according to claim 28 or 29, characterized in that the nasal seal forming structure and the mouth seal forming structure are detachably attached.

32. The patient interface according to any one of claims 28 to 31, further comprising an asphyxiation prevention valve configured to allow the patient to breathe from the surroundings in the absence of the airflow of the therapeutic pressure.

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