Adjustable head gear tubing for patient interface

Abstract

To provide a medical device for diagnosis, improvement, treatment, or prevention of a respiratory disturbance, having one or more of improved comfort, cost, effectiveness, usability, and manufacturability.SOLUTION: An aspect of the present technology includes a positioning and stabilizing structure for holding a seal formation structure at a therapeutically effective position of the head of a patient. The seal formation structure forms a seal with the face of the patient to seal and deliver an air flow at a therapeutic pressure higher than an ambient air pressure at least by 4 cmH2O in an entire respiratory cycle of the patient when in use. The positioning and stabilizing structure includes a front hoop arranged to come in contact with an area above the upper ear bottom point of the head of the patient when in use, and a rear strap. The positioning and stabilizing structure includes an adjustment mechanism for adjusting the front hoop and the rear strap relative to the head of the patient. The adjustment mechanism is arranged by a single operation for adjusting both the front hoop and the rear strap, and fitting the positioning and the stabilizing structure to the head of different sizes.SELECTED DRAWING: Figure 25A

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims the benefit of Australian Provisional Patent Application No. 2020900503 (filing date: February 21, 2020) and Australian Provisional Patent Application No. 2019904513 (filing date: November 29, 2019). The entire contents of both of these documents are incorporated herein by reference in their entirety.

[0002] 2 Statement regarding federally - supported research or development Not applicable

[0003] 3 Name of the group for collaborative research and development Not applicable

[0004] 4 Sequence listing Not applicable

Background Art

[0005] 5 Background of the technology 5.1 Field of the technology

[0006] This technology relates to one or more of the detection, diagnosis, treatment, prevention, and improvement of respiratory - related disorders. This technology also relates to medical devices or apparatuses and their use.

[0007] A particular form of this technology relates to patient interfaces used in respiratory therapy, prevention, and improvement of respiratory - related disorders.

[0008] 5.2 Description of related technologies 5.2.1 The human respiratory system and its disorders The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0009] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they proceed deeper into the lungs. The primary function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi make up the conducting airways and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See, e.g., "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2011.

[0010] There are a range of respiratory disorders. Certain disorders can be characterized by specific events (e.g., apnea, hypopnea, and hyperventilation).

[0011] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events such as closure or obstruction of the upper airway during sleep. It is caused by an abnormally small upper airway during sleep and a normal deficit in muscle tone in the tongue region, in combination with the soft palate and posterior oropharyngeal wall. Due to such conditions, the breathing pauses of affected patients typically last from 30 to 120 seconds and sometimes occur 200 to 300 times a night. As a result, excessive daytime sleepiness occurs and can cause cardiovascular disease and brain damage. This syndrome is a common disorder, particularly prevalent in middle-aged overweight men, and patients are often asymptomatic. See U.S. Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of the patient's respiratory controller, in which alternating periods of increasing and decreasing ventilation, known as the CSR cycle, occur periodically. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to the repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repeated sleep arousals that cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory insufficiency is a general term for breathing disorders, referring to the inability of the lungs to take in sufficient oxygen or exhale sufficient CO2 to meet the patient's needs. Respiratory insufficiency can include some or all of the following disorders.

[0014] Patients with respiratory insufficiency (a type of respiratory disorder) may experience abnormal shortness of breath during exercise.

[0015] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other clear causes of hypoventilation. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

[0016] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. This includes an increase in resistance to air movement, prolongation of the expiratory phase of breathing, and a decrease in normal elasticity in the lungs. Examples of COPD are emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0017] Neuromuscular disorders (NMDs) are a broad term encompassing a number of diseases and conditions that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Among NMD patients, some are characterized by progressive muscle impairment, which ultimately leads to inability to walk, confinement to a wheelchair, difficulty swallowing, reduced respiratory muscle strength, and finally death due to respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Characteristics of rapidly progressive disorders: Muscle impairment that worsens over several months and leads to death within a few years (such as amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in the teens, etc.). (ii) Degenerative or slowly progressive disorders: Muscle impairment that worsens over several years but only mildly shortens life expectancy (such as limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). The symptoms of respiratory failure in NMDs are listed below: increased general debility, difficulty swallowing, dyspnea during exertion and at rest, fatigue, drowsiness, headache upon waking, and difficulty with concentration and mood changes.

[0018] Chest wall disorders are a group of thoracic deformities that cause ineffectiveness of the connection between the respiratory muscles and the thoracic cage. These disorders are mainly characterized by restrictive disorders and share the possibility of long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may develop severe respiratory failure. The symptoms of respiratory failure are listed below: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, headache upon waking, fatigue, reduced quality of sleep, and loss of appetite.

[0019] To treat or improve such conditions, a range of treatments are being used. Furthermore, in other respects, healthy individuals can also advantageously utilize preventive and therapeutic treatments for respiratory disorders. However, there are several deficiencies in these.

[0020] 5.2.2 Treatment Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue to move forward or backward against the posterior oropharyngeal wall, continuous positive airway pressure functions as an air pressure sprint, thereby preventing upper airway closure. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following about the device used to provide the treatment, the patient may choose not to comply with the treatment: discomfort, difficulty of use, high cost, lack of aesthetic appeal.

[0021] Non-invasive ventilation (NIV) provides ventilatory assistance to a patient through the upper airway and performs part or all of the respiratory function to provide respiratory assistance to the patient and / or maintain an appropriate oxygen level in the body. The ventilatory assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0022] Invasive ventilation (IV) provides ventilatory assistance to patients who are no longer able to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0023] 5.2.3 Treatment system These treatments can be provided by a treatment system or device. Such systems and devices can also be used for diagnosis without treating the condition.

[0024] A treatment system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, and a patient interface.

[0025] 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 the 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 treatment applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby facilitating gas delivery at a sufficient distributed pressure along with the ambient pressure for treatment execution (e.g., at a positive pressure about 10 cmH2O higher than the ambient pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas supply to the airway at a positive pressure about 10 cmH2O higher.

[0026] Certain other mask systems may be functionally inappropriate 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 ambient.

[0027] Certain masks may be clinically unfavorable in the present technology (e.g., when the mask blocks airflow through the nose and only allows airflow through the mouth).

[0028] In certain masks, it may be uncomfortable or impractical in the present technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal through the lips.

[0029] Certain masks may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on a pillow).

[0030] There are several challenges in the design of patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to the other bones of the skull. The entire head can move throughout the course of respiratory therapy.

[0031] Due to these challenges, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the following reasons: overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic administration mask can withstand their original uses, but in the case of such masks, they can be unacceptably uncomfortable for long-term (e.g., several hours) wear. Due to such discomfort, the patient's compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0032] CPAP therapy is extremely effective in the treatment of certain respiratory disorders when the patient is committed to the treatment. If the mask is uncomfortable or difficult to use, the patient may not commit to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which can affect the patient's compliance.

[0033] Masks designed for the treatment of sleep apnea may be suitable for other uses in some cases, as masks for other uses (e.g., pilots) may be unsuitable for use in the treatment of sleep apnea.

[0034] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0035] 5.2.3.1.1 Seal-forming portion The patient interface may include a seal-forming portion. Since the patient interface makes 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.

[0036] The patient interface may be partially characterized according to the design intent of the location where the seal-forming portion engages the face during use. In one form of the patient interface, the seal-forming portion may include two sub-portions that engage each left and right nostril. In one form of the patient interface, the seal-forming portion may include a single element that surrounds both nostrils during use. Such a single element may be designed, for example, to cover the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming portion may include an element that surrounds the oral region by forming a seal on, for example, the lower lip region of the face during use. In one form of the patient interface, the seal-forming portion may include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces may be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers. An oro-nasal mask may include a compact full-face mask without a forehead support. Alternatively, an oro-nasal mask may include a full-face mask that seals around the entrances of the nose and mouth, and the nasal seal includes a cradle that seals under the lateral nasal cartilage.

[0037] A seal-forming portion that may be effective in one region of the patient's face may be inappropriate in another region, for example, due to different shapes, structures, variabilities, and sensitive regions of the patient's face. For example, the seal of a swimming goggle placed on the patient's forehead may be inappropriate for use on the patient's nose.

[0038] A particular seal-forming portion can be designed for mass production so that one design is suitable for a wide range of different face shapes and sizes and is comfortable and effective. To form a seal, it is necessary to conform one or both of the patient's face shape and the seal-forming portion of the mass-produced patient interface to the extent of the mismatch between them.

[0039] One type of seal-forming portion extends around the perimeter of the patient interface and is intended to seal the patient's face when force is applied to the patient interface with the seal-forming portion engaged facing the patient's face. This seal-forming portion can include an air or fluid-filled cushion or can include a shaped or formed surface of an elastic seal element composed of an elastomer such as rubber. With this type of seal-forming portion, if the fit is inappropriate, a gap can occur between the seal-forming portion and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0040] Another type of seal-forming portion employs a thin flap seal positioned around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previously described type of seal-forming portion, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal or leakage may occur from the mask. Further, if the shape of the seal-forming portion does not conform to the patient's shape, creases or buckling may occur in the seal-forming portion during use, causing leakage.

[0041] Another type of seal-forming portion can include friction-fit elements inserted, for example, into the nostrils, but there are also patients who find these seal-forming portions uncomfortable.

[0042] Another form of seal-forming portion can use an adhesive portion to achieve a seal. There are also patients who always find it inconvenient to attach or remove the adhesive portion to their face.

[0043] Regarding the technology of the patient interface seal forming portion within a certain range, there is disclosure in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.

[0044] One form of nasal pillows can be found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.) assigned to Puritan - Bennett Corporation.

[0045] ResMed Limited manufactures the following products that employ 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. In the following patent applications assigned to ResMed Limited, there are descriptions of examples of nasal pillow masks: International Patent Application WO2004 / 073,778 (particularly describing the appearance of ResMed Limited's SWIFT® Nasal Pillow), U.S. Patent Application No. 2009 / 0044808 (particularly describing the appearance of ResMed Limited's SWIFT® LT Nasal Pillow); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (particularly describing the appearance of ResMed Limited's MIRAGE LIBERTY™ Full Face Mask); International Patent Application WO2009 / 052,560 (particularly describing the appearance of ResMed Limited's SWIFT® FX Nasal Pillow).

[0046] 5.2.3.1.2 Positioning and Stabilization The seal - forming portion of the patient interface used in positive - pressure air therapy is subject to the corresponding forces of air pressure that interfere with the seal. Therefore, various techniques are used to position the seal - forming portion and maintain the seal against the appropriate part of the face.

[0047] In one technique, an adhesive portion is used. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, when an adhesive portion is used, there may be discomfort.

[0048] In another technique, one or more straps and / or a stabilization harness are used. In the case of a number of such harnesses, one or more of the points such as poor fit, bulky, uncomfortable and difficult to handle apply. In the case of a design worn on a patient's head, such a harness may be referred to as a headgear.

[0049] 5.2.3.1.3 Conduit for pressurized air In one type of treatment system, a pressurized air flow is provided to a patient interface through a conduit in an air circuit. This conduit is fluidly connected to the patient interface such that when the patient interface is positioned on the patient's face during use, the conduit extends away from the patient's face in a forward direction from the patient interface. This may sometimes also be referred to as an "elephant trunk" type interface.

[0050] Some patients find such an interface obstructive, and as a result, if they stop wearing it, patient compliance decreases. Further, when the conduit is connected to the interface in front of the patient's face, it may be prone to entanglement with bedding.

[0051] 5.2.3.1.4 Conduit for pressurized air used for positioning / stabilizing a seal-forming structure In a patient interface included in another type of treatment system attempting to address these problems, a tube responsible for delivering pressurized air to the patient's airway also functions as part of a headgear for positioning and stably disposing the seal-forming portion of the patient interface to an appropriate portion of the patient's face. This type of patient interface may also be referred to as one employing "headgear tubing" or "tubing headgear". When using such a patient interface, a conduit in an air circuit providing a pressurized air flow from a respiratory pressure treatment 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 treatment system is disclosed in U.S. Patent Publication No. US2007 / 0246043. The content of this document is incorporated herein by reference for reference purposes. In this document, the conduit is connected to a tube in the patient interface through a port positioned above the upper part of the patient's head during use.

[0052] Philips' DreamWear (trademark) nasal mask includes such headgear tubing. One problem with this mask is that the length of the headgear tube cannot be adjusted. Therefore, the DreamWear (trademark) mask is supplied in different sizes to accommodate patients with different face sizes. However, in that case, it causes an increase in complexity and cost in the manufacture of the DreamWear (trademark) mask and an increase in packaging. Furthermore, when supplying masks of different sizes, the range within which patients with different head sizes can be accommodated (e.g., whether the patient's head size fits between the provided mask sizes or not) is limited.

[0053] When using a patient interface employing headgear tubing, several advantages can be obtained (e.g., avoiding a conduit connecting to the patient interface in front of the patient's face which may be obstructive and uncomfortable). However, a patient interface employing headgear tubing is desirably comfortable while forming an effective seal with the patient's face when the patient wears it for a long time while sleeping.

[0054] 5.2.3.2 Respiratory Pressure Therapy (RPT) Device Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical use have specific requirements that cannot be satisfied by more general air pressure generators (e.g., reliability requirements, size requirements, and weight requirements for medical devices). In addition, even devices designed for medical treatment may have deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0055] One known RPT device used for the treatment of sleep apnea is the S9 Sleep Therapy System (manufacturer: ResMed Limited). Another example of an RPT device is a ventilator. In the case of a ventilator (e.g., the ResMed Stellar™ series of adult and pediatric ventilators), it can provide assistance for invasive and non-invasive non-dependent ventilation for patients over a certain range for the treatment of multiple conditions (including, but not limited to, NMD, OHS, and COPD).

[0056] 5.2.3.3 Humidifier If the delivery of the air flow is carried out without humidification, it may lead to drying of the airway. When a humidifier is used together with an RPT device and a patient interface, humidified gas is generated, minimizing the drying of the nasal mucosa and increasing the comfort of the patient's airway. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort compared to cold air. Summary of the Invention Means for Solving the Problems

[0057] 6 Brief Description of the Technology The present technology relates to the provision of medical devices used in the diagnosis, improvement, treatment, or prevention of respiratory disorders, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0058] The first aspect of the present technology relates to an apparatus used for diagnosing, improving, treating, or preventing respiratory disorders.

[0059] One aspect of a particular form of the present technology is to provide a method and / or apparatus for improving patient compliance with respect to respiratory therapy.

[0060] One form of the present technology includes a patient interface for delivering a supply of pressurized breathable gas to the inlet of a patient's airway.

[0061] Another aspect of one form of the present 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 can be constructed and arranged to form a seal with the region of the patient's face surrounding the inlet to the patient's airway for delivering an airflow at a treatment pressure that is at least 4 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilization structure can include at least one gas delivery tube for delivering the airflow to the inlet of the patient's airway through the seal-forming structure.

[0062] Another aspect of one form of the present 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 can be constructed and arranged to form a seal with the region of the patient's face surrounding the entrance to the patient's airway to deliver an air flow at a therapeutic pressure that is at least 4 cmH2O higher than the ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilization structure can include at least one gas delivery tube for delivering an air flow through the seal-forming structure to the entrance of the patient's airway. The at least one gas delivery tube can be constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use. The positioning and stabilization structure can include an adjustment mechanism for adjusting the length of the at least one gas delivery tube to enable the positioning and stabilization structure to fit heads of different sizes. The positioning and stabilization structure can include a biasing mechanism. This biasing mechanism 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 towards the entrance of the patient's airway during use.

[0063] Another aspect of one form of the present technology includes a patient interface including a plenum chamber that can be pressurized up to a therapeutic pressure that is at least 4 cmH2O higher than the ambient air pressure. The plenum chamber can include a plenum chamber inlet port sized and structured to receive an air flow at the therapeutic pressure for respiration by the patient. The patient interface can be constructed and arranged to form a seal with the region of the patient's face surrounding the entrance to the patient's airway, thereby including a seal-forming structure through which an air flow is delivered to at least the entrance to the patient's nostrils at the therapeutic pressure. The seal-forming structure can be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. The patient interface can include a positioning and stabilization structure for holding the seal-forming structure in a therapeutically effective position on the patient's head.

[0064] Another aspect of one form of the present technology includes a patient interface including a plenum chamber that can be pressurized to a therapeutic pressure at least 4 cmH2O higher than the ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient. The patient interface is constructed and arranged to form a seal with a region of the patient's face that surrounds the entrance to the patient's airway, and thereby may include a seal-forming structure through which the air flow is delivered at least to the entrance to the patient's nostrils at the therapeutic pressure. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's breathing cycle during use. The patient interface may include a connection port that fluidly connects to an air circuit connected to the air flow during use. The connection port may be located in the vicinity of the upper, side, or rear of the patient's head during use. The patient interface may include a positioning and stabilization structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure may include at least one gas delivery tube for delivering the air flow through the seal-forming structure to the entrance of the patient's airway. The at least one gas delivery tube may be constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use. The positioning and stabilization structure may include an adjustment mechanism for adjusting the length of the at least one gas delivery tube to enable the positioning and stabilization structure to fit heads of different sizes. The positioning and stabilization structure may include a biasing mechanism. The biasing mechanism applies a biasing force for propelling the seal-forming structure towards the entrance of the patient's airway during use along at least a portion of the length of the at least one gas delivery tube.

[0065] Another aspect of one form of the present 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 arranged to form a seal with the region of the patient's face surrounding the entrance to the patient's airway to deliver airflow at a therapeutic pressure that is at least 4 cmH2O higher than the ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilization structure may include at least one tie. The at least one tie may be configured to contact the patient's head during use. The at least one tie may include at least one gas delivery tube for delivering airflow to the entrance of the patient's airway through the seal-forming structure. The at least one gas delivery tube may be constructed and arranged to cover at least the region of the patient's head above the superior auricular point of the patient's head during use. The positioning and stabilization structure may include an adjustment mechanism for adjustment of at least one tie to enable a positioning and stabilization structure for fitting different sized heads. The positioning and stabilization structure may be configured to be positioned such that the adjustment mechanism does not contact the patient's face during use.

[0066] Another aspect of one form of the present technology includes a patient interface that includes a plenum chamber that can be pressurized to a treatment pressure at least 4 cmH2O higher than ambient air pressure. The plenum chamber can include a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for breathing by the patient. The patient interface is constructed and arranged to form a seal with an area of the patient's face that surrounds the entrance to the patient's airway, and thereby can include a seal-forming structure through which an air flow is delivered at least to the entrance to the patient's nostrils at the treatment pressure. The seal-forming structure can be constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use. The patient interface can include a connection port that fluidly connects to an air circuit connected to the air flow during use. The connection port can be arranged in the vicinity of the upper, side, or rear of the patient's head during use. The patient interface can include a positioning and stabilization structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure can include at least one tie. The at least one tie can be configured to contact the patient's head during use. The at least one tie can include at least one gas delivery tube for delivering the air flow through the seal-forming structure to the entrance of the patient's airway. The at least one gas delivery tube can be constructed and arranged to cover at least an area of the patient's head above the upper ear base point of the patient's head during use. The positioning and stabilization structure can include an adjustment mechanism for adjusting at least one tie to enable a positioning and stabilization structure for fitting different sized heads. The positioning and stabilization structure can be configured to be positioned such that the adjustment mechanism does not contact the patient's face during use.

[0067] Another aspect of one form of the present technology includes a patient interface including a plenum chamber that can be pressurized to a therapeutic pressure at least 4 cmH2O higher than the ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and configured to receive an air flow at a therapeutic pressure for breathing by the patient. The patient interface is constructed and arranged to form a seal with a region of the patient's face that surrounds the inlet to the patient's airway, and thereby may include a seal-forming structure through which an air flow is delivered at least to the inlet to the patient's nostrils at the therapeutic pressure. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's breathing cycle during use. The patient interface may include a positioning and stabilization structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure may include a first tube portion constructed and arranged to cover a region of the patient's head above the upper ear base point of the patient's head during use. The positioning and stabilization structure may include a strap portion that is placed on or covers the rear portion of the 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 continuously flow from inside the plenum chamber to the surroundings. The ventilation structure is sized and shaped to maintain the therapeutic pressure within the plenum chamber during use. The first tube portion may be configured to conduct at least a portion of the air flow breathed by the patient. The first tube portion may be configured to be in a tensioned state during use. The first tube portion may include a lengthwise adjustment mechanism.

[0068] Another aspect of one form of the present technology includes a positioning and stabilization structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure may be constructed and arranged to form a seal with the area of the patient's face surrounding the patient's airway inlet to deliver air flow at a therapeutic pressure that is at least 4 cmH2O higher than the ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilization structure may include a first conduit portion constructed and arranged to cover an area of the patient's head above the upper ear base point of the patient's head during use. The positioning and stabilization structure may include a strap portion that is placed on or covers the posterior portion of the occipital bone of the patient's head during use. The first conduit portion may be configured to conduct at least a portion of the air flow breathed by the patient. The first conduit portion may be configured to be in a tensioned state during use. The first conduit portion may include a length adjustment mechanism.

[0069] Another aspect of one form of the present technology includes a patient interface including a plenum chamber that can be pressurized to a therapeutic pressure at least 4 cmH2O higher than ambient air pressure. The plenum chamber can include a plenum chamber inlet port sized and structured to receive an air flow at the therapeutic pressure for respiration by the patient. The patient interface is constructed and arranged to form a seal with the area of the patient's face surrounding the entrance to the patient's airway, and thereby can include a seal-forming structure through which the air flow is delivered at least to the entrance to the patient's nostrils at the therapeutic pressure. The seal-forming structure can be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. The patient interface can include a positioning and stabilization structure that provides elasticity to hold the seal-forming structure in a therapeutically effective position on the patient's head for delivering the air flow in a sealed manner at the therapeutic pressure. The positioning and stabilization structure can include a strap. The strap can be constructed and arranged such that at least a portion of the strap covers an area of the patient's head above the upper ear base point of the patient's head during use. The strap can include a gas delivery tube with an adjustable length for delivering the air flow through the seal-forming structure to the entrance of the patient's airway. The gas delivery tube can be configured to contact a portion of the patient's head during use. The positioning and stabilization structure can include a biasing mechanism. This biasing mechanism adds a biasing force to the gas delivery tube with an adjustable length to propel the seal-forming structure towards the entrance of the patient's airway during use.

[0070] Another aspect of one form of the present 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 arranged to form a seal with an area of the patient's face that surrounds an inlet to the patient's airway to deliver an airflow at a therapeutic pressure that is at least 4 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilization structure may include a strap. The strap may be constructed and arranged such that at least a portion of the strap covers an area of the patient's head above the upper ear base point of the patient's head during use. The strap may include an adjustable-length gas delivery tube for delivering an airflow through the seal-forming structure to the inlet 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 adds a biasing force to the adjustable-length gas delivery tube to propel the seal-forming structure towards the inlet of the patient's airway during use.

[0071] Another aspect of one form of the present technology includes an inflatable positioning and stabilization structure that maintains a seal at the inlet of the patient's airway formed by a seal-forming structure of a patient interface for delivering an airflow continuously at a positive pressure relative to ambient air pressure, and maintains a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during the patient's sleep during use, and is configured to improve sleep disordered breathing. The positioning and stabilization structure may include at least one gas delivery tube for delivering an airflow through the seal-forming structure to the inlet of the patient's airway. The positioning and stabilization structure may also include an adjustment mechanism for enabling adjustment of the dimensions of the positioning and stabilization structure. The positioning and stabilization structure may also include a biasing mechanism that applies a biasing force to the adjustment mechanism to propel the seal-forming structure towards the inlet of the patient's airway.

[0072] Another aspect of one form of the present technology includes a patient interface for delivering a supply of pressurized air to the inlet of a patient's airway at a continuous positive pressure relative to ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than ambient air pressure throughout the patient's breathing cycle during sleep when in use, such that sleep disordered breathing is improved. The patient interface may include a connection port that is in fluid connection with an air circuit connected to a supply of pressurized air when in use. The connection port is positioned adjacent to the upper, side, or rear of the patient's head when in use. The patient interface may also include a seal-forming structure that seals an area surrounding the inlet to the patient's airway. The patient interface may also include an inflatable positioning and stabilization structure for maintaining a seal formed by the seal-forming structure. The positioning and stabilization structure may include at least one gas delivery tube for delivering air flow through the seal-forming structure to the inlet of the patient's airway.

[0073] Another aspect of a related form of the present technology includes a patient interface. This patient interface includes a positioning and stabilization structure that includes an adjustment mechanism for enabling adjustment of the dimensions of the positioning and stabilization structure.

[0074] Another aspect of a related form of the present technology includes a patient interface. This patient interface includes a biasing mechanism for applying a biasing force to the adjustment mechanism and for propelling the seal-forming structure toward the inlet of the patient's airway.

[0075] Another aspect of one form of the present technology includes an inflatable positioning and stabilization structure, which maintains a seal at the entrance of the patient's airway formed by a seal-forming structure of a patient interface for continuously delivering an air flow in a positive pressure relative to the ambient air pressure, and maintains a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure throughout the patient's breathing cycle during sleep in use, and is configured to improve sleep disordered breathing. The positioning and stabilization structure may include at least one gas delivery tube for delivering the air flow to the entrance of the patient's airway through the seal-forming structure. The positioning and stabilization structure may also include an adjustment mechanism for enabling adjustment of the dimensions of the positioning and stabilization structure. The positioning and stabilization structure may be configured such that the adjustment mechanism is positioned so as not to contact the patient's cheek region during use.

[0076] Another aspect of one form of the present technology includes a patient interface for continuously delivering a supply of pressurized air to the entrance of the patient's airway in a positive pressure relative to the ambient air pressure. This patient interface maintains a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure throughout the patient's breathing cycle during sleep in use, and is configured to improve 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 the air flow to the entrance of the patient's airway through the seal-forming structure. The positioning and stabilization structure may also include an adjustment mechanism for enabling adjustment of the dimensions of the positioning and stabilization structure. The positioning and stabilization structure may be configured such that the adjustment mechanism is positioned so as not to contact the patient's cheek region during use.

[0077] Another aspect of one form of the present technology includes a positioning and stabilization structure that holds the seal-forming structure in a therapeutically effective position on the patient's head, the seal-forming structure being constructed and arranged to form a seal with the region of the patient's face that surrounds the entrance to the patient's airway in order to deliver air flow at a therapeutic pressure that is at least 4 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilization structure may include a front hoop that extends across the patient's cheek region in use and is arranged to contact a region of the patient's head above the upper ear base point of the patient's head in use. The positioning and stabilization structure may also include a rear strap configured to surround the rear portion of the patient's head in use. The positioning and stabilization structure may also include an adjustment mechanism for adjustment relative to the patient's head of the front hoop and the rear strap. The adjustment mechanism may be arranged in a single operation that adjusts both the front hoop and the rear strap to fit the positioning and stabilization structure to heads of different sizes.

[0078] In some examples, the adjustment mechanism includes one or more tube insert members, the one or more tube insert members being configured to be selectively fluidly connected to the gas delivery tube to change the length of the gas delivery tube.

[0079] In some examples, a) two sections of the front hoop are connected by a link member; b) the adjustment mechanism is operable to adjust the length of the link member between the two hoop sections; c) by adjusting the length, both the front hoop and the rear strap are adjusted simultaneously; d) by adjusting the length of the link between the two sections of the front hoop, the effective length of the front hoop is adjusted by adjusting the allowable distance between the two sections of the front hoop; e) in response to the adjustment of the link length, a corresponding adjustment is made to the effective length of the rear strap; f) a part of the rear strap is formed by the link; g) the opposing end regions of the rear strap are connected to or adjacent to one of each of the two sections of the front hoop; h) the adjustment mechanism is selected from the group consisting of a rack and pinion, a tightening string, and a releasable mechanical connection; i) the adjustment mechanism is configured to enable adjustment of the link member; j) the adjustment mechanism enables adjustment of the link length through a continuous length range; and / or, k) the front hoop and / or the rear strap includes a link member.

[0080] In some examples, a) at least one gas delivery tube is provided for delivering an air flow to the inlet of a patient's airway through a seal-forming structure; b) the front hoop includes the lower portion of at least one gas delivery tube; c) the positioning and stabilization structure includes a disconnection mechanism, and the disconnection mechanism enables adjustment of the upper position of at least one gas delivery tube on the patient's head by disconnecting from the movement of the seal-forming structure away from the patient's face in the upper position adjustment of at least one gas delivery tube during use; d) the adjustment mechanism is disposed in front of the disconnection structure during use; e) the upper portion is bendable and includes a corrugated structure and / or a bellows structure to enable adjustment of the upper position of at least one tube on the patient's head during use; and / or, f) includes at least one swivel including a connection port configured to connect to an air circuit; g) at least one swivel is configured to enable relative rotation between the upper portion of at least one gas delivery tube and the air circuit connected to the connection port.

[0081] In some examples, a) the disconnection structure can be fluidly connected to an air circuit connected to the supply of pressurized air during use; b) the disconnection structure can be arranged in the vicinity of the upper, side or rear part of the patient's head during use; c) the two gas delivery tubes can be fluidly connected between the disconnection structure and the seal forming structure; d) the lower part of each gas delivery tube can extend across one of the patient's cheek regions during use; e) the two gas delivery tubes can be provided on different sides of the patient's head; f) the lower parts of the two gas delivery tubes at least partially form part of the front hoop; g) each lower part of the gas delivery tube respectively includes one of two sections of the front hoop; h) the disconnection structure is arranged on the upper part of the patient's head during use; i) during use, the adjustment mechanism is arranged on the upper part of the patient's head adjacent to the disconnection structure; and / or, j) the disconnection structure is in a y-shaped or v-shaped configuration.

[0082] In some examples, a) at least one swivel includes a first swivel and a second swivel configured to rotate relative to the first swivel; b) the first swivel rotates around a first axis, and the second swivel rotates around a second axis perpendicular to the first axis; c) the first swivel is rotatable independently of the second swivel; and / or, d) at least one swivel rotates around a swivel axis, and the swivel axis is oriented substantially parallel to the axis along the bendable portion.

[0083] In some examples, a) the adjustment mechanism employs one or more cables connected to both the hoop and the rear strap, and a controller that translates the one or more cables to induce adjustment of the hoop and the rear strap; b) the controller includes a rotatable dial; c) the adjustment mechanism includes a plurality of cables, and the translation speed of the plurality of cables is uniform; and / or, d) the adjustment mechanism includes a plurality of cables, and the translation speed of the plurality of cables is non-uniform.

[0084] In some forms, a) one or more cables are formed as lacing threads passed through the front hoop and / or the rear strap; b) the adjustment mechanism includes a release button configured to be engaged by the user for adjusting the length of the lacing thread; c) the lacing thread is passed through an opening; d) the release button is configured to change the diameter of the opening from a small diameter to a large diameter; e) the opening is configured to engage the lacing thread at a small diameter and provide frictional force to the lacing thread; f) the adjustment mechanism is controlled by a control unit; g) the control unit is directly operated by at least one button; and / or h) the control unit is indirectly operated by a remote device.

[0085] In some examples, a) during use, the adjustment mechanism is positioned above the upper ear root point of the patient's head; and / or b) the angle of the rear strap relative to the front hoop is adjustable under the operation of the adjustment mechanism.

[0086] Another aspect of one form of the present technology includes a positioning and stabilization structure that holds a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face that surrounds the entrance to the patient's airway so as to deliver air flow at a treatment pressure that is at least 4 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilization structure may include a front hoop that extends across the patient's cheek region in use and is arranged to contact a region of the patient's head above the upper ear base point of the patient's head in use. The front hoop may include lower portions of two gas delivery tubes fluidly connected to the seal-forming structure. Each lower portion of the gas delivery tube may extend across one of the patient's cheek regions in use, and the two gas delivery tubes may be provided on different sides of the patient's head. The front hoop may also include links that connect the two gas delivery tubes between the lower and upper portions of the two gas delivery tubes. The positioning and stabilization structure may also include a rear strap configured to surround the rear of the patient's head in use. The positioning and stabilization structure may also include a disconnect mechanism that enables adjustment of the position of the upper portion of the gas delivery tube on the patient's head by decoupling the adjustment of the position of the upper portion of the gas delivery tube from movement away from the patient's face of the seal-forming structure during use.

[0087] In some examples, a) the upper portion is bendable and includes a corrugated structure and / or a bellows structure on the upper portion to enable adjustment of the position of the upper portions of the two gas delivery tubes on the patient's head during use; b) at least one swivel includes a connection port for connection to an air circuit; c) at least one swivel is configured to enable relative rotation between the upper portion and the air circuit; d) the upper portion is positioned above the upper ear base point of the patient's head during use; d) the disconnect structure is in a Y-shaped or V-shaped configuration; and / or, e) the chin strap extends across the patient's cheek region in use and is arranged to contact a region of the patient's head below the lower ear base point of the patient's head in use.

[0088] In some examples, a) at least one swivel includes a first swivel and a second swivel configured to rotate relative to the first swivel; b) the first swivel rotates about a first axis, and the second swivel rotates about a second axis perpendicular to the first axis; c) the first swivel is rotatable independently of the second swivel; d) the disconnect structure includes a pipe connector connected to two gas delivery pipes branching from the pipe connector; e) the first swivel is directly connected to the pipe connector; f) the pipe connector is non-rotatable relative to the two gas delivery pipes; g) the first swivel is rotatable relative to the pipe connector; and / or h) at least one swivel rotates about a swivel axis, and the swivel axis is oriented substantially parallel to an axis along the upper part.

[0089] In some examples, a) an adjustment mechanism is provided for adjusting the front hoop and rear strap relative to the patient's head; b) the adjustment mechanism is arranged in a single operation that adjusts both the front hoop and rear strap to fit positioning and stabilization structures to heads of different sizes; c) the adjustment mechanism is operable to adjust the length of the link member between the lower parts; and / or d) by adjusting the length, both the front hoop and rear strap are adjusted simultaneously.

[0090] Another aspect of one form of the present technology is a plenum chamber capable of being pressurized to a treatment pressure at least 4 cmH2O higher than ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for breathing by a patient, and including a patient interface including the plenum chamber. The patient interface is constructed and arranged to form a seal with a region of the patient's face that surrounds an entrance to the patient's airway, whereby the seal-forming structure may include an air flow being delivered at least to an entrance to the patient's nostrils at the treatment pressure. The seal-forming structure may be constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use. The patient interface may also include a connection port fluidly connecting to an air circuit connected to the air flow during use. The connection port may be arranged in the vicinity of the upper, side or rear of the patient's head during use. The patient interface may also include a positioning and stabilization structure. The positioning and stabilization structure may include a front hoop extending across the patient's cheek region and arranged to contact a region of the patient's head above the upper ear base point of the patient's head during use. The positioning and stabilization structure may also include a rear strap configured to surround the rear of the patient's head during use. The positioning and stabilization structure may also include an adjustment mechanism for adjustment relative to the patient's head of the front hoop and the rear strap. The adjustment mechanism may be arranged in a single operation to adjust both the front hoop and the rear strap to fit the positioning and stabilization structure to heads of different sizes.

[0091] Another aspect of one form of the present technology includes a patient interface that includes a plenum chamber that can be pressurized to a therapeutic pressure at least 4 cmH2O higher than the ambient air pressure. The plenum chamber can include a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient. The patient interface is constructed and arranged to form a seal with the area of the patient's face that surrounds the entrance to the patient's airway, and thereby can also include a seal-forming structure through which the air flow is delivered at least to the entrance to the patient's nostrils at the therapeutic pressure. The seal-forming structure can be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's breathing cycle during use. The front hoop extends across the patient's cheek region during use and is arranged to contact an area of the patient's head above the upper ear base point of the patient's head during use. The front hoop can include the lower portions of two gas delivery tubes fluidly connected to the seal-forming structure. Each lower portion of the gas delivery tube can extend across one of the patient's cheek regions during use. The two gas delivery tubes can be provided on different sides of the patient's head. The front hoop can also include a link that connects the two gas delivery tubes between the lower and upper portions of the two gas delivery tubes. The patient interface can also include a rear strap configured to surround the rear of the patient's head during use. The patient interface can also include a disconnect mechanism that enables adjustment of the position of the upper portion of the gas delivery tube on the patient's head by disconnecting the adjustment of the position of the upper portion of the gas delivery tube from the movement of the seal-forming structure away from the patient's face during use.

[0092] In some examples, a system for treating a respiratory disorder includes a patient interface of either of the two aspects, an air circuit, and an air source at positive pressure relative to the ambient air pressure.

[0093] Another aspect of one form of the present technology includes a positioning and stabilization structure that holds a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face that surrounds an entrance to the patient's airway for delivering an airflow at a treatment pressure that is at least 4 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilization structure may include at least one hoop that extends across the patient's cheek region in use and is arranged to contact an area of the patient's head above the upper ear base point of the patient's head in use. The at least one hoop may include at least one gas delivery tube for delivering an airflow through the seal-forming structure to the entrance of the patient's airway. The at least one gas delivery tube is constructed and arranged to cover at least an area of the patient's head above the upper ear base point of the patient's head in use. The positioning and stabilization structure may also include an adjustment mechanism for fitting the positioning and stabilization structure to heads of different sizes by adjusting the at least one hoop. The adjustment mechanism includes one or more tube insert members, the one or more tube insert members being configured to be selectively fluidly connected to the gas delivery tube to change the length of the gas delivery tube.

[0094] Another aspect of one form of the present technology includes a positioning and stabilization structure that holds a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face that surrounds the entrance to the patient's airway for delivering an air flow at a therapeutic pressure that is at least 4 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilization structure may include at least one hoop that extends across the patient's cheek region in use and is arranged to contact an area of the patient's head above the superior tragus of the patient's head in use. The at least one hoop may include at least one gas delivery tube for delivering an air flow through the seal-forming structure to the entrance of the patient's airway. The at least one gas delivery tube is constructed and arranged to cover at least an area of the patient's head above the superior tragus of the patient's head in use. The positioning and stabilization structure may also include an adjustment mechanism for fitting the positioning and stabilization structure to heads of different sizes by adjusting the at least one hoop. The adjustment mechanism may include an extendable section of the gas delivery tube and one or more insert members configured to be selectively connected to the gas delivery tube to change the length of the extendable section of the gas delivery tube.

[0095] Another aspect of one form of the present technology includes a positioning and stabilization structure that holds a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face that surrounds the entrance to the patient's airway for delivering an airflow at a therapeutic pressure that is at least 4 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilization structure may include at least one hoop that extends across the patient's cheek region in use and is arranged to contact a region of the patient's head above the upper ear base point of the patient's head in use. The at least one hoop may include at least one gas delivery tube for delivering an airflow through the seal-forming structure to the entrance of the patient's airway. The at least one gas delivery tube is constructed and arranged to cover at least a region of the patient's head above the upper ear base point of the patient's head in use. The positioning and stabilization structure may include a rear strap configured to surround the rear portion of the patient's head in use. The positioning and stabilization structure may also include an adjustment mechanism for fitting the positioning and stabilization structure to heads of different sizes by adjusting at least one hoop. The adjustment mechanism includes one or more insert members, the one or more insert members being configured to be selectively connected to the gas delivery tube to change the length of the gas delivery tube. At least one of the inserts includes a connection portion that connects the rear strap to the gas delivery tube.

[0096] Another aspect of one form of the present technology includes a positioning and stabilization structure that holds a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face that surrounds the entrance to the patient's airway so as to deliver airflow at a therapeutic pressure that is at least 4 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilization structure may include at least one hoop that extends across the patient's cheek region in use and is arranged to contact a region of the patient's head above the upper ear base point of the patient's head in use. The at least one hoop may include at least one gas delivery tube for delivering airflow to the entrance of the patient's airway through the seal-forming structure. The at least one gas delivery tube is constructed and arranged to cover at least a region of the patient's head above the upper ear base point of the patient's head in use. The positioning and stabilization structure may include an adjustment mechanism for fitting the positioning and stabilization structure to heads of different sizes by adjustment of the at least one hoop. The adjustment mechanism may include one or more inflatable portions.

[0097] Another aspect of a particular form of the present technology is a system for the treatment of a respiratory disorder. The system includes a patient interface according to any one or more of the other aspects of the present technology, an air circuit, and an air source at positive pressure.

[0098] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complementary to the shape of the intended wearer.

[0099] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured to expose the patient's mouth in use.

[0100] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured such that a portion of the seal-forming structure does not enter the mouth in use.

[0101] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured such that the seal-forming structure does not extend into the interior of the patient's airway.

[0102] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured such that, in use, the seal-forming structure does not extend below the ala nasi ridge region.

[0103] Another aspect of a particular form of the present technology is a patient interface constructed and arranged to expose the patient's eyes in use.

[0104] Another aspect of a particular form of the present technology is a patient interface constructed and arranged to enable the patient to breathe ambient air in the event of a power failure.

[0105] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a seal-forming structure configured to form a seal on the underside of the patient's nose without contacting the nasal bridge region of the patient's nose.

[0106] Another aspect of a particular form of the present technology is a patient interface. This patient interface includes a vent and a plenum chamber. The patient interface is constructed and arranged such that gas from within the plenum chamber can move to the surroundings through the vent.

[0107] Another aspect of a particular form of the present technology is a patient interface constructed and arranged such that the patient can lie comfortably on their side or in a lateral sleeping position during use of the patient interface.

[0108] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a supine sleep position when using the patient interface.

[0109] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a prone sleep position when using the patient interface.

[0110] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or insight, or individuals with limited experience in using medical devices of this type.

[0111] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.One aspect of one form of the present technology is a humidifier tank that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0112] Of course, some of the above aspects may form sub-aspects of the present technology, and various one of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0113] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief description of the drawings]

[0114] 7 Brief description of the drawings The present technology is illustrated by way of example and not by way of limitation in the accompanying drawings in which like reference symbols include like elements: 7.1 Treatment System

[0115]

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DETAILED DESCRIPTION OF THE INVENTION

[0116] DETAILED DESCRIPTION OF EXAMPLE 8 TECHNOLOGY Before describing the technology in more detail, it should be understood that the technology is not limited to the specific examples that may be described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific examples described herein and are not limiting.

[0117] The following description is provided in relation to various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Additionally, any single feature or combination of features in any of these examples may constitute a further example.

[0118] 8.1 Treatment In one form as shown in FIG. 1A, the present technology includes a method for treating a respiratory disorder. The method includes the step of applying a positive pressure to the entrance of the airway of patient 1000.

[0119] 8.2 Treatment System In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 that supplies pressurized air to patient 1000 via an air circuit 4170 to a patient interface 3000. The treatment systems shown in FIGS. 1A, 1B, and 1C use different forms of patient interfaces 3000.

[0120] 8.3 Patient Interface Referring to FIG. 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 forms, the functional modes may be provided by one or more physical components. In some forms, one physical component may provide one or more functional modes.

[0121] The cushion assembly 3150 includes a seal-forming structure 3100 and a plenum chamber 3200. In use, the plenum chamber 3200 receives a positive-pressure air supply from the air circuit 4170, and the seal-forming structure 3100 is arranged to seal the area around the entrance to the patient's airway so as to facilitate a positive-pressure air supply to the airway.

[0122] 8.3.1 Seal-Forming Structure In one form of the present technology, the seal-forming structure 3100 provides a seal-forming surface and may further provide a cushion function.

[0123] The seal-forming structure 3100 according to the present technology may be composed of a soft, flexible, and elastic material (e.g., silicone).

[0124] The seal-forming structure 3100 can be non-invasive (i.e., it does not extend into the interior of the patient's airway). In some forms of the present technology, no part of the seal-forming structure 3100 enters the patient's mouth during use. In some forms of the present technology, the seal-forming structure 3100 is configured to leave the patient's mouth exposed during use. In some forms of the present technology, the seal-forming structure 3100 does not cover the patient's eyes during use.

[0125] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., from about 0.25 mm to about 0.45 mm). This member extends around the peripheral length of the plenum chamber 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use. During use, the sealing flange can act on its underside in easy response to the system pressure in the plenum chamber 3200 to form a tight sealing engagement with the surface.

[0126] In one form shown in FIG. 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 arranged to form a seal with each nostril of the patient's nose. The nasal pillow patient interface 3000 is also shown in FIG. 3A.

[0127] The nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a part of the frustum of the cone forms a seal on the lower side of the patient's nose, the handle portion, and a flexible region on the lower side of the frustum of the cone, and connects the frustum of the cone to the handle portion. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the handle portion. The flexible region may function to facilitate a freely jointed structure. The freely jointed structure accommodates the displacement and angle of the frustum of the cone and the relative movement between the structure to which the nasal pillow is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the handle portion is connected.

[0128] In one form, the non-invasive patient interface 3000 includes a seal-forming portion that forms a seal on the upper lip region (i.e., the upper lip), the nasal bridge region, and the cheek region of the patient's face during use. For example, the patient interface 3000 shown in FIG. 1B is the case here. This seal-forming portion delivers air supply or breathable gas to both nostrils of the patient 1000 through a single orifice. This type of seal-forming structure may also be referred to as a "nasal cushion" or a "nasal mask".

[0129] In another form, the seal-forming structure is configured to form a seal with the lower side of the nose and optionally the upper lip around the nostrils during use. This type of seal-forming structure may also be referred to as a "nasal cradle cushion" or a "sub-nasal mask". The shape of the seal-forming structure may be configured to conform to or closely follow the lower side of the patient's nose (i.e., the profile and angle of the seal-forming structure may be substantially parallel to the nasolabial angle of the patient). In one form of the nasal cradle cushion, the seal-forming structure includes a septum member that defines two orifices. Each of these two orifices supplies air or breathable gas to a different one of the patient's nostrils during use. The septum member may be configured to contact or seal the patient's nasal septum during use. In some forms of the present technology, the seal-forming structure 3100 is configured to form a seal with the lower side of the patient's nose without contacting the nasal bridge region of the patient's nose.

[0130] In one form, the non-invasive patient interface 3000 includes a seal-forming portion that forms a seal over the patient's jaw region, nasal bridge region, and cheek regions of the face. For example, the patient interface 3000 shown in FIG. 1C is such a case. This seal-forming portion delivers air supply or breathable gas through a single orifice to both nostrils and the mouth of the patient 1000. This type of seal-forming structure may also be referred to as a "full face mask".

[0131] In another form, 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 a nasal cradle cushion, and the oral seal-forming structure 3180 is configured to form a seal around the patient's mouth during use (this may also be referred to as an "oral cushion" or an "oral mask"). In such a mask, air or breathable substances are supplied to the patient's nostrils and the patient's mouth through separate orifices during use. This type of seal-forming structure 3100 may be referred to as an "oral-nasal mask". In one form, the nasal seal-forming structure 3170 and the oral seal-forming structure 3180 are integrally formed as a single component. This applies, for example, to the cushion assembly 3150 shown in FIGS. 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 reattached after being modularly removed. This enables the patient interface to be functionally converted from an oral-nasal mask to a nasal mask or a sub-nasal mask or vice versa as desired by the patient and / or the physician. This applies, for example, to the cushion assembly 3150 shown in FIGS. 4D and 4E.

[0132] In some forms of the present technology, the seal-forming structure 3100 is configured such that, in use, the seal-forming structure does not extend below the auricular eminence region of the patient's head.

[0133] Unless otherwise specified, embodiments of the patient interface according to the present technology may include any of the above types of seal-forming structures.

[0134] In certain forms of the present technology, the seal-forming structure 3100 is configured to correspond to a head and / or shape of a face of a particular size. For example, one form of the seal-forming structure 3100 is suitable for a large-sized head rather than a small-sized head. In another example, one form of the seal-forming structure 3100 is suitable for a small-sized head rather than a large-sized head.

[0135] 8.3.2 Plenum Chamber The plenum chamber 3200 receives pressurized breathable gas and is pressurized at a pressure above ambient pressure during use. In some forms of the present technology, the plenum chamber 3200 has a periphery 3210 shaped to be complementary to the surface contour of an average person's face in the region where the seal is formed during use. During use, the peripheral edge of the plenum chamber 3200 is positioned close to the adjacent surface of the face. The actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire periphery of the plenum chamber 3200 during use.

[0136] The plenum chamber 3200 may receive pressurized breathable gas through a plenum chamber inlet port sized and structured to receive gas from another part of the patient interface 3000.

[0137] 8.3.3 Positioning and Stabilization Structure The seal-forming structure 3100 of the patient interface 3000 of the present technology can be held in a sealed position by a positioning and stabilization structure 3300 during use. Since the positioning and stabilization structure 3300 engages the patient's head to hold it in the sealed position of the patient interface 3000, it can also be called a "headgear".

[0138] In one form of the present technology, a positioning and stabilization structure 3300 configured to be worn by a patient during sleep is provided. In one example, the positioning and stabilization structure 3300 has a low-profile or cross-sectional thickness to reduce the perceived or actual bulk of the device.

[0139] The positioning and stabilization structure 3300 may include at least one tie. A tie can be understood as a structure designed to resist tension. During use, the tie is a part of the positioning and stabilization structure 3300 that is under tension. Some ties add the elasticity resulting from this tension, as described above. The tie can function to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient's head. In a particular form of the present technology, the positioning and stabilization structure 3300 may include ties in the form of a headgear tube 3350 and / or headgear straps, as described below.

[0140] 8.3.3.1 Headgear Tubing In the form of the present technology shown in FIG. 3A, the positioning and stabilization structure 3300 includes at least one tube 3350 that delivers pressurized air received from a conduit forming part of the air circuit 4170 to the patient's airway from the RPT device through, for example, the plenum chamber 3200 and the seal forming structure 3100. These tubes 3350 are an integral part of the headgear 3300 of the patient interface 3000 for positioning and stably disposing the seal forming structure 3100 of the patient interface to an appropriate portion of the patient's face (e.g., the nose and / or mouth). As a result, it becomes possible to connect the conduit of the air circuit 4170 that provides the pressurized air flow to the connection port 3600 of the patient interface at a position other than in front of the patient's face, which may be obtrusive to some people. The headgear tubing may be as described in any one of the following patent applications: U.S. Patent Application No. 2019 / 0022343; U.S. Provisional Application No. 62 / 330,371; and U.S. Provisional Application No. 62 / 281,322. The entire content of the same is incorporated herein by reference for all purposes.

[0141] Since it is possible to accommodate and move air through the tube 3350 to deliver pressurized air from the air circuit 4170 to the patient's airway, the positioning and stabilization structure 3300 can be described as being inflatable. It is understood that the inflatable positioning and stabilization structure 3300 does not require all components of the positioning and stabilization structure 3300 to be inflatable.

[0142] In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 disposed adjacent to the upper, side, or rear of the patient's head. For example, in the form of the present technology shown in FIG. 3A, the connection port 3600 is disposed on the patient's head. In the case of a patient interface where the connection port 3600 is not positioned in front of the patient's face, it can be advantageous because there are patients who may find it obstructive and uncomfortable when a conduit is connected to the patient interface 3000 in front of the face. For example, a conduit connected to the patient interface 3000 in front of the face may easily become entangled with bedding or bed linen, especially when the conduit extends downward from the patient interface during use. According to a form of the present technology using a patient interface where the connection port 3600 is positioned adjacent to the upper part of the patient's head during use, the patient may be more easily or comfortably positioned when lying or sleeping in one or more of the following positions: a lateral or horizontal position, a supine position (i.e., a face-up position), and a prone position (i.e., a face-down prostrate position). Further, when the conduit is connected in front of the patient interface, it can also cause a problem known as tubing drag. That is, an undesirable pulling force may be generated on the patient interface 3000 from the conduit, resulting in detachment from the face (e.g., leakage between the seal-forming structure 3100 and the patient's face).

[0143] In the example of FIG. 3A, at least one tube 3350 extends between 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 covering the maxilla region of the patient's head during use and a portion of the tube 3350 covering the region of the patient's head above the upper ear base point on the patient's head). The tube 3350 may also contact the patient's face in front of the patient's ear so as to limit contact with the patient's ear.

[0144] In the form of the present technology shown in FIG. 3A, the positioning and stabilization 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 suprameatal point on the patient's head) through each cheek region to the connection port 3600 at the top of the patient's head. In this form of the technology, when the patient is lying on their side and one of the tubes is compressed such that the gas flow along that tube is blocked or partially blocked, the other tube remains open and can supply pressurized gas to the patient, which can be advantageous. In other embodiments of the technology, the patient interface may include a different number of tubes (e.g., one tube or three or more tubes). In an example where the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head (e.g., across one cheek region) during use, and the strap is positioned on the other side of the patient's head (e.g., across the other region) during use to form part of the positioning and stabilization structure 3300 and assist in securing the patient interface 3000 to the patient's head.

[0145] In the form of the present technology shown in FIG. 3A, these two tubes 3350 are fluidly connected to each other at their upper ends and are fluidly connected to the connection port 3600. In one embodiment, these two tubes are integrally formed. In other embodiments, these tubes are separate components and can be interconnected during use and disconnected, for example, during cleaning, storage, and / or replacement. When separate tubes are used, these tubes can be indirectly connected to each other. For example, they can be connected to a T-shaped conduit having two conduit arms each fluidly connectable to a respective tube 3350 and a third conduit arm or opening that functions as the connection port 3600 and is connectable to the air circuit 4170 during use.

[0146] These tubes 3350 can be formed of a semi-rigid material such as an elastomeric material (e.g., silicone). These tubes 3350 can have a natural pre-formed shape and can bend or move to take on another shape when a force is applied to the tube. For example, these tubes 3350 can generally take on an arcuate or curved shape that resembles the outer contour of the patient's head between the upper head and the nasal or oral region.

[0147] An exemplary form of the present technology shown in FIG. 3A has tubes 3350. These tubes 3350 curve rearwardly from the upper end of the tube 3350 that connects to the connection port 3600 on the upper head around the upper perimeter of the patient's head, in a state where there is no curvature in the sagittal plane, to the point where the rear headgear strap 3310 connects to the tube 3350. Between the point where the rear headgear strap 3310 connects to the tube 3350 and the lower end of the tube 3350 that connects to the cushion assembly 3150 in front of the patient's airway below the nose, the tube 3350 curves forwardly across the cheek region between the patient's ear and eye. The radius of curvature of this section of the tube 3350 can be in the range of approximately 60 mm to approximately 100 mm (e.g., approximately 70 mm to approximately 90 mm (e.g., 80 mm)). The lower end of the tube 3350 and the section of the tube 3350 (to which the rear headgear strap 3310 is connected) can be at an angle in the range of approximately 65° to approximately 90° (e.g., approximately 75° to approximately 80°).

[0148] In certain forms of the present technology, one or more portions of the tube 3350 can be hardened by one or more stiffening elements or supplementary stiffening elements. Examples of stiffening elements are given below: a section of the tube 3350 that is relatively thicker than other sections, a section of the tube 3350 formed from a material that is relatively higher in stiffness than the material forming other sections, and rigid members attached or embedded inside or outside a section of the tube. When such stiffening elements are used, it helps to control the positioning and functional mode of the positioning and stabilization structure 3300 during use (for example, when a force is applied to the tube 3350 and the tube 3350 is likely to deform, when a force is applied to the tube 3350 and the shape of the tube 3350 is likely to be maintained). By selecting where to position such stiffening elements within the tube 3350, it can help promote comfort when the patient interface 3000 is worn and can help maintain a good seal in the seal formation structure during use. The stiffening element or supplementary stiffening element can be disposed within the positioning and stabilization structure 3300. The positioning and stabilization structure 3300 is configured to support a relatively high-weight seal formation structure (for example, a full-face or nasal-oral cushion assembly).

[0149] The length of the tube 3350 in the form of the present technology shown in FIG. 3A is approximately 15 to approximately 30 cm (for example, approximately 20 to approximately 27 cm). In one embodiment, the length of the tube is approximately 25 cm. The length of the tube 3350 is selected to suit the dimensions of a typical patient's head (for example, when following a generally arcuate path that extends downward along the side of the head and over the patient's cheek region as shown in FIG. 3A, the upper end of the tube 3350 and the lower end of the tube 3350 are arranged in the vicinity of the opening to the patient's airway where it connects to the cushion assembly 3150, the distance between the vicinity of the upper part of the head (for example, covering the frontal bone and / or the parietal bone)). As described in more detail below, the patient interface 3000 is configured such that in some forms of the present technology, the length of the tube 3350 can be varied and the above length can be applied to a tube in a contracted, extended, or neutral state. It is understood that the length of the tube 3350 depends on the length of other components in the patient interface 3000 (for example, the arm length of the T-shaped conduit to which the upper end of the tube 3350 is connected).

[0150] The level of fitting the patient interface 3000 to an individual patient can be changed by varying 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 stabilization structure 3300 in the rearward or forward direction on the patient's head, the patient interface 3000 having a specific length of the tube 3350 can be adjusted to fit the patient better. Moving the positioning connection port 3600 further forward (i.e., in the forward direction) enables the patient interface 3000 having a specific length of the tube 3350 to fit a larger head than when the connection port 3600 is positioned further rearward (i.e., in the rearward direction).

[0151] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned within a certain range across the upper part of the patient's head, thereby enabling the patient interface 3000 to be positioned at a location suitable for the comfort or fit of an individual patient. As one way to achieve this such 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, there is a method of decoupling the movement of the upper part of the patient interface 3000 from the lower part of the patient interface 3000. Such decoupling can be achieved, for example, using a mechanism that allows components of the headgear tube 3350 to move or flex easily relative to other components of the patient interface 3000. Since the lower headgear portion can remain relatively stationary with respect to the patient's face (e.g., due to frictional force, non-elongation of materials, etc.), leakage between the seal-forming structure 3100 and the patient's face is substantially eliminated, and the upper headgear portion can move without affecting the position of the lower headgear portion. Such a mechanism will be described below.

[0152] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 is generally positioned at the upper point of the patient's head. The connection port 3600 can be positioned within the sagittal plane and can be aligned with the upper ear base point in a plane parallel to the coronal plane. The upper ear base point is shown in FIG. 2D. As described below, in some forms of the present technology, the headgear 3300 is configured to be worn at different positions, i.e., the connection port 3600 can be positioned adjacent to the upper part of the patient's head within the sagittal plane up to 20 mm forward or 20 mm backward from the upper ear base point.

[0153] The cross-sectional shape of the tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, as described, for example, in U.S. Patent No. 6,044,844, which is incorporated herein by reference for this purpose. The cross-sectional shape showing the flat surface of the tube on the side facing and contacting the patient's face or other part of the head can be worn more comfortably, for example, than in the case of a tube having a circular cross-section.

[0154] In some forms, the cross-sectional width and / or height of the tube 3350 can be in the range of approximately 8 mm to approximately 25 mm. In some forms, the cross-sectional width and / or height of the tube 3350 can be in the range of approximately 10 mm to approximately 20 mm. In some forms where the tube has a D-shaped cross-section, such as in the longitudinal cross-section of the headgear tubing 3350 shown in FIG. 3H, the width of the tube 3350 is approximately 15 to approximately 25 mm (e.g., approximately 20 mm), and the height is approximately 8 to approximately 15 mm (e.g., approximately 10 mm). The height can be considered as the dimension of the tube in the direction away from the patient's face (i.e., the distance between the side 3348 that contacts the patient and the outermost part of the side 3349 that does not contact the patient), and the width can be considered as the dimension across the surface of the patient's head. In some forms, the cross-sectional thickness of the material forming the tube 3350 can be in the range of approximately 0.8 mm to approximately 1.6 mm. In some forms, the cross-sectional thickness of the material forming the tube 3350 can be in the range of approximately 1.0 mm to approximately 1.5 mm. In some forms, the cross-sectional thickness of the material forming the tube 3350 can be approximately 1.3 mm.

[0155] The D-shaped cross-section tube 3350 shown in FIG. 3H has a curved edge 3347 located on the side surface of the side 3348 that contacts the patient. The curved edge that contacts or is in the vicinity of the patient's skin helps to increase the comfort during the wearing of the patient interface 3000 and to avoid marks or inflammation on the patient's skin. Making the tube have a D-shaped cross-section profile also makes it more resistant to buckling than in the case of other shaped outer profiles.

[0156] As described in U.S. Patent No. 6,044,844, the tube 3350 is capable of withstanding crushing in order to avoid a breathable gas flow passing through the tube when crushed during use (e.g., when crushed between the patient's face and the pillow). Since the pressurized gas in the tube can function as a spring to avoid or at least limit the crushing of the tube 3350 during use, a tube that can withstand crushing is not necessarily required in all cases. Using a tube that can withstand crushing can be advantageous when only a single tube 3350 is present. This is because when a single tube is blocked during use, the gas flow is restricted, and the treatment stops or its effectiveness decreases.

[0157] The two tubes 3350 are fluidly connected to the cushion assembly 3150 at their lower ends. In a particular form of the present technology, the connection between the tube 3350 and the cushion assembly 3150 is achieved by connecting two rigid components such that the patient can easily connect the two rigid components in a reliable manner. Using tactile feedback such as an audible "click" or a similar sound can make it easy for the patient to use and also enable the patient to know that the tube is correctly connected to the cushion assembly 3150. In one form, the tube 3350 is formed from silicone, and the lower end of the silicone tube 3350 is overmolded onto a rigid connector formed, for example, from polypropylene. The rigid connector can include a male engagement feature configured to connect to a female engagement feature on the cushion assembly 3150, although the male / female features may be arranged in other ways.

[0158] In another example, a compression seal is used to connect the tube 3350 to the cushion assembly 3150. For example, when using a tube 3350 having elastic flexibility (e.g., silicone) without a rigid connector, it becomes necessary to reduce the diameter by slightly compressing (e.g., squeezing) the tube 3350 so that it can be inserted into a port within the plenum chamber 3200. Due to the inherent elasticity of silicone, the tube 3350 can be pressed outward (e.g., can return to an uncompressed state) in order to make an airtight seal within the port of the tube 3350. If the engagement between the tube 3350 and the port is a rigid-to-rigid type of engagement, a pressure-activated seal such as a peripheral sealing flange can be used. When pressurized gas is supplied through the tube 3350, the sealing flange is advanced against the joint between the tube and the inner peripheral surface of the port of the plenum chamber 3200 to facilitate the seal between the two. When the port is flexible and a rigid connector is provided to the tube 3350, the pressure-activated seal as described above can also be used to confirm that the connection is airtight.

[0159] In some forms of the present technology, a similar connection mechanism can be used when fluidly connecting to the tube 3350 by an upper member having a T-shaped configuration that defines or is connectable to the connection port 3600. In one embodiment, since the swivel elbow connected at the connection port 3600 is rotatable, this rotation drives a port size adjustment mechanism that increases or decreases the size of the port that is the insertion destination of the tube 3350, improves the fit of the tube through increasing or decreasing the compression force, and reduces unintended leakage.

[0160] 8.3.3.2 Headgear Strap In a particular form of the present technology, the positioning and stabilization structure 3300 includes at least one headgear strap. These headgear straps function to position and stably arrange the seal-forming structure 3100 relative to the patient's airway inlet in addition to the tube 3350.

[0161] 8.3.3.2.1 Position of the Headgear Strap In one example, as shown in, for example, FIG. 3A, the positioning and stabilization structure 3300 includes a rear headgear strap 3310. The rear headgear strap 3310 is positioned on each side of the patient's head and is connected between two tubes 3350 that pass behind the patient's head (e.g., cover or enclose the posterior portion of the occipital bone of the patient's head during use). The rear strap 3310 connects to each tube above the patient's ear. In other embodiments, for example in the case of an oronasal mask, the positioning and stabilization structure 3300 further includes one or more lower headgear straps. These lower headgear straps connect between the tubes, pass under the patient's ear, and pass to the rear side of the patient's head.

[0162] In one form of the technology, the positioning and stabilization structure 3300 includes a jaw strap 3320. The jaw strap 3320 extends under the patient's jaw during use, as shown in, for example, FIGS. 10A and 10B. The jaw strap 3320 may connect to the headgear tube 3350 or, in another embodiment, may connect to a cushion assembly 3150 or a frame assembly operably connected to the cushion assembly.

[0163] Certain forms of the technology may include multiple headgear straps for increased stability as described above (e.g., rear straps, side headgear straps, and jaw straps).

[0164] In certain forms of the 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 directly or indirectly connected to the seal-forming structure 3100. In the case of the patient interface 3000 shown in FIG. 3A, for example, tabs 3345 configured to connect to the rear strap 3310 project generally rearwardly outward from each headgear tube 3350. These tabs 3345 have holes therein for receiving the ends of the rear strap 3310. Since the tabs 3345 may be positioned above the patient's ear, the rear strap 3310 connected to the tabs 3345 does not cover the patient's ear.

[0165] In some forms of the present technology, the rear strap 3310 is adjustable. For example, in the case of the patient interface shown in FIG. 3C, the rear strap 3310 is screwed through the holes in each tab 3345 during 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 the rear strap 3310 through the holes in the tabs 3345 using, for example, hook and loop fastening means. Thus, the rear strap 3310 can be adjusted to fit different head sizes. In some forms of the present 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.

[0166] In some forms of the present technology, the rear strap 3345 applies a force to the headgear tube 3350 to pull the headgear tube 3350 at least partially in a rearward (e.g., posterior) direction at the position of the tabs 3345. The rear strap 3310 can also apply a force to the headgear tube 3350 to pull the headgear tube 3350 at least partially in an inward (e.g., posterior) direction. The magnitude of this force can be adjusted by changing the length of the rear strap 3310 between the tabs 3345.

[0167] In some forms of the present technology, such as the form shown in FIG. 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 forms of the present technology, the position at which the force is applied from the rear strap 3310 to the headgear tube 3350 can be changed by adjusting the position at which the rear strap 3310 is fixed to the headgear tube 3350.

[0168] It may be advantageous if the headgear 3300 can accommodate a range of head sizes and head shapes, as it is possible to adjust the size and direction of the force applied from the rear strap 3310 to the headgear tube 3350. The rear strap 3310 can maintain the balance of forces in the headgear tube 3350, thereby assisting the headgear in maintaining its shape and obtaining an effective seal against the patient's face while maintaining comfort.

[0169] In some forms of the present technology, during patient wear, the point on the headgear tube 3350 adjacent to the tab 3345 generally receives an upward (e.g., upward) force from the upper part of the headgear tube 3350 due to a biasing mechanism (described in more detail below) that functions to hold the headgear in a fixed position on the patient's head. Further, the point on the headgear tube 3350 adjacent to the tab 3345 can receive generally forward (e.g., forward) and downward (e.g., downward) forces generated from a biasing mechanism that functions to propel the seal-forming structure 3150 upward and into the patient's nose. The direction and size of the forces required for a secure fit and effective seal can vary among patients based on, for example, the positioning and stabilization structure 3300 on the head, which can vary due to differences in head shape and size. In some forms of the present technology, since the rear strap 3310 is adjustable, it is possible to balance the forces for a range of head shapes and sizes so as to hold the headgear 3300 in a comfortable position while maintaining an effective seal.

[0170] For example, in order to balance the large forces applied on the portion of the headgear tube 3350 near the tab 3345 in the forward (e.g., front) direction, the rear strap 3310 can be adjusted by pulling a greater number of rear straps 3310 through the slots in the tab 3345, thereby shortening the length of the rear strap 3310. When the rear strap 3310 is elastic, a greater force is applied to the headgear tube 3350 in the rearward (e.g., back) direction. Similarly, the angle of the rear strap 3310 can be adjusted as needed to balance both the vertical and horizontal components of the forces acting on the portion of the headgear tube 3350 near the tab 3345 for a range of head shapes and sizes.

[0171] 8.3.3.2.2 Form of the headgear strap In one example, the positioning and stabilization structure 3300 includes at least one strap 3310 having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap. In another example, the positioning and stabilization structure 3300 includes at least one strap 3310. The profiles of these straps 3310 include one or more curved edges for improved comfort and reduced risk of patient marks or inflammation from the headgear strap.

[0172] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap 3310 composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous such that moisture (e.g., sweat) can pass through the strap 3310. In one form, the fabric outer layer includes a loop material that engages with a hook material portion. The hook material portion may be positioned at the distal portion of the strap 3310.

[0173] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap 3310 that is extensible (e.g., extensible with elasticity). For example, the strap 3310 can be configured to be taut like a string and direct a force to bring the seal forming structure 3100 into close contact with a part of the patient's face during use. In one example, the strap can be configured as a tie. In other forms of the present technology, the positioning and stabilization structure 3300 includes a strap 3310 that can be adjusted 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 additional adjustability to other adjustment features of the patient interface 3000, improving patient comfort and fit. In some forms of the present technology, the adjustable level provided from other parts of the positioning and stabilization structure means that the patient interface 3000 can be fully adjusted even without the strap 3310.

[0174] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap 3310 that is bendable and, for example, non-rigid. An advantage of this aspect is that the strap 3310 is more comfortable when the patient lies on their side during sleep.

[0175] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap 3310 that includes two or more strap bands separated by a split. Depending on the patient interface design, the split strap 3310 can anchor the patient interface 3000 on the patient's head in a particularly stable manner.

[0176] In certain forms of the present technology, the positioning and stabilization structure 3300 provides a holding force configured to correspond to a head of a particular size and / or a face of a particular shape. For example, one form of the positioning and stabilization structure 3300 provides a holding force suitable for a large-sized head rather than a small-sized head. In another example, one form of the positioning and stabilization structure 3300 provides a holding force suitable for a small-sized head rather than a large-sized head.

[0177] 8.3.3.3 Headgear Tubing Adjustment Mechanism In certain forms of the present technology, the positioning and stabilization structure 3300 includes an adjustment mechanism 3360. The adjustment mechanism 3360 is configured to enable dimensional adjustment of the positioning and stabilization structure 3300. In at least one embodiment, the adjustment mechanism 3360 can enable length adjustment of the positioning and stabilization structure 3300 (e.g., the length adjustment of the tie (e.g., the headgear tubing 3350)), particularly between the connection port 3600 and the seal-forming structure 3100. Additionally or alternatively, the adjustment mechanism 3360 is configured to enable bendable adjustment of the positioning and stabilization structure 3300 (e.g., the bending of the headgear tubing 3350). The adjustment mechanism 3360 enables adjustment of the patient interface 3000 to improve the fit of the patient interface 3000 to the patient's head, thereby enabling the patient interface 3000 to fit heads of different sizes. A patient interface that fits the patient can be worn comfortably, which can increase stability, reduce the likelihood of seal breakage, and maintain a sealed structure at the entrance of the patient's airway with a comfortable level of headgear tension. These elements improve patient compliance with treatment and also improve treatment results. It is understood that the adjustment mechanism can include multiple mechanisms for adjustment. For example, the combinations of adjustment mechanisms described below can be provided to the headgear in some forms of the present technology.

[0178] For example, the adjustment mechanism 3360 can enable adjustment of the size and / or shape of the patient interface 3000. In one form of the present technology, the length of the tube 3350 between the connection port 3600 and the seal-forming structure 3100 can be adjusted.

[0179] In some forms of the present technology, the adjustment mechanism 3360 can enable adjustment of the size of the patient interface 3000 by approximately 100 mm so that the patient interface 3000 fits a wide range of patients. For example, the adjustment mechanism 3360 can adjust the total length of the tube 3350 by up to approximately 100 mm. In one form of the present technology, the total length of the tube 3350 can be adjusted by up to approximately 80 mm. For example, the length of the tube 3350 positioned on each side of the patient's face during use can be adjusted by up to approximately 40 mm.

[0180] The patient interface 3000 is configured and constructed such that when the positioning and stabilization structure 3300 applies a force onto the patient's face to maintain a sealed relationship between the cushion assembly 3150 and the patient's face against the force applied by the positive pressure gas within the plenum chamber 3200, the force is approximately constant or within a predetermined limit over a certain range of sizes that the patient interface 3000 can accommodate. This will be described in more detail below.

[0181] Different forms of the adjustment mechanism 3360 will be 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 in a position remote from the headgear tubing 3350. Certain forms of the present technology can include multiple adjustment mechanisms 3360 as described below.

[0182] In some forms of the present technology, the adjustment mechanism 3360 is configured to be manually adjustable so that the patient interface 3000 can be fitted to provide comfort and treatment effectiveness to the patient (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 can be advantageous because it reduces the possibility that the patient interface 3000 will fit inaccurately or uncomfortably for the patient. On the other hand, some patients may prefer to be able to change the fit of the patient interface themselves.

[0183] In some forms of the present technology, the patient interface 3000 is configured to be able to interchangeably position and connect different forms of the seal-forming structure 3100 to 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, an oronasal cushion may be of higher weight than a nasal cushion. In such forms of the present technology, when using a manual adjustment mechanism, the advantage can be obtained that the mechanism can be initially set to be adapted to the type of seal-forming structure being used. For example, if a relatively high-weight seal-forming structure is used to reduce the tendency for the positioning and stabilization structure 3100 to be pulled downward, the manual adjustment mechanism can be set to obtain a tighter fit. Similar considerations can apply to seal-forming structures that are exposed to the patient's mouth movements (e.g., the movement of opening the mouth wide).

[0184] 8.3.3.3.1 Folding / Bellows Headgear Tube In a particular form of the present technology, the adjustment mechanism 3360 includes a tube 3350 having one or more folds, pleats, corrugated structures, or bellows. That is, the folds, pleats, corrugated structures, or bellows include the adjustment mechanism 3360. When each fold first assumes a first folded configuration, the length of each tube 3350 is different from the length when the fold is in a second non-folded configuration.

[0185] The patient interface 3000 shown in FIG. 3A includes a tube 3350 that includes a bellows tube section 3362. The bellows tube section 3362 is provided between the lengths of the non-bellows tube 3350. The bellows tube section 3362 includes a plurality of folds or bellows. These folds or bellows can be folded or unfolded individually or can cooperate to shorten or lengthen the bellows tube section 3362 and thus each tube 3350. The folds in the bellows tube section 3362 can be expanded (stretched) or contracted by changing the degree on different sides of the tube 3350. For example, if the bellows folds on the side of the tube 3350 closest to the patient's head are contracted to a greater extent than the bellows folds at the most remote position from the patient's head, the curvature of the tube 3350 increases. As a result, it becomes possible to change the shape and length of the tube 3350, and in this way, it is also supported to adjust the patient interface to fit the patient-specific head size and head shape.

[0186] In a particular form of the present technology, the bellows tube section 3362 enables the length of the tube 3350 of the patient interface 3000 to be continuously adjusted through a range of different lengths. In some embodiments, the length of each bellows tube section 3362 can be continuously adjustable. An adjustment mechanism 3360 such as the bellows section 3362 that provides continuous adjustment can fit comfortably to a wide range of head sizes. In contrast, in the case of an adjustment mechanism that provides adjustment between individual lengths, for a patient who requires a length between two of the individual length options to obtain an optimal fit, the comfortable fit can be reduced.

[0187] In some forms of the present technology, the tube 3350 includes a plurality of bellows tube sections 3362 at predetermined positions. These bellows tube sections 3362 are each separated by the length of the non-bellows tube 3350.

[0188] In some forms of the present technology, the bellows tube section 3362 is provided within a relatively straight portion of the tube 3350. This avoids the tendency for the bellows section 3362 to straighten when pressurized gas passes through the tube 3350. If the bellows section 3362 straightens, the position of the patient interface on the patient's head can be changed, which can have an adverse effect on seal stability and / or flow impedance.

[0189] In the form of the present technology shown in FIG. 3B, the patient interface 3000 includes a tube 3350 that includes a bellows tube section 3362. The bellows tube section 3362 is longer than the bellows tube section 3362 shown in FIG. 3A. In the form of the present technology shown in FIG. 3B, the bellows tube section 3362 encompasses most of the length of each tube 3350 between the point where the headgear strap 3310 connects to the tube 3350 and the upper end of the tube 3350 that connects to the connection port 3600 (e.g., the bellows tube section 3362 encompasses most of the upper length of the tube 3350). For example, the bellows tube section 3362 can have a lower end directly above the point where the headgear strap 3310 is connected to the tube 3350 and an upper end at the point where the tube 3350 is connected to the connection port 3600. A longer bellows tube section 3362 can also increase the extensibility of the tube 3350. Alternatively, the extensibility can be increased by increasing the number of bellows folds in the bellows tube section 3362. If the extensibility is increased, it can be advantageous because a desired level of holding force can be applied to the patient's face to ensure a good seal over this range of head sizes, and the patient interface 3000 can fit a large number of patients over a wide range of head sizes.

[0190] In some examples, the bellows tube section 3362 can be disposed generally above the patient's ear (e.g., at the upper portion of the tube 3350), so that the lower portion of the tube 3350 and the seal-forming structure 3100 can be substantially unaffected by the movement (e.g., compression or extension) of the bellows tube section 3362.

[0191] In the form of the present technology shown in FIGS. 3C, 3D, and 3E, the patient interface 3000 is similar to the patient interface 3000 shown in FIG. 3B. One difference is the configuration of the bellows tube section 3362. In the form of the present technology shown in FIGS. 3C, 3D, and 3E, the width and diameter of the bellows tube section 3362 vary along the length of each bellows tube section 3362. More specifically, the bellows tube section 3362 is formed in a tapered shape such that the width and diameter of the tube at one end of each bellows tube section 3362 are smaller than the width and diameter of the tube at the other end of each bellows tube section 3362. Even more specifically, the width and diameter of the upper end of each bellows tube section 3362 (where the bellows tube section 3362 is connected to the connection port 3600) are larger than the width and diameter of the lower end of each bellows tube section 3362 (where the bellows tube section 3362 is connected to a part of the tube 3350 without a bellows), and the width and diameter of the bellows tube section 3362 gradually increase between the upper end and the lower end and are generally linear. The tapered shape of the bellows tube section 3362 is also illustrated in FIG. 3F. FIG. 3F is a plan view of the patient interface 3000 of FIGS. 3C, 3D, and 3E. The tapered shape of the bellows tube section 3362 is also illustrated in FIG. 3G. FIG. 3G shows a cross-section of the patient interface 3000 of FIG. 3F along line 3G-3G. By making the bellows tube section 3362 in a tapered shape, the connection port 3600 is fluidly connected to the bellows-free lower length of the tube 3350 in such a manner as to reduce the discontinuity of the cross-sectional profile of the air path, enabling a smooth transition that reduces impedance increase and promotes fluid flow along the tube 3350.

[0192] One advantage of the bellows tube section 3362 for the adjustment mechanism 3360 is that, compared to other adjustment mechanisms, the bellows tube section 3362 can be more easily curved or bent and extended longitudinally. FIG. 3J shows the headgear 3300 being worn at three different positions on the patient's head with the reference numerals appended with "a", "b", and "c" at the end. As shown in FIG. 3J, the bellows tube sections 3362a, 3362b, and 3362c are curved to different levels, where the bellows tube section 3362a is curved forward on the patient's head, the bellows tube section 3362b has a smaller curvature in the rear / front direction, and the bellows tube section 3362c is substantially non-curved on the patient's head. The different curvatures may affect patient comfort but may not affect the pressurized air flow through the tube 3350.

[0193] In some forms of the present technology, the bellows tube section 3362 can extend by different amounts on the front and rear (e.g., front and back) sides of the headgear tube 3350. That is, the wall portion forming the bellows tube section 3362 can contract relatively more (e.g., be folded more) on one side of the tube and extend relatively more (e.g., be folded less) on the other side of the tube, thereby promoting a bent or curved shape in the tube. This effect is shown in FIG. 3L. As shown, the wall portion of the bellows tube section 3362 extends less (e.g., buckles more) in the front than in the rear in the case of the bellows tube section 3362a (i.e., when the headgear is worn on the patient's head in front of the coronal plane). Since the bellows tube section 3362 can be curved in the forward direction, it is supported that the headgear 3300 can be worn in the forward position without having to rotate the cushion assembly 3150 forward (as in the case where the headgear tube is rigid) to remove it from the sealed contact with the patient's face. Since the headgear tube 3350 can be curved in the forward or backward direction, it is supported to disconnect the connection port 3600 from the cushion assembly 3150. The difference in the extension amount of the bellows tube section 3362c between the front side and the rear side (i.e., when the headgear 3300 is worn in a rear position on the patient's head) is smaller than the difference in the extension amount of the bellows tube section 3362a between the front side and the rear side (i.e., when the headgear 3300 is worn in a front position on the patient's head). Such a bellows can reduce the degree of straightening (or curving) when the headgear tube 3350 is worn in the rear.

[0194] In one form, the bellows tube sections 3362 on each side of the patient interface 3000 are approximately 40 mm longer in the fully extended configuration than in the fully contracted configuration.

[0195] In other forms of the present technology, the bellows tube section 3362 can be arranged at different parts of the length of the tube 3350. As shown in FIGS. 3A and 3B, where the bellows tube section 3362 is arranged at a position along the length of the tube 3350 such that the bellows tube section 3362 contacts the upper part and / or the upper side of the patient's head (i.e., the area of the patient's head above the suprameatal point of the patient's head), one advantage of the patient interface 3000 is that the bellows tube section 3362 does not contact the patient's cheek area. As a result, the discomfort that may occur when the bellows tube section contacts the patient's cheek area during use is avoided.

[0196] The bellows tube section 3362 is prone to buckling, especially when it is stretched particularly large. Therefore, as a result of the bellows tube section 3362, there is a risk that the tube 3350 will become clogged, restricting or avoiding the delivery of breathable gas to the patient. In some forms of the present technology, the patient interface 3000 includes one or more structures configured to avoid or at least characterize the buckling of the bellows tube section 3362. In one embodiment, the patient interface 3000 includes one or more high-rigidity rings or semi-rigid rings. These rings are provided to the bellows tube section 3362 and are circumferentially positioned around the tube 3350. For example, these rings may be arranged inside the bellows tube section 3362, or may be molded (e.g., co-molded or overmolded) together with the bellows tube section 3362. In another embodiment, a helical element for buckling suppression is provided along the bellows tube section 3362. In such an embodiment, the section of material between the pitches of each helical winding, known as a tape, can impart elasticity to the tube. The tape may be formed of an elastic material, or may be structured to obtain an appropriate level of elasticity that can impart sufficient tension for contraction to the tube. In other embodiments, the bellows tube sub-section formed together with the bellows tube section 3362 is thicker, or is composed of a material with a higher composition than other bellows tube sub-sections for buckling suppression.

[0197] In another form of the technology, the patient interface 3000 includes an adjustment mechanism 3360 that includes a tube 3350. The tube 3350 has one or more circumferential folds for longitudinally folding adjacent sections of the tube 3350. When the circumferential fold is in a folded configuration, the length of the tube covers the adjacent length of the tube. The stiffness of the material forming the tube 3350 can 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 3350 during typical use of the patient interface 3000). Alternatively, the patient interface 3000 can include means (e.g., a clip) for maintaining the tube in a folded configuration. In another embodiment, magnets are embedded in the tube 3350 to align the overlapping folds (as long as the magnets are not pulled apart) when the tube is folded to maintain the tube 3350 in a folded configuration.

[0198] The patient interface 3000 shown in FIG. 5 includes an adjustment mechanism 3360 that includes a fold 3364. The fold 3364 includes a first tube wall portion 3366. The first tube wall portion 3366 can be folded at different levels on an adjacent tube portion 3368 by rotating on the adjacent tube portion. FIGS. 5A and 5B are cross-sectional views of the fold 3364 of the patient interface 3000 shown in FIG. 5. In FIG. 5A, the rotary fold 3366 is folded onto the adjacent tube portion 3368 at a higher level than the level at which it is folded in FIG. 5B. Thus, the length of the tube 3350 when the fold 3364 is in the configuration shown in FIG. 5B is longer than the length of the tube 3350 when the fold 3364 is in the configuration shown in FIG. 5A. As can be seen from FIGS. 5A and 5B, at the location of the fold 3364, three layers of the tube 3350 overlap each other, but the length of the overlapping tube sections is different between the configuration of FIG. 5A and the configuration of FIG. 5B. The rotary fold 3366 can include a local section of the tube wall that is thinner than other sections of the tube 3350.

[0199] Another form of the folding adjustment mechanism 3360 of the positioning and stabilization structure 3300 of the patient interface 3000 is shown in FIG. 6. In this embodiment of the present 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 generally has a 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 having sufficient flexibility such that the curved portions can increase or decrease the curvature so that each tube can fit on a smaller or larger head respectively. For example, these tubes 3350 can be formed of metasilicon having a hardness of 40 durometers on a Shore hardness meter.

[0200] In the form of the present technology shown in FIG. 6, the tube 3350 on one side of the patient's head extends generally in a front - rear direction away from the connection port 3600 at the upper end and generally in a downward direction on the patient's head side near the point where the headgear strap 3310 is attached to the tube 3350, with the position edge of the upper curved portion 3353A substantially covering the upper portion of the patient's head, and the outside of the front side of the rear - side curved portion and the outside of the curved portion on the inside are provided. Below the point where the headgear strap 3310 is attached to the tube 3350, the tube 3350 extends generally in a downward direction and becomes somewhat curved forward in the forward direction. The lower curved portion 3353B is generally positioned above the patient's cheek area during use. The lower end of the tube 3350 extends generally horizontally over the patient's cheek in the forward direction and extends to the tube end 3352 that connects to the cushion assembly 3150. The lower end of the tube 3350 can be directed somewhat downward (i.e., extends somewhat downward when worn by some patients). The lower curved portion 3353B generally positioned on the patient's cheek area has the outside of the curved portion on the rear side and the inside of the curved portion on the front side.

[0201] The lower portion of the tube 3350 in FIG. 6 is constructed and configured such that the tube 3350 is generally positioned in a direction away from the patient's eye during use, such that the tube 3350 does not enter the patient's field of view or, if it does enter, is at least minimized. This can be achieved by constructing the lower portion of the tube 3350 such that the apex or maximum curvature point of the lower curved portion 3353B is positioned over a rear region of the patient's cheek region during use.

[0202] Although not shown in FIG. 6, the tube 3350 positioned on the left side of the patient's face is constructed in contrast to the tube 3350 on the right side of the patient's face. In other forms, the tube 3350 can have different structures on each side of the patient's face.

[0203] 8.3.3.3.2 Telescopic Headgear Tube In a particular form of the technology, the adjustment mechanism 3360 includes a tube 3350 having a first tube portion 3370. The first tube portion 3370 is telescopically movable relative to a second tube portion 3372.

[0204] The patient interface 3000 shown in FIG. 7A includes an adjustment mechanism 3360 that includes a first tube portion 3370 and a second tube portion 3372. The first tube portion 3370 and the second tube portion 3372 slide telescopically relative to each other. In the embodiment of FIG. 7A, the first tube portion 3370 is connected to the connection port 3600 such that it is positioned higher on the patient's head than the first tube portion when the patient interface is worn. The second tube portion 3372 has a smaller diameter than the first tube portion 3370 (i.e., fits inside) and is fixedly connected to a portion of the tube 3350 positioned lower on the patient's head when the patient interface is worn. The first tube portion 3370 can be described as covering the second tube portion 3372 through the telescopic movement between the first tube portion 3370 and the second tube portion 3372.

[0205] In certain forms of the present technology, the patient interface includes a tube fixation mechanism. The tube fixation mechanism fixes the first tube portion 3370 and the second tube portion 3372 to each other at a plurality of distinct positions. For example, in the form of the present technology shown in FIG. 7A, the second tube portion 3372 includes a plurality of raised ribs 3374 on its outer surface, and the first tube portion 3370 includes one or more protrusions or detents (not shown). These protrusions or detents cooperate with the ribs 3374 to hold the first tube portion 3370 and the second tube portion 3372 at a plurality of relative longitudinal positions, enabling adjustment of the length of the tube 3350. In other forms of the present technology, these tube sections can be fixed to a plurality of distinct positions using other interlocking mechanisms (e.g., one or more grooves or holes that cooperate with one or more protrusions or detents). These grooves can be provided on the surface of the first tube portion or the second tube portion, and it is understood that protrusions are provided on the surface of the other of the first tube portion or the second tube portion at positions that cooperate with the grooves during use.

[0206] In one form, the patient interface 3000 of FIG. 7B includes a first tube portion 3370 and a second tube portion 3372. It includes an adjustment mechanism 3360. The first tube portion 3370 and the second tube portion 3372 slide telescopically relative to each other. The first tube portion 3370 can slide on the outer surface of the second tube portion 3372. The second tube portion 3372 is positioned below the first tube portion 3370 relative to the patient's head when the patient interface 3000 is worn (i.e., the second tube portion 3372 is provided downstream of the first tube portion 3370). The patient interface 3000 has two similar such adjustment mechanisms 3360, and one of these adjustment mechanisms 3360 is positioned on each side of the patient's head during use.

[0207] The patient interface 3000 includes an upper tube member 3351. The upper tube member 3351 is positioned above the patient's head during use. The first tube portions 3370 on each side of the patient's head are integrally formed as part of the upper tube member 3351. A connection port 3600 is provided to the upper tube member 3351. For example, the upper tube member 3351 has an opening in the upper side of its central portion.

[0208] 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 portion 3372 may include a second or lower tab 3373. The second tab 3373 may be pressed against the first tab 3371. For example, the user may place the thumb on the second tab 3373 and the index finger on the first tab 3371 and pinch these two tabs so that the second tab 3373 moves toward the first tab 3371. When the second tab 3373 is moved toward the first tab 3371, the first tube portion 3370 and the second tube portion 3372 telescopically slide, shortening the headgear tube 3350. When the second tab 3373 is moved away from the first tab 3371, the first tube portion 3370 and the second tube portion 3372 telescopically slide, lengthening the headgear tube 3350.

[0209] When the second tab 3373 is slid to the peripheral edge of the first tube 3370, it functions as a stop to avoid further shortening of the tube 3350 when the second tab 3373 contacts the peripheral edge.

[0210] The second tube portion 3372 of the patient interface 3000 shown in FIG. 7B is integrally formed with the length of the tube 3350 positioned to contact the side of the patient's head and extend across the patient's cheek region during use. To enable the patient interface 3000 to be comfortably worn and conform to a range of patient head shapes, the lower portion of the tube 3350 (where the second tube portion 3370 is an integral part) may be formed of a semi-rigid material such as an elastomeric material (e.g., silicone). In contrast, the upper tube member 3351 (and consequently the first tube section 3370) may be formed of a relatively rigid material.

[0211] As one possible result of telescopically moving a patient interface having a tube portion formed from a relatively flexible material to a tube portion formed from a relatively rigid material, when the inner tube portion is pressed against the outer tube portion, the tube portion composed of the relatively flexible material may buckle. As a result, the ease of adjusting the length of the tube 3350 may be affected. The patient interface 3000 shown in FIG. 7B includes a stiffening member 3379 to address this problem. The stiffening member 3379 functions to increase the rigidity of a section of the second tube portion 3372 that moves from the inside and outside of the first tube portion 3370 during use. In the illustrated embodiment, the stiffening member 3379 is the length of a relatively rigid material provided on the upper side of each of the second tube portions 3372. The stiffening member 3379 may be attached to the outside of the second tube portion 3372 or may be molded (e.g., co-molded or overmolded) as part of the second tube portion 3372. In a particular form of the present technology, each stiffening member 3379 may be integrally formed with a tab 3373 on the upper side of a tab 3373 on each second tube portion 3372.

[0212] The patient interface of FIG. 7B includes a padded member 3330 on the side of the upper tube member 3351 that contacts the patient to improve comfort when the patient interface 3000 is worn. One or more padded members 3330 may be provided at any part of any of the positioning and stabilizing structures 3300 of the 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 wearing 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 adhesion. Alternatively, the padded member 3330 may be removably attached to the tube 3350 using, for example, hook and loop fastening material or fasteners. Since the padded member 3330 contacts the patient's head during use, it may become soiled. It may be advantageous to be able to remove the padded member 3330 for cleaning and / or replacement.

[0213] Another form of this technology is shown in FIG. 7C. In this form, the patient interface 3000 includes a second tube portion 3372. The second tube portion 3372 telescopically slides on the outer surface of the first tube portion 3370. That is, a tube portion that telescopically fits inside another tube portion is positioned higher than the other tube portion on the patient's head during use.

[0214] In the embodiment of FIG. 7C, the first tube portion 3370 is relatively rigid. The second tube portion 3372 includes a relatively rigid ring member 3384 at its upper end. The ring member 3384 surrounds an opening within the upper end of the second tube portion 3372. The second tab 3373 may be provided on the ring member 3384 (e.g., integrally formed with the ring member 3384). Since both the first tube portion 3370 and the second tube portion 3372 are formed of a relatively rigid material, they can telescopically move relative to each other without buckling. Thus, the patient interface 3000 shown in FIG. 7C can avoid the need for a stiffening member as described in connection with FIG. 7B while allowing the same length extension of the tube 3350.

[0215] Another form of the telescopic adjustment of the tube 3350 is shown in FIG. 8. In this embodiment, the second tube portion 3372 of the tube 3350 slides relative to the first tube portion 3370 together with a telescopic ratchet mechanism 3376. By the ratchet mechanism, the situation where the first tube portion and the second tube portion that can move telescopically move relative to each other in one or both directions is avoided or suppressed unless the ratchet mechanism is released, for example, by pressing the button 3378. Each of the buttons 3378 is operably connected to a locking member (not shown). This locking member (not shown) interlocks with a groove or protrusion (e.g., rib 3374) on the second tube portion 3372 unless the button 3378 is pressed. The buttons 3378 and the associated locking member can assist in restricting accidental movement of the tube portions 3370 and 3372 during the patient's sleep.

[0216] Another form of the ratchet mechanism 3376 is shown in the form of the present technology shown in FIG. 7C. In this form, the ratchet mechanism 3376 includes a tongue 3397 provided on the head contact side of the second tube portion 3372. The tongue 3397 is connected to the second tube portion 3372 at its lower end and generally extends along the length of the second tube portion 3372. The tongue 3397 is free at its upper end and has a protrusion on its upper side. The first tube portion 3370 includes a plurality of groove portions 3398 on its head contact side. The protrusions on the end of the tongue 3397 are configured to selectively engage with each of the groove portions 3398 to hold the first tube portion 3370 and the second tube portion 3372 in relative positions. The tube 3350 can generally have a D-shaped cross-section, and the flat portion of the "D" contacts the patient. The ratchet mechanism 3376 can be advantageously disposed on the head contact side of the patient interface 3000 (as in the case of FIG. 7C for example). This is because the tongue and groove ratchet mechanism 3376 can be more effective because it provides a larger contact area when provided on a relatively flat area of the tube 3350 than when the meshing curved surfaces in the ratchet mechanism are large.

[0217] In another form of the present technology, button 3378 includes tabs positioned on the side of tube 3350. These tabs are tightened inwardly to release the interlocking mechanism and allow for the relative movement of the telescopic tube sections. These tabs may include a gap or window in the first tube section 3370 that surrounds the second tube section 3372, whereby a patient or clinician can squeeze a portion of the second tube section 3372 to release the interlock. Alternatively, the gap may be covered by one or more overmolded buttons. Pressing these buttons can tighten the second tube section 3372 to release the interlock. Covering the gap with overmolded buttons or eliminating the gap in the adjustment mechanism 3360 reduces the likelihood that a patient's hair will become entangled in the adjustment mechanism 3360, which would compromise comfort. In one exemplary embodiment, the adjustment mechanism 3360 is configured such that when the sides of the ring member 3384 at the upper end of the second tube portion 3372 are pressed inwardly, the interlocking feature between the second tube portion 3372 and the first tube portion 3370 is released, enabling telescopic movement between tube portions 3370, 3372. For example, the ring member 3384 may include a rigid plastic pinch button overmolded with silicone and one or more protrusions on its inner upper surface, allowing for interlocking with a groove on the upper surface of the first tube portion 3370, such that when the ring member 3384 is pressed inwardly at the sides, the protrusions and groove are pushed out of the interlocking engagement.

[0218] The patient interface of FIG. 8 includes a padded member 3330 on the side that contacts the patient of the positioning and stabilization structure 3300, improving comfort when wearing the patient interface 3000. The padded member 3330 can be constructed from a flexible and / or compressible material (e.g., foam) to comfortably contact the patient's head.

[0219] Another form of telescopic adjustment of the tube 3350 is shown in FIG. 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 the adjacent nested concentric tube section 3375 relative to the respective nested concentric tube section 3375. These nested concentric tube sections are interlocked with each other (e.g., via a snap-fit mechanism) to hold their positions in the fully extended or retracted positions. In some embodiments, the nested concentric tube sections 3375 can be held in an intermediate position (i.e., not fully extended or retracted).

[0220] In the embodiment shown in FIG. 9, each nested concentric tube section is marked with a visual indicator 3377 that indicates 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 color-coded indicators). Physical indicators such as embossments may also be used, which may be advantageous when the patient is sleeping in a dimly lit room. The nested concentric tube sections 3375a-3375c can be configured to extend or retract in a predetermined order.

[0221] Another form of the present technology includes a tube 3350 formed from a plurality of telescopic tube sections coupled to each other in other manners. For example, each tube 3350 can include a central inner tube section with two outer tube sections on both sides. The central inner tube section telescopically slides inside and outside each of these two outer tube sections during use. Alternatively, the central tube section may be provided outside the two outer tube sections.

[0222] In other forms of the telescopically adjustable headgear tube, other forms of size indicators may be provided. In certain forms, the first tube section 3370 of tube 3350 that surrounds the second tube section 3372 during telescopic movement between these two tube sections 3370, 3372 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 tube 3350 thus provided can be visually recognized.

[0223] Another telescopic adjustment mechanism 3360 for the headgear tube 3350 is shown in FIG. 10A. In this embodiment, the length of the headgear tube 3350 can be adjusted by an adjustment mechanism 3360 including teeth or a pinion 3383. When the teeth or pinion 3383 are rotated, the ribbed or rack-like portions of the adjacent first tube section 3370 and second tube section 3372 of tube 3350 move telescopically, thereby changing the length of tube 3350. The connection of the first tube section 3370 to the cushion assembly 3150 can be made integrally, permanently, or removably. In the embodiment shown in FIG. 10A, the adjustment mechanism 3360 is positioned at the lower end of the headgear tube 3350. For example, the adjustment mechanism 3360 can be provided adjacent to the cushion assembly 3150. Positioning the adjustment mechanism 3360 in this way can make it easier for the patient to confirm the position when wearing the patient interface 3000 (especially in a dark room). In the embodiment shown in FIG. 10A, when the teeth or pinion 3383 rotate, the lower end of tube 3350 moves telescopically relative to the cushion assembly 3150.

[0224] In another form of the technology, the adjustment mechanism 3360 is arranged to a connection port 3600 and a swivel elbow is provided to the teeth or pinion so that when the elbow rotates, the headgear tube sections move relative to each other or move relative to a T-shaped connection port member. When the desired arrangement configuration is achieved, a lock may be provided to avoid or limit the rotation of the elbow.

[0225] When a separate number of relative positions of the first tube section and the second tube section are provided by a telescopic adjustment mechanism, it is understood that a larger number of positions enable a larger number of adjustment positions and promote an improved fit to the patient. In some embodiments, 3, 4, 5, 6 or more adjustment positions are provided.

[0226] In a particular form of the present technique, the telescopic tube sections are configured to move relative to each other and be adjusted in a continuous manner (i.e., the relative positions of the tube sections are not limited to discrete positions). As a result, it becomes possible to more greatly customize the length of the tube 3350.

[0227] An example of a tube 3350 having a continuously adjustable length is shown in FIG. 10B. In FIG. 10B, tube section 3372 includes a first threaded portion 3382 on a first tube section 3370. The first threaded portion 3382 is threadedly engaged with a second threaded portion 3380 on a second tube section 3372. The first threaded portion 3382 and the second threaded portion 3380 can be at least partially hollow and can include a path for pressurized air flow. In other words, pressurized air flows through the second threaded portion 3380 and the first threaded portion 3382 receives the second threaded portion 3380. Rotating one of the threaded portions relative to the other converts the rotational movement into relative longitudinal movement of the associated tube sections, thereby adjusting the length of the tube 3350. In other words, the first tube section 3370 can be moved away from the second tube section 3372 so that the overall length of the tube 3350 can be increased on one side of the patient's face. The length of the second threaded portion 3380 exposed to the surroundings can increase with the increase in the length of the tube 3350. The length of the second threaded portion 3380 within the first tube section 3370 can increase with the reduction in the length of the tube 3350. Separate first threaded portions 3382 and second threaded portions 3380 can be provided on either side of the positioning and stabilization structure 3300. The left and right first threaded portions 3382 and second threaded portions 3380 can be independently adjustable (however, in some examples, a single adjustment can adjust both the left and right first threaded portions 3382 and second threaded portions 3380). One or both of the threaded portions are connected to the rotational engagement of the other part of each tube portion, so that the remaining part of the tube 3350 does not rotate even when the threaded portion rotates. The enclosed or smaller diameter second threaded portion 3380 can 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 the upper end of the tube 3350 (i.e., the portion of the tube 3350 connected to the connection port 3600) as shown in FIG. 10B). A pedestal or a screw limiting member (not shown) can be provided at one end of one of the threaded sections to prevent the screw from being unscrewed and removed during use of the threaded section.

[0228] In one form of the present technology, a screw mechanism is provided as a fine adjustment mechanism in addition to a coarser adjustment mechanism, and this fine adjustment mechanism can be, for example, any of the other adjustment mechanisms described herein. Generally, any of the adjustment mechanisms described herein can be used in combination with a first adjustment mechanism that allows for finer adjustment than a second adjustment mechanism.

[0229] In another embodiment of the present technology, the telescopic slide section of the tube 3350 is held in frictional contact through ribs on the slide surfaces of one or both of the slide sections. Alternatively, one or more O-rings may be provided between the telescopically sliding tube sections. These ribs or O-rings hold the tube sections with sufficient frictional force to hold the tube sections in a desired position during normal use of the patient interface, but allow their relative positions to be adjusted when a sufficient longitudinal adjustment force is applied.

[0230] In another form of the present technology, the telescopic tube sections can be fixed in a predetermined position using other fixing mechanisms. In one example, the length of a strap is attached to one of the telescopic tube sections together with a part of the hook and loop fastener material provided on the strap. This strap can be fixed to a complementary part of the hook and loop fastener material (for fixing the section at a desired position) provided on the other telescopic tube section, thereby enabling adjustment of the length of the tube 3350.

[0231] In the above-described embodiments of the present 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 can typically be provided.

[0232] In the case of the patient interface 3000 shown in FIG. 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 can be provided in a slot on the inner surface of the lower end of the first tube portion 3370. The O-ring makes a sealed contact with the outer surface of the upper end of the second tube portion 3372. In other forms of the present technology, the O-ring can 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.

[0233] The configuration and structure of the sealed contact between the first tube section and the second tube section that telescopically moves can be selected to obtain an appropriate frictional level so as to achieve a balance between the quality of the seal and the ease of adjustment of the first tube section and the second tube section. In some forms of the present technology (e.g., the patient interface 3000 shown in FIG. 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 amount, for example, when shaken by a patient or due to the patient's flexion or as a result of positive pressure gas flowing through the tube 3350, the first and second tube sections 3370, 3372 may move too easily in the separating direction, 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 amount, it may become overly difficult for the patient to move the first tube section and the second tube section 3370, 3372 to adjust the length of the tube 3350.

[0234] In another form of the present technology, the inner or outer surface of the first tube 3370 or the second tube portion 3372 can include one or more movable flap seals, lip seals, or compressible gasket seals. In another form, the leakage between the first tube portion 3370 and the second tube portion 3372 can be controlled so that interference and respiratory pressure therapy do not interfere with each other. In one form, the controlled leakage can function as an additional flushing ventilation section.

[0235] In the above-described form of the present technology in which one or more tube sections 3370, 3372 are telescopically movable relative to other tube sections 3372, 3370, the patient interface 3000 may include one or more end stops to avoid a situation where the first tube section 3370 and the second tube section 3372 become separated. In one form, the inner tube section includes a flange at its end, and the outer tube section includes an end stop on an inner surface adjacent to the flange at the maximum extension of the tube section.

[0236] Although the swivel elbow has been described, a ball-and-socket elbow that allows six degrees of freedom may be used instead to increase the disconnection of the tube pulling force.

[0237] 8.3.3.3.3 Modular Tube Section In the patient interface 3000 shown in FIG. 11, the adjustment mechanism 3360 takes the form of an interchangeable tube section 3385. The interchangeable tube section 3385 can be removed from the patient interface 3000 and can be exchanged with a replacement tube section 3386 having a different length with respect to the first tube section or module 3385. The interchangeable and replacement tube sections 3385 and 3386 can be described as tube modules.

[0238] In the example of FIG. 11, the interchangeable tube section 3385 includes a T-shaped tube member. This T-shaped tube member has three ports such that the interchangeable tube section 3385 fluidly connects to the tube 3350 and the air circuit 4170, respectively, during use. For example, the central port on the upper side of the interchangeable tube section 3385 is configured to connect to or include the connection port 3600. For example, the interchangeable tube section 3385 can be positioned over the patient's head during use.

[0239] The tube portion 3385 can be separated from other parts of the patient interface 3000 and can be exchanged with the replacement tube portions 3386a and 3386b. The tube sections of the replacement tube portions 3386a and 3386b extend outward from the connection port 3600 by varying the amount relative to the replaceable tube portion 3385. Any number of replacement tube portions can be provided, but in the embodiment of FIG. 11, the patient interface 3000 includes "small", "medium", and "large" replaceable parts.

[0240] In the form of the present technology shown in FIG. 12, the patient interface 3000 includes one or more tube insert members 3387a and 3387b. These tube insert members 3387a and 3387b are configured to be selectively fluidly connected to the tube 3350 so as to change the length of the tube. For example, the tube insert members 3387a and 3387b are configured to be fluidly connected between the tube 3350 and the cushion assembly 3150 so as to change the effective length of the tube 3350. In another embodiment, the tube insert member can 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 insert member 3387 can 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 the tube insert member.

[0241] In a further form of the present technology shown in FIG. 20A, the positioning and stabilization structure 3300 includes one or more tube insert members 7387a, 7387b, and 7387c. At least one of these inserts includes a connecting portion 7345. Since the connecting portion 7345 can have a hole, the connecting portion can take the form of an eyelet 7345 and can be arranged to receive the rear strap 3310 with respect to the gas delivery tube 3350.

[0242] In a further form of the technology, the tube insert member 7387 can be connected at a portion of the tube 3350 between the lower and upper segments of the tube. For example, the lower segment of the tube 3350 can be connected between the lower end of the insert 7387 (e.g., substantially in the middle section of the tube 3350) and the cushion assembly 3150. The upper segment of the tube 3350 can be connected between the upper end of the insert 7387 and the connection port 3600.

[0243] In this further form, the insert member 7387 forms part of a hoop that extends over the top of the patient's head. This hoop employs the insert member 7387, the tube 3350, and the cushion assembly 3150. In use, the portion of the insert member extends across the patient's cheek region, and the hoop is preferably arranged such that the portion of the insert member 7387 contacts a region of the patient's head above the upper ear attachment point of the patient's head.

[0244] The tube insert members 7387a, 7387b, and 7387c can be configured to be selectively fluid-connected to the tube 3350 to vary the actual length of the hoop. The tube insert member 7387 can have one or more different lengths and can be marked with size notations (e.g., "M" for medium and "L" for large).

[0245] Referring now to FIGS. 20A and 20B, the position of the eyelets 7345 can be different relative to any of the insert members 7387a, 7387b, and 7387c. For example, the eyelets 7345 can be positioned adjacent to the upper or lower end of the insert 7387. Referring to FIG. 20B, the eyelets can be spaced apart from each other evenly (e.g., by a distance x) between both ends of the insert 7387. In some forms, the position of the eyelets is skewed toward one end of the insert 7387 (i.e., as shown in FIG. 20B, the distance y is less than the distance z). The positions of the eyelets 7345 described above can be different between insert members 7387 of different sizes (e.g., insert 7387a can be evenly spaced, and insert 7387b can be skewed), and / or can form different versions of insert members 7387 of the same size (e.g., insert 7387b includes both an evenly spaced version and a skewed version).

[0246] Advantageously, the lengths of each of the inserts 7387a, 7387b, and 7387c can have corresponding eyelet positions optimized for fit with different head shapes and sizes. By providing different eyelet positions for each length of insert 7387, it is ensured that both the eyelets 7345 and the rear strap 3310 are properly positioned optimally relative to the patient's ear. Further, the direction and magnitude of the force applied from the rear strap 3310 to the patient interface 3300 can be optimized by the length of the corresponding insert 7387 and the position of the eyelets 7345.

[0247] In some forms, the positioning and stabilization structure 3300 can include insert members 7387 in which the eyelets 7345 are disposed only in the respective ones of the positioning and stabilization structure. On the opposite side of the positioning and stabilization structure 3300, a single insert member extending from the upper end of the insert 7387 from the cushion assembly 3150 (e.g., an insert member such as the insert member 7387 of FIG. 20A) can be included.

[0248] A single insert member (not shown) may employ an adjustment mechanism (such as the adjustment mechanism 3360 of FIG. 20A) or may be integrally formed with the adjustment mechanism, for example.

[0249] In some embodiments, one or more insert members 7387 may be attached to the tube portion 3350 so as to change the hoop length. For example, an insert member without an eyelet (not shown) is removably coupled to an insert member 7387 that includes an eyelet 7345. The insert member without an eyelet may be disposed at either the upper or lower end of the insert member 7387 depending on either leading to an optimization of the positioning of the eyelet 7345 (i.e., optimization of comfort and / or seal). The insert member without an eyelet may have different lengths (such as insert members 7387a, 7387b, and 7387c, for example). The insert member without an eyelet may be mixed and matched with the insert member 7387 that includes an eyelet 7345 (for example, the small insert member 7387a may be used with a small insert member without an eyelet, a medium insert member, or a large insert member).

[0250] Now, refer to FIGS. 21A-1 to 21B. In a further embodiment, the positioning and stabilization structure 3300 includes an insert member 8387. The insert member 8387 is positioned at the upper part of the patient's head (for example, above the patient's upper ear tragus point) during use (where a connecting portion 8345 is included within the insert).

[0251] In this further form, the insert member 8387 forms part of a hoop that extends over the upper part of the patient's head. This hoop employs the insert member 8387, the tube 3350, and the cushion assembly 3150. During use, the portion of the insert member 8387 extends over the vertex region of the patient's head (for example, placed on the patient's frontal bone and / or parietal bone in the upper region of the patient's head).

[0252] Since the insert member 8387 includes a U-shaped tube having three ports, the insert member 8387 is fluidly connected to each end of the tube 3350 and the air delivery tube 4170 (not shown) during use. For example, the central port 8602 on the upper side of the insert member 8387 is configured to connect to or include the connection port 3600 (not shown).

[0253] Since the insert member 8387 can be configured to be selectively connected to the tube 3350, the user can select the actual length of the tube (by selecting an insert member 8387 of a specific length). The insert member 8387 can be removed from the positioning and stabilizing structure 3300 and replaced with a first insert member as shown by the dotted lines in FIGS. 21A-1 and 21A-3. Any number of replacement insert members can be provided, in which case each insert member can have a different length and can be marked by size notification (e.g., small, medium, or large). For example, the tube section that a large insert member 8387 can have extends outward from the central port 8602 by a greater distance compared to the length (as shown by the length L in FIG. 21A-3) of the tube section that extends outward from the central port of a medium or small insert member 8387.

[0254] The insert member 8387 includes a connection portion 8345 in the form of an outlet at the end of the protrusion 8604. The protrusion 8604 extends downward (e.g., downwardly) from both lower sides 8606 of the insert member 8387. In some forms, the protrusion 8604 and the outlet 8345 are disposed on one lower side 8606 of the insert member. The protrusion 8604 extends downward from the rear side of the insert member 8387. The outlet 8345 generally protrudes outward from each protrusion 8604 in the rearward direction.

[0255] The earlet 8345 can be removably attached to the tube 3350 (e.g., by hook-and-loop fastening material or a fastener). A portion of the hook-and-loop fastening material can be provided on the earlet tab 8608 of the earlet 8345. By providing a complementary portion of the hook-and-loop fastener material on a corresponding earlet tab (not shown) of the tube 3350, the earlet is fixed to the tube. In the example of the insert member 8387 (e.g., small, medium, or large), the earlet 8345 can be removably attached to each tube 3350 above the upper ear bottom point (thereby, for example, allowing a strap connected to the earlet 8345 to pass above the patient's ear).

[0256] The protrusion 8604 extends downward from the lower side 8606 of the insert member by a distance corresponding to the length of the insert member 8387. For example, the protrusion 8604 that a large insert member 8387 may have extends downward by a greater distance compared to the length of the protrusion 8604 extending from a medium or small insert member 8387.

[0257] Advantageously, by corresponding the earlet position to the insert member length, it becomes possible to optimize the positioning and the fit feeling of the positioning and stabilization structure 3300 for different head shapes and sizes. By using different earlet positions for each length of the insert 8387, both the earlet 8345 and the rear strap 3310 (not shown) are reliably and optimally positioned with respect to the patient's ear. Further, the direction and magnitude of the force applied from the rear strap 3310 to the patient interface 3300 can be optimized by the corresponding insert length and earlet position.

[0258] 8.3.3.3.4 Cuttable Tube In another embodiment of the present technology, the tube 3350 can be cut to a desired length. To assist the patient or clinician in determining where to cut the tube 3350, these tubes may include one or more indicators indicating where to cut the tube to fit the patient interface to heads of different sizes. For example, lines or punched holes indicating the location to be cut may be provided around the diameter of the tube 3350. For each line or punched hole, marks of sizes such as "small", "medium" or "large" may be provided. 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.

[0259] In one embodiment, a cutting tool configured to cut the tube 3350 is supplied for the patient interface.

[0260] As a disadvantage of cutting the tube 3350 according to the size of the patient interface, if the tube is accidentally cut too short, it may be difficult to replace the cut section of the tube.

[0261] 8.3.3.3.5 Extendable tube In a particular form of the present technology, the adjustment mechanism includes one or more extendable sections 3355 of the headgear tube 3350 formed of an extendable material. The extendable section enables the length of the tube 3350 to be continuously adjusted to fit patient heads of different sizes. It is understood that a part of the tube can be extendable by the material constituting the tube (for example, when constituted by an extendable material), its configuration (for example, the bellows tube section 3362 shown in FIG. 3A is extendable by its configuration) or both.

[0262] The relatively extensible section of tube 3355 of the headgear tube 3350 shown in FIG. 13 is connected to one or more non-extensible or less extensible sections of tube 3354. When 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 attached to a certain length of the tube 3350 on one side of the extensible section 3355 and a second fixing member 3358 attached to a certain length of the tube 3350 on the other side of the extensible section 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). One of the fixing members 3358 may include a plurality of portions to which the other fixing member 3357 can be connected, enabling the tube 3350 to be fixed at the desired length.

[0263] In another embodiment, no fixing mechanism is provided and the elastic contraction of the extensible section 3355 automatically achieves a certain length of the tube 3350.

[0264] The extensible section of tube 3355 may include sections that are thinner than the less extensible section 3354. Alternatively or additionally, the extensible section of tube 3355 may include sections formed from a material that is softer and / or has a lower durometer value than the less extensible section 3354.

[0265] In one embodiment, the extensible section of tube 3355 has a cross-sectional thickness that decreases along its length. For example, the cross-sectional thickness may decrease in a stepped longitudinal cross-section. Alternatively, the cross-sectional thickness of tube section 3355 may alternate between a thicker longitudinal cross-section and a thinner longitudinal cross-section. The surface transitions between sections of different cross-sectional thicknesses may be smooth or abrupt. Regions of different cross-sectional thicknesses may have different stiffnesses and / or durometer values. The regions of different cross-sectional thicknesses may be formed from the same material or from different materials. By selecting the structure of the extensible section of tube 3355 using different materials and different cross-sectional thicknesses, a particular section of tube 3350 can be designed to be extended more than other sections. As a result, by causing the portion of tube 3350 that is positioned on the anatomical structure of a patient, particularly where there is a large difference in human size during use, to be extended more than other portions, it is possible to assist in fitting the patient interface to different patients. Additionally or alternatively, the extensible section of tube 3355 can be designed to substantially maintain a predetermined minimum aperture area during use such that the impedance of the patient interface to a breathable gas flow can be configured to match a respiratory therapy system (e.g., a desired gas flow rate).

[0266] 8.3.3.3.6 Different tube connection positions In certain forms of the technology, tube 3350 can be connected in a plurality of ways that allow for an effective length of the fluid path between connection port 3600 and the seal-forming structure 3100 to be adjusted.

[0267] In certain forms, each tube 3350 includes two or more separate tube members that can be fluidly connected at multiple positions to change the length of the fluid path formed by the tube members. In one form, the first tube member includes a plurality of ports along one side, and the second tube member includes one or more tubes that project from one side of the second tube member and engage with a selected port in the first tube member to fluidly connect the first tube member and the second tube member. The length of the tube 3350 formed by the first tube member and the second tube member can be adjusted by selecting which port to connect the projecting tube on the second tube member to. The ends of the first tube member and the second tube member adjacent to the connection port and the projecting tube are sealed so that breathable gas passes only through each tube member and does not leak intentionally. Also, the ports on one side of the first tube member may be provided with self-closing valves, in which case gas leakage when these ports are not connected to the second tube member is avoided.

[0268] In some forms of the present technology, multiple tube connections are provided at the connection ports and / or the cushion assembly 3150. For example, the plenum chamber 3200 may include two or more ports on each side to which the tube 3350 can be selectively fluidly connected. These ports can be arranged such that the size of the patient for which the patient interface is fitted is changed by adjusting which port to connect the tube to. For example, one port can be positioned closer to the patient's face than another port during use. Connecting to the tube 3350 closer to the patient's face allows for accommodation of a larger patient's head than connecting the tube 3350 to a port at a position remote from the patient's face.

[0269] 8.3.3.3.7 Changing the Patient Interface Loop In the patient interface 3000 included in a particular form of the present technology, the positioning and stabilization structure 3300 defines a loop configured to surround a part of the patient's head during use. In some forms of the present technology, for example, by one or more ties, a loop surrounding a part of the patient's head may be defined. For example, in the embodiment shown in FIG. 3A, the loop is defined by the tube 3350 and the cushion assembly 3150. When the patient interface 3000 is worn within the loop created by these components, the patient's head is positioned.

[0270] In some forms of the present 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, it becomes possible to individually adjust the patient interface to 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. Hereinafter, embodiments using other mechanisms for adjusting the loop size will be described.

[0271] 8.3.3.3.8 Loop adjustment mechanism In a particular form of the present technology, the patient interface 3000 includes a loop adjustment mechanism. This loop adjustment mechanism can operate to adjust the position that holds two regions of the positioning and stabilization structure 3300 together to adjust the loop size.

[0272] In FIG. 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 in the vicinity of the upper part of the patient's head during use. The strap 3390 may be formed to curve upward to accommodate the upper part of the patient's head. The strap 3390 may be formed of a flexible material, a rigid material, or a semi-rigid material.

[0273] In this embodiment, the loop of the patient interface 3000 that surrounds the patient's head when the patient interface 3000 is worn is defined by the strap 3390, the cushion assembly 3150, and the portion of the 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 length of the strap 3390 can be adjusted by the strap adjustment mechanism 3391. The strap adjustment mechanism 3391 may include an adjustable fastening attachment between two sections of the strap 3390. For example, one section of the strap 3390 can pass through a loop. This loop is attached to the end of the other section of the strap 3390 and attached to the strap 3390 using hook-and-loop material. Alternatively, these two strap sections can be connected together using poppers or interlocking members that can be connected at multiple different positions. In another embodiment, the two sections of the strap 3390 each include a rack portion that engages with a pinion or teeth. The length of the strap 3390 can be adjusted by rotating these teeth. In another embodiment, these two sections of the strap 3390 are telescopically slidable relative to each other and can be fixed in place via an interlocking mechanism, magnets, or frictional engagement.

[0274] In yet another embodiment, one or both ends of the strap 3390 can be connected to the tube 3350 by an adjustable strap connection mechanism so that the position where the strap 3390 is connected to one or both of the tubes 3350 can be changed.

[0275] 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 positioned around the upper end of the tube 3350 (i.e., the end of the tube 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 the 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 that holds the tubes together, and thus change the size of the loop defined by the patient interface 3000. Moving the band 3395 along the tube 3350 towards the connection port 3600 increases the size of the loop so that the patient interface can fit a larger head.

[0276] Due to an increased 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. The frictional force cannot substantially compress these tubes for the continuation of the airflow when the band 3395 is tightened. 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 place) can be provided on the inner surface of the band 3395. These detents can be disengaged from the ridges / protrusions by an appropriate mechanism that allows the band to be moved along the tube 3350 when desired.

[0277] In another embodiment, the upper sections 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 to change the loop size formed by the patient interface 3000, thereby enabling accommodation of patients with different head sizes. Since the slider can limit accidental movement, the patient will not accidentally change the size of the loop.

[0278] 8.3.3.3.8.1 Simultaneous adjustment In yet another embodiment, it is possible to adjust the lengths of the headgear strap 3310 and the strap 3390 together (i.e., simultaneously) in a single operation for changing the size of each loop surrounding a part of the patient's head and / or changing the position of each loop on the patient's head.

[0279] Referring to FIGS. 25A, 25B, and 25C, the rear strap 7310 defines a loop that passes between the tube 3350 and the cushion assembly 3150 at the rear side of the patient's head, similar to the embodiment of the headgear strap 3310. The front hoop 7390 defines a loop that extends over the upper part of the patient's head and employs the tube 3350 and the cushion assembly 3150, similar to the embodiment of the strap 3390. Thus, the front hoop 7390 may include at least one gas delivery tube 3350. In use, the front hoop 7390 extends across the patient's cheek region and is arranged to contact the region of the patient's head above the upper ear base point of the patient's head.

[0280] With a single operation by the adjustment mechanism 7391, it may be possible to simultaneously adjust both the rear strap 7310 and the front hoop 7390. The content of the adjustment by the adjustment mechanism 7391 may be a change in the actual length of the strap 7310 and / or the hoop 7390, an adjustment of the effective length of any or both of these components, and / or the position of any or both of these components on the patient's face.

[0281] The adjustment mechanism 7391 can simultaneously adjust the rear strap 7310 and the front hoop 7390 in a single operation to individually adjust the positioning and stabilization structure 3300 (to fit patients of different sizes). In other words, the length of the hoop 7390 extending over the upper part of the patient's head and the length of the rear strap 7310 extending behind the patient's head can be adjusted simultaneously. The adjustment mechanism 7391 can adjust the effective length of the rear strap 7310 and / or the effective length of the front hoop 7390 through a continuous length range (e.g., an infinite number of adjustments).

[0282] Referring now to FIGS. 26A and 26B, the link member 7394 may form part of the front hoop 7390. For example, the link member 7394 may be connected together to the two gas delivery tubes 3350 of the front hoop 7390. The link member 7394 may extend between the upper or end 7410 and the lower or end 7411 of the gas delivery tube 3350 such that the lower end 7411 forms part of the front hoop 7390. The link member 7394 includes the adjustment mechanism 7391, the first section 7392 and the second section 7393 of the front hoop 7390, and the rear strap 7310 of the first and second sections. The first and second sections of each hoop and strap may be connected in the opposing regions 7396 of the headgear tubing 3350. The positioning of the opposing regions 7396 may be selected to allow for optimal sizing of the patient interface.

[0283] In one example, the first section 7392 of each hoop and strap may extend through a link member 7394 attached to the end of the second section 7393 of each hoop and strap. Referring to FIGS. 26A and 26B, the first section 7392 and the second section 7393 of each hoop and strap each include a rack portion. The link member 7394 may take the form of a pinion or teeth, and the first section 7392 and the second section 7393 of each hoop and strap each engage the pinion or teeth. The lengths of the front hoop 7390 and the rear strap 7310 may be adjusted by rotation of the teeth, and may be individually adjusted to fit the positioning and stabilization structure 3300 to patients of different sizes.

[0284] In another form, the adjustment mechanism may take the form of an eyelet. In this form, the link member 7394 may include the first section 7392 and the second section 7393 of each hoop and strap connected around the eyelet. The eyelet may be attached to the end of the second section 7393 of each hoop and strap. The first section 7392 of each hoop and strap may extend through (e.g., may be threaded through) the eyelet and may be attached to itself using hook and loop material.

[0285] In yet another form, the link member 7394 may include a first hoop and a second hoop and a strap section connected together by a popper or interlock member that allows connection at a plurality of different positions.

[0286] In some further embodiments, the adjustment mechanism 7391 may take the form of a dial control, a drawstring, and / or an electronic control unit.

[0287] The link member 7394 can operate by adjusting the actual length of the link between the first section 7392 and the second section 7393 of each hoop and strap. Further, even if the length of the link is adjusted, the length of the headgear tubing 3350 does not change. However, by adjusting the link length, the sections of the tubing are drawn closer together or farther apart, so the effective length of the tubing 3350 is adjusted. For example, when the link length increases, the distance between the opposing regions 7396 of the headgear tubing 3350 can increase, and as a result, the effective length of the front hoop 7390 configured to surround the front of the patient's head can increase. Similarly, since the link 7394 forms part of the rear strap, when the distance between the opposing regions 7396 of the headgear tubing 3350 increases, the actual length of the rear strap 7310 configured to surround the front of the patient's head can increase.

[0288] Here, refer to FIGS. 25A, 25B, and 25C. In some forms, the adjustment mechanism 7391 can be a releasable mechanical connection (e.g., a dial control that allows for cable tensioning and release). The dial control can be connected to a cable inserted through the regions of the rear strap 7310 and the front hoop 7390. To shorten the length of the cable, the dial control can be wound in one direction, and to lengthen the length of the cable, the dial control can be wound in the opposite direction. In some forms, the length of the cable inserted through the regions of the rear strap 7310 and the front hoop 7390 can be changed at a uniform rate when the dial control is wound. Alternatively, when shortening one cable more than the other cables, the cable length adjustment can be performed at different rates when the dial control is wound. Such adjustments may be necessary for optimizing the force vectors.

[0289] Referring now to FIG. 27A. In some other forms, the adjustment mechanism 7391 can be a drawstring 7399 (e.g., one that can be formed from a cable). In this form, the drawstring 7399 can be configured along both the perimeter of the front hoop and the perimeter of the rear strap 7310. In a variation of this form, the drawstring 7399 of the front hoop 7390 can be configured along the entire perimeter of the front hoop 7390 or can be restricted to extend along a portion that extends over the top of the patient's head. Pulling or releasing the drawstring 7399 can simultaneously adjust the effective lengths of the front hoop 7390 and the rear strap 7310. Further, pulling or releasing the drawstring 7399 can cause the sections of the front hoop 7390 and the rear strap 7310 to be pulled together or released together, and the length of the link 7394 can be adjusted.

[0290] The drawstring 7399 can be inserted through a drawstring locking mechanism 7400. When the drawstring locking mechanism 7400 is deployed on the drawstring 7399, the drawstring 7399 can be fixed in place after adjustment of the drawstring length. The drawstring locking mechanism 7400 can have an opening for inserting (e.g., screwing) the drawstring 7399 through the front hoop 7390 and / or the rear strap 7310. The diameter of the opening can be made smaller than the diameter of the drawstring so that the drawstring 7399 is fixed in place by frictional force.

[0291] In some forms, the diameter of the opening can be adjustable. For example, when the diameter is small, frictional force for fixing the tightening string 7399 in a predetermined position can be obtained, while when the diameter is large, the tightening string 7399 can move more freely through the opening. The tightening string locking mechanism 7400 can include a release button 7401 capable of controlling the size of the opening. The opening can usually have a smaller diameter. The patient can pull the tightening string 7399 through the opening, but the situation where the tightening string 7399 returns through the opening can be restricted by the frictional force. The patient can engage with the release button 7401 to expand the diameter of the opening to a position (where the frictional force applied to the tightening string 7399 disappears). The tightening string 7399 can be biased into the opening and can automatically retract after the patient engages with the release button 7401. Thereby, it may be possible for the patient to quickly adjust (for example, increase or decrease) the exposed length of the tightening string 7399.

[0292] In some forms, the mechanical components of the adjustment mechanism described in this disclosure can be electronically controlled. For example, it may be possible to automatically move a rack and pinion arrangement or automatically fasten or loosen a cable. Referring to FIG. 28, the control unit 7402 can be arranged as part of the tubing 3350, enabling the sizing of the patient interface to be controlled. The control unit can be directly operable by using buttons on the control unit. Alternatively, the operation of the control unit may be performed remotely (i.e., by the mobile phone software application 7404). The connection of the mobile phone software application 7404 to the control unit 7402 can be made by Bluetooth, Wi-Fi, radio waves, or any similar form of wireless communication.

[0293] Referring now to FIGS. 25A, 25B, and 25C, in some forms, the front hoop 7390 and the rear strap 7310 of the positioning and stabilization structure 3300 can be added to the UCFF mask system. In this arrangement, two or more straps (e.g., the rear strap 7310 and the jaw strap 7320) can be attached to at least one of the headgear tube 3350 and the UCFF cushion assembly 3150. Since the adjustment mechanism 7391 can be operated to adjust the effective lengths of the front hoop 7390 and the rear strap 7310 within the UCFF system, each force vector of the positioning and stabilization structure 3300 can be adjusted.

[0294] Referring now to FIG. 29, the link can form part of the rear strap 7310. In this form, the adjustment of the rear strap 7310 can be performed in a single operation to simultaneously adjust the lengths of the front hoop 7390 and the rear strap 7310.

[0295] In some forms, the adjustment mechanism can form part of the rear strap. Referring now to FIG. 29, the adjustment mechanism 7391 can take the form of an end of the strap 7310. The intersection of the rear strap 7310 can be configured such that the end projects generally rearwardly by being screwed through a hole in the tab 7345. The adjustment mechanism 7391 at the end of the strap 7310 is attached to itself using hook and loop material or similar connecting means (e.g., snaps, magnets, etc.). In some forms, the adjustment mechanism 7391 can be located on one side of the patient's head and can allow for simultaneous adjustment of the rear strap 7310 and the front hoop 7390. The rear strap 7310 and the front hoop 7390 move relative to each other to adjust the effective length and / or positioning of the front hoop and rear strap configured to surround a portion of the patient's head.

[0296] The adjustment mechanism 7391 at the end of the rear strap 7310 can be connected to a cable 7406 inserted through the area of the rear strap 7310 and the front hoop 7390. Adjustment of the cable length can be done by increasing the traction of the rear strap 7310 through the tab 7345. The end of the rear strap 7391 can be fixed to itself after passing through the tab 7345.

[0297] In some forms, pulling the adjustment mechanism 7391 through the tab 7345 can change the lengths of the rear strap 7310 and the front hoop 7390 at an equal rate. In another form, pulling the adjustment mechanism 7391 through the tab 7345 at the end of the strap 7310 (such that one strap becomes shorter than the other) can adjust the lengths of the rear strap 7310 and the front hoop 7390 at different rates. This type of adjustment may be necessary for optimizing the force vectors.

[0298] 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 positioned around the upper end of the tube 3350 (i.e., the end of the tube 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 the loop that is partially defined by the tube 3350 surrounding a part 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, and thus the size of the loop defined by the patient interface 3000 can be changed. Moving the band 3395 along the tube 3350 towards the connection port 3600 increases the size of the loop so that the patient interface can fit a larger head.

[0299] Increasing the friction level between the band and the tube allows the band 3395 to 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 place) 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.

[0300] In another embodiment, the upper sections of these two tubes 3350 are fixed together by a clasp lock or a zipper. For example, a row of teeth of a clasp lock can be attached to one tube 3350, and another row of teeth of the clasp lock can be attached to 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 to change the loop size formed by the patient interface 3000, thereby accommodating patients with different head sizes.

[0301] The upper ends of the tubes 3350 as shown in FIG. 14 form a y-shaped configuration (i.e., two tubes converge into a single tube). Thus, the connection port can take the form of a y-shaped or v-shaped connection port 3600. Referring now to FIGS. 26A and 26B. Advantageously, the y-shaped configuration allows for an improvement in the laminar airflow within and through the headgear tubing 3350 compared to the flow through the above-described configuration of the patient interface 3000 (where the swivel elbow is connected at the connection port 3600 and oriented at 90 degrees with respect to the headgear tubing).

[0302] In some forms, the positioning and stabilization structure 3300 can include a disconnect mechanism 7600 that decouples the positioning of the conduits of the air circuit 4170 (e.g., the conveyance of pressurized air from the RPT device 4000 to the patient interface 3000) to enable positioning of the conduits of the air circuit 4170 from the movement of the seal forming structure 3100 in a direction away from the patient's face during use. In some forms, the disconnect mechanism 7600 can disconnect the positioning of at least a portion of the gas delivery tubes 3350 from the movement of the seal forming structure 3100 in a direction away from the patient's face during use, thereby enabling positioning of the conduits of the air circuit 4170 and / or the gas delivery tubes 3350 on the patient's head. In some forms, the disconnect structure 7600 can include a y-shaped (or v-shaped) arrangement. The tube connector 7407 can partially form a y-shaped or v-shaped arrangement (by connecting each gas delivery tube 3350 to a single body). The upper end 7410 of the gas delivery tube 3350 can be connected to the tube connector 7407. In some forms, during use, the disconnect structure 7600 is biased towards the rear of the patient's head. In other forms, the disconnect structure 7600 can be elastically flexible, enabling the conduit to freely move between rear, side, and front positions of the patient's head.

[0303] Referring to FIGS. 30A-32, in an example of the present embodiment, the disconnection mechanism 7600 may include a swivel joint 7408. The swivel joint 7408 may include a first end connected to the pipe connector 7407. In this configuration, the upper portion or end 7410 of the pipe 3350 converges to form one end of the pipe connector 7407, and the swivel joint 7408 extends from the other end of the pipe connector 7407 for forming an arrangement configuration of a y-shaped (or v-shaped) shape. In some configurations, the swivel joint 7408 may be a swivel elbow and may include a bent portion (e.g., a 90° bent portion). In some configurations, the swivel joint 7408 may be constructed from a flexible material (e.g., the same material as the pipe 3350). In some configurations, the swivel joint 7408 may be constructed from a rigid material or a semi-rigid material.

[0304] The swivel joint 7408 may include a first end directly connected to the pipe connector 7407 (however, the first end may be directly connected to at least one of the gas delivery pipes 3350). The swivel joint 7408 also includes a second end opposite the first end. The second end functions as a connection port 3600. In other words, the conduit of the air circuit 4170 may be directly connected to the second end of the swivel joint 7408.

[0305] The swivel joint 7408 and the flexible upper end 7410 of the gas delivery tube 3350 both function as a disconnect mechanism. In other words, the disconnect mechanism 7600 includes the swivel joint 7408, the tube connector 7407, and the upper end 7410 of the tube 3350. Advantageously, the swivel joint 7408 of the disconnect mechanism 7600 allows the air circuit 4170 to move relative to the seal-forming structure 3100 of the patient interface 3000. Specifically, since the swivel joint 7408 can rotate relative to the tube connector 7407, the upper end 7410 of the tube 3350 is not twisted even when the swivel joint 7408 rotates. The swivel joint 7408 enables the position adjustment of the conduit of the air circuit 4170, and the risk of destabilization of the seal against the patient's face of the seal-forming structure 3100 can be reduced.

[0306] The disconnect structure 7600 may also allow the upper end 7410 of the gas delivery tube 3350 to move relative to the rest of the gas delivery tube 3350. For example, the upper end 7410 of the tube 3350 can be made in a corrugated shape or can include a bellows section, so that the upper end 7410 can be bent (i.e., the upper end 7410 can be made bendable). Thereby, additional degrees of freedom can be provided to the entire disconnect structure 7600, and the movement of the upper end 7410 of the gas delivery tube 3350 relative to the lower end of the gas delivery tube 3350 can be possible (without interfering with the seal of the seal-forming structure 3100).

[0307] Now, refer to FIGS. 30A and 30B. In some forms, the disconnect structure 7600 includes a swivel joint 7408 configured to rotate about a single axis 7412. In this form, the swivel joint 7408 can be configured to rotate about a single axis parallel to the axis 7413 of the tube 3350 connected to the disconnect structure 7600 (e.g., the non-bent portion of the upper end 7410 as shown in FIG. 30A).

[0308] In some configurations, the upper end 7410 can be bent relative to the remainder of each tube 3350, at least partially due to the weight of the swivel joint 7408.

[0309] Referring now to FIGS. 31A, 31B, 32A and 32B, in some other configurations, the disconnect structure 8600 includes a plurality of swivel joints arranged as a sub-assembly of components configured to rotate about more than one axis.

[0310] Referring to FIGS. 31A and 31B, the swivel joint 8408 includes a first swivel 8415 and a second swivel 8416. The first swivel 8415 can be directly connected to the tube connector 8407 and can rotate about a first axis of rotation 8414 oriented perpendicular to the axis 8413 of the upper end 8410 of the tube 3350 (e.g., non-bent tube 3350 as shown in FIG. 31A). The second swivel 8416 can be connected adjacent to the first swivel 8415 and can provide a second axis of rotation 8412. The second axis of rotation 8412 can be oriented perpendicular to the first axis of rotation 8414. The second axis of rotation 8412 can be oriented parallel to the axis of the tube 3350 (e.g., non-bent portion of the upper end 8410 as shown in FIG. 31A). The first swivel 8415 and the second swivel 8416 can be rotatable simultaneously and / or can be openable independently of each other.

[0311] Referring to FIGS. 32A and 32B, a further variation of the disconnect structure 9600 may include a swivel joint 9408 with two rotational axes. The first swivel 9415 of the swivel joint 9408 may be directly connected to the tube connector 9407 and configured to rotate along the tube 3350 (e.g., the non-bent portion of the upper end 9411 as shown in FIG. 32A) around a first rotational axis 9414 parallel to the axis 9413. The second swivel 9416 of the swivel joint 9408 may be connected adjacent to the first swivel 9415 and may provide a second rotational axis 9412 perpendicular to the first rotational axis 9414. The second rotational axis 9412 may also be oriented perpendicular to the axis 9413 of the tube 3350 (e.g., the non-bent portion of the upper end 9411 as shown in FIG. 32A). The first swivel 9415 and the second swivel 9416 may be rotatable simultaneously and / or may be openable independently of each other.

[0312] The swivel joints 8408 and 9408 of both the disconnect structure 8600 and the disconnect structure 9600 include two degrees of opening freedom. The difference between the two disconnect structures 8600 and 9600 is related to the axis adjacent to the upper end 9411. As a result, the direction in which pressurized air flows into the disconnect structures 8600 and 9600 can be determined. For example, when the rotational axis 8414 is a vertical axis, the conduit for conveying pressurized air to the disconnect structure 8600 may extend substantially horizontally from the disconnect structure 8600. The opposite configuration applies to the disconnect structure 9600, in which case the conduit may extend substantially vertically. A patient may desire one of the disconnect structures 8600 and 9600 over the other based on a preferred sleeping position.

[0313] As best shown in FIG. 25A, the adjustment mechanism 7391 can be disposed in the vicinity of the top of the patient's head and in front of the Y-shaped connection release structure 7600 (i.e., in front of the Y-shaped connection release structure 7600). A conduit connected to the Y-shaped connection release structure 7600 (e.g., at the second end of the swivel joint 7408) can extend behind the adjustment mechanism 7391 so as not to cover or otherwise interfere with the adjustment mechanism 7391. Thereby, access by the patient to the adjustment mechanism 7391 can be facilitated (without interference from the Y-shaped connection port 7600). In another illustrated embodiment not shown, the adjustment mechanism 7391 can be disposed in the Y-shaped connection port 7600 or behind the Y-shaped connection port 7600.

[0314] Here, reference is made to FIGS. 26A and 26B. In some forms, the upper ends 7410 of the two tubes 3350 are fixed together by the adjustment mechanism 7391. The adjustment mechanism 7391 can be disposed on the top of the head (e.g., can be placed on the patient's frontal bone and / or parietal bone) in front of a Y-shaped junction that mainly converges.

[0315] In some forms, the adjustment mechanism 7391 can adjust the length of the front hoop 7390. A separate rear strap 7310 similar to the embodiment of the headgear strap 3310 can be positioned behind the patient's head and between the tubes 3350. Since the adjustment mechanism 7391 and the rear strap 7310 can be independently operable, the positioning and stabilization structure 3300 can be adjusted to fit patients of different sizes.

[0316] In some forms, the adjustment mechanism 7391 can individually adjust the positioning and stabilization structure 3300 (to fit patients of different sizes) by simultaneously adjusting the front hoop 7390 and the rear strap 7310 in a single operation. In this form, it is possible to simultaneously adjust both the length of the hoop extending over the upper part of the patient's head and the length of the rear strap extending behind the patient's head.

[0317] The adjustment mechanism 7391 can hold the tubes 3350 together in the upper section and can determine the size of the hoop partially defined by the tubes 3350 that surround a portion of the patient's head when the patient interface 3000 is worn.

[0318] Referring now to FIGS. 26A and 26B, the adjustment mechanism 7391 can include a link member 7394 between first 7392 and second 7393 sections of the front hoop 7390 and the rear strap 7310. As previously described for another embodiment of simultaneous adjustment, the link member 7394 can operate by adjusting the link length between the first hoop section 7392 and the second strap section 7393.

[0319] Referring now to FIGS. 26A and 26B. By adjusting the link member 7394 to different lengths, the link length between opposing regions 7396 of the headgear tubing 3350 can be changed. Increasing the length of the link member 7394 enables the positioning and stabilization structure 3300 to fit a larger head. Conversely, reducing the length of the link member 7394 enables the positioning and stabilization structure to fit a smaller head.

[0320] In some forms, the front hoop 7390 may include a textile element. In another embodiment, the front hoop may be entirely made of textile. Referring to FIGS. 27B-1 and 27B-2, the link member 7394 may include a first section 7292 and a second section 7293 as textile straps, and an adjustment mechanism disposed therebetween. The first section and the second section may be connected together by an adjustment mechanism in the form of a locking mechanism 8400. Referring to FIGS. 27B-1 and 27B-2, the locking mechanism 8400 may include an opening. Here, the first section 7392 and the second section 7393 of the strap are inserted through the opening. This opening may be configured to fix the strap after adjustment of the strap length. The diameter of the opening may be made smaller than the diameter of the strap so that the strap is fixed in the set position by frictional force.

[0321] 8.3.3.3.9 Loop Insert In certain forms of the technology, the positioning and stabilization structure 3300 includes one or more loop insert members. These loop insert members are configured to be fixed to another part of the patient interface 3000 (e.g., directly or indirectly fixed to the tube 3350). The loop insert member(s) are configured to be fixed so as to at least partially define a loop that surrounds a portion of the patient's head during use. By adjusting the size of the loop insert member or replacing the loop insert member with a loop insert member of a different size, the loop size can be adjusted to accommodate different sizes of patient heads.

[0322] One embodiment of the present technology is shown in FIG. 15. In this embodiment, the patient interface 3000 includes a loop insert member 3410. The loop insert member 3410 is connected to the lower side of the tube 3350 and the connection port 3600 and is positioned between the patient's head and the tube 3350 and the connection port 3600 during use. The loop insert 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 in the absence of the loop insert member.

[0323] The loop insert member 3410 is removably attached to the tube 3350. Therefore, the loop insert member 3410 can be removed and replaced with one or more replacement loop insert members 3411a, 3411b, or 3411c. The replacement loop insert members 3411a, 3411b, or 3411c are different in size from the loop insert member 3410, and by selecting the loop insert member, the size of the loop that surrounds a part of the patient's head can be adjusted, and as a result, the patient interface can be adapted to fit the patient more comfortably and securely. If the loop insert members 3410 and 3411 can be removed, it is also advantageous in terms of being able to be cleaned.

[0324] Since the loop insert member can be formed from a rigid or semi-rigid material that can be spaced from the patient's head by the tube 3350 during use, the shape of the loop that surrounds the patient's head can be changed. Using a material having a certain elasticity and flexibility can increase comfort during wearing (for example, a foam or gel material). Since the loop insert member comes into contact with the patient's hair or skin during wearing, the loop insert member is preferably formed of a material that can be easily cleaned.

[0325] The loop insert members 3410 and 3411 shown in FIG. 15 are generally U-shaped, and the apex of the letter "U" is positioned above the upper part of the patient's head under the connection port 3600 during use. As a result, it is assisted to adapt the patient interface to the shape of the upper part of the patient's head. In other embodiments, insert members of different shapes are used. For example, the insert member may include a short linear pad configured to contact a small area of the patient's head. The interchangeable insert member 3411 of different sizes may have different thicknesses, different lengths, and / or different levels of curvature. The patient contact surface of each insert member may be the same or similar to conform to the shape of the patient's head, regardless of the insert member used.

[0326] The loop insert members 3410 and 3411 are attached to the tube 3350 by a fastening mechanism. In one embodiment, the fastening mechanism includes hook and loop material. This hook and loop material is attached to the lower side of the tube 3350 and the upper sides of the loop insert members 3410 and 3411. In other embodiments, poppers, hemispherical shapes, clasp lockers, or magnets are used to connect the loop insert members 3410 and 3411 to the tube 3350.

[0327] In the embodiment of FIG. 15, the patient interface 3000 includes a single loop insert member 3410, and the replacement loop insert member 3411 is a single component or a monolithic component. In other embodiments, multiple loop insert members can be attached to the tube 3350 at any timing. For example, by attaching multiple loop insert members along the length of the tube 3350, they can function as multiple spacers that space different parts of the patient's head from the tube 3350. In another embodiment, multiple loop insert members 3410 and replacement loop insert members 3411 can be attached onto the tube 3350 at any timing. For example, loop insert members of different sizes can be arranged concentrically. To achieve this, the loop insert members 3410 and 3411 can be connected to each other using, for example, any of the loop insert member connection mechanisms described above.

[0328] In a further embodiment of FIG. 15, a pocket or pouch can be connected to the side of the tube 3350 or formed within the side of the tube 3350. This pocket can preferably be made of an elastic material (e.g., textile or silicon) that allows for easy insertion of the insert member 3410 into the pocket. In this form, the insert member 3410 can be made of a rigid material (e.g., Hytrel), and the distal end of the member is inserted into the pocket. In this embodiment, by selectively inserting a rigid material into the pocket, the overall elasticity of the positioning and stabilization structure 3300 is adjusted. For example, a portion of the tube 3350 is stretchable, and the rigid insert member 3410 can be used to maintain a predetermined amount of stretching within a section of the tube 3350.

[0329] In a further embodiment shown in FIG. 22, the positioning and stabilization structure 3300 can include an adjustment mechanism in the form of an insert member 9410 used in combination with a stretchable tube 9350.

[0330] In this further embodiment, the insert member 9410 forms a portion of a hoop that extends over the top of the patient's head and is defined by a loop that employs the tube 9350 and a cushion assembly 3150 (not shown). In use, the hoop extends across the patient's cheek region and is positioned to contact a region of the patient's head above the superior tragus of the patient's head.

[0331] In some forms, the insert member 9410 can be constructed from a rigid material (e.g., Hytrel). The extensible tube 9350 can include one or more extensible sections 9355 formed of an extensible material. A portion of the tube can be extensible by the material that makes up the tube (e.g., if it is formed of an extensible material), its configuration (e.g., the bellows tube section 3362 shown in FIG. 3A is extensible by its configuration), or both.

[0332] In use, the extensible section of the tube 9355 can be positioned over the top of the patient's head. The extensible section of the tube 9355 can be connected to one or more relatively inextensible or less extensible sections of the tube 9354. In some forms, the extensible section of the tube 9355 and / or the relatively inextensible or less extensible section or the thin-walled extensible sections of the tubes 9354 and 9355 can be made of silicon. In some other forms, at least some sections of the tube 9354 can be made of a textile material (e.g., spandex). In some other forms, a combination of materials such as silicon and textile can be used.

[0333] The fastening of the insert member 9410 to the tube 9350 can be performed by at least one retainer or first fastening member 9357 attached on the lower side of the tube 9350 (e.g., on the outer surface of the tube 9355) on both sides of the extensible section 9355. For example, one first fastening member 9357 can be attached to either end of the extensible section 9355 (e.g., the left end and the right end) (e.g., in the vicinity of the section 9354 that is relatively non-extensible or has a lower possibility of extension). When the positioning and stabilization structure 3300 is used, the first fastening member 9357 can be exposed to the surroundings. The second fastening member 9358 can be attached to both ends on the upper side of the insert member 9410. The first fastening member 9357 and the second fastening member 9358 are configured to be connected together by any suitable mechanism (e.g., hook and loop material). When attached to the first fastening member 9357, the insert member 9410 can be exposed to the surroundings and can contact the upper region of the patient's head (e.g., the insert member 9410 can be placed on the frontal bone and / or the parietal bone).

[0334] The extensible section of the tube 9355 enables the actual length of the tube 9350 to be changed when the rigid insert member 9410 is attached. The size of the hoop surrounding a part of the patient's head is changed corresponding to the length of the attached insert 9410 compared to the size of the hoop in the case where there is no insert member. By adjusting the size of the insert member or by replacing the insert member with an insert member including inserts of different sizes, it becomes possible to change the size of the hoop (to correspond to different sizes of the patient's head). In the embodiment shown in FIG. 22, three insert members 9410 of different lengths can be selectively fastened to the tube 9350. Each insert member 9410 of a different length is marked by a size notification (e.g., "S" (e.g., 9410a) for small, "M" (e.g., 9410b) for medium, and "L" (e.g., 9410c) for large).

[0335] To attach the insert member 9410, a second fastening member 9358 on one end of the insert member 9410 can be connected to a first fastening member 9357 on one end of the extendable section 9355. The insert member 9410 can be longer than the distance between the first fastening members 9357 on the other end of the extendable section 9355. The patient may need to extend the extendable section 9355 for alignment and connection of the first fastening member 9357 and the second fastening member 9358. After both second fastening members 9358 are connected to each first fastening member 9357, the length of the extendable section 9355 increases (i.e., the length of the extendable section becomes longer than its length in the relaxed position). The total increase in length can depend on the particular insert member 9410 (e.g., small, medium, or large) selected by the patient. The selected insert member 9410 can be positioned substantially symmetrically around the sagittal plane of the patient.

[0336] By extending the extendable section 9355 prior to the patient positioning and donning the positioning and stabilization structure 3300, improvement in patient comfort can be facilitated. For example, pre - extension of the extendable section 9355 (i.e., due to attachment of the insert member 9410) can limit the frictional force experienced by the patient from the extendable section 9355 that pulls on the patient's hair and / or skin.

[0337] In some alternative forms of the example shown in FIG. 22, the insert member 9410 can be releasably fastened inside the tube 9350. In this example, the insert member can be inserted into the tube through the central port 9602 and fastened to the bottom wall (e.g., the inner wall) of the tube 9350 by a fastening member (e.g., hook and loop material (not shown)). Thus, the insert member 9410 is provided within the pressurized volume of the tube 9350 during use (e.g., as opposed to being exposed peripherally). The insert member 9410 of FIG. 22 can be connected to the tube 9350 in a manner substantially similar to the insert member 9410 of FIG. 21 (e.g., after the stretchable section 9355 has been pre-stretched, the positioning and stabilization structure 3300 is worn by the patient).

[0338] In the form of the present technology shown in FIG. 16, the patient interface 3000 includes an inflatable loop insert member 3420. The inflatable loop insert member 3420 can 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 inside and outside this opening, the size of the bladder can be changed, and as a result, the size of the loop defined by the patient interface 3000 that surrounds a portion of the patient's head during use can be adjusted. In one embodiment, the patient interface includes a pump button. Repeatedly pressing this pump button causes air to be introduced into the bladder through a valve.

[0339] In the form shown in FIG. 16, the patient interface includes a single U-shaped bladder 3420. This U-shaped bladder 3420 is connected to each tube 3350 above the upper part of the patient's head on either side of the patient's head. The thickness of the bladder 3420 can be maximized at the upper part of the patient's head so as to be able to correspond to the symmetrical movement of the tube 3350 in the direction away from the surface of the patient's head when the bladder is inflated. In other embodiments, a plurality of inflatable bladders are attached onto the tube 3350. These inflatable bladders can be inflated collectively or individually. The individually inflatable bladders enable the patient to change the fit feeling of the patient interface as desired, for example, by inflating the bladder more on one side of the head than on the other side.

[0340] In FIGS. 23A and 23B, in a further form of the present technology, the patient interface 3000 includes an adjustment mechanism in the form of an inflatable portion 10420. The hoop formed by the inflatable portion 10420 is defined by a loop. This loop extends over the upper part of the patient's head and employs the tube 3350 and the cushion assembly 3150. In use, the hoop extends across the patient's cheek region and is arranged to contact the region of the patient's head above the upper ear base point of the patient's head.

[0341] In some forms, the inflatable portion 10420 is retained by a retainer disposed within the side of the gas delivery tube 3350. In some forms, the retainer can be one or more fasteners (e.g., hook and loop material) secured to the tube 3350, and the inflatable portion 10420 is selectively coupled to the tube 3350. The fasteners can be provided at each end of the inflatable portion 10420 to secure the inflatable portion 10420 to the tube 3350. For example, the fasteners can be disposed on the upper surface of the inflatable portion 10420 and connected to the lower surface of the gas delivery tube 3350. The inflatable portion 10420 can contact the upper portion of the patient's head (e.g., at a position placed on the frontal bone and / or the parietal bone) while the patient is wearing the patient interface 3000. Another form of retainer can include a loop (not shown) surrounding the tube 3350.

[0342] In another form, the inflatable portion 10420 can be secured to the tube 3350 (e.g., can be integrally formed with the tube).

[0343] In certain forms, the patient interface 3000 can include a plurality of inflatable portions 10420. For example, the inflatable portions 10420 can be connected to the gas delivery tube 3350 separately (e.g., removably or integrally). Further, the inflation of the inflatable portions can be performed independently or simultaneously.

[0344] The inner surface of the tube 3350 may include one or more inflatable portions 10420 that contact the patient's head. The inflatable portions can be used to adjust the position of the gas delivery tube on the patient's head and to change the effective length (e.g., inner circumference) of the hoop. Referring to FIG. 23A, a state in which the inflatable portion 10420 is in a decompressed state is illustrated. Here, the effective length of the hoop is maximized so as to accommodate patients with larger head sizes and shapes. Referring to FIG. 23B, a state in which the inflatable portion 10420 is in an inflated state is illustrated. Here, the effective length of the hoop is reduced (e.g., compared to the inflated state) so as to accommodate patients with smaller head sizes and shapes. In other words, the inflated state of the inflatable portion 10420 reduces the inner circumference of the hoop. The inflatable portion 10420 can expand in a direction approaching the center of the hoop (e.g., in a direction approaching the patient's head) and be brought into contact with the patient's head. The amount of inflation of the inflatable portion 10420 can be changed according to the individual patient's head. Thus, in the case of a patient with a small head, it may be necessary to inflate the inflatable portion 10420 more than in the case of a patient with a large head. The change in the effective length of the hoop correspondingly changes the force vector applied from the positioning and stabilization structure 3300 to the patient's head. The change in the effective length of the hoop can also change the tension applied from the gas delivery tube 3350 to the patient. In other words, by bringing the inflatable portion 10420 into an inflated state, the contact between the inflatable portion 10420 and the patient's head can be made narrower for restricting translational movement (e.g., in the front-rear direction) along the patient's head.

[0345] In some forms of the present technology, the volume of air in the inflatable portion 10420 can be controlled by the patient. For example, providing a valve in the inflatable portion 10420 enables the patient to provide air for inflation of the inflatable portion 10420 or remove air for decompression of the inflatable portion 10420. Advantageously, by enabling the patient to control the volume of air in the inflatable portion, a sense of control can be provided to the patient. After wearing the patient interface 3000, the patient may be able to adjust the volume of air in the inflatable portion 10420 (such that the inflatable portion is neither too tight nor too loose with respect to the patient's head).

[0346] In some other forms, the inflation of the inflatable portion 10420 can be performed by automatic means. This automatic means may include an inflatable portion, an instrument capable of detecting the inflation pressure of the inflatable portion, and one or more sensors may be employed. As shown in FIG. 24, the patient may activate the system 10500, and the controller may retrieve the stored pressure value 10505. The sensor may monitor the pressure within the inflatable portion 10510 and communicate with the controller 10515 for control of the valve opening and closing times and adjustment of the pressure within the inflatable portion 10520.

[0347] In some forms, the patient may wear the patient interface 3000, and the inflatable portion 10420 can be inflated until the patient indicates that the pressure within the inflatable portion 10420 has become comfortable. The controller may store the set valve, and by comparing the stored pressure valve with the pressure measured by the sensor, the inflatable portion 10420 can be inflated to the same level for each successive use.

[0348] In some forms, the sensor can be an optical sensor and / or a position sensor, and can detect the proximity between the patient's head and the inflatable portion 10420 for determination of the amount of air to be introduced into the inflatable portion 10420.

[0349] In some forms, the flow from the pressurized breathable gas RPT device 4000 can be diverted into the inflatable portion 10420. The conduit 10424 that may be included in the inflatable portion 10420 may be connected directly to the RPT device 4000 or alternatively may be connected to the gas delivery tube 3350. An inlet valve (e.g., one that can be adjusted automatically or manually) may selectively allow pressurized breathable gas to enter into the inflatable portion 10420. By selectively actuating an outlet valve, air can be released from the inflatable portion 10420.

[0350] As shown in FIG. 24, in a further embodiment of another form, one or more sensors may be included that can detect the occurrence of apnea 10525. When the sensor detects apnea 10525, the inflatable portion 10420 can automatically adjust the inflation level (10530) to change the effective length of the hoop. By changing the effective length of the hoop during apnea, the direction and magnitude of the force applied to the positioning and stabilization structure 3300 can be optimized, a secure fit can be re-established, and a seal can be provided to the patient. Changing the hoop length can lead to a reduction in the occurrence of further apnea, and the controller can save the newly set pressure value for the patient (10535). The system can compare this new value with the current pressure sensed (10510) within the inflatable portion 10420 (10515). Next, the system can perform further pressure adjustment (10520) (e.g., if the values are not equal) or can continue to sense for apnea (10525) (e.g., if the values are equal).

[0351] The inflatable portion 10420 can be constructed of a textile material. In some forms, the inflatable portion 10420 can be constructed of silicon. In some other forms, a combination of materials such as, for example, textile and silicon can be used together in forming the inflatable portion.

[0352] 8.3.3.3.10 Size of Headgear Tubing Dimensioning As described above, the positioning and stabilization structure 3300 can be configured to be mounted with the upper portion of the headgear tubing 3350 positioned at different positions according to the patient. For example, the position of the connection port 3600 of the patient's head during use can vary within a certain range of forward / backward positions in the sagittal plane. The headgear tubing 3350 that fits in a manner surrounding the circumference of the patient's head can be smaller when the upper portion of the headgear tubing 3350 is mounted more forward compared to when the headgear tubing 3350 is mounted further back. In some forms, the positioning and stabilization structure 3300 allows a patient with a large head size to mount the upper portion of the headgear on their head at a more forward (e.g., forward) position, thus reducing the amount of length adjustment required for the adjustment mechanism 3360 to accommodate the large head size.

[0353] Figure 3J shows three illustrations of patient interfaces 3000a, 3000b, and 3000c according to one form of the present technology. Each illustration of the patient interface 3000 is shown at different positions on the patient's head for comparison. The patient interface 3000b is shown in solid lines at the central position, and the patient interfaces 3000a and 3000c are shown in imaginary lines and are mounted forward and backward, respectively. In each of the illustrations of 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 with "a", "b", and "c". If there is no change in the length of the adjustment mechanism 3360, the patient interface 3000a (forward position) can fit a larger head (shown in imaginary lines) because it is mounted forward. Similarly, the patient interface 3000c (rear position) can fit a smaller head (shown in imaginary lines) appropriately with the adjustment mechanism 3360 of the same length.

[0354] ​In one illustration of FIG. 3J, as indicated by the reference numeral labeled with “b”, the patient is wearing the headgear at the central position. At this central position, the adjustment mechanism 3360b and the connection port 3600b are generally aligned in the vertical direction (e.g., parallel to or in the same plane as the coronal plane). The connection port 3600b is centered on the anterior-posterior axis. That is, the connection port 3600b is not disposed at a generally anterior (e.g., front) position or a generally posterior (e.g., rear) position but at the central position. The connection port 3600b is disposed at the upper point of the patient's head. The connection port 3600b can be positioned within the sagittal plane and aligned with the upper ear base point in a plane parallel to the coronal plane. The upper ear base point is shown in FIG. 2D.

[0355] In another illustration of FIG. 3J identified by the reference numeral labeled with “a”, the patient is wearing the headgear tubing 3350a at a relatively anterior position compared to the position of the headgear tubing 3350b (e.g., an anterior and inclined position relative to the coronal plane). In this configuration, the connection port 3600a is positioned generally anterior to the adjustment mechanism 3360a. At this position, the connection port 3600a is anterior to the upper ear base point. In another illustration of FIG. 3J identified by the reference numeral labeled with “c”, the patient is wearing the headgear tubing 3350c at a relatively posterior position compared to the position of the headgear tubing 3350b (e.g., a posterior and inclined position relative to the coronal plane). In this configuration, the connection port 3600c is positioned generally posterior to the adjustment mechanism 3360c. In this configuration, the connection port 3600c is posterior to the upper ear base point.

[0356] When worn at the position indicated by the headgear 3300a in FIG. 3J, the headgear tubing 3350a generally fits around a smaller circumference of the patient's head, enabling the positioning and stabilization structure 3300 to be worn at a relatively forward position, and making it possible to accommodate patients with larger heads (shown by the imaginary line). Similarly, when worn at the position indicated by the positioning and stabilization structure 3300c in FIG. 3J, the headgear tubing 3350c generally fits around a larger circumference of the patient's head, so that the positioning and stabilization structure 3300 can be worn at a relatively rearward position, thus making it possible to accommodate patients with smaller heads (shown by the imaginary line). The positioning and stabilization structure 3300 can generally be worn at positions within a continuous range between a generally forward position and a generally rearward position, depending on factors such as the patient's head size, head shape, and personal preferences. In some forms, the present technology's positioning and stabilization structure 3300 is configured to be worn such that the connection port 3600 is positioned at a position approximately 20 mm forward (e.g., anterior) from the central position to approximately 20 mm rearward (e.g., posterior) from the central position at the upper point of the head (the position arranged in the coronal plane) during use. In some forms of the present technology, the upper portion of the headgear tube 3350 (e.g., the portion above the rear strap 3310) is configured to flex, bend, or move in the forward or rearward direction (with substantially no corresponding movement in the lower or non-adjustable tube section 3363 (e.g., the portion below the rear strap 3310)). In other forms of the present technology, the upper and lower portions can move together (although not necessarily to the same extent). The rear strap 3310 can be configured to avoid or resist such movement of the non-adjustable tube section 3363. For example, by moving the upper portion of the headgear tube 3350 forward onto the patient's head (without loosening the rear strap 3310), it may be necessary to move the upper portion of the headgear tube 3350 more than the non-adjustable tube portion 3363.

[0357] In addition to being able to separately attach the positioning and stabilization structure 3300 at different forward / backward positions, in some forms of the present technology, the headgear tubing adjustment mechanism 3360 enables the positioning and stabilization structure 3300 to fit heads of different sizes. The headgear tubing adjustment mechanism 3360 can be configured to allow for a predetermined amount of length adjustment of the headgear tubing 3350. The amount of length adjustment of the headgear tubing 3350 can be determined at least in part based on a corresponding range of head sizes for which the positioning and stabilization structure 3300 is configured. In some forms of the present technology, the adjustment mechanism 3360 can enable the length of the headgear tube 3350 to be increased by an amount between approximately 10 mm and approximately 50 mm on either side of the positioning and stabilization structure 3300. In some forms of the present technology, the length increase can be performed on either side by an amount between approximately 20 mm and approximately 40 mm. In some forms of the present technology, the length increase that is performed is one of approximately 25 mm, approximately 30 mm, approximately 35 mm, or approximately 40 mm, and is performed on either side.

[0358] The patient interface 3000 shown in FIG. 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 in an imaginary line in a second configuration and is indicated by reference numeral 3360'. In the first configuration of the adjustment mechanism 3360, the headgear 3300 fits around the head of a patient with one size head, and in the second configuration of the adjustment mechanism 3360', the headgear 3300 fits around the head of a patient with a larger head. In this form of the technology, the adjustment mechanism 3360' enables the length of the headgear tube 3350 to be extended to fit around a larger head. As shown in FIG. 3K, the adjustment mechanism 3360 / 3360 enables the headgear to be adjusted (or adjusted) to accommodate different head sizes while the headgear is mounted in a central position (e.g., the connection ports 3600 / 3600' are centered above the upper point of the head within the coronal plane rather than in front of or behind the coronal plane).

[0359] In some forms of the present technology, the adjustment mechanism 3360 also enables the length of the headgear tube 3350 to be adjusted when the headgear 3300 is mounted at the front position, the center position, and / or the rear position. The patient interface 3000 shown in FIG. 3L includes the headgear 3300. The headgear 3300 is mounted at three positions on the patient's head as indicated by reference numerals with "a", "b", and "c". The positioning and stabilization structure 3300a is mounted at the front position, the positioning and stabilization structure 3300b is mounted at the center position, and the positioning and stabilization structure 3300c is mounted at the rear position. That is, the connection port 3600a is at the front position on the patient's head, the connection port 3600b is at the center position, and the connection port 3600c is at the rear position. At the front 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, by providing the adjustment mechanism 3360a at the front position, it becomes possible to reduce the length of the headgear tube 3350 (or reduce the elongation). At the rear position, the circumference of the patient's head around which the headgear tube 3350c fits is larger than the circumference at the center position. To accommodate this larger circumference, the adjustment mechanism 3360c makes it possible to make the length of the headgear tube 3350 longer compared to its length at the center position.

[0360] The combination of different positions where the positioning and stabilization 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. Such variety enables the positioning and stabilization structure 3300 to accommodate a wide range of head shapes and sizes (without undue discomfort) while allowing for a sufficient seal of the seal - forming structure 3150 against the patient's face. In some embodiments, the adjustment mechanism 3360 can reduce the magnitude of the length adjustment. This is because patients with larger head sizes can mount the upper portion of the headgear tubing 3350 in a forward position rather than relying solely on the adjustment mechanism 3360 to accommodate the larger head size. In other embodiments, the adjustment mechanism 3360 can increase the magnitude of the length adjustment, allowing patients with larger head sizes to mount the upper portion of the headgear tubing 3350 even further forward, thus enabling the patient interface 3000 to be adapted to a wider range of head sizes.

[0361] 8.3.3.4 Position of the Headgear Tubing Adjustment Mechanism It is generally desirable to avoid features of the patient interface that cause patient discomfort. Thus, the patient interface can be designed with several components that contact the patient's skin, and the components that actually contact the patient's skin can be flexible and / or smooth. The cheek area is known to be a cause of patient discomfort when wearing the patient interface.

[0362] A mechanism that enables adjustment of the positioning and stabilization structure as described above may include features that cause discomfort to the patient when in contact with the patient's face or head (particularly, the cheek region). Therefore, the positioning and stabilization structure included in a particular form of the present technology is configured such that, when the patient interface is worn, the adjustment mechanism or a part thereof is positioned so as not to come into contact with the patient's skin or hair region (e.g., not in contact with the patient's face such as the patient's cheek region). In some forms of the present technology, the adjustment mechanism is positioned above the patient's ear (i.e., above the upper ear base point of the patient's head or in the vicinity of the upper part of the patient's head). In these forms of the present technology, the headgear tube includes a non-adjustable headgear tube section. This non-adjustable headgear tube section is positioned adjacent to the patient's face during use (i.e., positioned such that the non-adjustable headgear tube section can come into contact with the patient's face during use of the patient interface). For example, in some forms, the non-adjustable headgear tube section is positioned adjacent to the patient's cheek region when worn. In some forms of the present technology, only the non-adjustable headgear tube section comes adjacent to the patient's cheek region, comes below the upper ear base point of the patient's head, or covers the maxilla region of the patient's head.

[0363] The non-adjustable headgear tube section is a section specifically configured to be dimensionally adjusted during use (i.e., the adjustment mechanism does not form part of the non-adjustable headgear tube section). That being said, it is not excluded that the non-adjustable headgear tube section can be dimensionally adjusted, for example, when excessive force is applied. However, the position of the non-adjustable headgear tube section may be adjusted during use. In some forms of the present technology, the non-adjustable headgear tube section may be substantially non-adjustable in axial length, but may also be adjustable by other modalities such as flexure, bending, straightening, etc. 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 extents such that different elongation amounts enabled by the adjustment mechanisms 3360a, 3360b, and 3360c facilitate different positions on the head where the positioning and stabilization structure 3300 is mounted.

[0364] Placing the adjustment mechanism outside the patient's field of view may also be useful in avoiding claustrophobia or a sense of obstructed vision.

[0365] In the case of the form of the patient interface 3000 shown in Figures 3A, 3B, 3C, 3D, 3E, and 3F, for example, the bellows section 3362 is positioned on either side of the patient's head between the height of both ears or one ear and the top of the head of the level head and the non-adjustable headgear tube section 3363. The level head and the non-adjustable headgear tube section 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 region when worn. Other examples of the non-adjustable headgear tube section 3363 are shown in Figures 5, 7A, 7B, 7C, and 17.

[0366] In certain forms of the present technology, the non-adjustable headgear tube section 3363 is configured to assist in maintaining a proper seal between the cushion assembly 3150 and the patient's face during use of the patient interface 3000. To that end, it may be necessary to make the flexibility (or rigidity) of the non-adjustable headgear tube section 3363 selectable, with sufficient flexibility to accommodate certain movements during use and certain variations in the position where individual patients wear the patient interface 3000, while also having sufficient rigidity so that the non-adjustable headgear tube section 3363 does not deform easily during use.

[0367] When using the rear headgear strap 3310, the headgear tube 3350 above the patient's head is stabilized, but the lower end of the headgear tube 3350 is more likely to move freely, especially at points relatively far from the point 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 in a direction away from the patient's face, thus interfering with the sealing performance. By increasing the rigidity of the lower end of the headgear tube 3350 (i.e., the non-adjustable headgear tube section 3363 in the forms of the present technology shown in FIGS. 3A, 3B, 3C, 3D, 3E, 3F, 5, 7A, 7B, 7C, and 17), the impact of such forward rotation can be reduced. For the purpose of this discussion, the lower end of the headgear tube 3350 is considered to be the portion of the headgear tube 3350 positioned below the point where the rear headgear strap 3310 is connected to each headgear tube 3350 (i.e., below when the patient interface 300 is worn on the patient). This is because this point is stable on the patient's head and can function as a pivot point for any movement below this point of the headgear tube 3350. It is understood that when using headgear straps with other positioning configurations, the position of the effective pivot point will also be different.

[0368] For similar reasons, in some forms of the technology, it may be advantageous to free the lower end of the headgear tube 3350 from any adjustment mechanism. If a bellows section is provided, for example, on the headgear tube 3350 at the point where the rear headgear strap 3310 is connected to the headgear tube 3350, the bellows section may buckle and bend during movement and tend to function as a natural pivot, which may cause the cushion assembly to move and thus interfere with the seal with the patient's face.

[0369] Furthermore, when an adjustment mechanism 3360 is provided at the upper part of the headgear tube 3350 (which, for the purposes of this discussion, is considered to be the part of the headgear tube 3350 positioned above (i.e., superior to) the point where the rear headgear strap 3310 is connected to each headgear tube 3350), it is assisted in disconnecting the upper and lower parts of the headgear tube 3350, so that even if the upper part (due to fluctuations in the position of the patient interface 3000 during use or on the patient's head) moves, excessive force that could cause interference with the seal with the patient's face is not applied to the cushion assembly 3150. Specifically, using an adjustment mechanism 3360 that can extend the length of the headgear tube 3350 helps to avoid a situation where the non-adjustable headgear tube section 3363 at the lower end of the headgear tube 3350 becomes straight. 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. Also, if the non-adjustable headgear tube section 3363 becomes overly straight and / or stretched, the cushion assembly 3150 may rotate forward, which may interfere with the seal with the patient's face.

[0370] In some forms of the present technology, the radius of curvature 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. As the radius of curvature increases, the disconnection effect between the upper and lower ends of the headgear tube 3350 also increases, so that it becomes possible to move the upper end of the headgear tube 3350 without causing significant forward rotation of the cushion assembly 3150 and the resulting seal loss.

[0371] In some forms of the present technology, by arranging the adjustment mechanism 3360 at the upper part of the headgear tube 3350 in the vicinity of the connection port 3600, it becomes possible to disconnect the connection through the stretching and bending caused by the adjustment mechanism, so that the reduction of tube dragging on the head can be assisted.

[0372] In some forms of the present technology, when the adjustment mechanism 3360 is provided on the upper part of the headgear tube 3350 arranged at an interval from the cushion assembly 3150, the influence on the cushion assembly 3150 due to the difference in elongation of the headgear tube 3350 can be reduced. For example, it becomes possible to reduce the influence due to the elongation of the adjustment mechanism 3360 on either side of the patient's head and / or the imbalance of any force applied from the adjustment mechanism 3360 to either side of the patient's head. When there is such an influence, the seal formed on the patient's face by the cushion assembly 3150 may be compromised.

[0373] In other forms of the present technology, the adjustment mechanism can be positioned in the vicinity of the cushion assembly 3150 of the patient interface and can be spaced from the patient's face due to the size of the plenum chamber and the position of the port (and thus the adjustment mechanism) where the tube 3350 is connected to the plenum chamber located at a distance from the patient's skin at the lower end of the tube 3350. The form of the present technology shown in FIG. 10B is one such example of a patient interface 3000 in which the adjustment mechanism is arranged at a distance from the patient's face during use.

[0374] 8.3.3.5 Headgear Tubing Biasing Mechanism In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a biasing mechanism. This biasing mechanism functions to propel the seal-forming structure 3100 during use towards the patient's face (i.e., towards the area surrounding the patient's airway inlet (where the seal-forming structure 3100 is sealed)). Thus, the biasing mechanism serves to assist in providing a good seal between the seal-forming structure 3100 and the patient's face during use of the patient interface 3000, and in promoting the retention of the seal when the patient interface supplies positive pressure gas to the patient. In some forms of the present technology, the biasing mechanism acts on (i.e., applies a biasing force to) the adjustment mechanism 3360. When the plenum chamber 3200 is pressurized, there is a tendency for the cushion assembly 3150 of the patient interface 3000 to move in a direction away from the patient's face. The biasing mechanism having the function of biasing or propelling the cushion assembly 3150 towards the patient's face nullifies this tendency in order to maintain the seal.

[0375] In some forms of the present 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 towards the inlet of the patient's airway during use. In such forms, the headgear tube 3350 or a portion thereof is in a tensioned state during use. In some forms, the biasing mechanism is included as part of the headgear tubing 3350, and in other forms, the biasing mechanism is separate from the headgear tubing 3350.

[0376] The biasing mechanism may also assist in automatically adjusting the patient interface to fit a particular patient's head.

[0377] 8.3.3.5.1 Magnitude of the Force Added by the Biasing Mechanism The biasing mechanism is preferably configured to apply sufficient inward (i.e., towards the patient's airway opening) force to maintain a good seal during use while avoiding the application of excessive force. If excessive force is applied, the seal-forming structure 3100 can be compressed and its geometry can change, causing a portion of the structure to move away from the patient's face and potentially allowing gas to leak from the seal-forming structure. Further, avoiding excessive force being applied from the patient interface onto the patient's face promotes comfort and avoids red marks, abrasions or sweating on the patient's face.

[0378] In some forms of the present technology, the acceptable force provided by the biasing mechanism can be approximately 0.5 to approximately 4 N on each side of the positioning and stabilization structure 3300. In some forms, the acceptable force can be approximately 1 to approximately 3.5 N. In some forms, a force of approximately 2 N can be considered acceptable. In some forms of the present technology, the positioning and stabilization structure 3300 is configured to support a seal-forming structure 3100 (e.g., the seal-forming structure 3100 shown in FIGS. 4A - 4E) in the form of a full-face or nasal-oral cushion assembly. In some forms of the present technology, the full-face or nasal-oral seal-forming structure 3100 is heavier than other forms of seal-forming structures (e.g., nasal cradles or nasal pillows) because it is larger in size. The positioning and stabilization structure 3300 is configured to provide a correspondingly high biasing force to bias the cushion assembly 3150 into the patient's face with a force high enough to maintain an effective seal without causing excessive discomfort, while absorbing its weight or counteracting the pull of the heavier seal-forming structure 3100. Further, when the patient relaxes or moves their jaw (known as "opening wide"), the full-face or nasal-oral seal-forming structure 3100 can receive a downward (e.g., downwardly directed) force. The positioning and stabilization structure 3100 can also be configured to account for the effect of opening wide by counteracting the downward force received when opening wide.

[0379] In some forms of the technology, the positioning and stabilization structure 3300 is configured to interchangeably receive seal-forming structures of different sizes, such as a relatively small or lightweight seal-forming structure (e.g., a nasal cradle cushion assembly) and a relatively large or heavy seal-forming structure (e.g., a full-face cushion assembly). The biasing mechanism that this positioning and stabilization structure may include is configured to support both types of seal-forming structures by imparting a biasing force that is strong enough (but not so excessive as to cause discomfort) for either type of seal-forming structure.

[0380] In some forms of the technology, the positioning and stabilization structure 3300 is configured to provide a force of a sufficient range of magnitudes in a plurality of adjustment configurations to maintain an effective seal (but not so excessive as to cause discomfort) against a nasal cradle or a full-face mask.

[0381] In some forms of the technology, the biasing mechanism is configured to impart a force to the headgear tubing 3350 or a portion thereof that propels the headgear tubing to fit around the patient's head. The biasing mechanism may be configured to provide a force of a magnitude within a predetermined range. Such a predetermined range may be limited to a magnitude such that the headgear 3300 is comfortable and can 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 a sufficient force to make a sealed contact 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 with a force that does not exceed the maximum force considered comfortable by the patient to fit around the patient's head. That is, this force may be less than or equal to the maximum comfortable force.

[0382] In some forms of the present technology, each headgear tube 3350 includes a force-elongation characteristic resulting from the relationship between the elongation of the headgear tube 3350 and the force applied to the headgear tube 3350 from the biasing mechanism. Alternatively or additionally, the force-elongation characteristic may result from the relationship between the force applied to the headgear tube 3350 from the biasing mechanism and the elongation of the headgear tube 3350. It is understood that the term "elongation" refers to a change in the overall length of the headgear tube and does not mean any manner in which a change in the overall length of the headgear tube 3350 occurs or the physical structure of the adjustment mechanism.

[0383] In a particular form of the present 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 forms of the present technology, the biasing mechanism applies a restoring force on the headgear tube 3350.

[0384] As described above, the adjustment mechanism 3360 of the patient interface 3000 according to some forms of the present technology enables adjustment of the length of the headgear tube 3350. In some embodiments, when there is a relationship between the biasing force and the elongation of the headgear tube 3350, when the headgear tube 3350 extends to a first amount of elongation (e.g., to a first elongation length), the force added from the biasing mechanism is equal to or greater than the minimum sealing force. Further, when the headgear tube 3350 extends to a second amount of elongation (e.g., to a second elongation length), the force added from the biasing mechanism is equal to or less than the maximum comfort level. Further, when there is an amount of elongation between the first amount of elongation and the second amount of elongation, the force added from the biasing mechanism can be between the minimum sealing force and the maximum comfort level.

[0385] In some forms of the present technology, the headgear tube 3350 may include force-elongation characteristics. In this force-elongation characteristic, when the headgear tube 3350 is adjusted to a first elongation amount (e.g., up to the elongation amount at which at least a minimum sealing force is obtained from the biasing mechanism), the positioning and stabilization structure 3300 can correspond to a predetermined minimum head size. Similarly, when the headgear tube 3350 is adjusted to a second elongation amount (e.g., up to the elongation amount at which further maximum comfort is no longer obtained from the biasing mechanism), the positioning and stabilization structure 3300 can correspond to a predetermined maximum head size. In the case of elongation between the first elongation amount and the second elongation amount, the positioning and stabilization structure 3300 can correspond to head sizes between the minimum head size and the maximum predetermined head size. The predetermined minimum head size can be, for example, the 5th percentile head size of a particular category of people, and the predetermined maximum head size can be, for example, the 95th percentile head size of a particular category of people. It is understood that other measurements / ranges can be used to determine the minimum and maximum head sizes to which the positioning and stabilization structure 3300 can correspond.

[0386] The force-elongation plot 6000 shown in FIG. 3I shows the force-elongation characteristic 6300 of the headgear tube 3350 of the patient interface 3000 according to one form of the present technology. The horizontal elongation axis 6100 and the vertical force axis 6200 shown in the force-elongation plot 6000 show the relationship between the length of the headgear tube 3350 and the force applied from the resulting biasing mechanism.

[0387] Three elongations of the headgear tube 3350 are shown on the elongation axis 6100: namely, zero elongation 6105, a first elongation amount 6110 corresponding to the elongation required to correspond to the 5th percentile head size (e.g., the predetermined minimum head size), and a second elongation amount 6120 corresponding to the elongation required to correspond to the 95th percentile head size (e.g., the predetermined maximum head size). Two force magnitudes are shown on the force axis 6200: namely, the minimum sealing force 6210 and the maximum comfort 6220.

[0388] In this exemplary form of the present technology, in the force-elongation characteristic 6300 included in the headgear tube 3350, the force applied from the biasing means exceeds the minimum sealing force 6210 and is below the maximum comfort 6220 throughout the elongation within the range between the first elongation amount 6110 and the second elongation amount 6120. That is, throughout the range of applicable head sizes, sufficient sealing can be maintained without causing discomfort due to excessive biasing force.

[0389] In some forms of the present technology, it is understood that the relationship between elongation and biasing force may not be directly proportional. For example, in some forms of the present technology, in the initial elongation stage, the force may increase relatively greatly, but there is little variation in the force within the elongation range required to accommodate the minimum predetermined head size and the maximum predetermined head size. 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 throughout the elongation range between the minimum head size and the maximum head size, an effective seal can be achieved without discomfort.

[0390] 8.3.3.5.2 Position of the biasing mechanism In some forms of the present technology, the 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, and can generally propel the seal-forming structure 3100 in the direction of the connection port 3600 and / or in the longitudinal direction along the length of the tube 3350.

[0391] 8.3.3.5.3 Form of the biasing mechanism The biasing mechanism can take multiple forms. In some forms of the present technology, the biasing mechanism is a mechanism separate from the adjustment mechanism and enables adjustment of the positioning and stabilization structures as described above. In such forms, the adjustment mechanism enables adjustment of the patient interface to fit the patient's head while providing the function of the biasing mechanism to push the sheet against the patient's face. In other forms, the biasing mechanism and the adjustment mechanism are at least partially provided by the same features of the patient interface, and the above-described adjustment and biasing are different functions performed by these same features.

[0392] In some forms of the present technology, the biasing mechanism includes an elastic or resilient member or assembly. In some forms, the elastic or resilient member or assembly is connected between the seal-forming structure 3100 and the connection port 3600. For example, the elastic or resilient member or assembly is included as part of the tube 3350 or connection assembly between the tube 3350 and the plenum chamber 3200 and / or the connection assembly between the tube 3350 and the connection port 3600 or is connected to the tube 3350 or connection assembly between the tube 3350 and the plenum chamber 3200 and / or the connection assembly between the tube 3350 and the connection port 3600.

[0393] For example, in the form of the present technology shown in FIGS. 3A, 3B, 3C, 3D, and 3E, the biasing mechanism includes a bellows tube portion 3362. The bellows tube portion 3362 is configured to be biased to a compressed position. As a result, the bellows tube portion 3362 functions to pull the seal-forming structure 3100 against the patient's face during use.

[0394] In some forms of the present technology, there is a relationship between the elongation of the bellows tube portion 3362 and the restoring force applied to the headgear tube 3350. This restoring force can be the tension within the bellows tube portion 3362. The bellows tube portion 3362 can have force-elongation characteristics similar to those described in relation to FIG. 3I.

[0395] The bellows tube portion 3362 can be designed to extend to a first elongation amount such that the positioning and stabilization structure 3300 can correspond to a predetermined minimum head size (e.g., the 5th percentile head size), and can also be designed to extend to a second elongation amount such that the positioning and stabilization structure 3300 can correspond to a predetermined maximum head size (e.g., the 95th percentile head size). The bellows tube portion 3362 can be designed such that at the first elongation amount, the tension exceeds the minimum force necessary to create an adequate seal of the seal forming structure 3100 against the patient's face. At the second elongation amount, the bellows tube portion 3362 can be designed such that the tension does not exceed the maximum force considered comfortable for the patient. In this way, the positioning and stabilization structure 3300 can accommodate a range of head sizes, thereby creating an adequate seal across the full range without causing discomfort due to force.

[0396] In a particular form of the present technology, the bellows tube portion 3362 can include a bellows profile that provides a bellows tube portion 3362 with force-elongation characteristics as described above. As shown in FIG. 3G, the bellows tube portion 3362 can include a wall. This wall has a bellows profile with a wavy repeating pattern where the inner valleys are curved and the outer peaks are flat. The outer flat peaks allow for a smooth flat surface that can be comfortably positioned against the patient's head. The bellows tube portion 3362 can include a plurality of ribs formed within the wall of the headgear tube 3350 to form the bellows. These ribs can extend inwardly as shown in FIG. 3G. Alternatively or additionally, the bellows tube portion 3362 can include a plurality of grooves.

[0397] The profile of the bellows tube portion 3362 can vary to achieve the desired force-elongation characteristics. For example, the pitch of the ribs (e.g., the peaks / valleys of the bellows waves) can be reduced so that a more extensible bellows tube portion 3362 is obtained (e.g., generally greater elongation is obtained at a given force). Further, the rib height (e.g., the amplitude of the bellows waveform) may be increased so that a more extensible bellows tube portion 3362 is obtained. Alternatively, a less extensible bellows tube portion 3362 may be provided by increasing the rib pitch or reducing the rib height.

[0398] Additionally or alternatively, a longer bellows tube portion 3362 may be provided for improved extensibility. This may be made possible, for example, by increasing the number of ribs formed in the wall of the bellows tube portion 3362.

[0399] Additionally or alternatively, a more extensible bellows tube portion 3362 may be obtained by reducing the wall thickness of the bellows tube portion 3362, or a more rigid bellows tube portion 3362 may be obtained by increasing the wall thickness of the bellows tube portion 3362.

[0400] Additionally or alternatively, the material forming the bellows tube portion 3362 may be selected to assist in providing the predetermined force-elongation characteristics. In one form of the present technology, the material is silicone of 50 durometer. Other materials and / or durometer values may also be selected (e.g., silicone of 40 durometer).

[0401] Additionally or alternatively, different bellows profile shapes may be used for the bellows tube portion 3362 to achieve different elongation amounts. For example, when a bellows tube portion 3362 with a wall defining the profile that is generally more folded is used, a more extensible bellows tube portion 3362 may be obtained.

[0402] The configuration of the bellows tube portion 3362 can vary along its length. For example, in some forms of the present technology as shown in FIG. 3G, the rib height decreases along the length of the bellows tube portion 3362 in the direction away from the connection port 3600 (e.g., the direction towards the non-adjustable headgear tube section 3363). The rib height can vary within a range such as approximately 0 mm to approximately 6 mm, approximately 0 mm to approximately 5 mm, approximately 0 mm to approximately 4 mm, approximately 1 mm to approximately 5 mm, etc. Alternatively, the rib height can be made constant at a value such as approximately 2 mm, approximately 3 mm, approximately 4 mm, etc. The wall thickness can be substantially constant along the length of the bellows tube portion 3362 or can be varied. In some forms of the present technology, the wall thickness can be approximately 0.5 mm to approximately 1.2 mm. In some forms, the wall thickness can be approximately 0.6 mm to approximately 1 mm. In some forms, the wall thickness can be approximately 0.8 mm or any other similar value. In some forms, the rib pitch can be approximately 3.5 mm to approximately 5 mm. In some forms, the rib pitch can be approximately 3.8 mm to approximately 4.5 mm. In some forms, the rib pitch can be approximately 4.2 mm or any similar value.

[0403] In other forms of the present technology, the shape and configuration of the bellows tube portion 3362 are different from the parameters exemplified above.

[0404] In the form of the present technology shown in FIG. 13, the relatively extensible section of the tube 3355 is elastically or elastically deformable and has a tendency to return to the non-extended state. Therefore, during use, the relatively extensible section of the tube 3355 has the function of pulling the seal formation structure 3100 into the patient's face. Alternatively, when extended, the tube 3350 can be completely formed from an elastic material that has a tendency to return to the non-extended state when extended.

[0405] Another form of this technology is shown in FIG. 17. In this form, the patient interface 3000 includes one or more elastic sleeves 3340 that cover the tube 3350. The elastic sleeve 3340 may partially cover the tube 3350, and it is understood that, for example, holes may be provided in the sleeve 3340 as described below. Alternatively, the headgear tube can 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 sleeve 3340 can be formed from any stretchable, elastic or extensible material (for example, an elastic fabric such as elastane tends to return to its original size and shape when stretched).

[0406] The elastic sleeve 3340 covers the tube 3350, each including a bellows tube section 3362. The bellows tube section 3362 may or may not be biased to a compressed position. Due to the presence of the bellows tube section 3362, while the elastic sleeve 3340 functions to pull the seal forming structure 3100 of the cushion assembly 3150 to improve the seal in the patient's face, it becomes possible to adjust the length of the tube 3350 so that the patient interface 3000 fits individual patients.

[0407] The elastic sleeve 3340 may include a single elastic material sheet, or alternatively, may be formed from a plurality of elastic material sheets connected together (for example, sewn or adhered). Alternatively, the patient interface 3000 may include a plurality of separate elastic sleeves, for example, one sleeve may cover each tube 3350.

[0408] The elastic sleeve 3340 may include an opening that allows a portion of the patient interface to pass through the sleeve. For example, the elastic sleeve may include a rear or side 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 may be connected to the connection port 3600 or the connection port 3600 may protrude. The headgear tube 3350 may contact the patient's head through the opening 3342.

[0409] The bellows tube section 3362 of the tube 3350 can cause discomfort when contacting the patient's skin or hair during use. The patient may perceive the bellows as an obstruction or feel discomfort during future wear, even if the bellows is not actually causing an increase in discomfort. These problems are avoided by covering the bellows section 3362 with the elastic sleeve 3340. In some embodiments, a non-elastic sleeve may be used to provide comfort advantages. In the case of this sleeve, there is an advantage that it can be formed of a soft material that is not uncomfortable when contacting the patient.

[0410] Since the elastic sleeve 3340 may come into contact with the patient's hair or skin during use, it is easily soiled by the patient's natural oils. Therefore, the elastic sleeve 3340 may advantageously be formed from a material such as a fabric that can be easily washed. 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 fixing the sleeve onto the tube 3350 that can be disengaged when removing the sleeve. For example, the elastic sleeve 3340 may surround the tube 3350 and connect itself by means of a clip, popper, hook and loop material or other suitable fastener.

[0411] In some forms of the technology, the elastic sleeve 3340 is formed from a material or textile that aids in venting moisture from the patient's face. As a result, comfort can be supported when the patient sweats during wearing of the patient interface.

[0412] In other forms of the technology, the elastic sleeve can include a tube or other portion of a positioning and stabilization mechanism that includes other adjustment mechanisms as described above. The sleeve can be advantageous in covering mechanisms or components that might otherwise detract from the patient's willingness to wear the patient interface due to a complex or medical appearance.

[0413] In other forms of the technology, the telescopically adjustable headgear tube can include a biasing mechanism that functions to contract a telescopically movable headgear tube section (e.g., a spring).

[0414] As an advantage when a manually adjustable adjustment mechanism also provides the biasing force (e.g., the adjustment mechanism 3360 shown in FIG. 7C), it is possible to support both a relatively high-weight seal-forming structure and a relatively lightweight seal-forming structure in a modular design (i.e., in a manner that allows different types of seal-forming structures to be exchanged). For example, when replacing the cushion assembly 3150 of the embodiment shown in FIG. 7C with a higher-weight nose and mouth cushion assembly, the patient can manually adjust the length of the headgear tube 3350 to a shorter configuration so as to counteract the weight of the nose and mouth cushion and prevent the cushion from sagging downward or being pressed downward by movement of the patient's jaw.

[0415] 8.3.4 Ventilation Section In one form, the venting portion included in the patient interface 3000 is constructed and arranged to reduce the risk of the patient rebreating such gases by allowing for a continuous flow or wash of exhaled gas (e.g., from inside the plenum chamber of carbon dioxide (CO2) to the ambient). That is, the venting portion allows the CO2 exhaled by the patient to flow outside the patient interface. The venting portion is sized and shaped to maintain the treatment pressure within the plenum chamber.

[0416] One form of the venting portion according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0417] The venting portion may be disposed within the plenum chamber 3200. Alternatively, the venting portion may be disposed within another portion of the patient interface (e.g., the tube 3350 that fluidly connects the plenum chamber 3200 and the connection port 3600).

[0418] 8.3.5 Disconnection Structure(s) In one form, the patient interface 3000 includes at least one disconnection structure (e.g., a swivel or ball and socket). This disconnection structure may be disposed at or near the connection port 3600 such that it enables the conduit of the air circuit 4170 to move relative to the patient interface 3000 and reduces the risk of destabilization of the seal between the seal forming structure 3100 and the patient's face.

[0419] 8.3.6 Connection Port The connection port 3600 enables connection to the air circuit 4170. In the embodiments of the present technology shown in FIGS. 3 and 5 to 17, for example, the connection port is positioned on the patient's head when the patient interface 3000 is worn. In other embodiments, the connection port is configured to be positioned adjacent to the upper, side, or rear of the patient's head during use. In the case of a patient interface where the connection port is not positioned in front of the patient's face, it can be advantageous because some patients may find a conduit connecting to a patient interface in front of the face to be obstructive and uncomfortable. For example, in the case of a conduit connecting to a patient interface in front of the face, especially when the conduit extends downward from the patient interface during use, it may be prone to entanglement with bedding.

[0420] 8.3.7 Forehead support In one form, the patient interface 3000 includes a forehead support. This forehead support contacts the patient's forehead region during use to support the patient interface on the patient's head and assist in maintaining a sealed contact with the patient's face in a sealed structure.

[0421] 8.3.8 Anti-asphyxiation valve In some forms of the present technology, the patient interface 3000 is constructed and arranged to enable the patient to breathe ambient air in the event of a power failure. In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0422] 8.3.9 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the volume within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the characteristics (e.g., pressure) of the gas within the plenum chamber 3200.

[0423] 8.4 RPT device An RPT device 4000 (as shown in FIG. 4A) according to one aspect of the present technology includes mechanical components 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. Further, the external housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0424] The pneumatic path of the pneumatic RPT device 4000 may include one or more air path items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0425] One or more of the air path items may be arranged within a removable integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be arranged within the external housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 or formed as part of the chassis 4016.

[0426] The RPT device 4000 can have an electrical 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 pro...

Claims

1. A positioning and stabilization structure that holds a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face that surrounds an entrance to the patient's airway so as to deliver air flow at least 4 cmH ２ O higher than ambient air pressure throughout the patient's breathing cycle, the positioning and stabilization structure being A front hoop that extends across the patient's cheek region during use and is arranged to contact a region above the suprameatal point of the patient's head of the patient's head during use; A rear strap configured to surround the rear portion of the patient's head during use; An adjustment mechanism for adjustment relative to the patient's head of the front hoop and the rear strap, the adjustment mechanism being arranged in a single operation that adjusts both the front hoop and the rear strap to fit the positioning and stabilization structure to heads of different sizes, the adjustment mechanism.

2. The positioning and stabilization structure according to claim 1, further comprising a link member connecting two sections of the front hoop.

3. The positioning and stabilization structure according to claim 2, wherein the front hoop and / or the rear strap includes the link member.

4. The adjustment mechanism according to claim 2 or 3, wherein the adjustment mechanism is operable to adjust the length of the link member between two sections of the front hoop, and by adjusting the length, both the front hoop and the rear strap are adjusted simultaneously.

5. The positioning and stabilization structure according to claim 4, wherein by adjusting the length of the link member between two sections of the front hoop, the effective length of the front hoop is adjusted by adjusting the allowable distance between the two sections of the front hoop.

6. The positioning and stabilization structure according to claim 4 or 5, wherein a corresponding adjustment is made to the effective length of the rear strap due to the adjustment of the length of the link member.

7. The positioning and stabilization structure according to claim 6, wherein a part of the rear strap is formed by a link.

8. The positioning and stabilization structure according to claim 6, wherein the opposing end regions of the rear strap are connected to or adjacent to one of each of the two sections of the front hoop.

9. The adjustment mechanism according to any one of claims 4 to 8, wherein the adjustment mechanism is selected from the group consisting of a rack and pinion, a tightening cord, and a releasable mechanical connection, and the adjustment mechanism is configured to enable adjustment of the link member.

10. The positioning and stabilization structure according to any one of claims 4 to 9, wherein the length of the link member can be adjusted through a continuous length range by the adjustment mechanism.

11. The positioning and stabilization structure according to any one of claims 1 to 10, further comprising at least one gas delivery tube for delivering the air flow to the inlet of the patient's airway through the seal forming structure, wherein the front hoop includes the lower part of at least one of the gas delivery tubes.

12. The positioning and stabilization structure according to claim 11, further comprising a disconnection mechanism, wherein the disconnection mechanism enables adjustment of the position of the upper part of the gas delivery tube on the patient's head by disconnecting the adjustment of the position of the upper part of at least one of the gas delivery tubes from the movement of the seal forming structure away from the patient's face during use.

13. The positioning and stabilization structure according to claim 12, wherein the adjustment mechanism is arranged in front of the disconnection mechanism during use.

14. The disconnection mechanism is flexible and includes a corrugated structure and / or a bellows structure to enable adjustment of the position of the upper part of at least one tube on the patient's head during use; at least one swivel including a connection port configured to connect to an air circuit, wherein at least one of the swivels is configured to enable relative rotation between the upper part of at least one of the gas delivery tubes and the air circuit connected to the connection port. The positioning and stabilization structure according to claim 12 or 13 includes at least one swivel.

15. The positioning and stabilization structure according to claim 14, wherein the disconnection mechanism is fluidly connected to the air circuit connected to the supply of pressurized air during use, and the disconnection mechanism is arranged in the vicinity of the upper part, side part or rear part of the patient's head during use.

16. The positioning and stabilization structure according to claim 15 includes two gas delivery tubes fluidly connected between the disconnection mechanism and the seal forming structure. The lower part of each gas delivery tube extends across one of the patient's cheek regions during use, and the two gas delivery tubes are provided on different side parts of the patient's head.

17. The lower portions of the two gas delivery tubes form at least partially a part of the front hoop, the positioning and stabilization structure according to claim 16.

18. The lower portion of each of the gas delivery tubes respectively includes one of two sections of the front hoop, the positioning and stabilization structure according to claim 17 when dependent on claim 2.

19. The disconnect mechanism is disposed on the upper portion of the patient's head during use, the positioning and stabilization structure according to claim 18.

20. During use, the adjustment mechanism is disposed on the upper portion of the patient's head adjacent to the disconnect mechanism, the positioning and stabilization structure according to claim 19.

21. The disconnect mechanism is in a y-shaped or v-shaped configuration, the positioning and stabilization structure according to any one of claims 12 - 20.

22. At least one swivel includes a first swivel and a second swivel configured to rotate relative to the first swivel, the positioning and stabilization structure according to any one of claims 14 - 21.

23. The first swivel rotates about a first axis, and the second swivel rotates about a second axis perpendicular to the first axis, the positioning and stabilization structure according to claim 22.

24. The first swivel is rotatable independently of the second swivel, the positioning and stabilization structure according to claim 22 or 23.

25. At least one swivel rotates about a swivel axis, and the swivel axis is oriented substantially parallel to an axis along the upper portion, the positioning and stabilization structure according to any one of claims 14 - 21.

26. The adjustment mechanism employs one or more cables connected to both the front hoop and the rear strap, and a controller for inducing adjustment of the front hoop and the rear strap by translating one or more of the cables, the positioning and stabilization structure according to any one of claims 1 - 25.

27. One or more of the cables are formed as tie cords passed through the front hoop and / or the rear strap, and the adjustment mechanism includes a release button configured to be engaged by a user for adjustment of the length of the tie cord, the positioning and stabilization structure according to claim 26.

28. The tightening strap is passed through the opening, the release button is configured to change the diameter of the opening from a small diameter to a large diameter, and the opening is configured to engage the tightening strap at the small diameter and provide a frictional force to the tightening strap. The positioning and stabilization structure according to claim 27.

29. The positioning and stabilization structure according to claim 26, further comprising a control unit for controlling the adjustment mechanism.

30. The positioning and stabilization structure according to claim 29, wherein the control unit can be directly operated by at least one button.

31. The positioning and stabilization structure according to claim 29, wherein the control unit can be indirectly operated by a remote device.

32. The positioning and stabilization structure according to claim 26, wherein the controller includes a rotatable dial.

33. The adjustment mechanism includes a plurality of cables, and the parallel movement speeds of the plurality of cables are uniform. The positioning and stabilization structure according to any one of claims 26 to 32.

34. The adjustment mechanism includes a plurality of cables, and the parallel movement speeds of the plurality of cables are non-uniform. The positioning and stabilization structure according to any one of claims 26 to 32.

35. During use, the adjustment mechanism is positioned above the upper ear base point of the patient's head. The positioning and stabilization structure according to any one of claims 1 to 34.

36. The angle of the rear strap with respect to the front hoop is adjustable under the operation of the adjustment mechanism. The positioning and stabilization structure according to any one of claims 1 to 35.

37. A positioning and stabilization structure that holds a seal-forming structure in a therapeutically effective position on a patient's head, wherein the seal-forming structure is configured to seal and deliver at a therapeutic pressure of at least 4 cmH ２ O higher against ambient air pressure throughout the patient's respiratory cycle, and is constructed and arranged to form a seal with a region of the patient's face that surrounds the entrance to the patient's airway, and the positioning and stabilization structure is A front hoop that extends across the patient's cheek region during use and is arranged to contact a region above the upper ear base point of the patient's head during use. The front hoop includes: The lower parts of two gas delivery tubes fluidly connected to the seal forming structure, each lower part of the gas delivery tube extending across one of the patient's cheek regions during use, and the two gas delivery tubes are provided on different sides of the patient's head. The lower parts of the two gas delivery tubes, and A link connecting the two gas delivery tubes between the lower and upper parts of the two gas delivery tubes; and A rear strap configured to surround the rear part of the patient's head during use; and A disconnect mechanism that enables adjustment of the position of the upper part of the gas delivery tube on the patient's head by disconnecting it from the movement of the seal-forming structure away from the patient's face during use, is included in the positioning and stabilization structure.

38. The disconnect mechanism is Flexible and includes a corrugated structure and / or a bellows structure on the upper part to enable adjustment of the position of the upper parts of the two gas delivery tubes on the patient's head during use; At least one swivel including a connection port configured to connect to an air circuit, and at least one of the at least one swivel is configured to enable relative rotation between the upper part and the air circuit. The positioning and stabilization structure according to claim 37.

39. The upper part is positioned above the upper ear base point of the patient's head during use. The positioning and stabilization structure according to claim 38.

40. At least one of the at least one swivel includes a first swivel and a second swivel configured to rotate relative to the first swivel. The positioning and stabilization structure according to claim 38 or 39.

41. The first swivel rotates around a first axis, and the second swivel rotates around a second axis perpendicular to the first axis. The positioning and stabilization structure according to claim 40.

42. The first swivel is rotatable independently of the second swivel. The positioning and stabilization structure according to claim 40 or 41.

43. The disconnect mechanism further includes a tube connector connected to the two gas delivery tubes, and the two gas delivery tubes branch from the tube connector. The positioning and stabilization structure according to any one of claims 40 to 42.

44. The first swivel is directly connected to the tube connector. The positioning and stabilization structure according to claim 43.

45. The tube connector is non-rotatable relative to the two gas delivery tubes, and the first swivel is rotatable relative to the tube connector. The positioning and stabilization structure according to claim 43 or 44.

46. At least one of said swivels rotates about a swivel axis, and said swivel axis is oriented substantially parallel to an axis along said upper part, the positioning and stabilization structure according to claim 39.

47. The disconnection mechanism is in a Y-shaped or V-shaped form, the positioning and stabilization structure according to any one of claims 37 to 39.

48. Further comprising an adjustment mechanism for adjustment relative to the patient's head of said front hoop and said rear strap, said adjustment mechanism being arranged in a single operation of adjusting both said front hoop and rear strap to fit the positioning and stabilization structure to heads of different sizes, the positioning and stabilization structure according to any one of claims 37 to 47.

49. The adjustment mechanism is operable to adjust the length of a link member between said lower parts, and by adjusting said length, both said front hoop and said rear strap are adjusted simultaneously, the positioning and stabilization structure according to claim 48.

50. Further comprising a jaw strap, said jaw strap extending across the patient's cheek region in use and being arranged to contact a region of the patient's head below the subauricular point of the patient's head in use, the positioning and stabilization structure according to any one of claims 37 to 49.

51. At least 4 cmH higher than the ambient air pressure ２ A plenum chamber capable of being pressurized to a treatment pressure at least 4 cmH higher than the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the treatment pressure for breathing by a patient; A seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, whereby said air flow is delivered at said treatment pressure to at least an entrance to the patient's nostrils, said seal-forming structure being constructed and arranged to maintain said treatment pressure within said plenum chamber throughout the patient's respiratory cycle during use; A connection port in fluid connection with an air circuit connected to said air flow in use, said connection port being arranged in the vicinity of the upper, side or rear part of the patient's head in use; and A positioning and stabilization structure, A front hoop extending across the patient's cheek region in use and arranged to contact a region of the patient's head above the supraauricular point of the patient's head in use; A rear strap configured to surround the rear part of the patient's head in use; An adjustment mechanism for adjusting the position of the front hoop and the rear strap relative to the patient's head, the adjustment mechanism being arranged in a single operation that adjusts both the front hoop and the rear strap to fit the positioning and stabilization structure to heads of different sizes, the positioning and stabilization structure, the patient interface including the adjustment mechanism.

52. At least 4 cmH higher than the ambient air pressure ２ A plenum chamber capable of being pressurized to a treatment pressure at least 4 cmH higher than the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the treatment pressure for breathing by a patient; A seal-forming structure constructed and arranged to form a seal with a region of the patient's face that surrounds the entrance to the patient's airway, whereby the air flow is delivered at the treatment pressure to at least the entrance to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use; A front hoop that extends across the patient's cheek region during use and is arranged to contact a region of the patient's head above the upper ear base point of the patient's head during use, the front hoop The lower portions of two gas delivery tubes fluidly connected to the seal-forming structure, each lower portion of the gas delivery tubes extending across one of the patient's cheek regions during use, the two gas delivery tubes being provided on different sides of the patient's head, the lower portions of the two gas delivery tubes, and A link connecting the two gas delivery tubes between the lower and upper portions of the two gas delivery tubes, the front hoop including; and A rear strap configured to surround the rear portion of the patient's head during use; and A disconnect mechanism that enables adjustment of the position of the upper portion of the gas delivery tube on the patient's head by decoupling the adjustment of the position of the upper portion of the gas delivery tube from the movement of the seal-forming structure away from the patient's face during use, the patient interface including the disconnect mechanism.

53. A system for treating a respiratory disorder, The patient interface according to claim 51 or 52; An air circuit; and An air source that is at a positive pressure relative to the ambient air pressure, the system including.

54. A positioning and stabilization structure that holds a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face that surrounds an entrance to the patient's airway so as to deliver air flow at a therapeutic pressure of at least 4 cmH ２ O high in a sealed manner throughout the patient's respiratory cycle, the positioning and stabilization structure being Including at least one hoop that extends across the patient's cheek region during use and is arranged to contact a region of the patient's head above the upper ear base point of the patient's head during use, at least one of the hoops At least one gas delivery tube for delivering the air flow to the inlet of the patient's airway through the seal forming structure, wherein at least one of the gas delivery tubes is constructed and arranged to cover at least a region of the patient's head above the upper ear base point of the patient's head during use, at least one hoop including at least one gas delivery tube; and An adjustment mechanism for fitting the positioning and stabilization structure to heads of different sizes by adjusting at least one of the hoops, the adjustment mechanism including one or more tube insert members configured to be selectively fluidly connected to at least one of the gas delivery tubes to change the length of the hoop, an adjustment mechanism, including a positioning and stabilization structure.

55. Further including a rear strap configured to surround the rear portion of the patient's head during use, wherein at least one of the one or more tube insert members includes a connecting portion for connecting the rear strap to at least one of the gas delivery tubes, the positioning and stabilization structure according to claim 54.

56. By the one or more tube insert members, a plurality of tube insert members are formed, and by sizing each of the plurality of tube insert members differently, the change in the length of the hoop is facilitated, the positioning and stabilization structure according to claim 54 or 55.

57. One or more tube insert members from the plurality of tube insert members are configured to be selected to enable optimization of comfort / force vectors by enabling adjustment of the position of the connecting portion, the positioning and stabilization structure according to claim 56.

58. The plurality of tube insert members includes at least one tube insert member having a connecting portion configured to receive a headgear strap, the positioning and stabilization structure according to claim 56 or 57.

59. The connecting portion is an eyelet, the positioning and stabilization structure according to claim 58.

60. The connecting portion is arranged at equal intervals between the upper end and the lower end of at least one of the tube insert members, the positioning and stabilization structure according to claim 58 or 59.

61. The positioning and stabilization structure according to claim 58 or 59, wherein the connecting portion is disposed in proximity to the upper end or the lower end of at least one of the tube insert members.

62. The positioning and stabilization structure according to claim 60 or 61, wherein at least one of the tube insert members includes a small tube insert member and a large tube insert member that is longer than the small tube insert member.

63. The positioning and stabilization structure according to any one of claims 58 to 62, further comprising at least one tube insert member without configuring the connecting portion to be selectively connected to at least one of the tube insert members having the connecting portion.

64. The positioning and stabilization structure according to claim 63, wherein each insert tube member of at least one insert tube member without a connecting portion is sized differently to facilitate changing the length of the tube.

65. The positioning and stabilization structure according to claim 63 or 64, wherein at least one insert tube member without a connecting portion is selectively connected to the upper end or the lower end of at least one of the tube insert members having the connecting portion.

66. The positioning and stabilization structure according to claim 56 or 57, wherein at least one of the tube insert members of the plurality of insert members includes a substantially U-shaped configuration.

67. At least one of the tube insert members of the plurality of tube insert members, a first opening configured to be fluidly connected to an end of a first gas delivery tube of at least one of the gas delivery tubes; a second opening configured to be fluidly connected to an end of a second gas delivery tube of at least one of the gas delivery tubes; and a third opening configured to be fluidly connected to an end of an air delivery tube, the air delivery tube being configured to convey the air flow to at least one of the gas delivery tubes at the treatment pressure, the positioning and stabilization structure according to claim 56, 57 or 66.

68. The positioning and stabilization structure according to claim 66 or 67, wherein at least one of the tube insert members includes a lower end and a protrusion extending below the lower end in use.

69. The positioning and stabilization structure according to claim 68, wherein the end of the protrusion includes a connecting portion.

70. The positioning and stabilization structure according to claim 69, wherein the connecting portion is an eyelet.

71. The positioning and stabilization structure according to claim 69 or 70, wherein the connecting portion is removably connected to at least one of the gas delivery tubes.

72. The positioning and stabilization structure according to claim 71, wherein the connecting portion is removably connected to at least one of the gas delivery tubes using a hook and loop material.

73. The positioning and stabilization structure according to any one of claims 68 to 72 when dependent on claim 67, wherein the first opening is disposed at the lower end and the protruding portion extends below the first opening during use.

74. A positioning and stabilization structure for holding a seal - forming structure in a therapeutically effective position on a patient's head, wherein the seal - forming structure is constructed and arranged to form a seal with a region of the patient's face that surrounds the entrance to the patient's airway so as to deliver air flow at a treatment pressure of at least 4 cmH ２ O higher than ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilization structure is Including at least one hoop that extends across the patient's cheek region during use and is arranged to contact a region above the upper ear base point of the patient's head during use, and at least one of the hoops is At least one gas delivery tube for delivering the air flow to the inlet of the patient's airway through the seal-forming structure, and at least one of the gas delivery tubes is constructed and arranged to cover at least a region above the upper ear base point of the patient's head during use; and An adjustment mechanism for fitting the positioning and stabilization structure to heads of different sizes by adjusting at least one of the hoops, the adjustment mechanism including an extendable section of at least one of the gas delivery tubes and one or more insert members configured to be selectively connected to at least one of the gas delivery tubes to change the length of the extendable section of at least one of the gas delivery tubes.

75. The positioning and stabilization structure according to claim 74, wherein the one or more insert members are constructed from a rigid material.

76. Further including at least one retainer, and at least one of the retainers is disposed within the side of at least one of the gas delivery tubes to hold the one or more insert members relative to at least one of the gas delivery tubes and change the length of the extendable section.

77. The positioning and stabilization structure according to claim 74 or 75, wherein at least one retainer is disposed on an extensible section of at least one of the gas delivery tubes.

78. The positioning and stabilization structure according to claim 77, wherein at least one of the retainers is disposed on an outer surface of the extensible section.

79. The positioning and stabilization structure according to claim 77, wherein at least one of the retainers is disposed on an inner surface of the extensible section.

80. The positioning and stabilization structure according to claim 79, wherein at least one gas delivery tube includes a central port, and the one or more insert members are configured to be inserted through the central port.

81. The positioning and stabilization structure according to any one of claims 76 - 79, wherein the retainer is connected to at least one of the gas delivery tubes or takes the form of a pocket formed within at least one of the gas delivery tubes.

82. The positioning and stabilization structure according to any one of claims 76 - 79, wherein the retainer takes the form of one or more fasteners fixed to at least one of the gas delivery tubes.

83. The positioning and stabilization structure according to claim 82, wherein the one or more fasteners include hook and loop material.

84. The positioning and stabilization structure according to any one of claims 74 - 83, further comprising a first substantially non - extensible section connected to a first end of the extensible section and a second substantially non - extensible section connected to a second end of the extensible section.

85. The positioning and stabilization structure according to claim 84, wherein the first substantially non - extensible section and the second substantially non - extensible section are constructed from silicone and / or textile.

86. The positioning and stabilization structure according to claim 84 or 85, wherein the first substantially non - extensible section is directly connected to the first end of the extensible section and the seal - forming structure, and the second substantially non - extensible section is directly connected to the second end of the extensible section and the seal - forming structure.

87. At least one retainer includes a left retainer and a right retainer, the left retainer is disposed adjacent to a first end of the extendable section, and the right retainer is disposed adjacent to a second end of the extendable section. The positioning and stabilization structure according to claim 84 or 85 when dependent on any one of claims 76 to 79.

88. The distance between the left retainer and the right retainer is less than the length of the one or more insert members in the relaxed position of the extendable section. The positioning and stabilization structure according to claim 87.

89. The distance between the left retainer and the right retainer is substantially equal to the length of the one or more insert members in the extended position of the extendable section. The positioning and stabilization structure according to claim 87.

90. By the one or more insert members, a plurality of insert members are formed. By making each insert member of the plurality of insert members of different sizes, the change of the length of the tube is promoted. The positioning and stabilization structure according to any one of claims 74 to 89.

91. One or more insert members from the plurality of insert members are configured to be selected so as to enable optimization of comfort / force vector by enabling adjustment of the position of the connecting portion. The positioning and stabilization structure according to claim 90.

92. The extendable section is constructed from silicone and / or textile. The positioning and stabilization structure according to any one of claims 74 to 91.

93. A positioning and stabilization structure for holding a seal-forming structure in a therapeutically effective position on a patient's head, wherein the seal-forming structure is configured and arranged to form a seal with a region of the patient's face that surrounds an inlet to the patient's airway so as to deliver air flow at a therapeutic pressure of at least 4 cmH ２ O higher in a sealed manner throughout the patient's respiratory cycle, and the positioning and stabilization structure is Including at least one hoop that extends across the patient's cheek region during use and is arranged to contact a region above the upper ear base point of the patient's head during use. At least one of the hoops is At least one gas delivery tube for delivering the air flow to the inlet of the patient's airway through the seal forming structure. At least one of the gas delivery tubes is constructed and arranged to cover at least a region above the upper ear base point of the patient's head during use. At least one gas delivery tube; A rear strap configured to surround the rear of the patient's head during use; and An adjustment mechanism for fitting the positioning and stabilization structure to heads of different sizes by adjusting at least one of the hoops, the adjustment mechanism including one or more insert members configured to be selectively connected to at least one of the gas delivery tubes so as to change the length of at least one of the gas delivery tubes, at least one of the one or more insert members including a connecting portion for connecting the rear strap to at least one of the gas delivery tubes, the positioning and stabilization structure including the adjustment mechanism.

94. A positioning and stabilization structure that holds a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face that surrounds an entrance to the patient's airway, for delivering a sealed flow of air at a treatment pressure of at least 4 cmH ２ O higher than ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilization structure being Including at least one hoop that extends across the cheek region of the patient during use and is arranged to contact a region above the suprameatal point of the patient's head of the patient's head during use, at least one of the hoops At least one gas delivery tube for delivering the air flow to the inlet of the patient's airway through the seal forming structure, at least one of the gas delivery tubes being constructed and arranged to cover at least a region above the suprameatal point of the patient's head of the patient's head during use; and An adjustment mechanism for fitting the positioning and stabilization structure to heads of different sizes by adjusting at least one of the hoops, the adjustment mechanism including one or more inflatable portions, the positioning and stabilization structure including the adjustment mechanism.

95. The positioning and stabilization structure according to claim 94, wherein at least one of the one or more inflatable portions forms a patient contact portion of the hoop and adjusts the position of at least one of the gas delivery tubes on the patient's head.

96. The positioning and stabilization structure according to claim 94 or 95, wherein the effective length of the hoop is adjusted by one or more of the inflatable portions.

97. The positioning and stabilization structure according to claim 96, wherein at least one of the inflatable portions is movable between a decompressed state and an inflated state, and the decompressed state forms a greater effective length than the inflated state.

98. Further including a retainer, the retainer being disposed within a side portion of at least one of the gas delivery tubes to hold one or more of the inflatable portions relative to at least one of the gas delivery tubes, the positioning and stabilization structure according to any one of claims 94 to 97.

99. The retainer takes the form of one or more fasteners fixed to at least one of the gas delivery tubes, the positioning and stabilization structure according to claim 98.

100. The retainer takes the form of a loop surrounding at least one of the gas delivery tubes, the positioning and stabilization structure according to claim 99.

101. The retainer is disposed on the lower side of at least one of the gas delivery tubes, and the complementary retainer is disposed on the upper surface of one or more of the inflatable portions, the positioning and stabilization structure according to claim 98 or 99.

102. One or more of the inflatable portions are fixed to at least one of the gas delivery tubes, the positioning and stabilization structure according to any one of claims 94 to 101.

103. Further comprising a controller and a sensor communicating with the controller, the controller being configured to adjust the volume of air within one or more of the inflatable portions, the positioning and stabilization structure according to any one of claims 94 to 102.

104. The sensor is a pressure sensor, an optical sensor and / or a position sensor, the positioning and stabilization structure according to claim 103.

105. Further comprising a valve configured to selectively provide an air flow within one or more of the inflatable portions, the positioning and stabilization structure according to claim 103 or 104.

106. The controller is configured to control the position of the valve, the positioning and stabilization structure according to claim 105.

107. The position of the valve is manually controllable, the positioning and stabilization structure according to claim 105.

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