Adjustable headgear tube for a patient interface

Abstract

The present invention relates to an adjustable headgear tube for a patient interface. One aspect of the technology includes a positioning and stabilising structure to hold a seal-forming structure in a therapeutically effective position on the head of a patient. The seal-forming structure can be constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways to deliver a flow of air at a therapeutic pressure of at least 4 cmH20 relative to ambient air pressure throughout the patient's respiratory cycle in use. The positioning and stabilising structure can include a front crown strap and a rear strap, the front crown strap being arranged to contact at least one region of the patient's head superior to an otobasion superior of the patient's head in use. The positioning and stabilising structure can include an adjustment mechanism for adjusting the front crown strap and the rear strap relative to the patient's head, the adjustment mechanism being arranged for a single operation to adjust both the front crown strap and the rear strap to enable the positioning and stabilising structure to fit different sized heads.

Description

[0001] This application is a divisional application of National Application No. 202080092942.0 (International Application No. PCT / AU2020 / 051286, International Application Date November 27, 2020, Invention Title "Adjustable Headband Tube for Patient Interface").

[0002] Cross-references to related applications

[0003] This application claims the benefit of Australian Provisional Patent Application No. 2020900503, filed on 21 February 2020, and Australian Provisional Patent Application No. 2019904513, filed on 29 November 2019, the entire contents of which are incorporated herein by reference.

[0004] Statement regarding federally funded research or development

[0005] not applicable

[0006] Names of the parties involved in the joint research and development

[0007] not applicable

[0008] sequence list

[0009] not applicable Technical Field 5.1 Technical Field

[0011] This technology relates to one or more of the following: detection, diagnosis, treatment, prevention, and improvement of respiratory-related conditions. This technology also relates to medical devices or equipment and their uses.

[0012] Some forms of this technology involve patient interfaces for treating respiratory conditions, preventing and improving respiratory-related illnesses. Background Technology

[0013] 5.2 Description of relevant technologies

[0014] 5.2.1 The Human Respiratory System and Its Disorders

[0015] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0016] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and expelling carbon dioxide. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the airway tubes and do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2011 by John B. West, Lippincott Williams & Wilkins.

[0017] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0018] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes the affected patient to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0019] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a dysregulation of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0020] Respiratory failure is a term for a respiratory disorder in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

[0021] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0022] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without any other known cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0023] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0024] Neuromuscular disease (NMD) is a broad term encompassing many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0025] The chest wall is a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0026] A range of treatments have been used to treat or improve these symptoms. Furthermore, other healthy individuals may utilize these treatments to prevent respiratory distress. However, these treatments have many drawbacks.

[0027] 5.2.2 Treatment

[0028] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, among other things.

[0029] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive respiratory disease (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0030] Noninvasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0031] 5.2.3 Treatment System

[0032] These therapies can be provided by treatment systems or devices. Such systems and devices can also be used to diagnose conditions without treating them.

[0033] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, and a patient interface.

[0034] 5.2.3.1 Patient Interface

[0035] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of approximately 10 cmH2O into the airway.

[0036] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient.

[0037] Some masks may be clinically disadvantageous for this technique, such as those that block airflow through the nose and only allow it through the mouth.

[0038] If some masks require patients to insert a portion of the mask structure into their mouths to create and maintain a seal through their lips, this may be uncomfortable or impractical for this technology.

[0039] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0040] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during a period of respiratory therapy.

[0041] Due to these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized face shield can lead to reduced compliance, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those designed for administering anesthetics are acceptable for their original applications, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the face shield is worn during sleep.

[0042] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean it, which could affect adherence.

[0043] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0044] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0045] 5.2.3.1.1 Sealing Formation Part

[0046] The patient interface may include a seal-forming portion. Because it comes into direct contact with the patient's face, the shape and construction of the seal-forming portion can directly affect the effectiveness and comfort of the patient interface.

[0047] The patient interface can be partially characterized based on the design intent of the sealing portion to engage with the face during use. In one form of patient interface, the sealing portion may include two sub-parts to engage with the left and right nostrils respectively. In another form of patient interface, the sealing portion may include a single element surrounding both nostrils during use. This single element may be designed to, for example, cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing portion may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing portion may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks. Oronasal masks may include compact full-face masks without forehead support. Alternatively, oronasal masks may include full-face masks that seal around the nasal and oral inlets, wherein the nasal seal includes a bracket sealing below the lateral cartilage.

[0048] A seal that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitivity of a patient's face differ. For instance, a seal on swimming goggles covering a patient's forehead may not be suitable for use on a patient's nose.

[0049] Certain seal-forming components can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming components of the mass-produced patient interface, one or both must be adapted to form a seal.

[0050] One type of seal-forming portion extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface and the seal-forming portion engages face-to-face with the patient's face. The seal-forming portion may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal-forming portion, if the fit is insufficient, a gap will exist between the seal-forming portion and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0051] Another type of seal-forming part incorporates a sheet-like seal of thin material surrounding the periphery of the mask to provide a self-sealing effect on the patient's face when positive pressure is applied inside the mask. Similar to the previous type of seal-forming part, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming part does not match the patient's shape, it may wrinkle or bend during use, causing leakage.

[0052] Another type of sealing component may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0053] Another form of sealant can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0054] A series of patient interface sealing technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0055] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0056] ResMed has manufactured the following products incorporating 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. The following patent application assigned to ResMed describes an example of a nasal pillow mask: International Patent Application WO2004 / 073,778 (which describes ResMed's SWIFT...). TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (which describes ResMed SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed's MIRAGE LIBERTY) TM (Regarding full-face masks); International Patent Application WO 2009 / 052,560 (which describes ResMed's SWIFT...) TM Other aspects of the FX nose pillow).

[0057] 5.2.3.1.2 Positioning and Stabilization

[0058] The sealing portion of the patient interface used in positive pressure therapy is subjected to a corresponding force from the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing portion and maintain it in a sealed relationship with the appropriate part of the face.

[0059] One technique involves using adhesives. See, for example, U.S. Patent Application Publication US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0060] Another technique involves using one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more problems, including ill-fitting, bulky, uncomfortable, and inconvenient to use. When designed to be worn on a patient's head, such a harness can be called a headband.

[0061] 5.2.3.1.3 Pressurized air duct

[0062] In one type of treatment system, pressurized airflow is supplied to the patient interface via a conduit in an air circuit fluidly connected to the patient interface, such that the conduit extends forward from the patient's face when the patient interface is positioned over the patient's face during use. This can sometimes be referred to as an "elephant trunk" type interface.

[0063] Some patients find the interface unsightly, thus hindering their wearing and reducing patient compliance. Furthermore, the catheter connected to the interface in front of the patient's face can sometimes easily get tangled in bedding.

[0064] 5.2.3.1.4 Pressurized air ducts used for positioning / stabilizing the sealing structure

[0065] Alternative types of treatment systems seeking to address these issues include patient interfaces in which the tubing delivering pressurized air to the patient's airway also functions as part of a headband to position and stabilize a sealing portion of the patient interface to the appropriate part of the patient's face. This type of patient interface may be referred to as a combination of a 'headband tube' or a 'catheter headband'. Such a patient interface allows a catheter in the air circuit providing a flow of pressurized air from a respiratory pressure therapy device to be connected to the patient interface at a location other than in front of the patient's face. One example of such a treatment system disclosed in U.S. Patent Publication US2007 / 0246043, the contents of which are incorporated herein by reference, involves a catheter connected to the tubing in the patient interface via a port positioned on the top of the patient's head during use.

[0066] The Philips DreamWear™ nasal mask includes a headband tube. One issue with this type of mask is that the headband tube length is not adjustable. Therefore, different sizes of DreamWear™ masks are offered to accommodate patients with different face sizes. However, this increases the complexity and cost of manufacturing DreamWear™ masks and larger packaging. Furthermore, the availability of discrete mask sizes limits the extent to which different patient head sizes can be accommodated, for example, if a patient's head size falls between or outside the available mask sizes.

[0067] Patient interfaces with headbands offer several advantages, such as avoiding the need for catheters that connect to the patient's face in front, which can be unsightly and protruding. Furthermore, patient interfaces with headbands allow for extended wear while the patient sleeps, creating an effective seal against the face and enhancing patient comfort.

[0068] 5.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0069] Pneumatic generators are known in applications such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that more general pneumatic generators cannot meet, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may suffer from drawbacks related to one or more of comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0070] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed. Another example of an RPT device is a ventilator. Ventilators, such as the ResMedStellar™ series of adult and pediatric ventilators, can provide invasive and non-invasive non-dependent ventilatory support for a range of patients to treat a variety of conditions, such as, but not limited to, NMD, OHS, and COPD.

[0071] 5.2.3.3 Humidifier

[0072] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RT device and patient interface to generate humidified gas minimizes dryness of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air. Summary of the Invention

[0073] This technology relates to providing medical devices for diagnosing, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0074] The first aspect of this technology relates to devices for diagnosing, improving, treating, or preventing respiratory disorders.

[0075] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0076] One form of this technology includes a patient interface for delivering a supply of pressurized breathable gas to the inlet of a patient's airway.

[0077] Another aspect of this technology includes a positioning and stabilizing structure to hold the sealing-forming structure in a therapeutically effective position on the patient's head. The sealing-forming structure can be configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, to deliver an 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 stabilizing structure may include at least one gas delivery tube to deliver airflow to the entrance of the patient's airway through the sealing-forming structure.

[0078] Another aspect of this technology includes a positioning and stabilizing structure to hold the sealing-forming structure in a therapeutically effective position on the patient's head. The sealing-forming structure may be configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway to deliver an 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 stabilizing structure may include at least one gas delivery tube to deliver airflow to the entrance of the patient's airway through the sealing-forming structure. At least one gas delivery tube may be configured and arranged to contact at least one region of the patient's head above an auricular base point during use. The positioning and stabilizing structure may include an adjustment mechanism for adjusting the length of at least one gas delivery tube to adapt the positioning and stabilizing structure to different head sizes. The positioning and stabilizing structure may include a biasing mechanism to apply a biasing force along at least a portion of the length of at least one gas delivery tube, thereby pushing the sealing-forming structure toward the entrance of the patient's airway during use.

[0079] Another aspect of one form of this technology includes a patient interface comprising an inflatable chamber that can be pressurized to a therapeutic pressure at least 4 cmH2O above ambient air pressure. The inflatable chamber may include an inflatable chamber inlet port, the size and configuration of which are determined to receive an airflow at the therapeutic pressure for patient breathing. The patient interface may include a sealing-forming structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, such that the airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing-forming structure may be configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface may include positioning and stabilizing structures to hold the sealing-forming structure in a therapeutically effective position on the patient's head.

[0080] Another aspect of this technology includes a patient interface comprising an inflatable chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient pressure. The inflatable chamber may include an inflatable chamber inlet port, sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface may include a sealing structure configured and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, such that the airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing structure may be configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface may include a connection port for fluid connection to an air circuit connected to the airflow during use. During use, the connection port may be located near the top, side, or back of the patient's head. The patient interface may include positioning and stabilizing structures to hold the sealing structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structures may include at least one gas delivery tube to deliver airflow through the sealing structure to the inlet of the patient's airway. At least one gas delivery tube may be configured and arranged to contact at least one region of the patient's head above an auricular base point during use. The positioning and stabilizing structure may include an adjustment mechanism for adjusting the length of the at least one gas delivery tube to accommodate different head sizes. The positioning and stabilizing structure may include a biasing mechanism to apply a biasing force along at least a portion of the length of the at least one gas delivery tube, thereby pushing the sealing structure toward the inlet of the patient's airway during use.

[0081] Another aspect of this technology includes a positioning and stabilizing structure to hold the sealing structure in a therapeutically effective position on the patient's head. The sealing structure can be configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, to deliver an 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 stabilizing structure may include at least one tether. The at least one tether can be configured to contact the patient's head during use. The at least one tether may include at least one gas delivery tube to deliver airflow through the sealing structure to the entrance of the patient's airway. The at least one gas delivery tube can be configured and arranged to cover at least one region of the patient's head above a supraacus abutment on the patient's head during use. The positioning and stabilizing structure may include an adjustment mechanism for adjusting the at least one tether to adapt the positioning and stabilizing structure to different head sizes. The positioning and stabilizing structure can be configured such that, during use, the adjustment mechanism is positioned not to contact the patient's face.

[0082] Another aspect of this technology includes a patient interface comprising an inflatable chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient pressure. The inflatable chamber may include an inflatable chamber inlet port, sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface may include a sealing-forming structure configured and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, such that the airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing-forming structure may be configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface may include a connection port for fluid connection in use to an air circuit connected to the airflow. In use, the connection port may be located near the top, side, or back of the patient's head. The patient interface may include positioning and stabilizing structures to hold the sealing-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structures may include at least one strap. At least one strap may be configured to contact the patient's head during use. The at least one tether may include at least one gas delivery tube to deliver airflow to the inlet of the patient's airway through a sealing structure. The at least one gas delivery tube may be configured and arranged to cover at least one region of the patient's head above an auricular base point during use. The positioning and stabilizing structure may include an adjustment mechanism for adjusting the at least one tether to accommodate different head sizes. The positioning and stabilizing structure may be configured such that, during use, the adjustment mechanism is positioned not to contact the patient's face.

[0083] Another aspect of one form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient pressure. The inflatable chamber may include an inflatable chamber inlet port, sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface may include a sealing-forming structure configured and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, such that the airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing-forming structure may be configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface may include positioning and stabilizing structures to hold the sealing-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include a first tube portion configured and arranged to cover, during use, a region above the patient's head above the supraacus base. The positioning and stabilizing structure may include a tether portion to cover or be below the occipital bone of the patient's head during use. The patient interface may include a ventilation structure configured to allow continuous flow of exhaled air from the interior of the inflatable chamber to the surrounding environment. The size and shape of the ventilation structure are configured to maintain therapeutic pressure within the inflatable chamber during use. A first tubing portion may be configured to guide at least a portion of the airflow for patient breathing. The first tubing portion may be configured to be tensioned during use. The first tubing portion may include a longitudinal adjustment mechanism.

[0084] Another aspect of this technology includes a positioning and stabilizing structure to hold the sealing structure in a therapeutically effective position on the patient's head. The sealing structure may be configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway to seal and deliver an 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 stabilizing structure may include a first catheter portion configured and arranged to cover an area of ​​the patient's head above an auricular base point during use. The positioning and stabilizing structure may include a ligature portion to cover or be below the occipital bone of the patient's head during use. The first catheter portion may be configured to guide at least a portion of the airflow for breathing by the patient. The first catheter portion may be configured to be tensioned during use. The first catheter portion may include a longitudinal adjustment mechanism.

[0085] Another aspect of one form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient pressure. The inflatable chamber may include an inflatable chamber inlet port, sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface may include a sealing-forming structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, such that the airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing-forming structure may be configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface may include positioning and stabilizing structures to provide elasticity to hold the sealing-forming structure in a therapeutically effective position on the patient's head for sealing the delivery of the airflow at the therapeutic pressure. The positioning and stabilizing structures may include a tether. The tether may be configured and arranged such that, during use, at least a portion of the tether covers a region of the patient's head above a supraacus aponeurosis. The strap may include an adjustable-length gas delivery tube to deliver airflow to the inlet of the patient's airway via a sealing formation. The gas delivery tube may be configured to contact a portion of the patient's head during use. The positioning and stabilizing structure may include a biasing mechanism to apply a biasing force to the adjustable-length gas delivery tube, thereby pushing the sealing formation toward the inlet of the patient's airway during use.

[0086] Another aspect of this technology includes a positioning and stabilizing structure to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure may be configured and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway, to deliver an 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 stabilizing structure may include a tether. The tether may be configured and arranged such that, during use, at least a portion of the tether covers an area of ​​the patient's head above a supraacus aponeurosis. The tether may include a length-adjustable gas delivery tube to deliver airflow through the seal-forming structure to the entrance of the patient's airway. The gas delivery tube may be configured to contact a portion of the patient's head during use. The positioning and stabilizing structure may include a biasing mechanism to apply a biasing force on the length-adjustable gas delivery tube, thereby pushing the seal-forming structure toward the entrance of the patient's airway during use.

[0087] Another aspect of this technology includes an inflatable positioning and stabilizing structure that maintains a seal formed by a sealing structure of the patient interface at the inlet of the patient's airway for sealing the delivery of airflow with a continuous positive pressure relative to ambient air pressure, and is configured to maintain a therapeutic pressure above ambient air pressure by approximately 4 cmH2O to approximately 30 cmH2O throughout the patient's respiratory cycle during use while the patient is asleep, to improve sleep-disordered breathing. The positioning and stabilizing structure may include at least one gas delivery tube for delivering airflow to the inlet of the patient's airway through the sealing structure. The positioning and stabilizing structure may also include an adjustment mechanism for dimensional adjustment of the positioning and stabilizing structure. The positioning and stabilizing structure may also include a biasing mechanism for applying a biasing force on the adjustment mechanism and pushing the sealing structure toward the inlet of the patient's airway.

[0088] Another aspect of this technology includes a patient interface for delivering a pressurized air supply at a continuous positive pressure relative to ambient pressure to the inlet of a patient's airway. The patient interface is configured to maintain a therapeutic pressure within a range of approximately 4 cmH2O to approximately 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle during sleep, to improve sleep-disordered breathing. The patient interface may include a connection port that is fluidly connected during use to an air circuit connected to a pressurized air supply source, the connection port being located near the top, side, or back of the patient's head. The patient interface may also include a sealing formation to seal against a region surrounding the patient's airway inlet. The patient interface may also include an inflatable positioning and stabilizing structure to maintain the seal formed by the sealing formation. The positioning and stabilizing structure may include at least one gas delivery tube to deliver airflow through the sealing formation to the inlet of the patient's airway.

[0089] Another aspect of this technology includes a patient interface comprising a positioning and stabilizing structure, the positioning and stabilizing structure including an adjustment mechanism to enable dimensional adjustment of the positioning and stabilizing structure.

[0090] Another aspect of the related forms of this technology includes a patient interface that includes a biasing mechanism that applies a biasing force to an adjustment mechanism and pushes a sealing-forming structure toward the inlet of the patient's airway.

[0091] Another aspect of this technology includes an inflatable positioning and stabilizing structure that maintains a seal formed by a sealing structure of the patient interface at the inlet of the patient's airway for sealing and delivering an airflow with a continuous positive pressure relative to ambient air pressure, and is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, in order to improve sleep-disordered breathing. The positioning and stabilizing structure may include at least one gas delivery tube for delivering airflow to the inlet of the patient's airway through the sealing structure. The positioning and stabilizing structure may also include an adjustment mechanism for dimensional adjustment of the positioning and stabilizing structure. The positioning and stabilizing structure may be configured such that, in use, the adjustment mechanism is positioned not to contact the patient's cheek.

[0092] Another aspect of this technology includes a patient interface for delivering a pressurized air supply to the inlet of a patient's airway at a continuous positive pressure relative to ambient pressure. The patient interface is configured to maintain a therapeutic pressure within a range of approximately 4 cmH2O to approximately 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle during sleep, in order to improve sleep-disordered breathing. The patient interface may include a positioning and stabilizing structure. The positioning and stabilizing structure may include at least one gas delivery tube to deliver airflow to the inlet of the patient's airway through a sealing formation. The positioning and stabilizing structure may also include an adjustment mechanism to allow for dimensional adjustment of the positioning and stabilizing structure. The positioning and stabilizing structure may be configured such that, during use, the adjustment mechanism is positioned to avoid contact with the patient's cheek.

[0093] Another aspect of this technology includes a positioning and stabilizing structure for holding a sealing-forming structure in a therapeutically effective position on a patient's head. The sealing-forming structure is configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, to seal the delivery of airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use. This positioning and stabilizing structure may include a front loop that extends across the patient's cheek region during use and is arranged to contact a region of the patient's head above an ear-based point. The positioning and stabilizing structure also includes a rear strap configured to wrap around the back of the patient's head during use. The positioning and stabilizing structure may further include an adjustment mechanism for adjusting the front loop and the rear strap relative to the patient's head. The adjustment mechanism may be configured to adjust both the front loop and the rear strap in a single operation, thereby enabling the positioning and stabilizing structure to accommodate different head sizes.

[0094] In some examples, the adjustment mechanism may include one or more tube insertion members configured to be selectively fluidly connected to the gas delivery tube in order to change the length of the gas delivery tube.

[0095] In some examples, a) the linkage member connects two sections of the front hoop; b) the adjustment mechanism is operable to adjust the length of the linkage member between these two hoop sections; c) the length adjustment simultaneously adjusts both the front hoop and the rear strap; d) the effective length of the front hoop is adjusted by adjusting the length of the linkage between the two sections of the front hoop, thereby adjusting the permissible distance between them; e) the length of the linkage causes a corresponding adjustment to the effective length of the rear strap; f) the linkage forms part of the rear strap; g) the opposite end regions of the rear strap are connected to or adjacent to corresponding sections of the two sections of the front hoop; h) the adjustment mechanism is selected from the group consisting of rack and pinion, drawstring, and releasable mechanical coupling; i) the adjustment mechanism is configured to allow adjustment of the linkage member; j) the adjustment mechanism allows the length of the linkage to be adjusted over a continuous length range; and / or k) the front hoop and / or the rear strap include the linkage member.

[0096] In some examples, a) has at least one gas delivery tube to deliver an airflow to the inlet of the patient's airway via a sealing structure; b) a front ring includes the lower portion of at least one gas delivery tube; c) the positioning and stabilizing structure includes a decoupling mechanism for decoupling the positioning adjustment of the upper portion of the at least one gas delivery tube from the movement of the sealing structure away from the patient's face during use, so that the upper portion of the gas delivery tube can be positioned on the patient's head; d) in use, the adjustment mechanism is located at the front of the decoupling structure; e) the upper portion is flexible and includes corrugations and / or accordion-like features to allow for positional adjustment of the upper portion of the at least one tube on the patient's head during use; and / or f) at least one rotary joint including a connection port configured to connect to an air circuit; g) at least one rotary joint is configured to allow relative rotation between the upper portion of at least one gas delivery tube and the air circuit connected to the connection port.

[0097] In some examples, a) the decoupling structure can be fluidly connected to an air circuit connected to a pressurized air supply during use; b) the decoupling structure can be located near the top, side, or back of the patient's head during use; c) two gas delivery tubes are fluidly connected between the decoupling structure and the sealing structure; d) the lower portion of each gas delivery tube can extend across one of the patient's cheek areas during use; e) the two gas delivery tubes can be located on different sides of the patient's head; f) the lower portions of the two gas delivery tubes at least partially form part of the anterior ring clamp; g) the corresponding lower portions of the gas delivery tubes each include one of the corresponding two segments of the anterior ring clamp; h) the decoupling structure is located on the top of the patient's head during use; i) the adjustment mechanism is positioned on the top of the patient's head adjacent to the decoupling mechanism during use; and / or j) the decoupling structure is Y-shaped or V-shaped.

[0098] In some examples: a) at least one rotary joint includes a first rotary joint and a second rotary joint configured to rotate relative to the first rotary joint; b) the first rotary joint rotates about a first axis and the second rotary joint rotates about a second axis perpendicular to the first axis; c) the first rotary joint can rotate independently of the second rotary joint; and / or d) the at least one rotary joint rotates about a rotation axis oriented substantially parallel to the axis along the bendable portion.

[0099] In some examples, a) the adjustment mechanism includes one or more cables connected to both the hoop and the back strap, and a controller that translates the one or more cables to cause adjustment of the hoop and the back strap; b) the controller includes a rotatable dial; c) the adjustment mechanism includes multiple cables with uniform translation rates; and / or d) the adjustment mechanism includes multiple cables with non-uniform translation rates.

[0100] In some forms, a) one or more cables are formed as pull cords passing through a front loop and / or a rear strap; b) an adjustment mechanism includes a release button configured to be engaged by a user to adjust the length of the pull cord; c) the pull cord passes through an opening; d) the release button is configured to change the diameter of the opening from a small diameter to a large diameter; e) the opening is configured to engage the pull cord in the small diameter and provide friction to the pull cord; f) a control unit that controls the adjustment mechanism; g) the control unit is directly operated by at least one button; and / or h) the control unit is indirectly operated by a remote device.

[0101] In some examples, a) in use, the adjustment mechanism is positioned above the supraauricular base of the patient's head; and / or b) the angle of the rear strap relative to the front loop is adjustable under the operation of the adjustment mechanism.

[0102] Another aspect of this technology includes a positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure is configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway to seal and deliver an 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 stabilizing structure includes: a front ring extending across the patient's cheek region during use and arranged to contact a region of the patient's head above an ear-based point. The front ring clamp may include the lower portions of two gas delivery tubes in fluid communication with the seal-forming structure. In use, each lower portion of the gas delivery tubes may extend across one of the patient's cheek regions, and the two gas delivery tubes may be located on different sides of the patient's head. The front ring clamp may also include a connecting rod linking the two gas delivery tubes between their lower and upper portions. The positioning and stabilizing structure may also include a rear strap configured to pass around the back of the patient's head during use; the positioning and stabilizing structure may also include a decoupling mechanism for decoupling the position adjustment of the upper part of the gas delivery tube from the movement of the sealing structure away from the patient's face during use, so that the upper part of the gas delivery tube can be positionally adjusted on the patient's head.

[0103] In some examples, a) the upper portion is flexible and includes multiple pleats and / or accordion-like features on the upper portion to allow for positional adjustment of the upper portions of the two gas delivery tubes on the patient's head during use; b) at least one rotary joint includes a connection port connected to the air circuit; c) at least one rotary joint is configured to allow relative rotation between these upper portions and the air circuit; d) during use, the upper portion is positioned above the supraauricular base point on the patient's head; d) the decoupling structure is Y-shaped or V-shaped; and / or e) a chin strap that extends across the patient's cheek area during use and is arranged to contact the area of ​​the patient's head below the supraauricular base point on the patient's head during use; In some examples: a) at least one rotary joint includes a first rotary joint and a second rotary joint configured to rotate relative to the first rotary joint; b) the first rotary joint rotates about a first axis and the second rotary joint rotates about a second axis perpendicular to the first axis; c) the first rotary joint is rotatable independently of the second rotary joint; d) the decoupling structure includes a pipe connector coupled to two gas delivery pipes, the two gas delivery pipes branching from the pipe connector; e) a first rotary joint directly connected to the pipe connector; f) the pipe connector is non-rotatable relative to the two gas delivery pipes; g) the first rotary joint is rotatable relative to the pipe connector; and / or h) the at least one rotary joint rotates about a rotation axis oriented substantially parallel to the axis along the upper portion.

[0104] In some examples: a) there is an adjustment mechanism for adjusting the anterior hoop and posterior strap relative to the patient's head; b) the adjustment mechanism is configured in a single operation to adjust both the anterior hoop and posterior strap, thereby enabling the positioning and stabilizing structure to accommodate different head sizes; c) the adjustment mechanism is operable to adjust the length of the linkage members between the lower parts; and / or d) the length adjustment simultaneously adjusts the anterior hoop and posterior strap.

[0105] Another aspect of this technology includes a patient interface comprising an inflatable chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient air pressure. The inflatable chamber includes an inlet port sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface may include a sealing structure configured and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, such that the airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing structure may be configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface may also include a connection port for fluid connection in use to an air loop connected to the airflow. In use, the connection port may be located near the top, side, or back of the patient's head. The patient interface may also include a positioning and stabilizing structure. This positioning and stabilizing structure may include a front ring extending across the patient's cheek region and arranged to contact a region of the patient's head above an ear-based point during use. The positioning and stabilizing structure may also include a rear bandage configured to wrap around the back of the patient's head during use; the positioning and stabilizing structure may also include an adjustment mechanism for adjusting the front loop and the rear bandage relative to the patient's head. The adjustment mechanism may be configured to adjust both the front loop and the rear bandage in a single operation, thereby enabling the positioning and stabilizing structure to accommodate different head sizes.

[0106] Another aspect of one form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient pressure. The inflatable chamber may include an inflatable chamber inlet port, sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface may further include a sealing-forming structure configured and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, such that the airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing-forming structure may be configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. A front ring collar extends across the patient's cheek region during use and is arranged to contact the patient's head in a region above a base point on the patient's ear. The front ring collar may include the lower portions of two gas delivery tubes fluidly connected to the sealing-forming structure. Each lower portion of the gas delivery tubes may extend through one of the patient's cheek regions during use. The two gas delivery tubes may be located on different sides of the patient's head. The front ring may also include a connecting rod linking the two gas delivery tubes between their lower and upper portions. The patient interface may also include a rear strap configured to wrap around the back of the patient's head during use. The patient interface may also include a decoupling mechanism for decoupling the position adjustment of the upper portion of the gas delivery tubes from the movement of the sealing structure away from the patient's face during use, thereby enabling position adjustment of the upper portion of the gas delivery tubes over the patient's head.

[0107] In some examples, a system for treating respiratory disorders includes a patient interface of either of the aforementioned aspects, an air circuit, and an air source that is under positive pressure relative to ambient air pressure.

[0108] Another aspect of this technology includes a positioning and stabilizing structure for holding a sealing structure in a therapeutically effective position on a patient's head. The sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, to deliver an 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 stabilizing structure may include at least one ring that extends across a region of the patient's cheek during use and is arranged to contact a region of the patient's head above an ear-based point. The at least one ring may include at least one gas delivery tube to deliver airflow to the entrance of the patient's airway through the sealing structure. At least one gas delivery tube is configured and arranged to cover at least one region of the patient's head above an ear-based point during use. The positioning and stabilizing structure may also include an adjustment mechanism for adjusting the at least one ring to adapt the positioning and stabilizing structure to different head sizes. The adjustment mechanism may include one or more tube insertion members configured to selectively fluidly connect to the gas delivery tube to change the length of the gas delivery tube.

[0109] Another aspect of this technology includes a positioning and stabilizing structure for holding a sealing-forming structure in a therapeutically effective position on a patient's head. The sealing-forming structure is configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, to deliver an 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 stabilizing structure may include at least one ring that extends across a region of the patient's cheek during use and is arranged to contact a region of the patient's head above an ear-based point. The at least one ring may include at least one gas delivery tube to deliver airflow to the entrance of the patient's airway through the sealing-forming structure. At least one gas delivery tube is configured and arranged to cover at least one region of the patient's head above an ear-based point during use. The positioning and stabilizing structure may also include an adjustment mechanism for adjusting the at least one ring to adapt the positioning and stabilizing structure to different head sizes. The adjustment mechanism may include a stretchable section of the gas delivery tube and one or more insert members configured to selectively connect to the gas delivery tube to change the length of the stretchable section of the gas delivery tube.

[0110] Another aspect of this technology includes a positioning and stabilizing structure for holding a sealing structure in a therapeutically effective position on a patient's head. The sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, to deliver an 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 stabilizing structure may include at least one ring that extends across a region of the patient's cheek during use and is arranged to contact a region of the patient's head above an ear-based point. The at least one ring may include at least one gas delivery tube to deliver airflow to the entrance of the patient's airway through the sealing structure. The at least one gas delivery tube is configured and arranged to cover at least one region of the patient's head above an ear-based point during use. The positioning and stabilizing structure may include a posterior band configured to wrap around the back of the patient's head during use; the positioning and stabilizing structure may also include an adjustment mechanism for adjusting the at least one ring to adapt the positioning and stabilizing structure to different head sizes. The adjustment mechanism may include one or more insert members configured to selectively connect to a gas delivery tube to change the length of the gas delivery tube. At least one insert member includes a coupling for connecting a rear strap to the gas delivery tube.

[0111] Another aspect of this technology includes a positioning and stabilizing structure for holding a sealing structure in a therapeutically effective position on a patient's head. The sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, to deliver an 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 stabilizing structure may include at least one ring that extends across a region of the patient's cheek during use and is arranged to contact a region of the patient's head above an ear-based point. The at least one ring may include at least one gas delivery tube to deliver airflow through the sealing structure to the entrance of the patient's airway. The at least one gas delivery tube is configured and arranged to cover at least one region of the patient's head above an ear-based point during use. The positioning and stabilizing structure may include an adjustment mechanism for adjusting the at least one ring to accommodate different head sizes. The adjustment mechanism may include one or more inflatable portions.

[0112] Another aspect of certain forms of this technology is a system for treating respiratory disorders, which includes a patient interface, an air circuit, and a positive pressure air source according to any one or more other aspects of this technology.

[0113] Another aspect of this technology is a patient interface, which is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0114] Another aspect of certain forms of this technology is a patient interface that includes a sealing formation configured not to cover the patient's mouth during use.

[0115] Another aspect of certain forms of this technology is a patient interface that includes a sealing formation configured such that no part of the sealing formation enters the mouth during use.

[0116] Another aspect of certain forms of this technology is a patient interface that includes a sealing formation structure configured such that the sealing formation structure does not extend inside the patient's airway.

[0117] Another aspect of certain forms of this technology is a patient interface that includes a sealing formation configured such that the sealing formation does not extend below the metal bulge area during use.

[0118] Another aspect of certain forms of this technology is a patient interface that is constructed and arranged so as not to cover the patient's eyes during use.

[0119] Another aspect of certain forms of this technology is a patient interface that is constructed and arranged to allow a patient to breathe ambient air in the event of a power failure.

[0120] Another aspect of certain forms of this technology is a patient interface that includes a sealing formation structure configured to form a seal on the underside of the patient's nose without contacting the bridge region of the patient's nose.

[0121] Another aspect of certain forms of this technology is a patient interface that includes an exhaust port and an inflation chamber, wherein the patient interface is constructed and arranged such that gas from the interior of the inflation chamber can be delivered to the surrounding environment via the exhaust port.

[0122] Another aspect of this technology, in certain forms, is a patient interface constructed and arranged such that, in the use of the patient interface, the patient can comfortably lie on their side or be in a side-lying sleeping position.

[0123] Another aspect of this technology, in certain forms, is a patient interface constructed and arranged such that, during use of the patient interface, the patient can be comfortably in a supine sleeping position.

[0124] Another aspect of this technology, in certain forms, is a patient interface constructed and arranged such that, during use of the patient interface, the patient can be comfortably in a prone sleeping position.

[0125] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for people without medical training, those who are clumsy, have limited vision, or have limited experience in using this type of medical device.

[0126] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing with soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be used in a patient's home, for example, by washing with soapy water, without requiring specialized cleaning equipment.

[0127] Of course, some of these aspects can form sub-aspects of this technology. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0128] Other features of the present technology will become apparent from the following detailed description, abstract, drawings and claims. Attached Figure Description

[0129] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including: 7.1 Treatment System Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown.

[0130] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0131] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0132] 7.2 Respiratory System and Facial Anatomy

[0133] Figure 2AA schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0134] Figure 2B This diagram shows a view of the human upper airway, including the nasal chambers, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0135] Figure 2C It is a front view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0136] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. The vertical and anteroposterior directions are also marked.

[0137] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0138] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and sagittal plane.

[0139] 7.3 Patient Interface

[0140] Figure 3A , 3B 3C, 3D, and 3E illustrate a patient interface 3000 including a positioning and stabilization structure 3300 according to the present technology.

[0141] Figure 3F It shows Figure 3C , 3D And a plan view of the patient interface 3000 shown in 3E.

[0142] Figure 3G It shows Figure 3F The patient interface 3000 shown is a cross-section of a portion thereof.

[0143] Figure 3H A longitudinal section of the headband tube 3350 of the patient interface 3000 is shown.

[0144] Figure 3IA graph illustrating the exemplary force-elongation characteristics of the headband tube 3350 of the patient interface 3000 is shown.

[0145] Figure 3J It shows the device worn by the patient. Figure 3C , 3D The patient interface shown in Figure 3E is a side view, with connection port 3600 in the center and indicated by dashed lines in the forward and backward positions.

[0146] Figure 3K It shows Figure 3C , 3D The side view of the patient interface shown in Figure 3E, which is worn by a patient with a head size, and a patient with a larger head size is shown in dashed lines.

[0147] Figure 3L It shows Figure 3C , 3D The side view of the patient interface shown in 3E, where the adjustment mechanism 3360 is positioned in the center and is shown forward and backward in dashed lines.

[0148] Figure 4A , 4B Figures 4C, 4D, and 4E illustrate a pad assembly 3150 of a patient interface 3000 in some form according to the present technology.

[0149] Figure 5 A patient interface 3000 according to the present technology is shown, the patient interface including a positioning and stabilizing structure 3300 having a folding portion 3364 and a strap 3390.

[0150] Figure 5A and 5B Shown in cross section Figure 5 The patient interface 3000 has a folding portion 3364, wherein the rolling folding portion 3366 folds over the adjacent tube portion 3368 to varying degrees.

[0151] Figure 6 A patient interface 3000 is shown, including a positioning and stabilization structure 3300, which includes a flexible tube 3350 in one form according to the present technology.

[0152] Figure 7A , 7B Figure 7C shows a patient interface 3000 including a positioning and stabilizing structure 3300 having a first tube portion 3370 and a second tube portion 3372 in some form according to the present technology.

[0153] Figure 8A portion of a patient interface 3000 according to the present technology is shown, the patient interface including a positioning and stabilization structure 3300 having a discretely adjustable first tube portion 3370 and a second tube portion 3372.

[0154] Figure 9 A portion of a patient interface according to the present technology is shown, the patient interface including a positioning and stabilizing structure 3300 having a first tube portion 3370 and a second tube portion 3372.

[0155] Figure 10A A patient interface 3000 according to the present technology is shown, the patient interface including a positioning and stabilizing structure 3300 having an adjustment mechanism 3360.

[0156] Figure 10B A patient interface 3000 according to the present technology is shown, the patient interface including a positioning and stabilizing structure 3300 having threaded tube sections 3380 and 3382.

[0157] Figure 11 A patient interface 3000 according to the present technology is shown, the patient interface including a positioning and stabilizing structure 3300 having replaceable tube portions 3385 and 3386.

[0158] Figure 12 A patient interface 3000 according to the present technology is shown, the patient interface including a positioning and stabilizing structure 3300 having an insertable tube portion 3387.

[0159] Figure 13 A portion of a tube 3350 for a patient interface according to the present technology is shown, the tube including a stretchable tube section 3355.

[0160] Figure 14 A patient interface 3000 according to the present technology is shown, the patient interface including a positioning and stabilization structure 3300 with a band 3395.

[0161] Figure 15 A portion of one form of patient interface according to the present technology is shown, the patient interface including replaceable ring insert members 3410 and 3411.

[0162] Figure 16 A portion of a patient interface comprising an inflatable ring insertion member 3420, according to one form of the present technology, is shown.

[0163] Figure 17A patient interface 3000 according to the present technology is shown, the patient interface including a positioning and stabilizing structure 3300 having an accordion-style tube section 3362 and an elastic sleeve 3340.

[0164] 7.4 RPT device

[0165] Figure 18 An RPT device of one form according to the present technology is shown.

[0166] 7.5 Humidifier

[0167] Figure 19A An isometric view of one form of humidifier according to the present technology is shown.

[0168] Figure 19B An isometric view of one form of humidifier according to the present technology is shown, which shows the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0169] 7.6 Inserting Components

[0170] Figure 20A and 20B One form of positioning and stabilizing structure 3300 according to the present technology is shown, which includes a tube insert 7387.

[0171] Figure 21A-1 A front view of a portion of a positioning and stabilizing structure 3300 according to the present technology is shown, the positioning and stabilizing structure including an insert member 8387.

[0172] Figure 21A-2 A side view of a portion of a positioning and stabilizing structure 3300 according to the present technology is shown, the positioning and stabilizing structure including an insert member 8387.

[0173] Figure 21A-3 A perspective view of a portion of a positioning and stabilizing structure 3300 according to the present technology is shown, the positioning and stabilizing structure including an insert member 8387.

[0174] Figure 21B It shows including Figure 21A-1 The positioning and stabilizing structure 3300 of the insertion component 8387.

[0175] Figure 22 A portion of a patient interface according to the present technology is shown, comprising a stretchable section 9355 and an insertion member 9410.

[0176] Figure 23A and 23BA portion of a patient interface including an inflatable portion 10420, according to one form of the present technology, is shown.

[0177] Figure 24 It shows Figure 23A and 23B A flowchart of controlled adjustment of the inflatable part 10420.

[0178] 7.7 Adjustment Mechanism

[0179] Figure 25A , 25B Figure 25C illustrates one form of patient interface according to the present technology, which includes a positioning and stabilization structure 3300 worn by a patient having a head size.

[0180] Figure 26A , 26B A patient interface including a positioning and stabilization structure 3300 in one form according to the present technology is shown.

[0181] Figure 27A An alternative form of the adjustment mechanism for positioning and stabilizing structure 3300 is shown.

[0182] Figure 27B-1 and 27B-2 Another alternative form of the adjustment mechanism for positioning and stabilizing structure 3300 is shown.

[0183] Figure 28 A patient interface including an adjustment mechanism in the form of an electronic controller is shown.

[0184] Figure 29 A patient interface including an adjustment mechanism is shown, in which the size of the anterior ferrule and the posterior strap can be controlled simultaneously.

[0185] Figure 30A and 30B One form of Y-connection with a corresponding connection port including a single rotary joint is shown.

[0186] Figure 31A and 31B One form of Y-connection with corresponding connection ports including two rotary joints is shown.

[0187] Figure 32A and 32B Another form of Y-connection with corresponding connection ports including two rotary joints is shown. Detailed Implementation

[0188] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific instances described herein, and the specific instances described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0189] The following description is provided in relation to various instances that may share one or more common features and / or characteristics. It should be understood that one or more features of any one instance may be combined with one or more features of another instance or other instances. In addition, in any instance, any single feature or combination of features may constitute another instance.

[0190] 8.1 Treatment

[0191] In such Figure 1A In one embodiment shown, the technology includes a method for treating respiratory distress, the method comprising the step of applying positive pressure to the airway inlet of a patient 1000.

[0192] 8.2 Treatment System

[0193] In one form, the technology includes a device or apparatus for treating respiratory disorders. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000. Figure 1A , 1B 1C illustrates a treatment system utilizing different forms of patient interfaces 3000.

[0194] 8.3 Patient Interface

[0195] refer to Figure 3A According to one aspect of the present technology, the non-invasive patient interface 3000 includes the following functional aspects: a pad assembly 3150, a positioning and stabilizing structure 3300, and a connection port 3600 for connection to an air circuit 4170. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects.

[0196] The liner assembly 3150 includes a sealing formation 3100 and an inflation chamber 3200. In use, the inflation chamber 3200 receives a positive pressure air supply from the air circuit 4170, and the sealing formation 3100 is arranged to seal with the area surrounding the patient's airway inlet to facilitate the supply of positive pressure air to the airway.

[0197] 8.3.1 Sealing Formation Structure

[0198] In one form of this technology, the sealing forming structure 3100 provides a sealing forming surface and may additionally provide a cushioning function.

[0199] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and resilient material such as silicone.

[0200] The sealing structure 3100 can be non-invasive, i.e., it does not extend inside the patient's airway. In some forms of the technology, no part of the sealing structure 3100 enters the patient's mouth during use. In some forms of the technology, the sealing structure 3100 is configured not to cover the patient's mouth during use. In some forms of the technology, the sealing structure 3100 does not cover the patient's eyes during use.

[0201] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use. In use, the sealing flange is able to readily respond to system pressure acting on its bottom surface by the inflation chamber 3200, thereby forming a tight sealing engagement with the surface.

[0202] In one form, such as Figure 1A As shown, the sealing portion of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is constructed and arranged to form a seal with the corresponding nostril of the patient's nose. Figure 3A The nasal pillow patient interface 3000 is also shown.

[0203] A nasal pillow according to one aspect of the present technology includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow connection structure of the present technology includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of both the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle connection structure.

[0204] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming portion that, during use, forms a seal on the upper lip region (i.e., above the lips), the bridge of the nose region, and the cheek region of the patient's face. For example, Figure 1BThe patient interface 3000 is shown in the illustration. This sealing portion delivers air or breathable gas to the two nostrils of the patient 1000 through a single hole. This type of sealing structure can be referred to as a "nasal pad" or "nasal mask".

[0205] In another form, the sealing-forming structure is configured to form a seal around the nostrils with the underside of the nose during use, and optionally with the upper lip. This type of sealing-forming structure may be referred to as a "nasal support pad" or "nasal shield." The shape of the sealing-forming structure can be configured to match or closely follow the underside of the patient's nose; that is, the contour and angles of the sealing-forming structure can be substantially parallel to the patient's nasolabial angle. In one form of nasal support pad, the sealing-forming structure includes a nasal septum member defining two orifices, each supplying air or breathable gas to a different one of the patient's nostrils during use. The nasal septum member can be configured to contact or seal the patient's columella during use. In some forms of the technology, the sealing-forming structure 3100 is configured to form a seal on the underside of the patient's nose without contacting the bridge region of the patient's nose.

[0206] In one form, the non-invasive patient interface 3000 includes a sealing portion that, during use, forms a seal on the chin, bridge of the nose, and cheek areas of the patient's face. For example, Figure 1C The patient interface 3000 is shown in the illustration. This sealing portion delivers air or breathable gas to the patient's two nostrils and mouth through a single hole. This sealing structure can be referred to as a "full-face mask".

[0207] In another form, the non-invasive patient interface 3000 includes a nasal seal-forming structure 3170 in the form of a nasal pad or nasal support pad and an oral seal-forming structure 3180 (which may be referred to as a "mouth pad" or "mask") configured to form a seal around the patient's mouth during use. In this mask, air or breathable gas is supplied to the patient's nostrils and mouth through separate openings during use. This type of seal-forming structure 3100 may be referred to as an "oronasal mask." In one form, the nasal seal-forming structure 3170 and the oral seal-forming structure 3180 are integrally formed as a single component. For example, Figure 4A , 4BThis is the case with the pad assembly 3150 shown in 4C. Alternatively, the nasal seal forming structure 3170 and the oral seal forming structure 3180 can be formed separately and configured to be attached together directly or indirectly, for example, by connecting the frames attached to each pad. For example, the nasal seal forming structure 3170 and the oral seal forming structure 3180 can be configured to be disassembled and reassembled in a modular manner. This allows the patient interface to be converted from an oronasal mask to a nasal mask or a subnasal mask, and vice versa, according to the needs of the patient and / or physician. For example, Figure 4D and 4E The pad assembly 3150 shown is an example of this.

[0208] In some forms of this technology, the sealing structure 3100 is configured such that it does not extend below the chin protuberance region of the patient's head during use.

[0209] Unless otherwise expressly stated, embodiments of the patient interface according to this technology may include any of the sealing formation structures of the types described above.

[0210] In some forms of this technology, the sealing structure 3100 is configured to correspond to a specific size and / or facial shape of the head. For example, one form of the sealing structure 3100 is suitable for large-sized heads but not for small-sized heads. In another example, the sealing structure 3100 is suitable for small-sized heads but not for large-sized heads.

[0211] 8.3.2 Inflation Chamber

[0212] The inflation chamber 3200 receives pressurized breathable gas during use and is pressurized at a pressure higher than ambient pressure. In some forms of this technology, the inflation chamber 3200 has a periphery 3210 that is shaped to complement the surface contour of a normal person's face in the area where a seal will be formed during use. In use, the boundary edges of the inflation chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by a sealing formation 3100. The sealing formation 3100 may extend along the entire periphery of the inflation chamber 3200 during use.

[0213] The inflation chamber 3200 can receive pressurized breathable gas through the inflation chamber inlet, the size and structure of which are designed to receive gas from another part of the patient interface 3000.

[0214] 8.3.3 Positioning and Stabilizing Structure

[0215] The sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed state during use by the positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 may be referred to as a "headband" because it engages with the patient's head to hold the patient interface 3000 in a sealed position.

[0216] In one form of this technology, a positioning and stabilization structure 3300 is provided, which is constructed in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument.

[0217] The positioning and stabilizing structure 3300 may include at least one frenulum. The frenulum will be understood as a structure designed to resist tension. In use, the frenulum is part of the positioning and stabilizing structure 3300 under tension. As will be described, some frenulum will exert elasticity due to tension. The frenulum can be used to hold the sealing formation structure 3100 in a therapeutically effective position on the patient's head. In some forms of this technology, the positioning and stabilizing structure 3300 may include a headband tube 3350 and / or a frenulum in the form of a headband strap, as will now be described.

[0218] 8.3.3.1 Headband

[0219] exist Figure 3A In the illustrated form of the present technology, 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 from the RPT device to the patient's airway, for example, through the inflation chamber 3200 and the sealing formation structure 3100. The tube 3350 is integral part of the headband 3300 of the patient interface 3000 to position and stabilize the sealing formation structure 3100 of the patient interface to an appropriate portion of the patient's face (e.g., the nose and / or mouth). This allows the conduit providing the pressurized airflow of the air circuit 4170 to connect to a connection port 3600 of the patient interface located outside the patient's face, which may be unsightly for some individuals. The headband tube may be as described in any of the following patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent Application No. 2019 / 0022343; U.S. Provisional Application No. 62 / 330,371; and U.S. Provisional Application No. 62 / 281,322.

[0220] Because it can contain air and allow it to pass through tube 3350 to deliver pressurized air from air circuit 4170 to the patient's airway, the positioning and stabilizing structure 3300 can be described as inflatable. It is understood that an inflatable positioning and stabilizing structure 3300 does not require all its components to be inflatable.

[0221] In some forms of this technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or rear of the patient's head. For example, in Figure 3A In the form of the present technology shown, the connection port 3600 is located at the top of the patient's head. Where the connection port 3600 is not positioned so that the catheter connected to the patient interface 3000 at the front of the face appears unsightly and protruding to the patient. For example, the catheter connected to the patient interface 3000 at the front of the face may easily become tangled in bedding or sheets, especially if the catheter extends downwards from the patient interface during use. The form of the technology using the patient interface 3600 with the connection port can make it easier or more comfortable for the patient to be in one or more of the following positions: lying on their side or supine; lying supine (i.e., face up); and lying prone (i.e., prone, face down). Furthermore, connecting the catheter to the front of the patient interface can also cause a problem known as tube resistance, where the catheter can provide undesirable resistance at the patient interface 3000, causing displacement away from the face (e.g., leakage between the sealing structure 3100 and the patient's face).

[0222] exist Figure 3A In the example, at least one tube 3350 extends from the connection port 3600 across the patient's cheek area and above the patient's ear between the padding assemblies 3150. Specifically, a portion of the tube 3350 connected to the padding assembly 3150 covers the maxillary region of the patient's head in use, and a portion of the tube 3350 covers an area of ​​the patient's head above the supraacus base point on the patient's head. The tube 3350 may also contact the face in front of the patient's ear to limit contact with the patient's ear.

[0223] exist Figure 3A In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each positioned on a different side of the patient's head during use and extending across the corresponding cheek region, above the corresponding ear (above the supraacus base point of the patient's head) to a connection port 3600 on the top of the patient's head. This form of the technology may be advantageous because if the patient sleeps with their head turned to the side and one tube is compressed to block or partially block the flow of gas along that tube, the other tube remains open to supply pressurized gas to the patient. In other embodiments of the technology, the patient interface may include a different number of tubes, such as one tube, or three or more tubes. In one example, the patient interface has tubes 3350, a single tube 3350 positioned on one side of the patient's head during use (e.g., across a cheek region), and a strap forming part of the positioning and stabilizing structure 3300 and positioned on the other side of the patient's head during use (e.g., across another region) to help secure the patient interface 3000 to the patient's head.

[0224] exist Figure 3A In the illustrated embodiment, two tubes 3350 are fluidly connected to each other at their upper ends and fluidly connected to a connection port 3600. In one embodiment, the two tubes are integrally formed, while in other embodiments, the tubes are separate components connected together in use and can be disconnected, for example, for cleaning, storage, and / or replacement. When using separate tubes, they can be indirectly connected together, for example, each can be connected to a T-shaped conduit with two conduit arms, each conduit arm being fluidly connected to tube 3350, and a third conduit arm or opening serving as a connection port 3600 and being connectable to an air circuit 4170 in use.

[0225] Tube 3350 may be formed from a semi-rigid material, such as an elastic material like silicone. Tube 3350 may have a natural, pre-formed shape and may be bent or moved into another shape if a force is applied to the tube. For example, tube 3350 may be generally arched or curved, its shape approximating the contour of the patient's head between the top of the head and the nasal or oral region.

[0226] Figure 3A An exemplary form of the technology shown has a tube 3350 that bends around the upper part of the patient's head from its upper end, which is connected to a connection port 3600 on the top of the head, to the point where a posterior headband strap 3310 connects to the tube 3350, with substantially no curvature in the sagittal plane. Between the point where the posterior headband strap 3310 connects to the tube 3350 and the lower end of the tube 3350, the lower end of the tube connects to a liner assembly 3150 in front of the patient's airway below the nose, and the tube 3350 bends forward between the patient's ear and eye and across the cheek area. The radius of curvature of this portion of the tube 3350 can be in the range of about 60 mm to about 100 mm, for example, between about 70 mm and about 90 mm, such as 80 mm. The lower end of the tube 3350 and the portion of the tube 3350 to which the posterior headband strap 3310 connects can be oriented at an angle in the range of about 65° to about 90°, for example, between about 75° and about 80°.

[0227] In some forms of the technology, one or more portions of the tube 3350 may be rigidified by one or more rigidifying or hardening elements. Examples of hardening elements include: sections of the tube 3350 that are relatively thicker than other sections; sections of the tube 3350 formed of a material that is relatively more rigid than the material forming other sections; and rigid members attached to the inside, outside, or embedded sections of the tube. The use of such rigidifying elements helps control how the positioning and stabilizing structure 3300 functions during use, for example, in cases where the tube 3350 is more likely to deform when a force is applied to it and where the tube 3350 is more likely to maintain its shape when a force is applied. Therefore, selecting a location for such a rigidifying element within the tube 3350 can help improve comfort when wearing the patient interface 3000 and can help maintain a good seal at the sealing formation during use. The rigidifying or hardening elements may be located within the positioning and stabilizing structure 3300, which is configured to support relatively heavy sealing formation structures, such as full-face or oronasal pad assemblies.

[0228] Figure 3A The tube 3350 of the illustrated technical form has a length between approximately 15 cm and approximately 30 cm, for example, between approximately 20 cm and approximately 27 cm. In one embodiment, the tube is approximately 25 cm long. The length of the tube 3350 is chosen to suit the size of a typical patient's head, such as the distance between areas near the top of the head (e.g., covering the frontal and / or parietal bones), wherein the upper end of the tube 3350 is located in the area close to the opening of the patient's airway, as it descends along a generally arched path along the side of the head and across the patient's cheek area, such as... Figure 3A As shown, the lower end of tube 3350 is connected to liner assembly 3150 in this area. As described in more detail below, patient interface 3000 is configured such that the length of tube 3350 can vary in some forms of the technology, and the above length can be applied to tubes in a contracted, stretched, or neutral state. It should be understood that the length of tube 3350 will depend on the length of other components in patient interface 3000, such as the length of the arm of the T-shaped catheter to which the upper end of tube 3350 is connected.

[0229] The level of adaptation of the patient interface 3000 to an individual patient can be altered by changing the length of the tube 3350 and optionally or additionally by changing the position of the patient interface 3000 on the patient's head. For example, by moving the positioning and stabilizing structure 3300 in a rearward or forward direction relative to the patient's head, the patient interface 3000 with a tube 3350 of a given length can be adjusted to better fit the patient. Positioning the connection port 3600 further forward (i.e., in the anterior direction) allows the patient interface 3000 with a tube 3350 of a given length to fit a larger head than if the connection port 3600 were positioned further backward (i.e., in the posterior direction).

[0230] In some forms of this technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned across the top of the patient's head, allowing the patient interface 3000 to be positioned to suit the comfort or fit of an individual patient. This can be achieved by separating the movement of the upper portion of the patient interface 3000 from the movement of the lower portion, regardless of the position of the connection port 3600 on the patient's head. This decoupling can be achieved, for example, by a mechanism that allows a portion of the headband tube 3350 to move or bend easily relative to other portions of the patient interface 3000. The lower headband portion can remain relatively stationary relative to the patient's face (e.g., due to friction, material inextensibility, etc.), resulting in substantially no leakage between the sealing structure 3100 and the patient's face, while the upper headband portion can move without affecting the position of the lower headband portion. Such a mechanism will be described below.

[0231] In one form of this technology, the patient interface 3000 is configured such that the connection port 3600 is positioned approximately at the top of the patient's head. The connection port 3600 can be positioned in the sagittal plane and aligned with a supraacus base point in a plane parallel to the coronal plane. Figure 2D The supraaural base point is marked in the middle. As will be described below, in some forms of this technology, the headband 3300 is configured to be worn in different positions, such that the connection port 3600 can be positioned in the sagittal plane close to the top of the patient's head, up to about 20 mm in front of or about 20 mm behind the supraaural base point.

[0232] The cross-sectional shape of the tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, as described, for example, in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference. A cross-sectional shape that presents a flat surface on the side of the tube facing and in contact with other parts of the patient's face or head may be more comfortable to wear than, for example, a tube with a circular cross-section.

[0233] In some forms, the cross-sectional width and / or height of the pipe 3350 can range from about 8 mm to about 25 mm. In some forms, the cross-sectional width and / or height of the pipe 3350 can range from about 10 mm to about 20 mm. In some forms where the pipe has a D-shaped cross-section, for example in... Figure 3HIn the case of the longitudinal cross-section of the headband tube 3350 shown, the tube 3350 has a width in the range of about 15 mm to about 25 mm, for example, about 20 mm, and a height in the range of about 8 mm to about 15 mm, for example, about 10 mm. The height can be considered as the dimension of the tube away from the patient's face, i.e., the distance between the outermost portions of the patient contact side 3348 and the non-patient contact side 3349, while the width can be considered as the dimension spanning the surface of the patient's head. In some forms, the cross-sectional thickness of the material forming the tube 3350 can be in the range of about 0.8 mm to about 1.6 mm. In some forms, the cross-sectional thickness of the material forming the tube 3350 can be in the range of about 1.0 mm to about 1.5 mm. In some forms, the cross-sectional thickness of the material forming the tube 3350 can be about 1.3 mm.

[0234] Figure 3H The D-shaped cross-section tube 3350 shown has rounded edges 3347 on both sides of the patient contact side 3348. The rounded edges, which are in contact with or close to the patient's skin, help the patient interface 3000 to be worn more comfortably and avoid leaving marks or causing skin irritation. Tubes with a D-shaped cross-section profile are also more resistant to bending than those with other shapes.

[0235] As also described in U.S. Patent No. 6,044,844, if the tube 3350 is crushed during use, for example, if it is crushed between the patient's face and a pillow, the tube 3350 can be crush-resistant to prevent breathable gas from flowing through it. In all cases, a crush-resistant tube may not be necessary, as the pressurized gas in the tube can act as a clamp to prevent or at least limit the crushing of the tube 3350 during use. A crush-resistant tube may be advantageous in the presence of only a single tube 3350, as gas flow would be restricted and therapeutic efficacy would cease or be reduced if the single tube became blocked during use.

[0236] Two tubes 3350 are fluidly connected to the liner assembly 3150 at their lower ends. In some forms of the technology, the connection between the tubes 3350 and the liner assembly 3150 is achieved by the connection of two rigid components, allowing the patient to easily and reliably connect the two components together. Tactile feedback such as a "re-secure click" or similar sound facilitates patient use or allows the patient to know that the tube has been correctly connected to the liner assembly 3150. In one form, the tubes 3350 are formed of silicone, and the lower ends of the silicone tubes 3350 are overmolded onto a rigid connector, for example, made of polypropylene. The rigid connector may include a convex mating feature configured for connection to a concave mating feature on the liner assembly 3150, although these convex / concave features may be arranged in opposite directions.

[0237] In another example, a compression seal is used to connect tube 3350 to gasket assembly 3150. For example, a flexible (e.g., silicone) tube 3350 without a rigid connector may need to be slightly compressed (e.g., squeezed) to reduce its diameter so that it can be inserted into a port in inflation chamber 3200. The inherent elasticity of silicone can push tube 3350 outward (e.g., back towards an uncompressed state) to seal tube 3350 in an airtight manner within the port. In a hard-to-hard engagement between tube 3350 and port, a pressure-actuated seal, such as a peripheral sealing flange, can be used. When pressurized gas is supplied through tube 3350, the sealing flange is pushed against the joint between the inner circumferential surfaces of the tube and the port of inflation chamber 3200 to enhance the seal between them. If the port is soft and a rigid connector is provided to tube 3350, a pressure-actuated seal as described above can also be used to ensure the connection is airtight.

[0238] Similar connection mechanisms can be used to fluidly connect tube 3350 to a T-shaped top member defining connection port 3600, or in some forms of the present technology, to connection port 3600. In one embodiment, the swivel bend connected to connection port 3600 is rotatable to drive a port sizing mechanism that decreases or increases the size of the port into which tube 3350 is inserted, thereby improving tube fit by increasing or decreasing pressure and reducing unintentional leakage.

[0239] 8.3.3.2 Headband Straps

[0240] In some forms of this technology, the positioning and stabilizing structure 3300 includes, in addition to the tube 3350, at least one headband strap for positioning and stabilizing the sealing forming structure 3100 at the patient's airway inlet.

[0241] 8.3.3.2.1 Headband strap position

[0242] In one example, for example, Figure 3A As shown, the positioning and stabilization structure 3300 includes a rear headband strap 3310 connected between two tubes 3350, which are positioned on each side of the patient's head and pass around the back of the patient's head, for example, covering or located below the occipital bone of the patient's head during use. The rear strap 3310 is connected to each tube above the patient's ear. In other embodiments, such as for a mouth and nose mask, the positioning and stabilization structure 3300 additionally includes one or more lower headband straps connected between the tubes and below the patient's ear and passing around the back of the patient's head.

[0243] In one form of this technology, the positioning and stabilizing structure 3300 includes a chin strap 3320 that extends below the patient's chin during use, for example as... Figure 10A and 10BAs shown. The chin strap 3320 can be connected to the headband tube 3350, or in another embodiment, to the padding assembly 3150 or a frame assembly operatively connected to the padding assembly.

[0244] Some forms of this technology may include multiple headband straps as described above for increasing stability, such as back straps, side headband straps, and chin straps.

[0245] In some forms of this technology, the positioning and stabilizing structure 3300 includes a mechanism for connecting the headband strap to the sealing forming structure 3100. The headband strap can be connected directly or indirectly to the sealing forming structure 3100. For example, in Figure 3A In the case of the patient interface 3000 shown, a tab 3345 configured to connect to the rear strap 3310 protrudes outward from each headband tube 3350 in a generally rearward direction. The tab 3345 has a hole therein to receive the end of the rear strap 3310. The tab 3345 can be positioned above the patient's ear such that the rear strap 3310 connected to the tab 3345 does not cover the patient's ear.

[0246] In some forms of this technology, the rear strap 3310 is adjustable. For example, in Figure 3C In the patient interface shown, the back strap 3310 passes through the holes in each tab 3345 during use. The length of the back strap 3310 between the tabs 3345 can be adjusted by pulling more or less of the back strap 3310 through one or two tabs 3345. The back strap 3310 can be secured to itself, for example, by a hook-and-loop fastening device after passing through the holes in the tabs 3345. The back strap 3310 can be adjusted to fit around different head sizes. In some forms of the technology, the angle of the back strap 3310 relative to the headband tube 3350 or the patient's head can be adjusted to fit at different positions around the patient's head. This adjustability helps the headband 3300 adapt to different head shapes and sizes.

[0247] In some forms of the technology, the rear strap 3345 applies force to the headband tube 3350 to pull the tabs at least partially rearward (e.g., backward) at the location of the tabs 3345. The rear strap 3310 may also apply force to the headband tube 3350 to pull them at least partially below (e.g., downward). The magnitude of the force can be adjusted by varying the length of the rear strap 3310 between the tabs 3345.

[0248] In some forms of this technology, for example Figure 3CAs shown, the direction of the force applied by the rear strap 3310 to the headband tube 3350 can also be changed. The direction can be changed by adjusting the angle of the rear strap 3310 relative to the headband tube 3350 or the patient's head. In some embodiments of the technology, the position where the rear strap 3310 applies force to the headband tube 3350 can be changed by adjusting the position of the rear strap 3310 fixed to the headband tube 3350.

[0249] The adjustable magnitude and direction of the force applied to the headband tube 3350 by the rear strap 3310 advantageously allows the headband 3300 to adapt to a range of head sizes and shapes. The rear strap 3310 can balance the force in the headband tube 3350, which helps the headband maintain its shape and provide an effective seal to the patient's face while remaining comfortable.

[0250] In some forms of the technology, when worn by a patient, a point on the headband tube 3350 near the tab 3345 receives a generally upward (e.g., above) force from the upper part of the headband tube 3350, and in some examples, this force is maintained on the patient's head due to a biasing mechanism (described in more detail below). Additionally, the point on the headband tube 3350 near the tab 3345 may receive generally forward (e.g., front) and downward (e.g., below) forces caused by the biasing mechanism, which pushes the sealing-forming structure 3150 upward and into the patient's nose. The direction and magnitude of the force required for a secure fit and effective seal can vary among patients based on the positioning and stabilizing structure 3300 on the head, which can vary due to differences in head shape and size, for example. In some forms of the technology, the adjustability of the back strap 3310 allows the force to be balanced across a range of head shapes and sizes to hold the headband 3300 in a comfortable position while maintaining an effective seal.

[0251] For example, to balance the larger force acting on the portion of the headband tube 3350 near the tab 3345 in the forward (e.g., forward) direction, the rear strap 3310 can be adjusted by pulling more of the rear strap 3310 through the slot in the tab 3345, thereby shortening the length of the rear strap 3310, and if the rear strap 3310 is elastic, applying a larger force on the headband tube 3350 in the rearward (e.g., backward) direction. Similarly, the angle of the rear strap 3310 can be adjusted as needed to balance the vertical and horizontal components of the force acting on the portion of the headband tube 3350 near the tab 3345 within the range of head shape and size.

[0252] 8.3.3.2.2 Headband binding method

[0253] In one example, the positioning and stabilizing structure 3300 includes at least one strap 3310 with a rectangular cross-section. In another example, the positioning and stabilizing structure 3300 includes at least one flat strap. In yet another example, the positioning and stabilizing structure 3300 includes at least one strap 3310 having a profile with one or more rounded edges to provide greater comfort and reduce the risk of headband marking or irritation to the patient.

[0254] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap 3310 constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam is porous to allow moisture (e.g., sweat) to pass through the strap 3310. In one embodiment, the fabric outer layer includes a loop material for engaging with a hook material portion. The hook material portion may be located at the distal end of the strap 3310.

[0255] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap 3310 that is extendable, for example, elastically extendable. For example, the strap 3310 may be configured to be tensioned during use and guide force to seal the sealing forming structure 3100 against a portion of the patient's face. In an example, the strap may be configured as a tie. In other forms of this technology, the positioning and stabilizing structure 3300 includes an adjustable strap 3310 to vary its length. For example, the strap 3310 may be connected to the tube 3350 via a strap adjustment mechanism (e.g., a hook-and-loop fastener). The adjustable strap 3310 can add further adjustability to other adjustment features of the patient interface 3000 to improve patient comfort and fit. In some forms of this technology, the degree of adjustability provided by other parts of the positioning and stabilizing structure may mean that the patient interface 3000 is sufficiently adjustable and the strap 3310 is also adjustable.

[0256] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap 3310, which is flexible and, for example, non-rigid. An advantage of this is that the strap 3310 makes it more comfortable for the patient to lie on it while sleeping.

[0257] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap 3310, which comprises two or more straps separated by a slit. In some patient interface designs, the slit strap 3310 can anchor the patient interface 3000 to the patient's head in a particularly stable manner.

[0258] In some forms of this technology, the positioning and stabilizing structure 3300 provides a holding force configured to correspond to a specific head size and / or facial shape. For example, one form of the positioning and stabilizing structure 3300 provides a holding force suitable for a large head rather than a small head. In another example, one form of the positioning and stabilizing structure 3300 provides a holding force suitable for a small head rather than a large head.

[0259] 8.3.3.3 Headband Tube Adjustment Mechanism

[0260] In some forms of this technology, the positioning and stabilizing structure 3300 includes an adjustment mechanism 3360. The adjustment mechanism 3360 is configured to allow for dimensional adjustment of the positioning and stabilizing structure 3300. In at least one embodiment, the adjustment mechanism 3360 may specifically allow for length adjustment of the positioning and stabilizing structure 3300 between the connection port 3600 and the sealing formation structure 3100, such as length adjustment of the strap (e.g., headband tube 3350). Additionally or alternatively, the adjustment mechanism 3360 is configured to allow the positioning and stabilizing structure 3300 to be flexibly adjusted, such as by bending the headband tube 3350. The adjustment mechanism 3360 allows for adjustment of the patient interface 3000 to improve the fit between the patient interface 3000 and the patient's head, thereby enabling the patient interface 3000 to accommodate different head sizes. A patient interface that fits the patient comfortably is likely to be more stable, thus reducing the likelihood of seal breach and maintaining the sealing structure against the patient's airway inlet at a comfortable level of headband tension. These factors improve patient adherence to treatment and improve treatment outcomes. It should be understood that the adjustment mechanism may include multiple mechanisms for adjustment. For example, combinations of adjustment mechanisms described below may be provided to the headgear in some forms of this technology.

[0261] For example, the adjustment mechanism 3360 may allow adjustment of the size and / or shape of the patient interface 3000. In one form of this technology, the length of the tube 3350 between the connection port 3600 and the sealing formation 3100 may be adjusted.

[0262] In some forms of this technology, the adjustment mechanism 3360 allows the size of the patient interface 3000 to be adjusted by a total of approximately 100 mm to accommodate a wide range of patients. For example, the adjustment mechanism 3360 can allow the total length of the tube 3350 to be adjusted to approximately 100 mm. In one form of this technology, the total length of the tube 3350 can be adjusted to approximately 80 mm. For example, the length of the tube 3350 located on each side of the patient's face during use can be adjusted to approximately 40 mm.

[0263] The patient interface 3000 can be configured and constructed such that if the positioning and stabilizing structure 3300 applies a force to the patient's face against the force exerted by the gas under positive pressure within the inflation chamber 3200 to maintain the pad assembly 3150 in a sealed relationship with the patient's face, the force is substantially constant or within predetermined limits within the dimensional range that the patient interface 3000 can employ. This will be described in more detail below.

[0264] Different forms of the adjustment mechanism 3360 will be described in the following description. In some forms, the adjustment mechanism 3360 is included as part of the headband tube 3350, while in other forms, the adjustment mechanism 3360 is separate from the headband tube 3350. Certain forms of the technology may include multiple adjustment mechanisms 3360 as described below.

[0265] In some forms of this technology, the adjustment mechanism 3360 is configured for manual adjustment so that the patient interface 3000 can comfortably fit the patient and provide a therapeutic effect, i.e., adjusted by the patient or another person. In other forms, the adjustment mechanism 3360 is configured for automatic adjustment to fit the patient. The advantage of an automatic adjustment mechanism is that it reduces the chance of the patient incorrectly or uncomfortablely fitting the patient interface 3000. On the other hand, some patients may prefer the ability to change the fit of the patient interface itself.

[0266] In some forms of this technology, the patient interface 3000 is configured such that different forms of seal-forming structures 3100 can be interchangeably connected to the positioning and stabilizing structure 3300. The different forms of seal-forming structures 3100 may include seal-forming structures of different sizes and weights. For example, an oronasal pad may be heavier than a nasal pad. In this form of the technology, a manual adjustment mechanism offers the advantage that it can be initially set to suit the type of seal-forming structure used. For example, if a relatively heavy seal-forming structure is used to counteract the tendency of the relatively heavy seal-forming structure to pull the positioning and stabilizing structure 3100 downwards, the manual adjustment mechanism can be set to provide a tighter fit. Similar considerations can be applied to seal-forming structures subjected to movements of the patient's mouth (e.g., jaw ptosis).

[0267] 8.3.3.3.1 Folding / Accordion-style headband tube

[0268] In some forms of this technology, the adjustment mechanism 3360 includes a tube 3350 having one or more folds, corrugations, or bellows, i.e., the folds, corrugations, or bellows include the adjustment mechanism 3360. When each fold is in a first folded configuration, the length of the corresponding tube 3350 is different from the length when the fold is in a second folded configuration.

[0269] Figure 3AThe patient interface 3000 shown includes tubes 3350, which include accordion-style tube segments 3362 between the lengths of these tubes 3350, without being accordion-style. The accordion-style tube segments 3362 include multiple folds or corrugations that can be folded and unfolded independently or uniformly to shorten or lengthen the accordion-style tube segments 3362 and thus shorten or lengthen the corresponding tubes 3350. The folds in the accordion-style tube segments 3362 can expand (stretch) or contract to varying degrees on different sides of the tubes 3350. For example, the accordion-style folds on the side of the tube 3350 closest to the patient's head can contract more than those furthest from the patient's head, increasing the curvature of the tube 3350. This allows for changes in the shape and length of the tubes 3350, which also helps to adjust the patient interface to fit the patient's specific head size and shape.

[0270] In some forms of this technology, the accordion-style tube segment 3362 provides a length of tube 3350 of the patient interface 3000 that is continuously adjustable via a series of different lengths. In some embodiments, the length of each accordion-style tube segment 3362 may be continuously adjustable. An adjustment mechanism 3360 providing continuous adjustment (e.g., accordion-style segment 3362) can comfortably fit a wide range of head sizes. Conversely, an adjustment mechanism providing adjustment between discrete lengths may fit less comfortably on the patient, for whom the most comfortable fit would require a length between two discrete length options.

[0271] In some forms of this technology, the tube 3350 includes a plurality of accordion-style tube segments 3362 at predetermined locations, each tube segment being separated by a length of the non-accordion-style tube 3350.

[0272] In some forms of this technology, the accordion-style tube section 3362 is located in a relatively straight portion of the tube 3350. This avoids the tendency of the accordion-style section 3362 to straighten as pressurized gas passes through the tube 3350, which could alter the position of the patient interface on the patient's head and adversely affect the stability of the seal and / or flow resistance.

[0273] exist Figure 3B In the illustrated form of the technology, the patient interface 3000 includes a tube 3350, which includes an accordion-style tube segment 3362, which is more than... Figure 3A The accordion-style pipe section shown is 3362 mm long. Figure 3BIn the illustrated embodiment, the accordion-style tube segment 3362 spans a significant portion of the length of the respective tube 3350 between the point where the headband strap 3310 connects to the tube 3350 and the upper end of the tube 3350 connected to the connection port 3600 (e.g., the accordion-style tube segment 3362 spans a significant portion of the upper part of the tube 3350). For example, the accordion-style tube segment 3362 may have a lower end just above the point where the headband strap 3310 connects to the tube 3350, and may have an upper end at the point where the tube 3350 connects to the connection port 3600. A longer accordion-style tube segment 3362 can provide greater flexibility to the tube 3350. Alternatively, high flexibility can be provided by increasing the number of accordion-style folds in the accordion-style tube segment 3362. The greater flexibility is advantageous in enabling the Patient Interface 3000 to fit a wide range of patients with large head sizes while applying the required level of holding force to the patient's face to ensure a good seal across that range of head sizes.

[0274] In some instances, the accordion-style tube segment 3362 may be located entirely above the patient's ear (e.g., in the upper part of the tube 3350), such that the lower part of the tube 3350 and the sealing formation 3100 may be substantially unaffected by movement (e.g., compression or extension) of the accordion-style tube segment 3362.

[0275] exist Figure 3C , 3D In the technical form shown in 3E, the patient interface 3000 is similar to Figure 3B The patient interface 3000 is shown. One difference is the construction of the accordion-style tube section 3362. Figure 3C , 3D In the technical form shown in 3E, the accordion-style pipe section 3362 has a width and diameter that vary along the length of each accordion-style pipe section 3362. More specifically, the accordion-style pipe section 3362 tapers gradually, such that the width and diameter of the pipe at one end of each accordion-style pipe section 3362 are smaller than the width and diameter of the pipe at the other end of each accordion-style pipe section 3362. More specifically, the upper end of each accordion-style pipe section 3362 (where the accordion-style pipe section 3362 is connected to the connection port 3600) has a larger width and diameter than the lower end of each accordion-style pipe section 3362 (where the accordion-style pipe section 3362 is connected to the non-accordion-style pipe section 3350), wherein the width and diameter of the accordion-style pipe section 3362 gradually and approximately linearly increase between the upper and lower ends. The tapering of the accordion-style pipe section 3362 is also present. Figure 3F As shown in the figure, Figure 3F It shows Figure 3C , 3D A floor plan of the 3E patient interface 3000. Figure 3GThe cone shape of accordion-style pipe section 3362 is also shown. Figure 3G The cross section along line 3G-3G is shown. Figure 3F The patient interface 3000. The tapered shape of the accordion-style tube section 3362 fluidly connects the connection port 3600 to the lower-length tube 3350, which does not have an accordion-style design, in a way that reduces discontinuities in the cross-sectional profile of the air path, thereby providing a smooth transition to reduce increased resistance and facilitate fluid flow along the tube 3350.

[0276] One advantage of the accordion-style tube section 3362 used in the adjustment mechanism 3360 is that, compared to other adjustment mechanisms, the accordion-style tube section 3362 can be bent or folded more easily and extended longitudinally. Figure 3J The diagram shows a headband 3300 worn in three different positions on the patient's head, indicated by reference numerals with the suffixes "a", "b", and "c". Figure 3J As shown, accordion-shaped tube sections 3362a, 3362b, and 3362c are curved to varying degrees. Accordion-shaped tube section 3362a curves forward over the patient's head, accordion-shaped tube section 3362b has a smaller curvature in the posterior / forward direction, while accordion-shaped tube section 3362c has virtually no curvature over the patient's head. These different curvatures may affect patient comfort but do not affect the pressurized airflow through tube 3350.

[0277] In some forms of this technology, the accordion-style tube segment 3362 can extend by different amounts on the front and rear sides (e.g., front and rear sides) of the headband tube 3350. That is, the wall forming the accordion-style tube segment 3362 can be relatively more constricted (e.g., more folded) on one side of the tube and relatively more extended (e.g., undisturbed) on the opposite side of the tube to facilitate bending or flexing within the tube. This effect is... Figure 3LAs can be seen in the figure, in the case of accordion-style tube segment 3362a, i.e., when the headband is worn on the patient's head anterior to the coronal plane, the wall of accordion-style tube segment 3362 extends less (e.g., collapses more) on the anterior side than on the posterior side. The ability of accordion-style tube segment 3362 to bend forward helps allow headband 3300 to be worn in an anterior position without causing padding assembly 3150 to roll forward and lose seal contact with the patient's face, which could happen if the headband tube were rigid. The ability of headband tube 3350 to bend forward or backward helps to separate connection port 3600 from padding assembly 3150. The difference in the amount of extension between the front and back sides of the accordion-style tube segment 3362a (i.e., when the headband 3300 is worn in the forward position on the patient's head) is smaller than the difference in the amount of extension between the front and back sides of the accordion-style tube segment 3362a. The accordion design allows the headband tube 3350 to be less straightened (or bent) for backward wearing.

[0278] In one configuration, compared to the fully contracted configuration, the accordion-style tube segment 3362 on each side of the patient interface 3000 is approximately 40 mm long in the fully expanded configuration.

[0279] In other forms of this technology, the accordion-style tube section 3362 can be located at different parts of the length of the tube 3350. Figure 3A and 3B One advantage of the patient interface 3000 shown is that the accordion-style tube section 3362 is positioned along the length of the tube 3350 such that the accordion-style tube section 3362 contacts the top and / or the upper sides of the patient's head, i.e., the area of ​​the patient's head above the supra-auricular base, while the accordion-style tube section 3362 does not contact the patient's cheek area. This avoids discomfort that might occur if the accordion-style tube section were to contact the patient's cheek area during use.

[0280] Accordion-style tube segments 3362 may collapse, especially when they are subjected to severe stretching. This poses a risk that the accordion-style tube segments 3362 may cause blockages in the tube 3350, restricting or preventing the delivery of inhalable gases to the patient. In some forms of this technology, the patient interface 3000 includes one or more structures configured to prevent or at least hinder collapse of the accordion-style tube segments 3362. In one embodiment, the patient interface 3000 includes one or more rigid or semi-rigid rings provided to the accordion-style tube segments 3362 and circumferentially positioned around the tube 3350. For example, these rings may be placed inside the accordion-style tube segments 3362, or they may be molded with the accordion-style tube segments 3362 (e.g., co-molded or overmolded). In another embodiment, a helical element is provided along the accordion-style tube segments 3362 to prevent collapse. In such an embodiment, a section of material between the pitches of each helical turn, referred to as a band, provides elasticity to the tube. The band can be formed of an elastic material or otherwise constructed to provide an appropriate level of elasticity to apply sufficient tension to the tube for contraction. In other embodiments, the accordion-style tube section 3362 is formed with a greater thickness than other accordion-style tube sections or is made of a harder material, thereby preventing collapse.

[0281] In another form of this technology, the patient interface 3000 includes an adjustment mechanism 3360 comprising a tube 3350 having one or more circumferential folds that allow adjacent portions of the tube 3350 to be folded longitudinally. When the circumferential folds are in a folded configuration, the length of the tube overlaps with the adjacent lengths of the tube. The rigidity of the material forming the tube 3350 can be configured such that the tubes tend to remain in the folded configuration unless pulled apart by a substantial force (e.g., a force greater than that applied to the tube 3350 during typical use of the patient interface 3000). Alternatively, the patient interface 3000 may include means for holding these tubes in the folded configuration, such as clips. In another embodiment, a magnet is embedded in the tube 3350, and when the tube 3350 is folded, the magnet aligns between the overlapping folded portions to hold the tube in the folded configuration unless the magnet is pulled apart.

[0282] Figure 5 The patient interface 3000 shown includes an adjustment mechanism 3360, which includes a folding portion 3364. The folding portion 3364 includes a first tube wall portion 3366, which is capable of folding to different degrees over adjacent tube portions 3368 by rolling over adjacent tube portions. Figure 5A and 5B yes Figure 5 The cross-sectional view of the folded portion 3364 of the patient interface 3000 shown. Figure 5A In the middle, the rolling fold portion 3366 folds onto the adjacent tube portion 3368 to a greater extent than it does on the other tube portion 3368. Figure 5B The degree of folding, and therefore when the folded portion 3364 is in Figure 5B In the configuration shown, the length of tube 3350 is longer than when the folded portion 3364 is in the position. Figure 5A The length of tube 3350 is shown in the configuration illustrated. From Figure 5A and 5B It can be seen that at the folded portion 3364, the three tubes 3350 overlap each other, although the length of the overlapping tube portion is... Figure 5A The structure and Figure 5B The constructions differ between the sections. The rolling fold section 3366 may include a localized section of the tube wall that is thinner than the other sections of the tube 3350.

[0283] Figure 6 Another form of the folding adjustment mechanism 3360 for the positioning and stabilization structure 3300 of the patient interface 3000 is shown. In this embodiment of the technology, a tube 3350 extends from the connection port 3600 to a tube end 3352, the tube end being configured to connect to the pad assembly 3150 of the patient interface 3000. The tube 3350 has a generally wavy shape along its length and includes at least one curved portion, such as curved portions 3353A, 3353B. The tube 3350 is formed of a material with sufficient flexibility so that the curved portions increase or decrease the curvature, thereby allowing each tube to fit a smaller or larger head respectively. For example, the tube 3350 may be formed of intercalary silicone having a rubber hardness of 40 on the Shore hardness scale.

[0284] exist Figure 6 In the illustrated embodiment, a tube 3350 extends at its upper end on one side of the patient's head, in a generally forward-downward direction away from the connection port 3600 and in a generally downward direction on the side of the patient's head near the point where the headband strap 3310 is attached to the tube 3350. This results in an upper curved portion 3353A positioned generally above the upper portion of the patient's head, having an outer curved portion on the front and an inner curved portion on the rear. Below the point where the headband strap 3310 is attached to the tube 3350, the tube 3350 generally extends in a downward direction and curves slightly forward in the forward direction. The lower curved portion 3353B is positioned generally above the patient's cheek area during use. The lower end of the tube 3350 extends generally horizontally across the patient's cheek in a forward direction toward the tube end 3352 connected to the padding assembly 3150. The lower end of the tube 3350 may be oriented slightly downward, i.e., extended slightly downward when worn by some patients. The lower curved portion 3353B, typically located above the patient's cheek area, has an outer curved portion on the posterior side and an inner curved portion on the anterior side.

[0285] Figure 6The lower portion of tube 3350 is constructed and configured such that, in use, tube 3350 is generally positioned away from the patient's eye, so that tube 3350 does not enter the patient's field of vision, or at least enters the patient's field of vision to a minimum. This can be achieved by constructing the lower portion of tube 3350 such that the apex or point of maximum curvature of the lower curved portion 3353B is positioned above the posterior region of the patient's cheek area in use.

[0286] Although not in Figure 6 As shown, tube 3350 located on the left side of the patient's face is configured symmetrically to tube 3350 on the right side of the patient's face. In other forms, tube 3350 may have different structures on each side of the patient's face.

[0287] 8.3.3.3.2 Telescopic headband hose

[0288] In some forms of this technology, the adjustment mechanism 3360 includes a tube 3350 having a first tube portion 3370 that is telescopically movable relative to a second tube portion 3372.

[0289] Figure 7A The patient interface 3000 shown includes an adjustment mechanism 3360, which includes a first tube portion 3370 and a second tube portion 3372 that are retractably slidable relative to each other. Figure 7A In this embodiment, the first tube portion 3370 is connected to the connection port 3600, and thus, when the patient interface is worn, the first tube portion 3370 is positioned above the patient's head. The second tube portion 3372 has a smaller diameter than the first tube portion 3370, i.e., it is fitted within the first tube portion, and when the patient interface is worn, the second tube portion is fixedly connected to a portion of the tube 3350 located below the patient's head. The first tube portion 3370 can be described as surrounding the second tube portion 3372 through telescopic movement between the two tube portions.

[0290] In some forms of this technology, the patient interface includes a tube-fixing mechanism that secures the first tube portion 3370 and the second tube portion 3372 relative to each other in a plurality of discrete positions. For example, in Figure 7AIn the illustrated embodiment, the second tube portion 3372 includes a plurality of protruding ribs 3374 on its outer surface, and the first tube portion 3370 includes one or more protrusions or pawls (not shown) that interlock with the ribs 3374 to hold the first tube portion 3370 and the second tube portion 3372 in a plurality of relative longitudinal positions, thereby enabling adjustment of the length of the tube 3350. In other embodiments of this technology, other interlocking mechanisms may be used to secure these tube sections in a plurality of discrete positions, such as one or more grooves or holes that interlock with one or more protrusions or pawls. It is understood that grooves may be provided on the surface of the first or second tube portion, while protrusions may be provided on the other surface of the first or second tube portion, in a position that interlocks with the groove during use.

[0291] In one form, Figure 7B The patient interface 3000 includes an adjustment mechanism 3360 comprising a first tube portion 3370 and a second tube portion 3372 that are retractably slidable relative to each other. The first tube portion 3370 can slide on the outer surface of the second tube portion 3372. When the patient interface 3000 is worn, the second tube portion 3372 is positioned below the first tube portion 3370 on the patient's head, i.e., downstream of the first tube portion 3370. The patient interface 3000 has two similar adjustment mechanisms 3360, one located on each side of the patient's head during use.

[0292] The patient interface 3000 includes an upper tube member 3351 positioned above the top of the patient's head during use. A first tube portion 3370 on each side of the patient's head is 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 on the upper side of its central portion.

[0293] The first tube segment 3370 on each side of the patient's head may include a first or upper tab 3371, and the second tube segment 3372 may include a second or lower tab 3373. The second tab 3373 may be pushed toward the first tab 3371. For example, the user may place their thumb on the second tab 3373 and their index finger on the first tab 3371 and clamp the two tabs together, causing the second tab 3373 to move toward the first tab 3371. Moving the second tab 3373 toward the first tab 3371 telescopically slides the first and second tube portions 3370 and 3372 to shorten the headband tube 3350. Moving the second tab 3373 away from the first tab 3371 telescopically slides the first and second tube portions 3370 and 3372 to lengthen the headband tube 3350.

[0294] The second tab 3373 can slide toward the outer edge of the first tube 3370, so that when the second tab 3373 contacts the outer edge, it acts as a stop to prevent further shortening of the tube 3350.

[0295] Figure 7B The second tube portion 3372 of the patient interface 3000 shown is integrally formed with the length of the tube 3350, which, in use, is positioned to contact the side of the patient's head and span the patient's cheek area. To ensure the patient interface 3000 is comfortable to wear and can accommodate a range of patient head shapes, the lower portion of the tube 3350 (where the second tube portion 3370 is integral) can be formed of a semi-rigid material, such as an elastomeric material like silicone. Conversely, the upper tube member 3351 (and therefore the first tube portion 3370) can be formed of a relatively rigid material.

[0296] One possible consequence of the patient interface, where the tubular portion made of a relatively flexible material is telescopically movable relative to the tubular portion made of a relatively rigid material, is that the tubular portion made of the relatively flexible material may bend when the inner tubular portion is pushed toward the outer tubular portion. This could affect the ease with which the length of the tube 3350 can be adjusted. Figure 7B The illustrated patient interface 3000 includes a rigidifying member 3379 to address this problem. The rigidifying member 3379 is used to increase the rigidity of the sections of the second tube portion 3372 that are moved into and out of the first tube portion 3370 during use. In the illustrated embodiment, the rigidifying member 3379 is the length of a relatively rigid material provided to the upper side of each second tube portion 3372. The rigidifying members 3379 may be mounted on the outer side of the second tube portion 3372, or they may be molded as part of the second tube portion 3372 (e.g., co-molded or overmolded). In some forms of this technology, each rigidifying member 3379 may be integrally formed with a tab 3373 on the upper side of the tab 3373 on the corresponding second tube portion 3372.

[0297] Figure 7BThe patient interface 3000 includes a padding member 3330 on the patient contact side of the upper tube member 3351 to improve comfort when wearing the patient interface 3000. One or more padding members 3330 may be provided to any part of any form of positioning and stabilizing structure 3300 of the patient interface 3000 described herein, unless otherwise stated. For example, the padding member 3330 may be provided on a portion of the tube 3350 to make wearing the patient interface more comfortable. The padding member 3330 may be permanently attached to a portion of the tube 3350, for example, by molding (e.g., co-molding or overmolding) or by adhesion. Alternatively, the padding member 3330 may be removably attached to the tube 3350, for example, using hook-and-loop fastening materials or fasteners. Since the padding members 3330 will come into contact with the patient's head during use, they may become soiled, and the ability to remove them for cleaning and / or replacement may be advantageous.

[0298] Another form of this technology is as follows: Figure 7C As shown. In this configuration, the patient interface 3000 includes a second tube portion 3372 that is retractably slidable on the outer surface of the first tube portion 3370. That is, in use, the tube portion retractably fitted within the other tube portion is positioned higher than the other tube portion on the patient's head.

[0299] exist Figure 7C In one embodiment, 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 in the upper end of the second tube portion 3372. A second tab 3373 may be provided, for example, integrally formed with the ring member 3384. Because both the first tube portion 3370 and the second tube portion 3372 are formed of relatively rigid materials, they are able to move telescopably relative to each other without bending. Therefore, Figure 7C The patient interface 3000 shown can avoid issues such as those related to... Figure 7B The description addresses the need for rigid components while still allowing for the same length extension of tube 3350.

[0300] Figure 8Another form of telescopic adjustment of tube 3350 is shown. In this embodiment, the second tube portion 3372 of tube 3350 is telescopically slidable relative to the first tube portion 3370 using a ratchet mechanism 3376. The ratchet mechanism prevents or impedes movement of the telescopically movable first and second tube portions relative to each other in one or both directions unless the ratchet mechanism is released, for example by pushing button 3378. Each button 3378 is operatively connected to a locking member (not shown) that interlocks with a groove or protrusion (e.g., rib 3374) on the second tube portion 3372 unless the button 3378 is pushed downward. The button 3378 and the associated locking member can help limit accidental movement of tube portions 3370, 3372 when the patient is asleep.

[0301] Another form of ratchet mechanism 3376 Figure 7C The technology is illustrated in the form shown. In this form, the ratchet mechanism 3376 includes a tongue 3397 disposed 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 substantially 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 grooves 3398 on its head contact side. The protrusion on the end of the tongue 3397 is configured to selectively engage with each groove 3398 to hold the first tube portion 3370 and the second tube portion 3372 in relative positions. The tube 3350 may have a generally D-shaped cross-section, wherein the flat portion of the 'D' contacts the patient. The ratchet mechanism 3376 may advantageously be located on the head contact side of the patient interface 3000 (e.g., Figure 7C (as in the case of the ratchet mechanism 3376), because if the ratchet mechanism 3376 is located on a relatively flat area of ​​the tube 3350, the ratchet mechanism 3376 can be more effective in providing a larger contact area than would be produced if more curved surfaces were engaged in the ratchet mechanism.

[0302] In an alternative form of this technology, button 3378 includes a tab positioned on the side of tube 3350, which is pressed inward to release the interlocking mechanism and allow accordion-style tube segments to move relative to each other. The tab may include a gap or window in the first tube segment 3370 that surrounds the second tube segment 3372, allowing a patient or clinician to press a portion of the second tube segment 3372 together to release the interlock. Alternatively, the gap may be covered by one or more overmolded buttons that are pressed to press against the second tube segment 3372 to release the interlock. Covering the gap with an overmolded button or otherwise avoiding the gap in the adjustment mechanism 3360 reduces the likelihood of the patient's hair being trapped in the adjustment mechanism 3360, which may reduce comfort. In one exemplary embodiment, the adjustment mechanism 3360 is configured such that when the ring member 3384 is pressed inward at the upper end of the second tube portion 3372, the interlocking feature between the second tube portion 3372 and the first tube portion 3370 is released, and telescopic movement between the tube portions 3370 and 3372 is possible. For example, the ring member 3384 may include a silicone-overmolded hard plastic snap and one or more protrusions on its inner top surface to interlock with a groove on the top surface of the first tube portion 3370, such that when the ring member 3384 is pressed inward at the side, the protrusions and grooves are pushed out to engage the interlocking mechanism.

[0303] Figure 8 The patient interface includes a padding member 3330 located on the patient contact side of the positioning and stabilizing structure 3300 to improve comfort when wearing the patient interface 3000. The padding member 3330 may be made of a flexible and / or compressible material (e.g., foam) to comfortably contact the patient's head.

[0304] Figure 9 Another form of telescopic adjustment of tube 3350 is shown. In this embodiment, tube 3350 includes a plurality of nested concentric tube segments 3375a, 3375b, and 3375c that slide relative to each other. Each nested concentric tube segment 3375 can be fully exposed or fully covered by extending or retracting relative to its adjacent nested concentric tube segment 3375, wherein the nested concentric tube segments interlock with each other in the fully extended or retracted position to maintain their position, for example by a snap-fit ​​mechanism. In some embodiments, the nested concentric tube segments 3375 may be held in an intermediate position, i.e., not fully extended or retracted.

[0305] exist Figure 9In the illustrated embodiment, each nested concentric tube segment is marked with a visual indicator 3377 indicating the length of the tube 3350 if the tube segment is exposed; for example, 'S' corresponds to small 3377a, 'M' to medium 3377b, and 'L' to large 3377c. Other forms of indicators, such as digital or color indicators, may also be used. Physical indicators, such as embossed ones, may also be used, which are advantageous in a dimly lit room before the patient falls asleep. The nested concentric tube portions 3375a-c can be configured to extend or retract in a predetermined order.

[0306] Other forms of this technology include a tube 3350 formed by multiple accordion-like tube segments connected together in other ways. For example, each tube 3350 may include a central inner tube segment laterally connected to two outer tube segments, the central inner tube segment being retractably sliding into and out of each of the two outer tube segments during use. Alternatively, the central tube segment may be located outside the two outer tube segments.

[0307] Other forms of retractable and adjustable headband tubes may provide other forms of size indicators. In some forms, the first tube section 3370 surrounding the tube 3350 during telescopic movement between the two tube sections 3370, 3372 may include a window or gap through which a visual indicator 3377 on the second tube section 3372 can be seen to indicate the size of the tube 3350 thus provided.

[0308] Figure 10A Another telescopic adjustment mechanism 3360 for the headband tube 3350 is shown. In this embodiment, the length of the headband tube 3350 can be adjusted by the adjustment mechanism 3360, which includes a toothed or pinion 3383. When rotated, the toothed or pinion causes the ribbed or racked portions of adjacent first and second tube sections 3370 and 3372 of the tube 3350 to telescopically move, thereby changing the length of the tube 3350. The first tube section 3370 can be integrally, permanently, or detachably connected to the padding assembly 3150. Figure 10A In the illustrated embodiment, the adjustment mechanism 3360 is located at the lower end of the headband tube 3350. For example, the adjustment mechanism 3360 may be provided within or near the padding assembly 3150. This location of the adjustment mechanism 3360 makes it easier for the patient to position the patient interface 3000 when wearing it, especially in a dark room. Figure 10A In the illustrated embodiment, rotation of the gear or pinion 3383 causes the lower end of the tube 3350 to move telescopically relative to the liner assembly 3150.

[0309] In another form of this technology, the adjusting mechanism 3360 is located at the connection port 3600, and a rotating bend is provided with a gear or pinion such that rotation of the bend causes movement of the headband tube section relative to each other or relative to the T-shaped connection port member. A lock can be provided to prevent or limit rotation of the bend when the desired arrangement is achieved.

[0310] When the first and second tube sections are provided with discrete numbers of relative positions via a telescopic adjustment mechanism, it should be understood that a larger number of positions allows for more adjustment positions and facilitates a better fit to the patient. In some embodiments, three, four, five, six, or more adjustment positions are provided.

[0311] In some forms of this technology, the telescopic tube sections are configured to move relative to each other and adjust in a continuous manner, meaning the relative positions of the tube sections are not limited to discrete locations. This allows for a greater degree of customization of the length of the tube 3350.

[0312] exist Figure 10B An example of a tube 3350 with a continuously adjustable length is shown, wherein a tube segment 3372 includes a first threaded portion 3382 on a first tube segment 3370, which threadedly engages with a second threaded portion 3380 on a second tube segment 3372. The first threaded portion 3382 and the second threaded portion 3380 may be at least partially hollow and include a path for pressurized airflow. In other words, pressurized air flows through the second threaded portion 3380, and the first threaded portion 3382 receives the second threaded portion 3380. Rotation of one of the threaded portions relative to the other adjusts the length of the tube 3350 by converting rotational motion into relative longitudinal motion of the associated tube segment. In other words, the first tube segment 3370 can be moved away from the second tube segment 3372, such that the total length of the tube 3350 can be increased on one side of the patient's face. As the length of the tube 3350 increases, the length of the second threaded portion 3380 exposed to the surrounding environment can be greater. As the length of tube 3350 decreases, the length of the second threaded portion 3380 within the first tube section 3370 can be greater. Separate first and second threaded portions 3382, 3380 can be present on either side of the positioning and stabilizing structure 3300. The left and right first and second threaded portions 3382, 3380 can be independently adjustable (although in some examples, a single adjustment can adjust both the left and right first and second threaded portions 3382, 3380). One or both threaded portions are rotatably engaged with other portions of their respective tube sections such that rotation of the threaded portions does not twist the remainder of tube 3350. An enclosed or smaller diameter second threaded portion 3380 can be positioned at the lower end of tube 3350, i.e., the connection of tube 3350 to the gasket assembly 3150 (e.g., ...). Figure 10BThe portion shown, or the upper end of tube 3350, i.e., the portion of tube 3350 that connects to connection port 3600. An abutment or screw restraint (not shown) may be provided at one end of a threaded section to prevent the threaded section from being unscrewed and accidentally disassembled during use.

[0313] In one form of this technology, in addition to the coarser adjustment mechanism, a screw mechanism is also provided as a fine adjustment mechanism. The coarser adjustment mechanism can be, for example, any other adjustment mechanism described herein. Typically, any adjustment mechanism described herein can be used in combination with a first adjustment mechanism that provides a finer adjustment than the second adjustment mechanism.

[0314] In another embodiment of this technology, the telescopic sliding sections of tube 3350 are maintained in frictional contact by ribs on the sliding surfaces of one or both sliding sections. Alternatively, one or more O-rings may be provided between these telescopically sliding tube sections. The ribs or O-rings hold the tube sections together with sufficient friction to hold them in the 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.

[0315] In another form of this technology, the telescopic tube sections can be secured in place using other fastening mechanisms. In one example, a strap is attached to one of the accordion-style tube sections via a portion of hook-and-loop fastening material disposed on the strap. The strap can be fastened to a complementary portion of hook-and-loop fastening material disposed on another accordion-style tube section to secure these portions in the desired position, thereby enabling adjustment of the length of tube 3350.

[0316] In the above embodiments of this technology, one or more tubing sections are telescopically movable relative to other tubing sections. It should be understood that the tubing sections are telescopically engaged in a substantially sealed manner to reduce the amount of breathable gas leaking from the patient interface. The manner in which this is achieved will vary depending on the nature of the telescopic engagement, but typically one or more O-rings or other seals may be provided.

[0317] exist Figure 7B In the case of the patient interface 3000 shown, for example, an O-ring is disposed on the inner surface of the lower end of the first tube portion 3370. For example, the O-ring may be disposed in a groove on the inner surface of the lower end of the first tube portion 3370. The O-ring makes sealing contact with the outer surface of the upper end of the second tube portion 3372. In other forms of this technology, the O-ring may be disposed on the outer surface of the upper end of the second tube portion 3372. In one example, the O-ring is disposed on or integrally formed with the rigidifying member 3379.

[0318] The configuration and structure of the sealing contact between the retractable and movable first and second pipe sections can be selected to provide an appropriate level of friction, thereby achieving a balance between sealing quality and ease of adjustment of the first and second pipe sections. In some forms of this technology, for example... Figure 7B The patient interface 3000 shown has been found to have a minimum holding force of approximately 10 N and a maximum holding force of approximately 20 N between the first and second tube sections 3370 and 3372. If the holding force is less than the predetermined minimum, the first tube section 3370 and the second tube section 3372 may be too easily separated, and the length of the tube 3350 may be accidentally adjusted during normal use of the patient interface 3000, for example, by the patient or the patient's bedding, or as a result of positive pressure airflow through the tube 3350. If the holding force is greater than the predetermined maximum, the first tube section 3370 and the second tube section 3372 may be too difficult for the patient to move to adjust the length of the tube 3350.

[0319] In an alternative form of this technology, the inner or outer surface of the first or second tubing section 3370, 3372 may include one or more movable valve seals, lip seals, or compressible gasket seals. In another form, a controlled leak may exist between the first and second tubing sections 3370, 3372, such that the leak does not interfere with respiratory pressure therapy. In one form, the controlled leak may be used as an additional flushing vent.

[0320] In the above-described forms of the technology in which one or more tubing segments 3370, 3372 are retractably movable relative to other tubing segments 3372, 3370, the patient interface 3000 may include one or more end stops to prevent the first tubing segment 3370 and the second tubing segment 3372 from separating. In one form, the inner tubing segment includes a flange at its end, and the outer tubing segment includes an end stop on its inner surface, the flange abutting against the end stop at the maximum extension of the tubing segment.

[0321] Although a rotary bend has been described, a ball-and-socket bend can also be used instead to provide six degrees of freedom, thus providing greater separation of tube resistance.

[0322] 8.3.3.3.3 Module Pipe Section

[0323] Figure 11 A patient interface 3000 is shown, wherein an adjustment mechanism 3360 takes the form of a replaceable tube portion 3385, which can be removed from the patient interface 3000 and replaced with a replacement tube portion 3386 having a different length than the first tube portion or module 3385. The replaceable and replacement tube portions 3385 and 3386 are described as tube modules.

[0324] exist Figure 11 In the example, the replaceable tube portion 3385 includes a T-shaped tube member with three ports, such that the replaceable tube portion 3385 is fluidly connected to each tube 3350 and the air circuit 4170 during use. For example, the central port in the upper side of the replaceable tube portion 3385 is configured to connect to or include a connection port 3600. For example, the replaceable tube portion 3385 can be positioned on top of the patient's head during use.

[0325] Tube portion 3385 can be disconnected from other parts of the patient interface 3000 and replaced with replacement tube portions 3386a and 3386b. Replacement tube portions 3386a and 3386b have tube sections extending outward from the connection port 3600 by varying amounts to the replaceable tube portion 3385. Any number of replacement tube portions can be provided, but... Figure 11 In one embodiment, the patient interface 3000 includes replaceable 'small', 'medium', and 'large' portions.

[0326] exist Figure 12 In the illustrated form of the present technology, the patient interface 3000 includes one or more tube insertion members 3387a and 3387b configured to be selectively fluidly connected to a barrel 3350 to vary the length of the tube. For example, tube insertion members 3387a and 3387b are configured to be fluidly connected between the tube 3350 and the liner assembly 3150 to vary the effective length of the tube 3350. In an alternative embodiment, the tube insertion members may be connected to other portions of the patient interface, such as at the upper end of the tube 3350 between the tube 3350 and the connection port 3600. Each tube insertion member 3387 may be marked with a size indication, such as 'M' for medium, 'L' for large, etc. A sized patient interface can be implemented without connecting tube insertion members.

[0327] exist Figure 20A In another form of the present technology shown, the positioning and stabilizing structure 3300 includes one or more tube insertion members 7387a, 7387b, and 7387c, wherein at least one insertion member includes a connector 7345. The connector 7345 may have a hole, such that the connector can take the form of an eyelet 7345 and be arranged for receiving the rear strap 3310 onto the gas delivery tube 3350.

[0328] In another embodiment of this technology, the tube insert 7387 may be connected between the lower and upper sections of the tube 3350 at a portion thereof. For example, the lower section of the tube 3350 may be connected between the lower end of the insert 7387 and the gasket assembly 3150, for example, substantially in the middle section of the tube 3350. The upper section of the tube 3350 may be connected between the upper end of the insert 7387 and the connection port 3600.

[0329] In this further form, the insertion member 7387 forms part of a ring that passes through the top of the patient's head. The ring includes the insertion member 7387, a tube 3350, and a padding assembly 3150. In use, portions of the insertion member extend across the patient's cheek area, and the ring is preferably arranged such that portions of the insertion members 7387 contact the area of ​​the patient's head above the upper ear base.

[0330] Pipe insert members 7387a, 7387b, and 7387c can be configured to selectively fluidly connect to pipe 3350 to change the actual length of the ring clamp. Pipe insert members 7387 can have one or more different lengths and can be marked with size indications, such as 'M' for medium, 'L' for large, etc.

[0331] Now for reference Figure 20A and 20B The location of the eyelet 7345 can be different for any of the insert members 7387a, 7387b, and 7387c. For example, the eyelet 7345 can be located near the upper or lower end of the insert member 7387. See also Figure 20B The holes can be spaced equidistantly from each end of the insert 7387, for example, by a distance x. In some forms, the position of the holes is offset towards one end of the insert 7387, i.e., the distance y is less than the distance z, such as... Figure 20B As shown. The position of the above-mentioned eyelet 7345 may be different between insert members 7387 of different sizes (for example, insert members 7387a may be equidistant and insert members 7387b may be skewed), and / or different versions of insert members 7387 of the same size may be formed (for example, insert member 7387b includes equidistant version and skewed version).

[0332] Advantageously, each length of the insertion members 7387a, 7387b, and 7387c can have a corresponding eyelet position optimized for fit around different head shapes and sizes. The different eyelet positions of each length of the insertion member 7387 ensure that both the eyelet 7345 and the rear strap 3310 are preferably optimally positioned relative to the patient's ear. Furthermore, the length of the corresponding insertion member 7387 and the position of the eyelet 7345 can optimize the direction and magnitude of the force applied by the rear strap 3310 to the patient interface 3300.

[0333] In some forms, the positioning and stabilizing structure 3300 may include an insert member 7387, wherein an eyelet 7345 is arranged only on one side of the positioning and stabilizing structure. The opposite side of the positioning and stabilizing structure 3300 may include a single insert (e.g., similar to) extending from the liner assembly 3150 to the upper end of the insert 7387. Figure 20A Insertion member of insert 7387).

[0334] A single insertion member (not shown) may include an adjustment mechanism (e.g., like...) Figure 20A The adjustment mechanism 3360), or for example, formed integrally with the adjustment mechanism.

[0335] In some embodiments, one or more insert members 7387 may be attached to the tube portion 3350 to vary the length of the ring clamp. For example, an insert member without an orifice (not shown) may be removably coupled to an insert member 7387 having an orifice 7345. The insert member without an orifice may be positioned at the upper or lower end of the insert member 7387, depending on the optimized location that would result in the orifice 7345, i.e., optimized for comfort and / or sealing. The insert members without an orifice may have different lengths (e.g., similar to insert members 7387a, 7387b, and 7387c). The insert member without an orifice may be mixed and matched with the insert member 7387 having an orifice 7345 (e.g., a small insert member 7387a may be used with small, medium, or large insert members that do not have an orifice).

[0336] Now for reference Figures 21A-1 to 21B In another embodiment, the positioning and stabilizing structure 3300 includes an insertion member 8387 that is positioned on top of the patient's head during use (e.g., above the patient's ear base point), wherein the insertion member includes a connector 8345.

[0337] In this further form, the insertion member 8387 forms part of a ring that passes through the top of the patient's head. The ring includes the insertion member 8387, a tube 3350, and a padding assembly 3150. In use, a portion of the insertion member 8387 extends across a region of the patient's head (e.g., covering the frontal and / or parietal bones in the upper region of the patient's head).

[0338] The insertion member 8387 includes a U-shaped tube with three ports, such that the insertion member 8387 is fluidly connected in use to the respective end of each of the tubes 3350 and the air delivery tube 4170 (not shown). For example, the center port 8602 in the upper side of the insertion member 8387 is configured to connect to or include the connection port 3600 (not shown).

[0339] The insertion member 8387 can be configured to selectively connect to the tube 3350, allowing the user to change the actual length of the tube by selecting an insertion member 8387 of a specific length. Figure 21A-1 and 21A-3As shown by the dashed lines, the insert member 8387 can be removed from the positioning and stabilizing structure 3300 and replaced with a replacement insert member having a different length than the first insert member. Any number of replacement insert members can be provided, wherein each insert member can have a different length and can be marked with a size indication (e.g., small, medium, or large). For example, the large insert member 8387 may have a tube section extending outward from the center port 8602 by a greater distance, when compared to the length of the tube section extending outward from the center port of the medium or small-sized insert member 8387, such as... Figure 21A-3 The length L is shown above.

[0340] The insertion member 8387 includes a connector 8345 in the form of an eyelet at the end of a protrusion 8604. The protrusion 8604 extends downward (e.g., in a downward direction) from two lower sides 8606 of the insertion member 8387. In some forms, the protrusion 8604 and the eyelet 8345 are located on one lower side 8606 of the insertion member. The protrusion 8604 extends downward from the rear side of the insertion member 8387. The eyelet 8345 projects outward from each protrusion 8604 in a generally rearward direction.

[0341] Eyelet 8345 can be removably attached to tube 3350, for example, by using a hook-and-loop fastening material or fastener. A portion of the hook-and-loop fastening material can be provided to the eyelet tab 8608 of eyelet 8345. A complementary portion of the hook-and-loop fastening material can be provided on a corresponding eyelet tab (not shown) of tube 3350 to secure the eyelet to the tube. In any example of the insertion member 8387 (e.g., small, medium, or large), eyelet 8345 can be removably attached to the respective tube 3350 above the supra-auricular base (e.g., so that a strap attached to eyelet 8345 can pass above the patient's ear).

[0342] The protrusion 8604 extends downward from the lower side 8606 of the insertion member by a distance corresponding to the length of the insertion member 8387. For example, a large insertion member 8387 may have a protrusion 8604 that extends downward a greater distance compared to the length of a protrusion extending from a medium or small-sized insertion member 8387.

[0343] Advantageously, aligning the eyelet position with the length of the insert allows for optimized positioning and stabilization of the structure 3300 to accommodate different head shapes and sizes. The varying eyelet positions for each length of the insert 8387 ensure optimal positioning of the eyelet 8345 and the rear strap 3310 (not shown) relative to the patient's ear. Furthermore, the corresponding insert length and eyelet position optimize the direction and magnitude of the force applied to the patient interface 3300 by the rear strap 3310.

[0344] 8.3.3.3.4 Cuttable pipe

[0345] In another embodiment of this technology, the tube 3350 can be cut to a desired length. To assist a patient or clinician in determining where to cut the tube 3350, the tube may include one or more indicators that indicate where the tube should be cut to fit the patient interface to a different sized head. For example, lines or perforations may be provided around the diameter of the tube 3350 to indicate where they can be cut. Each line or perforation may be marked with a size mark, such as 'small', 'medium', or 'large'. Cutting marks on the tube 3350 may be provided on the lower end of the tube configured to connect to the liner assembly 3150 or on the upper end of the tube configured to connect to the connection port 3600.

[0346] In one embodiment, the patient interface is provided with a cutting tool configured to cut the tube 3350.

[0347] One drawback of using the 3350 cut tube to customize the size of the patient interface is that if the tube is incorrectly cut too short, the cut portion may be difficult to replace.

[0348] 8.3.3.3.5 Stretchable Tube

[0349] In some forms of this technology, the adjustment mechanism includes one or more stretchable sections 3355 of a headband tube 3350 formed of a stretchable material. The stretchable sections allow for continuous adjustment of the length of the tube 3350 to fit different sizes of patient heads. It is understood that a section of the tube can be adjusted by the material it is made of (e.g., if made of a stretchable material), and its configuration (e.g., ... Figure 3A The accordion-style tube section 3362 shown is stretchable (either because its configuration is stretchable) or both.

[0350] Figure 13 A headband tube 3350 is shown, having a relatively stretchable section of tube 3355 connected to one or more non-stretchable sections or fewer stretchable sections of tube 3354. A fastening mechanism 3356 can be provided to hold tube 3350 in place when a desired length is achieved. The fastening mechanism 3356 may include a first fastener 3357 and a second fastener 3358, the first fastener being mounted on a section of tube 3350 on one side of the stretchable section 3355, and the second fastener being mounted on a section of tube 3350 on the other side of the stretchable section 3355. The first and second fasteners 3357 and 3358 are configured to be connected together by any suitable mechanism, such as an interlocking clip, a magnetic connection, or a hook-and-loop fastener. One of the fastening members 3358 may include multiple locations where another fastening member 3357 can be connected to it to allow tube 3350 to be secured to the desired length.

[0351] In another embodiment, no fastening mechanism is provided, and the length of the tube 3350 is automatically achieved by the elastic contraction of the stretchable section 3355.

[0352] The stretchable section of tube 3355 may include a section that is thinner than the non-stretchable section 3354. Alternatively or additionally, the stretchable section of tube 3355 may include a section formed of a material that is softer and / or has a lower hardness grade than the less stretchable section 3354.

[0353] In one embodiment, the stretchable section of tube 3355 has a cross-sectional thickness that decreases along its length. For example, the cross-sectional thickness may decrease in a stepped longitudinal section. Alternatively, the cross-sectional thickness of tube section 3355 may alternate between thicker and thinner longitudinal sections. The surface transition between sections of different cross-sectional thicknesses may be smooth or abrupt. Regions of different cross-sectional thicknesses may have different stiffness and / or hardness grades. Regions of different cross-sectional thicknesses may be formed of the same or different materials. By selecting the structure of the stretchable section of tube 3355 using different materials and different cross-sectional thicknesses, a particular section of tube 3350 can be designed to stretch more than other sections. This can help the patient interface adapt to different patients by allowing portions of tube 3350 that are positioned in use on the patient's anatomy and have particularly different dimensions between individuals to stretch more than other portions. Alternatively, the stretchable section of tube 3355 can be designed to substantially maintain a predetermined minimum opening area during use, so that the resistance of the patient interface to the breathable gas flow can be configured to suit the respiratory therapy system, such as the desired gas flow rate.

[0354] 8.3.3.3.6 Connection positions of different pipes

[0355] In some forms of this technology, the tube 3350 can be connected in a variety of ways, which makes it possible to adjust the effective length of the fluid path between the connection port 3600 and the sealing structure 3100.

[0356] In some forms, each tube 3350 includes two or more individual tube members capable of fluidly connecting together at multiple locations to vary the length of the fluid path formed by the tube members. In one form, the first tube member includes multiple ports along one side, and the second tube member includes one or more tubes protruding from one side of the second tube member and capable of engaging with selected ports in the first tube member to fluidly connect the first and second tube members. The length of the tube 3350 formed by the first and second tube members can be adjusted by selecting which port the protruding tube on the second tube member is connected to. The ends of the first and second tube members adjacent to the connection ports and protruding tubes are sealed so that breathable gas passes through each tube member without intentional leakage. Furthermore, the ports on one side of the first tube member may be provided with automatic shut-off valves to prevent gas leakage when these ports are not connected to the second tube member.

[0357] In some forms of this technology, multiple tube connections are provided at the connection ports and / or at the liner assembly 3150. For example, the inflation chamber 3200 may include two or more ports on each side, to which the tube 3350 can be selectively fluidly connected. The ports can be arranged such that adjustments to which the tube is connected change the patient size to which the patient interface is adapted. For example, one port may be positioned such that it is closer to the patient's face in use than another port. A connection of the tube 3350 to the port closer to the patient's face will accommodate a larger patient head than a connection of the tube 3350 to the port farther from the patient's face.

[0358] 8.3.3.3.7 Changes to the patient interface ring

[0359] Some forms of this technology include a patient interface 3000, wherein a positioning and stabilizing structure 3300 defines a loop configured to surround a portion of the patient's head during use. For example, in some forms of this technology, one or more straps may define a loop surrounding a portion of the patient's head. Figure 3A In the illustrated embodiment, the ring is defined by a tube 3350 and a padding assembly 3150. When the patient interface 3000 is worn, these components form a ring in which the patient's head is located.

[0360] In some forms of this technology, the positioning and stabilizing structure between the connection port 3600 and the sealing formation structure 3100 of the gasket assembly 3150 is adjusted by adjusting the size of the ring. Adjustment of the ring allows the patient interface to fit patients of different sizes. The foregoing embodiments illustrate how the size of the ring can be adjusted by changing the length of the tube 3350. Embodiments in which other mechanisms for adjusting the size of the ring are provided will now be described.

[0361] 8.3.3.3.8 Ring Adjustment Mechanism

[0362] In some forms of this technology, the patient interface 3000 includes a ring adjustment mechanism operable to adjust the position of two areas of the positioning and stabilizing structure 3300 held together, thereby adjusting the size of the ring.

[0363] exist Figure 5 In this embodiment, the patient interface 3000 includes a strap 3390 connected between tubes 3350. The strap 3390 is positioned below the connection port 3600 with its upper end facing the patient interface 3000, such that in use, the strap 3390 passes over or near the top of the patient's head. The strap 3390 can be bent upward to accommodate the top of the patient's head. The strap 3390 may be formed of a flexible, rigid, or semi-rigid material.

[0364] In this embodiment, when the patient interface 3000 is worn, a loop around a portion of the patient's head is defined by a strap 3390, a padding assembly 3150, and a portion of a tube 3350 connecting the strap 3390 and the padding assembly 3150. The size of this loop can be adjusted by adjusting the strap. The patient interface includes a strap adjustment mechanism 3391 by which the length of the strap 3390 can be adjusted. The strap adjustment mechanism 3391 may include an adjustable fastening connection between two portions of the strap 3390. For example, one segment of the strap 3390 may pass through a loop attached to the end of another segment of the strap 3390 and be attached to itself using a hook-and-loop material. Alternatively, the two strap segments may be able to be connected together using ejectors or interlocking members that can be connected in multiple different locations. In another embodiment, each of the two segments of the strap 3390 includes a rack portion that engages with a pinion or gear, and the length of the strap 3390 can be adjusted by rotating the gear. In another embodiment, the two portions of the strap 3390 can slide telescopically relative to each other and can be secured in place by an interlocking mechanism, a magnet, or friction engagement.

[0365] In another alternative embodiment, one or both ends of the strap 3390 can be connected to the tube 3350 via an adjustable strap connection mechanism, so that the position of the strap 3390 connected to one or both tubes 3350 can be changed.

[0366] Another form of this technology is... Figure 14As shown. In this form, the patient interface 3000 includes a strap 3395 positioned around the upper end of the tube 3350 (i.e., the end of the tube closest to the connection port 3600). The strap 3395 holds the tube 3350 together at its upper end, and its position defines the size of the loop, partially defined by the tube 3350, which surrounds a portion of the patient's head when the patient interface 3000 is worn. During use, the strap 3395 can be moved along the tube 3395 to change the position in which the tube 3350 is held together, thereby changing the size of the loop defined by the patient interface 3000. Moving the strap 3395 along the tube 3350 toward the connection port 3600 results in a larger loop, allowing the patient interface to accommodate larger heads.

[0367] The band 3395 can be tightly secured around the tube 3350, with a high level of friction between the band and the tube, preventing it from easily sliding upwards and loosening during use. For example, the band 3395 can be formed of rubber or other high-friction materials. The frictional force can be substantially non-compressive to allow airflow while the band 3395 is taut. Alternatively, the patient interface may include a mechanism for securing the band in place. For example, multiple ridges and / or protrusions may be provided on the outer edge of the tube 3350, and one or more pawls may be provided on the inner surface of the band 3395 to interlock with the ridges / protrusions of the tube 3350 and secure the band in place. The pawls can disengage from the ridges / protrusions via appropriate mechanisms to allow the band to move along the tube 3350 when needed.

[0368] In another embodiment, the upper sections of the two tubes 3350 are secured together by a latch or zipper. For example, one row of teeth of the latch can be mounted on one tube 3350, and another row of teeth of the latch can be mounted on the other tube 3350. A slider can move between the rows of teeth to adjust the position in which the two tubes 3350 are held together, thereby changing the size of the ring formed by the patient interface 3000 to accommodate different patient head sizes. The slider limits accidental movement so that the patient does not accidentally change the size of the ring.

[0369] 8.3.3.3.8.1 Synchronous Adjustment

[0370] In another alternative embodiment, the lengths of the headband straps 3310 and 3390 can be adjusted together in a single operation, i.e., simultaneously, to change the size of the corresponding loops surrounding part of the patient's head and / or to change the position of the corresponding loops on the patient's head.

[0371] Reference Figure 25A , 25BLike embodiment 25C, the rear band 7310, similar to headband 3310, defines a loop passing through the back of the patient's head and between tube 3350 and padding assembly 3150. Similar to embodiment 3390, the front ring 7390 defines a loop passing through the top of the patient's head and includes tube 3350 and padding assembly 3150. Therefore, the front ring 7390 may include at least one gas delivery tube 3350. In use, the front ring 7390 extends across the patient's cheek area and is arranged to contact the area of ​​the patient's head at the supra-auricular base point on the patient's head.

[0372] The posterior bandage 7310 and the anterior loop 7390 can be adjusted simultaneously in a single operation via the adjustment mechanism 7391. The adjustment mechanism 7391 can change the actual length of the bandage 7310 and / or the loop 7390, adjust the effective length of any one or both of these components, and / or the position of any one or both of these components on the patient's face.

[0373] The adjustment mechanism 7391 can simultaneously adjust the rear bandage 7310 and the front loop 7390 in a single operation, allowing the positioning and stabilization structure 3300 to be customized to fit patients of different sizes. In other words, the length of the loop 7390 passing through the top of the patient's head and the length of the rear bandage 7310 passing through the back of the patient's head can be adjusted simultaneously. The adjustment mechanism 7391 can adjust the effective length of the rear bandage 7310 and / or the effective length of the front loop 7390 through a continuous range of lengths (e.g., an unlimited number of adjustments).

[0374] Now refer to Figure 26A and 26B The connecting member 7394 can form part of the front ring 7390. For example, the connecting member 7394 can connect the two gas delivery tubes 3350 of the front ring 7390 together. The connecting member 7394 can extend between the upper or lower end 7410 and the lower or upper end 7411 of the gas delivery tube 3350, such that only the lower end 7411 forms part of the front ring 7390. The connector 7394 includes an adjustment mechanism 7391, a first portion 7392 and a second portion 7393 of the front ring 7390, and first and second portions of the rear strap 7310. The first and second sections of the corresponding ring and strap can be connected at opposite regions 7396 of the headband tube 3350. The position of the opposite regions 7396 can be selected to achieve optimal dimensions of the patient interface.

[0375] In one embodiment, the first segment 7392 of the corresponding hoop and strap can pass through a connecting member 7394 attached to the end of the second segment 7393 of the corresponding hoop and strap. See also Figure 26A and 26BThe first and second segments 7392 and 7393 of the corresponding hoop and strap each include a rack portion. The linkage member 7394 can take the form of a pinion or a gear, wherein the first and second segments 7392 and 7393 of the corresponding hoop and strap each engage with the pinion or gear. The lengths of the front hoop 7390 and the rear strap 7310 can be adjusted by rotating the gear, which allows the positioning and stabilization structure 3300 to be customized to fit patients of different sizes.

[0376] In an alternative form, the adjustment mechanism can take the form of an eyelet. In this form, the connecting rod member 7394 may include a first segment 7392 and a second segment 7393 of a corresponding loop and strap connected around the eyelet. The eyelet can be attached to the end of the second segment 7393 of the corresponding loop and strap. The first segment 7392 of the corresponding loop and strap can pass through the eyelet, for example, with a thread and be attached to itself using a hook-and-loop material.

[0377] In another alternative form, the linkage member 7394 may include first and second ring clamps and strap portions connected together using ejectors or interlocking members that can be connected in multiple different locations.

[0378] In some further embodiments, the adjustment mechanism 7391 may take the form of a dial control, a pull cord, and / or an electronic control unit.

[0379] The connector 7394 can be operated by adjusting the actual length of the links between the first segment 7392 and the second segment 7393 of the corresponding loops and straps. Furthermore, adjusting the length of the link does not change the length of the headband tube 3350. However, it does adjust the effective length of the tube 3350 by pulling these segments closer together or allowing them to separate further. For example, increasing the length of the link increases the distance between the relative areas 7396 of the headband tube 3350, and consequently increases the effective length of the front loop 7390 configured to surround the front of the patient's head. Similarly, increasing the distance between the relative areas 7396 of the headband tube 3350 increases the actual length of the rear strap 7310, which is configured to surround the front of the patient's head as the link 7394 forms part of the rear strap.

[0380] Now for reference Figure 25A , 25BAnd 25C. In some forms, the adjustment mechanism 7391 can be a releasable mechanical connection, such as a dial control that allows tensioning and releasing of the cable. The dial control can be connected to the cable inserted through the area of ​​the rear strap 7310 and the front loop 7390. The length of the cable can be shortened by winding the dial control in one direction and lengthened by winding the dial control in the opposite direction. In some forms, the length of the cable inserted through the area of ​​the rear strap 7310 and the front loop 7390 can be changed at an equal rate as the dial control is wound. Alternatively, the length of the cable can be adjusted at different rates when winding the dial control, so that one cable is shorter than another. This adjustment is necessary for force vector optimization.

[0381] Now for reference Figure 27A In some other forms, the adjustment mechanism 7391 may be a pull cord 7399 (e.g., which may be formed of cable). In this form, the pull cord 7399 may be configured along the periphery of the front loop 7390 and the periphery of the rear strap 7310. In a variation of this form, the pull cord 7399 of the front loop 7390 may be configured to run along the entire periphery of the front loop 7390 or restricted to running along a portion passing over the top of the patient's head. Pulling or releasing the pull cord 7399 can simultaneously adjust the effective length of the front loop 7390 and the rear strap 7310. Furthermore, pulling or releasing the pull cord 7399 can pull or release portions of the front loop 7390 and the rear strap 7310 together to adjust the length of the linkage 7394.

[0382] The pull cord 7399 can be inserted via the pull cord locking mechanism 7400. The pull cord locking mechanism 7400 can be arranged on the pull cord 7399 to secure it in place after the length has been adjusted. The pull cord locking mechanism 7400 may have an opening for inserting (e.g., through) the pull cord 7399 into the front loop 7390 and / or the rear strap 7310. The diameter of the opening may be smaller than the diameter of the pull cord, allowing friction to hold the pull cord 7399 in place.

[0383] In some forms, the diameter of the opening can be adjustable. For example, a smaller diameter provides friction to hold the pull cord 7399 in place, while a larger diameter allows the pull cord 7399 to move more freely through the opening. The pull cord locking mechanism 7400 may include a release button 7401 that controls the size of the opening. The opening can typically have a smaller diameter. The patient can pull the pull cord 7399 through the opening, but friction can limit the pull cord 7399 from returning through the opening. The patient can engage the release button 7401 to enlarge the diameter of the opening to a position where no more friction is applied to the pull cord 7399. The pull cord 7399 can be biased into the opening and automatically retracts once the patient engages the release button 7401. This allows the patient to quickly adjust (e.g., increase or decrease) the exposed length of the pull cord 7399.

[0384] In some forms, the mechanical components of the adjusting mechanism described in this disclosure can be electronically controlled. For example, the rack and pinion mechanism can move automatically, or the cable can be automatically tensioned or released. See also Figure 28 A control unit 7402 may be arranged on a portion of the tube 3350 to enable controlled determination of the size of the patient interface. The control unit can be operated directly using buttons on it. Alternatively, the control unit can be remotely operated, for example, by a mobile phone software application 7404, which can connect to the control unit 7402 via Bluetooth, Wi-Fi, radio waves, or any similar form of wireless communication.

[0385] Now for reference Figure 25A , 25B And 25C. In some forms, the front loop 7390 and rear strap 7310 of the positioning and stabilizing structure 3300 can be applied to the UCFF mask system. In this arrangement, two or more straps, such as the rear strap 7310 and the chin strap 7320, can be connected to at least one of the headband tube 3350 and the UCFF padding assembly 3150. An operable adjustment mechanism 7391 is used to adjust the effective length of the front loop 7390 and the rear strap 7310 in the UCFF system, and thus adjust the corresponding force vector of the positioning and stabilizing structure 3300.

[0386] Now refer to Figure 29 The connecting rod can form part of the rear strap 7310. In this configuration, the rear strap 7310 can be adjusted in a single operation to simultaneously adjust the lengths of the front hoop 7390 and the rear strap 7310.

[0387] In some forms, the adjustment mechanism can be integrated into the rear strap. Now refer to... Figure 29The adjustment mechanism 7391 may take the form of the end of the strap 7310. The rear strap 7310 may be configured such that its end passes through a hole in the tab 7345 and protrudes generally in a rearward direction. The adjustment mechanism 7391 at the end of the strap 7310 is attached to itself using a hook-and-loop material or similar connecting means (e.g., snaps, magnets, etc.). In some forms, the adjustment mechanism 7391 may be positioned on one side of the patient's head and is capable of adjusting both the rear strap 7310 and the front loop 7390 simultaneously. The rear strap 7310 and the front loop 7390 move relative to each other to adjust the effective length and / or positioning of the front loop and the rear strap, which are configured to surround a portion of the patient's head.

[0388] An adjustment mechanism 7391 at the end of the rear strap 7310 can be connected to a cable 7406 inserted through the area of ​​the rear strap 7310 and the front loop 7390. The length of the cable can be adjusted by pulling more or less of the rear strap 7310 through the tab 7345. The end of the rear strap 7391 can be secured to itself after passing through the tab 7345.

[0389] In some configurations, the lengths of the rear strap 7310 and the front loop 7390 can change at equal rates when the adjusting mechanism 7391, located at the end of the rear strap 7310, is pulled through the tab 7345. In an alternative configuration, the lengths of the rear strap 7310 and the front loop 7390 can be adjusted at different rates when the adjusting mechanism 7391, located at the end of the rear strap 7310, is pulled through the tab 7345, so that one strap is shortened more than the other. This type of adjustment may be necessary for force vector optimization.

[0390] Another form of this technology is as follows Figure 14 As shown. In this form, the patient interface 3000 includes a strap 3395 positioned around the upper end of the tube 3350 (i.e., the end of the tube closest to the connection port 3600). The strap 3395 holds the tube 3350 together at its upper end, and its position defines the size of the loop, partially defined by the tube 3350, which surrounds a portion of the patient's head when the patient interface 3000 is worn. During use, the strap 3395 can be moved along the tube 3395 to change the position in which the tube 3350 is held together, thereby changing the size of the loop defined by the patient interface 3000. Moving the strap 3395 along the tube 3350 toward the connection port 3600 results in a larger loop, allowing the patient interface to accommodate larger heads.

[0391] The strap 3395 can be tightly secured around the tube 3350, with a high level of friction between the strap and the tube, preventing it from easily sliding upwards and loosening during use. For example, the strap 3395 can be formed of rubber or other high-friction materials. Alternatively, the patient interface may include a mechanism for securing the strap in place. For example, multiple ridges and / or protrusions may be provided on the outer edge of the tube 3350, and one or more pawls may be provided on the inner surface of the strap 3395 to interlock with the ridges / protrusions of the tube 3350 and secure the strap in place. The pawls can disengage from the ridges / protrusions via appropriate mechanisms to allow the strap to move along the tube 3350 when needed.

[0392] In another embodiment, the upper sections of the two tubes 3350 are secured together by a latch or zipper. For example, one row of teeth of the latch can be mounted on one tube 3350, and another row of teeth of the latch can be mounted on the other tube 3350. A slider can move between the rows of teeth to adjust the position in which the two tubes 3350 are held together, thereby changing the size of the ring formed by the patient interface 3000 to accommodate different patient head sizes.

[0393] like Figure 14 The upper end of the pipe 3350 shown forms a Y-shape, meaning two pipes converge into a single pipe. Therefore, the connection port can be in the form of a Y-shaped or V-shaped connection port 3600. Now refer to Figure 26A and 26B Advantageously, compared to the flow through the previously described arrangement via the patient interface 3000, the Y-shaped arrangement can provide improved laminar flow into and through the headband tube 3350, wherein the rotating bend is connected at the connection port 3600 and oriented at 90 degrees to the headband tube.

[0394] In some forms, the positioning and stabilizing structure 3300 may include a decoupling mechanism 7600 to decouple the positioning of the conduit of the air circuit 4170 (e.g., a structure for delivering pressurized air from the RPT device 4000 to the patient interface 3000) from the movement of the sealing forming structure 3100 away from the patient's face during use, thereby enabling positioning of the conduit of the air circuit 4170. In some forms, the decoupling mechanism 7600 may decouple the positioning of at least a portion of the gas delivery tube 3350 from the movement of the sealing forming structure 3100 away from the patient's face during use, thereby enabling positioning of the conduit of the air circuit 4170 and / or the gas delivery tube 3350 on the patient's head. In some forms, the decoupling structure 7600 may include a Y-shaped (or V-shaped) arrangement. The tube connector 7407 may partially form a Y-shaped or V-shaped arrangement by connecting each gas delivery tube 3350 to a single body. The upper end 7410 of the gas delivery tube 3350 may be connected to the tube connector 7407. In some forms, the decoupling structure 7600 is biased toward the posterior aspect of the patient's head during use. In other forms, the decoupling structure 7600 may be elastic and flexible to allow the catheter to move freely between posterior, lateral, and anterior positions of the patient's head.

[0395] See Figure 30A In one embodiment, up to 32, the decoupling mechanism 7600 may include a rotary joint 7408. The rotary joint 7408 may include a first end connected to a pipe connector 7407. In this embodiment, the upper portion or end 7410 of the pipe 3350 converges to one end of the pipe connector 7407, and the rotary joint 7408 extends from the opposite end of the pipe connector 7407 to form a Y-shaped (or V-shaped) arrangement. In some embodiments, the rotary joint 7408 may be a rotary bend and may include a bend (e.g., a 90° bend). In some embodiments, the rotary joint 7408 may be made of a flexible material (e.g., the same material as the pipe 3350). In some embodiments, the rotary joint 7408 may be made of a rigid or semi-rigid material.

[0396] The rotary joint 7408 may include a first end that is directly connected to the pipe connector 7407 (although the first end may be directly connected to at least one of the gas delivery pipes 3350). The rotary joint 7408 also includes a second end opposite the first end, which serves as a connection port 3600. In other words, the conduit of the air circuit 4170 may be directly connected to the second end of the rotary joint 7408.

[0397] The rotary joint 7408 and the flexible upper end 7410 of the gas delivery tube 3350 together serve as a decoupling mechanism. In other words, the decoupling mechanism 7600 includes the rotary joint 7408, the tube connector 7407, and the upper end 7410 of the tube 3350. Advantageously, the rotary joint 7408 of the decoupling mechanism 7600 allows the air circuit 4170 to move relative to the sealing formation 3100 of the patient interface 3000. Specifically, the rotary joint 7408 can rotate relative to the tube connector 7407 such that rotation of the rotary joint 7408 does not twist the upper end 7410 of the tube 3350. The rotary joint 7408 enables positioning of the catheter in the air circuit 4170 and reduces the risk of instability in the seal of the sealing formation 3100 against the patient's face.

[0398] The decoupling structure 7600 also allows the upper end 7410 of the gas delivery pipe 3350 to move relative to the rest of the gas delivery pipe 3350. For example, the upper end 7410 of the pipe 3350 may be corrugated or include accordion-like sections, which allows the upper end 7410 to bend (i.e., the upper end 7410 may be flexible). This provides additional degrees of freedom to the decoupling structure 7600 as a whole and allows the upper end 7410 of the gas delivery pipe 3350 to move relative to the lower end of the gas delivery pipe 3350 without interfering with the sealing of the sealing formation structure 3100.

[0399] Now for reference Figure 30A and 30B In some forms, the decoupling structure 7600 includes a rotary joint 7408 configured to rotate about a single axis 7412. In this form, the rotary joint 7408 may be configured about an axis 7413 parallel to the axis 7413 of the tube 3350 connected to the decoupling structure 7600 (e.g., as shown in the image). Figure 30A Rotation along a single axis (the unbent portion of the upper end 7410 shown in the image).

[0400] In some configurations, the upper end 7410 may be bent at least partially relative to the rest of the tube 3350 due to the weight of the rotary joint 7408.

[0401] Now for reference Figure 31A , 31B 32A and 32B. In some other forms, the decoupling mechanism 8600 includes multiple rotary joints arranged as sub-assemblies of components configured to rotate about more than one axis.

[0402] Reference Figure 31A and 31BThe rotary joint 8408 includes a first rotary joint 8415 and a second rotary joint 8416. The first rotary joint 8415 can be directly connected to the pipe connector 8407 and can be positioned perpendicular to the pipe 3350 (e.g., as shown in the image). Figure 31A The upper end 8410 of the unbent tube 3350 shown rotates along a first axis of rotation 8414 oriented at its axis 8413. A second rotary joint 8416 may be connected adjacent to the first rotary joint 8415 and may provide a second axis of rotation 8412. The second axis of rotation 8412 may be oriented perpendicular to the first axis of rotation 8414. The second axis of rotation 8412 may also be oriented parallel to the axis of the tube 3350 (e.g., as shown). Figure 31A (The unbent portion of the upper end 8410 shown). The first rotary joint 8415 and the second rotary joint 8416 can rotate simultaneously and / or independently of each other.

[0403] See Figure 32A and 32B A further variation of the decoupling structure 9600 may include a rotary joint 9408 having two axes of rotation. A first rotary joint 9415 of the rotary joint 9408 may be directly connected to the pipe connector 9407 and may be configured to rotate around a first axis of rotation 9414 parallel to the axis 9413 along the pipe 3350 (e.g., as shown in the image). Figure 32A The unbent portion of the upper end 9411 shown rotates. The second rotary joint 9416 of the rotary joint 9408 can be connected adjacent to the first rotary joint 9415 and can provide a second rotary axis 9412 perpendicular to the first rotation axis 9414. The second rotation axis 9412 can also be oriented perpendicular to the axis 9413 of the tube 3350 (e.g., as shown). Figure 32A (The unbent portion of the upper end 9411 shown). The first rotary joint 9415 and the second rotary joint 9416 can rotate simultaneously and / or independently of each other.

[0404] The rotary joints 8408 and 9408 of decoupling structures 8600 and 9600 each include two rotational degrees of freedom. The difference between the two decoupling structures 8600 and 9600 relates to which axis is adjacent to the upper end 9411. This, in turn, determines the direction in which pressurized air flows into the decoupling structures 8600 and 9600. For example, if the axis of rotation 8414 is a vertical axis, then the conduit delivering pressurized air to decoupling structure 8600 can extend substantially horizontally from decoupling structure 8600. The opposite can be true in decoupling structure 9600, where the conduit can extend substantially vertically. Based on a preferred sleep position, the patient may prefer one decoupling structure 8600 or 9600 over the other.

[0405] like Figure 25AAs best shown, the adjustment mechanism 7391 can be positioned adjacent to the patient's crown and anterior (i.e., further forward) of the Y-shaped decoupling mechanism 7600. A conduit connected to the Y-shaped decoupling mechanism 7600 (e.g., at the second end of the rotary joint 7408) can extend posterior to the adjustment mechanism 7391 so as not to cover or otherwise obstruct it. This allows the patient easy access to the adjustment mechanism 7391 without interference from the Y-shaped connection port 7600. In an alternative embodiment not shown, the adjustment mechanism 7391 may be located at or behind the Y-shaped connection port 7600.

[0406] Now for reference Figure 26A and 26B In some configurations, the upper ends 7410 of the two tubes 3350 are secured together by an adjusting mechanism 7391. The adjusting mechanism 7391 may be located above the head (e.g., covering the patient's frontal and / or parietal bones), primarily in front of the converging Y-shaped junction.

[0407] In some configurations, the adjustment mechanism 7391 can adjust the length of the anterior loop 7390. Similar to embodiments of the headband 3310, a separate posterior strap 7310 can be positioned behind the patient's head between the tube 3350 and the headband. The adjustment mechanism 7391 and the posterior strap 7310 can operate independently to adjust the positioning and stabilization of the structure 3300 to accommodate patients of different sizes.

[0408] In some configurations, the adjustment mechanism 7391 can simultaneously adjust the front loop 7390 and the rear strap 7310 in a single operation, allowing the positioning and stabilization structure 3300 to be customized to fit patients of different sizes. In this configuration, the lengths of the loop passing over the top of the patient's head and the rear strap passing behind the patient's head can be adjusted simultaneously.

[0409] The adjustment mechanism 7391 can hold the tube 3350 together in its upper section and determine the size of the ring clamp partially defined by the tube 3350, which surrounds a portion of the patient's head when the patient interface 3000 is worn.

[0410] Now refer to Figure 26A and 26B The adjustment mechanism 7391 may include a link member 7394 between a first section 7392 and a second section 7393 of the front hoop 7390 and the rear strap 7310. As previously described in the alternative embodiment for simultaneous adjustment, the link member 7394 can be operated by adjusting the length of the link between the first hoop strap section 7392 and the second hoop strap section 7393.

[0411] Now for reference Figure 26A and 26BThe link member 7394 can be adjusted to different lengths to change the length of the link member between the relative regions 7396 of the headband tube 3350. Increasing the length of the link member 7394 allows the positioning and stabilization structure 3300 to accommodate a large head. Conversely, decreasing the length of the link member 7394 allows the positioning and stabilization structure to accommodate a smaller head.

[0412] In some forms, the front hoop 7390 may include a fabric element. In alternative embodiments, the front hoop may be a single piece of fabric. (See also...) Figure 27B-1 and 27B-2 The linkage member 7394 may include first and second portions 7292, 7293 as fabric straps, and an adjustment mechanism disposed therebetween. The first and second portions may be connected together by the adjustment mechanism in the form of a locking mechanism 8400. (See reference...) Figure 27B-1 and 27B-2 The locking mechanism 8400 may include an opening through which first and second sections 7392, 7393 of the strap are inserted. The opening may be configured to secure the strap after its length has been adjusted. The diameter of the opening may be smaller than the diameter of the strap, such that friction holds the strap in place.

[0413] 8.3.3.3.9 Ring Insert

[0414] In some forms of this technology, the positioning and stabilizing structure 3300 includes one or more ring insert members configured to be fastened to another portion of the patient interface 3000, for example, directly or indirectly to the tube 3350. The one or more ring insert members are configured to be fixed such that they at least partially define a ring that surrounds a portion of the patient's head during use. The size of the ring can be adjusted to accommodate different sizes of patient heads by adjusting the size of the ring insert, or by replacing the ring insert with a ring insert of a different size.

[0415] One form of this technology is as follows: Figure 15 As shown. In this configuration, the patient interface 3000 includes a ring insert member 3410, which is connected to the underside of the tube 3350 and the connection port 3600, and is positioned in use between the patient's head and the tube 3350 and the connection port 3600. If the ring insert member is not present, the ring insert member 3410 is used to change the size of a ring surrounding a portion of the patient's head compared to the size of the ring formed by the tube 3350.

[0416] The ring insert 3410 is detachably attached to the tube 3350. Therefore, the ring insert 3410 is removed and replaced by one or more replaceable ring insert members 3411a, 3411b, or 3411c. The replaceable ring insert members 3411a, 3411b, or 3411c differ in size from the ring insert 3410, and by selecting the ring insert, the size of the ring used to encircle a portion of the patient's head can be adjusted, and thus the patient interface can be adapted to accommodate the patient more comfortably and safely. The ability to remove the ring insert members 3410 and 3411 is also advantageous, allowing them to be cleaned.

[0417] The ring insert can be formed of a rigid or semi-rigid material that allows the tube 3350 to be spaced from the patient's head during use, thereby altering the shape of the ring encircling the patient's head. Materials with some elasticity that provide greater comfort during wear, such as foam or gel materials, are also suitable. Since the ring insert comes into contact with the patient's hair or skin when worn, they are preferably made of materials that are easy to clean.

[0418] Figure 15 The ring insert members 3410 and 3411 shown are generally U-shaped, with the apex of the 'U' located on top of the patient's head below the connection port 3600 during use. This helps the patient interface conform to the shape of the top of the patient's head. In other embodiments, insert members of different shapes are used; for example, the insert member may include a short, straight pad configured to contact a small portion of the patient's head. Replacement insert members 3411 of different sizes may have different thicknesses, different lengths, and / or different degrees of curvature. The patient contact surface of each insert member may be identical or similar to conform to the shape of the patient's head, regardless of which insert member is used.

[0419] Ring insert members 3410 and 3411 are connected to tube 3350 via a fastening mechanism. In one embodiment, the fastening mechanism includes hook-and-loop material connected to the lower side of tube 3350 and the upper side of ring insert members 3410 and 3411. In other embodiments, ejectors, domes, latches, or magnets are used to connect ring insert members 3410 and 3411 to tube 3350.

[0420] exist Figure 15In one embodiment, the patient interface 3000 includes a single ring insert member 3410, and a replacement ring insert member 3411 is a single or integral component. In other embodiments, multiple ring insert members can be attached to the tube 3350 at any time. For example, multiple ring insert members can be attached along the length of the tube 3350 to serve as multiple spacers separating different portions of the patient's head from the tube 3350. In another embodiment, multiple ring insert members 3410 and replacement ring insert members 3411 can be mounted on the tube 3350 at any time. For example, ring insert members of different sizes can be nested. To achieve this, the ring insert members 3410 and 3411 can be connected to each other, for example, using any of the ring insert member connection mechanisms described above.

[0421] exist Figure 15 In another embodiment, a bag or pouch may be attached to one side of the tube 3350 or formed within the tube. The bag may be made of a preferably elastic material to allow the insertion member 3410 to be easily inserted into the bag, such as fabric or silicone. In this form, the insertion member 3410 may be made of a rigid material (e.g., Hytrel), with its distal end inserted into the bag. In this embodiment, the rigid material may be selectively inserted into the bag to adjust the overall elasticity of the positioning and stabilizing structure 3300. For example, a section of the tube 3350 may be stretchable, and the rigid insertion member 3410 may be used to maintain a predetermined amount of stretch within a portion of the tube 3350.

[0422] exist Figure 22 In another embodiment shown, the positioning and stabilizing structure 3300 may include an adjustment mechanism in the form of an insertion member 9410 used in conjunction with the stretchable tube 9350.

[0423] In this further embodiment, the insertion member 9410 forms part of a ring defined by a ring that passes over the top of the patient's head and includes a tube 9350 and a pad assembly 3150 (not shown). In use, the ring extends across the patient's cheek area and is arranged to contact the area of ​​the patient's head at the ear base point.

[0424] In some forms, the insert member 9410 may be made of a rigid material (e.g., Hytrel). The stretchable tube 9350 may include one or more stretchable sections 9355 formed of a stretchable material. A section of the tube may be made of a material (e.g., if made of a stretchable material), and its configuration (e.g., Figure 3A The accordion-style tube section 3362 shown is stretchable (either because its configuration is stretchable) or both.

[0425] In use, the stretchable section of tube 9355 can be positioned at the top of the patient's head. The stretchable section of tube 9355 can be connected to one or more relatively non-stretchable or less stretchable sections of tube 9354. In some forms, the stretchable section of tube 9355 and / or the relatively non-stretchable or less stretchable sections or thin stretchable sections of tubes 9354 and 9355 can be made of silicone. In some other forms, at least some sections of tube 9354 can be made of a fabric material (e.g., spandex). In some other forms, a combination of materials, such as silicone and fabric, can be used.

[0426] The insertion member 9410 can be fastened to the tube 9350 by at least one retaining member or a first fastening member 9357 mounted on the underside of the tube 9350 (e.g., on the outer surface of the tube 9355) on both sides of the stretchable section 9355. For example, a first fastening member 9357 can be mounted on either end (e.g., the left and right ends) of the stretchable section 9355 (e.g., near a relatively non-stretchable or less stretchable section 9354). When the positioning and stabilizing structure 3300 is used, the first fastening member 9357 may be exposed to the surrounding environment. A second fastening member 9358 may be mounted on both ends of the upper side of the insertion member 9410. The first and second fastening members 9357 and 9358 are configured to be connected together by any suitable mechanism, such as a hook and loop material. When installed on the first fastening member 9357, the insertion member 9410 may be exposed to the surrounding environment and may contact the upper area of ​​the patient's head (e.g., the insertion member 9410 may cover the frontal and / or parietal bones).

[0427] When the rigid insert member 9410 is connected, the stretchable section of the tube 9355 allows for variation in the actual length of the tube 9350. The size of the hoop surrounding a portion of the patient's head changes according to the length of the attached insert 9410, compared to the size of the hoop if the insert member were not present. The size of the hoop can be changed to accommodate different sizes of patient heads by adjusting the size of the insert, or by replacing the insert with one of a different size. Figure 22 In the illustrated embodiment, three insertion members 9410 of different lengths can be selectively fastened to the tube 9350. Each of the different lengths of the insertion members 9410 is marked with a size indication, for example, 'S' represents small (e.g., 9410a), 'M' represents medium (e.g., 9410b), and 'L' represents large (e.g., 9410c).

[0428] To attach the insert member 9410, a second fastening member 9358 at one end of the insert member 9410 can be connected to a first fastening member 9357 at one end of the stretchable segment 9355. The insert member 9410 may be longer than the distance between the first fastening members 9357 at the other end of the stretchable segment 9355. The patient may need to stretch the stretchable segment 9355 to align and connect the first fastening members 9357 and the second fastening members 9358. Once the two second fastening members 9358 are connected to the corresponding first fastening members 9357, the length of the stretchable segment 9355 increases (i.e., the length of the stretchable segment is greater than its length in the relaxed position). The total increase in length may depend on the specific insert member 9410 selected by the patient (e.g., small, medium, or large). The selected insert member 9410 may be positioned substantially symmetrically about the patient's sagittal plane.

[0429] Stretching the stretchable section 9355 before the positioning and stabilizing structure 3300 is worn by the patient can help improve patient comfort. For example, pre-stretching in the stretchable section 9355 (i.e., caused by the attachment insert 9410) can limit the friction experienced by the patient when the stretchable section 9355 pulls on the patient's hair and / or skin.

[0430] exist Figure 22 In some alternative forms of the example shown, the insertion member 9410 may be releasably secured within the tube 9350. In this example, the insertion member may be inserted into the tube through the central port 9602 and secured to the bottom wall (e.g., the inner wall) of the tube 9350 by a fastening member such as a hook-and-loop material (not shown). Thus, the insertion member 9410 is in use within the pressurized volume of the tube 9350 (e.g., as opposed to exposure to the surrounding environment). Figure 22 The insertion member 9410 can be attached to the tube 9350 in a manner substantially similar to that of the insertion member 9410 in FIG21 (e.g., the stretchable section 9355 can be pre-stretched before the positioning and stabilizing structure 3300 is worn by the patient).

[0431] exist Figure 16 In the illustrated form of the present technology, the patient interface 3000 includes an inflatable ring insert member 3420. The inflatable ring insert member 3420 may include a bladder disposed on the inner surface of the tube 3350. The bladder has a sealable opening into which air can be introduced or released to change the size of the bladder and thus adjust the size of the ring defined by the patient interface 3000, which surrounds a portion of the patient's head during use. In one embodiment, the patient interface includes a pump button that can be repeatedly pressed to introduce air into the bladder through a valve.

[0432] exist Figure 16In the illustrated configuration, the patient interface includes a single U-shaped bladder 3420, which is connected to each tube 3350 on either side and at the top of the patient's head. The thickness of the bladder 3420 may be greatest at the top of the patient's head to accommodate symmetrical movement of the tubes 3350 away from the surface of the patient's head during bladder inflation. In other embodiments, multiple inflatable bladders are mounted on the tubes 3350. These inflatable bladders may inflate together or individually. Individual inflatable bladders allow the patient to modify the fit of the patient interface as needed, for example, by inflating the bladder on one side of the head more than the bladder on the other side.

[0433] exist Figure 23A and 23B In another embodiment of the present technology shown, the patient interface 3000 includes an adjustment mechanism in the form of an inflatable portion 10420. The inflatable portion 10420 forms a ring defined by a ring that extends over the top of the patient's head and connects to the tube 3350 and the padding assembly 3150. In use, the ring extends across the patient's cheek area and is positioned to contact the area of ​​the patient's head at the ear base point.

[0434] In some forms, the inflatable portion 10420 is held by a retainer disposed on one side of the gas delivery tube 3350. In some forms, the retainer may be one or more fasteners (e.g., hook and ring material) secured to the tube 3350, wherein the inflatable portion 10420 is optionally coupled to the tube 3350. Fasteners may be provided at each end of the inflatable portion 10420 to secure the inflatable portion 10420 to the tube 3350. For example, fasteners may be disposed on the upper surface of the inflatable portion 10420 and may be attached to the lower surface of the gas delivery tube 3350. When a patient wears the patient interface 3000, the inflatable portion 10420 may contact the upper part of the patient's head (e.g., at a location covering the frontal and / or parietal bones). An alternative form of the retainer may include a ring (not shown) surrounding the tube 3350.

[0435] In an alternative form, the inflatable portion 10420 may be fixed to the tube 3350, for example, integrally formed with the tube.

[0436] In some forms, the patient interface 3000 may include multiple inflatable portions 10420. For example, the inflatable portions 10420 may be individually (e.g., detachably or integrally) connected to the gas delivery line 3350. Alternatively, the inflatable portions may be inflated independently or simultaneously.

[0437] The inner surface of tube 3350 may include one or more inflatable portions 10420 that contact the patient's head. These inflatable portions can adjust the position of the gas delivery tube on the patient's head and change the effective length (e.g., inner circumference) of the clamp. See also Figure 23AThe inflatable portion 10420 shown is in a deflated state, with the effective length of the hoop at its maximum to accommodate larger patient head sizes and shapes. See also Figure 23B The inflatable portion 10420 shown is in an inflated state, wherein the effective length of the ring is reduced (e.g., compared to the inflated state) to accommodate a smaller patient head size and shape. In other words, the inflated state of the inflatable portion 10420 forms a smaller inner periphery of the ring. The inflatable portion 10420 expands toward the center of the ring (e.g., toward the patient's head) and can contact the patient's head. The inflatable portion 10420 can be inflated by different amounts depending on the individual patient's head. Therefore, a patient with a smaller head may require more inflation of the inflatable portion 10420 than a patient with a larger head. Changing the effective length of the ring correspondingly changes the force vector applied to the patient's head by the positioning and stabilizing structure 3300. Changing the effective length of the ring can also change the tension experienced by the patient from the gas delivery tube 3350. In other words, moving the inflatable portion 10420 to the inflated state can provide a closer contact between the inflatable portion 10420 and the patient's head to limit translation along the patient's head (e.g., in the anteroposterior direction).

[0438] In some forms of this technology, the air volume in the inflatable portion 10420 can be controlled by the patient. For example, a valve can be provided to the inflatable portion 10420, allowing the patient to supply air to inflate or deflate it. Advantageously, allowing the patient to control the air volume in the inflatable portion provides a sense of control. The patient can wear the patient interface 3000 and subsequently adjust the air volume in the inflatable portion 10420 so that it is neither too tight nor too loose relative to the patient's head.

[0439] In some alternative forms, the inflatable section 10420 can be inflated by an automatic device. This automatic device may include the inflatable section and incorporate a pressure gauge and one or more sensors capable of detecting the inflation pressure of the inflatable section. Figure 24 As shown, the patient can activate system 10500, and the controller can retrieve stored pressure values ​​10505. Sensors can monitor the pressure in the inflatable section 10510 and can communicate with controller 10515 to control when to open and close valves and adjust the pressure in the inflatable section 10520.

[0440] In some configurations, the patient can wear a patient interface 3000, and the inflatable section 10420 can be inflated until the patient indicates that the pressure within the inflatable section 10420 is comfortable. The controller can store setting valves and inflate the inflatable section 10420 to the same level each time it is used consecutively by comparing the stored pressure valves with the pressure measured by the sensors.

[0441] In some forms, the sensor may be a light sensor and / or a position sensor, and may detect the proximity between the patient’s head and the inflatable part 10420 in order to determine how much air should enter the inflatable part 10420.

[0442] In some configurations, pressurized breathable gas flow from the RPT device 4000 can be diverted to the inflatable section 10420. The inflatable section 10420 may include a conduit 10424, which may be directly connected to the RPT device 4000 or connected to a gas delivery line 3350. An inlet valve (e.g., automatically or manually adjustable) may selectively allow pressurized breathable gas into the inflatable section 10420. An outlet valve may be selectively actuated to release air from the inflatable section 10420.

[0443] like Figure 24 As shown, another embodiment of the alternative form includes one or more sensors capable of detecting the occurrence of apnea 10525. Upon detection of apnea 10525 by the sensors, the inflatable portion 10420 can automatically adjust 10530 its inflation level to change the effective length of the loop. Changing the effective length of the loop during apnea optimizes the direction and magnitude of the force applied to the positioning and stabilizing structure 3300 and re-establishes a firm fit and effective seal for the patient. The changed loop length can reduce the occurrence of further apnea, and the controller can store a new set pressure value 10535 for the patient. The system can compare this new value 10515 with the currently sensed pressure 10510 in the inflatable portion 10420. The system can then make further pressure adjustments 10520 (e.g., if the values ​​are not equal) or continue sensing apnea 10525 (e.g., if the values ​​are equal).

[0444] The inflatable part 10420 may be made of fabric material. In some forms, the inflatable part 10420 may be made of silicone. In some other forms, a combination of materials such as fabric and silicone may be used together to form the inflatable part.

[0445] 8.3.3.3.10 Adjustment range of headband tube size

[0446] As previously described, the positioning and stabilizing structure 3300 can be configured such that the upper portion of the headband tube 3350 is positioned differently for different patients when worn. For example, the position of the connecting port 3600 on the patient's head during use can vary within a range of forward / backward positions in the sagittal plane. If the upper portion of the headband tube 3350 is worn further forward, the circumference of the headband tube 3350 fitting around the patient's head can be smaller compared to if the headband tube 3350 is worn further backward. In some forms, the positioning and stabilizing structure 3300 allows patients with larger head sizes to wear the upper portion of the headband at a more forward (e.g., anterior) position on their head, thereby reducing the size of the length adjustment required by the adjustment mechanism 3360 to accommodate larger head sizes.

[0447] Figure 3J Three depictions of patient interfaces 3000a, 3000b, and 3000c according to one form of the present technology are shown. For comparison, each depiction of patient interface 3000 is shown in a different position on the patient's head. Patient interface 3000b is shown in a solid line in the center position, while patient interfaces 3000a and 3000c are shown in dashed lines and worn forward and backward, respectively. Figure 3J In the diagrams, the adjustment mechanism 3360 has a substantially uniform length. That is, the adjustment mechanism 3360 does not extend or retract between the depictions labeled "a", "b", and "c". Although the length of the adjustment mechanism 3360 remains unchanged, the patient interface 3000a (forward position) can be fitted onto a larger head (shown in dashed lines) because it is worn forward. Similarly, the patient interface 3000c (rearward position) can be appropriately fitted onto a smaller head (shown in dashed lines) with the same length of the adjustment mechanism 3360.

[0448] exist Figure 3J In one depiction, identified by the reference numeral "b", a patient wears a headband in a central position, with the adjustment mechanism 3360b and the connection port 3600b aligned substantially perpendicularly (e.g., parallel to or coplanar with the coronal plane). The connection port 3600b is located at the center of the anterior-posterior axis. That is, the connection port 3600b is located in a central position, rather than in a substantially forward (e.g., anterior) or substantially backward (e.g., posterior) position. The connection port 3600b is approximately located at the apex of the patient's head. The connection port 3600b can be positioned in the sagittal plane and aligned with a supraauricular base point in a plane parallel to the coronal plane. Figure 2D The base point on the ear is marked in the middle.

[0449] exist Figure 3JIn another depiction, identified by the reference numeral "a", the patient wears the headband tube 3350a in a position relatively forward compared to the position of the headband tube 3350b (e.g., in front of the coronal plane and tilted relative to the coronal plane). In this configuration, the connection port 3600a is typically located in front of the adjustment mechanism 3360a. In this position, the connection port 3600a is in front of the supraacular base point. Figure 3J In another depiction, identified by the reference numeral "c", the patient wears the headband tube 3350c in a position relatively rearward compared to the position of the headband tube 3350b (e.g., behind the coronal plane and tilted relative to the coronal plane). In this configuration, the connection port 3600c is typically located behind the adjustment mechanism 3360c. In this position, the connection port 3600c is located behind the supraaural base point.

[0450] When worn Figure 3J When the headband 3300a is in the position shown, the headband tube 3350a will typically fit around the smaller circumference of the patient's head, allowing the positioning and stabilizing structure 3300 to be worn in a relatively forward position to accommodate patients with larger heads (shown in dashed lines). Similarly, when worn in a position... Figure 3J When positioned as depicted in the positioning and stabilizing structure 3300c, the headband tube 3350c will generally conform to the larger circumference of the patient's head, allowing the positioning and stabilizing structure 3300 to be worn in a relatively rearward position to accommodate patients with smaller heads (shown in dashed lines). The positioning and stabilizing structure 3300 can be worn in a continuous range of positions between a generally forward position and a generally rearward position, depending on factors such as the patient's head size, head shape, and personal preference. In some forms of this technology, the positioning and stabilizing structure 3300 is configured to be worn such that the connecting port 3600 is positioned in use at the top point of the head (e.g., in the coronal plane) approximately 20 mm forward (e.g., anterior) and approximately 20 mm rearward (e.g., posterior) in the central position. In some forms of this technology, the upper portion of the headband tube 3350 (e.g., the portion above the posterior bandage 3310) is configured to flex, bend, and move substantially in a forward or backward direction without corresponding movement in the lower portion or the non-adjustable tube segment 3363 (e.g., the portion below the posterior bandage 3310). In other forms of this technology, the upper and lower portions may move together (although not necessarily to the same extent). The posterior bandage 3310 may be configured to prevent or resist movement of the non-adjustable tube segment 3363. For example, by moving the upper portion of the headband tube 3350 forward over the patient's head without loosening the posterior bandage 3310, more movement of the upper portion of the headband tube 3350 may be required compared to the non-adjustable tube segment 3363.

[0451] Independent of the ability of the positioning and stabilizing structure 3300 to be worn in different forward / backward positions, in some forms of the present invention, the headband tube adjustment mechanism 3360 enables the positioning and stabilizing structure 3300 to adapt to different head sizes. The headband tube adjustment mechanism 3360 can be configured to provide a predetermined amount of length adjustment to the headband tube 3350. The amount of adjustment to the length of the headband tube 3350 can be determined at least in part based on the range of head sizes to which the positioning and stabilizing structure 3300 is configured to be adapted. In some forms of the present invention, the adjustment mechanism 3360 can increase the length of the headband tube 3350 on either side of the positioning and stabilizing structure 3300 by an amount between approximately 10 mm and approximately 50 mm, including the endpoints. In some forms of the present invention, the increase in length can be an amount between approximately 20 mm and approximately 40 mm on either side, including the endpoints. In some forms of the present invention, the provided increase in length can be any one of approximately 25 mm, approximately 30 mm, approximately 35 mm, or approximately 40 mm on either side.

[0452] Figure 3K A patient interface 3000 with a positioning and stabilization structure 3300 is shown, which includes a headband tube 3350 and a headband tube adjustment mechanism in a first configuration identified by reference numeral 3360. The adjustment mechanism 3360 is also shown in dashed lines in a second configuration and identified by reference numeral 3360'. In the first configuration of the adjustment mechanism 3360, the headband 3300 adapts to a head of one size, and in the second configuration of the adjustment mechanism 3360', the headband 3300 adapts to a patient with a larger head. In this form of the technology, the adjustment mechanism 3360' allows the length of the headband tube 3350 to be extended to adapt to a larger head. Figure 3K As shown, the adjustment mechanism 3360 / 3360' enables the headband to be adjusted (or adjusted) to accommodate different head sizes while being worn in a centered position (e.g., the connection port 3600 / 3600' is centered at the apex of the head in the coronal plane, rather than forward or backward in the coronal plane).

[0453] In some forms of this technology, the adjustment mechanism 3360 can also adjust the length of the headband tube 3350 when the headband 3300 is worn in a forward, middle, and / or backward position. Figure 3LA patient interface 3000 with a headband 3300 in three positions worn on a patient's head is shown, as indicated by reference numerals with suffixes "a", "b", and "c". Positioning and stabilizing structure 3300a is worn in the forward position, positioning and stabilizing structure 3300b in the middle position, and positioning and stabilizing structure 3300c in the rearward position. That is, connection port 3600a is in the forward position on the patient's head, while connection port 3600b is in the middle position and connection port 3600c is in the rearward position. In the forward position, the headband tube 3350a fits around a smaller circumference of the patient's head compared to the circumference fitted by the headband tube 3350b in the middle position. To accommodate this smaller circumference, adjustment mechanism 3360a in the forward position provides a reduction (or a slight extension) in the length of the headband tube 3350. In the rearward position, the circumference of the headband tube 3350c around the patient's head it fits is larger than the circumference in the middle position. To accommodate the larger circumference, the adjustment mechanism 3360c provides an increase in the length of the headband tubes 3350 compared to their length at the center position.

[0454] The combination of different positions of the positioning and stabilizing structure 3300 and different length adjustments provided by the adjustment mechanism 3360 offers versatility in terms of adjustment options available to the patient. This versatility allows for a wide range of head shapes and sizes to be accommodated by the positioning and stabilizing structure 3300 without excessive discomfort, while simultaneously enabling the sealing structure 3150 to provide a adequate seal to the patient's face. In some embodiments, the adjustment mechanism 3360 provides a smaller range of length adjustments because patients with larger head sizes can wear the upper part of the headband tube 3350 in a forward position, rather than relying solely on the adjustment mechanism 3360 to accommodate their larger head size. In other embodiments, the adjustment mechanism 3360 provides a larger range of length adjustments, and the ability of patients with larger head sizes to wear the upper part of the headband tube 3350 further forward means that the patient interface 3000 can be adapted to a wide range of head sizes.

[0455] 8.3.3.4 Position of the headband adjustment mechanism

[0456] Patient interface features that typically cause discomfort are avoided. Therefore, patient interfaces can be designed with minimal contact with the patient's skin, and these contact areas can be soft and / or smooth. The cheek area is known to be a source of discomfort for patients when wearing a patient interface.

[0457] Mechanisms that allow for adjustment of positioning and stabilization structures, such as those described above, may include features that would cause discomfort to the patient if in contact with the patient's face or head, particularly the cheek area. Therefore, some forms of this technology include positioning and stabilization structures configured such that, when the patient interface is worn, the adjustment mechanism or its components are positioned to avoid contact with areas of the patient's skin or hair, such as the patient's face, like the cheek area. In some forms of this technology, the adjustment mechanism is positioned above the patient's ears, i.e., above the supraaural base point above the patient's head or close to the top of the patient's head. In these forms of the technology, the headband tube includes a non-adjustable headband tube segment positioned adjacent to the patient's face during use, i.e., at a location where the non-adjustable headband tube segment might come into contact with the patient's face during use of the patient interface. For example, in some forms, the non-adjustable headband tube segment is positioned adjacent to the patient's cheek area when worn, and in some forms of this technology, only the non-adjustable headband tube segment is adjacent to the patient's cheek area, below the supraaural base point of the patient's head, or covering the maxillary region of the patient's head.

[0458] It is understood that a non-adjustable headband tube section is a section that is not specifically configured to be dimensionally adjustable during use; that is, the adjustment mechanism does not form part of the non-adjustable headband tube section. However, this does not preclude the non-adjustable headband tube section from being dimensionally adjustable, for example, if excessive force is applied to it. However, the position of the non-adjustable headband tube section can be adjusted during use. In some forms of this technology, the non-adjustable headband tube section may be substantially non-adjustable in its axial length, but can be adjusted in other ways, such as by deflection, bending, straightening, etc. For example, as... Figure 3L As shown, the non-adjustable headband tube sections 3363a, 3363b and 3363c are configured to bend or curve to different degrees to facilitate positioning and stabilizing the structure 3300 when worn on the head at different positions, and the adjustment mechanisms 3360a, 3360b and 3360c provide different amounts of extension.

[0459] Positioning the device outside the patient's field of vision can also help avoid claustrophobic feelings or interrupted vision.

[0460] exist Figure 3A , 3B In the case of the patient interface 3000 shown in 3C, 3D, 3E, and 3F, for example, an accordion-style segment 3362 is positioned on either side of the patient's head, between the ear or ear level and the top or crown of the head, and a non-adjustable headband tube segment 3363 is positioned adjacent to (or on) the patient's cheek area when worn, the non-adjustable headband tube segment forming the lower end of the headband tube (i.e., the lower end when worn by the patient). Figure 5, 7A Examples of non-adjustable headband tube sections 3363 are shown in 7B, 7C and 17.

[0461] In some forms of this technology, the non-adjustable headband tube segments 3363 are configured such that they help maintain a sufficient seal between the padding assembly 3150 and the patient's face during use of the patient interface 3000. This may require selecting the flexibility (or rigidity) of the non-adjustable headband tube segments 3363 such that they are rigid enough not to deform too easily during use, while being flexible enough to accommodate some movement during use and some changes in the position of the individual patient wearing the patient interface 3000.

[0462] The rear headband strap 3310 stabilizes the headband tube 3350 on the patient's head, but the lower end of the headband tube 3350 is allowed more freedom of movement, particularly at points relatively far from where the rear headband strap 3310 connects to the headband tube 3350. This excessively flexible lower end of the headband tube 3350 tends to allow the padding assembly 3150 to roll forward away from the patient's face, disrupting the seal. This forward rolling effect can be mitigated by increasing the stiffness of the lower end of the headband tube 3350, which is the... Figure 3A , 3B The non-adjustable headband tube segment 3363 is shown in the technical forms of 3C, 3D, 3E, 3F, 5, 7A, 7B, 7C, and 17. For the purposes of this discussion, the lower end of the headband tube 3350 can be considered as a portion of the headband tube 3350 located at a point on the rear (i.e., at the rear when the patient wears the patient interface 300), where the rear headband strap 3310 connects to each headband tube 3350, because this point is stable on the patient's head and therefore can tend to act as a pivot point for any movement of the headband tube 3350 below this point. It is understood that other arrangements of the headband strap can lead to different locations of the effective pivot point.

[0463] For similar reasons, in some forms of this technology, it may be advantageous to have no adjustment mechanism at the lower end of the headband tube 3350. For example, positioning an accordion-style segment on the headband tube 3350 at the point where the rear headband strap 3310 connects to the headband tube 3350 means that the accordion-style segment tends to bend and twist in the event of movement and acts as a natural pivot, allowing movement of the padding assembly, which could compromise the seal with the patient's face.

[0464] Furthermore, the adjustment mechanism 3360 on the upper part of the headband tube 3350 (for the purposes of this discussion, this adjustment mechanism is considered to be the upper part of the headband tube 3350 (i.e., above the point where the rear headband strap 3310 connects to each headband tube 3350) helps to separate the upper and lower parts of the headband tube 3350, so that movement of the upper part (during use or due to changes in the positioning of the patient interface 3000 on the patient's head) does not exert an effect on the padding assembly 3150 that could disrupt the seal with the patient's face. Excessive force. In particular, the adjustment mechanism 3360, in which the length of the headband tube 3350 can extend, helps to prevent straightening of the non-adjustable headband tube segment 3363 in the lower end of the headband tube 3350, because this adjustment mechanism 3360 allows the lower end of the patient interface 3000 to move up and down relative to the patient's head (i.e., in the downward and upward directions). Excessive straightening and / or stretching of the non-adjustable headband tube segment 3363 may also cause the padding assembly 3150 to roll forward, compromising the seal against the patient's face.

[0465] In some forms of this technology, the radius of curvature of the non-adjustable headband tube section 3363 (or the lower end of the headband tube 3350) also affects the degree of movement of the upper end of the headband tube 3350. The larger the radius of curvature, the greater the decoupling effect between the upper and lower ends of the headband tube 3350, so that the upper end of the headband tube 3350 can move without causing significant forward rolling to the liner assembly 3150 and thus resulting in a loss of seal.

[0466] In some forms of this technology, providing an adjustment mechanism 3360 on the upper part of the headband tube 3350 near the connection port 3600 can help reduce tube resistance on the head, as it allows the connection to be decoupled by the stretching and bending provided by the adjustment mechanism.

[0467] In some forms of this technology, providing an adjustment mechanism 3360 at the upper part of the headband tube 3350, away from the padding assembly 3150, can reduce the impact on the padding assembly 3150 caused by differences in the extension of the headband tube 3350. For example, the effects of uneven extension of the adjustment mechanism 3360 on either side of the patient's head and / or any forces applied by the adjustment mechanism may be less noticeable. This effect could compromise the seal formed by the padding assembly 3150 on the patient's face.

[0468] In other forms of this technology, the adjustment mechanism may be positioned close to the pad assembly 3150 of the patient interface and spaced apart from the patient’s face by means of the size of the inflation chamber and the position of the port of tube 3350 connected to the inflation chamber, thereby separating the lower end of tube 3350 (and thus the adjustment mechanism) from the patient’s skin. Figure 10B The form of this technology shown is an example of a patient interface 3000, in which the adjustment mechanism is spaced apart from the patient's face during use.

[0469] 8.3.3.5 Head-mounted tube offset mechanism

[0470] In some forms of this technology, the positioning and stabilizing structure 3300 includes a biasing mechanism that, during use, pushes the seal-forming structure 3100 toward the patient's face, i.e., toward the area surrounding the entrance to the patient's airway to which the seal-forming structure 3100 seals. Thus, the biasing mechanism helps the seal-forming structure 3100 provide a good seal with the patient's face during use of the patient interface 3000 and promotes seal retention when the patient interface supplies gas to the patient under positive pressure. In some forms of this technology, the biasing mechanism acts (i.e., imparts a biasing force) on the adjusting mechanism 3360. When the inflation chamber 3200 is pressurized, the liner assembly 3150 of the patient interface 3000 tends to move away from the patient's face. The biasing mechanism for biasing or pushing the liner assembly 3150 toward the patient's face counteracts this tendency to maintain the seal.

[0471] In some forms of this technology, a biasing mechanism is used to apply a biasing force along at least a portion of the length of the headband tube 3350 to push a sealing formation structure toward the inlet of the patient's airway during use. In this form, the headband tube 3350 or a component thereof is in a tensioned state during use. In some forms, the biasing mechanism is included as part of the headband tube 3350, while in other forms, the biasing mechanism is separate from the headband tube 3350.

[0472] The biasing mechanism can also help automatically adjust the patient interface to fit the head of a specific patient.

[0473] 8.3.3.5.1 Magnitude of the force applied by the biasing mechanism

[0474] 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. Excessive force may cause the seal-forming structure 3100 to compress and its geometry to change, causing some portions of the structure to move away from the patient's face and gas to leak from the seal-forming structure. Furthermore, avoiding excessive force on the patient's face from the patient interface promotes comfort and prevents red marks, abrasions, or sweating on the patient's face.

[0475] In some forms of this technology, the acceptable force provided by the biasing mechanism can range from about 0.5 N to about 4 N on each side of the positioning and stabilizing structure 3300. In some forms, the acceptable force can range from about 1 N to about 3.5 N. In some forms, a force of about 2 N can be considered acceptable. In some forms of this technology, the positioning and stabilizing structure 3300 is configured to support a sealing forming structure 3100 in the form of a full-face or nostril liner assembly (e.g., as...). Figures 4A-4E The sealing structure 3100 shown is illustrated. In some forms of this technology, the full-face ororonasal sealing structure 3100 is heavier than other forms of sealing structures (e.g., nose pads or nasal pillows) due to its larger size, and the positioning and stabilizing structure 3300 is configured to provide a correspondingly greater biasing force to offset the weight of the heavier sealing structure 3100 or counteract its resistance, while still using sufficient force to advance the pad assembly 3150 into the patient's face to maintain an effective seal without causing excessive discomfort. Additionally, the full-face ororonasal sealing structure 3100 may be subjected to downward (e.g., down) forces when the patient relaxes or moves their jaw (which may be referred to as "jaw drooping"). The positioning and stabilizing structure 3100 may also be configured to counteract the effects of jaw drooping by counteracting the downward forces received during jaw drooping.

[0476] In some forms of this technology, the positioning and stabilizing structure 3300 is configured to interchangeably receive seal-forming structures of different sizes, including relatively small or lighter seal-forming structures, such as nose pad assemblies, and relatively large or heavier seal-forming structures, such as oronasal pad assemblies. The positioning and stabilizing structure may include a biasing mechanism configured to support both types of seal-forming structures by providing a sufficiently strong biasing force to either type, but not excessively so as to cause discomfort.

[0477] In some forms of this technology, the positioning and stabilizing structure 3300 is configured to provide a sufficient range of force magnitudes in multiple adjustment configurations to maintain an effective seal of the nose pad or full face mask without being so great as to cause discomfort.

[0478] In some forms of this technology, a biasing mechanism is configured to apply a force to the headband tube 3350 or a portion thereof, causing the headband tube to conform to the patient's head. The biasing mechanism can be configured to provide a force within a predetermined range. This predetermined range can be limited to a size in which the headband 3300 is both comfortable and maintains a sufficient seal of the sealing structure 3100 against the patient's face. The biasing mechanism can be configured to push the sealing structure 3100 into sealed contact with the patient's face with a force not less than the minimum force required for a sufficient seal. That is, this force can be equal to or greater than the minimum sealing force. The biasing mechanism can also be configured to push the headband tube 3350 to conform to the patient's head with a force not greater than the maximum force that the patient finds comfortable. That is, this force can be less than or equal to the maximum comfortable force.

[0479] In some forms of this technology, each headband tube 3350 includes a force-extension characteristic resulting from the relationship between the extension of the headband tube 3350 and the force applied to the headband tube 3350 by the biasing mechanism. Alternatively or additionally, the force-extension characteristic may be generated by the relationship between the force applied to the headband tube 3350 by the biasing mechanism and the extension of the headband tube 3350. It should be understood that "extension" refers to a change in the total length of the headband tube and does not imply any particular manner in which the change in the total length of the headband tube 3350 occurs or the physical structure of the adjustment mechanism.

[0480] In some forms of this technology, the biasing mechanism may provide a biasing force on the headband tube 3350, which tends to return the headband tube 3350 or a portion thereof to a predetermined length, such as the length before adjustment by the adjusting mechanism. In some forms of this technology, the biasing mechanism applies a restoring force on the headband tube 3350.

[0481] As described above, the adjustment mechanism 3360 of some forms of the patient interface 3000 according to the present technology allows adjustment of the length of the headband tube 3350. In some embodiments, such as when there is a relationship between the biasing force and the extension of the headband tube 3350, a first extension of the headband tube 3350 (e.g., to a first extension length) results in a force provided by the biasing mechanism equal to or greater than the minimum sealing force. Additionally, a second extension of the headband tube 3350 (e.g., to a second extension length) may result in a force provided by the biasing mechanism less than or equal to the maximum comfort force. Furthermore, the extension amount between the first and second extensions may result in a force applied by the biasing mechanism between the minimum sealing force and the maximum comfort force.

[0482] In some forms of this technology, the headband tube 3350 may include a force-extension feature, wherein when the headband tube 3350 is adjusted to a first extension amount (e.g., an extension amount to which the biasing mechanism provides at least a minimum sealing force), the positioning and stabilizing structure 3300 adapts to a predetermined minimum head size. Similarly, when the headband tube 3350 is adjusted to a second extension amount (e.g., an extension amount not exceeding the maximum comfort force exerted by the biasing mechanism), the positioning and stabilizing structure 3300 adapts to a predetermined maximum head size. At the extension between the first and second extension amounts, the positioning and stabilizing structure 3300 adapts to a head size between the minimum and maximum predetermined head sizes. The predetermined minimum head size may be, for example, a 5th percentile head size, and the predetermined maximum head size may be, for example, a 95th percentile head size for a particular category of people. It should be understood that other measurements / ranges may be used to determine the minimum and maximum head sizes accommodated by the positioning and stabilizing structure 3300.

[0483] Figure 3I A force-extension curve 6000 is shown illustrating the force-extension characteristics 6300 of a headband tube 3350 of a patient interface 3000 according to one form of the present technology. The force-extension curve 6000 includes a horizontal extension axis 6100 and a vertical force axis 6200 to show the relationship between the length of the headband tube 3350 and the resultant force applied by the biasing mechanism.

[0484] Three extensions of the headband tube 3350 are shown on the extension shaft 6100: zero extension 6105, a first extension 6110 corresponding to the extension required to accommodate the 5th percentile head size (e.g., a predetermined minimum head size), and a second extension 6120 corresponding to the extension required to accommodate the 95th percentile head size (e.g., a predetermined maximum head size). Two force values ​​are shown on the force shaft 6200: minimum sealing force 6210 and maximum comfort force 6220.

[0485] In this exemplary form of the technology, the headband tube 3350 includes a force-extension feature 6300, wherein, within the extension range between a first extension amount 6110 and a second extension amount 6120, the force applied by the biasing device is greater than a minimum sealing force 6210 and less than a maximum comfort force 6220. That is, sufficient sealing can be maintained without causing discomfort due to excessive biasing force throughout the entire range of accommodated head sizes.

[0486] It should be understood that in some forms of this technology, the relationship between the extension force and the bias force may not be directly proportional. For example, in some forms of this technology, the force may increase relatively significantly during the initial stage of extension, but the force may change only slightly or not at all within the extension range required to accommodate the minimum and maximum predetermined head sizes. If the magnitude of the force remains between the minimum sealing force and the maximum comfort force within the extension range between the minimum and maximum head sizes, an effective seal can be achieved without discomfort, regardless of how the force varies within its limits.

[0487] 8.3.3.5.2 Position of the bias mechanism

[0488] In some forms of this technology, a biasing mechanism acts between the sealing structure 3100 and the connection port 3600. For example, the biasing mechanism includes a component of a patient interface connected between the sealing structure 3100 and the connection port 3600, and can push the sealing structure 3100 generally in the direction of the connection port 3600 and / or longitudinally along the length of the tube 3350.

[0489] 8.3.3.5.3 Offset Mechanism Forms

[0490] The biasing mechanism can take many forms. In some forms of this technology, the biasing mechanism is a separate mechanism from the adjustment mechanism, capable of adjusting the positioning and stabilizing structure, such as those described above. In this form, the adjustment mechanism allows the patient interface to be adjusted to fit the patient's head, while the biasing mechanism is used to press the seal 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 aforementioned adjustment and biasing are different functions performed by said same features.

[0491] In some forms of this technology, the biasing mechanism includes an elastic or resilient member or assembly. In some forms, the elastic or resilient member or assembly is connected between the sealing forming structure 3100 and the connection port 3600, for example, it is included as part of or connected to the tube 3350 or the connection assembly between the tube 3350 and the inflation chamber 3200 and / or the connection assembly between the tube 3350 and the connection port 3600.

[0492] For example, in Figure 3A , 3B In the technical forms shown in 3C, 3D, and 3E, the biasing mechanism includes accordion-style tube sections 3362. The accordion-style tube sections 3362 are configured such that they are biased to a compressed position. Therefore, the accordion-style tube sections 3362 are used to pull the sealing structure 3100 into the patient's face during use.

[0493] In some forms of this technology, there is a relationship between the extension of the accordion-style tube section 3362 and the restoring force applied to the headband tube 3350. The restoring force can be the tension in the accordion-style tube section 3362. The accordion-style tube section 3362 can have a relationship with respect to... Figure 3I The force-extension characteristic discussed is similar to the force-extension characteristic.

[0494] The accordion-style tube segment 3362 can be designed to extend to a first extension amount, wherein the positioning and stabilizing structure 3300 can accommodate a predetermined minimum head size (e.g., a 5th percentile head size), and to a second extension amount, wherein the positioning and stabilizing structure 3300 can accommodate a predetermined maximum head size (e.g., a 95th percentile head size). The accordion-style tube segment 3362 can be designed such that, at the first extension amount, the tension is greater than the minimum force required to produce a proper seal between the seal-forming structure 3100 and the patient's face. At the second extension amount, the accordion-style tube segment 3362 can be designed such that the tension does not exceed the maximum force that the patient finds comfortable. In this way, the positioning and stabilizing structure 3300 can accommodate a range of head sizes, producing a sufficient seal throughout without causing discomfort due to excessive force.

[0495] In some forms of this technology, the accordion-shaped tube segment 3362 may include an accordion-shaped profile that provides the accordion-shaped tube segment 3362 with the force extension characteristics described above. For example... Figure 3G As shown, the accordion-shaped tube segment 3362 may include a wall with an accordion-shaped profile having a repeating wavy pattern with rounded inner valleys and flat outer peaks. The flat outer peaks provide a smooth, flat surface that can comfortably rest against the patient's head. The accordion-shaped tube segment 3362 may include multiple ribs formed in the wall of the headband tube 3350 to form an accordion shape. The ribs may extend inward, such as... Figure 3G As shown. Alternatively or additionally, the accordion-style tube portion 3362 may include a plurality of grooves.

[0496] The profile of the accordion-shaped tube section 3362 can be varied to achieve desired force-elongation characteristics. For example, the rib pitch (e.g., the peak / valley of the accordion waveform) can be reduced to provide a more elongated accordion-shaped tube section 3362 (e.g., generally more elongated for a given amount of force). Furthermore, the rib height (e.g., the amplitude of the accordion waveform) can be increased to provide a more elongated accordion-shaped tube section 3362. Alternatively, a less elongated accordion-shaped tube section 3362 can be produced by increasing the rib pitch or by decreasing the rib height.

[0497] Alternatively or additionally, a longer accordion-style tube portion 3362 may be provided to increase extensibility. This can be provided, for example, by increasing the number of ribs formed in the wall of the accordion-style tube portion 3362.

[0498] Alternatively or alternatively, the wall thickness of the accordion-style tube portion 3362 may be reduced to provide a more extendable accordion-style tube portion 3362, or increased to provide a stiffer accordion-style tube portion 3362.

[0499] Alternatively or concurrently, the material forming the accordion-style tube portion 3362 may be selected to help provide the predetermined force-elongation properties. In one form of this technology, the material is silicone with a hardness of 50. Other materials and / or hardness values ​​may also be selected, such as silicone with a hardness of 40.

[0500] Alternatively, different accordion-shaped profiles can be provided to the accordion-shaped tube portion 3362 to achieve different amounts of extension. For example, an accordion-shaped tube portion 3362 in which the walls defining the profile are folded together more generally can produce a more extendable accordion-shaped tube portion 3362.

[0501] The construction of the accordion-style tube section 3362 can vary along its length. In some forms of this technology, for example... Figure 3G In the form shown, the rib height decreases along the length of the accordion-style tube section 3362 in a direction away from the connection port 3600 (e.g., toward the non-adjustable headband tube section 3363). The rib height can vary, for example, between approximately 0 mm and approximately 6 mm, approximately 0 mm and approximately 5 mm, approximately 0 mm and approximately 4 mm, approximately 1 mm and approximately 5 mm, etc. Alternatively, the rib height can be constant and can be, for example, approximately 2 mm, approximately 3 mm, approximately 4 mm, etc. The wall thickness can be substantially constant along the length of the accordion-style tube section 3362, or it can vary. In some forms of this technology, the wall thickness can be between approximately 0.5 mm and approximately 1.2 mm. In some forms, the wall thickness can be between approximately 0.6 mm and approximately 1 mm. In some forms, the wall thickness can be approximately 0.8 mm or any other similar value. In some forms, the rib spacing can be between approximately 3.5 mm and approximately 5 mm. In some forms, the rib spacing can be between approximately 3.8 mm and approximately 4.5 mm. In some forms, the rib spacing can be approximately 4.2 mm or any similar value.

[0502] In other forms of this technology, the shape and configuration of the accordion-style tube portion 3362 differ from those parameters mentioned above by way of example.

[0503] exist Figure 13In the illustrated embodiment, the relatively stretchable portion of tube 3355 is elastic or elastically deformable and tends to return to its unstretched state. Therefore, in use, the relatively stretchable portion of tube 3355 is used to pull the sealing structure 3100 into the patient's face. Alternatively, tube 3350 can be formed entirely of an elastic material that tends to return to its unstretched state upon stretching.

[0504] Another form of this technology is as follows: Figure 17 As shown. In this form, the patient interface 3000 includes one or more resilient sleeves 3340 covering the tube 3350. It is understood that the resilient sleeve 3340 may partially cover the tube 3350, for example, an opening may be present in the sleeve 3340, as will be described below. Alternatively, the headband tube may be considered to include a resilient sleeve and an internal gas delivery conduit, wherein the resilient sleeve covers the internal gas delivery conduit. The resilient sleeve 3340 may be formed of any elastic, resilient, or stretchable material, such as elastic fabric, like elastane, which tends to return to its natural size and shape when stretched.

[0505] The resilient sleeve 3340 covers the tube 3350, each tube including an accordion-style tube section 3362. The accordion-style tube section 3362 may or may not be biased to a compressed position. The accordion-style tube section 3362 allows adjustment of the length of the tube 3350 so that the patient interface 3000 can be adapted to a single patient, while the resilient sleeve 3340 is used to pull the sealing formation 3100 of the pad assembly 3150 into the patient's face to enhance the seal.

[0506] The elastic sleeve 3340 may comprise a single elastic material sheet or may be formed from multiple elastic material sheets joined together, for example, by suturing or gluing them together. Alternatively, the patient interface 3000 may comprise multiple separate elastic sleeves, for example, one sleeve may cover each tube 3350.

[0507] The elastic sleeve 3340 may include an opening to allow 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 which a rear headband strap 3310 is connected to the tube 3350. Additionally or alternatively, the sleeve may include a top opening 3343 through which an air circuit 4170 is connected to a connection port 3600, or the connection port 3600 may protrude through the top opening. The headband tube 3350 may contact the patient's head through the opening 3342.

[0508] If the accordion-style tube segment 3362 of tube 3350 comes into contact with the skin or hair during use, it may be uncomfortable for the patient. The patient may also find the accordion-style segment unsightly, or may experience discomfort even if the accordion style does not actually cause additional discomfort, both of which are undesirable. Covering the accordion-style segment 3362 with an elastic sleeve 3340 avoids these problems. In some embodiments, a non-elastic sleeve may be used to provide the advantage of comfort. The sleeve may advantageously be formed of a soft material that will not cause discomfort if it comes into contact with the patient.

[0509] Because the flexible sleeve 3340 may come into contact with the patient's hair or skin during use, it may be easily soiled by the patient's natural oils. Therefore, the flexible sleeve 3340 can advantageously be formed of an easy-to-clean material, such as fabric. To facilitate patient cleaning, the flexible sleeve 3340 can be removed from the rest of the patient interface 3000. For example, the sleeve may include a mechanism for securing the sleeve to the tube 3350, which can be detached to remove the sleeve. For example, the flexible sleeve 3340 may be wrapped around the tube 3350 and attached to itself by a clip, ejector, hook and loop material, or other suitable fastener.

[0510] In some forms of this technology, the elastic sleeve 3340 is formed of a material or fabric that helps wick moisture away from the patient's face. This helps maintain comfort if the patient sweats while wearing the patient interface.

[0511] In other forms of this technology, the resilient sleeve can cover tubes or other portions with positioning and stabilizing mechanisms, such as those described above. The sleeve may be advantageous in covering mechanisms or components that appear complex or medically potentially hinder the wearing of patient interfaces.

[0512] In other forms of this technology, the retractable headband tube may include a biasing mechanism, such as a spring, for retracting the retractable headband tube section.

[0513] A manually adjustable adjustment mechanism for the bias force (e.g.) can also be provided. Figure 7C The advantage of the adjustment mechanism 3360 shown is its ability to support relatively heavy and relatively light sealing structures in a modular design, where different types of sealing structures are interchangeable. For example, if Figure 7C The shown mouth and nose pad assembly replaces Figure 7C In the illustrated embodiment, the pad assembly 3150 allows the patient to manually adjust the length of the headband tube 3350 to a shorter configuration to counteract the weight of the nasal pad and prevent the pad from drooping or being pushed downwards due to the movement of the patient's jaw.

[0514] 8.3.4 Vent

[0515] In one embodiment, the patient interface 3000 includes a vent that is configured and arranged to allow continuous flow or flushing of exhaled gases (e.g., carbon dioxide (CO2)) from the interior of the inflation chamber to the surrounding environment, thereby reducing the risk of the patient rebreathing such gases. In other words, the vent allows CO2 exhaled by the patient to flow to the outside of the patient interface. The size and shape of the vent are configured to maintain therapeutic pressure within the inflation chamber.

[0516] One form of the vent according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0517] The vent may be located in the inflation chamber 3200. Alternatively, the vent may be located in another part of the patient interface, such as in a tube 3350 that fluidly connects the connection port 3600 to the inflation chamber 3200.

[0518] 8.3.5 Decoupling Structure

[0519] In one embodiment, the patient interface 3000 includes at least one decoupling structure, such as a swivel or ball joint and socket. This decoupling structure may be positioned at or near the connection port 3600 to allow movement of the conduit of the air circuit 4170 relative to the patient interface 3000 and to reduce the risk of destabilizing the seal of the sealing formation 3100 against the patient's face.

[0520] 8.3.6 Connection Port

[0521] Connection port 3600 allows connection to air circuit 4170. For example, in the embodiment of the technology shown in Figures 3 and 5-17, the connection port is positioned on top of the patient's head when the patient interface 3000 is worn. In other embodiments, the connection port is configured to be positioned in use near the top, side, or back of the patient's head. Patient interfaces where the connection port is not positioned in front of the patient's face may be advantageous, as some patients find catheters connected to front-face patient interfaces unsightly and protruding. For example, catheters connected to front-face patient interfaces may easily become tangled in bedding, especially if the catheter extends downwards from the patient interface during use.

[0522] 8.3.7 Forehead Support

[0523] In one embodiment, the patient interface 3000 includes a forehead support for contacting the patient's forehead area to support the patient interface on the patient's head during use and help maintain a sealed contact between the sealing structure and the patient's face.

[0524] 8.3.8 Anti-asphyxiation valve

[0525] In some forms of this technology, the patient interface 3000 is constructed and arranged to allow the patient to breathe ambient air in the event of a power failure. In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0526] Port 8.3.9

[0527] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0528] 8.4RPT device

[0529] According to one aspect of the present technology, an RPT device 4000 (such as...) Figure 4A (As shown) includes mechanical and pneumatic components 4100, electronic components 4200, and is configured to execute one or more algorithms 4300. The RPT device may have an outer housing 4010, which is constructed in two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer 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.

[0530] The pneumatic path of the RPT device 4000 may include one or more air path objects, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0531] One or more air path components may be housed within a detachable, separate structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be housed within an outer housing 4010. In one embodiment, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.

[0532] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative embodiment, the RPT device 4000 may include more than one PCBA 4202.

[0533] 8.4.1 Mechanical and pneumatic components of the RPT device

[0534] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be configured as separate units.

[0535] 8.4.1.1 Air Filter

[0536] One form of RPT device according to the present technology may include one air filter 4110, or multiple air filters 4110.

[0537] In one configuration, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0538] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0539] 8.4.1.2 Pressure Generator

[0540] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply 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 may deliver an air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cm H2O to about 20 cm H2O, or in other forms up to about 30 cm H2O. The blower may be as described in any of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,14; U.S. Patent No. 8,636,479; and PCT Patent Application No. WO 2013 / 020167.

[0541] The pressure generator 4140 is controlled by the treatment device controller 4240.

[0542] In other words, the pressure generator 4140 can be a piston-driven pump, a pressure regulator (e.g., a compressed air reservoir) connected to a high-pressure source, or a bellows.

[0543] 8.4.1.3 Air Circuit

[0544] According to one aspect of the present technology, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow to travel between two components, such as the RPT device 4000 and the patient interface 3000.

[0545] Specifically, the air circuit 4170 can be connected to the outlet and patient interface fluid 3000 of the RPT device 4000. The air circuit may be referred to as an air delivery tube or conduit. In some cases, it may have separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0546] In some forms, the air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around an axis of the air circuit 4170. The heating element may be communicated with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0547] 8.5 Humidifier

[0548] 8.5.1 Humidifier Overview

[0549] In one form of this technology, a humidifier 5000 is provided (e.g., as...). Figure 5A As shown), it changes the absolute humidity of the air or gas used to deliver to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0550] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0551] 8.6 Glossary

[0552] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0553] 8.6.1 General Rules

[0554] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0555] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0556] For example, the ambient humidity relative to the humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0557] In another example, environmental stress can be stress that is directly around the body or outside the body.

[0558] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0559] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0560] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of such an indication.

[0561] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, that is, a quantity that only has a magnitude. In other cases, the reference to flow rate will be a vector quantity, that is, a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow'.

[0562] In the example of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Total flow rate Qt is the flow rate of air leaving the RPT device. Tidal flow rate Qv is the flow rate of air leaving the ventilator to allow flushing of exhaled air. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0563] Leakage: The word "leakage" is considered to refer to undesirable airflow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in the swivel bend leading to the surrounding environment.

[0564] Noise, conducted (acoustic): In this document, conducted noise refers to noise delivered to the patient through pneumatic pathways, such as air circuits and patient interfaces, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0565] Noise, radiated (acoustic): Radiated noise in this document refers to noise transmitted to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0566] Noise, ventilation (acoustic): Ventilation noise in this document refers to noise generated by the flow of air through any ventilation opening, such as a ventilation opening for a patient interface.

[0567] Patient: A person, regardless of whether they have a respiratory illness.

[0568] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 gf / cm³ 2 It is approximately 0.98 hectopascals. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0569] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained at the current moment through the mask pressure Pm.

[0570] Respiratory pressure therapy (RPT): Applying air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

[0571] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0572] 8.6.1.1 Materials

[0573] Silicone or silicone elastomer: Synthetic rubber. In this specification, reference to silicone refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0574] Polycarbonate: a typical transparent thermoplastic polymer of bisphenol A carbonate.

[0575] 8.6.1.2 Mechanical Properties

[0576] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0577] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.

[0578] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or an indentation hardness scale measured on a standardized sample size).

[0579] "Soft" materials can include silicone or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0580] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0581] Stiffness (or rigidity) of a structure or component: the energy of a structure or component to resist deformation in response to an applied load. force. Loads can be forces or torques, such as compression, tension, bending, or torsion. Structures or components can provide different resistances in different directions.

[0582] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0583] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway at a pressure of approximately 20 to 30 cmH2O.

[0584] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0585] 8.6.2 Respiratory and Circulatory Systems

[0586] Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is open. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0587] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0588] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0589] Effort (breathing): The work that spontaneous breathers do by trying to breathe.

[0590] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0591] Flow restriction: Flow restriction is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.

[0592] Types of flow-limited inhalation waveforms: (i) Flattened: It has an upward movement, followed by a relatively flat section, and then a downward movement.

[0593] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat section between the two peaks.

[0594] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat part.

[0595] (iv) Inverted chair shape: with a relatively flat section followed by a single local peak at the trailing edge.

[0596] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow rate, rather than a cessation of flow. In one form, insufficient breathing can be considered to occur when the flow rate drops below a threshold rate for a sustained period of time. Central insufficient breathing is considered to occur when insufficient breathing is detected due to a reduction in respiratory effort. In one form for adults, any of the following can be considered insufficient breathing: (i) The patient's breathing decreases by 30% for at least 10 seconds plus a related 4% desaturation; or (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% desaturation or arousal.

[0597] Hyperventilation: Increased airflow to above normal levels.

[0598] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0599] Openness (airway): The degree to which the airway is open or the degree to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, with a value (1) for open and a value of zero (0) for closed (obstructed).

[0600] Positive end-expiratory pressure (PEEP): The pressure above atmospheric pressure present in the lungs at the end of expiration.

[0601] Peak flow (Q peak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0602] Respiratory flow, patient airflow, and respiratory airflow (Qr): These synonymous terms can be understood as the RPT device's estimate of the respiratory airflow, as opposed to "true respiratory flow" or "real respiratory airflow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0603] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort.

[0604] (Inspiratory) Time (Ti): The duration of the inspiratory portion of the respirato...

Claims

1. A positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on a patient's head, said seal-forming structure being configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway to seal and deliver an airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, said positioning and stabilizing structure comprising: A front ring that extends across the patient’s cheek area during use and is positioned to contact the patient’s head in the area above the ear base point on the patient’s head during use. The front ring includes: The lower portions of two gas delivery tubes are fluidly connected to the sealing structure, each lower portion of which extends across one of the patient's cheek areas during use, the two gas delivery tubes being located on different sides of the patient's head. A connecting rod connects the two gas delivery pipes between their lower and upper parts; as well as A rear strap, configured to wrap around the back of the patient's head during use; and A decoupling mechanism is provided to decouple the position adjustment of the upper part of the gas delivery tube from the movement of the sealing structure away from the patient's face during use, so that the upper part of the gas delivery tube can be positionally adjusted on the patient's head.

2. The positioning stabilization structure as described in claim 1, wherein the decoupling mechanism comprises: The upper part is flexible and includes multiple pleats and / or accordion-like features on the upper part to allow for positional adjustment of the upper part of the two gas delivery tubes on the patient's head during use. as well as At least one rotary joint includes a connection port configured to connect to an air circuit, the at least one rotary joint being configured to allow relative rotation between the upper portion and the air circuit.

3. The positioning and stabilizing structure as claimed in claim 2, wherein, in use, the upper portion is positioned above the ear base point on the patient's head.

4. The positioning and stabilizing structure according to any one of claims 2 to 3, wherein the at least one rotary joint comprises a first rotary joint and a second rotary joint configured to rotate relative to the first rotary joint.

5. The positioning and stabilizing structure as claimed in claim 4, wherein the first rotary joint rotates about a first axis, and the second rotary joint rotates about a second axis perpendicular to the first axis.

6. The positioning and stabilizing structure as described in any one of claims 4 to 5, wherein the first rotary joint is rotatable independently of the second rotary joint.

7. The positioning and stabilizing structure as claimed in any one of claims 4 to 6, wherein the decoupling mechanism further includes a pipe connector connected to the two gas delivery pipes, the two gas delivery pipes branching off from the pipe connector.

8. The positioning and stabilizing structure as claimed in claim 7, wherein the first rotary joint is directly connected to the tube connector.

9. The positioning and stabilizing structure as claimed in any one of claims 7 to 8, wherein the tube connector is non-rotatable relative to the two gas delivery tubes, and wherein the first rotary joint is rotatable relative to the tube connector.

10. The positioning and stabilizing structure of claim 3, wherein the at least one rotary joint rotates about a rotation axis oriented substantially parallel to the axis along the upper portion.

11. The positioning and stabilizing structure as described in any one of claims 1 to 3, wherein the decoupling structure is Y-shaped or V-shaped.

12. The positioning and stabilizing structure according to any one of claims 1 to 11, further comprising an adjustment mechanism for adjusting the anterior ring and the posterior strap relative to the patient's head, the adjustment mechanism being configured to operate in a single operation to adjust both the anterior ring and the posterior strap, thereby enabling the positioning and stabilizing structure to accommodate heads of different sizes.

13. The positioning and stabilizing structure of claim 12, wherein the adjustment mechanism is operable to adjust the length of the connecting member between the lower portions, wherein the adjustment of the length simultaneously adjusts both the front hoop and the rear strap.

14. The positioning and stabilizing structure as described in any of the preceding claims, the positioning and stabilizing structure further comprising a chin strap that extends across the cheek area of ​​the patient in use and is arranged to contact the area below the subauricular base of the patient's head in use.

15. A patient interface comprising: An inflatable chamber, capable of being pressurized to a treatment pressure at least 4 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port, the inlet port being sized and structured to receive an airflow for patient respiration at the treatment pressure. A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, such that an airflow under the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use. A connection port that is fluidly connected in use to an air circuit connected to the airflow, the connection port being positioned in use near the top, side, or back of the patient's head; as well as Positioning and stabilizing structures, including: A front ring that extends across the patient’s cheek area during use and is positioned to contact the patient’s head in the area above the ear base point on the patient’s head during use. A rear strap, configured to wrap around the back of the patient's head during use; An adjustment mechanism for adjusting the front hoop and the rear strap relative to the patient's head, the adjustment mechanism being configured to operate in a single operation to adjust both the front hoop and the rear strap, thereby enabling the positioning and stabilization structure to adapt to different head sizes; The adjustment mechanism includes one or more cables connected to both the hoop and the rear strap, and a controller for translating the one or more cables to cause adjustment of the hoop and the rear strap.

16. A patient interface comprising: An inflatable chamber, capable of being pressurized to a treatment pressure at least 4 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port, the inlet port being sized and structured to receive an airflow for patient respiration at the treatment pressure. A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, such that an airflow under the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use. A front ring that extends across the patient’s cheek area during use and is positioned to contact the patient’s head in the area above the ear base point on the patient’s head during use. The front ring includes: The lower portions of two gas delivery tubes are fluidly connected to the sealing structure, each lower portion of which extends across one of the patient's cheek areas during use, the two gas delivery tubes being located on different sides of the patient's head. A connecting rod connects the two gas delivery pipes between their lower and upper parts; as well as A rear strap, configured to wrap around the back of the patient's head during use; and A decoupling mechanism is provided to decouple the position adjustment of the upper part of the gas delivery tube from the movement of the sealing structure away from the patient's face during use, so that the upper part of the gas delivery tube can be positionally adjusted on the patient's head.

17. A system for treating respiratory disorders, the system comprising: The patient interface as described in claim 15 or 16; Air circuit; as well as An air source that is at positive pressure relative to ambient air pressure.

18. A positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on a patient's head, said seal-forming structure being configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway to seal and deliver an airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, said positioning and stabilizing structure comprising: At least one ring, which extends across the patient's cheek region during use and is arranged to contact the patient's head in a region above a base point on the patient's ear, wherein the at least one ring comprises: At least one gas delivery tube for delivering the airflow to the inlet of the patient's airway via the sealing structure, the at least one gas delivery tube being configured and arranged to cover at least one region of the patient's head above an auricular base point in use; and An adjustment mechanism for adjusting the at least one ring clamp to adapt the positioning and stabilizing structure to heads of different sizes, the adjustment mechanism including one or more tube insertion members configured to be selectively fluidly connected to the at least one gas delivery pipe to change the length of the ring clamp; The one or more tube insertion members form a plurality of tube insertion members, each of the plurality of tube insertion members having a different size to facilitate changing the length of the annular clamp; and One or more of the plurality of tube insertion members are configured to allow for optimized comfort / force vector by allowing adjustment of the position of the coupling.

19. The positioning and stabilization structure of claim 18, further comprising a posterior strap configured to pass around the back of the patient's head in use, wherein at least one of the one or more tube insertion members includes a coupling for connecting the posterior strap to the at least one gas delivery tube.

20. The positioning and stabilizing structure of any one of claims 18 to 19, wherein the plurality of tube insertion members includes at least one tube insertion member having a coupling configured to receive a headband strap.

21. The positioning and stabilizing structure of claim 20, wherein the coupling is an eyelet.

22. The positioning and stabilizing structure according to any one of claims 20 to 21, wherein the coupling is equidistantly spaced between the upper and lower ends of the at least one tube insertion member.

23. The positioning and stabilizing structure as claimed in any one of claims 20 to 21, wherein the coupling is positioned closer to the upper or lower end of the at least one tube insertion member.

24. The positioning and stabilizing structure according to any one of claims 22 to 23, wherein the at least one tube insertion member comprises a small tube insertion member and a large tube insertion member, the length of the large tube insertion member being greater than the length of the small tube insertion member.

25. The positioning and stabilizing structure of any one of claims 20 to 24, wherein the plurality of tube insertion members further comprises at least one tube insertion member without the connector, the at least one tube insertion member without the connector being configured to selectively connect to at least one tube insertion member having the connector.

26. The positioning and stabilizing structure of claim 25, wherein each insert tube member without the at least one tube insert member has a different size to facilitate changing the length of the tube.

27. The positioning and stabilizing structure as claimed in any one of claims 25 and 26, wherein the at least one tube insertion member without the connector is selectively coupled to the upper or lower end of at least one tube insertion member having the connector.

28. The positioning and stabilizing structure according to any one of claims 18 to 19, wherein at least one of the plurality of insert members comprises a generally U-shaped tube insert member.

29. The positioning and stabilizing structure as claimed in any one of claims 18, 19, or 28, wherein at least one of the plurality of tube insertion members comprises: A first opening is configured to be fluidly connected to one end of the first gas delivery pipe of the at least one gas delivery pipe; A second opening is configured to be fluidly connected to one end of the second gas delivery pipe of the at least one gas delivery pipe; as well as A third opening is configured to be fluidly connected to one end of an air delivery tube, which is configured to deliver an airflow under the treatment pressure to the at least one gas delivery tube.

30. The positioning and stabilizing structure according to any one of claims 28 to 29, wherein, in use, the at least one tube insert includes a lower end and a protrusion extending below the lower end.

31. The positioning and stabilizing structure of claim 30, wherein the end of the protrusion includes a coupling.

32. The positioning and stabilizing structure as claimed in claim 31, wherein the coupling is an eyelet.

33. The positioning and stabilizing structure according to any one of claims 31 to 32, wherein the coupling is detachably connected to the at least one gas delivery pipe.

34. The positioning and stabilizing structure as claimed in claim 33, wherein the coupling is detachably connected to the at least one gas delivery pipe using a hook-and-loop material.

35. The positioning and stabilizing structure of any one of claims 30 to 34, which is dependent on claim 29, wherein the first opening is provided at the lower end, and in use, the protrusion extends further lower than the first opening.

36. A positioning and stabilizing structure for holding a sealing-forming structure in a therapeutically effective position on a patient's head, said sealing-forming structure being configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway to seal and deliver an airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, said positioning and stabilizing structure comprising: At least one ring, which extends across the patient's cheek region during use and is arranged to contact the patient's head in a region above a base point on the patient's ear, wherein the at least one ring comprises: At least one gas delivery tube for delivering the airflow to the inlet of the patient's airway via the sealing structure, the at least one gas delivery tube being configured and arranged to cover at least one region of the patient's head above an auricular base point in use; and An adjustment mechanism for adjusting the at least one ring clamp to adapt the positioning and stabilizing structure to different sized heads, the adjustment mechanism including a stretchable section of the at least one gas delivery pipe and one or more insert members configured to selectively connect to the at least one gas delivery pipe to change the length of the stretchable section of the at least one gas delivery pipe; The one or more insert members form a plurality of insert members, each of the plurality of insert members having a different size to facilitate changing the length of the tube; and One or more of the plurality of insert members are configured to allow for optimized comfort / force vector by allowing adjustment of the position of the coupling.

37. The positioning and stabilizing structure of claim 36, wherein the one or more insert members are made of a rigid material.

38. The positioning and stabilizing structure of any one of claims 36 to 37, further comprising at least one retainer disposed on one side of the at least one gas delivery pipe for retaining the one or more insert members relative to the at least one gas delivery pipe to change the length of the stretchable section.

39. The positioning and stabilizing structure according to any one of claims 36 to 37, wherein the at least one retainer is disposed on the stretchable section of the at least one gas delivery pipe.

40. The positioning and stabilizing structure of claim 39, wherein the at least one retainer is disposed on the outer surface of the stretchable section.

41. The positioning and stabilizing structure of claim 39, wherein the at least one retainer is disposed on the inner surface of the stretchable section.

42. The positioning and stabilizing structure of claim 41, wherein the at least one gas delivery tube includes a central port, and the one or more insertion members are configured to be inserted through the central port.

43. The positioning and stabilizing structure according to any one of claims 38 to 41, wherein the retainer is in the form of a bag connected to the at least one gas delivery pipe or formed in the at least one gas delivery pipe.

44. The positioning and stabilizing structure according to any one of claims 38 to 41, wherein the retainer is in the form of one or more fasteners fixed to the at least one gas delivery pipe.

45. The positioning and stabilizing structure of claim 44, wherein the one or more fasteners comprise a hook-and-loop material.

46. ​​The positioning and stabilizing structure as claimed in any one of claims 36 to 45, further comprising a first substantially non-stretchable section connected to a first end of the stretchable section, and a second substantially non-stretchable section connected to a second end of the stretchable section.

47. The positioning and stabilizing structure of claim 46, wherein the first substantially non-stretchable section and the second substantially non-stretchable section are made of silicone and / or fabric.

48. The positioning and stabilizing structure as claimed in any one of claims 46 to 47, wherein the first substantially non-stretchable section is directly connected to a first end of the stretchable section and the sealing structure, and wherein the second substantially non-stretchable section is directly connected to a second end of the stretchable section and the sealing structure.

49. The positioning and stabilizing structure of any one of claims 46 to 47, which is dependent on any one of claims 38 to 41, wherein the at least one retainer comprises a left retainer and a right retainer, the left retainer being positioned near a first end of the stretchable section and the right retainer being positioned near a second end of the stretchable section.

50. The positioning and stabilizing structure of claim 49, wherein when the stretchable section is in the relaxed position, the distance between the left retainer and the right retainer is less than the length of the one or more insert members.

51. The positioning and stabilizing structure of claim 49, wherein in the extended position of the stretchable section, the distance between the left retainer and the right retainer is approximately equal to the length of the one or more insert members.

52. The positioning and stabilizing structure of claim 36, wherein the stretchable section is made of silicone and / or fabric.

53. A positioning and stabilizing structure for holding a sealing-forming structure in a therapeutically effective position on a patient's head, said sealing-forming structure being configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway to seal and deliver an airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, said positioning and stabilizing structure comprising: At least one ring, which extends across the patient's cheek region during use and is arranged to contact the patient's head in a region above a base point on the patient's ear, wherein the at least one ring comprises: At least one gas delivery tube for delivering the airflow to the inlet of the patient's airway via the sealing structure, the at least one gas delivery tube being configured and arranged to cover at least one region of the patient's head above an ear-based point on the patient's head during use. A rear strap, configured to wrap around the back of the patient's head during use; and An adjustment mechanism for adjusting the at least one ring clamp to adapt the positioning and stabilizing structure to different head sizes, the adjustment mechanism including one or more insert members configured to selectively connect to the at least one gas delivery pipe to change the length of the at least one gas delivery pipe, at least one of the one or more insert members including a coupling to connect the rear strap to the at least one gas delivery pipe.

54. A positioning and stabilizing structure for holding a sealing-forming structure in a therapeutically effective position on a patient's head, said sealing-forming structure being configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway to seal and deliver an airflow at a therapeutic pressure of at least 4 cmH2O relative to ambient air pressure throughout the patient's respiratory cycle during use, said positioning and stabilizing structure comprising: At least one ring, which extends across the patient's cheek region during use and is arranged to contact the patient's head in a region above a base point on the patient's ear, wherein the at least one ring comprises: At least one gas delivery tube for delivering the airflow to the inlet of the patient's airway via the sealing structure, the at least one gas delivery tube being configured and arranged to cover at least one region of the patient's head above an auricular base point in use; and An adjustment mechanism for adjusting the at least one ring clamp to adapt the positioning and stabilizing structure to heads of different sizes, the adjustment mechanism comprising one or more inflatable parts.

55. The positioning and stabilizing structure of claim 54, wherein at least one of the one or more inflatable portions forms the patient contact portion of the ring and adjusts the position of the at least one gas delivery tube on the patient's head.

56. The positioning and stabilizing structure as claimed in any one of claims 54 to 55, wherein one or more inflatable portions adjust the effective length of the ring clamp.

57. The positioning and stabilizing structure of claim 56, wherein the at least one inflatable portion is movable between a deflated state and an inflated state, and wherein the deflated state forms an effective length greater than the inflated state.

58. The positioning and stabilizing structure according to any one of claims 54 to 57, further comprising a retainer disposed on one side of the at least one gas delivery pipe for retaining the one or more inflatable portions relative to the at least one gas delivery pipe.

59. The positioning and stabilizing structure of claim 58, wherein the retainer is in the form of one or more fasteners fixed to the at least one gas delivery pipe.

60. The positioning and stabilizing structure of claim 59, wherein the retainer is in the form of a ring surrounding the at least one gas delivery pipe.

61. The positioning and stabilizing structure as claimed in any one of claims 58 to 59, wherein the retainer is disposed on the underside of the at least one gas delivery pipe, and complementary retainers are disposed on the upper surface of the one or more inflatable portions.

62. The positioning and stabilizing structure as described in claims 54 to 61, wherein the one or more inflatable portions are fixed to the at least one gas delivery pipe.

63. The positioning and stabilization structure as claimed in any one of claims 54 to 62, further comprising a controller and a sensor in communication with the controller, the controller being configured to adjust the amount of air within the one or more inflatable portions.

64. The positioning and stabilization structure as described in claim 63, wherein the sensor is a pressure sensor, a light sensor, and / or a position sensor.

65. The positioning and stabilizing structure of any one of claims 63 to 64, further comprising a valve configured to selectively provide airflow to the one or more inflatable portions.

66. The positioning and stabilizing structure of claim 65, wherein the controller is configured to control the position of the valve.

67. The positioning and stabilizing structure as claimed in claim 65, wherein the position of the valve is manually controllable.

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