Adjustable headgear tubing for a patient interface

Abstract

To provide a positioning and stabilizing structure to hold a seal-forming structure in a therapeutically effective position on a head of a patient.SOLUTION: The seal-forming structure may be constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure throughout the patient's respiratory cycle in use. The positioning and stabilizing structure 3300 may comprise a gas delivery tube to deliver the flow of air to the entrance of a patient's airways via the seal-forming structure. The gas delivery tube may be constructed and arranged to contact, in use, a region of the patient's head superior to an otobasion superior of the patient's head. The positioning and stabilizing structure may comprise an adjustment mechanism 3360 for adjustment of a length of the gas delivery tube to enable the positioning and stabilizing structure to fit different size heads.SELECTED DRAWING: Figure 3A

Description

Technical Field

[0001] 1 Cross - References to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 281,322 and U.S. Provisional Application No. 62 / 330,371. The entire content of these documents is incorporated herein by reference for all purposes.

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

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

[0004] 4 Sequence Listing Not applicable

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

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

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

[0008] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The main function of the lungs is gas exchange, which involves 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 constitute the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is referred to as the respiratory region. See the following: Non-Patent Document 1.

[0009] There are a range of respiratory diseases. Certain diseases can be characterized by specific episodes (e.g., apnea, hypopnea, and hyperpnea).

[0010] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes such as closure or obstruction of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue area, as well as the normal loss of the soft palate and posterior oropharyngeal wall during sleep. Due to such a condition, the breathing stops of affected patients typically last for 30 to 120 seconds, and sometimes the breathing stops 200 to 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular diseases and brain damage. This syndrome is a common disease, especially common in middle-aged overweight men, but patients may have no symptoms. See Patent Document 1.

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

[0012] Respiratory insufficiency is a general term for respiratory disorders, indicating that the lungs are unable to perform sufficient oxygen inhalation or sufficient CO2 exhalation to meet the patient's needs. Respiratory insufficiency may include some or all of the following diseases.

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

[0014] Obesity-hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during wakefulness in a state where there is no other clear cause of hypoventilation. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

[0015] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases with certain common characteristics. This includes an increase in resistance to the movement of air, 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.

[0016] Neuromuscular disease (NMD) is 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 consequently leads to inability to walk, confinement to a wheelchair, dysphagia, reduced respiratory muscle strength, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified into the following two categories: rapid progressive and slow progressive: (i) Rapid progressive disorders: Characterized by muscle impairment that deteriorates over several months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slow progressive disorders: Characterized by muscle impairment that deteriorates over several years and only slightly reduces the average life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Respiratory failure symptoms in NMD include: increased general debility, dysphagia, dyspnea during exertion and at rest, fatigue, drowsiness, headache upon waking, and difficulty in concentration and mood changes.

[0017] 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 can cause severe respiratory failure. Respiratory failure symptoms include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, headache upon waking, fatigue, reduced quality of sleep, and loss of appetite.

[0018] To treat or improve such conditions, a range of treatments are being used. Additionally, in other aspects, healthy individuals can also benefit from preventive treatment for respiratory diseases. However, there are several deficiencies in these.

[0019] 5.2.2 Treatment methods 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, CPAP therapy 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 regarding the device used for treatment delivery, the patient may choose not to comply with the treatment: discomfort, difficulty of use, high cost, lack of aesthetic appeal.

[0020] 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 throughout 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.

[0021] Invasive ventilation (IV) provides ventilatory assistance to a patient who is unable 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.

[0022] 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 symptoms.

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

[0024] 5.2.3.1 Patient Interface A patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an airflow to the airway inlet. The airflow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can form a seal with, for example, the area of the patient's face, thereby facilitating gas delivery at a sufficient distributed pressure along with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the atmospheric pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O.

[0025] 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.

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

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

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

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

[0030] Due to these challenges, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the 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 such cases of masks, they can be unacceptably uncomfortable for long-term (e.g., several hours) wearing. Due to such discomfort, the patient's compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0031] CPAP treatment is extremely effective in the treatment of certain respiratory diseases when the patient 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.

[0032] In the case of masks for other uses (e.g., pilots), they may not be suitable for the treatment of sleep apnea, so masks designed for the treatment of sleep apnea may be suitable for other uses.

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

[0034] 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.

[0035] The patient interface may be characterized in part 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 to rest, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming portion may include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal-forming portion may include a single element that surrounds both nostrils and the oral cavity region during use. These different types of patient interfaces may be known by various names 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.

[0036] 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.

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

[0038] 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 against the patient's face. This seal-forming portion can include an air or fluid-filled cushion or can include a formed or shaped surface of an elastic sealing 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.

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

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

[0041] Another form of seal-forming portion can use an adhesive to achieve a seal. There are patients who always find it inconvenient to attach or remove the adhesive portion to their face.

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

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

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

[0045] 5.2.3.1.2 Positioning and Stabilization The seal forming portion of the patient interface used in positive pressure air therapy is 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 parts of the face.

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

[0047] In another technique, one or more straps and / or stabilization harnesses are used. In the case of a number of such harnesses, one or more of the 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.

[0048] 5.2.3.1.3 Conduit for pressurized air In one type of treatment system, the flow of pressurized air is provided to the patient interface through a conduit in the air circuit. This conduit fluidly connects to the patient interface such that when the patient interface is positioned on the patient's face during use, the conduit extends away from the patient's face in a forward direction from the patient interface. This is sometimes also referred to as an "elephant trunk" type interface.

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

[0050] 5.2.3.1.4 Conduit for pressurized air used for positioning / stabilizing the 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 airway also functions as part of a headgear for positioning and stably arranging the seal-forming portion of the patient interface on an appropriate part of the patient's face. This type of patient interface may also be referred to as using "headgear tubing" or "tubing headgear". When using such a patient interface, a conduit in an air circuit providing a pressurized air flow from a respiratory pressure treatment device can be provided to the patient interface located at a position other than in front of the patient's face. An example of such a treatment system is disclosed in Patent Document 12. In this specification, the content of the same document is incorporated by reference for reference purposes. In the same 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.

[0051] The Philips DreamWear® 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® 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® mask, as well as an increase in packaging. Furthermore, when supplying masks of different sizes, the range within which patients with different head sizes can be accommodated (for example, whether the patient's head size fits between the provided mask sizes or not) is limited.

[0052] When using a patient interface with headgear tubing, several advantages can be obtained (for example, 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 with headgear tubing is desirably comfortable while forming an effective seal with the patient's face when the patient wears it for a long time while sleeping.

[0053] 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 not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0054] One known RPT device used 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 independent breathing for patients over a certain range for the treatment of multiple conditions (non-limiting examples include NMD, OHS, and COPD).

[0055] 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, thus 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 more than in the case of cold air.

Prior Art Documents

Patent Documents

[0056]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Patent Document 9

Patent Document 10

Patent Document 11

Patent Document 12

Patent Document 13

Patent Document 14

Patent Document 15

Patent Document 16

Patent Document 17

Patent Document 18

Non-Patent Document

[0057]

Non-Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0058] 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 diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

Means for Solving the Problems

[0059] The first aspect of the present technology relates to a device used in the diagnosis, improvement, treatment or prevention of respiratory diseases.

[0060] One aspect of a specific form of the present technology is to provide a method and / or device for improving patient compliance with respect to respiratory therapy.

[0061] 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.

[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 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 of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilization structure may include at least one gas delivery tube for delivering airflow through the seal-forming structure to the entrance of the patient's airway. The at least one gas delivery tube may be constructed and arranged to contact at least one region of the patient's head above the auricular basal superior 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. This 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.

[0063] 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 of at least 4 cmH2O above ambient air pressure. The plenum chamber can include a plenum chamber inlet port sized and configured to receive an air flow at the treatment pressure for breathing by the patient. The patient interface can include a seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an inlet to the patient's airway, whereby the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils. 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 located 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 gas delivery tube for delivering the air flow through the seal-forming structure to an inlet to the patient's airway. The at least one gas delivery tube can be constructed and arranged to contact at least one area of the patient's head above the auricular basal 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. The biasing mechanism applies a biasing force along at least a portion of the length of the at least one gas delivery tube for propelling the seal-forming structure towards the inlet to the patient's airway during use.

[0064] 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 patient's airway inlet to deliver airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use. 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 airflow to the inlet of the patient's airway through the seal-forming structure. The at least one gas delivery tube can be constructed and arranged to cover at least one region of the patient's head above the suprameatal 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.

[0065] Another aspect of one form of the present technology includes a patient interface including a plenum chamber that can be pressurized to a treatment pressure of at least 4 cmH2O above 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 can include a seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an inlet to the patient's airway, whereby the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils. 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 an inlet to the patient's airway. The at least one gas delivery tube can be constructed and arranged to cover at least one area of the patient's head above the supraauricular point of the patient's head during use. The positioning and stabilization structure can 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 can 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 including a plenum chamber that can be pressurized to a treatment pressure of at least 4 cmH2O above 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 respiration by the patient. The patient interface can include a seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an inlet to the patient's airway, whereby the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils. The seal-forming structure can be constructed and arranged to maintain the treatment 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. The positioning and stabilization structure can include a first tube portion constructed and arranged to cover an area of the patient's head above the auricular basal point of the patient's head during use. The positioning and stabilization structure can include a strap portion that is placed on or covers a posterior portion of the occipital bone of the patient's head during use. The patient interface can include a ventilation structure to enable continuous flow of gas exhaled by the patient from within the plenum chamber to the surroundings. The ventilation structure is sized and shaped to maintain the treatment pressure within the plenum chamber during use. The first tube portion can be configured to conduct at least a portion of the air flow breathed by the patient. The first tube portion can be configured to be in a taut state during use. The first tube portion can include a lengthwise adjustment mechanism.

[0067] 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 area of the patient's face surrounding the patient's airway inlet to deliver air flow at a therapeutic pressure of at least 4 cmH2O relative to 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 auricular basal 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 longitudinal adjustment mechanism.

[0068] 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 of at least 4 cmH2O above ambient air pressure. The plenum chamber can include a plenum chamber inlet port sized and configured to receive an air flow at the treatment pressure for breathing by the patient. The patient interface can include a seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an inlet to the patient's airway, whereby the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils. 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 positioning and stabilization structure that provides elasticity to hold the seal-forming structure in a therapeutically effective position on the patient's head for sealing delivery of the treatment pressure in the air flow. The positioning and stabilization structure can include a tie. The tie can be constructed and arranged such that at least a portion of the tie covers an area of the patient's head above the auricular basal point of the patient's head during use. The tie can include a gas delivery tube with an adjustable length for delivering the air flow through the seal-forming structure to an inlet 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 inlet of the patient's airway during use.

[0069] 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 area of the patient's face surrounding the patient's airway inlet to deliver airflow in a sealed manner at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use. 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 auricular basal superior point of the patient's head during use. The strap can include a gas delivery tube with an adjustable length for delivering airflow through the seal-forming structure to the inlet 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 inlet of the patient's airway during use.

[0070] Another aspect of one form of the present technology includes an inflatable positioning and stabilization structure for delivering airflow in a sealed manner to the inlet of the patient's airway formed by the seal-forming structure of the patient interface at a continuous positive pressure relative to ambient air pressure, and 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 respiratory cycle during the patient's sleep, such that sleep disordered breathing is improved. The positioning and stabilization structure can include at least one gas delivery tube for delivering airflow through the seal-forming structure to the inlet of the patient's airway. The positioning and stabilization structure can also include an adjustment mechanism that enables adjustment of the dimensions of the positioning and stabilization structure. The positioning and stabilization structure can also include a biasing mechanism that imparts a biasing force to the adjustment mechanism and to move the propulsion seal-forming structure towards the inlet of the patient's airway.

[0071] 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 positive pressure continuously with respect 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, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep of the patient during use, so that sleep apnea is improved. The patient interface may include a connection port for fluidly connecting to an air circuit connected to the supply of pressurized air during use. The connection port is disposed in the vicinity of the upper, side, or rear of the patient's head during use. The patient interface may also include a seal-forming structure that seals the area surrounding the inlet to the patient's airway. The patient interface may also include an inflatable positioning and stabilization structure for maintaining the seal formed by the seal-forming structure. 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 inlet of the patient's airway.

[0072] Another aspect of a related form of the present technology includes a patient interface. This patient interface includes a positioning and stabilization structure including an adjustment mechanism for enabling adjustment of the dimensions of the positioning and stabilization structure.

[0073] 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 propelling the seal-forming structure toward the inlet of the patient's airway.

[0074] Another aspect of one form of the present technology includes an inflatable positioning and stabilization structure for delivering an air flow in a sealed manner to an inlet to a patient's airway formed by a seal-forming structure of a patient interface at a positive pressure continuously with respect to ambient air pressure, maintaining 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 in use, and configured such that sleep disordered breathing is improved. The positioning and stabilization structure may include at least one gas delivery tube for delivering the air flow to the inlet of the patient's airway through the seal-forming structure. The positioning and stabilization structure may also include an adjustment mechanism that enables 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.

[0075] Another aspect of one form of the present technology includes a patient interface for delivering a supply of pressurized air to an inlet of a patient's airway at a positive pressure continuously with respect 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 respiratory cycle during the patient's sleep in use, and configured such that sleep disordered breathing is improved. 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 inlet of the patient's airway through the seal-forming structure. The positioning and stabilization structure may also include an adjustment mechanism that enables 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 a particular form of the present technology is a system for the treatment of respiratory diseases. The system includes a patient interface according to any one or more of the other aspects of the present technology, an air circuit, and an air source at positive pressure.

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

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

[0079] 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 oral cavity during use.

[0080] 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.

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

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

[0083] Another aspect of a particular form of the present technology is a patient interface constructed and arranged to enable the patient to breathe ambient air during a power outage.

[0084] 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 over the lower portion of the patient's nose without contacting the nasal bridge region of the patient's nose.

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

[0086] Another aspect of a particular form of the present technology is a patient interface. This patient interface is constructed and arranged such that a patient can lie comfortably in a lateral or side-lying sleep position when using the patient interface.

[0087] Another aspect of a particular form of the present technology is a patient interface. This patient interface is constructed and arranged such that a patient can lie comfortably in a supine sleep position when using the patient interface.

[0088] Another aspect of a particular form of the present technology is a patient interface. This patient interface is constructed and arranged such that a patient can lie comfortably in a prone sleep position when using the patient interface.

[0089] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are not very dexterous or lack insight, or people with limited experience using this type of medical device.

[0090] One aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soapy water in the patient's home, and no special cleaning equipment is required. One aspect of one form of the present technology is a humidifier tank that can be cleaned, for example, with soapy water in the patient's home, and no special cleaning equipment is required.

[0091] Of course, some of the above aspects can form sub-aspects of the present technology. Also, various combinations of diverse sub-aspects and / or aspects can be made, which can also constitute further aspects or sub-aspects of the present technology.

[0092] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

[0093] 7 BRIEF DESCRIPTION OF THE DRAWINGS The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals indicate the following like elements:

BRIEF DESCRIPTION OF THE DRAWINGS

[0094]

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[0095] 8 DETAILED DESCRIPTION OF THE EXAMPLES OF THE PRESENT TECHNOLOGY Before further elaborating on the present technology, it should be understood that the present technology is not limited to the specific embodiments that may be described in this specification. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific embodiments described in this specification and are not limiting.

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

[0097] 8.1 Treatment Method In one form as shown in FIG. 1A, the present technology includes a method for treating a respiratory disease. The method includes the step of applying positive pressure to the inlet of the airway of patient 1000.

[0098] 8.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of 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.

[0099] 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.

[0100] The cushion assembly 3150 includes a seal formation 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 formation structure 3100 is arranged to seal the area around the inlet to the patient's airway so as to facilitate a positive pressure air supply to the airway.

[0101] 8.3.1 Seal formation structure In one form of the technology, the seal formation structure 3100 may provide a seal formation surface and may further provide a cushioning function.

[0102] The seal formation structure 3100 according to the technology may be composed of a soft, flexible and elastic material (for example, silicone).

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

[0104] 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 may 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.

[0105] 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.

[0106] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the underside of the patient's nose, the stem, and on a flexible region on the underside of the frustum of the cone, connecting the frustum of the cone to the stem. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible region can function to facilitate a freely jointed structure. The freely jointed structure corresponds to the mutual movement of both the displacement and the angle of the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone can be displaced axially towards the structure to which the stem is connected.

[0107] In one form, the non-invasive patient interface 3000 includes a seal-forming portion that forms a seal over the upper lip region (i.e., the upper lip), the nasal bridge region, and the cheek regions of the patient's face during use. For example, the patient interface 3000 shown in FIG. 1B is this case. 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".

[0108] In another form, the seal-forming structure is configured to form a seal with the lower 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 patient's nasolabial angle). In one form of the nasal cradle cushion, the seal-forming structure includes a septal 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 septal member may be configured to contact or seal the patient's nasal columella 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.

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

[0110] 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 (which may also be referred to as an "oral cushion" or an "oral mask"). In such a mask, air or breathable material is 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 removably attached and then reattached again. 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.

[0111] In some forms of the present technology, the seal forming structure 3100 is configured such that the seal forming structure does not extend below the auricular ridge region of the patient's head during use.

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

[0113] 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.

[0114] 8.3.2 Plenum Chamber The plenum chamber 3200 receives pressurizable gas during use and is pressurized at a pressure above ambient pressure. In some forms of the present technology, the plenum chamber 3200 has an edge 3210 shaped to be complementary to the surface contour of an average human 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. Actual contact with the face is provided by the seal forming structure 3100. The seal forming structure 3100 may extend around the entire perimeter of the edge of the plenum chamber 3200 during use.

[0115] The plenum chamber 3200 may receive pressurizable gas through a plenum chamber inlet port sized and configured to receive gas from another part of the patient interface 3000.

[0116] 8.3.3 Positioning and Stabilization Structure The seal forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by a positioning and stabilization structure 3300 during use. The positioning and stabilization structure 3300 may also be referred to as a "headgear" as it engages the patient's head to hold the patient interface 3000 in a sealed position.

[0117] In one aspect of the present technology, a positioning and stabilization structure 3300 configured to be worn by a patient during sleep is provided. In one embodiment, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness so as to reduce the perceived or actual bulk of the device.

[0118] The positioning and stabilization structure 3300 may include at least one tie. A tie can be understood as a structure designed to resist tension. In use, the tie is part of the positioning and stabilization structure 3300 that is under tension. Some ties add the resulting elasticity 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 aspect of the present technology, the positioning and stabilization structure 3300 may include ties in the form of a headgear tube 3350 and / or a headgear strap as described below.

[0119] 8.3.3.1 Headgear Tubing In the aspect 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, through, for example, the plenum chamber 3200 and the seal-forming structure 3100, to the patient's airway from the RPT device. 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 part 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 can be obtrusive to some people.

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

[0121] In certain forms of the technology, patient interface 3000 may include connection port 3600 disposed adjacent to the upper, side, or rear of the patient's head. For example, in the form of the technology shown in FIG. 3A, connection port 3600 is disposed on top of the patient's head. In the case of a patient interface where the connection port is not disposed in front of the patient's face, it can be advantageous because there are patients who feel obstructive and uncomfortable when a conduit is connected to a patient interface in front of the face. For example, a conduit connected to a patient interface in front of the face may be prone to entanglement with bedding or bed linen, especially when the conduit extends downward from the patient interface during use. According to a form of the technology using a patient interface where the connection port is disposed adjacent to the upper side 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 transverse position, a supine position (i.e., a face-up state), and a prone position (i.e., a face-down prostrate state). Further, when the conduit is connected in front of the patient interface, it can cause a problem known as tubing drag. In tubing drag, an undesirable pulling force can be generated on the conduit relative to the patient interface, resulting in being pulled down from the face.

[0122] In the example of FIG. 3A, at least one tube 3350 extends between connection port 3600 over the patient's cheek region and over the patient's ear to between cushion assemblies 3150 (i.e., between a portion of tube 3350 connected to cushion assembly 3150 that covers the upper jaw region of the patient's head during use and a portion of tube 3350 that covers the region of the patient's head above the point on the base of the ear on the patient's head).

[0123] In the form of the present technology shown in FIG. 3A, the positioning and stabilization structure 3300 includes two tubes 3350. Each tube is arranged on a different side of the patient's head during use and extends from above each ear (above the point on the base of the ear on the patient's head) through each cheek region to the connection port 3600 at the top of the patient's head. In the case of this technology form, 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 pressurized gas can be supplied to the patient as described, 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 arranged on one side of the patient's head (e.g., on one cheek region) during use, and the strap forms part of the positioning and stabilization structure 3300 and is arranged on the other side of the patient's head (e.g., on the other region) during use to assist in fixing the patient interface 3000 on the patient's head.

[0124] 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 or storage. If 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 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.

[0125] These tubes 3350 can be formed of a semi-rigid material such as an elastomeric material (e.g., silicone). These tubes can have a natural pre-formed shape and can bend or move to assume another shape when a force is applied to the tube. For example, these tubes can generally assume an arcuate or curvilinear shape that resembles the outer contour of the patient's head between the upper head and the nose or mouth region.

[0126] An exemplary form of the present technology shown in FIG. 3A has tubes 3350. These tubes 3350 curve rearwardly in a state where there is no sagittal plane curvature from the upper end of the tube 3350 that connects to the connection port 3600 on the upper head to the point where the rear headgear strap 3310 connects to the tube 3350 around the upper periphery of the patient's head. 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 portion of the tube 3350 can be in the range of 60 to 100 mm (e.g., 70 to 90 mm (e.g., 80 mm)). The lower end of the tube 3350 and the portion where the rear headgear strap 3310 connects to the tube 3350 can be at an angle in the range of 65 to 90° (e.g., 75 to 80°).

[0127] In certain forms of the present technology, one or more portions of the tube 3350 may be stiffened by one or more stiffening elements or reinforcing elements. Examples of stiffening elements include: portions of the tube 3350 that are relatively thicker than other portions, portions of the tube 3350 formed from a material having relatively higher rigidity than the material forming other portions, and rigid members attached to or embedded within the interior or exterior of a portion of the tube. When such stiffening elements are used, it aids in the positioning during use and the control of the functional mode of the stabilization structure 3300 (for example, when a force is applied to the tube 3350, the tube 3350 is likely to deform; when a force is applied to the tube 3350, the shape of the tube 3350 is likely to be maintained). By selecting where to place such stiffening elements within the tube 3350, it can aid in promoting comfort when the patient interface 3000 is worn and can aid in maintaining a good seal in the seal-forming structure during use. The stiffening element or reinforcing element may be disposed within the positioning and stabilization structure 3300. The positioning and stabilization structure 3300 is configured to support a relatively high-weight seal-forming structure (such as a full-face or nasal-oral cushion assembly).

[0128] In the form of the present technology shown in FIG. 3A, the length of the tube 3350 is 15 - 30 cm (for example, 20 - 27 cm). In one embodiment, the length of the tube is 25 cm. The length of the tube is selected to be suitable for 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 extends over the patient's cheek region as shown in FIG. 3A, the distance between the upper end of the tube 3350 and the region near the opening to the patient's airway where the lower end of the tube 3350 connects to the cushion assembly 3150 in the vicinity of the upper part of the head). As will be 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 tubes 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).

[0129] The level at which the patient interface 3000 is fitted to an individual patient can be changed by varying the length of the tube 3350 and, alternatively or additionally, by varying the position of the patient interface 3000 on the patient's head. For example, by moving the positioning and stabilization structure 3300 in a posterior or anterior direction on the patient's head, the patient interface 3000 with a particular length of tube 3350 can be adjusted to fit the patient. Positioning the connection port 3600 further forward (i.e., in the anterior direction) enables the patient interface 3000 with a particular length of tube 3350 to fit a larger head than when the connection port 3600 is positioned further posteriorly (i.e., in the posterior direction).

[0130] In certain forms of the technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned within a range of positions across the upper portion 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. 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 is to decouple the movement of the upper portion of the patient interface 3000 from the lower portion of the patient interface 3000. Such separation 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. Such a mechanism will be described below.

[0131] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 is disposed generally at the upper point of the patient's head. The connection port 3600 can be disposed within the sagittal plane and can be aligned with the upper point of the ear base within a plane parallel to the coronal plane. The upper point of the ear base 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 disposed adjacent to the upper part of the patient's head within the sagittal plane from 20 mm in front of or 20 mm behind the upper point of the ear base.

[0132] The cross-sectional shape of the tube 3350 can be circular, elliptical, oval, D-shaped or rounded rectangular as described, for example, in Patent Document 13. This document is incorporated herein by reference for reference purposes. 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.

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

[0134] The D-shaped cross-sectional tube 3350 shown in FIG. 3H has a curved edge 3347 located on the side of the side 3348 that contacts the patient. The curved edge that contacts the patient's skin or is in the vicinity of the patient's skin helps to increase the comfort when wearing the patient interface 3000 and to avoid marks or inflammation on the patient's skin. Making the tube have a D-shaped cross-sectional profile makes it more resistant to buckling than in the case of other shaped outer profiles.

[0135] As described in Patent Document 13, the tube 3350 can withstand buckling in order to avoid the flow of breathable gas passing through the tube when it is crushed during use (for example, 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 buckling of the tube 3350 during use, a tube that can withstand buckling is not necessarily required in all cases. Using a tube that can withstand buckling can be advantageous when there is only a single tube 3350. This is because when a single tube is blocked during use, the gas flow is restricted and the treatment stops or its effectiveness decreases.

[0136] The two tubes 3350 are fluidly connected to the cushion assembly 3150 at their lower ends. In a particular form of this technology, the connection between the tube 3350 and the cushion assembly 3150 is achieved by connecting two rigid components in such a way that the patient can easily connect the two rigid components in a highly 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.

[0137] In another embodiment, a compression seal is used to connect the tube 3350 to the cushion assembly 3150. For example, when using an elastic flexible (e.g., silicone) tube 3350 without a rigid connector, it may be necessary to slightly compress the tube 3350 to reduce its diameter so that it can be pushed into a port in the plenum chamber 3200. The inherent elasticity of the silicone presses the tube 3350 outward to airtight seal the tube 3350 in the port. When the engagement between the tube 3350 and the port is a rigid-to-rigid type of engagement, a pressure-activating seal such as a peripheral sealing flange may be used. When pressurized gas is supplied through the tube 3350, the sealing flange is advanced against the joint between the tube and the inner peripheral surface of the port in 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-activating seal as described above may also be used to ensure that the connection is airtight.

[0138] In some forms of the present technology, a similar connection mechanism may be used when fluidly connecting the tube 3350 by a T-shaped upper member that defines or is connectable to the connection port 3600. In one embodiment, since the swivel elbow connected at the connection port 3600 is rotatable, this rotation drives a port size adjustment mechanism that increases or decreases the size of the port at the insertion end of the tube 3350, improves the fit of the tube through increasing or decreasing the compression force, and reduces unintended leakage.

[0139] 8.3.3.2 Headgear Strap In certain forms 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.

[0140] 8.3.3.2.1 Position of the Headgear Strap In one example, as shown, for example, in FIG. 3A, the positioning and stabilization structure 3300 includes a rear headgear strap 3310. The rear strap 3310 is disposed 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 overlay 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.

[0141] In one form of the present 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, for example, in FIGS. 10A and 10B. The jaw strap 3320 may connect to the headgear tube 3350 or, in another embodiment, may connect to the cushion assembly 3150 or a frame assembly operably connected to the cushion assembly.

[0142] Certain forms of the present technology may include multiple headgear straps for increased stability as described above (e.g., rear straps, side headgear straps, and jaw straps).

[0143] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a mechanism for connecting the headgear strap to the seal-forming structure 3100. The headgear strap may be connected directly or indirectly to the seal-forming structure 3100. In the 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 outwardly from each headgear tube 3350. These tabs 3345 have holes therein for receiving the ends of the rear strap 3310.

[0144] 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 fixed 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 aids in the headgear 3300 accommodating different head shapes and sizes.

[0145] 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., rearward) direction. The magnitude of this force can be adjusted by changing the length of the rear strap 3310 between the tabs 3345.

[0146] 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.

[0147] It may be advantageous if the headgear 3300 can be made to correspond to a range of head sizes and head shapes by being able to adjust the magnitude 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 the 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.

[0148] In some forms of the present technology, upon donning by the patient, the point on the headgear tube 3350 adjacent to the tab 3345 generally receives an upward (e.g., upward) force from the upper portion of the headgear tube 3350 due to a biasing mechanism (described in further 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 a generally forward (e.g., forward) and downward (e.g., downward) force generated from a biasing mechanism that functions to propel the seal-forming structure 3150 upward and into the patient's nose. The direction and magnitude of the forces required for a secure fit and effective seal can vary among patients based on, 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.

[0149] For example, in order to balance the large forces applied to 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 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.

[0150] 8.3.3.2.2 Form of the headgear strap In one embodiment, the positioning and stabilization structure 3300 includes at least one strap 3310 having a rectangular cross-section. In one embodiment, 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.

[0151] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap 3310 composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous such that moisture (e.g., sweat) can pass through the strap 3310. In one form, the fabric outer layer includes a loop material that engages a hook material portion. The hook material portion may be disposed at the distal portion of the strap 3310.

[0152] 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 when in use and direct a force that causes the seal-forming structure 3100 to adhere to a part of the patient's face. In one embodiment, 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 adjustable without the strap 3310.

[0153] 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.

[0154] 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.

[0155] 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.

[0156] 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, particularly between the connection port 3600 and the seal-forming structure 3100 (e.g., length adjustment of the tie (e.g., headgear tubing 3350)). Additionally or alternatively, the adjustment mechanism 3360 is configured to enable bendable adjustment of the positioning and stabilization structure 3300 (e.g., 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 also be comfortably worn, resulting in increased stability, reduced likelihood of seal breakage, and a comfortable level of headgear tension that maintains the sealing structure at the entrance of the patient's airway. These elements improve patient compliance with the 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.

[0157] 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.

[0158] In some forms of the present technology, the adjustment mechanism 3360 can enable adjustment of the size of the patient interface 3000 by up to 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 100 mm. In one form of the present technology, the total length of the tube 3350 can be adjusted by up to 80 mm. For example, the length of the tube 3350 disposed on each side of the patient's face during use can be adjusted by up to 40 mm.

[0159] The patient interface 3000 is positioned and stabilized 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 from 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.

[0160] 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.

[0161] 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 as it reduces the likelihood that the patient interface 3000 will fit inaccurately or uncomfortably to the patient. On the other hand, some patients may prefer to be able to change the fit of the patient interface themselves.

[0162] 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 can include seal-forming structures of different sizes and weights. For example, an oronasal cushion can be of higher weight than a nasal cushion. In such forms of the present technology, when using a manual adjustment mechanism, an advantage can be obtained that the mechanism can be initially set to be compatible with the type of seal-forming structure being used. For example, if a relatively high-weight seal-forming structure is used to weaken 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 oral movements (e.g., opening the mouth wide).

[0163] 8.3.3.3.1 Folding / Bellows Headgear Tube In certain forms of the present technology, the adjustment mechanism 3360 includes a tube 3350 having one or more folding sites, pleats, corrugated patterns, or bellows. That is, the folding sites, pleats, corrugated patterns, or bellows include the adjustment mechanism 3360. When each folding site first assumes a first folded configuration, the length of each tube 3350 is different from the length when the folding site is in a second non-folded configuration.

[0164] The patient interface 3000 shown in FIG. 3A includes a tube 3350 that includes a bellows section 3362. The bellows section 3362 is provided between the lengths of the non-bellows tube 3350. The bellows 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 section 3362 and thus each tube 3350. The folds in the bellows section 3362 can be expanded (elongated) 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 this also helps to adjust the patient interface to fit the patient-specific head size and head shape.

[0165] In a particular form of the present technology, the bellows 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 section can be continuously adjustable. An adjustment mechanism such as a bellows section 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.

[0166] In some forms of the present technology, the tube 3350 includes a plurality of bellows sections 3362 at predetermined positions. These bellows sections 3362 are each separated by the length of the non-bellows tube 3350.

[0167] In some forms of the present technology, the bellows tube portion 3350 is provided within a relatively straight portion of the tube 3350. This avoids the tendency for the bellows portion 3350 to straighten when pressurized gas passes through the tube 3350. If the bellows portion 3350 straightens, the position of the patient interface on the patient's head can change, which can adversely affect seal stability and / or flow impedance.

[0168] In the form of the present technology shown in FIG. 3B, the patient interface 3000 includes a tube 3350 that includes a bellows tube portion 3362. The bellows tube portion 3362 is longer than the bellows tube portion 3362 shown in FIG. 3A. In the form of the present technology shown in FIG. 3B, the bellows tube portion 3362 extends over most of the length of each tube 3350 between the point where the headgear strap 3310 connects to the tube 3350 and the point where the upper end of the tube 3350 connects to the connection port 3600. For example, the bellows tube portion 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. Making the bellows tube portion longer 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 portion 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 with a wide range of head sizes.

[0169] In the form of the present technology shown in FIGS. 3C, 3D, and 3E, the patient interface 3000 is the same as the patient interface 3000 shown in FIG. 3B. One difference is the configuration of the bellows tube portion 3362. In the form of the present technology shown in FIGS. 3C, 3D, and 3E, the width and diameter of the bellows tube portion 3362 vary along the length of each bellows tube portion 3362. More specifically, the bellows tube portion 3362 is formed in a tapered shape such that the width and diameter of the tube at one end of each bellows tube portion 3362 are smaller than the width and diameter of the tube at the other end of each bellows tube portion 3362. Even more specifically, the width and diameter of the upper end of each bellows tube portion 3362 (where the bellows tube portion 3362 is connected to the connection port 3600) are larger than the width and diameter of the lower end of each bellows tube portion 3362 (where the bellows tube portion 3362 is connected to a part of the tube 3350 without a bellows), and the width and diameter of the bellows tube portion 3362 gradually increase between the upper end and the lower end and are generally linear. The tapered shape of the bellows tube portion 3362 is also shown in FIG. 3F. FIG. 3F is a plan view of the patient interface 3000 of FIGS. 3C, 3D, 3E, and 3G. FIG. 3G shows the patient interface 3000 of FIG. 3F in a cross-section along line 3G-3G. By making the bellows tube portion 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, thereby enabling a smooth transition that reduces an increase in impedance and promotes fluid flow along the tube 3350.

[0170] One advantage of the bellows tube portion 3362 for the adjustment mechanism 3360 is that, compared to other adjustment mechanisms, the bellows tube portion can be more easily curved or bent and extended in the longitudinal direction. FIG. 3J shows the headgear 3300 being worn at three different positions on the patient's head with the endings of the reference numerals assigned "a", "b", and "c". As shown in FIG. 3J, the bellows tube portions 3362a, 3362b, and 3362c are curved to different levels, the bellows tube portion 3362a is curved forward on the patient's head, the bellows tube portion 3362b has a smaller curvature in the rear / front direction, and the bellows tube portion 3362c is substantially non-curved on the patient's head.

[0171] In some forms of the present technology, the bellows tube portion 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 portion 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 portion 3362 extends less (e.g., buckles more) in front than in the rear in the case of the bellows tube portion 3362a (i.e., when the headgear is worn on the patient's head in front of the coronal plane). Since the bellows tube portion 3362 can be curved in the forward direction, it is assisted 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 sealed contact with the patient's face. Since the headgear tube 3350 can be curved in the forward or backward direction, it is assisted to disconnect the connection port 3600 from the cushion assembly 3150. The difference in the amount of extension of the bellows tube portion 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 amount of extension of the bellows tube portion 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.

[0172] In one form, the bellows tube portions 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.

[0173] In other forms of the present technology, the bellows tube portion 3362 can be disposed at different portions of the length of the tube 3350. As shown in FIGS. 3A and 3B, where the bellows tube portion 3362 is disposed along the length of the tube 3350 such that the bellows tube portion 3362 contacts the upper and / or upper side of the patient's head (i.e., the region of the patient's head above the supraaurale of the patient's head), one advantage of the patient interface 3000 is that the bellows tube portion 3362 does not contact the patient's cheek region. As a result, discomfort that may occur when the bellows tube portion contacts the patient's cheek region during use is avoided.

[0174] The bellows tube portion 3362 is prone to buckling, especially when it is particularly large and extended. Therefore, there is a risk that the tube 3350 may be blocked due to the bellows tube portion 3362, resulting in the delivery of breathable gas to the patient being restricted or avoided. 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 portion 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 portion 3362 and are circumferentially arranged around the tube 3350. For example, these rings may be disposed inside the bellows tube portion 3362, or may be molded (e.g., co-molded or overmolded) with the bellows tube portion 3362. In another embodiment, a helical element for buckling suppression is provided along the bellows tube portion 3362. In such an embodiment, the material portion 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-portion formed with the bellows tube portion 3362 is thicker, or is composed of a material with a higher composition than other bellows tube sub-portions for buckling suppression.

[0175] In another form of the technology, the patient interface includes an adjustment mechanism 3360 that includes a tube 3350. The tube 3350 has one or more circumferential folds for longitudinally folding adjacent portions of the tube 3350. When the circumferential folds are in a folded configuration, the length of the tube covers the adjacent length of the tube. The stiffness of the material forming the tube 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 forces applied to the tube during typical use of the patient interface). Alternatively, the patient interface can include means (e.g., a clip) for maintaining the tube in the folded configuration. In another embodiment, when the tube is folded to maintain it in the folded configuration, magnets are embedded in the tube to align between the overlapping folded sites (unless the magnets are pulled apart).

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

[0177] Another form of the folding adjustment mechanism 3360 of the positioning and stabilization structure 3300 of the patient interface 3000 is shown in 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 onto the respective smaller or larger head. For example, these tubes can be formed of metasilicone having a hardness of 40 durometers on a shore hardness scale.

[0178] In the form of the present technology shown in FIG. 6, the tube 3350 on one side of the patient's head extends at its upper end in a generally front-rear direction away from the connection port 3600 and in a generally downward direction on the patient's head side near the point where the headgear strap 3310 is attached to the tube 3350, so that the position edge of the upper curved portion 3353A generally covers the upper part of the patient's head, and the outside of the front side of the rear curved portion and the outside of the curved portion on the inner side are provided. Below the point where the headgear strap 3310 is attached to the tube 3350, the tube 3350 extends generally downward and curves slightly forward in the forward direction. The lower curved portion 3353B is generally disposed above the patient's cheek region 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 slightly downward (i.e., extends slightly downward when worn by some patients). The lower curved portion 3353B generally disposed on the patient's cheek region has the outside of the curved portion on the rear side and the inside of the curved portion on the front side.

[0179] The lower part of the tube 3350 in FIG. 6 is constructed and configured such that during use, the tube 3350 is generally disposed in a direction away from the patient's eye, such that the tube 3350 does not enter the patient's field of view or, if it does, is at least minimized. This can be achieved by constructing the lower part of the tube 3350 such that the apex or maximum curvature point of the lower curved portion 3353B is disposed over a rearward region of the patient's cheek region during use.

[0180] Although not shown in FIG. 6, the tube 3350 disposed on the left side of the patient's face is contrarily constructed with respect 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.

[0181] 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.

[0182] The patient interface 3000 shown in FIG. 7A includes an adjustment mechanism 3360 including 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, since the first tube portion 3370 is connected to the connection port 3600, it is disposed at a higher position 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 part of the tube 3350 disposed on the lower side 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.

[0183] 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 portions can be fixed to a plurality of distinct positions using other interlocking mechanisms (e.g., one or more groove portions or hole portions that cooperate with one or more protrusions or detents). It is understood that these groove portions can be provided on the surface of the first tube portion or the second tube portion, and 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 groove portions during use.

[0184] 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 telescopically slide 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 disposed 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 disposed on each side of the patient's head during use.

[0185] The patient interface 3000 includes an upper tube member 3351. The upper tube member 3351 is disposed 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 part of its central portion.

[0186] The first tube portion 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 can be pressed against the first tab 3371. For example, the user can place the thumb on the second tab 3373, place the index finger on the first tab 3371, and pinch these two tabs so that the second tab 3373 moves towards the first tab 3371. When the second tab 3373 is moved towards the first tab 3371, the first tube portion 3370 and the second tube portion 3372 telescopically slide, and the headgear tube 3350 is shortened. 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, and the headgear tube 3350 is lengthened.

[0187] When the second tab 3373 is slid towards 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.

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

[0189] 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 tube 3350 may be affected. Patient interface 3000 shown in FIG. 7B includes a stiffening member 3379 to address this issue. Stiffening member 3379 functions to increase the rigidity of portions of the second tube portion 3372 that move from inside and outside the first tube portion 3370 during use. In the illustrated embodiment, stiffening member 3379 is the length of a relatively rigid material provided on the upper side of each second tube portion 3372. Stiffening member 3379 may be attached to the outside of the second tube portion 3372 or may be molded (e.g., co-molded or over-molded) 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.

[0190] 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 to any part of the positioning and stabilizing structure 3300 of any form of the patient interface 3000 described herein unless otherwise specified. For example, the padded member 3330 may be provided as part of tube 3350 to make wearing of the patient interface more comfortable. The padded member 3330 may be permanently attached to a part of tube 3350, for example, by molding (e.g., co-molding or over-molding) or adhesion. Alternatively, the padded member 3330 may be removably attached to tube 3350 using, for example, hook and loop type fastening material or fasteners. Since the padded member 3330 contacts the patient's head during use, it may become soiled. It may be advantageous if the padded member 3330 can be removed for cleaning and / or replacement.

[0191] Another 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 disposed at a position higher than the other tube portion on the patient's head during use.

[0192] 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 to the ring member 3384 (for example, 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.

[0193] 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, a situation where the first tube portion and the second tube portion that are telescopically movable move relative to each other in one direction 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) is interlocked with a groove or a protrusion (for example, a rib 3374) on the second tube portion 3372 unless the button 3378 is pressed.

[0194] 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 extends generally 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 region of the tube 3350 than when the meshing curved surfaces in the ratchet mechanism are large.

[0195] In another form of the present technology, button 3378 includes tabs disposed on the side of tube 3350. These tabs are tightened inwardly to release the interlocking mechanism and allow for relative movement of the telescopic tube portions. These tabs may include a gap or window in the first tube portion 3370 that surrounds the second tube portion 3372, whereby a patient or clinician can pinch a portion of the second tube portion 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 portion 3372 to release the interlock. Covering the gap with overmolded buttons or eliminating the gap in adjustment mechanism 3360 reduces the likelihood of a patient's hair getting caught in adjustment mechanism 3360, which would compromise comfort. In one exemplary embodiment, adjustment mechanism 3360 is configured such that when the sides of ring member 3384 at the upper end of second tube portion 3372 are pressed inwardly, the interlock feature between second tube portion 3372 and first tube portion 3370 is released, enabling telescopic movement between the tube portions. For example, ring member 3384 may include a hard plastic pinch button overmolded with silicone and one or more protrusions on its inner upper surface, allowing for interlock with a groove on the upper surface of first tube portion 3370 such that when ring member 3384 is pressed inwardly at the sides, the protrusions and groove are pushed out of interlocking engagement.

[0196] The patient interface of FIG. 8 includes a padded member 3330 on the side that contacts the patient of positioning and stabilization structure 3300, thereby improving comfort when the patient interface 3000 is worn.

[0197] 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 portions 3375a, 3375b, and 3375c that slide relative to each other. Each nested concentric tube portion 3375 can be fully exposed or fully covered by telescopically extending or retracting the adjacent nested concentric tube portion 3375 relative to the respective nested concentric tube portion 3375. These nested concentric tube portions are interlocked with each other (e.g., via a snap-fit mechanism) to hold their positions when fully extended or contracted. In some embodiments, the nested concentric tube portions 3375 can be held in an intermediate position (i.e., not fully extended or retracted).

[0198] In the embodiment shown in FIG. 9, each nested concentric tube portion is marked with a visual indicator 3377 that indicates the length of the tube 3350. When the tube portion 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 portions 3375a - 3375c can be configured to extend or retract in a predetermined order.

[0199] Another form of the present technology includes a tube 3350 formed from a plurality of telescopic tube portions coupled to each other in other ways. For example, each tube 3350 can include a central inner tube portion with two outer tube portions on both sides. The central inner tube portion telescopically slides inside and outside each of these two outer tube portions during use. Alternatively, the central tube portion may be provided outside the two outer tube portions.

[0200] In other forms of telescopically adjustable headgear tubes, other forms of size indicators may be provided. In certain forms, the first tube portion 3370 of tube 3350 that surrounds the second tube portion 3372 during telescopic movement between these two tube portions may include a window or gap. Through this window or gap, a visual indicator 3377 on the second tube portion 3372 indicating the size of tube 3350 provided in this way can be visually recognized.

[0201] 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-type portions of the adjacent first tube portion 3370 and second tube portion 3372 of tube 3350 move telescopically, thereby changing the length of tube 3350. The connection of the first tube portion 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 disposed at the lower end of the headgear tube 3350. For example, the adjustment mechanism 3360 can be provided adjacent to the cushion assembly 3150. In the embodiment shown in FIG. 10A, when the teeth or pinion 3383 are rotated, the lower end of tube 3350 moves telescopically relative to the cushion assembly 3150.

[0202] In another form of the present technology, the adjustment mechanism 3360 is disposed at the connection port 3600, and a swivel elbow is provided with teeth or a pinion such that when the elbow rotates, the headgear tube portions 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.

[0203] When different numbers of relative positions of the first tube portion and the second tube portion are provided by a telescopic adjustment mechanism, it is understood that a greater number of positions allow for a greater number of adjustment positions, facilitating an improved fit to the patient. In some embodiments, 3, 4, 5, 6 or more adjustment positions are provided.

[0204] In a particular form of the present technique, the telescopic tube portion is configured to move relative to each other and be adjusted in a continuous manner (i.e., the relative position of the tube portions is not limited to discrete positions). As a result, it becomes possible to more greatly customize the length of tube 3350.

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

[0206] 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.

[0207] In another embodiment of the present technology, the telescopic slide portion of the tube 3350 is held in frictional contact through ribs on the slide surfaces of one or both of the slide portions. Alternatively, one or more O-rings may be provided between the telescopically sliding tube portions. These ribs or O-rings hold the tube portions with sufficient frictional force to hold the tube portions 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.

[0208] In another form of the present technology, the telescopic tube portion can be fixed in a predetermined position using other fixing mechanisms. In one example, the length of the strap is attached to one of the telescopic tube portions together with a part of the hook and loop fastener material provided on the strap. This strap can be fixed to a complementary portion of the hook and loop fastener material (for fixing a portion at a desired position) provided on the other telescopic tube portion, thereby enabling adjustment of the length of the tube 3350.

[0209] In the above-described embodiments of the present technology in which one or more tube portions are telescopically movable relative to other tube portions, it is understood that the amount of leakage of breathable gas from the patient interface is reduced because these tube portions 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.

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

[0211] The configuration and structure of the sealed contact between the first tube portion and the second tube portion that telescopically move can be selected so as to obtain an appropriate friction level to achieve a balance between the quality of the seal and the ease of adjustment of the first tube portion and the second tube portion. In some forms of the present technology (for example, the patient interface 3000 shown in FIG. 7B), it has been found that the minimum holding force between the first tube portion 3370 and the second tube portion 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 portions 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 portion and the second tube portion to adjust the length of the tube 3350.

[0212] 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, 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 portion.

[0213] In the above-described embodiment of the present technology in which one or more tube portions are telescopically movable relative to other tube portions, the patient interface 3000 may include one or more end stops to avoid a situation where the first tube portion 3370 and the second tube portion 3372 are separated. In one embodiment, the inner tube portion includes a flange at its end, and the outer tube portion includes an end stop on the inner surface adjacent to the flange at the maximum extension of the tube portion.

[0214] 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 decoupling of the tubing pull force.

[0215] 8.3.3.3.3 Modular Tube Portion In the patient interface 3000 shown in FIG. 11, the adjustment mechanism 3360 takes the form of an interchangeable tube portion 3385. The interchangeable tube portion 3385 can be removed from the patient interface 3000 and can be exchanged with a replacement tube portion 3386 having a different length with respect to the first tube portion or module 3385. The interchangeable and replacement tube portions 3385 and 3386 can be described as tube modules.

[0216] In the example of FIG. 11, the interchangeable tube portion 3385 includes a T-shaped tube member. This T-shaped tube member has three ports such that the interchangeable tube portion 3385 is fluidly connected to the tube 3350 and the air circuit 4170, respectively, during use. For example, the upper central port of the interchangeable tube portion 3385 is configured to connect to or include the connection port 3600. For example, the interchangeable tube portion 3385 can be disposed on the patient's head during use.

[0217] 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 portions 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.

[0218] In the form of the present technology shown in FIG. 12, the patient interface 3000 includes one or more tube insertion members 3387a and 3387b. These tube insertion members 3387a and 3387b are configured to be selectively fluidly connected to the tube 3350 so as to change the length of the tube. For example, the tube insertion 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 insertion 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 insertion member 3387 can be marked with a size indication (for example, "M" represents "medium" and "L" represents "large"). A patient interface of one size can be achieved without inserting the tube insertion member.

[0219] 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 can be provided on the lower end of the tube configured to connect to the cushion assembly 3150 or on the upper end of the tube configured to connect to the connection port 3600.

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

[0221] 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 portion of the tube.

[0222] 8.3.3.3.5 Extendable tube In a particular form of the present technology, the adjustment mechanism includes one or more extendable portions 3355 of the headgear tube 3350 formed of an extendable material. The extendable portion enables the length of the tube 3350 to be continuously adjusted according to the heads of different sizes of patients. 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 portion 3362 shown in FIG. 3A is extendable by its configuration) or both.

[0223] The relatively extensible portion of the tube 3355 of the headgear tube 3350 shown in FIG. 13 is connected to one or more non-extensible or less extensible portions of the 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 the tube 3350 of a certain length on one side of the extensible portion 3355, and a second fixing member 3358 attached to the tube 3350 of a certain length on the other side of the extensible portion 3355. The first fixing member 3357 and the second fixing member 3358 are configured to be connected to each other by any suitable mechanism (e.g., an interlocking clip, a magnetic connection, a hook and loop fastener). One of the fixing members 3358 may include a plurality of sites to which the other fixing member 3357 can be connected, enabling the tube 3350 to be fixed at the desired length.

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

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

[0226] In one embodiment, the extendable portion of the tube 3355 has a cross-sectional thickness that decreases along the length. For example, the cross-sectional thickness can decrease in a stepped longitudinal cross-section. Alternatively, the cross-sectional thickness of the tube portion 3355 can alternate between a thicker longitudinal cross-section and a thinner longitudinal cross-section. The surface transition between portions of different cross-sectional thicknesses may be smooth or abrupt. Regions of different cross-sectional thicknesses can have different rigidities and / or durometer values. Regions of different cross-sectional thicknesses may be formed from the same material or from different materials. By selecting the structure of the extendable portion of the tube 3355 using different materials and different cross-sectional thicknesses, a particular portion of the tube 3350 can be designed to be more flexible than other portions. As a result, by making the portion of the tube 3350 that is placed on the anatomical structure of a patient, especially where there is a large difference in individual sizes during use, more flexible than other portions, it is possible to assist in fitting the patient interface to different patients. Additionally or alternatively, the extendable portion of the tube 3355 can be designed to substantially maintain a predetermined minimum aperture area during use such that the impedance of the patient interface to the breathable gas flow can be configured to match the respiratory therapy system (e.g., a desired gas flow rate).

[0227] 8.3.3.3.6 Different Tube Connection Positions In a particular form of the present technology, the tube 3350 can be connected in a plurality of ways that allow for an effective length of the fluid path between the connection port 3600 and the seal-forming structure 3100 to be adjusted.

[0228] In certain forms, each tube 3350 includes two or more separate tube members that can be fluidly connected at multiple positions to vary 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 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 on the second tube member to connect the protruding tube to. The ends of the first and second tube members adjacent to the connection port and the protruding 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.

[0229] 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 fits can be varied by adjusting which port to connect the tube to. For example, one port can be arranged to be closer to the patient's face than another port during use. Connecting to the tube 3350 closer to the patient's face can accommodate a larger patient head than connecting the tube 3350 to a port at a position spaced from the patient's face.

[0230] 8.3.3.3.7 Modification of 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. Within the loop created by these components, when the patient interface 3000 is worn, the patient's head is positioned.

[0231] 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.

[0232] 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.

[0233] In FIG. 5, the patient interface 3000 includes a strap 3390 connected between the tubes 3350. The strap 3390 is arranged towards the upper end of the patient interface 3000 below the connection port 3600 so as to pass above or in the vicinity of the upper part of the patient's head during use. The strap 3390 may be formed to curve upward so as 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.

[0234] 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 can include an adjustable fastening attachment between two portions of the strap 3390. For example, one portion of the strap 3390 can pass through a loop. This loop is attached to the end of the other portion of the strap 3390 and attached to the strap 3390 using hook and loop material. Alternatively, these two strap portions can be connected together using poppers or interlocking members that can be connected at multiple different positions. In another embodiment, the two portions 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 portions 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.

[0235] 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.

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

[0237] Due to an increase in the friction level between the band and the tube, the band 3395 can be tightly fixed around the tube 3350 so that the tube 3350 does not easily move and loosen during use. For example, the band 3395 can be formed of rubber or other high-friction materials. Alternatively, the patient interface can include a mechanism for fixing the position of the band. 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.

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

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

[0240] One form of the present technology is shown in FIG. 15. In this form, the patient interface 3000 includes a loop insertion member 3410. The loop insertion member 3410 is connected to the lower side of the tube 3350 and the connection port 3600 and is disposed between the patient's head and the tube 3350 and the connection port 3600 during use. The loop insertion member 3410 functions to change the size of the loop that surrounds a part of the patient's head as compared to the size of the loop formed by the tube 3350 in the absence of the loop insertion member.

[0241] The loop insertion member 3410 is removably attached to the tube 3350. Therefore, the loop insertion member 3410 can be removed and replaced with one or more replacement loop insertion members 3411a, 3411b, or 3411c. The replacement loop insertion members 3411a, 3411b, or 3411c are different in size from the loop insertion member 3410, and by selecting the loop insertion member, the size of the loop surrounding 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 insertion members 3410 and 3411 can be removed, it is also advantageous in terms of being able to be cleaned.

[0242] The loop insertion 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, so that the shape of the loop surrounding 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 material or a gel material). Since the loop insertion member contacts the patient's hair or skin during wearing, the loop insertion member is preferably formed of a material that can be easily cleaned.

[0243] The loop insertion members 3410 and 3411 shown in FIG. 15 are generally U-shaped, and the apex of the letter "U" is arranged at the upper part of the patient's head below 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, insertion members of different shapes are used. For example, the insertion member may include a short linear pad configured to contact a small area of the patient's head. The replacement insertion members 3411 of different sizes can have different thicknesses, different lengths, and / or different levels of curvature. The patient contact surface of each insertion member may be the same or similar so as to conform to the patient's head shape regardless of the insertion member used.

[0244] The loop insertion 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 underside of the tube 3350 and the upper sides of the loop insertion members 3410 and 3411. In other embodiments, poppers, hemispherical shapes, clasp blockers or magnets are used to connect the loop insertion members 3410 and 3411 to the tube 3350.

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

[0246] In the form of the present technology shown in FIG. 16, the patient interface 3000 includes an inflatable loop insertion member 3420. The inflatable loop insertion 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 part 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 introduces air into the bladder through a valve.

[0247] 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 located above the patient's head on either side of the patient's head. The thickness of the bladder 3420 can be maximized at the top 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. With individually inflatable bladders, for example, by inflating the bladder to a greater extent on one side of the head than on the other side, it becomes possible for the patient to change the desired fit feeling of the patient interface as desired.

[0248] 8.3.3.3.10 Size of Dimension Adjustment of Headgear Tubing As described above, the positioning and stabilization structure 3300 can be configured to be attached together with the upper part of the headgear tubing 3350 arranged 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 positions / rearward 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 part of the headgear tubing 3350 is attached more forwardly compared to when the headgear tubing 3350 is attached more rearwardly. In some forms, the positioning and stabilization structure 3300 enables a patient with a large head size to attach the upper part of the headgear onto their head at a more forward (e.g., frontward) position, and thus the magnitude of the length adjustment required for the adjustment mechanism 3360 to accommodate the large head size is reduced.

[0249] Figure 3J shows three illustrations of patient interfaces 3000a, 3000b, and 3000c according to one embodiment of the present technology. Each illustration of patient interface 3000 is shown at a different position on the patient's head for comparison. Patient interface 3000b is shown as a solid line at the central position, and patient interfaces 3000a and 3000c are shown as imaginary lines and are worn 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, patient interface 3000a (front position) can fit a larger head (shown as an imaginary line) because it is worn forward. Similarly, patient interface 3000c (rear position) can fit a smaller head (shown as an imaginary line) appropriately with the adjustment mechanism 3360 of the same length.

[0250] In one illustration in Figure 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 vertically. The connection port 3600b is centered on the front-rear axis. That is, the connection port 3600b is not arranged at a generally forward (e.g., front) position or a generally rearward (e.g., rear) position but at the central position. The connection port 3600b is arranged at the upper point of the patient's head. The connection port 3600b can be arranged in the sagittal plane and is aligned with the upper point of the ear base in a plane parallel to the coronal plane. The upper point of the ear base is shown in Figure 2D.

[0251] In another illustration in FIG. 3J, as indicated by the reference numeral with "a" attached, the patient is wearing the headgear tubing 3350a in a relatively forward (e.g., front) position compared to the position of the headgear tubing 3350b. In this configuration, the connection port 3600a is disposed generally forward of the adjustment mechanism 3360a. In this position, the connection port 3600a is in front of the suprameatal point. In another illustration in FIG. J, as indicated by the reference numeral with "c" attached, the patient is wearing the headgear tubing 3350c in a relatively rearward (e.g., back) position compared to the position of the headgear tubing 3350b. In this configuration, the connection port 3600c is disposed generally rearward of the adjustment mechanism 3360c. In this configuration, the connection port 3600c is behind the suprameatal point.

[0252] 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, thus enabling the positioning and stabilization structure 3300 to be worn at a relatively rearward position, and 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 patient head size, head shape, personal preference, etc. In some forms, the present technology positioning and stabilization structure 3300 is configured to be worn such that the connection port 3600 is disposed at positions from approximately 20 mm forward (e.g., forward) to approximately 20 mm rearward (e.g., rearward) from the central position at the upper point of the head 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 at the lower or non-adjustable tube portion 3363 (e.g., the portion below the rear strap 3310)). In other forms of the present technology, the upper and lower portions can both move (although not necessarily to the same extent). The rear strap 3310 can be configured to avoid or resist movement of the non-adjustable tube portion 3363. For example, by moving the upper portion of the headgear tube 3350 forward over the patient's head (without loosening the rear strap 3310), it may be necessary to move the upper portion of the headgear tube 3350 more than the non-adjustable tube portion 3363.

[0253] In addition to being able to separately attach the positioning and stabilization structure 3300 at different front / rear 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 adjustment of a predetermined amount of the length 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 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 20 mm and 40 mm. In some forms of the present technology, the length increase performed is substantially one of 25 mm, 30 mm, 35 mm, or 40 mm and is performed on either side.

[0254] The patient interface 3000 shown in 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 a patient's head of one size, and in the second configuration of the adjustment mechanism 3360', the headgear 3300 fits around a patient's head of a larger size. In this form of the present 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 centered position (e.g., the connection ports 3600 / 3600' are centered above the top point of the head rather than in front or behind).

[0255] 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 forward position, the central position, and / or the rearward 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 forward position, the positioning and stabilization structure 3300b is mounted at the central position, and the positioning and stabilization structure 3300c is mounted at the rearward position. That is, the connection port 3600a is at the forward position on the patient's head, the connection port 3600b is at the central position, and the connection port 3600c is at the rearward position. At the forward position, the headgear tube 3350a fits around a smaller circumference of the patient's head compared to the circumference around which the headgear tube 3350b fits around the central position. To accommodate this smaller circumference, providing the adjustment mechanism 3360a at the forward position enables the length of the headgear tube 3350 to be reduced (or the extension to be reduced). At the rearward position, the circumference of the patient's head around which the headgear tube 3350c fits is larger than the circumference at the central position. To accommodate this larger circumference, the adjustment mechanism 3360c enables the length of the headgear tube 3350 to be made longer compared to its length at the central position.

[0256] 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 broadens the range of adjustment options for the patient. Such diversity 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, thereby enabling the patient interface 3000 to be adapted to a wider range of head sizes.

[0257] 8.3.3.4 Position of the Headgear Tubing Adjustment Mechanism It is generally desirable to avoid features of the patient interface that cause discomfort to the patient. 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.

[0258] A mechanism that enables adjustment of the positioning and stabilization structure as described above may include features that cause discomfort to the patient when 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 arranged so as not to come into contact with the patient's skin or hair region (for example, arranged so as not to contact the patient's face or not to contact the patient's cheek region). In some forms of the present technology, the adjustment mechanism is arranged above the patient's ear (that is, above the auricular basal superior 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 portion. This non-adjustable headgear tube portion is arranged at a position adjacent to the patient's face during use (that is, arranged at a position where the non-adjustable headgear tube portion can contact the patient's face during use of the patient interface). For example, in some forms, the non-adjustable headgear tube portion is arranged adjacent to the patient's cheek region when worn. In some forms of the present technology, only the non-adjustable headgear tube portion comes adjacent to the patient's cheek region, comes below the auricular basal superior point of the patient's head, or covers the maxillary region of the patient's head.

[0259] The non-adjustable headgear tube portion is a portion specifically configured to be dimensionally adjusted during use (i.e., the adjustment mechanism does not form part of the non-adjustable headgear tube portion). That being said, it is not excluded that the non-adjustable headgear tube portion can be dimensionally adjusted, for example, when excessive force is applied. However, the position of the non-adjustable headgear tube portion may be adjusted during use. In some forms of the present technology, the non-adjustable headgear tube portion 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 FIG. 3L, the non-adjustable headgear tube portions 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.

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

[0261] In the case of the form of the patient interface 3000 shown in FIGS. 3A, 3B, 3C, 3D, 3E, and 3F, for example, the bellows portion 3362 is disposed 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 portion 3363. The level head and the non-adjustable headgear tube portion 3363 form the lower end of the headgear tube (i.e., the lower end when worn by the patient) and are disposed adjacent to (or covering) the patient's cheek region when worn. Other examples of the non-adjustable headgear tube portion 3363 are shown in FIGS. 5, 7A, 7B, 7C, and 17.

[0262] In certain forms of the present technology, the non-adjustable headgear tube portion 3363 is configured to assist in maintaining an appropriate seal between the cushion assembly 3150 and the patient's face during use of the patient interface 3000. To do so, it may be necessary to make the flexibility (or rigidity) of the non-adjustable headgear tube portion 3363 selectable, such that it has sufficient flexibility to accommodate certain movements during use and certain variations in the position where an individual patient wears the patient interface 3000, while also having sufficient rigidity so that the non-adjustable headgear tube portion 3363 does not deform easily during use.

[0263] 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, particularly 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 portion 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 located below the point where the rear headgear strap 3310 is connected to each headgear tube 3350 (i.e., below the position 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 configurations, the position of the effective pivot point will also be different.

[0264] For similar reasons, in some forms of the present technology, it may be advantageous to free the lower end of the headgear tube 3350 from any adjustment mechanism. If a bellows portion 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 portion may buckle and bend during movement and tend to function as a natural pivot, so the cushion assembly may move, and the seal with the patient's face may be disrupted.

[0265] 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 the part of the headgear tube 3350 located above (i.e., upward) the point where the rear headgear strap 3310 is connected to each headgear tube 3350), since the upper and lower parts of the headgear tube 3350 are assisted in being decoupled, excessive forces that could cause seal interference with the patient's face are prevented from being applied to the cushion assembly 3150 even when the upper part (due to variations in the position of the patient interface 3000 during use or on the patient's head) moves. 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 portion 3363 at the lower end of the headgear tube 3350 becomes linear. 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 portion 3363 becomes overly linear and / or extended, the cushion assembly 3150 may rotate forward, and the seal with the patient's face may be disrupted.

[0266] In some forms of the present technology, the bending radius of the non-adjustable headgear tube portion 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. The larger the bending radius, the greater the separation effect between the upper and lower ends of the headgear tube 3350, enabling the upper end of the headgear tube 3350 to be moved without causing significant forward rotation of the cushion assembly 3150 and the resulting sealing loss.

[0267] In some forms of the present technology, by arranging the adjustment mechanism 3360 on the upper part of the headgear tube 3350 in the vicinity of the connection port 3600, it becomes possible to separate the connection through the elongation and bending brought about by the adjustment mechanism, thus assisting in reducing the tube dragging on the head.

[0268] 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 a distance 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 attenuate the influence of the elongation of the adjustment mechanism 3360 on either side of the patient's head and / or any force imbalance applied from the adjustment mechanism 3360 to either side of the patient's head. When such an influence exists, the seal formed on the patient's face by the cushion assembly 3150 may be compromised.

[0269] In other forms of the present technology, the adjustment mechanism can be arranged in the vicinity of the cushion assembly 3150 of the patient interface and can be arranged at a distance from the patient's face due to the size of the plenum chamber and the position of the port (and thus the adjustment mechanism) where the tube 3350 is connected to the plenum chamber at a position separated from the patient's skin from the lower end of the tube 3350. The form of the present technology shown in Figure 10B is one such example of a patient interface 3000 where the adjustment mechanism is arranged at a distance from the patient's face during use. 8.3.3.5 Headgear Tubing Biasing Mechanism

[0270] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a biasing mechanism. This biasing mechanism functions to propel the seal-forming structure 3100 towards the patient's face (i.e., towards the area surrounding the patient's airway inlet (where the seal-forming structure 3100 is sealed)) during use. Thus, the biasing mechanism functions 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., imparts 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 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 invalidates this tendency in order to maintain the seal.

[0271] In some forms of the present technology, the biasing mechanism has the function of imparting 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.

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

[0273] 8.3.3.5.1 Magnitude of the force added from the biasing mechanism The biasing mechanism is preferably configured to apply sufficient inward (i.e., toward 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.

[0274] In some forms of the technology, the acceptable force provided by the biasing mechanism can be between 0.5 and 4 N on each side of the positioning and stabilization structure 3300. In some forms, the acceptable force can be between 1 and 3.5 N. A force of about 2 N can be considered acceptable. In some forms of the 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 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 of its larger 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.

[0275] In some forms of the technology, the positioning and stabilization structure 3300 is configured to interchangeably receive seal-forming structures of different sizes (e.g., 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., an oro-nasal cushion assembly)). The biasing mechanism that the 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) to either type of seal-forming structure.

[0276] 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.

[0277] In some forms of the technology, the biasing mechanism is configured to impart a force to the headgear tubing 3350 or a portion thereof to urge 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 at which 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 urge 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 equal to or greater than the minimum sealing force. The biasing mechanism may be configured to urge 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 equal to or less than the maximum comfortable force.

[0278] 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.

[0279] 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.

[0280] 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 elongates to a first amount of elongation (e.g., to a first extended length), the force added from the biasing mechanism is equal to or greater than the minimum sealing force. Further, when the headgear tube 3350 elongates to a second amount of elongation (e.g., to a second extended 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.

[0281] 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 a head size 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.

[0282] 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.

[0283] 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.

[0284] 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.

[0285] 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 can 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 varies 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.

[0286] 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.

[0287] 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 separate mechanism 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.

[0288] In some forms of the present technology, the biasing mechanism includes an elastic or elastic member or assembly. In some forms, the elastic or elastic member or assembly is connected between the seal-forming structure 3100 and the connection port 3600. For example, the elastic or elastic member or assembly is included as part of the 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.

[0289] 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.

[0290] 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.

[0291] The bellows tube portion 3362 can be designed to extend to a first amount of extension 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 amount of extension 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 amount of extension, the tension exceeds the minimum force necessary to create a proper seal of the seal forming structure 3100 against the patient's face. At the second amount of extension, 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 a sufficient seal across the range without causing discomfort due to the force.

[0292] In a particular form of the present technology, the bellows tube portion 3362 can include a bellows profile that provides the bellows tube portion 3362 with the force-extension 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 enable 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.

[0293] The profile of the bellows section 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 section 3362 is obtained (e.g., generally greater elongation is obtained at a given force). Additionally, the rib height (e.g., the amplitude of the bellows waveform) can be increased so that a more extensible bellows section 3362 is obtained. Alternatively, a less extensible bellows section 3362 can be provided by increasing the rib pitch or reducing the rib height.

[0294] Additionally or alternatively, for improved extensibility, a longer bellows section 3362 can be provided. This can be made possible, for example, by increasing the number of ribs formed in the wall of the bellows section 3362.

[0295] Additionally or alternatively, a more extensible bellows section 3362 can be obtained by reducing the wall thickness of the bellows section 3362, or a highly rigid bellows section 3362 can be obtained by increasing the wall thickness of the bellows section 3362.

[0296] Additionally or alternatively, for the bellows section 3362, the material forming it may be selected to assist in providing the predetermined force-elongation characteristics. In one form of the present technology, the material is silicone with a 50 durometer. Other materials and / or durometer values can also be selected (e.g., silicone with a 40 durometer).

[0297] Additionally or alternatively, different bellows profile shapes can be used for the bellows section 3362 to achieve different elongation amounts. For example, when using a bellows section 3362 in which the wall defining the profile is generally more folded, a more extensible bellows section 3362 can be obtained.

[0298] 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 portion 3363). The rib height can vary within a range such as, for example, 0 - 6 mm, 0 - 5 mm, 0 - 4 mm, 1 - 5 mm, etc. Alternatively, the rib height may be constant at a value such as, for example, 2 mm, 3 mm, 4 mm, etc. The wall thickness may be substantially constant along the length of the bellows tube portion 3362 or may be varied. In some forms of the present technology, the wall thickness can be within the range of 0.5 mm to 1.2 mm (e.g., 0.6 mm - 1 mm or 0.8 mm). The rib pitch can be within the range of 3.5 - 5 mm (e.g., 3.8 - 4.5 mm or 4.2 mm).

[0299] In other forms of the present technology, the shape and configuration of the bellows tube portion 3362 are different from the parameters exemplified above.

[0300] In the form of the present technology shown in FIG. 13, the relatively extensible portion of the tube 3355 is elastically or stretchably deformable and has a tendency to return to the non-extended state. Therefore, during use, the relatively extensible portion of the tube 3355 has the function of pulling the seal formation structure 3100 into the patient's face. Alternatively, the tube 3350 may be completely formed from an elastic material that has a tendency to return to the non-extended state when stretched.

[0301] Another form of the present 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, for example, it is understood that holes may be provided in the sleeve 3340 as described below. Alternatively, the headgear tube may be considered to include both an elastic sleeve and an inner gas delivery conduit with an elastic sleeve covering the inner gas delivery conduit. The elastic sleeve 3340 may 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).

[0302] The elastic sleeve 3340 covers the tube 3350, each including a bellows tube portion 3362. The bellows tube portion 3362 may or may not be biased to a compressed position. Due to the presence of the bellows tube portion 3362, 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, while allowing the length of the tube 3350 to be adjusted so that the patient interface 3000 fits individual patients.

[0303] The elastic sleeve 3340 may include a single elastic material sheet or 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.

[0304] 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.

[0305] The bellows portion 3362 of the tube 3350 can cause discomfort when it comes into contact with the patient's skin or hair during use. The patient may perceive the bellows as an obstruction or may experience discomfort during future wear, even if the bellows is not actually the cause of increased discomfort. These problems can be avoided by covering the bellows portion 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 in contact with the patient.

[0306] Since the elastic sleeve 3340 may come into contact with the patient's hair or skin during use, it is likely to be soiled by the patient's natural oils. Therefore, it may be advantageous for the elastic sleeve 3340 to 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 securing 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 to itself by means of a clip, popper, hook and loop material or other suitable fastener.

[0307] In some forms of the technology, the elastic sleeve 3340 is formed from a material or fabric that aids in venting moisture from the patient's face. As a result, maintaining comfort when the patient sweats during wearing of the patient interface can be supported.

[0308] 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 that it covers mechanisms or components that might otherwise discourage the patient from wearing the patient interface due to a complex or medical appearance.

[0309] 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 portion (e.g., a spring).

[0310] As an advantage when also providing a biasing force by a manually adjustable adjustment mechanism (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 offset 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.

[0311] 8.3.4 Ventilation section In one form, the ventilation portion included in the patient interface 3000 is constructed and arranged to reduce the risk that the patient will rebreathe such gases by allowing 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 ventilation portion enables the exhaled CO2 of the patient to flow outside the patient interface. This ventilation portion is sized and shaped to maintain the treatment pressure within the plenum chamber.

[0312] The ventilation portion of one form 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).

[0313] The ventilation portion can be disposed within the plenum chamber 3200. Alternatively, the ventilation portion can 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).

[0314] 8.3.5 Disengagement Structure(s) In one form, the patient interface 3000 includes at least one disengagement structure (e.g., a swivel or ball and socket). This disengagement structure can be disposed at or near the connection port 3600 such that the conduit of the air circuit 4170 can move relative to the patient interface 3000 and reduce the risk of destabilization of the seal between the seal forming structure 3100 and the patient's face.

[0315] 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 arranged on the patient's head when the patient interface 3000 is worn. In other embodiments, the connection port is configured to be arranged in the vicinity of the upper, side or rear part of the patient's head during use. In the case of a patient interface where the connection port is not arranged in front of the patient's face, it can be advantageous because some patients may find the catheter connecting to the patient interface in front of the face obstructive and uncomfortable. For example, in the case of a catheter connecting to a patient interface in front of the face, especially when the catheter extends downward from the patient interface during use, it may be prone to entanglement with bedding.

[0316] 8.3.7 Frontal support In one form, the patient interface 3000 includes a frontal support. This frontal support contacts the patient's frontal region during use to support the patient interface on the patient's head and helps maintain a sealed contact with the patient's face in a sealed structure.

[0317] 8.3.8 Anti-asphyxia 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-asphyxia valve.

[0318] 8.3.9 Port In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the quantity within the plenum chamber 3200. In one form, this enables the clinician to supply supplemental oxygen. In one form, this enables the direct measurement of the characteristics of the gas (e.g., pressure) within the plenum chamber 3200.

[0319] 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.

[0320] The pneumatic path of the pneumatic RPT device 4000 may include one or more pneumatic circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

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

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

[0323] 8.4.1 RPT Device Machinery and Pneumatic Components The RPT device may include one or more of the following components in an integrated unit. In an alternative form, one or more of the following components may be arranged as separate units, respectively.

[0324] 8.4.1.1 Air Filter The RPT device according to one form of the present technology may include an air filter 4110 or a plurality of air filters 4110.

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

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

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

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

[0329] In other forms, the pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

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

[0331] Specifically, the air circuit 4170 can be in fluid connection with the outlet of the RPT device 4000 and the patient interface 3000. The air circuit can be referred to as an air delivery tube or conduit. In some cases, there can be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0332] In some forms, the air circuit 4170 can include one or more heating elements configured to heat the air in the air circuit (e.g., for maintaining or increasing the air temperature). The heating element can take the form of a heating wire circuit and can include one or more transducers (e.g., temperature sensors). In one form, the heating wire circuit can be wound helically around the axis of the air circuit 4170. The heating element can communicate with a controller (e.g., the central controller 4230). An example of an air circuit 4170 including a heating wire circuit is described in Patent Document 18. The entire content of this document is incorporated herein by reference for reference purposes.

[0333] 8.5 Humidifier 8.5.1 Overview of the Humidifier In one form of the technology, a humidifier 5000 is provided for changing the absolute humidity of the air or gas to be delivered to the patient relative to the ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and the temperature of the air flow before it is delivered to the patient airway.

[0334] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. In some forms as shown in FIGS. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

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

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

[0337] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) outside the treatment system or the patient, and (ii) that which directly surrounds the treatment system or the patient.

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

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

[0340] In certain forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the room where the patient is located, other than noise generated from, for example, the RPT device or from the mask or patient interface. The ambient noise can be generated from a source outside the room.

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

[0342] Continuous positive airway pressure (CPAP) therapy: A respiratory pressure therapy in which the therapy pressure is substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different respiratory cycles of the patient (e.g., increases in response to detection of signs of partial upper airway obstruction and decreases in the absence of notification of partial upper airway obstruction).

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

[0344] In an example of the patient's respiration, the flow rate can be nominally positive pressure with respect to the inhalation portion of the patient's respiratory cycle and thus can be negative with respect to the exhalation portion of the patient's respiratory cycle. The total flow rate Qt is the flow rate of air exiting the RPT device. The ventilation flow rate Qv is the flow rate of air exiting the ventilation section to allow the outflow of the exhaled gas. The leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. The respiratory flow rate Qr is the flow rate of air received in the patient's respiratory system.

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

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

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

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

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

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

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

[0352] Respiratory Pressure Therapy (RPT): Addition of air supply to the airway inlet at a therapeutic pressure that is typically positive pressure with respect to the atmosphere.

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

[0354] 8.6.1.1 Materials Silicone or silicone elastomer: A synthetic rubber. As used herein, when silicone is referred to, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this trademark). Another LSR manufacturer is Wacker. Unless otherwise stated, the Shore A (or Type A) indentation hardness of the exemplary form of LSR, when measured by ASTM D2240, is about 35 to about 45.

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

[0356] 8.6.1.2 Mechanical Properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading. · "Elastic": Releases substantially all energy during unloading. For example, includes certain silicones and thermoplastic elastomers.

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

[0358] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending, or torsion). A structure or component can provide different resistance in different directions. · "Flopy" structure or component: A structure or component that changes (e.g., bends) its shape within a relatively short period (e.g., 1 second) when supporting its own weight. · "Rigid" structure or component: A structure or component that shows substantially no shape change when subjected to a load typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a sealed manner against the entrance to the patient's airway under a pressure load of, for example, approximately 20 - 30 cmH 2 O.

[0359] As an example, an I - beam can include different flexural stiffnesses (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component can be floppy in a first direction and rigid in a second direction.

[0360] 8.6.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a continuous period, e.g., 10 seconds. Obstructive apnea is said to occur when, despite the patient's effort, air flow is not allowed due to some airway obstruction. Central apnea refers to a state where apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to a state where a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

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

[0362] Load cycle: Ratio of the total inspiratory time Ti to the total respiratory time Ttot.

[0363] Work (breathing): Breathing effort is said to refer to the movement performed by the spontaneous breathing of a person attempting to breathe.

[0364] Expiratory portion of the respiratory cycle: Period from the start of the expiratory flow to the start of the inspiratory flow.

[0365] Flow limitation: Flow limitation is interpreted as a situation in a patient's breathing where an increase in the patient's work does not cause a corresponding increase in the flow. When flow limitation occurs in the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. When flow limitation occurs in the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0366] Types of waveforms of flow-limited inspiration: (i) Flattening: After an ascent, a relatively flat portion follows, and then a descent occurs. (ii) M-shaped: It has one local peak at the rise and one local peak at the fall, and there is a relatively flat portion between these two peaks. (iii) Chair-shaped: It has a single local peak, and after this peak occurs in the rising portion, a relatively flat portion follows. (iv) Inverse chair-shaped: A single local peak follows a relatively flat portion, and this peak occurs in the falling portion.

[0367] Respiratory depression: According to some definitions, respiratory depression means a decrease in flow rather than an interruption of flow. In one form, when a flow decrease below a threshold velocity continues over a duration, it is said that respiratory depression has occurred. When respiratory depression is detected due to a decrease in breathing effort, it is said that central respiratory depression has occurred. In one form in adults, any of the following may occur and be regarded as respiratory depression: (i) A 30% decrease in patient breathing for at least 10 seconds + associated 4% desaturation, or, (ii) The decrease in the patient's breathing (less than 50%) continues for at least 10 seconds, and concomitantly, desaturation is at least 3% or arousal occurs.

[0368] Hyperventilation: The flow increases to a level higher than the normal flow rate.

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

[0370] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency refers to the opening. Quantification of airway patency can be performed, for example, with a value (1) indicating patency and a value (0) indicating closure (obstruction).

[0371] Positive end-expiratory pressure (PEEP): A pressure above the atmosphere in the lungs that exists at the end of exhalation.

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

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

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

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

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

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

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

[0379] Upper airway obstruction (UAO): Includes both partial upper airway obstruction and total upper airway obstruction. It may be associated with a state of flow limitation where flow may increase slightly or decrease with an increase in the pressure difference across the upper airway (Starling resistor behavior).

[0380] Ventilation (Vent): Measurement of the gas exchange rate performed by a patient's respiratory system. The measurement of ventilation may include one or both of the inspiratory and expiratory flows per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation may simply be given as a volume and is understood as volume per minute.

[0381] 8.6.3 Ventilation Adaptive servo - ventilator (ASV): A servo - ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's respiratory characteristics).

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

[0383] Cycle: The end of the inspiratory phase of the ventilator. When delivering breaths from the ventilator to a patient who is breathing spontaneously, at the end of the inspiratory portion of the respiratory cycle, the ventilator is said to cycle to stop breath delivery.

[0384] Expiratory positive airway pressure (EPAP): The base pressure to which a pressure that varies within the breath is added for the generation of the desired mask pressure that the ventilator attempts to achieve at a given time.

[0385] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion of a breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ) = 0 when Φ = 1), the EEP is equal to the EPAP.

[0386] Inspiratory positive airway pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of a breath.

[0387] Pressure assist: A number indicating the pressure increase during inspiration of the ventilator relative to expiration of the ventilator, mainly meaning the pressure difference between the maximum value during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure assist means the difference that the ventilator attempts to achieve (rather than the difference that the ventilator actually achieves).

[0388] Servo ventilator: A ventilator having patient ventilation and target ventilation, which adjusts the pressure assist level to bring the patient ventilation closer to the target ventilation.

[0389] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the start of a breath of a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period, the device automatically starts breath delivery.

[0390] Swing: A term corresponding to pressure assist.

[0391] Trigger: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is said to be triggered to deliver a breath when the patient himself / herself starts the inspiratory portion of the respiratory cycle.

[0392] Typical recent ventilation: The typical recent ventilation Vtyp is a range of values over a certain predetermined time scale where recent ventilation measurements tend to cluster. For example, a measurement of the central tendency of ventilation measurements over a recent history can be an appropriate value for the typical recent ventilation.

[0393] 8.6.4 Anatomical Structure 8.6.4.1 Anatomical Structure of the Face Ala: The outer wall or the "wing" of each nasal cavity (plural: alar)

[0394] Alare: The outermost point on the alar.

[0395] Alar curvature (or alar summit) point: The rearmost point on the curvilinear reference line of each alar, seen at the fold formed by the junction of the alar and the cheek.

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

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

[0398] (Nasal) Cartilage Skeleton: The nasal cartilage skeleton includes the septal cartilage, the lateral cartilage, the major cartilage, and the minor cartilage.

[0399] Columella: A skin flap that separates the nostrils and extends from the tip of the nose to the upper lip.

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

[0401] Frankfurt Horizontal Plane: A line extending from the lowest point of the orbital margin to the auricular point on the left ear. The auricular point is the deepest point from the upper notch to the tragus of the auricle.

[0402] Glabella: Located in the soft tissue, the most prominent point on the mid-sagittal of the forehead.

[0403] Lateral Nasal Cartilage: Generally a triangular plate of cartilage. Its upper peripheral edge is attached to the nasal bone and the frontal process of the maxilla, and its lower peripheral edge is connected to the major alar cartilage.

[0404] Lip, Lower (Labrale Inferius):

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

[0406] Greater alar cartilage: A plate of cartilage, located below the lateral nasal cartilage. It curves around the front part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar minor cartilages.

[0407] Nostrils (nasal cavities): Generally elliptical wing-shaped cavities that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nostril (naris) (nasal cavity). These nostrils are separated by the nasal septum.

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

[0409] Nasolabial angle: The angle between the nasal columella and the upper lip, intersecting with the subnasale point.

[0410] Subaurale: The lowest point of attachment of the auricle to the facial skin.

[0411] Supraaurale: The highest point of attachment of the auricle to the facial skin.

[0412] Gonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0413] Philtrum: A midline groove that extends from the lower border of the nasal septum to the upper part of the lip in the upper lip region.

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

[0415] (Nasal) sill: The nasal sill is a midline elevation of the nose that extends from the sellion to the gonion.

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

[0417] Cellion: It is the most concave point on the area of the fronto-nasal suture, located on the soft tissue.

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

[0419] Lowest alar point: It is the point on the lower peripheral edge of the alar base, where the alar base joins the skin of the upper (superior) lip.

[0420] Subnasale: It is the point located on the soft tissue where the columella joins the upper lip in the mid-sagittal plane.

[0421] Sulcus sublabialis: The most concave point in the midline of the lower lip between the midpoint of the lower lip and the soft tissue pogonion.

[0422] 8.6.4.2 Anatomical Structure of the Skull Frontal bone: The frontal bone includes the frontal squama, which is a large vertical part corresponding to the area known as the forehead.

[0423] Mandible: The mandible forms the lower jaw. The gonion is a bony prominence of the jaw and forms the jaw.

[0424] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward by the side of the nose and forms part of its outer boundary.

[0425] Nasal bone: The nasal bones are two small rectangular bones, which vary in size and shape among individuals. The nasal bones are arranged side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0426] Nasion: It is the intersection of the frontal bone and the two nasal bones, and is a concave area directly provided between the eyes and the upper side of the nasal bridge.

[0427] Occipital bone: The occipital bone is located at the back and lower part of the skull. The occipital bone contains the foramen magnum, which is an oval hole. Through this hole, the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

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

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

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

[0431] Zygomatic bone: The two zygomatic bones in the face are located in the upper and outer parts of the face and form the zygomatic arches.

[0432] 8.6.4.3 Anatomical Structure of the Respiratory System Diaphragm: A sheet of muscle that extends over the lower part of the thorax. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

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

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

[0435] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical fin called the nasal septum. There are three horizontal extensions called nasal conchae or turbinate bones on the sides of the nasal cavity. The nose is at the front of the nasal cavity, and the back connects to the nasopharynx through the posterior nares.

[0436] Pharynx: The part of the throat located directly below (inferior) the nasal cavity and above the esophagus and larynx. The pharynx has conventionally been divided into the following three parts: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

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

[0438] Elbow: An elbow is an example of a structure that directs the axis of the air flow moving inside and changes the direction through an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a substantially circular cross-section. In another form, the elbow can have an elliptical or rectangular cross-section. In a particular form, the elbow can be rotatable, for example, about 360 degrees relative to an engaging component. In a particular form, the elbow can be removable from an engaging component, for example, via a snap connection. In a particular form, the elbow can be assembled to an engaging component via a one-time snap during manufacture while being non-removable by the patient.

[0439] Frame: The frame is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of the mask frame can be airtight.

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

[0441] Membrane: A membrane is taken to typically mean a thin element, preferably substantially resistant to bending and resistant to stretching and contracting.

[0442] Pleural chamber: A mask pleural chamber is taken to mean a part of a patient interface having a wall that at least partially encloses a volume of space, and the air in the volume is pressurized to exceed atmospheric pressure during use. A shell can form part of the wall of the mask pleural chamber.

[0443] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("seal (off)"), it can refer to its effect. Two elements can be constructed and / or arranged to "seal" or obtain a "sealing" effect between them without requiring separate "seal" elements themselves.

[0444] Shell: A shell is taken to mean a curved, relatively thin structure having bending, tensile, and compressive rigidity. For example, the curved structural wall of a mask can be a shell. In some forms, the shell can be faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0445] Supplementary stiffener: A supplementary stiffener is taken to mean a structural component designed to increase the stiffness or softness of another component in at least one direction.

[0446] Strut: A strut is taken to mean a structural component designed to increase the compression resistance of another component in at least one direction.

[0447] Swerel (noun): A sub - assembly of components configured to rotate preferably independently and preferably under low torque about a common axis. In one form, a swerel can be configured to rotate at an angle of at least 360 degrees. In another form, a swerel can be configured to rotate at an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub - assembly of components preferably includes a pair of mating cylindrical conduits. There is little air leakage from the swerel during use.

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

[0449] Vent: (noun) A structure that allows air flow to the ambient air inside a mask or conduit, enabling a clinically effective wash - out of the exhaled gas. For example, in a clinically effective wash - out, a flow rate of about 10 liters / minute to about 100 liters / minute can be used depending on the mask design and treatment pressure.

[0450] 8.7 Other Considerations Part of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner reserves all copyrights in such material for all purposes other than, if any person makes a facsimile reproduction of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, for the sole purpose of reproduction thereof.

[0451] Unless otherwise clearly apparent from the context and unless a range of values is provided, it is understood that each intervening value to one-tenth of the unit of the lower limit, between the upper and lower limits of the range, and any other stated value or intervening value in the stated range is included in the present technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limits in the stated range, they are included in the present technology. If the stated range includes one or both of these limits, ranges exceeding either or both of these stated limits are also included in the present technology.

[0452] Furthermore, when a value(s) is embodied as part of the present technology herein, unless otherwise specified, it is understood that such value(s) may be approximated and such value(s) may be used to any appropriate significant digits to the extent allowed or required by the practical technical implementation.

[0453] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present technology, although a limited number of exemplary methods and materials are described herein.

[0454] Although a particular material is described as being preferably used for the construction of a component, obvious alternative materials with similar properties can be used as substitutes. Furthermore, unless stated to the contrary, any and all components described herein are understood to be manufacturable and thus can be manufactured either collectively or individually.

[0455] As used herein and in the appended claims, it should be noted that the singular forms "a", "an", and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0456] All of the published documents described in this specification are incorporated by reference for the disclosure and description of the methods and / or materials that are the subject of these published documents. The published documents described in this specification are provided only for their disclosure prior to the filing date of this application. Nothing in this specification should be construed as an admission that the technology of this application precedes such published documents for the purposes of prior art. Further, the dates of the published documents described may be different from the actual publication dates of the published documents and may need to be individually verified.

[0457] The terms "comprises" and "comprising" should be interpreted as referring to elements, components or steps in a non-exclusive sense, indicating that the recited elements, components or steps may be present, utilized or combined with other elements, components or steps not expressly recited.

[0458] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the claims. These headings should not be used in the interpretation of the claims or the scope of the limitations of the claims.

[0459] Although the technology herein has been described with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are unnecessary for the practice of the technology. For example, the terms "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Further, the description or illustration of process steps in this method may be presented in an ordered manner, but such order is not necessary. One skilled in the art will recognize that such order can be changed and / or that the acts can be performed simultaneously or even more synchronously.

[0460] Therefore, it should be understood that numerous modifications are possible in exemplary embodiments without departing from the spirit and scope of the present technology, and other arrangements can be devised.

[0461] Furthermore, it is also preferable that the present invention includes the following examples. [Item 1] 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 surrounding an inlet to the patient's airway for delivering an air flow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, and the positioning and stabilization structure comprises: At least one gas delivery tube for delivering the air flow through the seal-forming structure to an inlet of the patient's airway, the at least one gas delivery tube being constructed and arranged to contact at least one region of the patient's head above the auricular basal point of the patient's head during use; An adjustment mechanism for adjusting the at least one gas delivery tube to enable the positioning and stabilization structure to fit heads of different sizes; A biasing mechanism for applying 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 inlet of the patient's airway during use, A positioning and stabilization structure comprising. [Item 2] The positioning and stabilization structure according to item 1, wherein the at least one gas delivery tube includes the adjustment mechanism. [Item 3] The positioning and stabilization structure according to item 1 or 2, wherein the at least one gas delivery tube includes the biasing mechanism. [Item 4] Further comprising a connection port fluidly connected to an air circuit connected to the supply of pressurized air during use, said connection port being arranged in the vicinity of the upper, side or rear part of the patient's head during use, the positioning and stabilization structure according to any one of claims 1 to 3. [Claim 5] The biasing mechanism includes an elastic member provided between the seal-forming structure and the connection port, the positioning and stabilization structure according to claim 4. [Claim 6] The elastic member includes an elastic sleeve, the gas delivery tube includes the elastic sleeve and an inner gas delivery conduit, and the elastic sleeve covers the inner gas delivery conduit, the positioning and stabilization structure according to claim 5. [Claim 7] The elastic member includes a part of the gas delivery tube formed from an elastic material, the positioning and stabilization structure according to claim 5. [Claim 8] The elastic member includes a part of the gas delivery tube having a bellows structure, the positioning and stabilization structure according to claim 5. [Claim 9] The adjustment mechanism includes the bellows structure, the positioning and stabilization structure according to claim 8. [Claim 10] A part of the gas delivery tube having the bellows structure is arranged in contact with the region of the patient's head above the auricular basal point of the patient's head during use, the positioning and stabilization structure according to claim 8 or 9. [Claim 11] By means of the adjustment mechanism, it is possible to adjust the length of the at least one gas delivery tube over a continuous length range, the inflatable positioning and stabilization structure according to any one of claims 1 to 10. [Claim 12] The gas delivery tube includes a first tube portion and a second tube portion, and the first tube portion is telescopically movable relative to the second tube portion so as to adjust the length of the tube, the positioning and stabilization structure according to any one of claims 1 to 11. [Claim 13] The patient interface is the positioning and stabilization structure according to claim 12, including one or more tabs that facilitate relative telescopic movement between the first tube portion and the second tube portion. [Claim 14] The patient interface is the positioning and stabilization structure according to claim 12 or 13, including a tube fixing mechanism that fixes the first and second tube portions relative to each other at a plurality of separate positions. [Claim 15] The gas delivery tube is the positioning and stabilization structure according to any one of claims 1 to 14, including a folding portion such that the length of the gas delivery tube when the folding portion is in the folded configuration is different from the length of the gas delivery tube when the folding portion is not folded. [Claim 16] The gas delivery tube is the positioning and stabilization structure according to claim 15, including a plurality of folding portions in a part of the gas delivery tube having a bellows structure. [Claim 17] The adjustment mechanism is the positioning and stabilization structure according to any one of claims 1 to 16, including an extensible portion of the gas delivery tube. [Claim 18] The adjustment mechanism includes a first tube portion, the first tube portion is removable, and is replaceable with a second tube portion having a different length from the first tube portion. It is the positioning and stabilization structure according to any one of claims 1 to 17. [Claim 19] The adjustment mechanism includes one or more tube insertion members, and the one or more tube insertion members are configured to be selectively fluidly connected to the gas delivery tube so as to change the length of the gas delivery tube. It is the positioning and stabilization structure according to any one of claims 1 to 18. [Claim 20] The gas delivery tube is the positioning and stabilization structure according to any one of claims 1 to 19, including a plurality of indicators indicating where in the gas delivery tube should be cut to fit different sizes of patient heads. [Claim 21] The adjustment mechanism is configured to enable adjustable bending of the at least one gas delivery tube to fit the positioning and stabilization structure to heads of different sizes, the positioning and stabilization structure according to any one of claims 1 to 19. [Claim 22] The positioning and stabilization structure is configured to be positioned such that the adjustment mechanism does not contact the patient's face during use, the positioning and stabilization structure according to any one of claims 1 to 21. [Claim 23] The positioning and stabilization structure is configured to be arranged such that the adjustment mechanism does not contact the patient's cheek region during use, the positioning and stabilization structure according to claim 22. [Claim 24] The adjustment mechanism is arranged above the supra-aural point of the patient's head during use, the positioning and stabilization structure according to claim 23. [Claim 25] The positioning and stabilization structure extends across the patient's cheek region during use, the positioning and stabilization structure according to any one of claims 1 to 24. [Claim 26] The positioning and stabilization structure does not include any mechanism that enables adjustment of the length of the at least one gas delivery tube below the supra-aural point of the patient's head, the positioning and stabilization structure according to any one of claims 1 to 25. [Claim 27] The positioning and stabilization structure does not include any mechanism that enables adjustment of the length of the at least one gas delivery tube extending across the patient's cheek region during use, the positioning and stabilization structure according to claim 26. [Claim 28] The positioning and stabilization structure includes two gas delivery tubes fluidly connected between the connection port and the seal-forming structure, each 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 positioning and stabilization structure according to any one of claims 25 to 27. [Claim 29] The connection port is a positioning and stabilization structure according to any one of items 4 to 28 when dependent on item 4, which is provided above the upper part of the patient's head during use. [Item 30] The positioning and stabilization structure is a positioning and stabilization structure according to item 29, which extends between the patient's eye and the patient's ear during use. [Item 31] The positioning and stabilization structure is a positioning and stabilization structure according to item 29, which includes a rear strap connected between the two gas delivery tubes and is configured to pass behind the patient's head during use. [Item 32] The length of the rear strap between the two gas delivery tubes is adjustable, which is a positioning and stabilization structure according to item 31. [Item 33] The angle of the rear strap with respect to each gas delivery tube is adjustable, which is a positioning and stabilization structure according to item 31 or item 32. [Item 34] The positioning and stabilization structure includes an adjustment mechanism disposed above the point where the rear strap is connected to one of the gas delivery tubes during use. The positioning and stabilization structure does not include any mechanism that enables adjustment of the length of at least one of the gas delivery tubes disposed below the point where the rear strap is connected to one of the gas delivery tubes during use, which is a positioning and stabilization structure according to any one of items 31 to 33. [Item 35] A patient interface comprising: A plenum chamber capable of pressurizing to a treatment pressure of at least 4 cmH2O exceeding the ambient air pressure. The plenum chamber includes a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, and the plenum chamber; A seal-forming structure constructed and arranged to form a seal against the patient's facial region surrounding the entrance to the patient's airway, whereby airflow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use; A connection port fluidly connecting to an air circuit connected to the airflow during use, the connection port being arranged in the vicinity of the upper, side or rear of the patient's head during use; 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 being: At least one gas delivery tube for delivering airflow through the seal-forming structure to the entrance of the patient's airway, the at least one gas delivery tube being constructed and arranged to contact at least one region of the patient's head above the auricular basal point of the patient's head during use; An adjustment mechanism for adjusting the at least one gas delivery tube to enable the positioning and stabilization structure to fit heads of different sizes; and A biasing mechanism for applying a biasing force for propelling the seal-forming structure towards the entrance of the patient's airway along at least a portion of the length of the at least one gas delivery tube during use, a positioning and stabilization structure including; A patient interface including. [Item 36] A system for the treatment of respiratory diseases, the system comprising: The patient interface according to item 35; An air circuit; and An air source having a positive pressure relative to the ambient air pressure A system including. [Item 37] 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 an area of the patient's face surrounding an inlet to the patient's airway so as to deliver an air flow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilization structure comprising: At least one tie, the at least one tie being configured to contact the patient's head during use, the at least one tie comprising: At least one gas delivery tube for delivering the air flow through the seal-forming structure to an inlet of the patient's airway, the at least one gas delivery tube being constructed and arranged to cover at least one area of the patient's head above the auricular basal point of the patient's head during use, the at least one tie including the at least one gas delivery tube; An adjustment mechanism for adjustment of the at least one tie to enable the positioning and stabilization structure to fit heads of different sizes, The positioning and stabilization structure being configured to be positioned such that the adjustment mechanism does not contact the patient's face during use. [Item 38] The at least one gas delivery tube includes the adjustment mechanism, the positioning and stabilization structure according to item 37. [Item 39] The at least one gas delivery tube includes the biasing mechanism, the positioning and stabilization structure according to item 37 or 38. [Item 40] Further including a connection port for fluid connection to an air circuit connected to a supply of pressurized air during use, the connection port being arranged in the vicinity of the upper, side or rear of the patient's head during use, the positioning and stabilization structure according to any one of items 37 to 39. [Item 41] The positioning and stabilization structure according to any one of paragraphs 37 to 40, which is configured such that the adjustment mechanism does not contact the patient's cheek region during use. [Paragraph 42] The positioning and stabilization structure according to any one of paragraphs 37 to 41, wherein the adjustment mechanism is disposed above the supra-aural point of the patient's head during use. [Paragraph 43] The positioning and stabilization structure according to any one of paragraphs 37 to 42, comprising a biasing mechanism that applies a biasing force along at least a part of the length of the at least one gas delivery tube to propel the seal-forming structure into the region surrounding the inlet of the patient's airway during use. [Paragraph 44] The positioning and stabilization structure according to paragraph 43, wherein the biasing mechanism includes an elastic member provided between the seal-forming structure and the connection port. [Paragraph 45] The positioning and stabilization structure according to paragraph 44, wherein the elastic member includes an elastic sleeve, the gas delivery tube includes the elastic sleeve and an inner gas delivery conduit, and the elastic sleeve covers the inner gas delivery conduit. [Paragraph 46] The positioning and stabilization structure according to paragraph 44, wherein the elastic member includes a part of the gas delivery tube formed from an elastic material. [Paragraph 47] The positioning and stabilization structure according to paragraph 44, wherein the elastic member includes a part of the gas delivery tube having a bellows structure. [Paragraph 48] The positioning and stabilization structure according to paragraph 47, wherein the adjustment mechanism includes the bellows structure. [Paragraph 49] A part of the gas delivery tube having the bellows structure is disposed in contact with the region of the patient's head above the supra-aural point of the patient's head during use, according to paragraph 47 or 48. [Paragraph 50] The at least one gas delivery tube has a wavy shape along its length, the positioning and stabilization structure according to any one of items 37 to 49. [Item 51] The adjustment mechanism enables adjustment of the length of the at least one type, the positioning and stabilization structure according to any one of items 37 to 49. [Item 52] The adjustment mechanism enables adjustment of the length of the at least one type through a continuous length range, the positioning and stabilization structure according to item 51. [Item 53] The adjustment mechanism enables adjustment of the length of the at least one gas delivery tube, the positioning and stabilization structure according to any one of items 37 to 52. [Item 54] The gas delivery tube includes a first tube portion and a second tube portion, and the first tube portion is telescopically movable relative to the second tube portion to adjust the length of the gas delivery tube, the positioning and stabilization structure according to item 52 or item 53. [Item 55] The patient interface includes one or more tabs for facilitating relative telescopic movement between the first tube portion and the second tube portion, the positioning and stabilization structure according to item 54. [Item 56] The patient interface includes a tube fixing mechanism for fixing to each other at a plurality of separate positions of the first and second tube portions, the positioning and stabilization structure according to item 54 or item 55. [Item 57] The gas delivery tube includes a folding portion such that the length of the gas delivery tube when the folding portion is in a folded configuration is different from the length of the gas delivery tube when the folding portion is not folded, the positioning and stabilization structure according to any one of items 37 to 56. [Item 58] The gas delivery tube includes a plurality of folding portions in a part of the gas delivery tube having a bellows structure, the positioning and stabilization structure according to item 57. [Item 59] The adjustment mechanism includes an extendable portion of the gas delivery tube, and is the positioning and stabilization structure according to any one of items 37 to 58. [Item 60] The adjustment mechanism includes a first tube portion, the first tube portion is removable, and can be exchanged with a second tube portion having a length different from that of the first tube portion, and is the positioning and stabilization structure according to any one of items 37 to 59. [Item 61] The adjustment mechanism includes one or more tube insertion members configured to be selectively fluidly connected to the gas delivery tube so as to change the length of the gas delivery tube, and is the positioning and stabilization structure according to any one of items 37 to 60. [Item 62] The gas delivery tube includes a plurality of indicators indicating where the gas delivery tube should be cut to fit different sizes of patient heads, and is the positioning and stabilization structure according to any one of items 37 to 61. [Item 63] The adjustment mechanism is configured to be able to adjust the at least one gas delivery tube bendably so as to fit the positioning and stabilization structure to different sizes of heads, and is the positioning and stabilization structure according to any one of items 37 to 62. [Item 64] The at least one tie defines a loop configured to surround a part of the patient's head during use, the at least one gas delivery tube defines at least a part of the loop, and the positioning and stabilization structure includes a loop adjustment mechanism operable to adjust the position where two regions of the at least one tie are held together to adjust the size of the loop, and is the positioning and stabilization structure according to any one of items 37 to 63. [Item 65] The at least one tie defines a loop configured to surround a portion of the patient's head in use, the at least one gas delivery tube defines at least a portion of the loop, and the positioning and stabilization structure includes a loop insertion member configured to be directly or indirectly fixed to the at least one gas delivery tube in use, the loop insertion member defining at least a portion of the loop, the positioning and stabilization structure according to any one of paragraphs 37 to 62. [Paragraph 66] The positioning and stabilization structure according to paragraph 65, wherein the loop insertion member is inflatable. [Paragraph 67] The positioning and stabilization structure according to paragraph 65 or paragraph 66, wherein the loop insertion member is configured to be exchanged with exchange loop insertion members of different sizes for adjusting the size of the loop. [Paragraph 68] The positioning and stabilization structure according to any one of paragraphs 37 to 67, wherein the adjustment mechanism is arranged above the supraauricular point of the patient's head in use. [Paragraph 69] The positioning and stabilization structure according to any one of paragraphs 37 to 68, wherein the positioning and stabilization structure extends across the patient's cheek region in use. [Paragraph 70] The positioning and stabilization structure according to any one of paragraphs 37 to 69, wherein the positioning and stabilization structure does not include any mechanism for enabling length adjustment of the at least one tie below the supraauricular point of the patient's head. [Paragraph 71] The positioning and stabilization structure according to paragraph 70, wherein the positioning and stabilization structure does not include any mechanism for enabling length adjustment of the at least one tie that extends across the patient's cheek region in use. [Paragraph 72] The positioning and stabilization structure includes two gas delivery tubes fluidly connected between the connection port and the seal forming structure, each gas delivery tube extending across one of the patient's cheek regions in use, the two gas delivery tubes being on different sides of the patient's head, the positioning and stabilization structure according to any one of paragraphs 69 to 71. [Paragraph 73] The connection port is arranged on the upper part of the patient's head in use, the positioning and stabilization structure according to any one of paragraphs 40 to 72 when dependent on paragraph 40. [Paragraph 74] The positioning and stabilization structure extends between the patient's eye and the patient's ear in use, the positioning and stabilization structure according to paragraph 73. [Paragraph 75] The at least one tie includes a rear strap connected between the two gas delivery tubes and is configured to pass around the rear of the patient's head in use, the positioning and stabilization structure according to paragraph 72. [Paragraph 76] The length of the rear strap between the two gas delivery tubes is adjustable, the positioning and stabilization structure according to paragraph 75. [Paragraph 77] The angle of the rear strap with respect to each gas delivery tube is adjustable, the positioning and stabilization structure according to paragraph 75 or paragraph 76. [Paragraph 78] The positioning and stabilization structure includes an adjustment mechanism arranged above the point where the rear strap is connected to one of the gas delivery tubes in use, the positioning and stabilization structure not including any mechanism that enables adjustment of the at least one tie arranged below the point where the rear strap is connected to one of the gas delivery tubes in use, the positioning and stabilization structure according to any one of paragraphs 75 to 77. [Paragraph 79] A patient interface comprising: A plenum chamber capable of pressurizing to a treatment pressure of at least 4 cmH2O exceeding the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's breathing, the plenum chamber; A seal-forming structure constructed and arranged to form a seal against the patient's face region surrounding the entrance to the patient's airway, whereby the air flow at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, the seal-forming structure; A connection port fluidly connecting to an air circuit connected to the air flow during use, the connection port being arranged in the vicinity of the upper, side or rear of the patient's head during use, the connection port; 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 being: At least one tie, the at least one tie being configured to contact the patient's head during use, the at least one tie being: 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 including at least one tie constructed and arranged to cover at least one region of the patient's head above the auricular basal point of the patient's head during use, the at least one tie; An adjustment mechanism for adjusting the at least one tie to enable the positioning and stabilization structure to fit heads of different sizes, including, The positioning and stabilization structure is configured such that the adjustment mechanism is positioned so as not to contact the patient's face during use, the positioning and stabilization structure, including, a patient interface. [Item 80] A system for treating a respiratory disorder, the system comprising: The patient interface according to item 79; An air circuit; and An air source having a positive pressure relative to the ambient air pressure A system comprising. [Item 81] A patient interface comprising: A plenum chamber pressurizable to a treatment pressure of at least 4 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the treatment pressure for the patient's respiration; A seal-forming structure constructed and arranged to form a seal against the patient's facial region surrounding an inlet to the patient's airway, whereby an air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use; A positioning and stabilization structure for holding the seal-forming structure in a therapeutically effective position on the patient's head, A first tube portion constructed and arranged to cover a region of the patient's head above the supra-aural point of the patient's head during use; and A positioning and stabilization structure including a tie portion that is placed on or covers a posterior portion of the occipital bone of the patient's head during use Including a positioning structure; A ventilation structure that enables the gas exhaled by the patient to continuously flow from inside the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use; Including, The first tube portion is configured to conduct at least a portion of the air flow breathed by the patient; The first tube portion is configured to be in a taut state during use; The first tube portion includes a lengthwise adjustment mechanism, a patient interface. [Item 82] The positioning and stabilization structure includes a second tube portion, and the second tube portion is configured to cover the maxillary region of the patient's head during use and to connect to the plenum chamber during use, the patient interface according to Item 81. [Item 83] The patient interface further includes a connection port configured to receive an air supply and deliver the air supply to the first tube portion, the patient interface according to Item 81 or 82. [Item 84] The connection port is constructed and arranged to be disposed on top of the upper portion of the patient's head during use, the patient interface according to Item 83. [Item 85] The positioning and stabilization structure includes a third tube portion configured to connect to the connection port and cover the region of the patient's head above the auricular basal point of the patient's head during use, the patient interface according to any one of Items 81 to 84. [Item 86] The positioning and stabilization structure includes a fourth tube portion configured to cover the maxillary region of the patient's head during use and to connect to the plenum chamber during use, the patient interface according to any one of Items 81 to 85. [Item 87] The seal forming structure is configured to expose the patient's oral cavity during use, the patient interface according to any one of Items 81 to 86. [Item 88] The seal forming structure is configured such that no portion of the seal forming structure enters the oral cavity during use, the patient interface according to any one of Items 81 to 87. [Item 89] The seal forming structure is configured such that the seal forming structure does not extend into the interior of the patient's airway, the patient interface according to any one of Items 81 to 88. [Item 90] The seal forming structure is configured such that, during use, the seal forming structure does not extend below the auricular ridge region, the patient interface according to any one of Items 81 to 89. [Item 91] The patient interface is constructed and arranged such that, during use, the plenum chamber does not cover the eye, the patient interface according to any one of Items 81 to 90. [Item 92] 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 being constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway so as to deliver, during use, an air flow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilization structure comprising: A first conduit portion constructed and arranged to cover a region of the patient's head above the supra-auricular point of the patient's head during use; and A strap portion that is placed on or covers a rear portion of the occipital bone of the patient's head during use including, The first conduit portion is configured to conduct at least a portion of the air flow breathed by the patient. The first conduit portion is configured to be in a tensioned state during use. The first conduit portion is a positioning and stabilization structure including a longitudinal adjustment mechanism. [Item 93] A patient interface comprising: A plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the therapeutic pressure for the patient's respiration, a plenum chamber; A seal-forming structure constructed and arranged to form a seal against a patient's facial region surrounding an entrance to the patient's airway, whereby airflow at the treatment pressure is delivered at least to an entrance to the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within a plenum chamber throughout the patient's respiratory cycle during use; A positioning and stabilizing structure that provides an elastic force for holding the seal-forming structure in a therapeutically effective position on the patient's head for delivering the treatment pressure in a sealed manner in the airflow, the positioning and stabilizing structure comprising: A tie, the tie being constructed and arranged such that at least a portion of the tie covers a region of the patient's head above the supra-aural point of the patient's head during use, the tie including a gas delivery tube of adjustable length for delivering the airflow through the seal-forming structure to an entrance to the patient's airway, the gas delivery tube being configured to contact a portion of the patient's head during use; and A biasing mechanism for adding a biasing force to the adjustable-length gas delivery tube to urge the seal-forming structure towards the entrance to the patient's airway during use comprising a positioning and stabilizing structure; A patient interface comprising the same. [Item 94] The patient interface according to item 93, wherein the gas delivery tube of adjustable length includes an extensible portion. [Item 95] The patient interface according to item 94, wherein the extensible portion is configured such that the extensible portion avoids contact with the patient's face during use. [Item 96] The patient interface according to item 95, wherein the extensible portion is configured such that the extensible portion is disposed above the supra-aural point of the patient's head during use. [Item 97] The patient interface according to any one of items 94 to 96, wherein the extensible portion includes a bellows structure. [Item 98] The bellows structure includes one or more elastic portions, and the one or more elastic portions are configured to expand and contract so as to enable adjustment of the length of the gas delivery tube during use, the patient interface according to claim 97. [Claim 99] The bellows structure includes one or more elastic portions, and the one or more elastic portions are configured to retract so as to apply the biasing force onto the gas delivery tube with adjustable length, the patient interface according to claim 97 or 98. [Claim 100] The gas delivery tube with adjustable length further includes a bendable portion for enabling adjustment of the position of the gas delivery tube with adjustable length on the patient's head during use, the patient interface according to any one of claims 93 to 99. [Claim 101] The bendable portion is configured such that the bendable portion is disposed above the supra-aural point of the patient's head during use, the patient interface according to claim 100. [Claim 102] The bendable portion is configured to decouple the adjustment of the position of the gas delivery tube with adjustable length from the movement of the seal-forming structure away from the patient's face during use, the patient interface according to claim 101. [Claim 103] The bendable portion includes one or more elastic portions, the patient interface according to any one of claims 100 to 102. [Claim 104] A positioning and stabilization structure for holding the seal-forming structure in a therapeutically effective position on the patient's head, wherein the seal-forming structure is constructed and arranged to form a seal with the region of the patient's face surrounding the patient's airway inlet for hermetically delivering an air flow at a therapeutic pressure of at least 4 cmH2O relative to the ambient air pressure throughout the patient's respiratory cycle during use, and the positioning and stabilization structure is: A tie that is configured in Thailand, at least a part of the tie is constructed and arranged to cover a region of the patient's head above the auricular basal point of the patient's head during use, the tie includes a gas delivery tube with an adjustable length for delivering the airflow to the inlet of the patient's airway through the seal-forming structure, and the gas delivery tube is configured to contact a part of the patient's head during use; and A biasing mechanism that adds a biasing force to the gas delivery tube with an adjustable length to propel the seal-forming structure to the inlet of the patient's airway during use A positioning and stabilization structure including the same.

Explanation of reference numerals

[0462] 1000 Patient 1100 Bedmate 3000 Patient interface 3100 Sealing or seal-forming structure 3150 Cushion assembly 3170 Nasal seal-forming structure 3180 Oral seal-forming structure 3200 Plenum chamber 3210 Plenum chamber edge 3300 Positioning and stabilization structure / headgear 3310 Headgear strap 3320 Jaw strap 3330 Padded member 3340 Elastic sleeve 3342 Lateral opening 3343 Upper opening 3345 Tab 3347 Curved edge 3348 Side in contact with the patient 3349 Side not in contact with the patient 3350 Headgear tube 3351 Upper tube member 3352 Tube end 3353A Upper curved portion 3353B Lower curved portion Tube section that cannot be extended much Tube section that can be extended more Fixing mechanism First fixing member Second fixing member Adjusting mechanism Bellows tube section Head gear tube section that cannot be adjusted Folding part Tube wall folding / rotary folding part Adjacent tube section First tube section First tab Second tube section Second tab Rib Nested concentric tube section Ratchet mechanism Visual indicator Button Hardening member First threaded part Second threaded part Pinion Ring member Replaceable tube section Replacement tube section Tube insertion member Strap Strap adjusting mechanism Band Tong Groove part Loop insertion member Replacement loop insertion member Expandable loop insertion member Connection port ISO 4000 RPT device External housing Upper part 4014 part 4015 panel 4016 chassis 4018 handle 4020 pneumatic block 4100 pneumatic component 4110 air filter 4112 inlet air filter 4114 outlet air filter 4122 inlet muffler 4124 outlet muffler 4140 pressure generator 4142 controllable blower 4144 air circuit 4200 electrical component 4202 printed circuit board assembly (PCBA) 4210 power supply 4220 input device 4230 central controller 4240 treatment device controller 4250 protection circuit 4260 memory 4270 converter 4272 pressure sensor 4274 flow sensor 4280 data communication interface 4290 output device 4300 algorithm 5000 humidifier 5002 humidifier inlet 5004 humidifier outlet 5006 humidifier base 5110 humidifier reservoir 5130 humidifier reservoir dock 5240 heating element 6000 force-elongation plot 6100 elongation axis 6105 zero elongation 6110 first elongation amount 6120 second elongation amount 6200 force axis 6210 minimum sealing force 6220 Maximum comfort 6300 Force-elongation characteristics

Claims

Claim 1 A positioning and stabilization structure configured to hold a cushion assembly of a patient interface in a therapeutically effective position on a patient's head, the cushion assembly comprising a pair of plenum chamber inlet ports, The positioning and stabilization structure, Two gas delivery tubes, each of the two gas delivery tubes being connected at a first end to a corresponding one of the pair of plenum chamber inlet ports so as to deliver an air flow to an inlet to the patient's airway through the cushion assembly, each of the two gas delivery tubes being configured to be positioned on a corresponding side of the patient's head during use, each of the two gas delivery tubes being constructed and arranged to contact at least one region of the patient's head above the point on the base of the ear on the corresponding side of the patient's head during use, each of the two gas delivery tubes having a tab, the tab protruding from the corresponding one of the two gas delivery tubes in a direction configured to be substantially rearward with respect to the patient's head during use, the tab having a hole, two gas delivery tubes; A bellows configured to enable adjustment of the length of each of the two gas delivery tubes to fit different sized heads, configured to be positioned above the point on the base of the ear of the patient during use, and configured to apply a biasing force along at least a portion of the length of each of the two gas delivery tubes to urge the cushion assembly towards the patient's face during use; A connection port configured to fluidly connect the two gas delivery tubes to an air circuit during use to deliver the air flow to the patient's airway, the connection port being configured to be positioned above the patient's head during use; Comprising, The bellows is positioned on each of the two gas delivery tubes between the connection port and the first end, Each of the tabs is positioned on the corresponding one of the gas delivery tubes between the bellows and the first end, a positioning and stabilization structure. Claim 2 The positioning and stabilization structure according to claim 1, further comprising an elastic sleeve covering each of the two gas delivery tubes. Claim 3 The positioning and stabilization structure according to claim 2, wherein the elastic sleeve is formed of an elastic material.

4. The positioning and stabilization structure according to any one of claims 1 to 3, wherein the positioning and stabilization structure is configured such that the bellows is positioned so as not to contact the patient's face during use.

5. The positioning and stabilization structure according to any one of claims 1 to 4, wherein the positioning and stabilization structure is configured such that the bellows is arranged so as not to contact the patient's cheek region during use.

6. The positioning and stabilization structure according to any one of claims 1 to 5, wherein each of the two gas delivery tubes is configured to extend across the corresponding cheek region of the patient during use.

7. The positioning and stabilization structure according to any one of claims 1 to 6, wherein each of the two gas delivery tubes is configured to contact the patient's head below the auricular basal superior point on the corresponding side of the patient's head, and does not include any mechanism for adjusting the length of each of the two gas delivery tubes.

8. The positioning and stabilization structure according to any one of claims 1 to 7, wherein each of the two gas delivery tubes is configured to extend across the patient's cheek region during use, and does not include any mechanism for adjusting the length of each of the two gas delivery tubes.

9. The positioning and stabilization structure according to any one of claims 1 to 8, wherein each of the two gas delivery tubes is configured to extend between the corresponding eye and the corresponding ear of the patient during use.

10. A length-adjustable rear strap, wherein the ends of the length-adjustable rear strap are configured to pass through the respective holes of the tabs so as to removably connect the length-adjustable rear strap to the corresponding one of the gas delivery tubes, and further comprising a length-adjustable rear strap configured to pass around the rear portion of the patient's head during use. The positioning and stabilization structure according to any one of claims 1 to 9.

11. The angle of the length - adjustable rear strap with respect to each of the two gas delivery tubes is adjustable to enable the length - adjustable rear strap to fit around the head of the patient at different positions, a positioning and stabilization structure according to claim 10.

12. The length - adjustable rear strap comprises a loop material and a pair of hook material portions, the loop material and the hook material portions being configured to removably connect the length - adjustable rear strap to the corresponding one of the tabs, a positioning and stabilization structure according to claim 10 or 11.

13. Each of the two gas delivery tubes varies in width and diameter along the length of each bellows section, a positioning and stabilization structure according to any one of claims 1 to 12.

14. Each of the two gas delivery tubes is tapered along the length of the corresponding bellows section such that the width and diameter of each of the two gas delivery tubes at one end of the bellows section is smaller than the width and the diameter of each of the two gas delivery tubes at the other end of the bellows section, a positioning and stabilization structure according to any one of claims 1 to 13.

15. Further comprising an elbow including a first end rotatably connected to the connection port and a second end having a swivel configured to be connected to the air circuit, the elbow being rotatable 360 degrees around the connection port, the swivel being rotatable 360 degrees around the second end of the elbow, the elbow being configured to direct the air flow from the air circuit through the connection port to the gas delivery tube, a positioning and stabilization structure according to any one of claims 1 to 14.

16. A patient interface for delivering, during use, an air flow at a therapeutic pressure of at least 4 cmH ２ O relative to ambient air pressure throughout a patient's respiratory cycle, the patient interface comprising A cushion assembly, a plenum chamber pressurizable to the treatment pressure, the plenum chamber including a pair of plenum chamber inlet ports, each of the pair of plenum chamber inlet ports being sized and configured to receive the air flow at the treatment pressure for breathing by the patient, the plenum chamber; A seal-forming structure configured and arranged to seal against a region of the patient's face surrounding an inlet to the patient's airway such that the airflow at the treatment pressure is delivered at least to the inlet to the patient's nostrils, the seal-forming structure being configured and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, A cushion assembly comprising, The positioning and stabilization structure according to any one of claims 1 to 15, A patient interface comprising.

17. The plenum chamber includes a ventilation structure, and the ventilation structure allows CO exhaled by the patient to flow out of the patient interface while maintaining the treatment pressure in the plenum chamber. ２ The patient interface according to claim 16, characterized in that it has a plurality of holes configured to allow ２ to flow outside the patient interface while maintaining the treatment pressure in the plenum chamber.

18. The seal-forming structure, A nasal seal-forming structure configured to seal around the patient's nose during use, the nasal seal-forming structure having a nasal aperture configured to deliver the airflow at the treatment pressure to the patient's nostrils during use, An oral seal-forming structure configured to seal around the patient's mouth during use, the oral seal-forming structure having an oral aperture configured to deliver the airflow at the treatment pressure to the patient's mouth during use, The patient interface according to claim 16 or 17, characterized in that it comprises.

19. The patient interface according to claim 18, characterized in that the nasal seal-forming structure and the oral seal-forming structure are integrally formed.

20. The patient interface according to claim 18, characterized in that the nasal seal-forming structure and the oral seal-forming structure are removably attached.

21. The patient interface according to any one of claims 18 to 20, further comprising an anti-asphyxia valve configured to allow the patient to breathe from the surroundings.

22. The seal-forming structure is a nasal seal-forming structure configured to seal around the patient's nose during use, the seal-forming structure comprising a nasal seal-forming structure having a nasal aperture configured to deliver the airflow at the treatment pressure to the patient's nostrils during use, The patient interface according to claim 16 or 17, characterized in that the seal-forming structure is configured to expose the patient's mouth during use.

23. The seal-forming structure includes nasal pillows, each nasal pillow being constructed and arranged to form a seal with each nostril of the patient's nose, and each nasal pillow having a nasal orifice configured to deliver the airflow at the treatment pressure to the corresponding one of the patient's nostrils during use. The patient interface according to claim 16 or 17, wherein the seal-forming structure is configured to expose the patient's oral cavity during use.

24. A patient interface system comprising the patient interface according to claim 16 or 17, a first cushion assembly, wherein the seal-forming structure is a nasal seal-forming structure configured to seal around the patient's nose during use and having a nasal orifice configured to deliver the airflow at the treatment pressure to the patient's nostrils during use, an oral seal-forming structure configured to seal around the patient's oral cavity during use and having an oral orifice configured to deliver the airflow at the treatment pressure to the patient's oral cavity during use, the first cushion assembly comprising a second cushion assembly, wherein the seal-forming structure is a nasal seal-forming structure configured to seal around the patient's nose during use and having a nasal orifice configured to deliver the airflow at the treatment pressure to the patient's nostrils during use, and the seal-forming structure is configured to expose the patient's oral cavity during use, a third cushion assembly, wherein the seal-forming structure includes nasal pillows, each nasal pillow being constructed and arranged to form a seal with each nostril of the patient's nose, and each nasal pillow having a nasal orifice configured to deliver the airflow at the treatment pressure to the corresponding one of the patient's nostrils during use, and the seal-forming structure is configured to expose the patient's oral cavity during use, the patient interface system comprising.

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